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Phentermine and Topiramate

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1. Topiramate + phentermine (Qsiva and other brands): an excessively dangerous appetite-suppressant combination

Topiramate + phentermine (Qsiva and other brands): an excessively dangerous appetite-suppressant combination Prescrire IN ENGLISH - Spotlight: Archive ''Topiramate + phentermine (Qsiva° and other brands): an excessively dangerous appetite-suppressant combination'', 1 March 2013 {1} {1} {1} | | > > > Topiramate + phentermine (Qsiva° and other brands): an excessively dangerous appetite-suppressant combination Spotlight: Archives Every month, the subjects in Prescrire’s Spotlight. 2013 :   (...) |   |  Spotlight Archives Topiramate + phentermine (Qsiva° and other brands): an excessively dangerous appetite-suppressant combination FEATURED REVIEW Overweight and obese patients must not be exposed to the topiramate + phentermine combination. No beneficial impact on clinical complications of obesity has been demonstrated. A portion of the weight lost is regained after treatment withdrawal. And numerous serious adverse effects have already been observed. Full review (4 pages) available

2014 Prescrire

2. 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

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 score was calculated using baseline quantitative clinical data including waist circumference, blood glucose, blood pressure, and blood lipids. Incident diabetes was defined based on serial measures

2017 EvidenceUpdates

3. Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa. (PubMed)

Study protocol and rationale for a randomized double-blinded crossover trial of phentermine-topiramate ER versus placebo to treat binge eating disorder and bulimia nervosa. Bulimia nervosa (BN) and binge eating disorder (BED) are associated with severe psychological and medical consequences. Current therapies are limited, leaving up to 50% of patients symptomatic despite treatment, underscoring the need for additional treatment options. Qsymia, an FDA-approved medication for obesity, combines (...) phentermine and topiramate ER. Topiramate has demonstrated efficacy for both BED and BN, but limited tolerability. Phentermine is FDA-approved for weight loss. A rationale for combined phentermine/topiramate for BED and BN is improved tolerability and efficacy. While a prior case series exploring Qsymia for BED showed promise, randomized studies are needed to evaluate Qsymia's safety and efficacy when re-purposed in eating disorders. We present a study protocol for a Phase I/IIa single-center, prospective

2018 Contemporary clinical trials

4. Combination of venlafaxine and phentermine/topiramate induced psychosis: A case report (PubMed)

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 (...) approximately 1 month prior to admission. Furthermore, the patient was restarted on a previously prescribed medication, oral phentermine/topiramate for weight loss, in combination with venlafaxine, approximately 1 week prior to the bizarre behavior. The patient denied any psychosis or changes in behavior when medications were taken individually prior to the combination. The patient was treated with lurasidone (40 mg by mouth daily) with resolution of psychosis.A PubMed search revealed no current literature

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2018 The Mental Health Clinician

5. Cardiovascular Safety During and After Use of Phentermine and Topiramate. (PubMed)

Cardiovascular Safety During and After Use of Phentermine and Topiramate. Increases in heart rate were seen during the clinical program for fixed-dose combination phentermine (PHEN) and topiramate (TPM), an oral medication indicated for weight management; however, the effect on cardiovascular (CV) outcomes is uncertain.The aim of the present study was to determine the extent to which the rates of major adverse CV events (MACE) in patients using PHEN and TPM (including fixed dose) differed from

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2018 Journal of Clinical Endocrinology and Metabolism

6. Phentermine

of this page. But if you still have questions please contact us via jon.brassey@tripdatabase.com Top results for phentermine 1. 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 28455281 2017 04 29 2017 04 29 1935-5548 2017 Apr 28 Diabetes care Diabetes Care 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. dc170088 (...) 10.2337/dc17-0088 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

2018 Trip Latest and Greatest

7. Randomised controlled trial: The combination of phentermine and topiramate is an effective adjunct to diet and lifestyle modification for weight loss and measures of comorbidity in overweight or obese adults with additional metabolic risk factors

Randomised controlled trial: The combination of phentermine and topiramate is an effective adjunct to diet and lifestyle modification for weight loss and measures of comorbidity in overweight or obese adults with additional metabolic risk factors The combination of phentermine and topiramate is an effective adjunct to diet and lifestyle modification for weight loss and measures of comorbidity in overweight or obese adults with additional metabolic risk factors | BMJ Evidence-Based Medicine We (...) of institutional accounts Username * Password * your user name or password? You are here The combination of phentermine and topiramate is an effective adjunct to diet and lifestyle modification for weight loss and measures of comorbidity in overweight or obese adults with additional metabolic risk factors Article Text Therapeutics Randomised controlled trial The combination of phentermine and topiramate is an effective adjunct to diet and lifestyle modification for weight loss and measures of comorbidity

2012 Evidence-Based Medicine (Requires free registration)

8. 4-Year Cost Trajectories in Real-World Patients Matched to the Metabolic Profiles of Trial Subjects Before/After Treatment with Phentermine-Topiramate. (PubMed)

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, hospitalizations, and drug prescriptions over 4 years, linking them to reimbursements to estimate US private insurance costs for post-trial (n = 2295) versus pre-trial intention-to-treat (ITT) patients (n = 2295

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2015 Drugs - real world outcomes

9. Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED)

Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED) Phentermine/Topiramate Extended Release in Binge Eating Disorder (BED) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Phentermine (...) participants Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Open-label Phentermine/Topiramate Extended Release (PHEN/TPM ER; Qsymia®) in Ten Subjects With Overweight or Obesity and DSM-V Binge Eating Disorder (BED) Study Start Date : September 2015 Actual Primary Completion Date : July 2016 Actual Study Completion Date : September 2016 Resource links provided by the National Library of Medicine related topics: available for: Arms

2016 Clinical Trials

10. Phentermine and Topiramate

Phentermine and Topiramate Phentermine and Topiramate Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Phentermine and Topiramate (...) Phentermine and Topiramate Aka: Phentermine and Topiramate , Qsymia , Qnexa From Related Chapters II. Indications BMI >30 or BMI >27 and one comorbid condition III. Dosing / Start: 3.75 mg/23 mg for the first 2 weeks Titrate to maximum of 15 mg/92 mg Discontinuation Discontinue if 5% weight loss not achieved at maximum dose at 12 weeks Taper off gradually (risk of ) IV. Efficacy Weight loss is promising at 24 pounds in one year or 10% of body weight Weight loss of at least 5% in up to 70% of patients

2018 FP Notebook

11. Topiramate

randomized, placebo-controlled, double-blind study. Fifty three patients with DSM-IV diagnosis of MDD who had failed to respond 2011 6. 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 28455281 2017 04 29 2017 04 29 1935-5548 2017 Apr 28 Diabetes care Diabetes Care 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. dc170088 (...) 10.2337/dc17-0088 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

2018 Trip Latest and Greatest

12. Evaluation of phentermine and topiramate versus phentermine/topiramate extended-release in obese adults. (PubMed)

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, topiramate ER 92 mg, PHEN/TPM ER 7.5/46 mg, or PHEN/TPM ER 15/92 mg. All subjects received lifestyle (...) intervention counseling. Primary endpoints were percent weight loss (WL) and achievement of ≥5% WL.At week 28, PHEN/TPM ER 7.5/46 (-8.5%) and 15/92 (-9.2%) achieved greater percentage WL versus placebo (-1.7%; P < 0.0001) and their respective monotherapies (P < 0.05). The percentage of subjects achieving ≥5% WL was 15.5% for placebo, 43.3% for phentermine 7.5, 46.2% for phentermine 15, 39.2% for topiramate ER 46, 48.6% for topiramate ER 92, 62.1% for PHEN/TPM ER 7.5/46, and 66.0% for PHEN/TPM ER 15/92

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2013 Obesity

13. Health-related quality of life in two randomized controlled trials of phentermine/topiramate for obesity: What mediates improvement? (PubMed)

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 (...) demonstrated that treatment with phentermine/topiramate improved HRQOL compared with placebo. Although reduction in BMI accounted for the majority of improvements in obesity-specific and physical HRQOL, decrease in depressive symptoms was also a significant mediator. Results highlight the predominance of weight reduction as a key factor in improving HRQOL in obesity.

2015 Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation

14. The new weight-loss drugs, lorcaserin and phentermine-topiramate: slim pickings? (PubMed)

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 heart disease and euphoria; and for phentermine-topiramate, the label warns of metabolic acidosis, increased heart rate, anxiety, insomnia, and elevated creatinine levels. Neither medication

2014 JAMA Internal Medicine

15. Prevention of type 2 diabetes in subjects with prediabetes and metabolic syndrome treated with phentermine and topiramate extended release. (PubMed)

Prevention of type 2 diabetes in subjects with prediabetes and metabolic syndrome treated with phentermine and topiramate extended release. OBJECTIVE To evaluate over 108 weeks the effect of phentermine and topiramate extended release (PHEN/TPM ER) treatment on progression to type 2 diabetes and/or cardiometabolic disease in subjects with prediabetes and/or metabolic syndrome (MetS) at baseline. RESEARCH DESIGN AND METHODS Subanalysis of a phase 3, randomized, placebo-controlled, double-blind

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2014 Diabetes Care

16. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. (PubMed)

Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Treatment algorithms for type 2 diabetes recommend weight loss for disease management. The safety and efficacy of treatment with phentermine (PHEN)/topiramate (TPM) extended release (ER) plus lifestyle modification for weight loss and glycemic benefits were assessed in two randomized, double-blind, placebo-controlled 56-week studies of obese/overweight adults with type 2 diabetes.The OB-202/DM-230

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2014 Diabetes Care

17. Qsiva - phentermine / topiramate

Qsiva - phentermine / topiramate 7 Westferry Circus ? Canary Wharf ? London E14 4HB ? United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail info@ema.europa.eu Website www.ema.europa.eu © European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. 21 February 2013 EMA/CHMP/108692/2013 Committee for Medicinal Products for Human Use (CHMP) Assessment report Qsiva International non-proprietary name (...) : PHENTERMINE / TOPIRAMATE Procedure No. EMEA/H/C/002350/0000 Note Assessment report as adopted by the CHMP with all information of a commercially confidential nature deleted. Qsiva CHMP assessment report EMA/CHMP/108692/2013 Page 2/91 Table of contents 1. Background information on the procedure 5 1.1. Submission of the dossier 5 1.2. Manufacturers 6 1.3. Steps taken for the assessment of the product 6 2. Scientific discussion 7 2.1. Introduction 7 2.2. Quality aspects 9 2.2.1. Introduction 9 2.2.2. Active

2013 European Medicines Agency - EPARs

18. Topiramate-Phentermine Combinations for Cocaine Dependence

Topiramate-Phentermine Combinations for Cocaine Dependence Topiramate-Phentermine Combinations for Cocaine Dependence - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Topiramate-Phentermine Combinations (...) Collaborator: National Institute on Drug Abuse (NIDA) Information provided by (Responsible Party): Craig Rush, University of Kentucky Study Details Study Description Go to Brief Summary: This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine. Condition or disease Intervention/treatment Phase Cocaine Use Disorder Drug: Cocaine Drug: Placebo Drug: Phentermine Drug: Topiramate

2014 Clinical Trials

19. Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. (PubMed)

Weight-loss therapy in type 2 diabetes: effects of phentermine and topiramate extended release. Treatment algorithms for type 2 diabetes recommend weight loss for disease management. The safety and efficacy of treatment with phentermine (PHEN)/topiramate (TPM) extended release (ER) plus lifestyle modification for weight loss and glycemic benefits were assessed in two randomized, double-blind, placebo-controlled 56-week studies of obese/overweight adults with type 2 diabetes.The OB-202/DM-230

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2014 Diabetes Care

20. Management of obesity and cardiometabolic risk – role of phentermine/extended release topiramate (PubMed)

Management of obesity and cardiometabolic risk – role of phentermine/extended release topiramate The US Food and Drug Administration (FDA) recently approved lorcaserin and the combination of phentermine and extended release topiramate (phentermine/topiramate ER) for the treatment of obesity in conjunction with a lifestyle intervention, expanding the therapeutic options for long-term obesity pharmacotherapy, which was previously limited to orlistat. Combination phentermine/topiramate ER (...) is associated with greater weight loss compared to its constituent monotherapy, with a more favorable adverse effect profile. Phentermine/topiramate ER also appears to have beneficial effects on cardiometabolic risk, although longer-term cardiovascular safety data are required. While there are no head-to-head studies among the currently available obesity pharmacotherapy agents, phentermine/topiramate ER appears to have a superior weight loss profile. This review will discuss the epidemiology, natural

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2014 Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy

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