Clinical Efficacy of Orlistat Therapy in Overweight and Obese Patients With Insulin-Treated Type 2 Diabetes
A 1-year randomized controlled trial
A 1-year randomized controlled trial
Abstract
OBJECTIVE—Weight loss improves glycemic control, lipid profiles, and blood pressure in patients with type 2 diabetes. However, successful long-term weight loss is difficult for these patients, particularly those treated with insulin. The aim of this study was to assess the effect of orlistat, a gastrointestinal lipase inhibitor, on weight loss, glycemic control, and cardiovascular risk factors in overweight or obese insulin-treated type 2 diabetic patients.
RESEARCH DESIGN AND METHODS—This study was a 1-year multicenter, randomized, double-blind, placebo-controlled trial of orlistat (120 mg three times a day) or placebo combined with a reduced-calorie diet in overweight or obese adults (BMI 28–40 kg/m2) with type 2 diabetes treated with insulin alone or combined with oral agents, but with suboptimal metabolic control (HbA1c 7.5–12.0%). Outcome measurements included changes in body weight, glycemic control, blood pressure, and serum lipids.
RESULTS—After 1 year, the orlistat group lost significantly more weight (−3.89 ± 0.3% of baseline body weight, means ± SE) than the placebo group (−1.27 ± 0.3%, P < 0.001). Orlistat treatment, compared with placebo, produced greater decreases in HbA1c (−0.62 ± 0.08 vs. −0.27 ± 0.08%, P = 0.002), fasting serum glucose (−1.63 ± 0.3 vs. −1.08 ± 0.3 mmol/l, P = 0.02), and the required doses of insulin and other diabetic medications. Orlistat also produced greater improvements than placebo in serum total cholesterol (P = 0.0002) and LDL cholesterol concentrations (P = 0.001) and LDL/HDL ratio (P = 0.01).
CONCLUSIONS—Orlistat therapy produces clinically significant weight loss, with improvements in glycemic control and cardiovascular disease risk factors, in overweight or obese patients with type 2 diabetes who have suboptimal metabolic control with insulin therapy.
Footnotes
Address correspondence and reprint requests to David E. Kelley, MD, 3459 Fifth Ave., University of Pittsburgh Montefiore Hospital, N809 Pittsburgh, PA 15213. E-mail: kelley{at}msx.dept-med.pitt.edu.
Received for publication 12 July 2001 and accepted in revised form 10 February 2002.
D.E.K. has received honoraria for continuing medical education–related speaking engagements and research support from Hoffman-La Roche. G.A.B. has received research grant support for the study of orlistat from Hoffman-La Roche. He has also received research grants from Johnson & Johnson, Regeneron, Proctor and Gamble, and Novartis and has been a member of advisory boards and speaker bureaus for Johnson & Johnson and Takeda Pharmaceuticals. F.X.P.-S. has received honoraria from Roche as a member of an advisory panel. S.K. has received honoraria for speaking engagements from Roche and research support from Roche and RW Johnson. J.H. has received honoraria, consulting fees, and research support from Roche. J.M. has received honoraria for speaking engagements and research support from Hoffman-La Roche. P.H. has received honoraria for speaking engagements from and has been on advisory boards for Roche.
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