Efficacy of Rosuvastatin Among Men and Women With Moderate Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein
|
|
- Avis Burke
- 7 years ago
- Views:
Transcription
1 Journal of the American College of Cardiology Vol. 55, No. 12, by the American College of Cardiology Foundation ISSN /10/$36.00 Published by Elsevier Inc. doi: /j.jacc EXPEDITED PUBLICATION Efficacy of Among Men and Women With Moderate Chronic Kidney Disease and Elevated High-Sensitivity C-Reactive Protein A Secondary Analysis From the JUPITER (Justification for the Use of Statins in Prevention an Intervention Trial Evaluating ) Trial Paul M Ridker, MD, MPH,* Jean MacFadyen, BS,* Michael Cressman, DO, Robert J. Glynn, SCD* Boston, Massachusetts; and Wilmington, Delaware Objectives Background Methods Results Conclusions We evaluated the efficacy of statin therapy in primary prevention among individuals with moderate chronic kidney disease (CKD). Whether patents with moderate CKD (estimated glomerular filtration rate [egfr] 60 ml/min/1.73 m 2 ) benefit from statin therapy is uncertain, particularly among those without hyperlipidemia or known cardiovascular disease. Within the JUPITER (Justification for the Use of statins in Prevention an Intervention Trial Evaluating ) primary prevention trial of rosuvastatin 20 mg compared with placebo among men and women free of cardiovascular disease who had low-density lipoprotein cholesterol (LDL-C) 130 mg/dl and high-sensitivity C-reactive protein (hscrp) 2 mg/l, we performed a secondary analysis comparing cardiovascular and mortality outcomes among those with moderate CKD at study entry (n 3,267) with those with baseline egfr 60 ml/min/1.73 m 2 (n 14,528). Median follow-up was 1.9 years (maximum 5 years). Compared with those with egfr 60 ml/min/1.73 m 2, JUPITER participants with moderate CKD had higher vascular event rates (hazard ratio [HR]: 1.54, 95% confidence interval [CI]: 1.23 to 1.92, p ). Among those with moderate CKD, rosuvastatin was associated with a 45% reduction in risk of myocardial infarction, stroke, hospital stay for unstable angina, arterial revascularization, or confirmed cardiovascular death (HR: 0.55, 95% CI: 0.38 to 0.82, p 0.002) and a 44% reduction in all-cause mortality (HR: 0.56, 95% CI: 0.37 to 0.85, p 0.005). Median LDL-C and hscrp reductions as well as side effect profiles associated with rosuvastatin were similar among those with and without CKD. Median egfr at 12 months was marginally improved among those allocated to rosuvastatin as compared with placebo. reduces first cardiovascular events and all-cause mortality among men and women with LDL-C 130 mg/dl, elevated hscrp, and concomitant evidence of moderate CKD. (JUPITER Crestor 20 mg Versus in Prevention of Cardiovascular [CV] Events; NCT ) (J Am Coll Cardiol 2010;55: ) 2010 by the American College of Cardiology Foundation Compared with individuals with more preserved renal function, those with moderate chronic kidney disease (CKD) (estimated glomerular filtration rate [egfr] 60 ml/min/1.73 m 2 ) are at increased risk of myocardial infarction, stroke, and vascular death (1 3). However, 2 recent trials have found statin therapy to be ineffective among high-risk patients with severe renal failure undergoing maintenance hemodialysis (4,5). Given these data, questions have been raised in the clinical From the *Center for Cardiovascular Disease Prevention and the Division of Cardiovascular Medicine, Brigham and Women s Hospital, Harvard Medical School, Boston, Massachusetts; and AstraZeneca, Wilmington, Delaware. The JUPITER trial was supported by Astra-Zeneca. The JUPITER trial was investigator-initiated; the study sponsor collected trial data and monitored sites but had no access to unblinded data until after drafting of the trial primary report, published in November During the period of this project, Dr. Ridker reports having received investigator-initiated research grant support from the National Heart Lung and Blood Institute, the National Cancer Institute, the Donald W. Reynolds Foundation, the Leducq Foundation, AstraZeneca, Novartis, Merck, Abbott, Roche, and Sanofi-Aventis; and consulting fees and/or lecture fees from Astra- Zeneca, Novartis, Merck, Merck-Schering Plough, Sanofi-Aventis, ISIS, Dade- Behring, and Vascular Biogenics; and he is listed as a co-inventor on patents held by the Brigham and Women s Hospital that relate to the use of inflammatory biomarkers in cardiovascular disease. These patents have been licensed to several entities, including AstraZeneca. Dr. Cressman is an employee of AstraZeneca. Dr. Glynn reports receiving research grant support from the National Heart, Lung, and Blood Institute, AstraZeneca, and Bristol-Myers Squibb. Manuscript received December 9, 2009; revised manuscript received January 20, 2010, accepted January 25, 2010.
2 JACC Vol. 55, No. 12, 2010 March 23, 2010: Ridker et al., hscrp, and Moderate CKD 1267 community about the relative efficacy of statin therapy among those with moderate CKD. This is particularly relevant in primary prevention where available data are scarce; in the WOSCOPS (West of Scotland Coronary Prevention Study) primary prevention trial, pravastatin had no significant benefit on clinical cardiovascular events among those with CKD, despite evidence in the same trial of efficacy among those with egfr 60 ml/min/1.73 m 2 and evidence of efficacy based on a meta-analysis of secondary prevention trials conducted among patients with and without CKD (6). The recently completed JUPITER (Justification for the Use of statins in Prevention an Intervention Trial Evaluating ) trial of 17,802 men and women with low-density lipoprotein cholesterol (LDL-C) 130 mg/dl but elevated high-sensitivity C-reactive protein (hscrp) ( 2 mg/l) demonstrated a 44% reduction in major vascular events and a 20% reduction in all-cause mortality for those allocated to rosuvastatin 20 mg as compared with placebo during a median follow-up of 1.9 years (maximum 5 years) (7). Because the JUPITER trial included 3,267 primary prevention patients with egfr 60 ml/min/1.73 m 2 at trial entry, we had the opportunity to perform a secondary analysis of these data according to the presence or absence of moderate CKD. Methods The study population derived from the JUPITER trial, a randomized, double-blind, placebo-controlled trial designed to investigate whether rosuvastatin 20 mg daily compared with placebo decreases the rate of first-ever cardiovascular events among apparently healthy men over age 50 years and women over age 60 years with LDL-C 130 mg/dl at increased vascular risk due to hscrp 2 mg/l (7,8). Full details of the trial protocol, procedures, and methods of confirming clinical end points and ascertaining adverse events have been previously presented. Trial exclusion criteria included treatment within 6 weeks of screening with any lipid lowering therapies, current use of hormone replacement therapy, evidence of hepatic dysfunction, creatinine 2.0 mg/dl, diabetes, uncontrolled hypertension, prior malignancy, uncontrolled hypothyroidism, or a recent history of alcohol, drug abuse, or other medical condition that might compromise safety. Because a core scientific hypothesis of the JUPITER trial related to underlying low-grade inflammation, individuals with conditions such as severe arthritis, lupus, or inflammatory bowel disease were excluded, as were individuals taking immunosuppressant agents. As previously reported, allocation to rosuvastatin was associated with a 44% reduction in the trial primary end point (nonfatal myocardial infarction, nonfatal stroke, hospital stay for unstable angina, arterial revascularization, or cardiovascular death) (7) as well as a 43% reduction in the pre-specified secondary end point of incident venous thromboembolism (8). Study participants had baseline creatinine levels measured, which were used to calculate egfr with the Modified Diet and Renal Disease method. Baseline clinical characteristics of the study population were compared between those with moderate CKD at baseline and those with baseline egfr 60 ml/min/1.73 m 2 ;in these analyses, significance was evaluated with t tests for continuous variables and the chisquare test for proportions. In stratified analyses according to egfr at study entry, Cox proportional hazards models were Abbreviations and Acronyms CKD chronic kidney disease egfr estimated glomerular filtration rate hscrp high-sensitivity C-reactive protein LDL-C low-density lipoprotein cholesterol NNT number needed to treat used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs) for the comparison of event rates between those allocated to rosuvastatin or placebo. All analyses were performed on an intention-to-treat basis. Analyses were performed for the JUPITER pre-specified primary end point (nonfatal myocardial infarction, nonfatal stroke, hospital stay for unstable angina, arterial revascularization, or confirmed cardiovascular death) and for combined end points that additionally included incident venous thromboembolism and all-cause mortality. Per protocol, number needed to treat [NNT] values were calculated as the reciprocal of the absolute difference between risks of the outcome of interest based on Kaplan-Meier estimates. Estimated 95% CIs for the NNT were based on inversion of the CIs for risk differences with standard errors of risks estimated by Greenwood s formula. Consistent with prior JUPITER publications, 5-year NNT values were computed on the basis of 4-year absolute rates projected over an average 5-year period according to the methods of Altman and Anderson (9). Results Baseline characteristics. Of participants in the JUPITER trial, 3,267 (18%) had baseline egfr 60 ml/min/1.73 m 2 ), whereas 14,528 (82%) had higher levels. Seven participants did not have egfr values available. Among those with reduced egfr, 3,253 had stage 3 impairment (egfr between 30 and 59 ml/min/1.73 m 2 ) and 14 had stage 4 impairment (egfr between 15 and 29 ml/min/1.73 m 2 ). Study participants with moderate CKD were older, more likely to be female, more likely to have a family history of premature atherothrombosis, and less likely to smoke (Table 1). Median baseline levels of LDL-C, high-density lipoprotein cholesterol, triglycerides, apolipoprotein A, apolipoprotein B, and hscrp were somewhat higher among those with moderate CKD, whereas blood pressure, glucose, and hemoglobin A1c were similar. Within each egfr category, there was no imbalance between study characteristics among those allocated to rosuvastatin or placebo.
3 1268 Ridker et al. JACC Vol. 55, No. 12, 2010, hscrp, and Moderate CKD March 23, 2010: Baseline Table 1Clinical Baseline Characteristics Clinical Characteristics of Participants of Participants in the JUPITER in the Trial JUPITER According Trial toaccording Entry egfr to Entry egfr egfr <60 ml/min/1.73 m 2 (n 3,267) egfr >60 ml/min/1.73 m 2 (n 14,528) p Value Age, yrs 70.0 ( ) 65.0 ( ) Female 2129 (65.2) 4667 (32.1) Race/ethnicity Caucasian 2,425 (74.2)/ 10,253 (70.6) Black 109 (3.3) 2,115 (14.6) Hispanic 630 (19.3) 1,629 (11.2) Other/unknown 103 (3.2) 531 (3.7) Body mass index, kg/ m ( ) 28.2 ( ) Blood pressure, mm Hg Systolic 133 ( ) 134 ( ) Diastolic 80 (72 85) 80 (75 88) Current smoking 264 (8.1) 2556 (17.6) Family history of premature CHD* 464 (14.3) 1,581 (10.9) hscrp, mg/l 4.5 ( ) 4.2 ( ) Total cholesterol, mg/dl 189 ( ) 184 ( ) LDL-C, mg/dl 109 ( ) 108 (94 119) HDL-C, mg/dl 49 (40 60) 48 (40 59) 0.03 Triglycerides, mg/dl 130 (96 183) 115 (83 166) Apolipoprotein A, mg/dl 164 ( ) 162 ( ) Apolipoprotein B, mg/dl 111 (99 124) 108 (95 122) Glucose, mg/dl 95 (89 103) 94 (87 101) HbA1c, % 5.7 ( ) 5.7 ( ) egfr, ml/min/1.73 m 2 56 (51 58) 77 (69 89) All values are median (IQR) or n (%). For high-sensitivity C-reactive protein (hscrp), values are based on the average of the screening and randomization visits. All blood values were done fasting. *Congestive heart disease (CHD) in a male first-degree relative before age 55 years or in a female first-degree relative before age 65 years. egfr estimated glomerular filtration rate; HbA1c hemoglobin A1c; HDL-C high-density lipoprotein cholesterol; JUPITER Justification for the Use of statins in Prevention an Intervention Trial Evaluating ; LDL-C low-density lipoprotein cholesterol. Event rates associated with moderate CKD. Irrespective of statin or placebo allocation, at trial conclusion 111 participants in the moderate CKD group suffered a primary trial end point (incidence rate 1.51 per 100 person-years) as compared with 282 participants in the group with more preserved egfr (incidence rate 0.95 per 100 person-years). Thus, in crude analysis, those with lower egfr at study entry were at significantly higher risk of developing a study primary end point during follow-up (HR: 1.54, 95% CI: 1.23 to 1.92, p ). Those with lower egfr were at increased risk of developing myocardial infarction, stroke, or cardiovascular death (HR: 1.44, 95% CI: 1.08 to 1.92, p 0.02) as well as Study TableOutcomes 2 StudyinOutcomes the JUPITER in the Trial JUPITER Among Trial ThoseAmong Allocated Those toallocated to or, According, toaccording Baseline egfr to Baseline egfr egfr <60 ml/min/1.73 m 2 egfr >60 ml/min/1.73 m 2 n Rate* n Rate* HR (95% CI) p Value n Rate* n Rate* HR (95% CI) p Value Primary end point ( ) ( ) Myocardial infarction ( ) ( ) Stroke ( ) ( ) Arterial revascularization ( ) ( ) Myocardial infarction, stroke, ( ) ( ) or confirmed cardiovascular death Venous thromboembolism ( ) ( ) 0.08 All-cause mortality ( ) ( ) 0.25 Primary end point plus any ( ) ( ) death Primary end point plus VTE plus any death ( ) ( ) *Rates are per 100 person-years. CI confidence interval; HR hazard ratio; VTE venous thromboembolism; other abbreviations as in Table 1.
4 JACC Vol. 55, No. 12, 2010 March 23, 2010: Ridker et al., hscrp, and Moderate CKD 1269 A Primary Endpoint No. at Risk CKD No CKD Cumulative Incidence Follow-up (years) 1,638 1,574 1,538 1, ,629 1,557 1,510 1, ,259 7,054 6,871 5,256 3,020 1,407 1, ,269 7,061 6,840 5,272 3,033 1, CKD, No CKD, CKD, No CKD, B Primary Endpoint + All Death No. at Risk CKD No CKD Cumulative Incidence Follow-up (years) 1,638 1,574 1,538 1, ,629 1,557 1,510 1, ,259 7,054 6,871 5,256 3,020 1,407 1, ,269 7,061 6,840 5,272 3,033 1, CKD, No CKD, CKD, No CKD, Figure 1 Cumulative Incidence of Cardiovascular Events in the JUPITER Trial Among Those With and Without Moderate CKD, According to or Assignment Panel A shows data for the JUPITER primary end point (nonfatal myocardial infarction, nonfatal stroke, hospital stay for unstable angina, arterial revascularization, or cardiovascular death), whereas panel B shows data for the primary end point plus all-cause mortality. Continued on the next page. arterial revascularization (HR: 1.53, 95% CI: 1.13 to 2.08, p 0.008). All-cause mortality was similar in the 2 groups (incidence rates 1.19 vs per 100 person-years, respectively; HR: 1.06, 95% CI: 0.85 to 1.33, p 0.61) as were rates of venous thromboembolism (0.31 and 0.24 per 100 personyears, respectively; HR: 1.26, 95% CI: 0.79 to 2.02, p 0.35). Adjustment for baseline differences between groups had little influence on these rates; after adjustment for age, sex,
5 1270 Ridker et al. JACC Vol. 55, No. 12, 2010, hscrp, and Moderate CKD March 23, 2010: C Primary Endpoint + VTE + All Death CKD, No. at Risk CKD No CKD Cumulative Incidence No CKD, CKD, No CKD, Follow-up (years) 1,638 1,573 1,536 1, ,629 1,554 1,507 1, ,259 7,048 6,861 5,244 3,011 1, ,269 7,055 6,828 5,255 3,021 1, Figure 1 Continued Panel C shows data for the primary end point, venous thromboembolism, and all-cause mortality. CKD chronic kidney disease; VTE venous thromboembolism. smoking, and drug allocation, the HR for the primary trial end point comparing those with CKD with those with preserved renal function remained 1.54 (95% CI: 1.22 to 1.96, p ). Effects of rosuvastatin on trial end points according to baseline renal function. Among those with moderate CKD at study entry, 71 suffered a primary trial end point among those allocated to placebo (incidence rate 1.95 per 100 personyears) as compared with 40 among those allocated to rosuvastatin (incidence rate 1.08 per 100 person-years, HR: 0.55, 95% CI: 0.38 to 0.82, p 0.002) (Table 2). An almost identical effect of rosuvastatin was observed among those with more preserved renal function; in this subgroup, 180 suffered a primary trial end point among those allocated to placebo (incidence rate 1.21 per 100 person-years) as compared with 102 among those allocated to rosuvastatin (incidence rate 0.69 per 100 person-years, HR: 0.57, 95% CI: 0.45 to 0.72, p 0.001). Figure 1A presents cumulative incidence curves for the primary end point among those with and without moderate CKD, according to rosuvastatin assignment. Figures 1B and C show similar data for the primary end point plus all-cause mortality and venous thromboembolism. As also shown in Table 2, rosuvastatin had similar efficacy for most individual clinical outcomes within the JUPITER trial when comparing participants with and without moderate CKD. A possible exception was total mortality, which was reduced 44% by rosuvastatin among those with moderate CKD (HR: 0.56, 95% CI: 0.37 to 0.85, p 0.005) as compared with 12% among those with more preserved egfr (HR: 0.88, 95% CI: 0.72 to 1.09, p 0.25) (p for interaction 0.048). Effects of rosuvastatin were consistent across all pre-specified subgroups evaluated (Fig. 2). Among those with moderate CKD, the NNT at 5 years was 14 (95% CI: 9 to 30) for the primary end point and 9 (95% CI: 6 to 17) for the end point that also included total deaths and venous thromboembolism. Among those with more preserved renal function, the corresponding values were 35 (95% CI: 22 to 82) and 25 (95% CI: 16 to 58). Effects of rosuvastatin on the change in egfr at 12- month follow-up according to baseline renal function. As previously reported (7), there is no evidence in the JUPITER trial that rosuvastatin led to any impairment of renal function as measured by egfr at the 12-month visit; if anything, in the trial as a whole, median egfr at 12 months was marginally improved among those randomly allocated to rosuvastatin as compared with placebo (66.8 vs ml/min/1.73 m 2,p 0.02). In analyses stratified by baseline egfr, similar results were observed. Among those with egfr 60 ml/min/1.73 m 2 at baseline, the median egfr levels at 12 months were 53.0 and 52.8 ml/min/1.73 m 2 in the rosuvastatin and placebo groups, respectively (p 0.44). Among those with egfr 60 ml/min/1.73 m 2 at baseline, the median egfr levels at 12 months were 70.5 and 70.0 ml/min/1.73 m 2 in the rosuvastatin and placebo groups, respectively (p 0.007). Effects of rosuvastatin on achieved LDL-C and achieved hscrp according to baseline renal function. Within the JUPITER trial, the largest relative risk reductions were observed among those who not only reduced LDL-C more than 50% but also reduced hscrp levels more than
6 JACC Vol. 55, No. 12, 2010 March 23, 2010: Ridker et al., hscrp, and Moderate CKD 1271 Figure 2 Effect of on the Primary Trial End Point Among Those With and Without Moderate CKD, According to Baseline Characteristics The relative hazard ratios for the primary end point (nonfatal myocardial infarction, nonfatal stroke, arterial revascularization, hospital stay for unstable angina, or confirmed cardiovascular death) are shown for rosuvastatin as compared with placebo on the left for those with estimated glomerular filtration rate (egfr) 60 ml/min/1.73 m 2 and on the right for those with higher egfr values at study entry. The size of each black square is proportionate to the number of participants in the subgroup; the horizontal lines indicate 95% confidence intervals; and the dashed vertical line indicates the overall relative risk reduction for each group. BMI body mass index; HDL high-density lipoprotein; hscrp high-sensitivity C-reactive protein; LDL-C low-density lipoprotein cholesterol. 50%; as reported previously, a 79% relative risk reduction in vascular events was observed in the JUPITER trial among those who achieved low levels of both LDL-C and hscrp (10). We thus also sought to evaluate the reduction in both LDL-C and hscrp according to baseline renal function. Among those with moderate CKD, rosuvastatin reduced LDL-C by 52% and hscrp by 37%, whereas among those with more preserved renal function, LDL-C was reduced by 46% and hscrp by 37% (all p values 0.001) (Table 3). Safety. Adverse event rates associated with rosuvastatin were similar in the JUPITER trial among those with and without moderate CKD (Table 4). Discussion In this secondary analysis of participants in the JUPITER trial, rosuvastatin was effective at reducing cardiovascular event rates and all-cause mortality among the 3,267 study participants who had evidence of moderate CKD at study entry. As
7 1272 Ridker et al. JACC Vol. 55, No. 12, 2010, hscrp, and Moderate CKD March 23, 2010: Lipid Table and 3 hscrp LipidLevels and hscrp DuringLevels Follow-Up During Among Follow-Up ThoseAmong Allocated Those toallocated to or, According, toaccording Baseline egfr to Baseline egfr 12 Months 24 Months 36 Months 48 Months hscrp (mg/l) egfr 60 ml/min/1.73 m ( ) 3.8 ( ) 2.4 ( ) 3.9 ( ) 2.3 ( ) 3.8 ( ) 2.1 ( ) 4.0 ( ) egfr 60 ml/min/1.73 m ( ) 3.5 ( ) 2.1 ( ) 3.4 ( ) 1.9 ( ) 3.4 ( ) 1.8 ( ) 3.0 ( ) LDL cholesterol (mg/dl) egfr 60 ml/min/1.73 m 2 53 (42 68) 110 (95 126) 53 (43 68) 110 (93 124) 54 (42 70) 107 (92 124) 55 (44 66) 108 (88 122) egfr 60 ml/min/1.73 m 2 57 (45 76) 106 (88 124) 55 (43 69) 107 (92 125) 55 (44 74) 109 (91 129) 50 (42 76) 113 (87 131) HDL cholesterol (mg/dl) egfr 60 ml/min/1.73 m 2 52 (43 64) 50 (41 61) 53 (44 65) 50 (42 62) 52 (42 66) 50 (41 61) 53 (42 62) 50 (42 59) egfr 60 ml/min/1.73 m 2 52 (43 63) 50 (41 61) 52 (43 64) 50 (42 61) 49 (41 61) 48 (40 58) 50 (41 61) 49 (42 60) Triglycerides (mg/dl) egfr 60 ml/min/1.73 m (81 143) 128 (97 182) 107 (81 141) 125 (94 179) 109 (79 146) 128 (95 183) 99 (73 140) 129 (92 170) egfr 60 ml/min/1.73 m 2 97 (72 136) 116 (85 164) 96 (71 132) 113 (81 162) 106 (76 150) 120 (88 169) 99 (75 141) 114 (81 160) All values are median (IQR). Blood values were done fasting. hscrp high-sensitivity C-reactive protein; other abbreviations as in Table 1. anticipated, absolute rates of future vascular disease were higher among those with moderate CKD. Thus, absolute risk reductions associated with rosuvastatin were higher (and NNT values were lower) among JUPITER participants with egfr 60 ml/min/1.73 m 2 when compared with those with higher egfr levels. As such, these data support guidelines from the American Heart Association and the National Kidney Foundation to provide more aggressive cardiovascular prevention efforts among those with mild to moderately reduced renal function (2,3,11). The increased absolute vascular risk in the JUPITER trial among those with moderate CKD is consistent with prior observational cohorts and trials (1 3,6). However, our data regarding the efficacy of statin therapy is consistent with some but not all prior data. For example, although the Pravasatatin Pooling Project found that pravastatin significantly reduced vascular event rates and mortality in a combined analysis of CKD patients participating in the WOSCOPS, CARE (Cholesterol and Recurrent Events), and LIPID (Long-term Intervention with Pravastatin in Ischemic Disease) trials, the primary prevention data in this overview were not statistically significant (6). Thus, our finding of benefit for rosuvastatin among a primary cardiovascular prevention cohort who have concomitant moderate Occurrence Values, and of Other Occurrence Monitored Reported of Adverse Monitored EventsEvents, ofadverse Interest Measured Events, DuringLaboratory Follow-Up Measured Laboratory Table 4 Values, and Other Reported Events of Interest During Follow-Up Monitored adverse events, n (rate) egfr <60 ml/min/1.73 m 2 egfr >60 ml/min/1.73 m 2 p Value Any serious adverse event 315 (9.16) 320 (9.40) ,035 (7.26) 1,056 (7.36) 0.75 Muscular weakness, stiffness, or pain 292 (8.75) 303 (9.24) ,129 (8.32) 1,072 (7.78) 0.15 Myopathy 2 (0.05) 4 (0.11) (0.05) 5 (0.03) 0.40 Rhabdomyolysis 1 (0.03)* 0 (0.0) 0 (0.0) 0 (0.0) Cancer 79 (2.10) 76 (2.05) (1.44) 238 (1.56) 0.41 Gastrointestinal disorders 387 (12.1) 403 (12.8) ,365 (10.2) 1,308 (9.64) 0.14 Renal disorders 146 (4.02) 141 (3.90) (2.59) 339 (2.25) 0.05 Bleeding 76 (2.04) 61 (1.64) (1.20) 214 (1.41) 0.11 Hepatic disorders 33 (0.86) 35 (0.93) (1.20) 151 (0.98) 0.07 Laboratory values Creatinine, 100% increase from baseline, n (%) 3 (0.08) 0 (0.0) 13 (0.08) 10 (0.06) 0.53 ALT 3 ULN on consecutive visits, n (%) 2 (0.05) 4 (0.1) (0.14) 13 (0.08) 0.17 HbA1c (% at 24 months) 5.9 ( ) 5.8 ( ) ( ) 5.8 ( ) 0.01 Fasting glucose (mg/dl at 24 months) 97 (90 107) 96 (90 106) (91 106) 98 (90 107) 0.23 Other events, n (rate) Physician reported diabetes 54 (1.44) 52 (1.40) (1.42) 164 (1.07) 0.01 Hemorrhagic stroke 2 (0.05) 3 (0.08) (0.03) 6 (0.04) 0.53 p Value Rates are per 100 person-years. All blood values were done fasting. *Occurred after trial completion. HbA1c (%), and fasting glucose (mg/dl) are reported as median (IQR) values at 24 months. ALT alanine transferase; ULN upper limit of normal; other abbreviations as in Table 1.
8 JACC Vol. 55, No. 12, 2010 March 23, 2010: Ridker et al., hscrp, and Moderate CKD 1273 CKD importantly extends prior data. Our observation of benefit with rosuvastatin 20 mg in a population with moderate CKD is also consistent with data from the secondary prevention Treat-to-New-Targets trial where atorvastatin 80 mg was superior to atorvastatin 10 mg among those with and without CKD (12). By contrast, our data conflict with those from both the German Diabetes and Dialysis Study (4) and the AURORA (A Study to Evaluate the Use of in Subjects on Regular Haemodialysis: an Assessment of Survival and Cardiovascular Events) trial (5), where those receiving maintenance hemodialysis failed to have a clinical benefit from statin therapy. Patients receiving hemodialysis differ in many ways from those with moderate CKD, and thus our data demonstrate that null data from these settings should not be generalized to that of individuals without severe renal failure. For example, individuals receiving hemodialysis tend to have more calcification of arterial plaque than those with normal renal function. Nonetheless, our data raise a potential explanation for the failure of statins in the setting of hemodialysis; in both the German Diabetes and Dialysis Study and the AURORA study, LDL-C reductions were large, but reductions in hscrp were small, likely the result of chronic and repeated proinflammatory stimulation associated with the dialysis membrane (4,5). By contrast, within the JUPITER trial, those with and without moderate CKD had a similar magnitude of LDL-C and hscrp reduction. Because both LDL-C reduction and hscrp reduction have been independent predictors of clinical benefit in several statin trials (13 16) as well as in the JUPITER trial (10), the possibility that the antiinflammatory effects of statin therapy were blunted in the hemodialysis trials merits consideration. This hypothesis requires testing in future trials. A limitation of our analysis is that creatinine 2 mg/dl was an exclusion criterion. Despite this exclusion, 3,276 individuals were randomized into the trial with egfr 60 ml/min/1.73 m 2, reinforcing the observation that many individuals with creatinine levels often considered in the normal range nonetheless have impaired renal function. Our findings were similar when the Cockcroft-Gault equation was alternatively used to define egfr. Because an entry glucose level of 126 mg/dl was an exclusion criterion for the JUPITER trial, our study is limited to those without overt diabetes. Finally, all JUPITER participants had elevated hscrp, an inflammatory biomarker associated with increased risk of cardiovascular events and diabetes. Therefore it is unknown whether rosuvastatin would be effective in primary prevention among those with CKD and lower hscrp levels. Reprint requests and correspondence: Dr. Paul M Ridker, Director, Center for Cardiovascular Disease Prevention, Brigham and Women s Hospital, 900 Commonwealth Avenue, Boston, Massachusetts pridker@partners.org. REFERENCES 1. Go AS, Chertow GM, Fan D, McCulloch CE, Hsu CY. Chronic kidney disease and the risks of death, cardiovascular events, and hospitalization. N Engl J Med 2004;351: Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med 2003;139: Sarnak MJ, Levey AS, Schoolwerth AC, et al. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research, Clinical Cardiology, and Epidemiology and Prevention. Circulation 2003;108: Wanner C, Krane V, Marz W, et al. Atorvastatin in patients with type 2 diabetes mellitus undergoing hemodialysis. N Engl J Med 2005;353: Fellstrom BC, Jardine AG, Schmieder RE, et al. and cardiovascular events in patients undergoing hemodialysis. N Engl J Med 2009;360: Tonelli M, Isles C, Curhan GC, et al. Effect of pravastatin on cardiovascular events in people with chronic kidney disease. Circulation 2004;110: Ridker PM, Danielson E, Fonseca FA, et al. to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359: Glynn RJ, Danielson E, Fonseca FA, et al. A randomized trial of rosuvastatin in the prevention of venous thromboembolism. N Engl J Med 2009;360: Altman DG, Andersen PK. Calculating the number needed to treat for trials where the outcome is time to an event. BMJ 1999;319: Ridker PM, Danielson E, Fonseca FA, et al. Reduction in C-reactive protein and LDL cholesterol and cardiovascular event rates after initiation of rosuvastatin: a prospective study of the JUPITER trial. Lancet 2009;373: Brosius FC III, Hostetter TH, Kelepouris E, et al. Detection of chronic kidney disease in patients with or at increased risk of cardiovascular disease: a science advisory from the American Heart Association Kidney and Cardiovascular Disease Council; the Councils on High Blood Pressure Research, Cardiovascular Disease in the Young, and Epidemiology and Prevention; and the Quality of Care and Outcomes Research Interdisciplinary Working Group: developed in collaboration with the National Kidney Foundation. Circulation 2006;114: Shepherd J, Kastelein JJ, Bittner V, et al. Intensive lipid lowering with atorvastatin in patients with coronary heart disease and chronic kidney disease: the TNT (Treating to New Targets) study. J Am Coll Cardiol 2008;51: Ridker PM, Rifai N, Clearfield M, et al. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med 2001;344: Ridker PM, Cannon CP, Morrow D, et al. C-reactive protein levels and outcomes after statin therapy. N Engl J Med 2005;352: Morrow DA, de Lemos JA, Sabatine MS, et al. Clinical relevance of C-reactive protein during follow-up of patients with acute coronary syndromes in the Aggrastat-to-Zocor Trial. Circulation 2006;114: Ridker PM, Rifai N, Pfeffer MA, Sacks F, Braunwald E. The Cholesterol and Recurrent Events (CARE) Investigators. Long-term effects of pravastatin on plasma concentration of C-reactive protein. Circulation 1999;100: Key Words: chronic kidney disease y CRP y statins y trial.
MANAGEMENT OF LIPID DISORDERS: IMPLICATIONS OF THE NEW GUIDELINES
MANAGEMENT OF LIPID DISORDERS: IMPLICATIONS OF THE NEW GUIDELINES Robert B. Baron MD MS Professor and Associate Dean UCSF School of Medicine Declaration of full disclosure: No conflict of interest EXPLAINING
More informationSystolic Blood Pressure Intervention Trial (SPRINT) Principal Results
Systolic Blood Pressure Intervention Trial (SPRINT) Principal Results Paul K. Whelton, MB, MD, MSc Chair, SPRINT Steering Committee Tulane University School of Public Health and Tropical Medicine, and
More informationMain Effect of Screening for Coronary Artery Disease Using CT
Main Effect of Screening for Coronary Artery Disease Using CT Angiography on Mortality and Cardiac Events in High risk Patients with Diabetes: The FACTOR-64 Randomized Clinical Trial Joseph B. Muhlestein,
More informationStatins and Risk for Diabetes Mellitus. Background
Statins and Risk for Diabetes Mellitus Kevin C. Maki, PhD, FNLA Midwest Center for Metabolic & Cardiovascular Research and DePaul University, Chicago, IL 1 Background In 2012 the US Food and Drug Administration
More informationADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes
ADVANCE: a factorial randomised trial of blood pressure lowering and intensive glucose control in 11,140 patients with type 2 diabetes Effects of a fixed combination of the ACE inhibitor, perindopril,
More informationPrognostic impact of uric acid in patients with stable coronary artery disease
Prognostic impact of uric acid in patients with stable coronary artery disease Gjin Ndrepepa, Siegmund Braun, Martin Hadamitzky, Massimiliano Fusaro, Hans-Ullrich Haase, Kathrin A. Birkmeier, Albert Schomig,
More informationKDIGO CLINICAL PRACTICE GUIDELINE FOR LIPID MANAGEMENT IN CHRONIC KIDNEY DISEASE. Supplemental Tables November 2013
KDIGO CLINICAL PRACTICE GUIDELINE FOR LIPID MANAGEMENT IN CHRONIC KIDNEY DISEASE Supplemental Tables November 2013 Suppl Table 1: Summary table of RCT examining the effect of exercise in CKD 5HD patients
More informationJournal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators
Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators Shaikha Al Naimi Doctor of Pharmacy Student College of Pharmacy Qatar University
More informationROLE OF LDL CHOLESTEROL, HDL CHOLESTEROL AND TRIGLYCERIDES IN THE PREVENTION OF CORONARY HEART DISEASE AND STROKE
ROLE OF LDL CHOLESTEROL, HDL CHOLESTEROL AND TRIGLYCERIDES IN THE PREVENTION OF CORONARY HEART DISEASE AND STROKE I- BACKGROUND: Coronary artery disease and stoke are the major killers in the United States.
More informationIndividual Study Table Referring to Part of Dossier: Volume: Page:
2.0 Synopsis AbbVie Inc. Name of Study Drug: Trilipix (ABT-335) Name of Active Ingredient: choline salt of fenofibric acid Individual Study Table Referring to Part of Dossier: Volume: Page: (For National
More informationJournal of the American College of Cardiology Vol. 59, No. 17, 2012 2012 by the American College of Cardiology Foundation ISSN 0735-1097/$36.
Journal of the American College of Cardiology Vol. 59, No. 17, 2012 2012 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2011.12.035
More information2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Athersclerotic Risk
2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Athersclerotic Risk Lynne T Braun, PhD, CNP, FAHA, FAAN Professor of Nursing, Nurse Practitioner Rush University Medical Center 2
More informationHDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial
D-10-02654 S0140-6736(10)60713-1 10TL2654 Articles TD HDL cholesterol and residual risk of first cardiovascular events after treatment with potent statin therapy: an analysis from the JUPITER trial Paul
More informationAbstract. n engl j med 359;21 www.nejm.org november 20, 2008 2195
The new england journal of medicine established in 1812 november 20, 2008 vol. 359 no. 21 to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein Paul M Ridker, M.D., Eleanor Danielson,
More informationDISCLOSURES RISK ASSESSMENT. Stroke and Heart Disease -Is there a Link Beyond Risk Factors? Daniel Lackland, MD
STROKE AND HEART DISEASE IS THERE A LINK BEYOND RISK FACTORS? D AN IE L T. L AC K L AN D DISCLOSURES Member of NHLBI Risk Assessment Workgroup RISK ASSESSMENT Count major risk factors For patients with
More informationApixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial
Apixaban Plus Mono vs. Dual Antiplatelet Therapy in Acute Coronary Syndromes: Insights from the APPRAISE-2 Trial Connie N. Hess, MD, MHS, Stefan James, MD, PhD, Renato D. Lopes, MD, PhD, Daniel M. Wojdyla,
More informationGuidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes
Guidance for Industry Diabetes Mellitus Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes U.S. Department of Health and Human Services Food and Drug Administration Center
More informationBMC Med 7/19/2007; Simvastatin linked to reduced incidence of dementia, Parkinson s disease.
March 3, 2012 BD Response to FDA statement regarding Statins The Food and Drug Administration announced on Tuesday (February 28, 2012) the changes to the safety information on the labels of statins regarding
More informationNew Cholesterol Guidelines: Carte Blanche for Statin Overuse Rita F. Redberg, MD, MSc Professor of Medicine
New Cholesterol Guidelines: Carte Blanche for Statin Overuse Rita F. Redberg, MD, MSc Professor of Medicine Disclosures & Relevant Relationships I have nothing to disclose No financial conflicts Editor,
More informationMetabolic Syndrome Overview: Easy Living, Bitter Harvest. Sabrina Gill MD MPH FRCPC Caroline Stigant MD FRCPC BC Nephrology Days, October 2007
Metabolic Syndrome Overview: Easy Living, Bitter Harvest Sabrina Gill MD MPH FRCPC Caroline Stigant MD FRCPC BC Nephrology Days, October 2007 Evolution of Metabolic Syndrome 1923: Kylin describes clustering
More informationHYPERCHOLESTEROLAEMIA STATIN AND BEYOND
HYPERCHOLESTEROLAEMIA STATIN AND BEYOND Andrea Luk Division of Endocrinology Department of Medicine & Therapeutics The Chinese University of Hong Kong HA Convention 4 May 2016 Statins reduce CVD and all-cause
More informationYour healthcare provider has ordered a Boston Heart Cardiac Risk Assessment
Your healthcare provider has ordered a Boston Heart Cardiac Risk Assessment What does that mean for you? Your healthcare provider has determined that you may be at risk for cardiovascular disease (CVD).
More informationMY TYPE 2 DIABETES NUMBERS
BLOOD SUGAR MANAGEMENT GUIDE MY TYPE 2 DIABETES NUMBERS Understanding and Tracking the ABCs of Type 2 Diabetes 1 BLOOD MY TYPE SUGAR 2 DIABETES MANAGEMENT ABC NUMBERS GUIDE When you have type 2 diabetes,
More informationCardiovascular Disease in Diabetes
Cardiovascular Disease in Diabetes Where Do We Stand in 2012? David M. Kendall, MD Distinguished Medical Fellow Lilly Diabetes Associate Professor of Medicine University of MInnesota Disclosure - Duality
More informationMany asymptomatic individuals
Facts, myths and misconceptions about LDL-C and HDL-C By Michael B. Clearfield, DO Many asymptomatic individuals will succumb to cardiovascular disease (CVD), which is the leading cause of death and loss
More informationPrimary Care Management of Women with Hyperlipidemia. Julie Marfell, DNP, BC, FNP, Chairperson, Department of Family Nursing
Primary Care Management of Women with Hyperlipidemia Julie Marfell, DNP, BC, FNP, Chairperson, Department of Family Nursing Objectives: Define dyslipidemia in women Discuss the investigation process leading
More informationJNC-8 Blood Pressure and ACC/AHA Cholesterol Guideline Updates. January 30, 2014
JNC-8 Blood Pressure and ACC/AHA Cholesterol Guideline Updates January 30, 2014 GOALS Review key recommendations from recently published guidelines on blood pressure and cholesterol management Discuss
More informationKevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013
Kevin Saunders MD CCFP Rivergrove Medical Clinic Wellness Institute @ SOGH April 17 2013 Family physician with Rivergrove Medical Clinic Practice in the north end since 1985 Medical Director of the Wellness
More informationStatins for Hyperlipidemia (High Cholesterol)
Statins for Hyperlipidemia (High Cholesterol) Examples of statin drugs Brand Name Mevacor Pravachol Zocor Lescol, Lescol XL Lipitor Crestor Chemical Name lovastatin pravastatin sodium simvastatin fluvastatin
More informationCardiovascular Effects of Drugs to Treat Diabetes
Cardiovascular Effects of Drugs to Treat Diabetes Steven E. Nissen MD Chairman, Department of Cardiovascular Medicine Cleveland Clinic Disclosure Consulting: Many pharmaceutical companies Clinical Trials:
More informationHôpitaux Universitaires de Genève Lipides, métabolisme des hydrates de carbonne et maladies cardio-vasculaires
Hôpitaux Universitaires de Genève Lipides, métabolisme des hydrates de carbonne et maladies cardio-vasculaires Prof. J. Philippe Effect of estrogens on glucose metabolism : Fasting Glucose, HbA1c and C-Peptide
More informationEvidence for Statins in
Evidence for Statins in Secondary & Primary Prevention Jennifer G. Robinson, MD, MPH Professor, Departments of Epidemiology & Medicine (Cardiology) Co Director, Prevention Intervention Center University
More informationClinical Research on Lifestyle Interventions to Treat Obesity and Asthma in Primary Care Jun Ma, M.D., Ph.D.
Clinical Research on Lifestyle Interventions to Treat Obesity and Asthma in Primary Care Jun Ma, M.D., Ph.D. Associate Investigator Palo Alto Medical Foundation Research Institute Consulting Assistant
More informationThe Link Between Obesity and Diabetes The Rapid Evolution and Positive Results of Bariatric Surgery
The Link Between Obesity and Diabetes The Rapid Evolution and Positive Results of Bariatric Surgery Michael E. Farkouh, MD, MSc Peter Munk Chair in Multinational Clinical Trials Director, Heart and Stroke
More informationCOMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE EVALUATION OF MEDICINAL PRODUCTS FOR CARDIOVASCULAR DISEASE PREVENTION
European Medicines Agency Pre-Authorisation Evaluation of Medicines for Human Use London, 25 September 2008 Doc. Ref. EMEA/CHMP/EWP/311890/2007 COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE
More informationFULL COVERAGE FOR PREVENTIVE MEDICATIONS AFTER MYOCARDIAL INFARCTION NEW ENGLAND JOURNAL OF MEDICINE 2011; DOI: 10.
FULL COVERAGE FOR PREVENTIVE MEDICATIONS AFTER MYOCARDIAL INFARCTION NEW ENGLAND JOURNAL OF MEDICINE 2011; DOI: 10.1056/NEJMSA1107913 Niteesh K. Choudhry, MD, PhD, 1 Jerry Avorn, MD, 1 Robert J. Glynn,
More informationManagement of Lipids in 2015: Just Give them a Statin?
Management of Lipids in 2015: Just Give them a Statin? James H. Stein, M.D. Division of Cardiovascular Medicine University of Wisconsin School of Medicine and Public Health Stone NJ, et al. Circulation
More informationMeasure #257 (NQF 1519): Statin Therapy at Discharge after Lower Extremity Bypass (LEB) National Quality Strategy Domain: Effective Clinical Care
Measure #257 (NQF 1519): Statin Therapy at Discharge after Lower Extremity Bypass (LEB) National Quality Strategy Domain: Effective Clinical Care 2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: REGISTRY ONLY
More informationAssociate Professor Patrick Kay Interventional cardiologist Middlemore, Auckland and Mercy Hospitals Auckland
Associate Professor Patrick Kay Interventional cardiologist Middlemore, Auckland and Mercy Hospitals Auckland 14:00-14:55 WS #45: New Therapies for Lipid Management 15:05-16:00 WS #57: New Therapies for
More informationSponsor. Novartis Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Investigational.
Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin Therapeutic Area of Trial Type 2 diabetes Approved Indication Investigational Study Number CLAF237A2386 Title A single-center,
More informationPRESCRIBING GUIDELINES FOR LIPID LOWERING TREATMENTS for SECONDARY PREVENTION
Hull & East Riding Prescribing Committee PRESCRIBING GUIDELINES FOR LIPID LOWERING TREATMENTS for SECONDARY PREVENTION For guidance on Primary Prevention please see NICE guidance http://www.nice.org.uk/guidance/cg181
More informationThe WHI 12 Years Later: What Have We Learned about Postmenopausal HRT?
AACE 23 rd Annual Scientific and Clinical Congress (2014) Syllabus Materials: The WHI 12 Years Later: What Have We Learned about Postmenopausal HRT? JoAnn E. Manson, MD, DrPH, FACP, FACE Chief, Division
More informationAfrican Americans & Cardiovascular Diseases
Statistical Fact Sheet 2013 Update African Americans & Cardiovascular Diseases Cardiovascular Disease (CVD) (ICD/10 codes I00-I99, Q20-Q28) (ICD/9 codes 390-459, 745-747) Among non-hispanic blacks age
More informationESCMID Online Lecture Library. by author
Do statins improve outcomes of patients with sepsis and pneumonia? Jordi Carratalà Department of Infectious Diseases Statins for sepsis & community-acquired pneumonia Sepsis and CAP are major healthcare
More informationInternational Task Force for Prevention Of Coronary Heart Disease. Clinical management of risk factors. coronary heart disease (CHD) and stroke
International Task Force for Prevention Of Coronary Heart Disease Clinical management of risk factors of coronary heart disease and stroke Economic analyses of primary prevention of coronary heart disease
More informationEvidence-Based Secondary Stroke Prevention and Adherence to Guidelines
Evidence-Based Secondary Stroke Prevention and Adherence to Guidelines Mitchell S.V. Elkind, MD, MS Associate Professor of Neurology Columbia University New York, NY Presenter Disclosure Information Mitchell
More informationMortality Assessment Technology: A New Tool for Life Insurance Underwriting
Mortality Assessment Technology: A New Tool for Life Insurance Underwriting Guizhou Hu, MD, PhD BioSignia, Inc, Durham, North Carolina Abstract The ability to more accurately predict chronic disease morbidity
More informationCoronary Heart Disease (CHD) Brief
Coronary Heart Disease (CHD) Brief What is Coronary Heart Disease? Coronary Heart Disease (CHD), also called coronary artery disease 1, is the most common heart condition in the United States. It occurs
More informationPHARMACOLOGICAL Stroke Prevention in Atrial Fibrillation STROKE RISK ASSESSMENT SCORES Vs. BLEEDING RISK ASSESSMENT SCORES.
PHARMACOLOGICAL Stroke Prevention in Atrial Fibrillation STROKE RISK ASSESSMENT SCORES Vs. BLEEDING RISK ASSESSMENT SCORES. Hossam Bahy, MD (1992 2012), 19 tools have been identified 11 stroke scores 1
More informationCardiac Assessment for Renal Transplantation: Pre-Operative Clearance is Only the Tip of the Iceberg
Cardiac Assessment for Renal Transplantation: Pre-Operative Clearance is Only the Tip of the Iceberg 2 nd Annual Duke Renal Transplant Symposium March 1, 2014 Durham, NC Joseph G. Rogers, M.D. Associate
More informationLipid levels in patients hospitalized with coronary artery disease: An analysis of 136,905 hospitalizations in Get With The Guidelines
Lipid levels in patients hospitalized with coronary artery disease: An analysis of 136,905 hospitalizations in Get With The Guidelines Amit Sachdeva, MD, a Christopher P. Cannon, MD, b Prakash C. Deedwania,
More informationFULL COVERAGE FOR PREVENTIVE MEDICATIONS AFTER MYOCARDIAL INFARCTION IMPACT ON RACIAL AND ETHNIC DISPARITIES
FULL COVERAGE FOR PREVENTIVE MEDICATIONS AFTER MYOCARDIAL INFARCTION IMPACT ON RACIAL AND ETHNIC DISPARITIES Niteesh K. Choudhry, MD, PhD Harvard Medical School Division of Pharmacoepidemiology and Pharmacoeconomics
More informationBarriers to Healthcare Services for People with Mental Disorders. Cardiovascular disorders and diabetes in people with severe mental illness
Barriers to Healthcare Services for People with Mental Disorders Cardiovascular disorders and diabetes in people with severe mental illness Dr. med. J. Cordes LVR- Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität
More informationRATE VERSUS RHYTHM CONTROL OF ATRIAL FIBRILLATION: SPECIAL CONSIDERATION IN ELDERLY. Charles Jazra
RATE VERSUS RHYTHM CONTROL OF ATRIAL FIBRILLATION: SPECIAL CONSIDERATION IN ELDERLY Charles Jazra NO CONFLICT OF INTEREST TO DECLARE Relationship Between Atrial Fibrillation and Age Prevalence, percent
More informationThe largest clinical study of Bayer's Xarelto (rivaroxaban) Wednesday, 14 November 2012 07:38
Bayer HealthCare has announced the initiation of the COMPASS study, the largest clinical study of its oral anticoagulant Xarelto (rivaroxaban) to date, investigating the prevention of major adverse cardiac
More informationPerspectives on the Selection and Duration of Dual Antiplatelet Therapy
Perspectives on the Selection and Duration of Dual Antiplatelet Therapy Dominick J. Angiolillo, MD, PhD, FACC, FESC, FSCAI Director of Cardiovascular Research Associate Professor of Medicine University
More informationStatin Template Guidance Use of statins in primary and secondary prevention of vascular disease Endorsed by ABHB MTC for use in Gwent (October 2012)
Statin Template Guidance Use of statins in primary and secondary prevention of vascular disease Endorsed by ABHB MTC for use in Gwent (October 2012) Notes relating to this guidance This guidance serves
More informationMaking Sense of the New Statin guidelines. They are more than just lowering your cholesterol!
Making Sense of the New Statin guidelines They are more than just lowering your cholesterol! No Disclosures Margaret (Peg) O Donnell DNPs, FNP, ANP B-C, FAANP Senior Nurse Practitioner South Nassau Communities
More informationAddendum to Clinical Review for NDA 22-512
Addendum to Clinical Review for DA 22-512 Drug: Sponsor: Indication: Division: Reviewers: dabigatran (Pradaxa) Boehringer Ingelheim Prevention of stroke and systemic embolism in atrial fibrillation Division
More informationHigh Blood Cholesterol
National Cholesterol Education Program ATP III Guidelines At-A-Glance Quick Desk Reference 1 Step 1 2 Step 2 3 Step 3 Determine lipoprotein levels obtain complete lipoprotein profile after 9- to 12-hour
More informationQuantifying Life expectancy in people with Type 2 diabetes
School of Public Health University of Sydney Quantifying Life expectancy in people with Type 2 diabetes Alison Hayes School of Public Health University of Sydney The evidence Life expectancy reduced by
More informationRivaroxaban for acute coronary syndromes
Northern Treatment Advisory Group Rivaroxaban for acute coronary syndromes Lead author: Nancy Kane Regional Drug & Therapeutics Centre (Newcastle) May 2014 2014 Summary Current long-term management following
More informationDrug Class Review on HMG-CoA Reductase Inhibitors (Statins)
Drug Class Review on HMG-CoA Reductase Inhibitors (Statins) Final Report September 2005 The purpose of this report is to make available information regarding the comparative effectiveness and safety profiles
More informationTHE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT
THE INTERNET STROKE CENTER PRESENTATIONS AND DISCUSSIONS ON STROKE MANAGEMENT Stroke Prevention in Atrial Fibrillation Gregory Albers, M.D. Director Stanford Stroke Center Professor of Neurology and Neurological
More informationMedical management of CHF: A New Class of Medication. Al Timothy, M.D. Cardiovascular Institute of the South
Medical management of CHF: A New Class of Medication Al Timothy, M.D. Cardiovascular Institute of the South Disclosures Speakers Bureau for Amgen Background Chronic systolic congestive heart failure remains
More informationUnderstanding diabetes Do the recent trials help?
Understanding diabetes Do the recent trials help? Dr Geoffrey Robb Consultant Physician and Diabetologist CMO RGA UK Services and Partnership Assurance AMUS 25 th March 2010 The security of experience.
More informationAspirin to Prevent Heart Attack and Stroke: What s the Right Dose?
The American Journal of Medicine (2006) 119, 198-202 REVIEW Aspirin to Prevent Heart Attack and Stroke: What s the Right Dose? James E. Dalen, MD, MPH Professor Emeritus, University of Arizona, Tucson
More informationEducation. Panel. Triglycerides & HDL-C
Triglycerides & HDL-C Thomas Dayspring, MD, ACP Clinical Assistant Professor of Medicine University of Medicine and Dentistry of New Jersey Attending in Medicine: St Joseph s s Hospital, Paterson, NJ Certified
More informationCOMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) DRAFT GUIDELINE ON THE EVALUATION OF MEDICINAL PRODUCTS FOR CARDIOVASCULAR DISEASE PREVENTION
European Medicines Agency London, 19 July 2007 Doc. Ref. EMEA/CHMP/EWP/311890/2007 COMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) DRAFT GUIDELINE ON THE EVALUATION OF MEDICINAL PRODUCTS FOR CARDIOVASCULAR
More informationRandomized trials versus observational studies
Randomized trials versus observational studies The case of postmenopausal hormone therapy and heart disease Miguel Hernán Harvard School of Public Health www.hsph.harvard.edu/causal Joint work with James
More informationFewer people with coronary heart disease are being diagnosed as compared to the expected figures.
JSNA Coronary heart disease 1) Key points 2) Introduction 3) National picture 4) Local picture of CHD prevalence 5) Mortality from coronary heart disease in Suffolk County 6) Trends in mortality rates
More informationEstimated GFR Based on Creatinine and Cystatin C
Estimated GFR Based on Creatinine and Cystatin C Lesley A Stevens, MD, MS Tufts Medical Center, Tufts University School of Medicine Boston MA Chronic Kidney Disease-Epidemiology Collaboration UO1 DK 053869,
More informationYour Life Your Health Cariodmetabolic Risk Syndrome Part VII Inflammation chronic, low-grade By James L. Holly, MD The Examiner January 25, 2007
Your Life Your Health Cariodmetabolic Risk Syndrome Part VII Inflammation chronic, low-grade By James L. Holly, MD The Examiner January 25, 2007 The cardiometabolic risk syndrome is increasingly recognized
More informationCardiac Rehabilitation An Underutilized Class I Treatment for Cardiovascular Disease
Cardiac Rehabilitation An Underutilized Class I Treatment for Cardiovascular Disease What is Cardiac Rehabilitation? Cardiac rehabilitation is a comprehensive exercise, education, and behavior modification
More informationFreiburg Study. The other 24 subjects had healthy markers closer to what would be considered ideal.
Freiburg Study The Freiburg Study was conducted with 48 healthy human subjects of various ages. None of the test subjects had been diagnosed with any disease prior to the study. None were taking any type
More informationAtrial Fibrillation: A Different Perspective. Michael Heffernan MD PhD FRCPC FACC Staff Cardiologist Oakville Hospital
Atrial Fibrillation: A Different Perspective Michael Heffernan MD PhD FRCPC FACC Staff Cardiologist Oakville Hospital Faculty/Presenter Disclosure Faculty: Dr. Michael Heffernan Relationships with commercial
More informationCohort Studies. Sukon Kanchanaraksa, PhD Johns Hopkins University
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this
More informationStroke Risk Scores. CHA 2 DS 2 -VASc. CHA 2 DS 2 -VASc Scoring Table 2
Bleeding/Clotting Risk Evaluation Tools for Atrial Fibrillation Patients Before prescribing anticoagulants, providers should weigh the risk of thrombosis against the risk of bleeding. The tools below can
More informationDrug discontinuation and switching during the Medicare Part D coverage gap
Drug discontinuation and switching during the Medicare Part D coverage gap Jennifer M. Polinski, ScD, MPH William H. Shrank, MD, MSHS; Haiden A. Huskamp, PhD; Robert J. Glynn, PhD, ScD; Joshua N. Liberman,
More informationDual Antiplatelet Therapy. Stephen Monroe, MD FACC Chattanooga Heart Institute
Dual Antiplatelet Therapy Stephen Monroe, MD FACC Chattanooga Heart Institute Scope of Talk Identify the antiplatelet drugs and their mechanisms of action Review dual antiplatelet therapy in: The medical
More informationAppendix: Description of the DIETRON model
Appendix: Description of the DIETRON model Much of the description of the DIETRON model that appears in this appendix is taken from an earlier publication outlining the development of the model (Scarborough
More information嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯
The Clinical Efficacy and Safety of Sodium Glucose Cotransporter-2 (SGLT2) Inhibitors in Adults with Type 2 Diabetes Mellitus 嘉 義 長 庚 醫 院 藥 劑 科 Speaker : 翁 玟 雯 Diabetes Mellitus : A group of diseases characterized
More informationThe Canadian Association of Cardiac
Reinventing Cardiac Rehabilitation Outside of acute care institutions, cardiovascular disease is a chronic, inflammatory process; the reduction or elimination of recurrent acute coronary syndromes is a
More informationNovel Anticoagulation Agents DISCLOSURES. Objectives ATRIAL FIBRILLATION TRIALS. NOAC Comparison 6/12/2015
Novel Anticoagulation Agents DISCLOSURES James W. Haynes, MD Department of Family Medicine Univ of TN Health Science Center (Chattanooga) Objectives Understand mechanism of action behind the NOAC agents
More informationThis clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.
abcd Clinical Study Synopsis for Public Disclosure This clinical study synopsis is provided in line with s Policy on Transparency and Publication of Clinical Study Data. The synopsis which is part of the
More informationHow To Treat Dyslipidemia
An International Atherosclerosis Society Position Paper: Global Recommendations for the Management of Dyslipidemia Introduction Executive Summary The International Atherosclerosis Society (IAS) here updates
More informationSummary HTA. HTA-Report Summary. Introduction
Summary HTA HTA-Report Summary Antioxidative vitamines for prevention of cardiovascular disease for patients after renal transplantation and patients with chronic renal failure Schnell-Inderst P, Kossmann
More informationWill The Coronary Calcium Score Affect the Decision To Treat With Statins?
Will The Coronary Calcium Score Affect the Decision To Treat With Statins? Amresh Raina M.D. Division of Cardiology University of Pennsylvania Disclosures No financial relationships relevant to this presentation
More informationThe Women s Health Initiative: The Role of Hormonal Therapy in Disease Prevention
The Women s Health Initiative: The Role of Hormonal Therapy in Disease Prevention Robert B. Wallace, MD, MSc Departments of Epidemiology and Internal Medicine University of Iowa College of Public Health
More informationOsama Jarkas. in Chest Pain Patients. STUDENT NAME: Osama Jarkas DATE: August 10 th, 2015
STUDENT NAME: Osama Jarkas DATE: August 10 th, 2015 PROJECT TITLE: Analysis of ECG Exercise Stress Testing and Framingham Risk Score in Chest Pain Patients PRIMARY SUPERVISOR NAME: Dr. Edward Tan DEPARTMENT:
More informationAtherosclerosis of the aorta. Artur Evangelista
Atherosclerosis of the aorta Artur Evangelista Atherosclerosis of the aorta Diagnosis Classification Prevalence Risk factors Marker of generalized atherosclerosis Risk of embolism Therapy Diagnosis Atherosclerosis
More informationImpact of Massachusetts Health Care Reform on Racial, Ethnic and Socioeconomic Disparities in Cardiovascular Care
Impact of Massachusetts Health Care Reform on Racial, Ethnic and Socioeconomic Disparities in Cardiovascular Care Michelle A. Albert MD MPH Treacy S. Silbaugh B.S, John Z. Ayanian MD MPP, Ann Lovett RN
More informationA list of FDA-approved testosterone products can be found by searching for testosterone at http://www.accessdata.fda.gov/scripts/cder/drugsatfda/.
FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke
More informationRisk Factors for Fire Fighter Cardiovascular Disease
Risk Factors for Fire Fighter Cardiovascular Disease EXECUTIVE SUMMARY Prepared by: Jefferey L. Burgess, MD, MS, MPH Mel and Enid Zuckerman College of Public Health The University of Arizona The Fire Protection
More informationMississippi Delta Health Collaborative Mississippi State Department of Health 1
The Impact of Community Health Workers on Cardiovascular Risk Reduction : Findings from the Clinical Community Health Worker Initiative Mississippi Delta Health Collaborative Mississippi State Department
More informationHEDIS CY2012 New Measures
HEDIS CY2012 New Measures TECHNICAL CONSIDERATIONS FOR NEW MEASURES The NCQA Committee on Performance Measurement (CPM) approved five new measures for HEDIS 2013 (CY2012). These measures provide feasible
More informationCardiac Rehabilitation The Best Medicine for Your CAD Patients. James A. Stone
James A. Stone BPHE, BA, MSc, MD, PhD, FRCPC, FAACVPR, FACC Clinical Professor of Medicine, University of Calgary Total Cardiology, Calgary Acknowledgements and Disclosures Acknowledgements Jacques Genest
More informationRisk Factors of chronic complex co-morbidities. Aldo Pietro Maggioni, MD ANMCO Research Center Firenze, Italy
Risk Factors of chronic complex co-morbidities Aldo Pietro Maggioni, MD ANMCO Research Center Firenze, Italy Statement 1 In real world practice (and in clinical trials), complex co-morbidities are the
More informationCardiovascular Endpoints
The Malmö Diet and Cancer Study Department of Clinical Sciences Skåne University Hospital, Malmö Lund University The Malmö Diet and Cancer Study CV-cohort Cardiovascular Endpoints End of follow-up: 30
More informationWhat is an NNT? What is...? series Second edition Statistics. Supported by sanofi-aventis
...? series Second edition Statistics Supported by sanofi-aventis What is an NNT? Andrew Moore MA DPhil DSc CChem FRSC Senior Research Fellow, Pain Research and Nuffield Department of Anaesthetics, University
More information