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An SR (72) only includes patients with intolerance while the rest include<br />

mixed population groups. The Agency for Healthcare Research and Quality<br />

(AHRQ) (70) report analyses the risks to develop diabetes, cardiovascular and<br />

general morbimortality through a meta-analysis of cohort studies.<br />

The assessed evidence is of high quality and all the editions are based on the<br />

same RCT group. The grouping of these varies depending on the aim of the SR.<br />

There are isolated Cochrane SRs for acarbose and to lose weight through diet and<br />

exercise (73; 74; 76). The other two reviews assess all the measures.<br />

The most recent SR includes all the pharmacological measures (metformin,<br />

glitazones, orlistat, acarbose) and non-pharmacological (diet and exercise)<br />

and carries out a meta-analysis. It does not compare the measures among them.<br />

However, the AHRQ report does develop this analysis based on a single RCT<br />

(77) where the non-pharmacological measures proved to be more efficient than<br />

metformin.<br />

There is coherence between the evidence analysed on the effectiveness to<br />

prevent diabetes both through diet and exercise as through drugs.<br />

Life styles and oral antidiabetic drugs (acarbose, rosiglitazone and metformin)<br />

and orlistat are effective in the prevention of diabetes. Life styles have a greater<br />

impact according to the patients’ initial weight: for each 0.04 BMI increase, the<br />

preventive effect of the diet increases 7.3%.<br />

In the DREAM study performed on 5,269 people suffering from Impaired<br />

Glucose Tolerance or Impaired Fasting Glucose without cardiovascular disease<br />

antecedents, rosiglitazone showed to be effective to prevent diabetes [RR 0.38 (CI<br />

95%: 0.33-0.40); NNT 7], though it increased the oedemas incidence [RR 1.41<br />

(CI 95%: 1.13- 1.76); NNH 51], the BMI and heart failure frequency [RR 7.03<br />

(CI 95%: 1.6-30.9); NNH 250] (75). The study follow-up period was three years.<br />

Recently rosiglitazone has ben withdrawn from the market because of its negative<br />

cardiovascular profile.<br />

Adverse effects are more frequent in the group following pharmacological<br />

treatment (gastrointestinal effects and diarrhoea). The effect of the diet is coherent<br />

at all risk levels to develop diabetes. On the other hand, hypoglycaemic-agents do<br />

not have any approved indication to be used in pre-diabetic stages.<br />

The effect on cardiovascular morbimortality has not been proved conclusive,<br />

due to the length of the studies. Acarbose proved to be efficient in the decrease of<br />

cardiovascular complications only in an RCT included in the reviews (78). This<br />

finding is based on only 48 events and it must be interpreted with caution, as the<br />

aim of the study was not the effect on cardiovascular morbimortality.<br />

SR of RCT<br />

1++<br />

RCT<br />

1++<br />

RCT<br />

1+/-<br />

Evidence summary<br />

1++ The structured interventions which enable physical exercise and diet reduce the risk to<br />

develop diabetes [RR 0.51 (CI 95%: 0.44-0.60); NNT 6.4] in patients with pre-diabetes<br />

(70; 72; 73).<br />

1++ The interventions with anti-diabetic drugs (metformin and acarbose) reduce the risk to<br />

develop diabetes [RR 0.70 (CI 95%: 0.62-0.79); NNT 11 (8 to 15)] (70; 72; 74).<br />

CLINICAL PRACTICE GUIDELINE ON TYPE 2 DIABETES 49

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