TY - JOUR
T1 - V.A. Cooperative study of antiplatelet agents in diabetic patients after amputation for gangrene
T2 - Unobserved, sudden, and unexpected deaths
AU - Colwell, John A.
AU - Bingham, Stephen F.
AU - Abraira, Carlos
AU - Anderson, James W.
AU - Comstock, John P.
AU - Kwaan, Hau C.
AU - Nuttall, Frank
N1 - Funding Information:
Supported by the Veterans Administration Cooperative Studies Program of the Medical Research Service.
PY - 1989
Y1 - 1989
N2 - 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.
AB - 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.
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U2 - 10.1016/0891-6632(89)90029-9
DO - 10.1016/0891-6632(89)90029-9
M3 - Article
C2 - 2533210
AN - SCOPUS:0024744010
VL - 3
SP - 191
EP - 197
JO - Journal of Diabetes and its Complications
JF - Journal of Diabetes and its Complications
SN - 1056-8727
IS - 4
ER -
