To investigate the hypothesis that weight reduction with orlistat plus mild caloric restriction leads to better blood pressure control than diet alone in obese individuals with inadequately controlled hypertension.Design
This was a 1-year, prospective, randomized, double-blind, placebo-controlled, multicenter trial of orlistat plus diet versus placebo plus diet in obese hypertensives.Interventions
Participants were randomized to receive either orlistat or placebo; all received a 600 kcal deficient diet with no more than 30% of calories from fat. Weight and blood pressure, lipid levels and fasting glucose and insulin levels were followed.Main outcome measures
Patients on orlistat experienced greater weight loss (−5.4 ± 6.4 versus −2.7 ± 6.4 kg, P< 0.001) and greater reduction in body mass index (−1.9 ± 2.3 versus −0.9 ± 2.2 kg/m2, P< 0.001). Target weight loss, defined as ≥ 5% body weight (BW), was obtained in more orlistat-treated patients than in the placebo group (46 versus 23%, P< 0.001). Diastolic BP decreased more in orlistat-treated patients than in the placebo group (−11.4 ± 8.3 versus −9.2 ± 8.4 mmHg, P = 0.002). A greater percentage of orlistat-treated patients reached goal diastolic blood pressure (BP), defined as final diastolic BP < 90 mmHg or a reduction of at least 10 mmHg (67 versus 53%, P< 0.001). The orlistat-treated group had significantly greater reductions in total cholesterol (P< 0.001), low-density lipoprotein cholesterol (P = 0.001) and non-high-density lipoprotein cholesterol (P< 0.005) and target 30% cardiovascular risk reduction was obtained in more orlistat-treated patients (36.1 versus 24.0%, P< 0.04).Conclusion
A weight-loss program with orlistat is more effective than diet alone to lower blood pressure and results in greater cardiovascular risk reduction.