Safety of Drug Therapies Used for Weight Loss and Treatment of Obesity
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Some of the medications used for weight loss in the management of obesity have been associated with unacceptable morbidity and mortality. Safety concerns have led to the withdrawal of aminorex, followed by the fenfluramines in 1997, and phenylpropanolamine (norephedrine) in 2000. Aminorex was associated with an increased prevalence of primary pulmonary hypertension (PPH), fenfluramines with an increased prevalence of PPH and valvulopathy, and phenylpropanolamine with an increased risk of haemorrhagic stroke. Several studies have investigated the safety of the fenfluramines, yet the benefit-risk profile has not been conclusively quantified. This is due to several deficiencies in the published studies, including a lack of data on the baseline prevalences of comorbid conditions in obese subjects, and potential confounders and biases in the study designs. Although several studies and systematic reviews support an increased risk of PPH and valvulopathy in patients who have taken fenfluramines, without knowledge of the background prevalence it is not possible to determine if the exposure preceded the outcome. The population at higher risk of these adverse effects includes those taking higher doses or with a longer duration of exposure to fenfluramines and those with pre-existing cardiac disease or a genetic predisposition. Patients exposed to fenfluramines continue to be monitored, with some follow-up studies indicating no overall worsening in valvulopathy over time. There are limited efficacy and safety data for amfepramone (diethylpropion) and phentermine and their approval for the management of obesity is limited to short-term use. Orlistat and sibutramine are the only currently approved medications for long-term management of obesity. Although the benefit-risk profiles of sibutramine and orlistat appear positive, sibutramine continues to be monitored because of long-term safety concerns. The safety and efficacy of currently approved drug therapies have not been evaluated in children and elderly patient populations and there is limited information in adolescents, whilst the long-term safety of current and potential new drug therapies in adults will require several years of postmarketing surveillance to fully elucidate their adverse effect profiles.Keywords:
Orlistat
Sibutramine
Phentermine
Phenylpropanolamine
Stroke
Postmarketing surveillance
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Importance of the field: The prevalence of overweight and obesity in children and adolescents is increasing rapidly, while the short- and long-term morbid outcomes make these entities a major public health concern. Initial steps in therapy are based on dietary and lifestyle intervention. In the presence of an insufficient progress, medication or – eventually – surgery may be recommended. Three drugs are currently used: orlistat, metformin, and sibutramine; other candidates are in development. However, trials assessing the efficacy and safety of the current medications are frequently affected by methodological limitations, in particular insufficient power and period of follow-up. Areas covered in this review: The efficacy and safety of antiobesity drugs currently used for children and adolescents are reviewed. Additional information on upcoming agents is presented. What the reader will gain: This is an exhaustive review of current state on controversial issues regarding drugs used in children and adolescent obesity, specifically related with their efficacy and safety. Take home message: The efficacy of these drugs is modest. Our knowledge of their efficacy and safety comes from clinical trials affected by insufficient follow-up (1 year or less); very often, these trials are of limited power. Further data from larger and longer well-designed clinical trials would be advisable.
Orlistat
Sibutramine
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The past few decades have shown an increase in the prevalence of chronic conditions in the pediatric population. One of the chronic conditions that appears to be on the rise in this population is hypercholesterolemia. At the same time, the rate of obesity is increasing in children and adolescents and may be putting our youth at risk for abnormal lipid levels. First-line prevention and treatment should involve intensive lifestyle medicine therapy. If warranted, however, the use of medications may be started as early as 8 years of age, but this has many unknown variables related to safety and efficacy. Caution and vigilant observation for drug interactions and adverse events is warranted by the health care team and family members throughout treatment with drug therapy.
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1 NP from Home LLC Munds ParkArizona CorrespondenceAngela Golden, DNP, FNP‐C, NP from Home LLC, Munds Park, AZ. E‐mail: [email protected] Received April 26, 2017 Received in revised form August 08, 2017 Accepted August 11, 2017
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Abstract Objective : Long‐term, possibly lifetime, use of medications for the management of obesity may be thought to be similar to the use of pharmacotherapy for other chronic diseases such as hypertension or diabetes. Because there have been no systematic studies of this extended use, the experience of eight patients who have used obesity medications in a sustaining manner was studied. Research Methods and Procedures : The clinical characteristics of eight adult patients, each of whom has experience with long‐term (more than 10 years) use of medications for weight loss and weight maintenance, were studied. Results : The clinical experience of these eight patients was analyzed. Each chose to sustain the use of weight management medications for more than 10 years because of perceived benefit, comfort, and the absence of significant side effects. There has been no evidence of the development of tolerance, addiction, or misuse and no adverse events related to the medication. The beneficial effects of the medication have not diminished with time. Discussion : The clinical characteristics of eight patients, each of whom has used obesity pharmacotherapy for more than 10 years, are described. The experience of these eight individuals cannot be generalized to the entire population of overweight or obese patients. It does suggest, however, that some patients respond successfully to this form of therapy and that they will derive value from it for the management of this disease. Efforts should be made to identify these patients, and consideration should be given to the use of chronic medications for the continuing management of obesity.
Pharmacotherapy
Management of obesity
Weight management
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Introduction Childhood depression is a cause of substantial morbidity and mortality in this population. Although antidepressants are used frequently for the treatment of this disorder, there has been recent controversy about their efficacy and safety in this population. Objective Providing updated information from the scientific point of view on some burning issues in relation to the prescription of antidepressants in childhood depression. Methods It has been made a review of the recent studies which have been published about the safety and efficacy of antidepressants, and the consequences of the warnings given by Regulatory Agencies on health care professionals to prescribe antidepressants for children. Results Impact of Safety Warnings: there has been a decrease in prescribing antidepressants and an increased suicide in this population since the FDA and EMA warnings announced an increased risk of suicide with pediatric antidepressant agents versus placebo. This is not possible to extract it because of causal relations. Effectiveness: nine of the sixteen controlled trials published between 1990 and 2010 provide evidence of effectiveness versus placebo in the treatment of major depressive disorder (MDD) in pediatric population (three for fluoxetine, two for sertraline, one for citalopram, two for escitalopram, and one for venlafaxine). Conclusions The antidepressant studies in children and adolescents have significant and methodological limitations that prevent getting conclusive findings. It is required further studies to determine which subgroups of patients and what drugs there have a risk / benefit ratio favorable, because no treatment can lead to serious damage in depressed children and adolescents.
Sertraline
Escitalopram
Citalopram
Depression
Childhood Depression
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Recently, the recognition of obesity as a complex disease that requires chronic management has become more widespread. There has also been a movement away from a focus on body mass index alone, and toward the management of obesity‐related comorbidities as well as excess weight. This article examines the current and emerging pharmacological options for weight management in people with overweight or obesity who have, or are at a high risk of, weight‐related comorbidities. In the USA , the current options for pharmacological weight management are phentermine (indicated for short‐term use only), orlistat, combined phentermine/topiramate extended release, lorcaserin, naltrexone/bupropion and liraglutide 3.0 mg. Currently, orlistat, naltrexone/bupropion and liraglutide 3.0 mg are approved in E urope. All of the above‐mentioned medications have shown weight‐loss efficacy versus placebo. Those approved for long‐term weight management have also been associated with improvements in weight‐related comorbidities, such as hypertension, prediabetes, diabetes or dyslipidaemia, or related biomarkers. As with all drugs, the safety and tolerability profiles of medications for weight management should be considered alongside their efficacy to ensure correct use. Additional medications for weight management that are in clinical development include bupropion/zonisamide and beloranib. The field of obesity treatment is advancing with a number of medications being recently approved, and with other pharmacological options emerging.
Phentermine
Orlistat
Bupropion
Tolerability
Weight management
Management of obesity
Zonisamide
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Pharmacotherapy
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Stimulant
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Several drugs, or categories of drugs, listed by the WHO and other writers and used in the treatment of chronic disease, are consistently associated with weight gain as a side effect and considered 'obesogenic'. The extent to which they may contribute to the multifactorial process behind obesity is not well documented. We systematically reviewed papers from Medline 1966–2004, Embase 1980–2004, PsycINFO 1967–2004, and Cochrane Register of Controlled Trials, to determine the effect on body weight of some drugs that are believed to favour weight gain. We included randomized controlled studies of adult participants (>18 years) prescribed a drug considered obesogenic, that compared the 'obesogenic' drug with placebo, an alternative drug or other treatment, and that had a duration of at least 3 months: 43 studies totalling 25 663 subjects met these criteria. The main objective of the majority of studies was to compare the efficacy and safety of drug therapy, with weight change recorded under safety outcomes; weight change was a primary outcome measure in only six studies. There was evidence of weight gain for all drugs included, up to 10 kg at 52 weeks. Differences in dosage, patient population, duration of treatment and dietary advice make generalization of the results difficult. Data on body weight are often not recorded in published clinical trials or is reported in insufficient detail. This side-effect has potentially serious consequences, and should be mentioned to patients. Weight management measures should be routinely considered when prescribing drugs known to promote weight gain. Future clinical trials should always document weight changes.
PsycINFO
Weight change
Weight management
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