Store phentermine and topiramate in a safe place so that no one else can take it accidentally or on purpose. Erratum in Drugs Today Barc. Thorpe KE, Philyaw M. Ask your doctor if you have any questions about how you will receive your medication. Qsymia is indicated for chronic weight management in conjunction with a reduced- calorie diet and increased physical activity. Topamax may also cause side effects such as weakness, hair loss, insomnia, abnormal hair growth, skin problems, and numerous other complications that includes one popular and positive side effect; weight loss. Healthcare providers and patients are encouraged to report pregnancies by calling Topiramate Dosage for Weight Loss or Weight Loss before and after
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The fact that another fixed drug combination agent; naltrexone sustained release and bupropion sustained release; trade name Contrave is currently undergoing FDA review for use in obesity management possible approval pending the results of ongoing cardiovascular safety trials is encouraging and indicative of this evolving trend. The other authors report no conflicts of interest in this work.
National Center for Biotechnology Information , U. Drug Des Devel Ther. Published online Apr 5. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited. This article has been cited by other articles in PMC. Abstract Obesity is now a major public health concern worldwide with increasing prevalence and a growing list of comorbidities and complications.
Introduction Obesity is a highly prevalent, complex condition that now appears to best fit the chronic disease model well known to apply to other clinical conditions like type 2 diabetes and essential hypertension. Table 1 Oral agents for potential combination therapy in obesity management. Open in a separate window.
Clinical trials of phentermine use in the pharmacotherapy of obesity Most of the Clinical research studies on phentermine use for obesity management were relatively short duration, involving small cohorts and completed between the s and 80s. Table 2 Identified and putative modes of action of topiramate peripherally and centrally 65 , Carbonic anhydrase 2 and 4 Inhibitor Systemic 4.
Glutamate ionotropic kainate type 1 Antagonist Central 5. Cytochrome P 2C19 Inhibitor Systemic 6. Cytochrome P 3A4 Inducer Systemic 7. Use in special populations Topiramates use in children older than 2-years is well-established in the treatment of epilepsy and usually well tolerated, although there is a higher incidence of metabolic acidosis in younger patients. Clinical trials of topiramate use in the pharmacotherapy of obesity Weight loss was noted as a side effect as topiramate was being investigated for other uses such as migraine prevention, seizures and bipolar disorder.
Overview of combination therapy of phentermine and topiramate Vivus Mountain View, CA, USA have spearheaded the clinical development of a combination of phentermine and topiramate for the clinical management of obesity. Table 3 Clinical approval trials for Qsymia. Conclusion Overall the clinical results of the trials thus far completed for the fixed drug combination of phentermine and topiramate-ER give reason for measured optimism.
Report from the CDC. Changes in selected chronic disease-related risks and health conditions for nonpregnant women 18—44 years old BRFSS. J Womens Health Larchmt Jun; 14 5: Geographic variation in the prevalence of obesity, diabetes, and obesity-related behaviors. Epidemiology of obesity in the Western Hemisphere. J Clin Endocrinol Metab. Trends in obesity and abdominal obesity among hypertensive and nonhypertensive adults in the United States.
Thorpe KE, Philyaw M. The medicalization of chronic disease and costs. Annu Rev Public Health. Current updates in the medical management of obesity. Managing obesity in adults in primary care. Surg Clin North Am. Li Z, Heber D. Sarcopenic obesity in the elderly and strategies for weight management. A systematic review of the literature concerning the relationship between obesity and mortality in the elderly. J Nutr Health Aging. Prevalence, pathophysiology, health consequences and treatment options of obesity in the elderly: Current and future drug targets in weight management.
Pharmacological and surgical treatment of obesity. Pharmacotherapy for weight loss in adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. Chugh PK, Sharma S. Recent advances in the pathophysiology and pharmacological treatment of obesity. J Clin Pharm Ther. Derosa G, Maffioli P. Expert Opin Drug Saf. Kushner RF, Manzano H. Pharmacological management of appetite expression in obesity.
Combination drugs for treating obesity. Two new drugs approved for obesity. Taylor AA, Ragbir S. Fixed-dose combination therapy in hypertension: High Blood Press Cardiovasc Prev. Glycemic effectiveness and medication adherence with fixed-dose combination or coadministered dual therapy of antihyperglycemic regimens: Curr Med Res Opin. Multiple action fixed combination. Gerbino PP, Shoheiber O. Adherence patterns among patients treated with fixed-dose combination versus separate antihypertensive agents.
Am J Health Syst Pharm. Compliance and fixed-dose combination therapy. Sanz G, Fuster V. Polypill and global cardiovascular health strategies. Semin Thorac Cardiovasc Surg. Klonoff DC, Greenway F. Drugs in the pipeline for the obesity market. J Diabetes Sci Technol. Long-term drug treatment of obesity in a private practice setting. Long-term pharmacologic treatment of morbid obesity in a community practice.
A double blind trial. Long-term weight control study. II weeks 34 to An open-label study of continuous fenfluramine plus phentermine versus targeted intermittent medication as adjuncts to behavior modification, caloric restriction, and exercise. I weeks 0 to The enhancement of behavior modification, caloric restriction, and exercise by fenfluramine plus phentermine versus placebo.
Thermogenic synergism between ephedrine and caffeine in healthy volunteers: Ornellas T, Chavez B. Comparison of combined bupropion and naltrexone therapy for obesity with monotherapy and placebo. Rational design of a combination medication for the treatment of obesity. Obesity Silver Spring Jan; 17 1: Effects of low-dose, controlled-release, phentermine plus topiramate combination on weight and associated comorbidities in overweight and obese adults CONQUER: Am J Clin Nutr.
N Engl J Med. A study of abrupt phentermine cessation in patients in a weight management program. How physician obesity specialists use drugs to treat obesity. Obesity Silver Spring Sep; 17 9: Blood pressure and heart rate effects, weight loss and maintenance during long-term phentermine pharmacotherapy for obesity. Obesity Silver Spring Dec; 19 Lexicomp Online Web Site. Nat Clin Pract Gastroenterol Hepatol.
Teva Pharmaceuticals, USA; Is a combination with topiramate on the horizon? Comparison of continuous and intermittent anorectic therapy in obesity. Am J Emerg Med. Makoundou V, Golay A. Drug control of appetite. A case of profound weight loss secondary to use of phentermine. J Miss State Med Assoc. Efficacy and safety of topiramate in the treatment of obese subjects with essential hypertension.
An overview of the preclinical aspects of topiramate: Molecular pharmacodynamics, clinical therapeutics, and pharmacokinetics of topiramate. Pub Chem compound [website] [Accessed Dec ]. Topiramate; Compound summary CID Topiramate in migraine prevention: Topiramate as add-on treatment for patients with bipolar mania. A 6-month randomized, placebo-controlled, dose-ranging trial of topiramate for weight loss in obesity. Predictors of weight loss in adults with topiramate-treated epilepsy.
A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects. Astrup A, Toubro S. Drugs Today Barc Dec; 47 Expert Rev Cardiovasc Ther. Phentermine and topiramate extended release qsymia: Malgarini RB, Pimpinella G. Phentermine plus topiramate in the treatment of obesity. Mydriasis may or may not be present. This syndrome may be associated with supraciliary effusion resulting in anterior displacement of the lens and iris , with secondary angle closure glaucoma.
Symptoms typically occur within 1 month of initiating treatment with topiramate but may occur at any time during therapy. The primary treatment to reverse symptoms is immediate discontinuation of Qsymia. Elevated intraocular pressure of any etiology , if left untreated, can lead to serious adverse events including permanent loss of vision. Qsymia can cause mood disorders, including depression, and anxiety, as well as insomnia.
Patients with a history of depression may be at increased risk of recurrent depression or other mood disorders while taking Qsymia. For clinically significant or persistent symptoms consider dose reduction or withdrawal of Qsymia. If patients have symptoms of suicidal ideation or behavior, discontinue Qsymia. Qsymia can cause cognitive dysfunction e.
Since Qsymia has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles, until they are reasonably certain Qsymia therapy does not affect them adversely. If cognitive dysfunction persists consider dose reduction or withdrawal of Qsymia for symptoms that are moderate to severe, bothersome, or those which fail to resolve with dose reduction.
Conditions or therapies that predispose to acidosis i. Concomitant use of Qsymia and a carbonic anhydrase inhibitor e. Therefore, if Qsymia is given concomitantly with another carbonic anhydrase inhibitor to a patient with a predisposing condition for metabolic acidosis the patient should be monitored for the appearance or worsening of metabolic acidosis. Some manifestations of acute or chronic metabolic acidosis may include hyperventilation , nonspecific symptoms such as fatigue and anorexia , or more severe sequelae including cardiac arrhythmias or stupor.
The effect of Qsymia on growth and bone-related sequelae has not been systematically investigated in long-term, placebo-controlled trials. Measurement of electrolytes including serum bicarbonate prior to starting Qsymia and during Qsymia treatment is recommended. In Qsymia clinical trials, the peak reduction in serum bicarbonate occurred by week 4, and in most subjects there was a correction of bicarbonate by week 56, without any change to study drug. However, if persistent metabolic acidosis develops while taking Qsymia, reduce the dose or discontinue Qsymia.
Qsymia can cause an increase in serum creatinine. Peak increases in serum creatinine were observed after 4 to 8 weeks of treatment. On average, serum creatinine gradually declined but remained elevated over baseline creatinine values. Elevations in serum creatinine often signify a decrease in renal function, but the cause for Qsymia-associated changes in serum creatinine has not been definitively established. Therefore, measurement of serum creatinine prior to starting Qsymia and during Qsymia treatment is recommended.
Qsymia has not been studied in combination with insulin. Measurement of blood glucose levels prior to starting Qsymia and during Qsymia treatment is recommended in patients with type 2 diabetes. Decreases in medication doses for antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia. If a patient develops hypoglycemia after starting Qsymia, appropriate changes should be made to the antidiabetic drug regimen.
In hypertensive patients being treated with antihypertensive medications, weight loss may increase the risk of hypotension , and associated symptoms including dizziness, lightheadedness , and syncope. Measurement of blood pressure prior to starting Qsymia and during Qsymia treatment is recommended in patients being treated for hypertension. If a patient develops symptoms associated with low blood pressure after starting Qsymia, appropriate changes should be made to the antihypertensive drug regimen.
The concomitant use of alcohol or central nervous system CNS depressant drugs e. Therefore, avoid concomitant use of alcohol with Qsymia. Abrupt withdrawal of topiramate, a component of Qsymia, has been associated with seizures in individuals without a history of seizures or epilepsy. In situations where immediate termination of Qsymia is medically required, appropriate monitoring is recommended. Phentermine and topiramate, the components of Qsymia, are cleared by renal excretion.
Adjust dose of Qsymia for both patient populations. Qsymia has not been studied in patients with end-stage renal disease on dialysis. In patients with mild Child-Pugh score 5 -6 or moderate Child-Pugh score 7 -9 hepatic impairment, exposure to phentermine was higher compared to healthy volunteers. Adjust dose of Qsymia for patients with moderate hepatic impairment. Qsymia has not been studied in patients with severe hepatic impairment Child-Pugh score 10 Use of Qsymia has been associated with kidney stone formation.
Topiramate, a component of Qsymia, inhibits carbonic anhydrase activity and promotes kidney stone formation by reducing urinary citrate excretion and increasing urine pH. Avoid the use of Qsymia with other drugs that inhibit carbonic anhydrase e. Use of topiramate by patients on a ketogenic diet may also result in a physiological environment that increases the likelihood of kidney stone formation. Oligohidrosis decreased sweating , infrequently resulting in hospitalization, has been reported in association with the use of topiramate, a component of Qsymia.
Decreased sweating and an elevation in body temperature above normal characterized these cases. Some of the cases have been reported with topiramate after exposure to elevated environmental temperatures. Patients treated with Qsymia should be advised to monitor for decreased sweating and increased body temperature during physical activity, especially in hot weather. Caution should be used when Qsymia is prescribed with other drugs that predispose patients to heat-related disorders; these drugs include, but are not limited to, other carbonic anhydrase inhibitors and drugs with anticholinergic activity.
Qsymia can increase the risk of hypokalemia through its inhibition of carbonic anhydrase activity. In addition, when Qsymia is used in conjunction with non- potassium sparing diuretics such as furosemide loop diuretic or hydrochlorothiazide thiazide-like diuretic this may further potentiate potassium- wasting. Qsymia was associated with changes in several clinical laboratory analytes in randomized, double-blind, placebo-controlled studies.
Qsymia is indicated for chronic weight management in conjunction with a reduced- calorie diet and increased physical activity. Qsymia is only available through certified pharmacies that are enrolled in the Qsymia certified pharmacy network. Advise patients on how to access Qsymia through certified pharmacies. Additional information may be obtained via the website www.
Advise patients to tell healthcare provider s about all medications, nutritional supplements, and vitamins including any weight loss products that are being taken or may be taken while on Qsymia. If an increase in Qsymia dose is prescribed after medical evaluation, advise patients to increase the dose of Qsymia as follows:. Oligohidrosis decreased sweating has been reported in association with the use of topiramate, a component of Qsymia.
The following data are based on findings in studies performed individually with phentermine or topiramate, Qsymia's two active ingredients. Phentermine was not mutagenic or clastogenic with or without metabolic activation in the Ames bacterial mutagenicity assay, a chromosomal aberration test in Chinese hamster lung CHL-K1 cells, or an in vivo micronucleus assay. No animal studies have been conducted with phentermine to determine the potential for impairment of fertility.
Topiramate did not demonstrate genotoxic potential when tested in a battery of in vitro and in vivo assays. Topiramate was not mutagenic in the Ames test or the in vitro mouse lymphoma assay; it did not increase unscheduled DNA synthesis in rat hepatocytes in vitro; and it did not increase chromosomal aberrations in human lymphocytes in vitro or in rat bone marrow in vivo.
The relevance of this finding to human carcinogenic risk is uncertain. Qsymia is contraindicated in pregnant women. The use of Qsymia can cause fetal harm and weight loss offers no potential benefit to a pregnant woman. Available epidemiologic data indicate an increased risk in oral clefts cleft lip with or without cleft palate with first trimester exposure to topiramate, a component of Qsymia. When multiple species of pregnant animals received topiramate at clinically relevant doses, structural malformations, including craniofacial defects, and reduced fetal weights occurred in offspring.
If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, treatment should be discontinued immediately and the patient should be apprised of the potential hazard to a fetus. There is a Qsymia Pregnancy Surveillance Program to monitor maternal-fetal outcomes of pregnancies that occur during Qsymia therapy. Healthcare providers and patients are encouraged to report pregnancies by calling Oral clefts occur from the fifth through the ninth week of gestation.
The lip is formed between the beginning of the fifth week to the seventh week of gestation, and the palate is formed between the beginning of the sixth week through the ninth week of gestation. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.
Qsymia can cause metabolic acidosis. Data evaluating the risk of major congenital malformations and oral clefts with topiramate a component of Qsymia exposure during pregnancy is available from the North American Anti-Epileptic Drug NAAED Pregnancy Registry and from several larger retrospective epidemiologic studies. Larger retrospective epidemiology studies showed that topiramate monotherapy exposure in pregnancy is associated with an approximately two to five-fold increased risk of oral clefts Table 5.
Embryo-fetal development studies have been conducted in rats and rabbits with combination phentermine and topiramate treatment. Phentermine and topiramate co-administered to rats during the period of organogenesis caused reduced fetal body weights but did not cause fetal malformations at the maximum dose of 3. In a similar study in rabbits, no effects on embryo-fetal development were observed at approximately 0.
Significantly lower maternal body weight gain was recorded at these doses in rats and rabbits. A pre-and post-natal development study was conducted in rats with combination phentermine and topiramate treatment. There were no adverse maternal or offspring effects in rats treated throughout organogenesis and lactation with 1. Treatment with higher doses of Offspring effects included lower pup survival after birth, increased limb and tail malformations, reduced pup body weight and delayed growth, development, and sexual maturation without affecting learning, memory, or fertility and reproduction.
The limb and tail malformations were consistent with results of animal studies conducted with topiramate alone [see Nonclinical Toxicology ]. Animal reproduction studies have not been conducted with phentermine. Topiramate causes developmental toxicity, including teratogenicity, at clinically relevant doses [see Nonclinical Toxicology ]. The effect of Qsymia on labor and delivery in humans is unknown.
Qsymia may be present in human milk because topiramate and amphetamines phentermine has pharmacologic activity and a chemical structure similar to amphetamines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and effectiveness of Qsymia in pediatric patients below the age of 18 years have not been established and the use of Qsymia is not recommended in pediatric patients.
Serious adverse reactions seen in pediatric patients using topiramate, a component of Qsymia, include acute angle glaucoma, oligohidrosis and hyperthermia , metabolic acidosis, cognitive and neuropsychiatric reactions, hyperammonemia and encephalopathy , and kidney stones. Juvenile animal studies have not been conducted with Qsymia. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out.
Clinical studies of Qsymia did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Females who become pregnant during Qsymia therapy should stop Qsymia treatment immediately and notify their healthcare provider. Contraception Females of reproductive potential should use effective contraception during Qsymia therapy. Compared to healthy volunteers, patients with moderate and severe renal impairment as estimated by the Cockcroft-Gault equation had higher phentermine and topiramate exposures. No dose adjustments are necessary in patients with mild renal impairment. In patients with mild Child-Pugh 5 -6 and moderate Child-Pugh 7 -9 hepatic impairment, exposure to phentermine was higher compared to healthy volunteers.
Exposure to topiramate, a component of Qsymia, was similar among patients with mild and moderate hepatic impairment and healthy volunteers. No dose adjustments are necessary in patients with mild hepatic impairment. In patients with moderate hepatic impairment, the dose should not exceed Qsymia 7. In the event of a significant overdose with Qsymia, if the ingestion is recent, the stomach should be emptied immediately by gastric lavage or by induction of emesis.
Appropriate supportive treatment should be provided according to the patient's clinical signs and symptoms. Acute overdose of phentermine may be associated with restlessness, tremor , hyperreflexia, rapid respiration , confusion, aggressiveness, hallucinations, and panic states. Fatigue and depression usually follow the central stimulation.
Cardiovascular effects include arrhythmia , hypertension or hypotension , and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning usually terminates in convulsions and coma. Manifestations of chronic intoxication with anorectic drugs include severe dermatoses, marked insomnia, irritability, hyperactivity , and personality changes. A severe manifestation of chronic intoxication is psychosis , often clinically indistinguishable from schizophrenia.
Management of acute phentermine intoxication is largely symptomatic and includes lavage and sedation with a barbiturate. Acidification of the urine increases phentermine excretion. Intravenous phentolamine has been suggested for possible acute, severe hypertension, if this complicates phentermine overdosage. Topiramate overdose has resulted in severe metabolic acidosis. Other signs and symptoms include convulsions, drowsiness, speech disturbance, blurred vision, diplopia , mentation impaired, lethargy , abnormal coordination, stupor, hypotension, abdominal pain, agitation, dizziness, and depression.
The clinical consequences were not severe in most cases, but deaths have been reported after poly- drug overdoses involving gram amounts of topiramate. A patient who ingested a dose between 96 and grams topiramate was admitted to hospital with coma lasting 20 to 24 hours followed by full recovery after 3 to 4 days. Activated charcoal has been shown to adsorb topiramate in vitro. Hemodialysis is an effective means of removing topiramate from the body. The exact mechanism of action is not known.
The precise mechanism of action of topiramate on chronic weight management is not known. Typical actions of amphetamines include central nervous system stimulation and elevation of blood pressure. Tachyphylaxis and tolerance have been demonstrated with all drugs of this class in which these phenomena have been looked for. A total of 54 healthy subjects were administered Qsymia 7.
Phentermine pharmacokinetics is approximately dose-proportional from Qsymia 3. Topiramate pharmacokinetics is approximately dose-proportional from Qsymia 3. The fraction bound decreased as blood topiramate increased. Phentermine has two metabolic pathways, namely p-hydroxylation on the aromatic ring and N-oxidation on the aliphatic side chain. The mean phentermine terminal half-life is about 20 hours. Topiramate does not show extensive metabolism. The mean topiramate terminal half-life is about 65 hours.
Creatinine clearance was estimated from serum creatinine based on the Cockcroft-Gault equation. An inverse relationship between phentermine or topiramate Cmax or AUC and creatinine clearance was observed. Pharmacokinetics of topiramate was not affected in patients with mild and moderate hepatic impairment when compared with healthy volunteers. Phentermine is not a P- glycoprotein substrate. However, topiramate is a mild inhibitor of CYP2C Topiramate is a mild inducer of CYP3A4.
Topiramate is not a P-glycoprotein substrate. Potential interactions between topiramate and standard antiepileptic AED drugs were assessed in controlled clinical pharmacokinetic studies in patients with epilepsy. The effects of these interactions on mean plasma AUCs are summarized in Table 8. In Table 8, the second column AED concentration describes what happens to the concentration of the AED listed in the first column when topiramate is added. The third column topiramate concentration describes how the co-administration of a drug listed in the first column modifies the concentration of topiramate in experimental settings when topiramate was given alone.
The clinical relevance of this observation has not been established. A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of hydrochlorothiazide HCTZ 25 mg q24h and topiramate 96 mg q12h when administered alone and concomitantly. The clinical significance of this change is unknown.
The steady-state pharmacokinetics of HCTZ were not significantly influenced by the concomitant administration of topiramate. Clinical laboratory results indicated decreases in serum potassium after topiramate or HCTZ administration, which were greater when HCTZ and topiramate were administered in combination. A drug-drug interaction study conducted in healthy volunteers evaluated the steady-state pharmacokinetics of topiramate and pioglitazone when administered alone and concomitantly.
This finding was not statistically significant. The clinical significance of these findings is not known. When topiramate is added to pioglitazone therapy or pioglitazone is added to topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state. The steady-state pharmacokinetics of topiramate were unaffected by concomitant administration of glyburide. Lithium levels should be monitored when co-administered with high-dose topiramate.
The pharmacokinetics of a single dose of haloperidol 5 mg were not affected following multiple dosing of topiramate mg every 12 hours in 13 healthy adults 6 males, 7 females. Some subjects may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made according to the patient's clinical response and not on the basis of plasma levels.
Multiple dosing of topiramate mg every 12 hrs in 24 healthy volunteers 14 males, 10 females did not affect the pharmacokinetics of single-dose sumatriptan either orally mg or subcutaneously 6 mg. No alterations of 9-hydroxyrisperidone levels were observed. There were no clinically significant changes in the systemic exposure of risperidone plus 9-hydroxyrisperidone or of topiramate; therefore, this interaction is not likely to be of clinical significance. Multiple dosing of venlafaxine mg extended release did not affect the pharmacokinetics of topiramate.
Topiramate, a component of Qsymia, causes developmental toxicity, including teratogenicity, in multiple animal species at clinically relevant doses. When female rats were treated during the latter part of gestation and throughout lactation 0. The effect of Qsymia on weight loss in conjunction with reduced caloric intake and increased physical activity was studied in 2 randomized, double-blind, placebo-controlled studies in obese patients Study 1 and in obese and overweight patients with two or more significant co-morbidities Study 2.
Both studies had a 4-week titration period, followed by 52 weeks of treatment. There were 2 co-primary efficacy outcomes measured after 1 year of treatment Week Patients with type 2 diabetes were excluded from participating in Study 1. The average weight and BMI of patients at the start of the study was kg and Table 9 provides the results for the weight loss at 1 year in Studies 1 and 2.
After 1 year of treatment with Qsymia, all dose levels resulted in statistically significant weight loss compared to placebo Table 9, Figures 1 and 2. Type 1 error was controlled across all pairwise treatment comparisons. Study 2 Percent Weight Change. The changes in cardiovascular , metabolic, and anthropometric risk factors associated with obesity from Study 1 and 2 are presented in Table 10 and LS Mean Qsymia 3. LS Mean Qsymia 7. Among the subjects with type 2 diabetes treated in study 2, reductions in HbA1c from baseline 6.
Read this Medication Guide before you start taking Qsymia and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Qsymia, talk to your healthcare provider or pharmacist. If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Healthcare providers and patients should report all cases of pregnancy to:.
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: These problems can lead to permanent vision loss if not treated. Tell your healthcare provider right away if you have any new eye symptoms. Qsymia is a prescription medicine that contains phentermine and topiramate extended-release that may help some obese adults or some overweight adults who also have weight-related medical problems lose weight and keep the weight off.
Qsymia should be used with a reduced calorie diet and increased physical activity. It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke. It is not known if Qsymia is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. Qsymia is a federally controlled substance CIV because it contains phentermine and can be abused or lead to drug dependence.
Keep Qsymia in a safe place, to protect it from theft. Never give your Qsymia to anyone else, because it may cause death or harm them. Selling or giving away this medicine is against the law. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Qsymia taken with other medicines may affect how each medicine works and may cause side effects. Know the medicines you take.
Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking to your healthcare provider. Your healthcare provider should tell you to stop taking Qsymia if you have not lost a certain amount of weight after an additional 12 weeks of treatment on the higher dose. Do not stop taking Qsymia without talking to your healthcare provider. Stopping Qsymia suddenly can cause serious problems, such as seizures.
Your healthcare provider will tell you how to stop taking Qsymia slowly. Figure A,B,C and D. If you take too much Qsymia, call your healthcare provider or go to the nearest emergency room right away.