Sibutramine Use Associated with Reversible Hepatotoxicity

Chounta, Athina; Tsiodras, Sotirios; Zouridakis, Spyros; Doumas, Michael; Giamarellou, Helen

doi:10.7326/0003-4819-143-10-200511150-00030

Cited by 10 publications

(9 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…There is a published case report of reversible hepatotoxicity in association with sibutramine (38). In PEM, there were 5 cases of abnormal LFTs assessed as possibly related to sibutramine treatment.…”

Section: Resultsmentioning

confidence: 99%

The Safety Profiles of Orlistat and Sibutramine: Results of Prescription‐Event Monitoring Studies in England

Perrio

Wilton

Shakir

2007

Obesity

View full text Add to dashboard Cite

PERRIO, MICHAEL J., LYNDA V. WILTON, AND SAAD A. W. SHAKIR. The safety profiles of orlistat and sibutramine: results of prescription-event monitoring studies in England. Obesity. 2007;15:2712-2722. Introduction: Observational cohort studies were conducted using prescription-event monitoring (PEM) to examine the safety profiles of the anti-obesity agents orlistat and sibutramine. Adverse events reported as case reports were also evaluated to determine whether these events were also identified by PEM. Research Methods and Procedures:Patients were identified from dispensed prescriptions written by general practitioners (GPs) in England for orlistat or sibutramine. Patient demographic and clinical event information, including reasons for stopping and adverse drug reactions, were requested on questionnaires posted to GPs at least 6 months after the first prescription for individual patients. Event incidence densities (IDs) (number of first reports of event/ 1000 patient-months treatment) were calculated for month 1 (ID 1 ) and months 2-3 (ID 2-3 ). Published case reports were identified by searching Medline and Embase. Results: The cohorts comprised 16,021 and 12,336 patients prescribed orlistat and sibutramine, respectively. Both cohorts had a median age of 45 years, and ϳ80% were female. The most common reason for stopping orlistat within 3 months was diarrhea (332 patients; 2.1% cohort), and for stopping sibutramine it was hypertension (203 patients; 1.6%). Clinical events significantly associated with taking orlistat were mainly gastrointestinal and those for sibutramine included central nervous system effects, nausea/vomiting, palpitation, and sweating. We identified 8 published case reports for orlistat and 10 for sibutramine that had equivalent or similar events assessed as causally related in the PEM studies. Conclusions:The PEM studies highlighted different adverse event profiles for orlistat and sibutramine that were consistent with their distinct pharmacological mechanisms and other published information.

show abstract

Section: Resultsmentioning

confidence: 99%

The Safety Profiles of Orlistat and Sibutramine: Results of Prescription‐Event Monitoring Studies in England

Perrio

Wilton

Shakir

2007

Obesity

View full text Add to dashboard Cite

show abstract

“…There is only one report of sibutramine‐induced liver injury in the literature (88). Chounta et al .…”

Section: Methodsmentioning

confidence: 99%

“…The above data indicate a causal relationship between sibutramine and hepatotoxicity. However, no underlying mechanism was suggested (88).…”

Section: Methodsmentioning

confidence: 99%

Sibutramine‐associated adverse effects: a practical guide for its safe use

2007

View full text Add to dashboard Cite

Obesity is a multifactorial chronic disorder which comprises a serious health problem nowadays. The effective management of obesity is difficult in contemporary societies where abundance of hypercaloric food and sedentary lifestyle is the rule. Apart from lifestyle interventions, which include diet, exercise and behavioural treatment, weight-loss medications can also be used for the management of obesity. Sibutramine, a selective monoamine reuptake inhibitor, is a drug with established efficacy in sustained weight reduction and an overall favourable safety profile. However, its action on the sympathetic nervous system has linked sibutramine to blood pressure and heart rate elevations. These potentially adverse effects as well as other sibutramine-associated side effects and their possible underlying mechanisms are reviewed in the present article. Compelling evidence from the majority of data in the literature shows that sibutramine can be effectively used in conjunction with caloric restriction and exercise in obese patients. Hypertension, if adequately treated and frequently monitored, is not an absolute contraindication for the prescription of sibutramine.

show abstract

“…Some sporadic cases of panic attack [88] , impaired memory [89] , mania in bipolar patients [90] , psychosis [91,92] and relapse of delusional disorder [93] have been reported with sibutramine. Similarly, cases with severe bullous drug eruption [94] , reversible hepatotoxicity [95] , QT-prolongation and dysrhythmias [96] associated with sibutramine have been reported. However, sibutramine does not cause valvular heart diseases [97,98] or impair ventricular structure and function [98,99] .…”

Section: Adverse Effects and Contraindications Of Sibutraminementioning

confidence: 89%

Sibutramine: current status as an anti-obesity drug and its future perspectives

Sharma

Henderson

2008

Expert Opinion on Pharmacotherapy

View full text Add to dashboard Cite

Background : Obesity has become a global epidemic with recent estimates of > 400 million obese adults. Despite this, there are few safe and effective pharmacological interventions for obesity. Sibutramine is a weight loss agent, for use as an adjuvant to a comprehensive program of calorie restriction, exercise and behavioral therapy. Objective : The goal of this article is to review the available literature of pharmacological interventions for obesity and specifically to ex amine data with sibutramine for the short term on safety and efficacy for weight loss. Methods : The literature on sibutramine was reviewed after a PubMed and Medline search in March 2008. All randomized clinical trails were reviewed. Results/conclusions : Sibutramine appears to be safe and effective in producing clinically significant weight loss for up to 1 year. Longer prospective clinical studies with sibutramine are needed to evaluate its safety (effect on blood pressure) and ability to maintain weight loss, improve metabolic profiles and reduce the risk of cardiovascular diseases.

show abstract

Sibutramine Use Associated with Reversible Hepatotoxicity

Cited by 10 publications

References 3 publications

The Safety Profiles of Orlistat and Sibutramine: Results of Prescription‐Event Monitoring Studies in England

The Safety Profiles of Orlistat and Sibutramine: Results of Prescription‐Event Monitoring Studies in England

Sibutramine‐associated adverse effects: a practical guide for its safe use

Sibutramine: current status as an anti-obesity drug and its future perspectives

Contact Info

Product

Resources

About