Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group
- PMID: 9683204
- DOI: 10.1016/s0140-6736(97)11509-4
Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group
Abstract
Background: We undertook a randomised controlled trial to assess the efficacy and tolerability of orlistat, a gastrointestinal lipase inhibitor, in promoting weight loss and preventing weight regain in obese patients over a 2-year period.
Methods: 743 patients (body-mass index 28-47 kg/m2), recruited at 15 European centres, entered a 4-week, single-blind, placebo lead-in period on a slightly hypocaloric diet (600 kcal/day deficit). 688 patients who completed the lead-in were assigned double-blind treatment with orlistat 120 mg (three times a day) or placebo for 1 year in conjunction with the hypocaloric diet. In a second 52-week double-blind period patients were reassigned orlistat or placebo with a weight maintenance (eucaloric) diet.
Findings: From the start of lead-in to the end of year 1, the orlistat group lost, on average, more bodyweight than the placebo group (10.2% [10.3 kg] vs 6.1% [6.1 kg]; LSM difference 3.9 kg [p<0.001] from randomisation to the end of year 1). During year 2, patients who continued with orlistat regained, on average, half as much weight as those patients switched to placebo (p<0.001). Patients switched from placebo to orlistat lost an additional 0.9 kg during year 2, compared with a mean regain of 2.5 kg in patients who continued on placebo (p<0.001). Total cholesterol, low-density lipoprotein (LDL) cholesterol, LDL/high-density lipoprotein ratio, and concentrations of glucose and insulin decreased more in the orlistat group than in the placebo group. Gastrointestinal adverse events were more common in the orlistat group. Other adverse symptoms occurred at a similar frequency during both treatments.
Interpretation: Orlistat taken with an appropriate diet promotes clinically significant weight loss and reduces weight regain in obese patients over a 2-year period. The use of orlistat beyond 2 years needs careful monitoring with respect to efficacy and adverse events.
Comment in
-
Obesity: a time bomb to be defused.Lancet. 1998 Jul 18;352(9123):160-1. doi: 10.1016/S0140-6736(98)22029-0. Lancet. 1998. PMID: 9683198 No abstract available.
-
Orlistat and weight loss.Lancet. 1998 Oct 31;352(9138):1473; author reply 1474. doi: 10.1016/S0140-6736(05)61300-1. Lancet. 1998. PMID: 9808019 No abstract available.
-
Orlistat and weight loss.Lancet. 1998 Oct 31;352(9138):1473-4. doi: 10.1016/s0140-6736(05)61301-3. Lancet. 1998. PMID: 9808020 No abstract available.
Similar articles
-
Orlistat: its current status as an anti-obesity drug.Eur J Pharmacol. 2002 Apr 12;440(2-3):109-17. doi: 10.1016/s0014-2999(02)01422-x. Eur J Pharmacol. 2002. PMID: 12007529 Review.
-
[Randomized placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients].Ter Arkh. 2000;72(8):50-4. Ter Arkh. 2000. PMID: 11019429 Clinical Trial. Russian.
-
One-year treatment of obesity: a randomized, double-blind, placebo-controlled, multicentre study of orlistat, a gastrointestinal lipase inhibitor.Int J Obes Relat Metab Disord. 2000 Mar;24(3):306-13. doi: 10.1038/sj.ijo.0801128. Int J Obes Relat Metab Disord. 2000. PMID: 10757623 Clinical Trial.
-
Orlistat: a review of its use in the management of obesity.Drugs. 1999 Oct;58(4):743-60. doi: 10.2165/00003495-199958040-00015. Drugs. 1999. PMID: 10551441 Review.
-
Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial.JAMA. 1999 Jan 20;281(3):235-42. doi: 10.1001/jama.281.3.235. JAMA. 1999. PMID: 9918478 Clinical Trial.
Cited by
-
A Comprehensive Review on Weight Gain following Discontinuation of Glucagon-Like Peptide-1 Receptor Agonists for Obesity.J Obes. 2024 May 10;2024:8056440. doi: 10.1155/2024/8056440. eCollection 2024. J Obes. 2024. PMID: 38765635 Free PMC article. Review.
-
Obesity medications: A narrative review of current and emerging agents.Osteoarthr Cartil Open. 2024 Apr 25;6(2):100472. doi: 10.1016/j.ocarto.2024.100472. eCollection 2024 Jun. Osteoarthr Cartil Open. 2024. PMID: 38737985 Free PMC article.
-
Obesity: a 100 year perspective.Int J Obes (Lond). 2024 May 7. doi: 10.1038/s41366-024-01530-6. Online ahead of print. Int J Obes (Lond). 2024. PMID: 38714830 Review.
-
The maintenance of long-term weight loss after semaglutide withdrawal in obese women with PCOS treated with metformin: a 2-year observational study.Front Endocrinol (Lausanne). 2024 Apr 11;15:1366940. doi: 10.3389/fendo.2024.1366940. eCollection 2024. Front Endocrinol (Lausanne). 2024. PMID: 38665260 Free PMC article.
-
Gut microbiota and therapy for obesity and type 2 diabetes.Front Endocrinol (Lausanne). 2024 Mar 26;15:1333778. doi: 10.3389/fendo.2024.1333778. eCollection 2024. Front Endocrinol (Lausanne). 2024. PMID: 38596222 Free PMC article. Review.
Publication types
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical