Orginal Publication Date
MCV/Q, Medical College of Virginia Quarterly
In conclusion, comment is made on the findings of the University Group Diabetes Program (UGDP). The purpose of the UGDP was to determine whether or not control of blood glucose levels would help to prevent or delay vascular disease in non-insulin-requiring diabetics. After 8 1/2 years of follow-up at 12 university-affiliated treatment centers, "The findings of the study indicate that the combination of diet and tolbutamide therapy is no more effective than diet alone in prolonging life. Moreover, the findings suggest that tolbutamide and diet may be less effective than diet alone or diet and insulin, at least insofar as cardiovascular mortality is concerned." The debate on the validity of this study still rages. A number of the criticisms leveled against the study by diabetologists, other clinicians, epidemiologists, and statisticians are discussed. These include inappropriate patient selection and randomization, higher risk factors at the outset of the study, manipulation of electrocardiographic data, risk factors such as smoking and hypertension not measured or monitored, use of fixed dosage of drug, clinic preponderance regarding mortality (it has been alleged that the bulk of tolbutamide mortality occurred in four clinics, Birmingham, Boston, Cincinnati, and Minneapolis), use of "patient data" against "computerized data," neglect of appropriate "vascular" history, neglect of "co-morbidity," contradictory clinical studies here and abroad, and the danger of extrapolation of the UGDP findings to other sulfonylurea agents.
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VCU University Archives