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1.
Mayo Clin Proc ; 94(7): 1374-1377, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31272579

RESUMO

Women presenting to the cardiac catheterization laboratory with normal coronary arteries without significant atherosclerotic disease is a common presentation. In such patients, it is important to maintain a wide differential and consider alternate diagnoses. We present two cases of women presenting with chest pain found to have severe coronary vasospasm in the setting of recent initiation of phentermine. Phentermine may have vasospastic proprieties which are important to consider when prescribing to patients.


Assuntos
Estimulantes do Sistema Nervoso Central/efeitos adversos , Vasoespasmo Coronário/induzido quimicamente , Infarto do Miocárdio/induzido quimicamente , Fentermina/efeitos adversos , Estimulantes do Sistema Nervoso Central/administração & dosagem , Dor no Peito/etiologia , Vasoespasmo Coronário/diagnóstico , Vasoespasmo Coronário/tratamento farmacológico , Eletrocardiografia , Feminino , Humanos , Pessoa de Meia-Idade , Nitroglicerina/uso terapêutico , Fentermina/administração & dosagem , Vasodilatadores/uso terapêutico
3.
J Psychopharmacol ; 32(12): 1351-1361, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-30269642

RESUMO

BACKGROUND: This study evaluated the human abuse potential of solriamfetol (formerly JZP-110), a selective dopamine and norepinephrine reuptake inhibitor with robust wake-promoting effects. METHODS: Adults with a recent history of recreational polydrug use, including stimulants, and who met criteria in a Qualification Phase were randomized to one of six sequences in a Test Phase. Each Test Phase sequence included a single administration of placebo, solriamfetol (300, 600, and 1200 mg), and phentermine (45 and 90 mg), with a two-day washout between periods. The primary endpoint was peak rating ( Emax) of Liking at the Moment across the first 12 h on a liking/disliking visual analog scale; key secondary endpoints were Next Day Overall Drug Liking, how much the participant would like to Take the Drug Again, and positive and negative subjective effects. Safety was also assessed throughout the study. RESULTS: Of 43 participants (74.4% male; mean age 29.3 years), 37 completed the study. Peak Emax Liking at the Moment for all solriamfetol doses was significantly greater than placebo and significantly less than phentermine 90 mg ( p < 0.05). Overall Next Day Drug Liking was greater than placebo for solriamfetol 300 mg and phentermine 45 and 90 mg ( p < 0.05). Willingness to Take the Drug Again was significantly greater than placebo and significantly less than both doses of phentermine for all doses of solriamfetol ( p < 0.05). Ratings of negative subjective effects (bad effects, disliking, anxiety, agitation) were higher with solriamfetol 600 and 1200 mg relative to phentermine. The most common treatment-emergent adverse events with solriamfetol were hypervigilance, elevated mood, dry mouth, hyperhidrosis, and insomnia. CONCLUSION: Solriamfetol appears to have abuse potential similar to or lower than phentermine.


Assuntos
Inibidores da Captação Adrenérgica/administração & dosagem , Carbamatos/administração & dosagem , Inibidores da Captação de Dopamina/administração & dosagem , Transtornos Relacionados ao Uso de Substâncias/psicologia , Inibidores da Captação Adrenérgica/efeitos adversos , Inibidores da Captação Adrenérgica/farmacologia , Adulto , Carbamatos/efeitos adversos , Carbamatos/farmacologia , Estudos Cross-Over , Inibidores da Captação de Dopamina/efeitos adversos , Inibidores da Captação de Dopamina/farmacologia , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Masculino , Fentermina/administração & dosagem , Fentermina/efeitos adversos , Fentermina/farmacologia , Adulto Jovem
4.
Contemp Clin Trials ; 64: 173-178, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29038069

RESUMO

INTRODUCTION: 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, double-blinded, randomized, crossover trial examining safety and preliminary efficacy of Qsymia for BED and BN. METHODS: Adults with BED (n=15) or BN (n=15) are randomized 1:1 to receive 12weeks Qsymia (phentermine/topiramate ER, 3.75mg/23mg-15mg/92mg) or placebo, followed by 2-weeks washout and 12-weeks crossover, where those on Qsymia receive placebo and vice versa. Subsequently participants receive 8weeks follow-up off study medications. The primary outcome is the number of binge days/week measured by EDE. Secondary outcomes include average number of binge episodes, percentage abstinence from binge eating, and changes in weight/vitals, eating psychopathology, and mood. DISCUSSION: To our knowledge this is the first randomized, double-blind protocol investigating the safety and efficacy of phentermine/topiramate in BED and BN. We highlight the background and rationale for this study, including the advantages of a crossover design. TRIAL REGISTRATION: Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824.


Assuntos
Depressores do Apetite/uso terapêutico , Transtorno da Compulsão Alimentar/tratamento farmacológico , Bulimia Nervosa/tratamento farmacológico , Frutose/análogos & derivados , Fentermina/uso terapêutico , Adolescente , Adulto , Depressores do Apetite/administração & dosagem , Depressores do Apetite/efeitos adversos , Estudos Cross-Over , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Frutose/administração & dosagem , Frutose/efeitos adversos , Frutose/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Fentermina/administração & dosagem , Fentermina/efeitos adversos , Estudos Prospectivos , Projetos de Pesquisa , Adulto Jovem
5.
Pharmacotherapy ; 38(1): 19-28, 2018 01.
Artigo em Inglês | MEDLINE | ID: mdl-29044720

RESUMO

STUDY OBJECTIVE: To compare the effectiveness of weight-management medications used to assist with weight loss in real-world clinical practice in the Veterans Health Administration (VHA). DESIGN: Retrospective, multicenter, observational cohort study. DATA SOURCE: National VA Corporate Data Warehouse. PATIENTS: A total of 66,035 VA patients aged 18 years or older with a body mass index of 25 kg/m2 or greater who had an initial fill for a study medication (orlistat [6153 patients], phentermine [304 patients], lorcaserin [298 patients], or phentermine-topiramate extended release [233 patients]) or participation in the VA's MOVE! weight-management program with at least three total visits in a clinic coded as a MOVE clinic in the subsequent 24 weeks (59,047 patients) between January 1, 2012, and July 1, 2016. MEASUREMENTS AND MAIN RESULTS: The primary outcome was the percentage change in weight from baseline to at least 20 weeks or later (i.e., closest weight to 6 months). Secondary outcomes were difference in the percentage of weight loss at 12 and 36 weeks; changes in blood pressure, hemoglobin A1c , high-density and low-density lipoprotein cholesterol and triglyceride levels; and percentage of patients who achieved at least a 5% and 10% weight loss at 6 months from baseline in each group after at least 20 weeks. For the primary outcome, the percentage decrease in weight from baseline after at least 20 weeks in the lorcaserin, phentermine-topiramate, phentermine, orlistat, and MOVE! groups were 3.6%, 4.1%, 3.6%, 2.1%, and 1.6%, respectively (phentermine-topiramate group vs. MOVE! group, p<0.05). Achievement of at least a 5% weight loss after at least 20 weeks differed significantly among groups, ranging from 26.2% for the MOVE! Program only group to 40.3% for patients in the phentermine-topiramate group. CONCLUSION: In the VA population, the effectiveness of four available weight-management medications was similar. Patients receiving phentermine-topiramate had a greater proportion of weight loss after at least 20 weeks compared with those solely enrolled in the VA's MOVE! weight-management program.


Assuntos
Fármacos Antiobesidade/administração & dosagem , Peso Corporal/efeitos dos fármacos , Obesidade/tratamento farmacológico , Perda de Peso/efeitos dos fármacos , Adulto , Idoso , Benzazepinas/administração & dosagem , Estudos de Coortes , Preparações de Ação Retardada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Orlistate/administração & dosagem , Fentermina/administração & dosagem , Estudos Retrospectivos , Topiramato/administração & dosagem , Estados Unidos , United States Department of Veterans Affairs
6.
Curr Med Res Opin ; 33(10): 1773-1781, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28704161

RESUMO

OBJECTIVE: Dravet syndrome (DS) is a rare, treatment-resistant epilepsy syndrome for which current treatment regimens are often ineffective. Fenfluramine is currently in development for treatment of DS, based on reports in the 1980s and 1990s of its anti-epileptic activity in pediatric patients with intractable epilepsy. However, fenfluramine was withdrawn from global markets in 1997 following reports of its association with pulmonary hypertension and heart valve disease in adult patients treated for obesity. This review was conducted to assess cardiac safety of fenfluramine when used at lower doses for treatment of DS. METHODS: Pubmed was searched for clinical studies of fenfluramine in obese adults who reported incidence of heart valve disease. These data were reviewed against published results from Belgian patients with DS who have been treated with low-dose fenfluramine for up to 28 years. RESULTS: Nine controlled studies of fenfluramine and related compounds (dexfenfluramine and/or phentermine) which assessed incidence and severity of cardiac valve disease in 3,268 treated patients and 2,017 control subjects have been reported. Mild or greater aortic valve regurgitation was found in 9.6% of treated patients compared with 3.9% of control subjects, and moderate or greater mitral valve regurgitation was found in 3.1% of treated patients and 2.5% of control subjects. Nineteen DS patients have been treated for up to 28 years with 10-20 mg/day fenfluramine, with no clinical signs or symptoms of cardiac valve disease or pulmonary hypertension. Slight and clinically unimportant changes in valve structure have been seen on echocardiography in five patients at some time during the observation period. CONCLUSIONS: A different benefit-risk relationship appears to be emerging when fenfluramine is used at low doses for extended periods in young patients with DS. Continued cardiac assessments during ongoing Phase 3 clinical trials will provide additional safety information for this potential new and effective treatment.


Assuntos
Depressores do Apetite/administração & dosagem , Epilepsias Mioclônicas/tratamento farmacológico , Fenfluramina/administração & dosagem , Adulto , Depressores do Apetite/efeitos adversos , Dexfenfluramina/administração & dosagem , Dexfenfluramina/efeitos adversos , Fenfluramina/efeitos adversos , Doenças das Valvas Cardíacas/epidemiologia , Humanos , Hipertensão Pulmonar/epidemiologia , Incidência , Obesidade/tratamento farmacológico , Fentermina/administração & dosagem , Fentermina/efeitos adversos
7.
Obesity (Silver Spring) ; 25(5): 857-865, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28440045

RESUMO

OBJECTIVE: To assess the short-term tolerability of lorcaserin alone or with two dose regimens of phentermine. METHODS: This was a 12-week, randomized, double-blind, pilot safety study of N = 238 nondiabetic patients with obesity or overweight with ≥1 comorbidity randomized to lorcaserin 10 mg twice daily (BID; LOR BID) alone or with phentermine 15 mg once daily (QD; LOR BID+PHEN QD) or 15 mg twice daily (LOR BID+PHEN BID). Patients reporting ≥ 1 of 9 potentially serotonergic adverse events (AEs), mean weight loss (WL), and ≥5% WL are reported. RESULTS: N = 238 were randomized, and N = 235 were treated. N = 94 reported potentially serotonergic AEs: 37.2% LOR BID, 42.3% LOR BID+PHEN QD, and 40.5% LOR BID+PHEN BID. AEs leading to discontinuation were reported approximately twice as often in the LOR BID+PHEN BID group versus the LOR BID group. Mean WL was 3.5 kg/3.3%, 7.0 kg/6.7%, and 7.6 kg/7.2% for LOR BID, LOR BID+PHEN QD, and LOR BID+PHEN BID, respectively. At least 5% WL was achieved by 28.2% LOR BID, 59.0% LOR BID+PHEN QD (P = 0.0002 vs. LOR BID), and 70.9% LOR BID+PHEN BID (P < 0.0001 vs. LOR BID) patients. CONCLUSIONS: Phentermine added to lorcaserin enhanced short-term weight loss but did not increase incidence of potentially serotonergic AEs; however, phentermine twice daily increased discontinuation compared to both lorcaserin alone and lorcaserin plus phentermine once daily.


Assuntos
Fármacos Antiobesidade/uso terapêutico , Benzazepinas/uso terapêutico , Fentermina/uso terapêutico , Perda de Peso/efeitos dos fármacos , Adolescente , Adulto , Fármacos Antiobesidade/administração & dosagem , Fármacos Antiobesidade/farmacologia , Benzazepinas/administração & dosagem , Benzazepinas/farmacologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fentermina/administração & dosagem , Fentermina/farmacologia , Projetos Piloto , Adulto Jovem
8.
Diabetes Care ; 40(7): 856-862, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-28455281

RESUMO

OBJECTIVE: To assess the ability of medication-assisted weight loss to prevent diabetes as a function of the baseline weighted Cardiometabolic Disease Staging (CMDS) score. RESEARCH DESIGN AND METHODS: 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 of fasting glucose, 2-h oral glucose tolerance test glucose, and/or HbA1c. RESULTS: The absolute decrease in 1-year diabetes incidence rates in subjects treated with medication versus placebo was greatest in those with high-risk CMDS scores at baseline (10.43-6.29%), intermediate in those with moderate CMDS risk (4.67-2.37%), and small in the low-risk category (1.51-0.67%). The number of participants needed to treat to prevent one new case of diabetes over a 56-week period was 24, 43, and 120 in those with baseline CMDS scores of ≥60, 30-59, and 0-29, respectively. CONCLUSIONS: Numbers needed to treat to prevent one case of type 2 diabetes are markedly lower in patients with high-risk scores. CMDS can be used to quantify risk of diabetes in overweight/obese individuals and predict the effectiveness of weight-loss therapy to prevent diabetes.


Assuntos
Fármacos Antiobesidade/administração & dosagem , Diabetes Mellitus Tipo 2/prevenção & controle , Frutose/análogos & derivados , Obesidade/tratamento farmacológico , Fentermina/administração & dosagem , Adulto , Glicemia , Ensaios Clínicos Fase III como Assunto , Preparações de Ação Retardada/administração & dosagem , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/etiologia , Método Duplo-Cego , Feminino , Frutose/administração & dosagem , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Obesidade/sangue , Obesidade/complicações , Topiramato , Circunferência da Cintura , Perda de Peso
9.
Diabetes Care ; 40(5): 632-639, 2017 05.
Artigo em Inglês | MEDLINE | ID: mdl-28289041

RESUMO

OBJECTIVE: To assess the efficacy and safety of coadministration of canagliflozin (CANA) and phentermine (PHEN) compared with placebo (PBO) and CANA or PHEN monotherapies in individuals who were overweight and obese without type 2 diabetes. RESEARCH DESIGN AND METHODS: This 26-week, phase 2a, randomized, double-blind, PBO-controlled, multicenter, parallel-group study enrolled individuals who were obese or overweight without type 2 diabetes (N = 335, aged 18-65 years, BMI ≥30 to <50 kg/m2 or BMI ≥27 to <50 kg/m2 with hypertension and/or dyslipidemia). Participants were randomized (1:1:1:1) to receive PBO, CANA 300 mg, PHEN 15 mg, or coadministration of CANA 300 mg and PHEN 15 mg (CANA/PHEN) orally once daily. The primary end point was percent change in body weight from baseline to week 26; key secondary end points were the proportion of participants achieving weight loss ≥5% and change from baseline in systolic blood pressure. RESULTS: CANA/PHEN provided statistically superior weight loss from baseline versus PBO at week 26 (least squares mean difference -6.9% [95% CI -8.6 to -5.2]; P < 0.001). CANA/PHEN also provided statistically superior achievement of weight loss ≥5% and reduction in systolic blood pressure compared with PBO. CANA/PHEN was generally well tolerated, with a safety and tolerability profile consistent with that of the individual components. CONCLUSIONS: CANA/PHEN produced meaningful reductions in body weight and was generally well tolerated in individuals who were overweight or obese without type 2 diabetes. Further studies are warranted to evaluate potential use of this combination for long-term weight management.


Assuntos
Depressores do Apetite/administração & dosagem , Canagliflozina/administração & dosagem , Hipoglicemiantes/administração & dosagem , Obesidade/tratamento farmacológico , Sobrepeso/tratamento farmacológico , Fentermina/administração & dosagem , Adulto , Depressores do Apetite/efeitos adversos , Pressão Sanguínea/efeitos dos fármacos , Canagliflozina/efeitos adversos , Diabetes Mellitus Tipo 2 , Método Duplo-Cego , Feminino , Humanos , Hipoglicemiantes/efeitos adversos , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade/fisiopatologia , Sobrepeso/complicações , Sobrepeso/fisiopatologia , Fentermina/efeitos adversos , Tiofenos/uso terapêutico
10.
Expert Opin Drug Saf ; 16(1): 27-39, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-27732121

RESUMO

INTRODUCTION: Few studies on combination therapies for the treatment of obesity had been conducted until recently, when two fixed-dose combinations, bupropion-naltrexone ER fixed-dose combination and phentermine-topiramate ER titrated-dose combinations were evaluated in clinical studies that ultimately led to FDA approval. Areas covered: In this review, we discuss safety concerns about both combinations, the rationale and history of combination therapies for obesity (including phentermine plus fenfluramine), and possible future new combinations. Expert opinion: Combination therapies are a promising new area in obesity treatment, similar to what occurs with diabetes and hypertension. Safety assessment is highly important due to the high number of potential users on a chronic basis.


Assuntos
Fármacos Antiobesidade/administração & dosagem , Obesidade/tratamento farmacológico , Animais , Fármacos Antiobesidade/efeitos adversos , Fármacos Antiobesidade/uso terapêutico , Bupropiona/administração & dosagem , Bupropiona/efeitos adversos , Bupropiona/uso terapêutico , Preparações de Ação Retardada , Combinação de Medicamentos , Frutose/administração & dosagem , Frutose/efeitos adversos , Frutose/análogos & derivados , Frutose/uso terapêutico , Humanos , Naltrexona/administração & dosagem , Naltrexona/efeitos adversos , Naltrexona/uso terapêutico , Fentermina/administração & dosagem , Fentermina/efeitos adversos , Fentermina/uso terapêutico , Topiramato
11.
Obesity (Silver Spring) ; 24(11): 2344-2350, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27664021

RESUMO

OBJECTIVE: To examine the effects of phentermine combined with a meal replacement program on weight loss and food cravings and to investigate the relationship between food cravings and weight loss. METHODS: In a 12-week randomized, double-blind, placebo-controlled clinical trial, 77 adults with obesity received either phentermine or placebo. All participants were provided Medifast® meal replacements, were instructed to follow the Take Shape for Life® Optimal Weight 5&1 Plan for weight loss, and received lifestyle coaching in the Habits of Health program. The Food Craving Inventory and the General Food Cravings State and Trait Questionnaires were used to measure food cravings. RESULTS: The phentermine group lost 12.1% of baseline body weight compared with 8.8% in the placebo group. Cravings for all food groups decreased in both groups; however, there was a greater reduction in cravings for fats and sweets in the phentermine group compared with the placebo group. Percent weight loss correlated significantly with reduced total food cravings (r = 0.332, P = 0.009), cravings for sweets (r = 0.412, P < 0.000), and state food cravings (r = 0.320, P = 0.007). CONCLUSIONS: Both phentermine combined with a meal replacement program and meal replacements alone significantly reduced body weight and food cravings; however, the addition of phentermine enhanced these effects.


Assuntos
Depressores do Apetite/administração & dosagem , Fissura/efeitos dos fármacos , Obesidade/terapia , Fentermina/administração & dosagem , Perda de Peso/efeitos dos fármacos , Programas de Redução de Peso/métodos , Adulto , Terapia Combinada , Método Duplo-Cego , Feminino , Humanos , Estilo de Vida , Masculino , Refeições/efeitos dos fármacos , Pessoa de Meia-Idade
12.
J Fam Pract ; 65(7 Suppl): S16-23, 2016 07.
Artigo em Inglês | MEDLINE | ID: mdl-27565106

RESUMO

The recent approval of liraglutide, lorcaserin, naltrexone/bupropion extended-release, and phentermine/topiramate extended-release, brings the number of medications for long-term weight loss to 5 (including orlistat). Indicated for the treatment of patients with overweight (body mass index [BMI] ≥27 kg/m2 with ≥1 weight-related comorbidity) or obesity (BMI ≥30 kg/m2), these medications provide new opportunities to address this burgeoning health problem.


Assuntos
Fármacos Antiobesidade/administração & dosagem , Estilo de Vida , Obesidade/tratamento farmacológico , Atenção Primária à Saúde , Perda de Peso/efeitos dos fármacos , Fármacos Antiobesidade/efeitos adversos , Benzazepinas/administração & dosagem , Índice de Massa Corporal , Bupropiona/administração & dosagem , Guias como Assunto , Humanos , Lactonas/administração & dosagem , Liraglutida/administração & dosagem , Naltrexona/administração & dosagem , Obesidade/terapia , Orlistate , Sobrepeso/tratamento farmacológico , Fentermina/administração & dosagem , Fatores de Risco , Resultado do Tratamento
13.
Obes Surg ; 26(2): 452-8, 2016 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-26615406

RESUMO

BACKGROUND: Bariatric surgery is an effective therapeutic option for management of obesity. However, weight recidivism (WR) and weight loss plateau (WLP) are common problems. We present our experience with the use of two pharmacotherapies in conjunction with our standard diet and exercise program in those patients who experienced WR or WLP. METHODS: From June 2010 to April 2014, bariatric surgery patients who experienced WR or WLP after undergoing Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), and who were treated with phentermine (Ph) or phentermine-topiramate (PhT), were reviewed retrospectively. Generalized estimating equations were used to compare patient weights through 90 days between initial surgery type and medication type. Patient weights, medication side effect, and co-morbidities were collected during the first 90 days of therapy. RESULTS: Fifty-two patients received Ph while 13 patients received PhT. Overall, patients in both groups lost weight. Among those whose weights were recorded at 90 days, patients on Ph lost 6.35 kg (12.8% excess weight loss (EWL); 95% confidence interval (CI) 4.25, 8.44) and those prescribed PhT lost 3.81 kg (12.9% EWL; CI 1.08, 6.54). Adjusting for baseline weight, time since surgery, and visit through 90 days, patients treated with Ph weighed significantly less than those on PhT throughout the course of this study (1.35 kg lighter; 95% CI 0.17, 2.53; p = 0.025). There were no serious side effects reported. CONCLUSIONS: Phentermine and phentermine-topirimate in addition to diet and exercise appear to be viable options for weight loss in post-RYGB and LAGB patients who experience WR or WLP.


Assuntos
Fármacos Antiobesidade/administração & dosagem , Frutose/análogos & derivados , Obesidade/terapia , Fentermina/administração & dosagem , Adulto , Cirurgia Bariátrica , Dieta Redutora , Terapia por Exercício , Feminino , Frutose/administração & dosagem , Humanos , Laparoscopia , Masculino , Pessoa de Meia-Idade , Obesidade/cirurgia , Estudos Retrospectivos , Topiramato , Perda de Peso/efeitos dos fármacos
14.
J Clin Neurosci ; 22(8): 1363-4, 2015 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-25911503

RESUMO

We report a 49-year-old female migraineur who experienced paradoxical hyperphagia and concurrent intrusive food thoughts leading to rapid weight gain and a substantial increase in waist circumference. A significant reduction in migraine frequency was also observed during topiramate treatment, a widely used migraine prophylactic agent which is generally associated with weight loss. Withdrawal of topiramate saw appetite return to baseline levels, however, migraine frequency was again increased. Topiramate was reinitiated in combination with phentermine, a drug indicated for weight management, without reoccurrence of adverse effects. Migraine control was maintained and progressive weight loss ensued. Combination treatment with phentermine may be a useful strategy should other patients experience this adverse reaction while gaining therapeutic anti-migraine benefit from topiramate.


Assuntos
Depressores do Apetite/administração & dosagem , Frutose/análogos & derivados , Hiperfagia/induzido quimicamente , Transtornos de Enxaqueca/tratamento farmacológico , Fármacos Neuroprotetores/efeitos adversos , Fentermina/administração & dosagem , Quimioterapia Combinada/métodos , Feminino , Frutose/administração & dosagem , Frutose/efeitos adversos , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuroprotetores/administração & dosagem , Topiramato , Ganho de Peso/efeitos dos fármacos
15.
Pharmacoeconomics ; 33(7): 699-706, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24986038

RESUMO

BACKGROUND: Phase 3 clinical trial results reveal that Qsymia is a clinically effective long-term treatment for obesity, but whether this treatment is cost-effective compared to a diet and lifestyle intervention has yet to be explored. OBJECTIVE: To quantify the incremental cost-effectiveness of Qsymia (phentermine and topiramate extended-release) for health-related quality of life improvements. STUDY DESIGN AND METHODS: Estimates are based on cost and quality of life outcomes from a 56-week, multicenter, placebo-controlled, phase 3 clinical trial undertaken in 93 health centers in the US. Participants were overweight and obese adults (aged 18-70 years) with a body-mass index of 27-45 kg/m(2) and two or more comorbidities (hypertension, dyslipidemia, diabetes or pre-diabetes or abdominal obesity). The intervention was diet and lifestyle advice plus the recommended dose of Qsymia (phentermine 7.5 mg plus topiramate 46.0 mg) vs. control, which included diet and lifestyle advice plus placebo. The study was from the payer perspective. Costs included the prescription cost, medication cost offsets and physician appointment costs. Effectiveness was measured in terms of quality-adjusted life years gained (QALYs). The main outcome measure was incremental cost per QALY gained of the intervention relative to control. RESULTS: Our base-case model, in which participants take Qsymia for 1 year with benefits linearly decaying over the subsequent 2 years, generates an incremental cost-effectiveness ratio (ICER) of $48,340 per QALY gained. Using the base-case assumptions, probabilistic sensitivity analyses reveal that the ICER is below $50,000 per QALY in 54 % of simulations. However, results are highly dependent on the extent to which benefits are maintained post medication cessation. If benefits persist for only 1 year post cessation, the ICER increases to $74,480. CONCLUSION: Although base-case results suggest that Qsymia is cost-effective, this result hinges on the time on Qsymia and the extent to which benefits are maintained post medication cessation. This should be an area of future research.


Assuntos
Fármacos Antiobesidade/economia , Custos de Medicamentos , Frutose/análogos & derivados , Obesidade/tratamento farmacológico , Fentermina/economia , Perda de Peso/efeitos dos fármacos , Fármacos Antiobesidade/administração & dosagem , Fármacos Antiobesidade/uso terapêutico , Ensaios Clínicos Fase III como Assunto , Análise Custo-Benefício , Combinação de Medicamentos , Frutose/administração & dosagem , Frutose/economia , Frutose/uso terapêutico , Humanos , Obesidade/economia , Fentermina/administração & dosagem , Fentermina/uso terapêutico , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto
17.
Clin Cardiol ; 37(11): 693-9, 2014 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-25223901

RESUMO

Obesity is a major correlate of cardiovascular disease. Weight loss improves cardiovascular risk factors and has the potential to improve outcomes. Two drugs, phentermine plus topiramate and lorcaserin, have recently been approved by the US Food and Drug Administration for the indication of obesity; a third, bupropion plus naltrexone, is under consideration for approval. In clinical trials, these drugs cause weight loss and improve glucose tolerance, lipid profile, and, with the exception of bupropion plus naltrexone, blood pressure. However, their effect on cardiovascular outcomes is unknown. In defining appropriate roles for these drugs in preventive cardiology, it is important to remember the checkered history of drugs for obesity. New weight-loss drugs share the serotonergic and sympathomimetic mechanisms that proved harmful in the cases of Fen-Phen and sibutramine, respectively, albeit with significant differences. Given these risks, randomized cardiovascular outcomes trials are needed to establish the safety, and potential benefit, of these drugs. This review will discuss the history of pharmacotherapy for obesity, existing efficacy and safety data for the novel weight-loss drugs, and issues in the design of postapproval clinical trials.


Assuntos
Fármacos Antiobesidade/administração & dosagem , Fármacos Antiobesidade/efeitos adversos , Doenças Cardiovasculares/prevenção & controle , Coração/efeitos dos fármacos , Obesidade/tratamento farmacológico , Benzazepinas/administração & dosagem , Benzazepinas/efeitos adversos , Bupropiona/administração & dosagem , Bupropiona/efeitos adversos , Ensaios Clínicos como Assunto , Combinação de Medicamentos , Frutose/administração & dosagem , Frutose/efeitos adversos , Frutose/análogos & derivados , Humanos , Naltrexona/administração & dosagem , Naltrexona/efeitos adversos , Fentermina/administração & dosagem , Fentermina/efeitos adversos , Topiramato
18.
Diabetes Care ; 37(12): 3309-16, 2014 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-25249652

RESUMO

OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: The OB-202/DM-230 Study was a 56-week phase 2 trial that randomized subjects to receive once-daily placebo or PHEN/TPM ER 15 mg/92 mg (15/92). The primary end point was change in HbA1c level. A post hoc analysis of a subpopulation with type 2 diabetes from a second study, CONQUER, is also presented. All subjects made lifestyle modifications, and comorbidities were managed to the standard of care. RESULTS: The study groups comprised 130 subjects with type 2 diabetes enrolled in the OB-202/DM-230 Study (mean baseline HbA1c 8.7% [72 mmol/mol]) and 388 subjects with type 2 diabetes in the CONQUER Study (mean baseline HbA1c 6.8% [51 mmol/mol]). At week 56 in the OB-202/DM-230, change in weight (from intent-to-treat sample with last observation carried forward [ITT-LOCF]) was -2.7% for placebo and -9.4% for PHEN/TPM ER 15/92 (P < 0.0001 vs. placebo). Change in HbA1c level (from ITT-LOCF) was -1.2% (-13.1 mmol/mol) for placebo and -1.6% (-17.5 mmol/mol) for PHEN/TPM ER 15/92 (P = 0.0381). In both the OB-202/DM-230 and CONQUER, greater numbers of patients randomized to receive PHEN/TPM ER treatment achieved HbA1c targets with reduced need for diabetic medications when compared with the placebo group. Common adverse events included paraesthesia, constipation, and insomnia. CONCLUSIONS: PHEN/TPM ER plus lifestyle modification can effectively promote weight loss and improve glycemic control as a treatment approach in obese/overweight patients with type 2 diabetes.


Assuntos
Fármacos Antiobesidade/administração & dosagem , Diabetes Mellitus Tipo 2/tratamento farmacológico , Frutose/análogos & derivados , Obesidade/tratamento farmacológico , Fentermina , Perda de Peso , Adulto , Fármacos Antiobesidade/efeitos adversos , Glicemia , Preparações de Ação Retardada , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/terapia , Método Duplo-Cego , Feminino , Frutose/administração & dosagem , Frutose/efeitos adversos , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Obesidade/complicações , Obesidade/terapia , Fentermina/administração & dosagem , Fentermina/efeitos adversos , Topiramato , Resultado do Tratamento , Perda de Peso/efeitos dos fármacos
19.
Drug Saf ; 37(9): 693-702, 2014 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-25096956

RESUMO

Worldwide obesity prevalence has nearly doubled since 1980. Due to numerous co-morbidities, obesity represents a serious health and socioeconomic problem worldwide. Pharmacotherapy should be an integral part of comprehensive obesity management. Drug therapy can assist in weight loss and its maintenance in those individuals who do not achieve appropriate weight loss through lifestyle interventions alone. After the withdrawal of sibutramine from the market in 2010, orlistat, a lipase inhibitor, was the only remaining prescription drug approved for the long-term treatment of obesity. In 2012, phentermine/topiramate extended-release (PHEN/TPM ER) combination and lorcaserin were approved by the US FDA as novel medications for long-term weight management. Three major phase III trials conducted with each drug confirmed their efficacy in terms of weight loss/maintenance and improvement of cardiometabolic risks. No head-to-head studies between the two new anti-obesity drugs have been carried out. However, in the existing studies PHEN/TPM ER had a superior weight loss profile to lorcaserin but the incidence of adverse effects was lower with lorcaserin. Both drugs were well-tolerated, and adverse events were modest in intensity, dose dependent, rather rare, and tended to decrease with the duration of treatment. Major safety concerns regarding PHEN/TPM ER include elevations in resting pulse rate, teratogenicity, mild metabolic acidosis, and psychiatric and cognitive adverse events. Valvulopathy, cognitive impairment, psychiatric disorders, and hypoglycemia represent major safety concerns for lorcaserin. Although existing trials have not demonstrated any significant issues with PHEN/TPM ER-induced heart rate elevation and lorcaserin-induced valvulopathy, all safety concerns should be seriously taken into account in patients treated with either of these novel anti-obesity medications.


Assuntos
Fármacos Antiobesidade/efeitos adversos , Obesidade/tratamento farmacológico , Fármacos Antiobesidade/administração & dosagem , Benzazepinas/efeitos adversos , Benzoxazinas/efeitos adversos , Bupropiona/efeitos adversos , Química Farmacêutica , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Frutose/administração & dosagem , Frutose/efeitos adversos , Frutose/análogos & derivados , Peptídeo 1 Semelhante ao Glucagon/efeitos adversos , Peptídeo 1 Semelhante ao Glucagon/análogos & derivados , Humanos , Liraglutida , Naltrexona/efeitos adversos , Fentermina/administração & dosagem , Fentermina/efeitos adversos , Topiramato
20.
Med J Aust ; 201(4): 224-6, 2014 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-25164851

RESUMO

OBJECTIVE: To investigate the safety, tolerability and efficacy of combination phentermine and topiramate therapy for maintenance of weight loss. DESIGN, SETTING AND PATIENTS: Retrospective audit of patients attending the Austin Health Weight Control Clinic who were dispensed phentermine-topiramate between 22 January 2010 and 16 July 2012 and after reaching a target weight by following a very low energy diet (VLED). Data collection continued until July 2013. MAIN OUTCOME MEASURES: Number of patients who ceased pharmacotherapy; duration of use of pharmacotherapy; types and numbers of adverse effects; and mean weight and blood pressure measurements at the initial visit, the end of the VLED and the last observation during pharmacotherapy. RESULTS: Data were available for 103 patients who were dispensed phentermine-topiramate; 61 patients ceased combination pharmacotherapy before the end of the data collection period, 41 due to adverse effects (eg, paraesthesia, cognitive changes, dry mouth and depression). The mean duration of use of pharmacotherapy was 10 months. Mean weight decreased by 10% due to the VLED (from 135.5 kg to 122.5 kg) and this loss was maintained. For 30 patients who continued on phentermine-topiramate, the mean duration of pharmacotherapy was 22 months and the mean weight decreased by 6.7 kg between the end of the VLED and the last observation during pharmacotherapy. CONCLUSION: Phentermine-topiramate therapy was not well tolerated; more than half of the patients in our study stopped taking it because of adverse effects, and more than half of the adverse events reported were ascribed to topiramate. However, in those able to continue with pharmacotherapy, the combination was efficacious for both maintenance of weight loss and ongoing weight loss.


Assuntos
Fármacos Antiobesidade/administração & dosagem , Frutose/análogos & derivados , Obesidade/tratamento farmacológico , Fentermina/administração & dosagem , Perda de Peso , Fármacos Antiobesidade/efeitos adversos , Austrália/epidemiologia , Índice de Massa Corporal , Quimioterapia Combinada , Seguimentos , Frutose/administração & dosagem , Frutose/efeitos adversos , Humanos , Auditoria Médica , Obesidade/epidemiologia , Fentermina/efeitos adversos , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Topiramato , Falha de Tratamento , Resultado do Tratamento , Perda de Peso/efeitos dos fármacos
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