Off-label pharmacological treatment of obesity: a systematic review of clinical studies

Abstract

Introduction: There are 2.0 billion overweight and obese people in the world, and Brazil ranks fifth in the world. The World Health Organization (WHO) advises that the use of drugs to combat obesity is indicated for patients who have a body mass index (BMI) above 30 kg/m2 or when the BMI is 25 kg/m2 associated with comorbidities. that permeate excess weight. A variety of drug classes approved for other indications have been used off-label in an attempt to promote weight loss. Objective: It was to list and present the main off-label drugs for obesity in adults, as well as to show the scientific evidence of clinical studies. Methods: The present study followed a concise systematic review (PRISMA) model. The literary search process was carried out from July 2022 to September 2022 and was developed based on Scopus, PubMed, Science Direct, Scielo, and Google Scholar, using scientific articles from 2002 to 2022. The low quality of evidence was attributed to reports of cases, editorials, and brief communications, according to the GRADE instrument. The risk of bias was analyzed according to the Cochrane instrument using the Funnel Plot. Results and Conclusion: We found 98 studies that underwent eligibility analysis, and then 15 of the 12 total studies were selected. Most studies showed homogeneity in their results, with I2 =96.5% >50%. The Funnel Plot showed a symmetrical behavior, not suggesting a significant risk of bias in the studies. Off-label prescribing is very common among physicians who treat obesity. However, randomized controlled studies should be increasingly encouraged and increased to clearly present the scientific evidence and, thus, propose a scientific formalism for the safe and effective use of off-label anti-obesity drugs. Physicians, however, have adopted a more pragmatic approach, giving much greater credibility to shared clinical experience, particularly in situations where favorable outcomes have been consistently observed over decades. International medical bodies do not recommend the off-label use of drugs approved for the exclusive use of weight loss. In Brazil, the Brazilian Association for the Study of Obesity and Metabolic Syndrome (ABESO) recommends that drugs approved for the treatment of obesity be prescribed preferentially over off-label treatments. In addition, the patient must be well informed and aware that the drug is not approved by Anvisa for this indication or chronic use.