Objective To investigate the effects of long-term weight management with orlistat on blood pressure in obese hypertensive patients. Design A meta-analysis of data from five multicenter, randomized, placebo-controlled studies, conducted in Europe and the USA, was performed. Patients Obese adults [body mass index (BMI) 28-43 kg/m(2)] with uncontrolled diastolic hypertension or isolated systolic hypertension (ISH) were eligible for inclusion. Interventions Following a 4-week placebo lead-in period, patients were randomized to orlistat 120 mg or placebo three times daily, in conjunction with a mildly reduced calorie diet for 1 year. Main outcome measures Change in body weight was the primary efficacy parameter. Blood pressure, heart rate and systolic workload were assessed as secondary efficacy parameters. Results A total of 628 patients were included in the intent-to-treat (ITT) analysis. After 56 weeks, orlistat-treated patients had lost significantly more body weight than placebo recipients (8.0 versus 4.0%; P < 0.001). Among patients with ISH, mean systolic pressure was reduced to a significantly greater degree after 1 year with orlistat compared to placebo (-9.4 versus -4.6 mmHg; P = 0.022). Similarly, reductions in mean diastolic pressure in patients with diastolic hypertension were greater with orlistat than with placebo (-7.7 versus -5.6 mmHg; P = 0.017). Weight loss of greater than or equal to 10% was associated with significant reductions in blood pressure, heart rate and systolic workload. Conclusions Orlistat promotes clinically meaningful weight loss that is associated with significant reductions in blood pressure and heart rate, and may therefore have a role in the management of hypertension in overweight and obese patients. (C) 2002 Lippincott Williams Wilkins.