These recommendations are largely based on the Executive Summary of the "European Guidelines on Cardiovascular Disease Prevention in Clinical Practice" proposed by the "Third Joint Task Force of European and other Societies on Cardiovascular Disease Prevention in Clinical Practice". The model used to assess the overall risk was adapted for Belgium. Otherwise, very few things were changed from the Executive Summary of the European Guidelines.
These recommandations are largely based on the "European Guidelines on Cardiovascular Disease Prevention in Clinical Practice" proposed by the "Third Joint Task Force of European and other Societies on Cardiovascular Disease Prevention in Clinical Practice". The model used to assess the overall risk was adapted for Belgium. Otherwise, very few things were changed from the Exectutive Summary of the European Guidelines.
OBJECTIVE: Assessment of the effects of orlistat 120 mg three times daily vs placebo on weight loss and serum lipids in obese hypercholesterolemic patients. DESIGN: A 24 week multicentre, double-blind, randomized, placebo-controlled trial. After a 2-week single-blind run-in period (placebo+diet (−600 kcal/day; ≤30% of calories as fat)), 294 patients were submitted to the hypocaloric diet and randomly assigned to either orlistat 120 mg or placebo three times daily. Patients who completed the double-blind study (n=255) were eligible for participation in a subsequent 24 week open-label orlistat extension phase. SUBJECTS: Patients with body mass index (BMI) 27–40 kg/m2 and hypercholesterolemia (low-density-lipoprotein cholesterol, LDL-C, 4.1–6.7 mmol/l). MEASUREMENTS: Efficacy assessments included weight loss, lipid levels, other cardiovascular risk factors and anthropometric parameters. Safety assessments. RESULTS: Weight loss during run-in was similar in both groups. After randomization, orlistat-treated patients lost significantly more weight than placebo recipients: mean percentage weight loss from start of run-in to week 24 was−6.8% in the orlistat group and −3.8% in the placebo group (P<0.001). Moreover, more patients in the orlistat group than in the placebo group achieved clinically meaningful weight loss of ≥5% (64 vs 39%) or ≥10% (23 vs 13%) at week 24. Treatment with orlistat was associated with significantly greater changes in total cholesterol (−11.9% vs −4.0%; P<0.001) and LDL-C (−17.6 vs −7.6%; P<0.001). For any category of weight loss during the double-blind treatment period, change in LDL-C was more pronounced in orlistat-treated patients than in placebo recipients, indicating that orlistat had a direct cholesterol-lowering effect that was independent of weight reduction (P<0.001). Adjunction of orlistat during the extension phase in patients who initially received placebo induced a further decrease in weight, total cholesterol and LDL-C. Orlistat was generally well tolerated with a safety profile comparable to placebo, with the exception of a higher incidence of gastrointestinal events (≥1 event in 64 vs 38% of patients). CONCLUSION: Orlistat as an adjunct to dietary intervention promotes weight loss and reduces LDL-C beyond the effect of weight loss in overweight or obese patients with concomitant hypercholesterolemia.
Weight reduction is essential in the management of most non-insulin-dependent diabetics, but this therapeutical goal is difficult to obtain. In this double-blind parallel study, 82 non-insulin-dependent diabetics, moderately obese (BMI = 30 - 39 kg/m2), were given for an 8-week period either placebo (P) or fluoxetine (F), a specific serotonin reuptake inhibitor, in addition to their usual antidiabetic treatment. Thirty-nine of them received 60 mg fluoxetine a day and 43 were given the placebo. At admission, both groups had similar weight excess, metabolic control and serum lipid values. In comparison with the P-treated subjects, those treated with fluoxetine (F) lost more weight after 3 weeks (-1.9 vs. -0.7 kg, p < -0.0009) and after 8 weeks (-3.1 vs. -0.9 kg, p < 0.0007). Fasting blood glucose decreased in group F after 3 weeks (-1.5 vs -0.4 mmol/L, p < 0.003) and after 8 weeks (-1.7 vs. -0.02 mmol/L, p < 0.0004). HbAlc decreased from 8.5% to 7.7% in group F and from 8.6% to 8.3% in group P (p = 0.057). Mean triglyceride level was also reduced in group F after 8 weeks (p = 0.042). Fasting C-peptide did not change in either group, but fasting insulin values decreased in group F after 3 weeks (p < 0.02) and after 8 weeks (p < 0.05). The insulin/C-peptide molar ratio decreased significantly in group F after 3 weeks (p < 0.04) and after 8 weeks (p < 0.05) in comparison with group P. The drug was generally well tolerated and no major side effects were reported. In conclusion, the addition of fluoxetine to the usual oral hypoglycemic agent therapy might be beneficial in obese non-insulin-dependent diabetics, at least on a short-term basis.
A double-blind placebo-controlled trial was conducted, involving 97 obese diabetic and glucose intolerant patients receiving either 60 mg fluoxetine daily (47 patients) or a placebo (50 patients); a similar calorie-restricted diet was prescribed to all patients. Weight loss was significantly higher in the fluoxetine-treated patients, whose diabetic status improved. Drop-out rate was not significantly different for both groups of patients.