| Abstract | We report on unobserved, sudden, and unexpected deaths that occurred in a randomized multicenter trial. The long-term effects of aspirin plus dipyridamole on major vascular outcome variables were studied in 231 non insulin-dependent diabetic men with either a recent amputation for gangrene or active gangrene. Depending upon the definition of sudden death used, there were 14, 22, or 17 deaths in the drug group versus 6, 6, or 3 deaths in the placebo group (p = 0.04, 0.001, or 0.001, respectively). Total deaths from atherosclerotic vascular disease or deaths from all causes did not differ in the two treatment groups. Since this finding of a secondary end point is found only after multiple analyses of the data, it must be interpreted with caution. However, it is suggested that further studies on effects of antiplatelet agents on sudden deaths should be performed. |
| Authors | J A Colwell, S F Bingham, C Abraira, J W Anderson, J P Comstock, H C Kwaan, F Nuttall
(Affiliation: VA Medical Center, Charleston, SC 29403.)
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| Journal | The Journal of diabetic complications
(J Diabet Complications)
1989 Oct-Dec
Vol. 3
Issue 4
Pg. 191-7
ISSN: 0891-6632 UNITED STATES |
| PMID | 2533210
(Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, U.S. Gov't, Non-P.H.S.)
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| Chemical References |
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| Topics |
- Amputation
- Aspirin
(adverse effects, therapeutic use)
- Death, Sudden
- Diabetes Mellitus, Type 2
(drug therapy)
- Dipyridamole
(adverse effects, therapeutic use)
- Drug Therapy, Combination
- Gangrene
(surgery)
- Hospitals, Veterans
- Humans
- Male
- Middle Aged
- Multicenter Studies as Topic
- Myocardial Infarction
(chemically induced, mortality)
- Random Allocation
- Risk Factors
- South Carolina
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