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The UGDP Controversy

The first report from the University Group Diabetes Program (UGDP) on the use of diet, insulin, and tolbutamide in treatment of maturity-onset diabetes was presented at the annual scientific meeting at the American Diabetes Association (ADA) in June 1970 and published soon thereafter. Controversy regarding the findings preceded its presentation and was recognized in the original statements on the UGDP report released by the ADA." Unusual attention was directed to the first report of the UGDP because of the pioneering nature, ambitious scope, and magnitude of the study and because of the surprising conclusion that a relationship might exist between cardiovascular mortality and use of the sulfonylurea drug, tolbutamide. Since 1970, further reports from the UGDP" as well as critiques of the initial and subsequent reports have been presented. ~ Despite these and other published material, no broad agreement has developed within scientific circles regarding the conclusions of the UGDP study or its significance as a guide to the medical community, except the suggestion that dietotherapy should be the basis of treatment for the patient with maturity-onset diabetes. Indeed, much disagreement has arisen on how pertinent the findings of the UGDP study are to individual physicians who advise diabetic patients. It is no surprise that an awareness of this disagreement between physicians has spilled over into the nonscientific press whose writings have added confusion and not a little consternation to interested consumers who must read of professional disputations without benefit either of the historical-scientific background or of the basic data. A real consumer uncertainty also has involved physicians and other health advisers who do not specialize in diabetes care, yet who are expected to advise diabetic patients. During the years since the initiation of the UGDP study and its reports, advances in knowledge have occurred about the nature of diabetes, about the influence of metabolic control on microvascular complications, about the adverse effect of obesity on diabetes, and about the meaning of cardiovascular risk factors. Thus, it is clear that obese diabetics must lose weight, and for this a restricted calorie intake is the key mode of therapy. It has become clearer that careful control of blood glucose levels favorably affects microvascular problems. Cardiovascular risk factors are more precisely defined now, and the distinction between juvenile-onset (insulin-dependent) and maturity-onset (noninsulin-dependent) diabetes is receiving broad acceptance. Physicians have responded to these newer attitudes by adopting therapeutic maneuvers different from those extant in 1961 when the UGDP study was started. Today, neither insulin nor oral hypoglycemic agents would be given initially to asymptomatic diabetic patients in whom a dietary trial had not been pursued. Cigarettes are interdicted and lower fat diets are emphasized. Hypertension is controlled. Attention to normalizing fasting and postprandial blood glucose levels by appropriate adjustments of therapeutic modalities is a more common practice. Regular physical activity is encouraged. Thus, the management of maturity-onset diabetes has significantly advanced since 1961. The American Diabetes Association recognizes these advances and submits that advice pertinent in 1970 based on a study initiated in 1961 would be incomplete in 1979. Reappraisal of some of the existing UGDP data with a stricter definition of patient selection, as well as reports by others, has again suggested that some of the inferences from the UGDP reports deserve restudy and modification. This is especially true in view of the reanalyses by the Biometric Society in 1975 and by the 1978 report of the Food and Drug Administration (FDA) of some of the pooled final data, neither of which dealt exhaustively with the primary data from the 12 participating centers. For example, neither study analyzed in detail (nor examined in the light of newer knowledge) the appropriateness of patient inclusion in the study, the specifics on follow-up management of patients in the study, and the cumulative effect of dropout and crossover between treatment groups on continuing morbidity and mortality.