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Pharmacological Management of the Patient with Obesity
Published in James M. Rippe, Lifestyle Medicine, 2019
Magdalena Pasarica, Nikhil V. Dhurandhar
Phentermine-topiramate ER was approved in 2012 as an adjunct to lifestyle changes in adults with a BMI at or above 30 kg/m2 or at or above 27 kg/m2 in the presence of at least one weight-related comorbidity. The trade name is Qsymia and is dispensed in 3.75 mg/23 mg, 7.5 mg/46 mg, 11.25 mg/69 mg, and 15 mg/92 mg of phentermine and topiramate ER combination, respectively, and to be taken once a day in the morning. Providers are instructed to start with the lowest dose and increase to the next dose in 14 days. It should be discontinued if, after 12 weeks, the weight loss is less than 3% (with 7.5 mg/46 mg dosage) or 5% (with 15 mg/92 mg). The two largest dosages are contraindicated in patients with moderate or severe renal impairment or patients with moderate hepatic impairment. Patients should avoid concomitant use of alcohol and monitor irregular bleeding in women using oral contraceptives and potassium levels in patients using non-potassium sparring diuretics. Serious adverse reactions include cardiac ischemia, tachycardia, pulmonary HTN, and psychosis. Common side effects include paresthesia, xerostomia, constipation, and insomnia (https://www.qsymia.com/pdf/prescribing-information.pdf).
Pharmacological Treatment of Obesity
Published in Emmanuel C. Opara, Sam Dagogo-Jack, Nutrition and Diabetes, 2019
Amie A. Ogunsakin, Ayotunde O. Dokun
Phentermine is a noradrenergic and possibly dopaminergic sympathomimetic amine that was originally approved for obesity in 1959; the drug was used on-label until 1977, when an amendment to the Food Drug and Cosmetic Act required that the FDA approve new drugs based on efficacy as well as safety. There was concern for addiction potential; hence it was approved for short-term use. Topiramate is a neuro-stabilizer and anti-seizure medication that suppresses appetite by unknown mechanism. Topiramate was FDA approved for treatment of refractory epilepsy in 1996, with weight loss noted as a side effect. The FDA approved fixed-dose phentermine/topiramate for long-term management of obesity in 2012. Phentermine/topiramate is a once-daily, extended-release capsule combining two separate drugs with different pharmacokinetics. Combining the two drugs into one formulation provides an immediate release of phentermine and delayed release of topiramate, which theoretically provides better appetite suppression throughout the day. Phentermine/topiramate has been associated with cleft lip and palate and should not be used in individuals who are pregnant or planning to become pregnant while being treated with phentermine-topiramate. Other contraindications include glaucoma, hyperthyroidism and recent monoamine inhibitor use during or within 14 days as well as allergies to either topiramate or symptanomimetic amines [33,34].
Current research and future hope
Published in G. Michael Steelman, Eric C. Westman, Obesity, 2016
Greenway Frank L., R. Smith Steven
Presently, there is a limited arsenal of medications with which to treat obesity. In fact, there are only four drugs approved by the FDA for use in the United States without time limitations, based on the indications in the package insert. Approval of these drugs was based on 1- to 2-year trials. Liraglutide is approved for the treatment of diabetes, and its new drug application is presently pending at the FDA at a higher dose for the treatment of obesity. Orlistat, which causes a loss of fat in the stool, can be likened to a thiazide diuretic in the treatment of hypertension that causes a loss of sodium into the urine. As with thiazides, due to their safety and proven efficacy, orlistat is likely to remain an obesity treatment option even as more effective medications are developed. Phentermine/topiramate, lorcaserin, NAL/BUP, and liraglutide act on the central nervous system. Although these medications are effective and reasonably well tolerated, targeting of the central nervous system increases the risks of unintended adverse events in other systems. Symptoms such as headache may be only an annoyance, but teratogenicity has created concern in the medical community. It seems likely that phentermine/ topiramate will become relegated to use in unusual circumstances for the treatment of obesity, much as α-methyldopa, an antihypertensive drug with actions in the central nervous system and once a popular treatment for hypertension is now reserved for unusual circumstances.
What is clinically relevant weight loss for your patients and how can it be achieved? A narrative review
Published in Postgraduate Medicine, 2022
Deborah B. Horn, Jaime P. Almandoz, Michelle Look
In a separate trial, individuals receiving liraglutide 3.0 mg who had a mean weight loss of 6.2% also had significant improvements in several cardiometabolic risks compared with placebo [75]. In another randomized trial, naltrexone–bupropion plus intensive behavior modification led to significantly more participants with ≥5% and ≥10% weight loss than placebo, and individuals receiving naltrexone–bupropion had significantly greater improvements in markers of cardiovascular disease risk versus placebo, including waist circumference (–10 vs –6.8 cm), plasma triglycerides (–16.6 vs –8.5% change), insulin (–28.0 vs –15.5% change), and homeostatic model assessment for insulin resistance (HOMA-IR) (–29.9 vs –16.6% change) [76]. Furthermore, in a randomized trial in patients with obesity or overweight, mean weight loss of 9.8% achieved with phentermine–topiramate improved blood pressure, low-density lipoprotein (reduction of 6.9%), and high-density lipoprotein (increase of 6.8%) cholesterol [35].
The risk of cardiovascular complications with current obesity drugs
Published in Expert Opinion on Drug Safety, 2020
Ariana M. Chao, Thomas A. Wadden, Robert I. Berkowitz, Kerry Quigley, Frank Silvestry
The increases in heart rate prompted the FDA to mandate a randomized, post-marketing outcome study to demonstrate that phentermine-topiramate ER is not associated with an increase in major adverse cardiovascular events (MACE). The cardiovascular outcomes study, referred to as A Qysimia ™ cardiovascular morbidity and mortality study in subjects with documented cardiovascular disease (AQCLAIM), is currently ongoing[35]. In a retrospective cohort study of medical claims databases, the incidence rate ratio of MACE did not differ among current and former users of fixed-dose phentermine/topiramate (incidence rate ratio = 0.24, 95% CI = 0.03, 1.70)[36]. However, there were too few MACE events to provide definitive conclusions. Phentermine/topiramate should be used with caution in patients with cardiovascular disease or elevated cardiovascular risk, pending results of the AQCLAIM trial which will provide further guidance.
How viable is pre-surgery weight reduction for the reduction of periprosthetic joint infection risk after total joint arthroplasty?
Published in Expert Review of Medical Devices, 2020
Michael Yayac, Rajesh Aggarwal, Javad Parvizi
For many patients, pharmacological or surgical intervention may be required to achieve and maintain significant weight loss. Currently, there are five FDA-approved medications for weight reduction: orlistat, lorcaserin, naltrexone-bupropion, phentermine-topiramate, and liraglutide [6]. All five of these medications have demonstrated superiority to placebo in aiding patients to achieve significant weight loss, with phentermine-topiramate potentially being superior to the other four agents [6]. However, each carries a risk of adverse events, which vary based upon their mechanism of action, with liraglutide demonstrating the greatest risk of discontinuation due to adverse outcomes having an OR of 2.82 compared to placebo [6]. In a meta-analysis, additional weight loss following 1 year of treatment ranged from 2.6 kg (5.7 lb) with orlistat to 8.8 kg (19.4 lb) with phentermine-topiramate compared to placebo [6]. No studies have been performed to determine their efficacy to significantly reduce weight prior to TJA or impact on outcomes, but as with lifestyle modification alone, weight reduction appears only modest and may not have a significant effect on the risk of PJI. If considering pharmacological weight loss therapy prior to TJA, physicians must weigh the potential for adverse effects against the potential for improved outcomes and reduced risk of PJI which has yet to be substantiated in the literature.