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. 2001 Oct 13;323(7317):854–858. doi: 10.1136/bmj.323.7317.854
19834 199510
•No specific end points reported: “morbidity and excess mortality of the disease,” “complications including macrovascular events or retinopathy, nephropathy or peripheral neuropathy” Main comparison and interdrug comparison
19845 • “Diabetes-related mortality—death from: heart attacks, sudden death, stroke, complications of peripheral vascular disease or amputations, renal failure, or hyperglycemic or hypoglycemic coma”
Main comparison and interdrug comparison • “Diabetes-related mortality and major clinical endpoints including non-fatal myocardial infarct, clinical angina, . . . heart failure, . . . major stroke, . . . amputation, retinal photocoagulation, vitreous hemorrhage, blindness, . . . and renal failure”
•“Deaths from vascular events, sudden death or renal failure” • “Total mortality”
•“Complication-free interval, including avoidance of death from any cause, heart attack, angina, renal failure, blindness, major stroke or amputation” 19969
19917 (interpretation using the stopping criteria set out in tables 4 and 5 of the 1991 paper) Main comparison and interdrug comparison
Main comparison and interdrug comparison • “Diabetes-related mortality—death from: heart attacks, sudden death, stroke, complications of peripheral vascular disease or amputations, renal failure, hyperglycemic or hypoglycemic coma”
•“Diabetes-related deaths, ie vascular, renal, hyper- or hypoglycemia or sudden death” • “Diabetes-related mortality and major clinical endpoints”:
•“Diabetes-related death and major morbitity”: myocardial infarction, angina and ischaemic heart disease, major stroke, major limb complications requiring amputation, blindness in one eye, renal failure (“death from any cause” removed) • Macrovascular: fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, ischaemic heart disease, heart failure
19917 (interpretation using the aggregates set out in table 5 of the 1991 paper) • Microvascular: fatal and non-fatal renal disease, ophthalmic (blindness, retinal photocoagulation, vitreous haemorrhage), peripheral neuropathy (amputation)
Main comparison and interdrug comparison • Cataract
•Non-fatal end points: myocardial infarction, angina and ischaemic heart disease, major stroke, major limb complications requiring amputation of a digit or limb, blindness in one eye, renal failure (“death from any cause” removed) • “Total mortality”
•“Clinical events not included in stopping criteria” (cataract extraction, vitreous haemorrhage, heart failure, photocoagulation) 19981
•Total mortality Main comparison
19938 (translated from the French) • “Diabetes-related death (death from myocardial infarction, stroke, peripheral vascular disease, renal disease, hyperglycaemia or hypoglycaemia,sudden death)”
Main comparison and interdrug comparison • “Any diabetes-related endpoint (sudden death, death from hyperglycaemia or hypoglycaemia, fatal or non-fatal myocardial infarction, angina, heart failure, stroke, renal failure, amputation, . . . vitreous hemorrhage, photocoagulation, blindness in one eye, or cataract extraction)”
•Diabetes related deaths: cardiovascular events, sudden death, hypoglycaemia, hyperglycaemia, renal failure • “All-cause mortality”
•Diabetes related major morbidity: non-fatal cardiovascular accidents (heart attacks, strokes, and lower limb amputations), renal insufficiency, blindness 19981
•(Total mortality removed) Interdrug comparison
• Main comparison end points (as above) and:
• “Myocardial infarction (fatal and non-fatal) and sudden death”
• “Stroke (fatal and non-fatal)”
• “Amputation or death due to peripheral vascular disease”
• “Microvascular complications (retinopathy requiring photocoagulation, vitreous hemorrhage, and fatal and non-fatal renal failure)”