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February 10, 1975

Report of the Committee for the Assessment of Biometric Aspects of Controlled Trials of Hypoglycemic Agents

JAMA. 1975;231(6):583-608. doi:10.1001/jama.1975.03240180019013

1. INTRODUCTION  In a report that was published as a supplement to the November 1970 issue of Diabetes, the University Group Diabetes Program (UGDP) concluded that in patients with adult-onset diabetes, "tolbutamide and diet may be less effective [in prolonging life] than diet alone... at least insofar as cardiovascular mortality is concerned."1,2 Of the subjects treated with tolbutamide, 12.7% died from cardiovascular causes, as compared with 6.2% or fewer in the other treatment groups. As a result of these findings, the Food and Drug Administration (FDA) recommended that tolbutamide should be used only in patients who had adult-onset, stable diabetes that could not be controlled by diet alone, and who, for some good reason, could not be treated with insulin.The findings of the UGDP and the action of the FDA had a dramatic impact. Tolbutamide had been in general use in the treatment of diabetes since about 1956