Meridia (sibutramine) / AbbVie - LARVOL DELTA

Cross-Analytical Strategies to Tackle "Medicines in Disguise" Presented as Food Supplements, a New Threat for Human Health. (PubMed, Molecules) - "The samples contained active pharmaceutical ingredients, including diclofenac, piroxicam, dexamethasone 21-acetate, and sibutramine. We provided evidence of "medicines in disguise" presented as food supplements, which raises concerns about their quality and safety."

Journal

TOLERASIT: Observational, Real-life, Retrospective, Data Collection, Use Sibutramine/topiramate in Overweight Comorbidities/obesity (clinicaltrials.gov) - P=N/A | N=0 | Withdrawn | Sponsor: Eurofarma Laboratorios S.A. | N=1500 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Genetic Disorders • Obesity

Pharmacological interventions for addressing pediatric and adolescent obesity: A systematic review and network meta-analysis. (PubMed, PLoS One) - "The study found that semaglutide outperformed other AOMs in reducing BMI and additional weight-related outcomes in children and adolescents with obesity, while PHEN/TPM showed comparable efficacy."

Clinical • Journal • Retrospective data • Review • Genetic Disorders • Obesity • Pediatrics

Postoperative Weight Loss After Antiobesity Medications and Revision Risk After Joint Replacement. (PubMed, JAMA Netw Open) - "Emulated analyses of a hypothetical target trial were assessed for the association of small-to-moderate (2%-10%) or large (≥10%) weight loss after initiating antiobesity medications (orlistat, sibutramine, glucagon-like peptide-1 receptor agonists, and rimonabant) within 1 year with the risk of 5-year and 10-year revision after initiation of antiobesity medications. In this cohort study using a target trial emulation, a higher proportion of weight loss after initiating antiobesity medications within 1 year was associated with a lower risk of 5-year and 10-year revision among patients with obesity undergoing joint replacement. These results suggest that antiobesity medication use, with relatively safe and sustainable weight loss, may be an effective strategy for improving implant survivorship of hip and knee replacements in the obese population."

Journal • Retrospective data • Genetic Disorders • Musculoskeletal Diseases • Obesity • Orthopedics • Rheumatology

UNLIMITED: A Phase 3, Double-blind/double-dummy, Safety/efficacy/superiority of Sibutramine/topiramate XR in Adults with Overweight (clinicaltrials.gov) - P3 | N=1855 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial completion date: Jul 2027 ➔ Mar 2028 | Trial primary completion date: Mar 2027 ➔ Mar 2028

Head-to-Head • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

Emerging pharmacotherapies for obesity: A systematic review. (PubMed, Pharmacol Rev) - "Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, and TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide and survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate...This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives."

Journal • Review • Genetic Disorders • Obesity

Presence of sibutramine and sildenafil in weight loss dietary supplements: a case series with analytical and clinical investigation. (PubMed, Clin Toxicol (Phila)) - "As such, the unregulated use of these products pose a serious risk to public health, particularly in individuals with underlying cardiovascular disease. We detected sibutramine and sildenafil in all 12 weight loss supplements tested, which highlights the need for stricter regulation and monitoring."

Journal • Anorexia • Cardiovascular • CNS Disorders • Epilepsy • Insomnia • Pain • Sleep Disorder

Pharmacologic Treatment of Obesity in adults and its impact on comorbidities: 2024 Update and Position Statement of Specialists from the Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso) and the Brazilian Society of Endocrinology and Metabolism (SBEM). (PubMed, Arch Endocrinol Metab) - "This document is an 2024 Update Position Statement of Specialists from the Brazilian Association for the Study of Obesity and Metabolic Syndrome (Abeso) and the Brazilian Society of Endocrinology and Metabolism (SBEM), with the aim of reviewing all the approved medications for the management of obesity in Brazil (sibutramine, orlistat, liraglutide, semaglutide and bupropion/naltrexone fixed dose), with the addition of tirzepatide, that is approved in other countries and likely approved soon in Brazil. The review is focused on efficacy, safety profile and the impact of drugs (based on existing studies) on different comorbidities."

Journal • Review • Endocrine Disorders • Genetic Disorders • Metabolic Disorders • Obesity

Trends in the Prescription of Weight Loss Medications in Patients With Obesity: A Nationwide Cross-Sectional Analysis, 1999-2018 (ACG 2024) - "Prescription medication data included FDA-approved weight-loss drugs such as phentermine, sibutramine, diethylpropion, phentermine/topiramate, orlistat, bupropion/naltrexone, GLP-1 agonist. Weight-loss inducing anti-diabetic drugs included pramlintide, SGLT-2 inhibitors, metformin...The most prescribed FDA-approved medication was phentermine followed by liraglutide and orlistat... The proportion of subjects who met the criteria for receiving weight-loss drugs increased from 42.4% in 1999-2000 to 51.9% in 2017-2018. However, the use of FDA-approved drugs alone remained low ranging from 0.29% in 1999-2000 to 1.12% in 2017-2018. When anti-diabetes drugs with weight-loss effects were included, the proportion of use ranged from 5.16% in 1999-2000 to 14.24% in 2017-2018."

Clinical • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Hypertension • Obesity

In vitro Evaluation of Anti-obesity Potential of Phyllanthus Fraternus Leaves. (PubMed, Arch Razi Inst) - "Treatments available for obesity include FDA-approved drugs such as Lorcaserin, Orlistat, Bupropion, combinations of Phentermine and Topiramate, and Sibutramine; however, these have adverse effects on health. The results obtained from the current study revealed that the plant exhibits potent anti-obesity properties. Thus, this plant extract is a potential source as an alternative treatment to treat obesity."

Journal • Preclinical • Genetic Disorders • Obesity

Effect of Anti-Obesity Treatments on Heart Rate Variability: Review of a 20 Years Evolution (OBESITY WEEK 2024) - "Exenatide (acute, 1 week) increased the LF/HF ratio (median: 0.6, [-0.3 to -3.2]; p 0.05).Twelve observational studies 6 to 12 months after bariatric surgery consistently reported a positive impact on HRV (p<0.05).Two studies showed further improvement in HRV for patients who exercised(aerobic exercise) after surgery.Findings were mixed in sibutramine. Most studies only assess HRV for short periods, and longer evaluations are needed since some treatments may have fluctuating effects. Overall, more research is necessary, and wearable devices could be valuable tools for continuous HRV monitoring."

Review • Genetic Disorders • Obesity

Portable unibody semi-flow injection voltammetric sensor for on-site screening of illegal additive sibutramine in food supplements. (PubMed, Talanta) - "The sensor delivered a response in a short time and demonstrated not only good reproducibility (RSDs ranging from 2.9 % to 4.9 % (n = 10)) and excellent resistance to interference but also high accuracy. The developed sensor was utilized for the screening and quantification of SBM in food supplements but the system could be used in a wider range of electrochemical (bio) sensor applications in the future."

Journal

The Effectiveness of Nonsurgical Interventions for Weight Loss Maintenance in Adults: An Updated, GRADE-Assessed Systematic Review and Meta-Analysis of Randomized Clinical Trials. (PubMed, Nutr Rev) - "The findings of this review indicate there is a favorable impact of behavior-based interventions and antiobesity medications on weight maintenance."

Clinical • Journal • Retrospective data • Review • Genetic Disorders • Obesity

Emerging Pharmacotherapies for Obesity: A Systematic Review. (PubMed, Pharmacol Rev) - "Oral semaglutide 50 mg is the only medication that has completed a phase 3 trial. There are 14 ongoing phase 3 trials on glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) (ecnoglutide, orforglipron, TG103), GLP-1 RA/amylin agonist (CagriSema), GLP-1/glucagon RAs (mazdutide, survodutide), GLP-1/glucose-dependent insulinotropic polypeptide and glucagon RA (retatrutide), dapagliflozin, and the combination sibutramine/topiramate...This systematic review identifies the state and mechanism of action of emerging pharmacotherapies undergoing or having completed phase 2 and phase 3 clinical trials. The information provided herein furthers the understanding of obesity management, implying direct clinical implications and stimulating research initiatives."

Journal • Review • Developmental Disorders • Genetic Disorders • Obesity

Charting New Territories in Obesity Management- Traditional Techniques to Tirzepatide. (PubMed, Endocr Pract) - "Traditional approaches, including lifestyle modification, and diverse drugs targeting a gastrointestinal hormone, including glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) (Liraglutide, Semaglutide, Exenatide, Albiglutide, Dulaglutide, Lixisenatide, Orlistat, Phentermine/Topiramate, Lorcaserin, Sibutramine, Rimonabant) offer tailored strategies; yet their effectiveness is limited and some drugs were taken off the market. Its Food and Drug Administration (FDA) approval marks a milestone in the realm of obesity therapeutics. Going beyond a recapitulation of findings, the conclusion emphasizes the imperative for ongoing exploration and vigilant safety monitoring in tirzepatide's application."

Journal • Review • Diabetes • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Model for Predicting the Effect of Sibutramine Therapy in Obesity. (PubMed, J Pers Med) - " Although our developed prediction model may not exhibit high precision compared to certain benchmarks, it significantly outperforms random chance or models relying only on BMI parameters. Our model used the available range of laboratory tests, which makes it possible to use this model for routine clinical use and help doctors decide whether to prescribe sibutramine."

Journal • Genetic Disorders • Obesity

Exploring the Anti-Obesity Effects of Specific Medicinal Herbs: Focus on Herbal Approaches and their Role in Gut Microbiota. (PubMed, Curr Pharm Biotechnol) - "The most convenient therapy for treating obesity is the use of synthetic drugs available in the markets, like orlistat and sibutramine, but these drugs have serious side effects, along with this surgical procedure, and are also not safe. They achieve this by acting on various signaling pathways, reducing the levels of hormones associated with obesity, and regulating the abundance and composition of gut microbiota. This review concludes by highlighting the potential role of various herbal plants in managing obesity."

Journal • Atherosclerosis • Cardiovascular • Diabetes • Dyslipidemia • Genetic Disorders • Hypertension • Metabolic Disorders • Obesity • Oncology

Sibutramine-induced pheochromocytoma crisis: A rare and lethal occurrence. (PubMed, J Forensic Leg Med) - "The cause of death was attributed to sibutramine-induced PCC. To our knowledge, this is the first report to document the occurrence of sibutramine-induced PCC."

Journal • Cardiovascular • Endocrine Cancer • Genetic Disorders • Neuroendocrine Tumor • Obesity • Oncology • Solid Tumor

Enzyme-linked immunoassay for simultaneous detection of methyl parathion and sibutramine in apple cider vinegar. (PubMed, Anal Methods) - "Sibutramine, a non-amphetamine central nervous system depressant, helps lose weight by disrupting hormone regulation, stimulating sympathetic nerves, and suppressing appetite. The antibody was used to develop a standard curve for the detection of sibutramine at the half-maximum inhibitory concentration (IC50) is 4.59 ng mL-1, the limit of detection (IC10) is 2.21 ng mL-1, the detection range is 2.89 to 7.28 ng mL-1, methyl p-phosphorus at the half-maximum inhibitory concentration (IC50) is 15.34 ng mL-1, the limit of detection (IC10) is 0.42 ng mL-1, the detection range is ng mL-1. Under these conditions, the recovery rate was between 88% and 102%, within reasonable limits, indicating the successful establishment of a rapid enzyme-linked ELISA assay."

Journal

Pharmacological interventions for antipsychotic-induced weight gain in schizophrenia: A network meta-analysis. (PubMed, Gen Hosp Psychiatry) - "Metformin 750 mg with lifestyle modification was the most effective treatment for AIWG, followed by topiramate 200 mg, metformin 750 mg, and topiramate 100 mg with moderate certainty of evidence."

Journal • Retrospective data • Cardiovascular • CNS Disorders • Psychiatry • Schizophrenia

Determination of 13 potential anti-obesity agents in hair by dispersive liquid-liquid microextraction-assisted UHPLC-MS/MS. (PubMed, J Pharm Biomed Anal) - "The developed method successfully detected 13 anti-obesity agents within 11 min, including bambuterol, clenbuterol, ractopamine, clorprenaline, formoterol, salbutamol, terbutaline, procaterol, phentermine, bupropion, sibutramine, desmethyl sibutramine, and N,N-didesmethyl sibutramine, which improved the screening efficiency. The validated method was successfully applied to 369 real cases and detected six analytes, including bambuterol, salbutamol, terbutaline, sibutramine, desmethyl sibutramine, and N,N-didesmethyl sibutramine. This method offers several advantages, including simple pretreatment, high extraction efficiency, rapid extraction, solvent economy, and pollution mitigation, making it highly suitable for large-scale surveillance of usage of added anti-obesity agents."

Journal • Cardiovascular • Genetic Disorders • Obesity

Bilateral Adrenalectomy And Bariatric Surgery For Hormonal And Metabolic Control Of Classic Congenital Adrenal Hyperplasia (ENDO 2024) - "Androgen levels were supressed, glucocorticoid dose was reduced to 5mg prednisone (hydrocortisone dose equivalent 20mg) and she lost 10 kg of weight, but she remained in class III Obesity (BMI 42.5 kg/m2)...Pharmacologic obesity treatment was done (sibutramine plus topiramate) and she lost 16 kg of weight, reaching 90 kg and a BMI of 36 from April 2017 to February 2020... Even though treatment was aggressive with two surgeries that could lead to increased risk of adrenal crises, the patient had a benign course. New medicines that block CRH or ACTH action in CAH patients could prevent excessive glucocorticoid doses and weight gain and would be a better alternative to bilateral adrenalectomy in cases such as this one."

Bariatric surgery • Late-breaking abstract • Surgery • Congenital Adrenal Hyperplasia • Endocrine Disorders • Genetic Disorders • Infectious Disease • Novel Coronavirus Disease • Obesity

Sex, race, and BMI in clinical trials of medications for obesity over the past three decades: a systematic review. (PubMed, Lancet Diabetes Endocrinol) - "Clinical trials of 12 medications for obesity (ie, orlistat, naltrexone-bupropion, topiramate-phentermine, liraglutide, semaglutide, lorcaserin, sibutramine, rimonabant, taranabant, tirzepatide, retatrutide, and orforglipron) published from Jan 20, 1999, to Nov 12, 2023, were assessed through a systematic review for methodological quality and baseline demographic characteristics. Our systematic review suggests that future trials need to recruit traditionally under-represented populations to allow for accurate measures of efficacy of medications for obesity, enabling more informed decisions by clinicians. It is also hoped that these data will help to refine trial recruitment strategies to ensure that future studies are relevant to the population affected by obesity."

Journal • Review • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Development and validation of a high-performance thin-layer chromatography method for detection of sibutramine in dietary supplements. (PubMed, Folia Med (Plovdiv)) - "Due to safety concerns, in 2010 all medicines containing sibutramine were urgently withdrawn from the USA and European pharmaceutical market. Although sibutramine is no longer available in pharmaceutical products, there have been numerous reports of mislabeled weight-loss dietary supplements containing sibutramine."

Journal • Genetic Disorders • Obesity

Thirst and drugs: A study in the World Health Organization's pharmacovigilance database. (PubMed, Br J Clin Pharmacol) - "Analysis of the 3186 reports of thirst (978 'serious') allowed, first, to confirm the association between thirst and exposure to vasopressin antagonists (tolvaptan), lithium, gliflozins (dapagliflozin, empagliflozin), pregabalin and antimuscarinic drugs (glycopyronium, oxybutynin, tiotropium). Second, new safety signals were described with monoamine reuptake inhibitors (antidepressants: duloxetine, venlafaxine; anti-obesity agent: sibutramine), antipsychotic (olanzapine), glucocorticoid (prednisolone), diuretic (furosemide) drugs as well with ribavirin or sodium oxybate. This study is the first to offer a list of drugs associated with thirst in humans."

Adverse events • Journal • CNS Disorders • Genetic Disorders • Obesity