 |
|
Aspirin Effects on Mortality and Morbidity in Patients With Diabetes MellitusEarly Treatment Diabetic Retinopathy Study Report 14
ETDRS Investigators;
Aaron Kassoff, MD;
Sheldon M. Buzney, MD;
J. Wallace McMeel, MD;
John J. Weiter, MD, PhD;
Gerald J. Doyle, MD;
Rodney L. Immerman, OD;
Gerald R. Friedman, OD;
Michael L. Klein, MD;
Richard Dreyer, MD;
Richard Chenoweth, MD;
Irvin Handelman, MD;
Richard Hohl, MD;
Robert Biesbroeck, MD;
Jack Sipperley, MD;
Charles A. Garcia, MD;
Michael A. Bloome, MD;
Richard S. Ruiz, MD;
F. Tempel Riekhof, MD;
William A. Bohart, MD;
Roy A. Goodart, MD;
Dana H. Clarke, MD;
David H. Orth, MD;
Timothy P. Flood, MD;
Kirk H. Packo, MD;
Jayant Malhotra, MD;
Akbar Rahmani, MD;
Edward J. Winter, MD;
Harish Bhatia, MD;
Robert P. Murphy, MD;
Stuart L. Fine, MD;
Michael J. Elman, MD;
Frederick L. Ferris III, MD;
Thaddeus E. Prout, MD;
Arnall Patz, MD;
Thomas A. Rice, MD;
David Newsome, MD;
Lloyd M. Aiello, MD;
Lawrence I. Rand, MD;
Sabera T. Shah, MD;
Ramachandiran Cooppan, MD;
Jerry Cavallerano, OD, PhD;
Robert Poole, OD;
Philip Silver, OD;
Jose Briones, Jr, MD;
Mohammed Z. Wafai, MD;
Abdul C. Asmal, MD, PhD;
Rudolph M. Franklin, MD;
Laurence Arend, MD;
Donald Bergsma, MD;
Lance Turkish, MD;
Paul Beer, MD;
Denis Carroll, MD;
Edgar Thomas, MD;
Thomas C. Burton, MD;
Gary W. Abrams, MD;
Hak-Joong Kim, MD;
George A. Williams, MD;
Trexler M. Topping, MD;
Frederick H. Reeser, MD;
Thomas M. Aaberg, MD;
Gregory S. Brinton, MD;
James K. Kingham, MD;
Travis A. Meredith, MD;
Raymond R. Margherio, MD;
Patrick L. Murphy, MD;
Morton S. Cox, MD;
Michael Trese, MD;
Steven Winokur, MD;
Everett Ai, MD;
Robert Sorenson, MD;
Gary Arsham, MD;
John Cavender, MD;
Stanley M. Kopelow, MD;
Alan L. Shabo, MD;
Jose C. Briones, Jr, MD;
Richard D. Hornichter, MD;
Norman P. Blair, MD;
Morton F. Goldberg, MD;
C. Ronald Lindberg, MD;
Neil L. Ross, MD;
Lynn E. Hauser, MD;
Jose Cunha-Vaz, MD, PhD;
J. Terry Ernest, MD, PhD;
James C. Liang, MD;
Steven B. Cohen, MD;
Charles Vygantas, MD;
Gerald Williams, MD;
Harry W. Flynn, Jr, MD;
George W. Blankenship, MD;
William H. Knobloch, MD;
Robert C. Ramsay, MD;
Herbert L. Cantrill, MD;
Frederick C. Goetz, MD;
Byron Hoogwerf, MD;
José Berrocal, MD;
Raúl Pérez, MD;
A. Ramos Umpierre, MD;
James L. Kinyoun, MD;
Robert E. Kalina, MD;
Craig G. Wells, MD;
Steven V. Guzak, MD;
Jerry Palmer, MD;
Frank L. Myers, MD;
George H. Bresnick, MD;
Suresh R. Chandra, MD;
Matthew D. Davis, MD;
Ronald Klein, MD;
Thomas S. Stevens, MD;
Ingolf H. Wallow, MD;
Russell Dixon, MD;
Edward Ehrlich, MD;
Robin Ewart, MD;
Robert N. Frank, MD;
Stephenie Lucas, MD;
Fred Whitehouse, MD;
Harold Weiss, MD;
Ann E. Ballen, MD;
Michael Teske, MD;
Maria Warth, MD;
William E. Benson, MD;
William S. Tasman, MD;
Gary C. Brown, MD;
J. Archibald McNamara, MD;
Hunter L. Little, MD;
Robert L. Jack, MD;
Lawrence Basso, MD;
Dayton T. Miller, PhD;
Elaine Gunter;
David D. Bayse, PhD;
W. Harry Hannon, PhD;
James E. Myrick, PhD;
Genell L. Knatterud, PhD;
Marian R. Fisher, PhD;
Mary Jane Prior, PhD;
Franca Barton, MS;
Joseph Kufera, MA;
Thomas W. Miller, MS;
CDR James K. Hooper, MS;
Richard S. Crow, MD;
Richard R. Baker, MD;
Ronald Prineas, MBBS, PhD;
Matthew D. Davis, MD;
Larry D. Hubbard, MAT;
Yvonne L. Magli;
Paul Segal, MD;
Frederick L. Ferris III, MD;
Richard L. Mowery, PhD;
Emily Y. Chew, MD;
Daniel G. Seigel, ScD;
Gary Cassel, MD
JAMA. 1992;268(10):1292-1300.
Abstract
| |
Objectives.
—This report presents information on the effects of aspirin on mortality, the occurrence of cardiovascular events, and the incidence of kidney disease in the patients enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS).
Study Design.
—This multicenter, randomized clinical trial of aspirin vs placebo was sponsored by the National Eye Institute.
Patients.
—Patients (N=3711) were enrolled in 22 clinical centers between April 1980 and July 1985. Men and women between the ages of 18 and 70 years with a clinical diagnosis of diabetes mellitus were eligible. Approximately 30% of all patients were considered to have type I diabetes mellitus, 31% type II, and in 39% type I or II could not be determined definitely.
Intervention.
—Patients were randomly assigned to aspirin or placebo (two 325-mg tablets once per day).
Main Outcome Measures.
—Mortality from all causes was specified as the primary outcome measure for assessing the systemic effects of aspirin. Other outcome variables included cause-specific mortality and cardiovascular events.
Results.
—The estimate of relative risk for total mortality for aspirin-treated patients compared with placebo-treated patients for the entire study period was 0.91 (99% confidence interval, 0.75 to 1.11). Larger differences were noted for the occurrence of fatal and nonfatal myocardial infarction; the estimate of relative risk was 0.83 for the entire follow-up period (99% confidence interval, 0.66 to 1.04).
Conclusions.
—The effects of aspirin on any of the cardiovascular events considered in the ETDRS were not substantially different from the effects observed in other studies that included mainly nondiabetic persons. Furthermore, there was no evidence of harmful effects of aspirin. Aspirin has been recommended previously for persons at risk for cardiovascular disease. The ETDRS results support application of this recommendation to those persons with diabetes at increased risk of cardiovascular disease.
(JAMA. 1992;268:1292-1300)
Author Affiliations
| |
Albany (NY) Medical College; Eye Research Institute of Retina Foundation/Retina Associates, Boston, Mass.; Good Samaritan Hospital and Medical Center, Portland, Ore; Hermann Eye Center, University of Texas, Houston; Holy Cross Hospital, Salt Lake City, Utah; Ingalls Memorial Hospital, Harvey, III; Johns Hopkins Hospital (Wilmer Institute), Baltimore, Md.; Joslin Diabetes Center (Beetham Eye Institute), Boston, Mass.; Louisiana State University Eye Center, New Orleans; Medical College of Wisconsin, Milwaukee; Michigan State University (Associated Retinal Consultants), East Lansing; Pacific Presbyterian Medical Center, San Francisco, Calif.; UCLA Center for Health Sciences (Jules Stein Eye Institute), Los Angeles, Calif.; University of Illinois, Chicago; University of Miami, Fla (Bascom Palmer Eye Institute); University of Minnesota, Minneapolis; University of Puerto Rico, Rio Piedras; University of Washington, Seattle; University of Wisconsin, Madison; Wayne State University (Kresge Eye Institute), Detroit, Mich.; Wills Eye Hospital, Philadelphia, Pa; Zweng Memorial Retinal Research Foundation, Menlo Park, Calif.; Central Laboratory (Centers for Disease Control, Atlanta, Ga); Coordinating Center (Maryland Medical Research Institute, Baltimore); Drug Distribution Center (US Public Health Service, Perry Point, Md); ECG Coding Center (University of Minnesota, Minneapolis); Fundus Photograph Reading Center (University of Wisconsin, Madison); National Eye Institute, National Institutes of Health, Bethesda, Md.
Footnotes
A complete list of the investigators and centers participating in the Early Treatment Diabetic Retinopathy Study appears at the end of this report.
Reprint requests to the Biometry and Epidemiology Program, National Eye Institute, Room 6A-24, 9000 Rockville Pike, Bethesda, MD 20892 (Dr Frederick L. Ferris).
 CiteULike  Connotea  Del.icio.us  Digg  Reddit  Technorati  Twitter
What's this?
THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES
|
Aspirin for primary prevention of cardiovascular events in people with diabetes: meta-analysis of randomised controlled trials
De Berardis et al.
BMJ 2009;339:b4531-b4531.
ABSTRACT
| FULL TEXT
Aspirin for primary prevention of cardiovascular disease?
DTB 2009;47:122-125.
ABSTRACT
| FULL TEXT
COX-1 sensitivity and thromboxane A2 production in type 1 and type 2 diabetic patients under chronic aspirin treatment
Pulcinelli et al.
Eur Heart J 2009;30:1279-1286.
ABSTRACT
| FULL TEXT
Antiplatelet Therapy in Diabetes: Efficacy and Limitations of Current Treatment Strategies and Future Directions
Angiolillo
Diabetes Care 2009;32:531-540.
FULL TEXT
Aspirin for Cardiovascular Prevention in Patients With Diabetes
Pignone
Clin. Diabetes 2009;27:70-71.
FULL TEXT
Update on the Canadian Diabetes Association 2008 clinical practice guidelines
Bhattacharyya et al.
cfp 2009;55:39-43.
FULL TEXT
CHAPTER 14 Diabetes Mellitus and Metabolic Syndrome
Cosentino et al.
ESC Textbook of Cardiovascular Medicine 2009;2:med-9780199566990-chapter-med-9780199566990-chapter.
ABSTRACT
| FULL TEXT
Management of cardiovascular disease in patients with diabetes: the 2008 Canadian Diabetes Association guidelines
Bhattacharyya et al.
CMAJ 2008;179:920-926.
FULL TEXT
Aspirin in type 2 diabetes: is there any evidence base?
Walsh and Spurling
BMJ 2008;337:a1902-a1902.
FULL TEXT
Use of Antiplatelet Agents for Primary and Secondary Prevention of Cardiovascular Disease Amongst Type 2 Diabetic Patients
Zaman Huri et al.
Journal of Pharmacy Practice 2008;21:287-301.
ABSTRACT
Best Practices for Lowering the Risk of Cardiovascular Disease in Diabetes
Triplitt and Alvarez
Diabetes Spectr. 2008;21:177-189.
ABSTRACT
| FULL TEXT
Aspirin: Promise and Resistance in the New Millennium
Patrono and Rocca
Arterioscler. Thromb. Vasc. Bio. 2008;28:s25-s32.
ABSTRACT
| FULL TEXT
Review: Aspirin and Diabetes Mellitus: revisiting an old player
Manrique et al.
Ther Adv Cardiovasc Dis 2008;2:37-42.
ABSTRACT
AHA/ADA vs. ESC/EASD recommendations on aspirin as a primary prevention strategy in people with diabetes: how the same data generate divergent conclusions
Nicolucci et al.
Eur Heart J 2007;28:1925-1927.
ABSTRACT
| FULL TEXT
Primary Prevention of Cardiovascular Diseases in People With Diabetes Mellitus: A Scientific Statement From the American Heart Association and the American Diabetes Association: Response to Buse et al.
Nicolucci et al.
Diabetes Care 2007;30:e57-e57.
FULL TEXT
Primary Prevention of Cardiovascular Diseases in People With Diabetes Mellitus: A Scientific Statement From the American Heart Association and the American Diabetes Association
Buse et al.
Circulation 2007;115:114-126.
ABSTRACT
| FULL TEXT
Analyzing the Risks and Benefits of Aspirin
DOC News 2007;4:4-4.
FULL TEXT
Primary Prevention of Cardiovascular Diseases in People With Diabetes Mellitus: A scientific statement from the American Heart Association and the American Diabetes Association
Buse et al.
Diabetes Care 2007;30:162-172.
ABSTRACT
| FULL TEXT
Reconsidering medication appropriateness for patients late in life.
Holmes et al.
Arch Intern Med 2006;166:605-609.
FULL TEXT
Review: Aspirin and diabetes
Raghavan et al.
British Journal of Diabetes & Vascular Disease 2006;6:74-82.
ABSTRACT
Review: Managing cardiovascular risk in patients with diabetes
Donnelly
British Journal of Diabetes & Vascular Disease 2005;5:325-329.
ABSTRACT
Risk of Hemorrhagic Stroke With Aspirin Use: An Update
Gorelick and Weisman
Stroke 2005;36:1801-1807.
ABSTRACT
| FULL TEXT
Sex Disparities in Treatment of Cardiac Risk Factors in Patients With Type 2 Diabetes
Wexler et al.
Diabetes Care 2005;28:514-520.
ABSTRACT
| FULL TEXT
Associations of Mortality and Diabetes Complications in Patients With Type 1 and Type 2 Diabetes: Early Treatment Diabetic Retinopathy Study report no. 27
Cusick et al.
Diabetes Care 2005;28:617-625.
ABSTRACT
| FULL TEXT
Aspirin Use Among Adults With Diabetes: Recent Trends and Emerging Sex Disparities
Persell and Baker
Arch Intern Med 2004;164:2492-2499.
ABSTRACT
| FULL TEXT
Use of Aspirin to Reduce Risks of Cardiovascular Disease in Patients With Diabetes: Clinical and research challenges
Hennekens et al.
Diabetes Care 2004;27:2752-2754.
FULL TEXT
Picotamide, a combined inhibitor of thromboxane A2 synthase and receptor, reduces 2-year mortality in diabetics with peripheral arterial disease: the DAVID study
Neri Serneri et al.
Eur Heart J 2004;25:1845-1852.
ABSTRACT
| FULL TEXT
Aspirin Resistance in Diabetic Patients: Response to de Gaetano
Sacco et al.
Diabetes Care 2004;27:1246-1246.
FULL TEXT
Inpatient to Outpatient Transfer of Care in Urban Patients With Diabetes: Patterns and Determinants of Immediate Postdischarge Follow-up
Wheeler et al.
Arch Intern Med 2004;164:447-453.
ABSTRACT
| FULL TEXT
Expert Consensus Document on the Use of Antiplatelet Agents: The Task Force on the Use of Antiplatelet Agents in Patients with Atherosclerotic Cardiovascular Disease of the European Society of Cardiology
Patrono et al.
Eur Heart J 2004;25:166-181.
FULL TEXT
Aspirin Therapy in Diabetes
Diabetes Care 2004;27:s72-73.
FULL TEXT
Primary Prevention of Cardiovascular Events With Low-Dose Aspirin and Vitamin E in Type 2 Diabetic Patients: Results of the Primary Prevention Project (PPP) trial
Sacco et al.
Diabetes Care 2003;26:3264-3272.
ABSTRACT
| FULL TEXT
Aspirin for Primary Prevention of Cardiovascular Events in Diabetes
Colwell
Diabetes Care 2003;26:3349-3350.
FULL TEXT
Statin Treatment in Diabetes Mellitus
Buse
Clin. Diabetes 2003;21:168-172.
FULL TEXT
Diabetes and Vascular Disease: Pathophysiology, Clinical Consequences, and Medical Therapy: Part II
Luscher et al.
Circulation 2003;108:1655-1661.
FULL TEXT
Setting evidence-based priorities for diabetes care improvement
O'Connor
Int J Qual Health Care 2003;15:283-285.
FULL TEXT
The Platelet in Diabetes: Focus on prevention of ischemic events
Colwell and Nesto
Diabetes Care 2003;26:2181-2188.
ABSTRACT
| FULL TEXT
Addressing the Burden of Diabetes in the 21st Century: Better Care and Primary Prevention
Engelgau et al.
J. Am. Soc. Nephrol. 2003;14:S88-91.
ABSTRACT
| FULL TEXT
Effects of an Automated Electronic Reminder in Changing the Antiplatelet Drug-Prescribing Behavior Among Italian General Practitioners in Diabetic Patients: An intervention trial
Filippi et al.
Diabetes Care 2003;26:1497-1500.
ABSTRACT
| FULL TEXT
Screening Adults for Type 2 Diabetes: A Review of the Evidence for the U.S. Preventive Services Task Force
Harris et al.
ANN INTERN MED 2003;138:215-229.
ABSTRACT
| FULL TEXT
Aspirin Dose for Prevention of Cardiovascular Disease in Diabetics
Nowak and Jaber
The Annals of Pharmacotherapy 2003;37:116-121.
ABSTRACT
| FULL TEXT
Cardiac Outcomes After Myocardial Infarction in Elderly Patients With Diabetes Mellitus
Chyun et al.
Am J Crit Care 2002;11:504-519.
ABSTRACT
| FULL TEXT
Aspirin for the Primary Prevention of Coronary Events
Mehta et al.
NEJM 2002;347:948-948.
FULL TEXT
Review: The pathogenesis of type 2 diabetes and cardiovascular disease
Marso
British Journal of Diabetes & Vascular Disease 2002;2:350-356.
ABSTRACT
Optimizing the diabetic formulary: beyond aspirin and insulin
Marso
J Am Coll Cardiol 2002;40:652-661.
ABSTRACT
| FULL TEXT
Aspirin Use and Counseling About Aspirin Among Patients With Diabetes
Krein et al.
Diabetes Care 2002;25:965-970.
ABSTRACT
| FULL TEXT
Diabetes and Atherosclerosis: Epidemiology, Pathophysiology, and Management
Beckman et al.
JAMA 2002;287:2570-2581.
ABSTRACT
| FULL TEXT
Aspirin for Primary Prevention of Coronary Events
Lauer
NEJM 2002;346:1468-1474.
FULL TEXT
The Impact of Clinical Trials on the Treatment of Diabetes Mellitus
Nathan
J. Clin. Endocrinol. Metab. 2002;87:1929-1937.
ABSTRACT
| FULL TEXT
Control of Cardiovascular Risk Factors in Patients With Diabetes and Hypertension at Urban Academic Medical Centers
McFarlane et al.
Diabetes Care 2002;25:718-723.
ABSTRACT
| FULL TEXT
Aspirin for the Primary Prevention of Cardiovascular Events: A Summary of the Evidence for the U.S. Preventive Services Task Force
Hayden et al.
ANN INTERN MED 2002;136:161-172.
ABSTRACT
| FULL TEXT
Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients
Collaboration
BMJ 2002;324:71-86.
ABSTRACT
| FULL TEXT
Managing Type 2 Diabetes in the Elderly
The Diabetes Educator 2002;28:3-11.
The Diabetes Quality Improvement Project: Moving science into health policy to gain an edge on the diabetes epidemic
Fleming et al.
Diabetes Care 2001;24:1815-1820.
FULL TEXT
Organizing Diabetes Care: Identify, Monitor, Prioritize, Intensify
O'Connor
Diabetes Care 2001;24:1515-1516.
FULL TEXT
Impact of Diabetes on Long-Term Survival After Acute Myocardial Infarction: Comparability of risk with prior myocardial infarction
Mukamal et al.
Diabetes Care 2001;24:1422-1427.
ABSTRACT
| FULL TEXT
Aspirin Therapy in Diabetes is Underutilized
Colwell
Diabetes Care 2001;24:195-196.
FULL TEXT
Aspirin Use Among Adults With Diabetes: Estimates from the Third National Health and Nutrition Examination Survey
Rolka et al.
Diabetes Care 2001;24:197-201.
ABSTRACT
| FULL TEXT
American Diabetes Association 60th Scientific Sessions, 2000: Cardiovascular disease in diabetes
Bloomgarden
Diabetes Care 2001;24:399-404.
FULL TEXT
Aspirin in Diabetes: Beware of Retinopathy
Ong and Kajubi
Arch Intern Med 2000;160:3004-3004.
FULL TEXT
Aspirin for the Primary Prevention of Stroke and Other Major Vascular Events: Meta-analysis and Hypotheses
Hart et al.
Arch Neurol 2000;57:326-332.
ABSTRACT
| FULL TEXT
Treatment of Diabetic Retinopathy
Ferris et al.
NEJM 1999;341:667-678.
FULL TEXT
Diabetes and Coronary Heart Disease
Simons et al.
NEJM 1998;339:1714-1716.
FULL TEXT
Aspirin Use and Incident Stroke in the Cardiovascular Health Study
Kronmal et al.
Stroke 1998;29:887-894.
ABSTRACT
| FULL TEXT
North of England evidence based guideline development project: guideline on the use of aspirin as secondary prophylaxis for vascular disease in primary care
Eccles et al.
BMJ 1998;316:1303-1309.
FULL TEXT
Coronary artery disease and diabetes
RUTTER et al.
Heart 1997;78:527-529.
FULL TEXT
The Feasibility of Intensive Insulin Management in Non-Insulin-dependent Diabetes Mellitus: Implications of the Veterans Affairs Cooperative Study on Glycemic Control and Complications in NIDDM
Colwell
ANN INTERN MED 1996;124:131-135.
ABSTRACT
| FULL TEXT
Which diabetic patients should be taking aspirin?
Yudkin
BMJ 1995;311:641-642.
FULL TEXT
Prophylaxis with aspirin should be considered
Moriarty
BMJ 1995;310:1008b-1008.
FULL TEXT
Retinopathy as a Risk Factor for Nonembolic Stroke in Diabetic Subjects
Petitti and Bhatt
Stroke 1995;26:593-596.
ABSTRACT
| FULL TEXT
Effects of Aspirin on Vitreous/Preretinal Hemorrhage in Patients With Diabetes Mellitus: Early Treatment Diabetic Retinopathy Study Report No. 20
Chew et al.
Arch Ophthalmol 1995;113:52-55.
ABSTRACT
Patient-Directed, Nonprescription Approaches to Cardiovascular Disease
Simon
Arch Intern Med 1994;154:2283-2296.
ABSTRACT
Aspirin as an Antiplatelet Drug
Patrono
NEJM 1994;330:1287-1294.
FULL TEXT
Collaborative overview of randomised trials of antiplatelet therapy Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients
Antiplatelet Trialists
BMJ 1994;308:81-106.
ABSTRACT
| FULL TEXT
|
