Effect of orlistat on cardiovascular disease risk in obese adults
Abstract
AIM: The aim of this study is to compare the effect of orlistat vs. placebo on the predicted 10-year cardiovascular disease (CVD) risk in obese people with one or more cardiovascular risk factors treated for 12 months, in conjunction with a fat-reduced, but otherwise ad libitum, diet. METHODS: A double-blind, randomized, placebo-controlled, parallel study was performed in conjunction with a fat-reduced diet and physical activity advice for 1 year. Participants (n = 339) from eight centres in Australia and New Zealand were randomized to either orlistat (120 mg) three times daily (n = 104 women, 66 men; mean +/- s.d. age = 52.0 +/- 7.5 years, body mass index (BMI) = 37.6 +/- 5.1 kg/m(2)) or placebo three times daily (n = 89 women, 80 men; age = 52.5 +/- 7.4 years, BMI = 38.0 +/- 4.9 kg/m(2)). The primary efficacy criterion was the 10-year risk of developing CVD calculated from the Framingham equation. Secondary efficacy criteria were body weight, waist circumference, blood pressure and serum concentrations of triglycerides, cholesterol (total, LDL and HDL), glucose, insulin and glycated haemoglobin and quality of life. RESULTS: There was no difference in the change in 10-year CVD risk between orlistat and placebo groups over 1 year. The orlistat group, however, had significant favourable changes in many of the individual CVD risk factors (total cholesterol, LDL-cholesterol, glucose, glycated haemoglobin, insulin, body weight and waist circumference) and one of the domains of quality of life measured by means of the SF-36 questionnaire (vitality), compared to the placebo group. Significant reductions in medication use for hypertension and diabetes were observed in the orlistat group, compared to those in placebo, but there were no significant differences in medication use for blood lipids. CONCLUSIONS: Orlistat may have reduced CVD risk, as judged by the favourable changes in individual risk factors and reductions in medication use, but the method used in order to measure absolute CVD risk in this study (Framingham CVD equation) was not sensitive enough to detect the changes in this relatively low-risk group (approximately 10% of risk of a CVD event over 10 years).
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Some studies were designed for other purposes, for example, prevention of CVD or T2D.
“However, some studies were designed for other purposes17,18,30,41–44—for example, prevention of CVD or T2D.”
From A systematic review and meta-analysis of the efficacy and safety of pharmacological treatments for obesity in adults (2025) · cites this paper as [30]
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- Authors
- Swinburn, B. A., Carey, D., Hills, A. P., Hooper, M., Marks, S., Proietto, J., Strauss, B. J., Sullivan, D., Welborn, T. A., & Caterson, I. D.
- Affiliations
- University of Auckland (NZ)
- The University of Queensland (AU)
- Queensland University of Technology (AU)
- The University of Sydney (AU)
- Monash Medical Centre (AU)
- The Royal Melbourne Hospital (AU)
- Royal Prince Alfred Hospital (AU)
- Sir Charles Gairdner Hospital (AU)
- Corresponding author
- Swinburn, B. A.
- Venue
- Diabetes, Obesity and Metabolism
- Publisher
- Wiley
- Published
- 2005-04-04
- Volume
- 7
- Issue
- 3
- Pages
- 254-262
- ISSN
- 1462-8902 (ISSN-L)
- 1463-1326
- OpenAlex
- W1517951941
- Cited by
- 81
- References
- 2
- Citations by year
- 2026: 2 · 2025: 6 · 2024: 3 · 2023: 2 · 2022: 5 · 2021: 2 · 2020: 3 · 2019: 2 · 2018: 4 · 2017: 2 · 2016: 5 · 2015: 4 · 2014: 5 · 2013: 5 · 2012: 3
- FWCI
- 3.18
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Diabetes Obesity and Metabolism (publishedVersion)
- PubMed (publishedVersion)
- Centre for Health Research; Faculty of Health; Institute of Health and Biomedical Innovation
- Topics
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Surgery › Bariatric Surgery and Outcomes
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
- Keywords
- orlistat, cardiovascular risk, obesity, ad libitum feeding, 10-year cardiovascular risk prediction, Framingham risk equation, cardiovascular risk factors, LDL cholesterol, HbA1c, insulin, blood pressure, quality of life, weight loss, medication use
- MeSH terms
- Orlistat, Adult, Aged, Antihypertensive Agents, Blood Glucose, Body Constitution, Cardiovascular Diseases, Cholesterol, Diet, Reducing, Double-Blind Method, Exercise Therapy, Female, Humans, Hypoglycemic Agents, Insulin, Lactones, Lipids, Cholesterol, LDL, Male, Middle Aged, Obesity, Probability, Risk Factors, Single-Blind Method, Anti-Obesity Agents
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