sibutramine (Meridia, Reductil)
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Introduction
Withdrawn from US market 10/08/2010[11]
Indications
- weight loss (43% long-term weight loss[2]) large weight loss maintained for 1 year[8]
- obesity
Contraindications
- history of coronary artery disease
- history of stroke or transient ischemic attack
- history of cardiac arrhythmias
- history of congestive heart failure
- history of peripheral arterial disease
- uncontrolled hypertension (e.g., > 145/90 mmHg)[10]
Dosage
- start 10 mg PO QD
- may increase to 15 mg PO QD after 4 weeks
- max 15 mg QD
- intermittent therapy (4 month on, 2 months off) may be as effective as continuous therapy[5]
Tabs: 10 mg, 15 mg.
Pharmacokinetics
- metabolized in the liver by cyt P450 3A4
elimination via liver
Adverse effects
- hypertension
- tachycardia
- increased risk for cardiovascular events among adults with cardiovascular disease[11]
- SIADH & hyponatremia[7]
- low discontinuation rate[8]
- drug adverse effects of SSRIs
- drug adverse effects of antidepressants
- drug adverse effects of psychotropic agents
Drug interactions
- other serotonergic agents (may lead to serotonin syndrome)
- alcohol
- cimetidine
- any drug that inhibits cyt P450 3A4 may increase levels of sibutramine
- any drug that induces cyt P450 3A4 may diminish levels of sibutramine
- drug interaction(s) of oral anticoagulants with selective serotonin reuptake inhibitor (SSRI)
- drug interaction(s) of ondanstetron with SSRIs
- drug interaction(s) of dextromethorphan with SSRIs
- drug interaction(s) of trazodone with SSRIs
- drug interaction(s) of tramadol with SSRIs
- drug interaction(s) of triptans with SSRIs
- drug interaction(s) of anti-platelet agents with SSRIs
- drug interaction(s) of methylene blue with SSRIs
- drug interaction(s) of linezolid with SSRIs
- drug interaction(s) of statins with SSRIs
- drug interaction(s) of hypericum perforatum (Sr John's wort) with SSRI
- drug interaction(s) of tamoxifen with SSRI
- drug interaction(s) of benzodiazepines with antidepressants
- drug interaction(s) of antidepressants with benzodiazepines
- drug interaction(s) of NSAIDs with SSRIs
- drug interaction(s) of NSAIDs with antidepressants
- drug interaction(s) of coxib with SSRI
Laboratory
Mechanism of action
- appetite suppressant
- serotonin & norepinephrine re-uptake inhibitor
Weight loss of:
- 7.8 kg vs 3.8 kg over 1 year in obese patients with body mass index of 30-40 (22-25 normal)[5]
- better than placebo[9]
More general terms
Additional terms
- cytochrome P450 3A4 (cytochrome P450 C3, nifedipine oxidase, P450-PCN1, NF-25, CYP3A4)
- serotonin syndrome (serotonism)
- weight loss
References
- ↑ Kaiser Permanente Pharmacy update
- ↑ 2.0 2.1 Journal Watch 21(5):38, 2001 James WP et al Effect of sibutramine on weight maintenance after weight loss: a randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance. Lancet 356:2119, 2000 PMID: https://www.ncbi.nlm.nih.gov/pubmed/11191537
- ↑ Drug Bulletin, Kaiser Permanente, 27:2, 2001
- ↑ Prescriber's Letter 13(3): 2006 Cytochrome P450 drug interactions Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=220233&pb=PRL (subscription needed) http://www.prescribersletter.com
- ↑ 5.0 5.1 5.2 Journal Watch 21(21):173, 2001 Wirth A & Krause J Long-term weight loss with sibutramine: a randomized controlled trial. JAMA 286:1331, 2001 PMID: https://www.ncbi.nlm.nih.gov/pubmed/11560538
- ↑ 6.0 6.1 6.2 Prescriber's Letter 9(4):23 2002 FDA MedWatch - Meridia (sibutramine): Early Communication about cardiovascular events http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm191655.htm
- ↑ 7.0 7.1 Prescriber's Letter 9(8):38 2002
- ↑ 8.0 8.1 8.2 Wadden TA, Berkowitz RI, Womble LG, Sarwer DB, Phelan S, Cato RK, Hesson LA, Osei SY, Kaplan R, Stunkard AJ. Randomized trial of lifestyle modification and pharmacotherapy for obesity. N Engl J Med. 2005 Nov 17;353(20):2111-20. PMID: https://www.ncbi.nlm.nih.gov/pubmed/16291981
- ↑ 9.0 9.1 Berkowitz RI et al Effects of sibutramine treatment in obese adolescents. A randomized trial. Ann Intern Med 2006, 145:81 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16847290
Dietz WH What constitutes successful weight management in adolescents? Ann Intern Med 2006, 145:145 PMID: https://www.ncbi.nlm.nih.gov/pubmed/16847296 - ↑ 10.0 10.1 FDA MedWatch Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm198221.htm11) James WP, - James WP et al Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects N Engl J Med 2010; 363:905-917 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/20818901 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1003114
- ↑ 11.0 11.1 11.2 11.3 11.4 FDA MedWatch 10/08/2010 Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm228830.htm