Primary Prevention of Cardiovascular Disease with a Mediterranean diet

Size: px
Start display at page:

Download "Primary Prevention of Cardiovascular Disease with a Mediterranean diet"

Transcription

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

2 Background The traditional Mediterranean diet is characterized by a high intake of olive oil, fruit, nuts, vegetables, and cereals. Increasing adherence to the Mediterranean diet has been consistently beneficial with respect to cardiovascular risk. Aim Test the efficacy of two Mediterranean diets (1 and 2) on primary cardiovascular prevention. 1. one supplemented with extra-virgin olive oil 2. and another with nuts 3. as compared with a control diet (advice on a low-fat diet), 2

3 Study design Parallel-group, multicenter, randomized trial. Inclusion criteria Participants were men (55 to 80 years of age) and women (60 to 80 years of age). No cardiovascular disease at enrollment. Either type 2 diabetes mellitus or at least three of the following major risk factors: smoking, hypertension, elevated low or highdensity lipoprotein cholesterol levels, overweight/obesity, or a family history of premature coronary heart disease. 3

4 Intervention groups Participants were randomly assigned, in a 1:1:1 ratio, to one of three dietary intervention groups: 1. a Mediterranean diet supplemented with extra-virgin olive oil. 2. a Mediterranean diet supplemented with nuts. 3. a control diet. Randomization was performed centrally by means of a computergenerated random-number sequence. 4

5 5

6 Intervention 1. Participants in the two Mediterranean-diet groups received either extra-virgin olive oil (approximately1 liter per week) 2. or 30 g of mixed nuts per day (15 g of walnuts, 7.5 g of hazelnuts, and 7.5 g of almonds) 3. Control group received small nonfood gifts. Participants in the control group also received dietary training at the baseline visit No total calorie restriction was advised, nor was physical activity promoted. 6

7 Measurements A baseline visit and quarterly thereafter (group 1 and 2) dietary screener was used to assess adherence to the Mediterranean diet. Three general medical questionnaire were administered on a yearly basis. Biomarkers of compliance (urinary and blood samples). Control group also received dietary training at the baseline visit. Thereafter, during the first 3 years of the trial, they received a leaflet explaining the low fat diet. 7

8 End Points Primary end point was a composite of myocardial infarction, stroke, and death from cardiovascular causes Secondary end points were stroke, myocardial infarction, death from cardiovascular causes, and death from any cause. 8

9 Statistical analysis power calculation We initially estimated that a sample of 9000 participants would be required to provide statistical power of 80% to detect a relative risk reduction of 20% in each Mediterranean-diet group versus the control-diet group during a 4-year follow-up period, assuming an event rate of 12% in the control group. lower-than-expected rates of end-point events, the sample size was recalculated as 7400 participants, with the assumption of a 6-year. Yearly interim analyses. Reach the boundary to the primary endpoint and the study stopped

10 Statistical methods All primary analyses were performed on an intention-to-treat basis by two independent analysts. Time-to-event data were analyzed with the use of Cox models with two dummy variables (one for the Mediterranean diet with extra-virgin olive oil and another for the Mediterranean diet with nuts) to obtain two hazard ratios for the comparison with the control group. To account for small imbalances in risk factors at baseline among the groups, Cox regression models were used to adjust for sex, age, and baseline risk factors. We tested the proportionality of hazards with the use of timevarying covariates. 10

11 Statistical analysis All primary analyses were performed on an intention-to-treat basis by two independent analysts. Time-to-event data were analyzed with the use of Cox models with two dummy variables. Sensitivity analyses were conducted under several assumptions, including imputation of data for missing values and participants who dropped out. All analyses were stratified according to center. Prespecified subgroup analyses were conducted according to sex, age, body-mass index (BMI), cardiovascular-risk-factor status, and baseline adherence to the Mediterranean diet.

12 Results N= 7447 Follow up time: median 4.8 years (IQR ) Women 57% - Mean age 67 years Compliance to diet: scores improved in the MEDdiet groups and changes in biomarkers supported this Dropout: 523 (7.0%)lost to follow-up for 2 or more years were: younger (1.4 years) higher BMI (0.4) higher waist-to height ratio (by 0.01) lower score for adherence to the Mediterranean diet (1.0 points) (all p<0.05) Dropout rates were higher in the control group (11.3%) than in the Mediterranean diet groups (4.9%)

13 Hazard Kaplan Meier ratio for Med Estimates diets of combined the Incidence of Outcome Events in the Total Study Population. vs control (95% CI) Interested in the length of time for the patient to reach endpoint Primary end point event (composite of MI, stroke or CVD death) occurred in 288 participants. Multivariable-adjusted hazard ratios were: 0.70 (CI p<0.01) Oil 0.72 (CI p<0.01) - Nuts 30% risk reduction with Med diet. Mortality: No effect on all-cause mortality Kaplan Meier curve: Shows the cumulative incidence of the endpoint (1-survival probability) Allows to take into account censored data (pts lost from sample before final outcome is observed Estruch R et al. N Engl J Med 2013;368:

14 Subgroup analysis: Results of Subgroup Analyses. Squares denote hazard ratios and horizontal lines CI Most hazard ratios are below 1 => Mediterranean diet better Estruch R et al. N Engl J Med 2013;368:

15 Cox? A proportional hazard model = a class of survival analysis when you need to control for several variables (multivariable) Fits models for survival time or time-to-event outcomes on one ore more predictors; time is measured until outcome occurs or subjects are censored (no outcome) time measure starts at a fixed point Independent random sample from the population Semiparametric, more robust than parametric methods 15

16 Cox regression? 16

17 Cox? The Cox model provides an estimate of the treatment effect on survival / time-to-event outcome after adjustment for other explanatory variables. In addition, it allows us to estimate the hazard (or risk) of event for an individual, given their prognostic variables. 17

18 Conclusions An energy-unrestricted Mediterranean diet, supplemented with extra-virgin olive oil or nuts, resulted in a substantial reduction in the risk of major cardiovascular events among high-risk persons. The results support the benefits of the Mediterranean diet for the primary prevention of cardiovascular disease.

19 THANKS!

National Lipid Association 2014 Scientific Sessions, Orlando, FL

National Lipid Association 2014 Scientific Sessions, Orlando, FL National Lipid Association 2014 Scientific Sessions, Orlando, FL Lori Alexander, MSHS, RD, CCRC, CLS, FNLA Site Director St Johns Center for Clinical Research Ponte Vedra, FL Financial Disclosures None

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

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

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

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

Tips for surviving the analysis of survival data. Philip Twumasi-Ankrah, PhD

Tips for surviving the analysis of survival data. Philip Twumasi-Ankrah, PhD Tips for surviving the analysis of survival data Philip Twumasi-Ankrah, PhD Big picture In medical research and many other areas of research, we often confront continuous, ordinal or dichotomous outcomes

More information

Always Start with PECO

Always Start with PECO Goals of This Course Be able to understand a study design (very basic concept) Be able to understand statistical concepts in a medical paper Be able to perform a data analysis Understanding: PECO study

More information

DIETARY ISSUES IN DIABETES

DIETARY ISSUES IN DIABETES DIETARY ISSUES IN DIABETES Elizabeth J Mayer Davis, PhD Department of Nutrition, Gillings School of Global Public Health Department of Medicine, School of Medicine University of North Carolina at Chapel

More information

Journal 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 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 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

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

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

Hormones and cardiovascular disease, what the Danish Nurse Cohort learned us

Hormones and cardiovascular disease, what the Danish Nurse Cohort learned us Hormones and cardiovascular disease, what the Danish Nurse Cohort learned us Ellen Løkkegaard, Clinical Associate Professor, Ph.d. Dept. Obstetrics and Gynecology. Hillerød Hospital, University of Copenhagen

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

Mediterranean diet: A heart-healthy eating plan Source: mayoclinic.org/mediterranean-diet

Mediterranean diet: A heart-healthy eating plan Source: mayoclinic.org/mediterranean-diet Mediterranean diet: A heart-healthy eating plan Source: mayoclinic.org/mediterranean-diet The heart-healthy Mediterranean is a healthy eating plan based on typical foods and recipes of Mediterranean-style

More information

UNDERSTANDING CLINICAL TRIAL STATISTICS. Prepared by Urania Dafni, Xanthi Pedeli, Zoi Tsourti

UNDERSTANDING CLINICAL TRIAL STATISTICS. Prepared by Urania Dafni, Xanthi Pedeli, Zoi Tsourti UNDERSTANDING CLINICAL TRIAL STATISTICS Prepared by Urania Dafni, Xanthi Pedeli, Zoi Tsourti DISCLOSURES Urania Dafni has reported no conflict of interest Xanthi Pedeli has reported no conflict of interest

More information

Prognostic impact of uric acid in patients with stable coronary artery disease

Prognostic 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 information

This supplementary material has been provided by the authors to give readers additional information about their work.

This supplementary material has been provided by the authors to give readers additional information about their work. SUPPLEMENTAL MATERIAL Table S1. The logistic regression model used to calculate the propensity score. Table S2. Distribution of propensity score among the treat and control groups of the full and matched

More information

Social inequalities in all cause and cause specific mortality in a country of the African region

Social inequalities in all cause and cause specific mortality in a country of the African region Social inequalities in all cause and cause specific mortality in a country of the African region Silvia STRINGHINI 1, Valentin Rousson 1, Bharathi Viswanathan 2, Jude Gedeon 2, Fred Paccaud 1, Pascal Bovet

More information

Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73)

Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73) open access Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73) Christopher E Ramsden, 1,2 Daisy Zamora, 3 Sharon Majchrzak-Hong,

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

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

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

General and Abdominal Adiposity and Risk of Death in Europe

General and Abdominal Adiposity and Risk of Death in Europe Deutsches Institut für Ernährungsforschung Potsdam-Rehbrücke General and Abdominal Adiposity and Risk of Death in Europe Tobias Pischon Department of Epidemiology German Institute of Human Nutrition Potsdam-Rehbruecke

More information

Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study

Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study DOI 10.1007/s00198-012-2224-2 ORIGINAL ARTICLE Health risks and benefits from calcium and vitamin D supplementation: Women's Health Initiative clinical trial and cohort study R. L. Prentice & M. B. Pettinger

More information

The 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 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 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

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

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

Η δίαιτα στην πρόληψη του αγγειακού εγκεφαλικού επεισοδίου

Η δίαιτα στην πρόληψη του αγγειακού εγκεφαλικού επεισοδίου ΠΡΟΓΡΑΜΜΑ ΜΕΤΑΠΤΥΧΙΑΚΩΝ ΣΠΟΥΔΩΝ «Η ΔΙΑΤΡΟΦΗ ΣΤΗΝ ΥΓΕΙΑ ΚΑΙ ΣΤΗ ΝΟΣΟ» Η δίαιτα στην πρόληψη του αγγειακού εγκεφαλικού επεισοδίου Γεώργιος Ντάιος Παθολογική Κλινική Πανεπιστημίου Θεσσαλίας Stroke Statistics

More information

Does Diabetes Control Matter?

Does Diabetes Control Matter? Does Diabetes Control Matter? Laurence Kennedy, MD, FRCP Endocrinology Department Cleveland Clinic, OH Disclosures None Does Diabetes Control Matter? Generality of patients Relative Risk Complications

More information

The role of a low sodium diet in the management of hypertension. Dave Glover Consultant Nephrologist, Wrexham

The role of a low sodium diet in the management of hypertension. Dave Glover Consultant Nephrologist, Wrexham The role of a low sodium diet in the management of hypertension Dave Glover Consultant Nephrologist, Wrexham Salt Aims Is it all a bit Woman s Own / Daily Mail? Current guidelines An idea about salt What

More information

Margarines and Heart Disease. Do they protect?

Margarines and Heart Disease. Do they protect? Margarines and Heart Disease Do they protect? Heart disease Several studies, including our own link margarine consumption with heart disease. Probably related to trans fatty acids elevate LDL cholesterol

More information

Randomized trials versus observational studies

Randomized 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 information

Quantifying Life expectancy in people with Type 2 diabetes

Quantifying 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 information

4/9/2015. Risk Stratify Our Patients. Stroke Risk in AF: CHADS2 Scoring system JAMA 2001; 285: 2864-71

4/9/2015. Risk Stratify Our Patients. Stroke Risk in AF: CHADS2 Scoring system JAMA 2001; 285: 2864-71 Anticoagulation in the 21 st Century Adam Karpman, D.O. Saint Francis Medical Center/Oklahoma State University Medical Center Disclosures: None Atrial Fibrillation Most common arrhythmia in clinical practice.

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

chapter 1 Chapter 2 chapter 3

chapter 1 Chapter 2 chapter 3 SUMMARY summary Theaimofthisthesiswastodescribethedevelopmentandevaluationofanindividual basedlifestyleinterventionamongworkersintheconstructionindustrywithanelevated risk of cardiovascular disease (CVD).

More information

Combined Diet and Physical Activity Promotion Programs to Prevent Type 2 Diabetes Among People at Increased Risk

Combined Diet and Physical Activity Promotion Programs to Prevent Type 2 Diabetes Among People at Increased Risk Combined Diet and Physical Activity Promotion s to Prevent Type 2 Diabetes Among People at Increased Risk Results of Comparative Studies of Combined Diet & Physical Activity vs. Categorical Outcomes Author,

More information

Assmann Foundation for Prevention 1

Assmann Foundation for Prevention 1 Clinical guidelines usually recommend that the level of high density lipoprotein cholesterol (HDL-C) should be measured. It is frequently argued that HDL-C levels below 35 mg/dl are causally associated

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

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

Article in Review. Citations to date: 67!

Article in Review. Citations to date: 67! Journal Club Week 1 Doctor, I have migraine with aura, am I more likely to die of cardiovascular disease?!!!!!!!!!!!!!! Samantha Warhurst! Med3000 Student! ! Article in Review Gudmundsson, L. S., Scher,

More information

If several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form.

If several different trials are mentioned in one publication, the data of each should be extracted in a separate data extraction form. General Remarks This template of a data extraction form is intended to help you to start developing your own data extraction form, it certainly has to be adapted to your specific question. Delete unnecessary

More information

Cardiovascular risk calculator for diabetic patients 이해영서울대학병원순환기내과

Cardiovascular risk calculator for diabetic patients 이해영서울대학병원순환기내과 Cardiovascular risk calculator for diabetic patients 이해영서울대학병원순환기내과 Contents Need of risk engine for diabetic patients Three main approaches of global cardiovascular risk estimation in diabetes Validation

More information

4/4/2013. Mike Rizo, Pharm D, MBA, ABAAHP THE PHARMACIST OF THE FUTURE? METABOLIC SYNDROME AN INTEGRATIVE APPROACH

4/4/2013. Mike Rizo, Pharm D, MBA, ABAAHP THE PHARMACIST OF THE FUTURE? METABOLIC SYNDROME AN INTEGRATIVE APPROACH METABOLIC SYNDROME AN INTEGRATIVE APPROACH AN OPPORTUNITY FOR PHARMACISTS TO MAKE A DIFFERENCE Mike Rizo, Pharm D, MBA, ABAAHP THE EVOLUTION OF THE PHARMACIST 1920s 1960s 2000s THE PHARMACIST OF THE FUTURE?

More information

PRACTICE PROBLEMS FOR BIOSTATISTICS

PRACTICE PROBLEMS FOR BIOSTATISTICS PRACTICE PROBLEMS FOR BIOSTATISTICS BIOSTATISTICS DESCRIBING DATA, THE NORMAL DISTRIBUTION 1. The duration of time from first exposure to HIV infection to AIDS diagnosis is called the incubation period.

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

Dual Antiplatelet Therapy. Stephen Monroe, MD FACC Chattanooga Heart Institute

Dual 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 information

Diabetes Complications

Diabetes Complications Managing Diabetes: It s s Not Easy But It s s Worth It Presenter Disclosures W. Lee Ball, Jr., OD, FAAO (1) The following personal financial relationships with commercial interests relevant to this presentation

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

Risk Engines in Diabetes

Risk Engines in Diabetes Risk Engines in Diabetes Martin Bland Prof. of Health Statistics University of York http://www-users.york.ac.uk/~mb55/msc/ What is a risk engine? A fancy name for a prediction of risk from the characteristics

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

Study Design. Date: March 11, 2003 Reviewer: Jawahar Tiwari, Ph.D. Ellis Unger, M.D. Ghanshyam Gupta, Ph.D. Chief, Therapeutics Evaluation Branch

Study Design. Date: March 11, 2003 Reviewer: Jawahar Tiwari, Ph.D. Ellis Unger, M.D. Ghanshyam Gupta, Ph.D. Chief, Therapeutics Evaluation Branch BLA: STN 103471 Betaseron (Interferon β-1b) for the treatment of secondary progressive multiple sclerosis. Submission dated June 29, 1998. Chiron Corp. Date: March 11, 2003 Reviewer: Jawahar Tiwari, Ph.D.

More information

Preventing Heart Disease

Preventing Heart Disease Preventing Heart Disease Debra Krummel, PhD, RDN, FAND 3/4/16 1 Risk Factors Modifiable Dyslipidemia High LDL-C Low HDL-C Elevated triglycerides Hypertension Diabetes Obesity Dietary factors Sedentary

More information

Metabolic Syndrome with Prediabetic Factors Clinical Study Summary Concerning the Efficacy of the GC Control Natural Blood Sugar Support Supplement

Metabolic Syndrome with Prediabetic Factors Clinical Study Summary Concerning the Efficacy of the GC Control Natural Blood Sugar Support Supplement CLINICALLY T E S T E D Natural Blood Sugar Metabolic Syndrome with Prediabetic Factors Clinical Study Summary Concerning the Efficacy of the GC Control Natural Blood Sugar Metabolic Syndrome with Prediabetic

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

Pediatric Metabolic Syndrome

Pediatric Metabolic Syndrome University of Michigan Hospitals and Health Centers Pediatric Metabolic Syndrome A growing epidemic Shannon Russell Dietetic Intern June 2012 Overview Causes Risk Factors Signs and Symptoms Identification/Diagnosis

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

Study Design and Statistical Analysis

Study Design and Statistical Analysis Study Design and Statistical Analysis Anny H Xiang, PhD Department of Preventive Medicine University of Southern California Outline Designing Clinical Research Studies Statistical Data Analysis Designing

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

Guide to Biostatistics

Guide to Biostatistics MedPage Tools Guide to Biostatistics Study Designs Here is a compilation of important epidemiologic and common biostatistical terms used in medical research. You can use it as a reference guide when reading

More information

Health risk assessment: a standardized framework

Health risk assessment: a standardized framework Health risk assessment: a standardized framework February 1, 2011 Thomas R. Frieden, MD, MPH Director, Centers for Disease Control and Prevention Leading causes of death in the U.S. The 5 leading causes

More information

Prognostic Outcome Studies

Prognostic Outcome Studies Prognostic Outcome Studies Edwin Chan PhD Singapore Clinical Research Institute Singapore Branch, Australasian Cochrane Centre Duke-NUS Graduate Medical School Contents Objectives Incidence studies (Prognosis)

More information

With Big Data Comes Big Responsibility

With Big Data Comes Big Responsibility With Big Data Comes Big Responsibility Using health care data to emulate randomized trials when randomized trials are not available Miguel A. Hernán Departments of Epidemiology and Biostatistics Harvard

More information

Inflammation, Arthritis, and Nutrition

Inflammation, Arthritis, and Nutrition Inflammation, Arthritis, and Nutrition Kristin Baker, PhD Assistant Research Professor ENACT Sargent College at Boston University Email: krbaker@bu.edu ENACT website: www.bu.edu/enact Brief Bio Primary

More information

Inter99 Description of diet and physical activity intervention in lifestyle consultation

Inter99 Description of diet and physical activity intervention in lifestyle consultation Inter99 Description of diet and physical activity intervention in lifestyle consultation By MD, PhD Charlotta Pisinger and clinical dietician Lis Kristoffersen Introduction In general Advices given on

More information

Appendix: Description of the DIETRON model

Appendix: 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

Challenges with Clinical Trials in Nephrology. Bruce Culleton, MD MSc FRCPC University of Calgary

Challenges with Clinical Trials in Nephrology. Bruce Culleton, MD MSc FRCPC University of Calgary Challenges with Clinical Trials in Nephrology Bruce Culleton, MD MSc FRCPC University of Calgary Challenges (with the design, conduct, and interpretation) of Clinical Trials in Nephrology Bruce Culleton,

More information

Summary HTA. HTA-Report Summary. Introduction

Summary 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 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

Improving cardiometabolic health in Major Mental Illness

Improving cardiometabolic health in Major Mental Illness Improving cardiometabolic health in Major Mental Illness Dr. Adrian Heald Consultant in Endocrinology and Diabetes Leighton Hospital, Crewe and Macclesfield Research Fellow, Manchester University Metabolic

More information

Treatment of Diabetic Patient with Multivessel Coronary Artery Disease: the Surgeon Perspective

Treatment of Diabetic Patient with Multivessel Coronary Artery Disease: the Surgeon Perspective Treatment of Diabetic Patient with Multivessel Coronary Artery Disease: the Surgeon Perspective Fabio B. Jatene Full Professor of Cardiovascular Surgery Heart Institute - HC-FMUSP fabiojatene@incor.usp.br

More information

REACH Risk Evaluation to Achieve Cardiovascular Health

REACH Risk Evaluation to Achieve Cardiovascular Health Dyslipidemia and obesity History: A 13-year-old girl is seen for a routine clinic follow-up visit. She has been previously healthy, but her growth curve shows increasing body mass index (BMI) percentiles

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

Design and principal results

Design and principal results International Task Force for Prevention Of Coronary Heart Disease Coronary heart disease and stroke: Risk factors and global risk Slide Kit 1 (Prospective Cardiovascular Münster Heart Study) Design and

More information

Survival Analysis Using SPSS. By Hui Bian Office for Faculty Excellence

Survival Analysis Using SPSS. By Hui Bian Office for Faculty Excellence Survival Analysis Using SPSS By Hui Bian Office for Faculty Excellence Survival analysis What is survival analysis Event history analysis Time series analysis When use survival analysis Research interest

More information

Supplementary appendix

Supplementary appendix Supplementary appendix This appendix formed part of the original submission and has been peer reviewed. We post it as supplied by the authors. Supplement to: Gold R, Giovannoni G, Selmaj K, et al, for

More information

Greg Peterson, MPA, PhD candidate Melissa McCarthy, PhD Presentation for 2013 AcademyHealth Annual Research Meeting

Greg Peterson, MPA, PhD candidate Melissa McCarthy, PhD Presentation for 2013 AcademyHealth Annual Research Meeting Greg Peterson, MPA, PhD candidate Melissa McCarthy, PhD Presentation for 2013 AcademyHealth Annual Research Meeting Medicare Coordinated Care Demonstration (MCCD) Established in Balanced Budget Act of

More information

Summary Evaluation of the Medicare Lifestyle Modification Program Demonstration and the Medicare Cardiac Rehabilitation Benefit

Summary Evaluation of the Medicare Lifestyle Modification Program Demonstration and the Medicare Cardiac Rehabilitation Benefit The Centers for Medicare & Medicaid Services' Office of Research, Development, and Information (ORDI) strives to make information available to all. Nevertheless, portions of our files including charts,

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

Comparative Tolerability and Harms of Individual Statins

Comparative Tolerability and Harms of Individual Statins Comparative Tolerability and Harms of Individual Statins J.J.Brugts MD PhD MSc(1); H. Naci PhD MHS(2); T. Ades PhD(2) (1) Department of Cardiology, Erasmus MC, Rotterdam, the Netherlands (2) London School

More information

Success factors in Behavioral Medicine

Success factors in Behavioral Medicine Success factors in Behavioral Medicine interventions post myocardial infarction Depression Gunilla post myocardial Burell, PhD infarction Department of Public Health, Uppsala University, Sweden XIII Svenska

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

PRECOMBAT Trial. Seung-Whan Lee, MD, PhD On behalf of the PRECOMBAT Investigators

PRECOMBAT Trial. Seung-Whan Lee, MD, PhD On behalf of the PRECOMBAT Investigators Premier of Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients with Left Main Coronary Artery Disease PRECOMBAT Trial Seung-Whan Lee, MD, PhD On behalf

More information

Comparative Effectiveness of Interventions for Secondary Prevention of Atrial Fibrillation Following Ablation. Larisa Tereshchenko, MD, PhD

Comparative Effectiveness of Interventions for Secondary Prevention of Atrial Fibrillation Following Ablation. Larisa Tereshchenko, MD, PhD Comparative Effectiveness of Interventions for Secondary Prevention of Atrial Fibrillation Following Ablation Larisa Tereshchenko, MD, PhD Rationale for trial: Atrial fibrillation (AF) is associated with

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

Safety & Effectiveness of Drug Therapies for Type 2 Diabetes: Are pharmacoepi studies part of the problem, or part of the solution?

Safety & Effectiveness of Drug Therapies for Type 2 Diabetes: Are pharmacoepi studies part of the problem, or part of the solution? Safety & Effectiveness of Drug Therapies for Type 2 Diabetes: Are pharmacoepi studies part of the problem, or part of the solution? IDEG Training Workshop Melbourne, Australia November 29, 2013 Jeffrey

More information

DDD is Superior to VVI?

DDD is Superior to VVI? DDD is Superior to VVI? Jeong-Gwan Cho, MD, FACC Division of Cardiology Chonnam University Hospital What is your answer? My answer is no, based on the several randomized clinical trials. The era of evidence-based

More information

REACH Risk Evaluation to Achieve Cardiovascular Health

REACH Risk Evaluation to Achieve Cardiovascular Health Dyslipidemia and type 2 diabetes mellitus History: A 17-year-old Hispanic female patient is seen for a routine clinic follow-up visit. She was diagnosed with type 2 diabetes 6 months ago. Her hemoglobin

More information

PROTOCOL ACTION FOR HEALTH IN DIABETES. Look AHEAD. Clinical Trial

PROTOCOL ACTION FOR HEALTH IN DIABETES. Look AHEAD. Clinical Trial PROTOCOL ACTION FOR HEALTH IN DIABETES Look AHEAD Clinical Trial Approved by the Look AHEAD Protocol Review Committee First Issue February 06, 2001 First Revision, May 10, 2001 Second Revision, October

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

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

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

Chronic diseases in low and middle income countries: more research or more action? Shah Ebrahim London School of Hygiene & Tropical Medicine

Chronic diseases in low and middle income countries: more research or more action? Shah Ebrahim London School of Hygiene & Tropical Medicine Chronic diseases in low and middle income countries: more research or more action? Shah Ebrahim London School of Hygiene & Tropical Medicine More action needed Overview Growing burden of chronic diseases

More information

on behalf of the AUGMENT-HF Investigators

on behalf of the AUGMENT-HF Investigators One Year Follow-Up Results from AUGMENT-HF: A Multicenter Randomized Controlled Clinical Trial of the Efficacy of Left Ventricular Augmentation with Algisyl-LVR in the Treatment of Heart Failure* Douglas

More information

2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: CLAIMS, REGISTRY

2016 PQRS OPTIONS FOR INDIVIDUAL MEASURES: CLAIMS, REGISTRY Measure #317: Preventive Care and Screening: Screening for High Blood Pressure and Follow-Up Documented National Quality Strategy Domain: Community / Population Health 2016 PQRS OPTIONS F INDIVIDUAL MEASURES:

More information

Taking a statin to reduce the risk of coronary heart disease and stroke

Taking a statin to reduce the risk of coronary heart disease and stroke Patient decision aid Taking a statin to reduce the risk of coronary heart disease and stroke http://www.nice.org.uk/guidance/cg181/resources/cg181-lipid-modification-update-patient-decisionaid2 Published:

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

Protein Intake and Diabetic Kidney Disease. Robert C. Stanton Joslin Diabetes Center

Protein Intake and Diabetic Kidney Disease. Robert C. Stanton Joslin Diabetes Center Protein Intake and Diabetic Kidney Disease Robert C. Stanton Joslin Diabetes Center 1/Serum Creatinine Plot Low Protein Protects in Renal Ablation Model 24% Protein Diet 6% Protein Diet Right Nephrectomy

More information