Evaluation of the efficacy and safety of controlled-release phentermine/topiramate in adults with obesity in Korea: A randomized, double-blind, placebo-controlled, phase 4 trial (QUEEN's study) This study evaluated the efficacy and safety of a combination of phentermine and delayed-release topiramate (PHEN/TPM CR) versus placebo as an adjunct to standard lifestyle recommendations in Korean
Efficacy of phentermine/topiramate extended release in weight management and metabolic profiles: A multicentre study in South Korea. Clinical trials have demonstrated the effectiveness of the phentermine and topiramate combination in weight management. This research evaluated the efficacy and safety of phentermine/topiramate extended release (ER) for weight management, focusing on alterations in body weight and metabolic parameters in routine clinical practice. We retrospectively included people with obesity who initiated phentermine/topiramate ER between January 2020 and April 2023 at 10 tertiary hospitals in South Korea. The study assessed body weight changes at 5-6 months and for those who continued, at 12 months, along with metabolic parameters. Total body weight was measured using
Assessment of the Risk Evaluation and Mitigation Strategy (REMS) for Phentermine-Topiramate to Prevent Exposure During Pregnancy. The U.S. Food and Drug Administration approved phentermine-topiramate for obesity in 2012 and required a Risk Evaluation and Mitigation Strategy (REMS) to prevent prenatal exposure. No such requirement was introduced for topiramate. To evaluate the rate of prenatal exposure, contraceptive use, and pregnancy testing among patients with phentermine-topiramate compared with topiramate or other antiobesity medications (AOMs). Retrospective cohort study. Nationwide health insurance claims database. Females aged 12 to 55 years with no infertility diagnosis or sterilization procedure. Patients with other indications for topiramate were excluded to identify a cohort
Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study. A fixed-dose combination of phentermine and extended-release topiramate (PHEN/TPM - approved for weight management) has demonstrated in-clinic reduction of blood pressure (BP). Ambulatory BP
Phentermine/Topiramate for the Treatment of Adolescent Obesity. Antiobesity medication may be useful for the treatment of pediatric obesity, yet few safe and effective options exist. We evaluated phentermine/topiramate (PHEN/TPM) for weight management in adolescents with obesity. This 56-week, randomized, double-blind trial enrolled adolescents 12 to less than 17 years of age with obesity
Exenatide, Dapagliflozin, or Phentermine/Topiramate Differentially Affect Metabolic Profiles in Polycystic Ovary Syndrome. Glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors reduce weight and improve insulin sensitivity via different mechanisms. The efficacy of once-weekly exenatide (EQW) and dapagliflozin (DAPA) alone and coadministered (EQW/DAPA), DAPA /extended-release (ER) metformin (DAPA/MET), and phenterminetopiramate extended release (PHEN/TPM) on metabolic parameters, body composition, and sex hormones were examined in obese women with PCOS. Nondiabetic women (n = 119; aged 18-45 years) with a body mass index (BMI) greater than 30 and less than 45 and polycystic ovary syndrome (National Institutes of Health criteria) were randomly assigned
A randomized, double-blind, placebo-controlled, pharmacokinetic and pharmacodynamic study of a fixed-dose combination of phentermine/topiramate in adolescents with obesity. To assess the pharmacokinetic (PK) and pharmacodynamic characteristics of VI-0521, a fixed-dose combination of immediate-release phentermine (PHEN) and extended-release topiramate (TPM) in adolescents aged 12 to 17 years
A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa. Open trials suggest phentermine/topiramate ER (PHEN/TPM-ER), food and drug administration (FDA) approved for obesity, has utility for binge eating. With no randomized controlled trials (RCTs) yet performed, this trial aimed to evaluate PHEN/TPM-ERs efficacy
Use of phentermine-topiramate extended release in combination with sleeve gastrectomy in patients with BMI 50 kg/m2 or more. Super obesity (body mass index [BMI] ≥50 kg/m) treatment can be complicated and high risk. We studied whether the pre and postoperative use of phentermine and topiramate (phen/top) combined with laparoscopic sleeve gastrectomy (LSG) in super obesity increases
Cardiometabolic Disease Staging Predicts Effectiveness of Weight Loss Therapy to Prevent Type 2 Diabetes: Pooled Results From Phase III Clinical Trials Assessing Phentermine/Topiramate Extended Release To assess the ability of medication-assisted weight loss to prevent diabetes as a function of the baseline weighted Cardiometabolic Disease Staging (CMDS) score. We pooled data from 3,040 overweight and obese participants in three randomized controlled trials-CONQUER, EQUIP, and SEQUEL-assessing efficacy and safety of phentermine/topiramate extended release (ER) for weight loss. In these double-blind phase III trials, overweight/obese adult patients were treated with a lifestyle intervention and randomly assigned to placebo versus once-daily oral phentermine/topiramate ER. The weighted CMDS
Combination of venlafaxine and phentermine/topiramate induced psychosis: A case report Various publications have noted increases in dopamine, specifically in the mesolimbic region of the brain, to have a direct correlation to psychotic-like symptoms. Venlafaxine, a first-line medication for depression, inhibits the reuptake of both serotonin and norepinephrine. Additionally, venlafaxine weakly inhibits the reuptake of dopamine. Phentermine/topiramate (Qsymia®), specifically the phentermine component, functions by blocking the dopamine and norepinephrine transporter, similar to amphetamine. A 40-year-old Hispanic woman was admitted to the inpatient mental health unit based on reports of delusional thinking and several attempts of self-harm. Past medical history was significant for major
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity Hypothalamic obesity (HO) refers to the substantial weight gain that often complicates hypothalamic brain tumors. Children with this treatment-recalcitrant form of obesity have excess rates of metabolic sequelae compared to otherwise healthy children with similar obesity, and later experience excess mortality related to cardiometabolic disease. In this pilot trial, our objective is to gather key preliminary data about phentermine/topiramate (Ph/T) that is FDA-approved for "common" obesity but has never been tested in HO. The subset of individuals with HO who experience hyperphagia or excess daytime sleepiness may benefit from the Ph/T-induced decrease in appetite and increase in alertness.We will make preliminary assessments
Health-related quality of life in two randomized controlled trials of phentermine/topiramate for obesity: What mediates improvement? Phentermine/topiramate combination therapy resulted in significant weight loss and improvements in cardiometabolic risk factors in patients with obesity/overweight in two published 56-week randomized, placebo-controlled trials (EQUIP and CONQUER). The purpose of the current study was to examine whether phentermine/topiramate is also associated with greater improvements in health-related quality of life (HRQOL) and whether HRQOL improvements are solely attributable to weight reduction. Patients in EQUIP (n = 751) had a body mass index (BMI) ≥ 35 with no obesity-related comorbidity. Patients in CONQUER (n = 1623) had a BMI ≥ 27 and ≤ 45 and at least two obesity
4-Year Cost Trajectories in Real-World Patients Matched to the Metabolic Profiles of Trial Subjects Before/After Treatment with Phentermine-Topiramate. Our objective was to estimate 4-year healthcare costs associated with the metabolic profile of patients before and after 1 year of treatment with phentermine (15 mg) and topiramate extended-release (92 mg) [phentermine-topiramate ER]. Using a medical records database, we created two patient cohorts reflecting metabolic profiles of subjects before and after phentermine-topiramate ER therapy during the 1-year CONQUER trial. We matched database patients with trial subjects by age, sex, body mass index (BMI), and hypertension, glycemic, and triglyceride status. We collected real-world data on emergency department and outpatient visits
Phentermine/Topiramate as Preventive Pharmacotherapy for Obesity This study will test the use of phentermine and topiramate compared with placebo in helping adolescents who are at high risk for developing obesity to lose weight This study will evaluate the effects of preventative pharmacotherapy on body mass index (BMI), as well as incidence of obesity and normal weight, in adolescents at high
The New Weight-Loss Drugs, Lorcaserin and Phentermine-Topiramate: Slim Pickings? In 2012, the US Food and Drug Administration approved 2 drugs for long-term weight loss: lorcaserin hydrochloride (Belviq; Eisai Inc) and phentermine-topiramate (Qysmia; Vivus Inc). The approvals were based on 1-year trials showing that on top of recommendations to follow a calorie-restricted diet and to increase exercise, patients randomized to either drug lost more weight than patients randomized to placebo (3% [95% CI, 3%-4%] more weight lost with lorcaserin; 7% [95% CI, 3%-4%] more with phentermine /topiramate). The drugs have been associated with serious harms: Both drugs' labels include warnings about memory, attention, or language problems and depression; for lorcaserin, the label also warns of valvular
A systematic review of psychiatric and cognitive effects of phentermine and phentermine/topiramate in adult and pediatric populations PROSPEROInternational prospective register of systematic reviews Print | PDFA systematic review of psychiatric and cognitive effects of phentermine and phentermine/topiramate in adult and pediatric populationsYoon Ji Ahn, Vibha SinghalTo enable PROSPERO to focus Singhal. A systematic review of psychiatric and cognitive effects of phentermine and phentermine/topiramate in adult and pediatric populations. PROSPERO 2022 CRD42022380836 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022380836Review questionWhat are the psychiatric and/or cognitive effects of phentermine and/or phentermine-topiramate in children and adolescents ≥12
Phentermine/Topiramate in Adolescents With Type 2 Diabetes and Obesity As the prevalence of obesity rises in the U.S., so does the incidence of pediatric type 2 diabetes (T2D), which is associated with more aggressive disease progression than in adults. From 2002-2012, the incidence of T2D in youth increased by 7% annually in the U.S. Compared to adults. T2D in adolescents is a much more for pediatric T2D.In 2012, the FDA approved the use of Phentermine/Topiramate for the treatment of obesity in adults. This orally-administered medication is available in mid- (phentermine 7.5 mg; topiramate 46 mg) and high- (phentermine 15 mg; topiramate 92 mg) doses, administered once per day. In a meta-analysis, phentermine/topiramate was shown to be one of the most effective obesity medication currently
Evaluation of phentermine and topiramate versus phentermine/topiramate extended-release in obese adults. A 28-week, randomized, controlled trial compared the combination of phentermine and topiramate extended-release (PHEN/TPM ER) with its components as monotherapies and with placebo in obese adults. Subjects were randomized to placebo, phentermine 7.5 mg, phentermine 15 mg, topiramate ER 46 mg