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aOnly 21% had IGT and both groups were submitted to an intensive lifestyle-modification program.

The efficacy of metformin in reducing the risk of diabetes in IGT subjects was confirmed by the Diabetes Prevention Program published in 2002 [9]. In this study, 3,234 subjects with IGT were randomized to a lifestyle program, metformin 850 mg b.i.d. or placebo b.i.d., and followed for 2.8 years. Overall, metformin reduced the risk of diabetes by 31% (p = 0.001) based on 2 oral glucose tolerance tests (OGTTs) compared to an incidence of 11.0%/year in the placebo group (table 1). However, it was less effective in the older subjects (>60 years) and the less obese (body mass index <35kg/m2) [9].

The efficacy of acarbose was also confirmed by the Study to Prevent NIDDM trial, also published in 2002 [10]. In this international trial, 1,368 subjects with IGT were randomized to acarbose 100 mg or placebo t.i.d. with meals and followed for an average of 3.3 years. Based on 1 OGTT, acarbose reduced the risk of diabetes by 25% (p = 0.0015) compared to an incidence of 12.1%/year in the placebo group. If the diagnosis of diabetes was based on 2 OGTTs as now recommended by the American Diabetes Association [11], the drug was associated with a 36.4% reduction in the risk of diabetes (p = 0.0003; table 1). The beneficial effect was seen independent of age, gender or body mass index.

Also published in 2002, the TRIPOD study examined the effect of troglitazone on the prevention of diabetes in Hispanic women (n = 236) with a history of gestational diabetes [12]. The overweight women were randomized to placebo or troglitazone 400 mg o.d. and followed for 2.5 years. Troglitazone reduced the risk of diabetes by 55% (p = 0.009) compared to the placebo group (incidence = 12.1%/year; table 1). Though troglitazone proved to be an effective drug for prevention of diabetes, it was discontinued because of liver toxicity.

Metformin Acarbose Troglitazone Orlistat

Metformin Acarbose Troglitazone Orlistat

e la

e la

Fig. 1. Non-pharmacological and pharmacological interventions on the prevention of type-2 diabetes as a primary outcome. The histograms represent the population-adjusted mean risk reduction where there is more than one intervention trial.

More recently, the Xenical in the Prevention of Diabetes in Obese Subjects Study assessed the effect of orlistat as an adjunct to a lifestyle-modification program on the prevention of diabetes in obese non-diabetic subjects [13]. Overall, 3,305 subjects were submitted to an intensive lifestyle program; only 21% had IGT. They were also randomized to orlistat 120 mg or placebo t.i.d. with meals. Both groups lost weight, but it was more important in the orlistat group (5.8 versus 3.0kg; p < 0.001). Orlistat resulted in a 37% reduction in the risk of diabetes compared to an incidence of 2.25%/year in the placebo group (p = 0.003; table 1). Despite methodological problems with the study, it does support a preventive effect of orlistat on the development of diabetes in a high-risk population.

The evidence that pharmacological intervention can prevent or delay the progression of IGT to diabetes is overwhelming (fig. 1). This is definitely true for metformin and acarbose. It is also true for troglitazone but unfortunately it is liver toxic and has been taken off the market. It is hoped that the other thiazo-lidinediones will also be as effective in decreasing the incidence of diabetes in high-risk populations. Current studies are now testing rosiglitazone and pioglita-zone [14]. Xenical is very likely effective in decreasing weight and thus reducing the risk of diabetes. However, methodological problems, such as the high drop out rate and the carry forward analysis, make the study difficult to interpret.

Bariatric Surgery

We still have very few data on the use of bariatric surgery in massively obese subjects on the prevention of diabetes. Three studies, however, have sufficient

Table 2. Bariatric surgery and the prevention of type-2 diabetes

Study Number of subjects (surgery/control)

Duration of follow-up years

Weight loss

%

Incidence of diabetes, %/year after surgery

Pories et al. [15] 152/-

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