A Cochrane review included 4 studies with a total of 3 132 subjects. Orlistat was compared with placebo in hypertensive participants with a mean age of 46 to 55 years, a baseline systolic BP of 142 to 154 mm Hg and a baseline diastolic BP of 85 to 98 mm Hg. Mean treatment duration was 6 to 48 months. In all studies patients received either 120 mg orlistat three times daily or placebo.
There was a significant reduction of SBP with a MD of -2.5 mm Hg (95% CI -4.0 to -0.9) in favour of orlistat. DBP was also significantly reduced in patients treated with orlistat with a MD of -1.9 mm Hg (95% CI -3.0 to -0.9). Orlistat was found to lower body weight significantly more effectively than placebo with a WMD of -3.7 kg (95% CI: -4.7 to -2. 8). No study included mortality and cardiovascular morbidity as a pre-defined outcome. Incidence of gastrointestinal side effects was consistently higher in those participants treated with orlistat versus those treated with placebo.
Comment: The quality of evidence is downgraded by study quality (inadequate follow up). Studies of phentermine/topiramate and sibutramine were included in the original review but excluded from this evidence summary because sibutramine was suspended from market in January 2010 due to an increase of cardiovascular risk, and the EMA refused marketing authorisation for phentermine/topiramate in Europe because of safety concerns.