Xenical and Dyslipidemia

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Even a relatively small weight loss of 5% to 10% of initial body weight lowers levels of triglycerides, decreases total cholesterol and increases levels of HDL cholesterol - thereby improving the ratio of LDL cholesterol to HDL cholesterol and reducing the risk of atherosclerosis.

In one study, three times as many patients (25% on Xenical plus diet versus 8% on placebo plus diet, P<0.001) lost 10% or more of their body weight from randomization (mean: 31 lbs; range: 18 to 67 lbs).

Xenical is indicated for obesity management in patients with an initial body mass index (BMI) of 30 or more and in patients with a BMI of 27 or more in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia). After 6 months, 72% of patients lost 5% or more of their initial body weight, with a mean loss of 23 lbs. Weight loss with Xenical plus diet has been shown to significantly reduce total and LDL cholesterol levels, increase HDL cholesterol and improve the LDL/HDL ratio.

Specific Health Benefits:
Population with Abnormal (Untreated) Risk Factors at Randomization

Weight Loss with Xenical Plus Diet: Improved Lipid Levels

The changes from randomization following 1-year treatment in the population with abnormal lipid levels (LDL >130 mg/dL, LDL/HDL >3.5, HDL <35 mg/dL) were greater for patients on Xenical plus diet compared to patients on placebo plus diet with respect to LDL cholesterol (-7.83% vs. +1.14%) and the LDL/HDL ratio (-0.64 vs. -0.46). HDL cholesterol increased in the placebo group by 20.1% and in the Xenical group by 18.8%.

Population As A Whole
In clinical trials involving 1064 patients, 69% on Xenical plus diet lost 3% or more of initial body weight within 3 months, with a mean loss of 13 lbs.

The mean change in total cholesterol was -2.0% for patients on Xenical plus diet and +5.0% for patients on placebo plus diet. The mean change in LDL cholesterol was -4.0% for patients on Xenical plus diet and +5.0% for patients on placebo plus diet. The mean change in HDL cholesterol was +9.3% for patients on Xenical plus diet and +12.8% for patients on placebo plus diet.

In clinical trials, the overall mean weight loss from randomization to the end of 1 year in the intent-to-treat population was 13.4 lbs in patients treated with Xenical plus diet versus 5.8 lbs in placebo-treated patients.

The long-term effects of orlistat on morbidity and mortality associated with obesity have not been established.

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