Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators

Size: px
Start display at page:

Download "Journal Club: Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy by the AIM-HIGH Investigators"

Transcription

1 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 December 14, 2011 The Journal What is the name of the journal? New England Journal of Medicine What is the reputation of the journal? Free access? Impact factor? Medical journal cited more often than any other medical journal, with weekly publications Online, peer-reviewed, and requires subscription Biomedical and clinical research Impact factor: What was the submission date, publication date and the related time interval? Published: November 15, 2011 Submission: May-November

2 Authors Are the authors qualified? Were any authors involved with the study sponsors? Were conflicts of interest declared? Has the senior/coordinating author published other papers in this area? Physicians specialized in cardiology from USA and Canada Some are affiliated to universities Conflict of interest Principal investigator received fees from Abbott, some authors received fees from other companies Principal investigator (William Boden): Several articles in the field of cardiology Funding What was the source and nature of the study funding, if any? Was the study registered? Supported by National Heart, Lung, and Blood Institute and by an unrestricted grant from Abbott Laboratories. Abbott Laboratories donated the extended-release niacin, the matching placebo, and the ezetimibe; Merck donated the simvastatin 2

3 Article Title Is the title appropriate for the content? Is the title unbiased? Does the title adequately describe the trial? Good title: Clear Doesn t give away results But did not describe: Study design, Randomized Controlled Trial (RCT) Study drugs and circumstances (simvastatin, ezetimibe, in patiens with Cornary Heart Disease, CHD) Study duration Introduction Was the introduction structured? Structured and has a logical flow Described: Benefits of strict lipid management Benefits of niacin when added to statins, fibrates, or alone versus placebo Do they describe pertinent research? Described studies focusing on the effect of niacin in CHD patients 3

4 Introduction Rationale: why authors think this study important? No clear rationale, they do not state the gap in research that this study is addressing E.g. There was no study assessing the effect of niacin when added to intensive statin therapy in patients where strict control of lipds is desired Introduction Objective: what are they going to do in this study? Note: 1. They did not state death from cardiovascular disease as the outcome of interest 2. They don t address intensive statin therapy 4

5 Methods What was the general design of the study? Multicenter, double-blind RCT Randomization was performed with the use of a secure internet application Allocation concealment?? Disease definition: Patients with cardiovascular disease defined as documented CHD, PAD, and cerebrovascular or carotid disease, with dyslipidemia+low HDL Subjects provided informed consent The study was approved by ethics committee Methods What were the inclusion/exclusion criteria? Inclusion Males and females, age >= 45, with established vascular disease and dyslipidemia Exclusion Hospitalized 4 weeks before enrollment (ACS, CABG) Stroke (past 8 weeks before enrollment) Run-in period (4-8 weeks) Subjects received simvastatin 40 mg qd + niacin 500 mg qd titrated to 2g qd Subjects tolerating at least a daily niacin dose (1.5g) were randomized 5

6 Methods Treatment (independent variable) Intervention: simvastatin+ niacin (1.5g-2g qd) +/- ezetimibe (10mg qd) What determined the dose for niacin? Control: simvastatin+ placebo (niacin 50 mg) +/- ezetimibe (10mg qd) Why did placebo contain niacin? No information on ensuring the physical form of the niacin/placebo were identical Dose adjusted to maintain LDL mg/dl Adherence assessed by manual pill count Methods Outcome (dependent variable) Primary endpoint: Death from CHD, nonfatal MI, ischemic stroke, hospitalization (>23 hours) for an ACS, or coronary/cerebral revascularization Secondary endpoint composite: Death from CHD, nonfatal MI, ischemic stroke, or hospitalization for a high-risk ACS Tertiary endpoint include: Death from any cause 6

7 Statistics Level of significance Efficacy= Other outcomes=0.05 Calculated study power (85%) for events detected during 4.6 years No information on the calculated sample size to achieve this power analyzed as per intention to treat Subgroup analysis (age, gender, diabetes, metabolic syndrome, prior myocardial infarction, and use of statins at entry) Baseline table did not include: weight, smoking status, and p- value of difference 7

8 Population 4273 began the open-label niacin run-in period 3414 of those patients were randomized Intervention=1718, control=1696 Men=85.2%, white=92.2%, diabetes=33.9% (type 1 or type 2) Generalizability??? Lipid levels HDL increased by 25.0% in intervention group 9.8% in the control group (P<0.001) LDL decreased by 12.0% in the intervention group 5.5% in the control group 8

9 Adherence More subjects in the niacin group discontinued the study drug (p<0.001) Effect on blinding? More subjects in placebo received 80mg simvastatin (24.7% vs. 17.5%, P = 0.02) Study was d/c prematurely (18 months) for lack of efficacy and because more patients had ischemic stroke in the niacin group 9

10 How were the results presented? were complemented by tables However, no randomization figure was presented All patients were accounted for as per the intention to treat Almost all results were presented Not enough information was provided regarding subgroup analysis except for absence of statistical significance 10

11 Discussion Did the authors inappropriately introduce any new data in this section? No new data presented in the discussion Did the authors compare the results of the trial to the resultsof similar previous trials? Discussed previous trials were that assessed the efficacy of niacin Did the authors discuss the limitations of the trial? Limitations: generalizability, placebo, premature d/c Conclusion Were valid conclusions drawn? The conclusion was clear, concise, and based on objectives, and results Proposal for future studies? Benefit of niacin may be studied: Higher-risk cardiac patients Patients with LDL not intensively controlled by a statin 11

12 External Validity In the Coronary Drug Project, niacin 3 grams/day reduced mortality 11% over placebo Niacin can be an option for patients unable to use statins The efficacy of niacin on clinically relevant outcomes seems to be unremarkable in high risk patients already receiving intensive statin therapy Ischemic stroke?? 12

13 Thank you 13

What is meant by "randomization"? (Select the one best answer.)

What is meant by randomization? (Select the one best answer.) Preview: Post-class quiz 5 - Clinical Trials Question 1 What is meant by "randomization"? (Select the one best answer.) Question 2 A. Selection of subjects at random. B. Randomization is a method of allocating

More information

ADVANCE: 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 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 information

MANAGEMENT OF LIPID DISORDERS: IMPLICATIONS OF THE NEW GUIDELINES

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 information

Main Effect of Screening for Coronary Artery Disease Using CT

Main 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 information

The Trial to Assess Chelation Therapy (TACT)

The Trial to Assess Chelation Therapy (TACT) The Trial to Assess Chelation Therapy (TACT) Chelation-Placebo Comparison Gervasio A. Lamas MD Professor of Clinical Medicine Columbia University Division of Cardiology Mount Sinai Medical Center Miami

More information

HYPERCHOLESTEROLAEMIA STATIN AND BEYOND

HYPERCHOLESTEROLAEMIA 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 information

Cholesterol Treatment Trialists (CTT) Collaboration. Slide deck

Cholesterol Treatment Trialists (CTT) Collaboration. Slide deck Cholesterol Treatment Trialists (CTT) Collaboration Slide deck CTT Collaboration: Background* History: Founded in 1993 (prior to publication of 4S trial in 1994) Original protocol published in 1995 Trial

More information

NUTS! The Story of My Life. Prof. Joan Sabaté Department of Nutrition Loma Linda University

NUTS! The Story of My Life. Prof. Joan Sabaté Department of Nutrition Loma Linda University NUTS! The Story of My Life Prof. Joan Sabaté Department of Nutrition Loma Linda University Dr. Joan Sabate Chair, Nutrition, School of Public Health, Loma Linda University CA From Spain, Dr. Sabaté is

More information

New Cholesterol Treatment Guidelines. Charles F. Dahl, MD, FACC Cardiologist and Lipidologist, Central Utah Clinic

New Cholesterol Treatment Guidelines. Charles F. Dahl, MD, FACC Cardiologist and Lipidologist, Central Utah Clinic New Cholesterol Treatment Guidelines Charles F. Dahl, MD, FACC Cardiologist and Lipidologist, Central Utah Clinic Objectives: List the 4 treatment groups under the new guidelines Identify how to calculate

More information

Statins patient decision aid

Statins patient decision aid Statins patient decision aid What this decision aid is for This decision aid is intended to assist health professionals in consultations with patients in whom treatment with a statin is being considered,

More information

South African Cholesterol Guidelines Compared

South African Cholesterol Guidelines Compared South African Cholesterol Guidelines Compared Jacqueline van Schoor, Amayeza Info Centre While infectious diseases are currently the leading cause of death in South Africa, cardiovascular disease (CVD)

More information

Statins and Risk for Diabetes Mellitus. Background

Statins 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 information

UNIVERSITY OF MEDICINE AND PHARMACY CRAIOVA DOCTORAL SCHOOL DOCTORATE THESIS. - Summary

UNIVERSITY OF MEDICINE AND PHARMACY CRAIOVA DOCTORAL SCHOOL DOCTORATE THESIS. - Summary UNIVERSITY OF MEDICINE AND PHARMACY CRAIOVA DOCTORAL SCHOOL DOCTORATE THESIS - Summary CHRONIC COMPLICATIONS IN PATIENTS WITH TYPE 1 DIABETES MELLITUS - Epidemiological study - PhD Manager: Professor PhD.

More information

Proposed Retirement for HEDIS : Cholesterol Management for Patients with Cardiovascular Conditions (CMC)

Proposed Retirement for HEDIS : Cholesterol Management for Patients with Cardiovascular Conditions (CMC) Draft Document for HEDIS 2015 Public Comment Obsolete After March 19, 2014 1 Proposed Retirement for HEDIS 1 2015: Cholesterol Management for Patients with Cardiovascular Conditions (CMC) NCQA seeks comments

More information

PRESCRIBING GUIDELINES FOR LIPID LOWERING TREATMENTS for SECONDARY PREVENTION

PRESCRIBING 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 information

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C

FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C FREEDOM C: A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Comparison of the Efficacy and Safety of Oral UT-15C SR in Combination with an ERA and/or a PDE-5 Inhibitor

More information

Measure #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 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 information

DISCLOSURES RISK ASSESSMENT. Stroke and Heart Disease -Is there a Link Beyond Risk Factors? Daniel Lackland, MD

DISCLOSURES 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 information

Duration of Dual Antiplatelet Therapy After Coronary Stenting

Duration of Dual Antiplatelet Therapy After Coronary Stenting Duration of Dual Antiplatelet Therapy After Coronary Stenting C. DEAN KATSAMAKIS, DO, FACC, FSCAI INTERVENTIONAL CARDIOLOGIST ADVOCATE LUTHERAN GENERAL HOSPITAL INTRODUCTION Coronary artery stents are

More information

Apixaban 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 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 information

ROLE 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 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 information

2013 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 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 information

AHA/ASA Guidelines on Prevention of Recurrent Stroke

AHA/ASA Guidelines on Prevention of Recurrent Stroke AHA/ASA Guidelines on Prevention of Recurrent Stroke MARA LAMBERT Guideline source: American Heart Association/American Stroke Association Evidence rating system used? Yes Literature search described?

More information

Primary Prevention of Cardiovascular Disease with a Mediterranean diet

Primary Prevention of Cardiovascular Disease with a Mediterranean diet Primary Prevention of Cardiovascular Disease with a Mediterranean diet Alejandro Vicente Carrillo, Brynja Ingadottir, Anne Fältström, Evelyn Lundin, Micaela Tjäderborn GROUP 2 Background The traditional

More information

FORTH VALLEY. LIPID LOWERING GUIDELINES v4 May 2010

FORTH VALLEY. LIPID LOWERING GUIDELINES v4 May 2010 FORTH VALLEY LIPID LOWERING GUIDELINES v4 May 2010 This guideline applies to people over 16 years of age. This guideline is not intended to serve as a standard of medical care or be applicable in every

More information

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs

Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Recent and Ongoing Cardiovascular Outcomes Trials with Diabetes Drugs Jay S. Skyler, MD, MACP Division of Endocrinology, Diabetes, and Metabolism and Diabetes Research Institute University of Miami Miller

More information

JNC 8 & Cholesterol 11/12/2014 NCEP-III. Where d those target LDLs come from? Lessons from Zetia. It s all about that bass dose!

JNC 8 & Cholesterol 11/12/2014 NCEP-III. Where d those target LDLs come from? Lessons from Zetia. It s all about that bass dose! JNC 8 & Cholesterol NCEP-III Count up the risk factors Goal LDL based on risk factors Titrate statin up to achieve goal We can get through it together LaDonna Hale, PharmD Wichita State University Where

More information

DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study

DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study DCCT and EDIC: The Diabetes Control and Complications Trial and Follow-up Study National Diabetes Information Clearinghouse U.S. Department of Health and Human Services NATIONAL INSTITUTES OF HEALTH What

More information

Individual Study Table Referring to Part of Dossier: Volume: Page:

Individual 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 information

o Antiplatelet therapy is used for both the management of acute o Meta analysis of 195 randomized controlled trials

o Antiplatelet therapy is used for both the management of acute o Meta analysis of 195 randomized controlled trials Introduction o Antiplatelet therapy is used for both the management of acute ischemic stroke and for the prevention of stroke o Antiplatelet therapy reduces the incidence of stroke in patients at high

More information

COMMITTEE FOR HUMAN MEDICINAL PRODUCTS (CHMP) DRAFT GUIDELINE ON THE EVALUATION OF MEDICINAL PRODUCTS FOR CARDIOVASCULAR DISEASE PREVENTION

COMMITTEE 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 information

Addendum to Clinical Review for NDA 22-512

Addendum 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 information

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE (CHMP) GUIDELINE ON THE EVALUATION OF MEDICINAL PRODUCTS FOR CARDIOVASCULAR DISEASE PREVENTION

COMMITTEE 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 information

Disclosures Funded by VHA HSR&D Investigator Initiated Award (IIR ) Dr. Bosworth was supported by a VHA HSR&D Senior Scientist Award (08-027) Dr

Disclosures Funded by VHA HSR&D Investigator Initiated Award (IIR ) Dr. Bosworth was supported by a VHA HSR&D Senior Scientist Award (08-027) Dr Multifaceted Intervention to Improve Medication Adherence and Secondary Prevention Measures (Medication Study) After Acute Coronary Syndrome Hospital Discharge Ho PM, Lambert-Kerzner A, Carey EP, Fahdi

More information

Drug Class Review on HMG-CoA Reductase Inhibitors (Statins)

Drug 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 information

FULL 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. 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 information

University of Ulsan College of Medicine, Asan Medical Center on behalf of the REAL-LATE and the ZEST-LATE trial

University of Ulsan College of Medicine, Asan Medical Center on behalf of the REAL-LATE and the ZEST-LATE trial Duration of Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation A Pooled Analysis of the REAL-LATE and the ZEST-LATE Trial Seung-Jung Park MD PhD Seung-Jung Park, MD, PhD, University of Ulsan

More information

FULL 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 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 information

Evidence-Based Secondary Stroke Prevention and Adherence to Guidelines

Evidence-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 information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE SCOPE 1 NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Guideline title SCOPE Hypertension: clinical management of primary hypertension in adults 1.1 Short title Hypertension (partial update) 2 The remit

More information

NCEP Report. Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines

NCEP Report. Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines NCEP Report Implications of Recent Clinical Trials for the National Cholesterol Education Program Adult Treatment Panel III Guidelines Scott M. Grundy; James I. Cleeman; C. Noel Bairey Merz; H. Bryan Brewer,

More information

The BEAUTIFUL Study Backgrounder

The BEAUTIFUL Study Backgrounder The BEAUTIFUL Study Backgrounder About the BEAUTIFUL study The BEAUTIFUL (MorBidity-mortality EvAlUaTion of the I f inhibitor Procoralan in patients with coronary disease and left ventricular dysfunction)

More information

Quiz 1 hypertension answers. The correct answers to questions are indicated by *.

Quiz 1 hypertension answers. The correct answers to questions are indicated by *. 1 Quiz 1 hypertension answers The correct answers to questions are indicated by *. All students were awarded 2 points for question #3 due answer b being misleading. The answer should have read b. calcium

More information

Who typically has Metabolic Syndrome? According to the American Heart Association, three groups of people often have metabolic syndrome:

Who typically has Metabolic Syndrome? According to the American Heart Association, three groups of people often have metabolic syndrome: Metabolic Syndrome By Seth Bilazarian, MD, FACC, FSCAI, RPVI Clinical and Intervential Cardiologist What is the Metabolic Syndrome? The Metabolic Syndrome is a collection of five problems that greatly

More information

Listen to your heart: Good Cardiovascular Health for Life

Listen to your heart: Good Cardiovascular Health for Life Listen to your heart: Good Cardiovascular Health for Life Luis R. Castellanos MD, MPH Assistant Clinical Professor of Medicine University of California San Diego School of Medicine Sulpizio Family Cardiovascular

More information

Management of Lipids in 2015: Just Give them a Statin?

Management 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 information

Associate Professor Patrick Kay Interventional cardiologist Middlemore, Auckland and Mercy Hospitals Auckland

Associate 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 information

Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety

Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety Novel Trial Designs in T2D to Satisfy Regulatory Requirements for CV Safety Anders Svensson MD, PhD Head of Global Clinical Development Metabolism, F Hoffmann LaRoche Ltd. Basel, Switzerland Overview of

More information

JNC-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 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 information

ASCVD Risk Calculators, Controversies and Women

ASCVD Risk Calculators, Controversies and Women ASCVD Risk Calculators, Controversies and Women Ann Cannon, RN, BSN Clinical Specialist for Cardiovascular Health and Heart Failure, MaineHealth Nurse Care Manager, Turning Point Heart Health Program Maine

More information

Will The Coronary Calcium Score Affect the Decision To Treat With Statins?

Will 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 information

Medical 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 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 information

Statins for Hyperlipidemia (High Cholesterol)

Statins 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 information

Systolic Blood Pressure Intervention Trial (SPRINT) Principal Results

Systolic 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 information

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data.

This clinical study synopsis is provided in line with Boehringer Ingelheim s Policy on Transparency and Publication of Clinical Study Data. abcd Clinical Study 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 clinical

More information

GENDER PERSPECTIVE IN CARDIOVASCULAR PHARMACOLOGY & PREVENTION

GENDER PERSPECTIVE IN CARDIOVASCULAR PHARMACOLOGY & PREVENTION GENDER PERSPECTIVE IN CARDIOVASCULAR PHARMACOLOGY & PREVENTION Porter Avital, M.D Head of intermediate ICCU Dept. of Cardiology, Rabin Medical Center- Beilinson Campus, Petah Tiqva, Israel And the Tel

More information

Michel Farnier 1, Kjetil Retterstøl 2, Miroslaw Dluzniewski 3, Albert Császár 4, Armin Steinmetz 5. Dijon, France; 2 Oslo, Norway; 3 Warsaw, Poland; 4

Michel Farnier 1, Kjetil Retterstøl 2, Miroslaw Dluzniewski 3, Albert Császár 4, Armin Steinmetz 5. Dijon, France; 2 Oslo, Norway; 3 Warsaw, Poland; 4 Comparative efficacy and safety of Fenofibrate/Pravastatin/Ezetimibe therapy and Simvastatin/Ezetimibe therapy in Type 2 Diabetic patients with combined hyperlipidemia and cardiovascular disease Michel

More information

Cholesterol - New Guidelines and Treatment Protocols

Cholesterol - New Guidelines and Treatment Protocols Cholesterol - New Guidelines and Treatment Protocols By: James L. Holly, MD The New Year brings new opportunities to improve our health. Many of us receive gifts which we can't use because there's too

More information

Cardiovascular Disease in Diabetes

Cardiovascular 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 information

New 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 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 information

Therapeutic Approach in Patients with Diabetes and Coronary Artery Disease

Therapeutic Approach in Patients with Diabetes and Coronary Artery Disease Home SVCC Area: English - Español - Português Therapeutic Approach in Patients with Diabetes and Coronary Artery Disease Martial G. Bourassa, MD Research Center, Montreal Heart Institute, Montreal, Quebec,

More information

High Blood Cholesterol

High 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 information

Cohort Studies. Sukon Kanchanaraksa, PhD Johns Hopkins University

Cohort 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 information

Sponsor. Novartis Generic Drug Name. Vildagliptin. Therapeutic Area of Trial. Type 2 diabetes. Approved Indication. Investigational.

Sponsor. 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 information

Expert Commentary. A response to the recent JAMA meta analysis on omega 3 supplementation and cardiovascular events

Expert Commentary. A response to the recent JAMA meta analysis on omega 3 supplementation and cardiovascular events Expert Commentary A response to the recent JAMA meta analysis on omega 3 supplementation and cardiovascular events Dr. Bruce J. Holub, Ph.D., Professor Emeritus, University of Guelph Expert Commentary:

More information

Managing High Cholesterol with Heart360

Managing High Cholesterol with Heart360 Managing High Cholesterol with Heart360 For Healthcare Providers and Their Patients rev 11/2014 Managing High Cholesterol with Heart360 For Healthcare Providers and Their Patients Communicating with Your

More information

An International Atherosclerosis Society Position Paper: Global Recommendations for the Management of Dyslipidemia

An International Atherosclerosis Society Position Paper: Global Recommendations for the Management of 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 information

Primary 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 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 information

WENBIT Western Norway B-vitamin Intervention Trial

WENBIT Western Norway B-vitamin Intervention Trial WENBIT Western Norway B-vitamin Intervention Trial Marta Ebbing, MD Department of Heart Disease, Haukeland University Hospital, Bergen The WENBIT Study Group Background and Objectives Background Homocysteine-hypothesis

More information

Description of problem Description of proposed amendment Justification for amendment ERG response

Description of problem Description of proposed amendment Justification for amendment ERG response KEY INACCURACIES Issue 1 Distinguishing between groups of STEMI patients Key issue throughout the report The ERG distinguishes between groups of STEMI patients defining four patient groups: STEMI without

More information

The largest clinical study of Bayer's Xarelto (rivaroxaban) Wednesday, 14 November 2012 07:38

The 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 information

Biostat Methods STAT 5820/6910 Handout #6: Intro. to Clinical Trials (Matthews text)

Biostat Methods STAT 5820/6910 Handout #6: Intro. to Clinical Trials (Matthews text) Biostat Methods STAT 5820/6910 Handout #6: Intro. to Clinical Trials (Matthews text) Key features of RCT (randomized controlled trial) One group (treatment) receives its treatment at the same time another

More information

LDL cholesterol and cardiovascular outcomes?

LDL cholesterol and cardiovascular outcomes? LDL cholesterol and cardiovascular outcomes? Prof Kausik Ray, BSc (hons), MBChB, FRCP, MD, MPhil (Cantab), FACC, FESC Professor of Cardiovascular Disease Prevention St Georges University of London Honorary

More information

Clinical Trials for PCSK9

Clinical Trials for PCSK9 2014 NLA Scientific Sessions, Orlando, FL Clinical Trials for PCSK9 James M. McKenney, PharmD President and CEO, National Clinical Research, Inc. Professor Emeritus, Virginia Commonwealth University Richmond,

More information

ESC/EASD Pocket Guidelines Diabetes, pre-diabetes and cardiovascular disease

ESC/EASD Pocket Guidelines Diabetes, pre-diabetes and cardiovascular disease Diabetes, prediabetes and cardiovascular disease Classes of recommendations Levels of evidence Recommended treatment targets for patients with diabetes and CAD Definition, classification and screening

More information

ABOUT XARELTO CLINICAL STUDIES

ABOUT XARELTO CLINICAL STUDIES ABOUT XARELTO CLINICAL STUDIES FAST FACTS Xarelto (rivaroxaban) is a novel, oral direct Factor Xa inhibitor. On September 30, 2008, the European Commission granted marketing approval for Xarelto for the

More information

Making 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! 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 information

International 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. 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 information

DUAL ANTIPLATELET THERAPY. Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania

DUAL ANTIPLATELET THERAPY. Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania DUAL ANTIPLATELET THERAPY Dr Robert S Mvungi, MD(Dar), Mmed (Wits) FCP(SA), Cert.Cardio(SA) Phy Tanzania Cardiac Society Dar es Salaam Tanzania DUAL ANTIPLATELET THERAPY (DAPT) Dual antiplatelet regimen

More information

Guidance 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 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 information

Secondary Stroke Prevention. Lawrence R. Wechsler, M.D.

Secondary Stroke Prevention. Lawrence R. Wechsler, M.D. Secondary Stroke Prevention Lawrence R. Wechsler, M.D. Outline Risk factor modification Antiplatelet therapy Anticoagulation Intracranial stenosis PFO and stroke Risk Factor Control Hypertension - < 140/90,

More information

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd.

The Clinical Trial Protocol Guide. BioStrategics Consulting Ltd. The Clinical Trial Protocol Guide 2011 BioStrategics Consulting Ltd. BioStrategics Consulting Ltd THE CLINICAL TRIAL PROTOCOL The clinical trial protocol to test one s product, to confirm or reject a specific

More information

First step: determine the goal for dyslipidemia treatment (primary prevention vs. secondary prevention)

First step: determine the goal for dyslipidemia treatment (primary prevention vs. secondary prevention) The American college of cardiology (ACC) and American Heart Association (AHA) in combination with National Heart, Lung and blood institute (NHLBI) have released 4 new guidelines. At the invitation of the

More information

REACH Risk Evaluation to Achieve Cardiovascular Health

REACH Risk Evaluation to Achieve Cardiovascular Health Dyslipidemia and type 1 diabetes mellitus History: A 15-year-old girl is seen in the endocrinology clinic for a routine follow-up visit for type 1 diabetes. She was diagnosed with diabetes at 12 years

More information

Cardiovascular Effects of Drugs to Treat Diabetes

Cardiovascular 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 information

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain

PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain P a g e 1 PROTOCOL SYNOPSIS Evaluation of long-term opioid efficacy for chronic pain Clinical Phase 4 Study Centers Study Period 25 U.S. sites identified and reviewed by the Steering Committee and Contract

More information

AKB-6548 clinical development overview early clinical studies (CI-0001 to CI-

AKB-6548 clinical development overview early clinical studies (CI-0001 to CI- AKB-6548 clinical development overview early clinical studies (CI-0001 to CI- 0004, and CI-0006) To date, AKB-6548 has been studied in 8 clinical trials across 4 separate patient populations: healthy volunteers

More information

Brief Communications. Awad Mohamed Ahmed, MD. Abstract

Brief Communications. Awad Mohamed Ahmed, MD. Abstract Awad Mohamed Ahmed, MD Professor of Medicine, University of Bahr Elghazal, Khartoum, Sudan For correspondence Professor Awad Mohamed Ahmed E-mail: awad.sd@gmail.com Tel.: +249 912344936 Abstract Randomized

More information

Statins: Can there be too much of a good thing?

Statins: Can there be too much of a good thing? Statins: Can there be too much of a good thing? Spoiler alert No Oh Contraire Haaaaiiiiiiile No! Frequently under prescribing statin therapy! Typical Case 68 YO Smoker ACS Multiple prior PCI s Multiple

More information

Sponsor Novartis Pharmaceuticals

Sponsor Novartis Pharmaceuticals Clinical Trial Results Database Page 1 Sponsor Novartis Pharmaceuticals Generic Drug Name Indacaterol Therapeutic Area of Trial Chronic Obstructive Pulmonary Disease (COPD) Indication studied: COPD Study

More information

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background:

1.0 Abstract. Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA. Keywords. Rationale and Background: 1.0 Abstract Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians taking HUMIRA Keywords Rationale and Background: This abbreviated clinical study report is based on a clinical surveillance

More information

Outline Introduction Oidti Oxidative damage Antioxidants properties Antioxidants and antiaging interventions Hormonal therapy Benefits of DHEA, testos

Outline Introduction Oidti Oxidative damage Antioxidants properties Antioxidants and antiaging interventions Hormonal therapy Benefits of DHEA, testos Anti-Aging Aging g Medications What is the Evidence? Sixth Annual Family Medicine Conference Crown Plaza November 11, 2007 Presented by : Jad J. Sakr, Pharm.D. Outline Introduction Oidti Oxidative damage

More information

Texto proveniente de: ACSM s Certified News

Texto proveniente de: ACSM s Certified News Texto proveniente de: ACSM s Certified News Peripheral Arterial Disease By Nina Markil, B.S. Exercise Science and Health Promotion at Florida Atlantic University. CNews19.2Final.JR:Layout 1 5/6/09 Peripheral

More information

Evidence for Statins in

Evidence 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 information

Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II).

Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). Complete Summary GUIDELINE TITLE (1)Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment

More information

Effects of Clopidogrel Added to Aspirin in Patients with Recent Lacunar Stroke

Effects of Clopidogrel Added to Aspirin in Patients with Recent Lacunar Stroke Effects of Clopidogrel Added to Aspirin in Patients with Recent Lacunar Stroke N Eng J Med, 2012 Karen Hecht und Thomas Gattringer Introduction Stroke 20% ICH 80% ischemia atherosclerosis cardioembolism

More information

THE ROLE OF BETA-BLOCKERS IN THE MANAGEMENT AFTER MYOCARDIAL INFARCTION

THE ROLE OF BETA-BLOCKERS IN THE MANAGEMENT AFTER MYOCARDIAL INFARCTION THE ROLE OF BETA-BLOCKERS IN THE MANAGEMENT AFTER MYOCARDIAL INFARCTION Dr. Nani Hersunarti, SpJP(K) Department of Cardiology and Vascular Medicine Faculty of Medicine Universitas Indonesia National Cardiovascular

More information

Endorsement Summary: Cardiovascular Measures

Endorsement Summary: Cardiovascular Measures January 2012 Purpose of the Project The human and financial costs of cardiovascular disease are enormous. Heart disease is the leading cause of death for men and women in the United States and was estimated

More information

What You Need to Know about High Blood Cholesterol

What You Need to Know about High Blood Cholesterol What You Need to Know about High Blood Why is high cholesterol bad? is a natural substance found in our diet and made by our liver. It is important for many functions throughout our body. High blood cholesterol

More information

Perspectives on the Selection and Duration of Dual Antiplatelet Therapy

Perspectives 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 information