Pharmacological studies

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Pharmacological interventions to prevent diabetes or its complications early in the natural history have been published since the 1960s180. The rationale for drug intervention includes: (1) the drug may reverse one or more specific pathophysiological defects; (2) changes in lifestyle for otherwise healthy people are difficult to make and have not yet been shown to have long-term efficacy; (3) some people are unable to change their lifestyle due to disability or other disease; and (4) it may be easier to take a drug over longer periods than it is to make significant behavioral changes. While each of these issues has a certain amount of validity, it is also important to show, through well designed clinical trials, that pharmacological interventions are efficacious before they enter widespread use, especially if they are to be given to otherwise healthy, non-diseased persons as preventive agents5.

Reviews of the use of such agents have been published10,180-182. Early trials were often aimed at subjects with 'chemical diabetes', considered to be 'early diabetes' by older criteria. Such studies often included a majority of people with what would now be considered IGT, and thus are reasonably relevant to a review of primary prevention. Agents available in the 1960s included firstgeneration sulfonylureas and biguanides. Similar to lifestyle studies, criteria for outcomes varied and were a mixture of glucose tolerance, fasting glucose and other end-points. Table 6.7 summarizes the RCTs that have been published.

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