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63. Drugs That May Cause or Exacerbate Heart Failure

suppressants x Major A Valvular damage Intermediate Fenfluramine, dexfenfluramine, and sibutramine have been removed from the US market Bipolar medications Lithium x Major C Direct myofibrillar degeneration, adrenergic stimulation, calcium ion influx interference Intermediate to delayed Reversible on discontinuation Ophthalmological medications Topical β-blockers x Major C Negative inotrope Immediate to intermediate Consider lowering the dose or discontinuing; reversible on discontinuation Topical

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2016 American Heart Association

64. Contributory Risk and Management of Comorbidities of Hypertension, Obesity, Diabetes Mellitus, Hyperlipidemia, and Metabolic Syndrome in Chronic Heart Failure: A Scientific Statement From the American Heart Association

committee cautions against the use of ephedra, sibutramine, and other weight-loss prepara- tions because they may contribute to the development of HF and should be avoided. 8 Currently, given the above concerns and the lack of evidence on intentional weight loss in HF, the 2009 AHA scientific statement on promoting self-care in individu- als with HF suggests weight loss only if the BMI is >40 kg/m 2 . 249 If the BMI is 35 kg/m 2 , gastrointestinal surgery may be an option. Additionally, in patients (...) or physical activity for the pur- poses of improving health-related QOL or managing comorbidities such as diabetes mellitus, hypertension, or sleep apnea may be reasonable in obese patients with HF (Class IIb; Level of Evidence C). 2. Sibutramine or ephedra weight loss prepara- tions are contraindicated in HF . Use of ephedra weight-loss preparations may contribute to the development of HF and should be avoided (Class III: Harm; Level of Evidence C). No Data Weight reduction, including with bariatric

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2016 American Heart Association

65. American Association of Clinical Endocrinologists and American College of Endocrinology Clinical Practice Guidelines for Comprehensive Medical Care of Patients with Obesity

; RR = rel- ative risk; RYGB = Roux-en-Y gastric bypass; SAD = sagittal abdominal diameter; SBP = systolic blood pres- sure; SCOUT = Sibutramine Cardiovascular Outcome Trial; SG = sleeve gastrectomy; SHBG = sex hormone- binding globulin; SIEDY = Structured Interview on Erectile Dysfunction; SNRI = serotonin-norepinephrine reuptake inhibitors; SOS = Swedish Obese Subjects; SS = surveillance study; SSRI = selective serotonin reuptake inhibitors; STORM = Sibutramine Trial on Obesity Reduction

2016 American Association of Clinical Endocrinologists

66. Drugs for Type 2 Diabetes – Project Protocol

of interest outlined in Table 3. Interventions of interest, including fixed-dose combinations and mixed insulin products are further detailed in Tables 1 and 2. Detailed eligibility criteria for studies are provided in Table 4. Studies will not be excluded based on outcomes reported. Weight-loss drugs (e.g., orlistat, sibutramine) included in previous CADTH reviews will not be included in this update. The primary role of such drugs is to lower body weight rather than to treat hyperglycemia. Table 3

2016 CADTH - Therapeutic Review

67. Naltrexone + bupropion (Mysimba°): too risky for only modest weight loss

. Sibutramine: cardiovascular events Prescrire Int 2010; 19 (107): 125. Obesity: weight loss without drugs Prescrire Int 2007; 16 (90): 162-167. | | | Prescrire Your change of address has been received and will be processed promptly but will not appear instantaneously Prescrire Your message has been sent

2015 Prescrire

68. "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention"

"Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention" "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention" - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have (...) reached the maximum number of saved studies (100). Please remove one or more studies before adding more. "Efficacy in Adolescents of Continued Behavior Modification Following a Six Month Sibutramine-based Weight Management Intervention" (AOS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01023139

2009 Clinical Trials

69. Pioglitazone metabolic effect in metformin-intolerant obese patients treated with sibutramine. (PubMed)

Pioglitazone metabolic effect in metformin-intolerant obese patients treated with sibutramine. Metformin is the drug of choice to treat obese type 2 diabetes patients because it reduces either insulin-resistance and body weight. We aimed to comparatively test the efficacy and tolerability of pioglitazone and sibutramine in metformin-intolerant obese type 2 diabetic patients treated with sibutramine.Five hundred and seventy-six consecutive Caucasian obese type 2 diabetic patients were evaluated (...) during a 12-months period and fifty-two patients were resulted intolerant to metformin at maximum dosage (3,000 mg/day). All intolerant patients to metformin received a treatment with pioglitazone (45 mg/day) and sibutramine (10 mg/day) and they were compared with fifty-three patients treated with metformin (3,000 mg/day) and sibutramine (10 mg/day) for 6 months in a single-blind controlled trial. We assessed body mass index, waist circumference, glycated hemoglobin, Fasting Plasma glucose

2009 Internal medicine (Tokyo, Japan)

70. Comparative bioavailability of two formulations of sibutramine. (PubMed)

Comparative bioavailability of two formulations of sibutramine. This study was conducted in order to compare the bioavailability of two capsule formulations containing 15 mg of sibutramine, N-{1-[1-(4-chlorophenyl)cyclobutyl]-3-methylbutyl}-N,N-dimethylamine hydrochloride monohydrate, 84485-00-7 CAS registry number. 62 healthy subjects were enrolled in a single-center, randomized, single-dose, open-label, 2-way crossover study, with a minimum washout period of 14 days. Plasma samples were (...) collected up to 72.0 hours post-dosing. R-sibutramine, S-sibutramine, N-mono-desmethyl-sibutramine (M1) and N-di-desmethyl-sibutramine (M2) levels were determined by reverse liquid chromatography and detected by tandem mass spectrometry detection, LC/MS/MS method. Pharmacokinetic parameters used for bioequivalence assessment were the area under the concentration-time curve from time zero to time of last non-zero concentration (AUC0-t) and the maximum observed concentration (Cmax). These parameters were

2009 International journal of clinical pharmacology and therapeutics

71. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. (PubMed)

Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. The objective of this article was to estimate the risk of discontinuation due to adverse events in trials of orlistat, sibutramine and rimonabant. Medline, EMBASE, the Cochrane controlled trials register and reference lists of identified articles were searched from 1990 to May 2008. All randomized placebo-controlled trials of 12-24 months of duration on adults using licensed (...) sibutramine and 5 rimonabant). The risk ratios for discontinuation due to adverse events were significantly elevated for rimonabant (2.00; 1.66-2.41) and orlistat (1.59; 1.21-2.08), but not sibutramine (0.98, 0.68-1.41). Compared with placebo, the risk difference was the largest for rimonabant (7%, 5-9%; NNH 14, 11-19), followed by orlistat (3%, 1-4%; NNH 39, 25-83), while no significant difference was seen for sibutramine (0.2%, -3 to 4%; NNH 500). The most common adverse events leading to withdrawal

2009 Obesity reviews : an official journal of the International Association for the Study of Obesity

72. Acute effect of weight loss on levels of total bilirubin in obese, cardiovascular high-risk patients: an analysis from the lead-in period of the Sibutramine Cardiovascular Outcome trial. (PubMed)

Acute effect of weight loss on levels of total bilirubin in obese, cardiovascular high-risk patients: an analysis from the lead-in period of the Sibutramine Cardiovascular Outcome trial. Low levels of bilirubin are associated with an increased risk of cardiovascular adverse events. Weight reduction is known to reduce several cardiovascular risk factors, but effects on bilirubin levels have not been reported. We studied the response of weight loss therapy with sibutramine and lifestyle change (...) on levels of total bilirubin in an overweight or obese, cardiovascular high-risk population. Data from the first 4 weeks of the lead-in period of the Sibutramine Cardiovascular Outcome study were analyzed. A total of 10 198 patients provided body weight measurements before and after 4 weeks of sibutramine treatment (10 mg daily), of whom 1059 (10.4%) gained weight, 1467 (13.7%) lost greater than 0% to 1%, 2492 (23.2%) lost greater than 1% to 2%, 2280 (21.2%) lost greater than 2% to 3%, 1498 (13.9%) lost

2009 Metabolism: clinical and experimental

73. 5-HT(1A) Activation Counteracts Cardiovascular But Not Hypophagic Effects of Sibutramine in Rats. (PubMed)

5-HT(1A) Activation Counteracts Cardiovascular But Not Hypophagic Effects of Sibutramine in Rats. The noradrenaline (NA) and serotonin reuptake inhibitor, sibutramine, gives effective weight loss, but full efficacy cannot be attained at approved doses due to cardiovascular side effects. We assessed in rats the contributions of NA and serotonin transporters to sibutramine's hypophagic and cardiovascular effects, and whether selective 5-hydroxytryptamine (5-HT(1A)) receptor activation could (...) counteract the latter without affecting the former. Food intake was assessed in freely feeding rats and cardiovascular parameters in conscious telemetered rats. Ex vivo radioligand binding was used to estimate brain monoamine transporter occupancy. Sibutramine (1-10 mg/kg p.o.) dose-dependently reduced food intake; however, 10 mg/kg p.o. markedly elevated blood pressure and heart rate. Sibutramine gave greater occupancy of NA than serotonin reuptake sites. Coadministration of the selective 5-HT(1A

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2009 Obesity

74. Obesity: European patients protected against lorcaserin, a psychotropic drug sold as an appetite suppressant

) Benfluorex: the appetite- suppressant amphetamine is finally suspended from sale in France (November 2009) Sibutramine: withdrawn from the European market at last! (July 2010) Obesity: diet, physical exercise and support are the priorities (April 2009) Rimonabant: marketing authorisation suspended... at last! Prescrire Int 2009; 18 (100) : 61. | | | Prescrire Your change of address has been received and will be processed promptly but will not appear instantaneously Prescrire Your message has been sent

2014 Prescrire

75. Centrally-acting drugs for obesity cause more harm than good

products (16 trials with 24,555 participants) – three (lorcaserin, naltrexone-bupropion and phentermine-topiramate ) of which are currently available and two (rimonabant and sibutramine) withdrawn from the market because of serious adverse reactions. Centrally acting medicines increased the chance of losing at least 5% of body weight, but their use was associated with increased risk of harms and discontinuation because of these harms. In particular, the risk of nervous and psychiatric adverse events

2018 Evidence-Based Medicine blog

76. Antidepressants for polycystic ovary syndrome. (PubMed)

potential sources of bias.We found no studies reporting any of our primary review outcomes (depression and allied mood disorder scores, quality of life and adverse events). Only one study with 16 women was eligible for inclusion. This study compared sibutramine versus fluoxetine in women with PCOS, and reported only endocrine and metabolic outcomes. It was unclear whether the participants had psychological problems at baseline. No significant difference was found between the groups for any

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2013 Cochrane

77. Vagal Nerve Blockade for Obesity: VBLOC Therapy Using the Maestro RC2 Device

Apr 13]. Available from: National Heart, Lung, and Blood Institute. Aim for a healthy weight: key recommendations [Internet]. Bethesda (MD): The Institute; [2014]. [cited 2015 Apr 13]. Available from: Johansson K, Neovius K, DeSantis SM, Rossner S, Neovius M. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. Obes Rev. 2009 Sep;10(5):564-75. Bray GA. Medications for weight reduction. Med Clin North Am. 2011 Sep;95(5):989-1008

2015 CADTH - Issues in Emerging Health Technologies

79. Vagal Nerve Blockade for Obesity: VBLOC Therapy Using the Maestro RC2 Device

Apr 13]. Available from: National Heart, Lung, and Blood Institute. Aim for a healthy weight: key recommendations [Internet]. Bethesda (MD): The Institute; [2014]. [cited 2015 Apr 13]. Available from: Johansson K, Neovius K, DeSantis SM, Rossner S, Neovius M. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. Obes Rev. 2009 Sep;10(5):564-75. Bray GA. Medications for weight reduction. Med Clin North Am. 2011 Sep;95(5):989-1008

2015 CADTH - Issues in Emerging Health Technologies

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