Qsymia can help many of the patients you frequently see.1,2
Adult Study: CONQUER clinical trial
Overweight and obese adult patients with comorbidities achieved significant weight loss1
Review the study design and clinical data for the CONQUER clinical trial.
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QSYMIA (phentermine and topiramate extended-release capsules) CIV vs placebo for 1 year of treatment (P<0.0001)1,2†
- 2,487 overweight or obese patients (BMI 27 or greater and less than or equal to 45) 18 years and older with 2 or more weight-related comorbidities were evaluated1
- 66% of patients in the Qsymia groups completed the trial vs 57% in the placebo group2
- Most common reasons for discontinuation were withdrawal of consent (11.0%), loss to follow-up (10.2%), and adverse event (4.9%)2
Co-primary endpoints
- Overall percent weight loss from baseline, ITT-LOCF analysis†
- 9.8% weight loss achieved by patients who took the top dose (15 mg/92 mg) of Qsymia and 7.8% for patients who took the recommended dose (7.5 mg/46 mg), compared with 1.2% in the placebo group (P<0.0001)1
- 84% of patients responded to Qsymia who were randomized to the 7.5 mg/46 mg cohort. Responders were defined as patients who achieved at least 3% weight loss at 12 weeks1,2
- Within 8 weeks, patients achieved at least 5% weight loss, on average; these patients were randomized to Qsymia 7.5 mg/46 mg or 15 mg/92 mg1
- Patients achieving at least 5% weight loss at end of study
- 70% of patients who took the top dose (15 mg/92 mg) and 62% who took the recommended dose (7.5 mg/46 mg) achieved 5% or greater weight loss after 1 year vs 21% of those who took placebo (P<0.0001)1
- 10% or greater weight loss was achieved by 48% and 37% of patients in the Qsymia groups vs 7% in the placebo group (P<0.0001)1
- Patients randomized to Qsymia 7.5 mg/46 mg or 15 mg/92 mg achieved, on average, at least 5% weight loss within 8 weeks1,2
Secondary metabolic parameters
STUDY—CONQUER: Treatment difference‡ from placebo in risk factors following 1 year of treatment1
| PLACEBO: LS MEAN | |||||
|---|---|---|---|---|---|
| CONQUER (OVERWEIGHT AND OBESE WITH COMORBIDITIES) | PLACEBO (N=979) | QSYMIA 7.5 mg/46 mg (N=488) | QSYMIA 15 mg/92 mg (N=981) | QSYMIA 7.5 mg/46 mg | QSYMIA 15 mg/92 mg |
| HEART RATE, BPM | |||||
| BASELINE MEAN (SD) | 72.1 (9.9) | 72.2 (10.1) | 72.6 (10.1) | +0.6 | +1.7 |
| LS MEAN CHANGE (SE) | -0.3 (0.3) | +0.3 (0.4) | +1.4 (0.3) | ||
| SYSTOLIC BLOOD PRESSURE, mmHg | |||||
| BASELINE MEAN (SD) | 128.9 (13.5) | 128.5 (13.6) | 127.9 (13.4) | -2.3 | -3.2 |
| LS MEAN CHANGE (SE) | -2.4 (0.48) | -4.7 (0.63) | -5.6 (0.5) | ||
| DIASTOLIC BLOOD PRESSURE, mmHg | |||||
| BASELINE MEAN (SD) | 81.1 (9.2) | 80.6 (8.7) | 80.2 (9.1) | -0.7 | -1.1 |
| LS MEAN CHANGE (SE) | -2.7 (0.3) | -3.4 (0.4) | -3.8 (0.3) | ||
| TOTAL CHOLESTEROL, % | |||||
| BASELINE MEAN (SD) | 205.8 (41.7) | 201.0 (37.9) | 205.4 (40.4) | -1.6 | -3.0 |
| LS MEAN CHANGE (SE) | -3.3 (0.5) | -4.9 (0.7) | -6.3 (0.5) | ||
| LDL-CHOLESTEROL, % | |||||
| BASELINE MEAN (SD) | 124.2 (36.2) | 120.3 (33.7) | 123.9 (35.6) | +0.4 | -2.8 |
| LS MEAN CHANGE (SE) | -4.1 (0.9) | -3.7 (1.1) | -6.9 (0.9) | ||
| HDL-CHOLESTEROL, % | |||||
| BASELINE MEAN (SD) | 48.9 (13.8) | 48.5 (12.8) | 49.1 (13.8) | +4.0 | +5.6 |
| LS MEAN CHANGE (SE) | +1.2 (0.7) | +5.2 (0.9) | +6.8 (0.7) | ||
| TRIGLYCERIDES, % | |||||
| BASELINE MEAN (SD) | 163.5 (76.3) | 161.1 (72.2) | 161.9 (73.4) | -13.3 | -15.3 |
| LS MEAN CHANGE (SE) | +4.7 (1.7) | -8.6 (2.2) | -10.6 (1.7) | ||
| FASTING INSULIN, QIU/mL | |||||
| BASELINE MEAN (SD) | 17.8 (13.2) | 18.0 (12.9) | 18.4 (17.5) | -4.2 | -4.7 |
| LS MEAN CHANGE (SE) | +0.7 (0.8) | -3.5 (1.1) | -4.0 (0.8) | ||
| FASTING GLUCOSE, mg/dL | |||||
| BASELINE MEAN (SD) | 106.6 (23.7) | 106.2 (21.0) | 105.7 (21.4) | -2.4 | -3.6 |
| LS MEAN CHANGE (SE) | +2.3 (0.6) | -0.1 (0.8) | -1.3 (0.6) | ||
| WAIST CIRCUMFERENCE, cm | |||||
| BASELINE MEAN (SD) | 113.4 (12.2) | 112.7 (12.4) | 113.2 (12.2) | -5.2‡ | -6.8‡ |
| LS MEAN CHANGE (SE) | -2.4 (0.3) | -7.6 (0.4) | -9.2 (0.3) | ||
SD=standard deviation; SE=standard error. Least-squares (LS) mean. Study 1 adjusted for baseline body weight and diabetic status.
‡Statistically significant versus placebo based on the pre-specified method for controlling Type I error across multiple doses.
- The effect of Qsymia (phentermine and topiramate extended-release) capsules CIV on cardiovascular morbidity and mortality has not been established1
- Among the 388 subjects with type 2 diabetes treated in study 2, reductions in HbA1c from baseline (6.8%) were 0.1% for placebo compared to 0.4% and 0.4% with Qsymia 7.5 mg/46 mg and Qsymia 15 mg/92 mg, respectively1
- Among the 388 subjects with type 2 diabetes treated in study 2, reductions in HbA1c from baseline (6.8%) were 0.1% for placebo compared to 0.4% and 0.4% with Qsymia 7.5 mg/46 mg and Qsymia 15 mg/92 mg, respectively1
- Qsymia patients with Type 2 diabetes achieved an average HbA1c level below AACE- recommend HbA1c levels of 6.5%1,10
- Qsymia is not indicated for the treatment of hypertension, type 2 diabetes mellitus, stroke, or heart disease
Study Design1
- Qsymia was specifically studied in overweight patients 18 years and older with comorbidities including:
- Hypertension: Elevated blood pressure (greater than or equal to 140/90 mmHg, or greater than or equal to 130/85 mmHg for diabetics) or requirement for greater than or equal to 2 antihypertensive medications
- High cholesterol: Triglycerides greater than 200-400 mg/dL or were receiving treatment with 2 or more lipid- lowering agents
- Diabetes: Elevated fasting blood glucose (greater than 100 mg/dL) or diabetes
- Waist circumference: 102 cm or greater in men, 88 cm or greater in women
- At the beginning of the study, the average weight and BMI of patients was 227 pounds and 36.6 kg/m2, respectively
- For all patients, a well-balanced, reduced-calorie diet (decrease of 500 kcal/day) was recommended, and nutritional and lifestyle modification counseling was also offered
†Intent-to-treat, last observation carried forward
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Additional resources for Healthcare Professionals
Choose once-daily Qsymia as first-line for obesity treatment — explore the following:
*Retail and Home Delivery Pharmacy - $75 is the average retail pharmacy price for a 30-day Rx for patients covered by commercial insurance after covering $70 copay. $134 is the average price for patients paying cash or if Qsymia is not covered by commercial insurance. Source: McKesson Specialty Health, calculated between Jan-Sep 2023. Pharmacy fees may vary by location. Patients with commercial insurance coverage are eligible to receive $65 off 3.75 mg/23 mg dose quantities of 14-15 days and all other doses with quantities of 28-30 days. Patients paying cash or if Qsymia is not covered by commercial insurance, can receive $70 off 3.75 mg/23 mg dose quantities of 14-15 days and $75 off all other doses with quantities of 28-30 days. Please note that quantity claims of 16-27 days are not eligible for the Qsymia Savings Card. See full terms and conditions. $98 home delivery pharmacy pricing includes 6-week New Patient Packs, 6-week Titration Packs and all 30-day prescriptions. Additional shipping and handling costs will apply. This is a cash only program - insurance claims will not be processed. Please see QsymiaEngage.com for full program details.
**IQVIA Reporting - July 2023
Indication
Qsymia should be used together with a reduced-calorie diet and increased physical activity for chronic weight management in:
- Adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia
- Pediatric patients aged 12 years and older with an initial BMI in the 95th percentile or greater standardized for age and sex
LIMITATIONS OF USE:
- 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
Important Safety Information
Qsymia is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity or idiosyncrasy to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
The most commonly observed side effects in controlled clinical studies, 5% or greater and at least 1.5 times placebo, in adults include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth. Common side effects in pediatric patients aged 12 years and older at ≥4% and greater than placebo include depression, dizziness, arthralgia, pyrexia, influenza, and ligament sprain.
Qsymia can cause fetal harm. Data from a pregnancy registry and epidemiologic studies indicate that a fetus exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate). Pregnancy testing is recommended before initiating Qsymia treatment in patients who can become pregnant and monthly during Qsymia therapy. Advise patients who can become pregnant of the potential risk to a fetus and to use effective contraception during Qsymia therapy.
Qsymia is associated with a reduction in height velocity (centimeters of height gained per year) in obese pediatric patients 12 to 17 years of age. Monitor height velocity in pediatric patients treated with Qsymia. Consider dosage reduction or discontinuation of Qsymia if pediatric patients are not growing or gaining height as expected.
Qsymia can cause an increase in resting heart rate. Regular measurement of resting heart rate is recommended for all patients taking Qsymia, especially patients with cardiac or cerebrovascular disease or when initiating or increasing the dose of Qsymia. Qsymia has not been studied in patients with recent or unstable cardiac or cerebrovascular disease and therefore use is not recommended. Patients should inform healthcare providers of palpitations or feelings of a racing heartbeat while at rest during Qsymia treatment. For patients who experience a sustained increase in resting heart rate while taking Qsymia, the dose should be reduced or Qsymia discontinued.
Topiramate, a component of Qsymia, increases the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Patients should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior. Discontinue Qsymia in patients who experience suicidal thoughts or behaviors. Qsymia is not recommended in patients with a history of suicidal attempts or active suicidal ideation.
Acute angle closure glaucoma has been reported in patients treated with topiramate, a component of Qsymia. Symptoms include acute onset of decreased visual acuity and/or eye pain. 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. For clinically significant or persistent symptoms consider dose reduction or withdrawal of Qsymia.
Visual field defects (independent of elevated intraocular pressure) have been reported in clinical trials and in postmarketing experience in patients receiving topiramate. In clinical trials, most of these events were reversible after topiramate discontinuation. If visual problems occur at any time during treatment, consider discontinuing Qsymia.
Qsymia can cause cognitive dysfunction (e.g., impairment of concentration/attention, difficulty with memory, and speech or language problems, particularly word-finding difficulties). Since Qsymia has the potential to impair cognitive function, patients should be cautioned about operating hazardous machinery, including automobiles.
Hyperchloremic, non-anion gap, metabolic acidosis has been reported in patients treated with Qsymia. Measurement of electrolytes including serum bicarbonate prior to starting Qsymia and during Qsymia treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing Qsymia.
Qsymia can cause an increase in serum creatinine that reflects a decrease in renal function (glomerular filtration rate). In phase 3 trials, 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. The changes in serum creatinine (and measured GFR) with short-term Qsymia treatment appear reversible with treatment discontinuation, but the effect of chronic treatment on renal function is not known. Therefore, measurement of serum creatinine prior to starting Qsymia and during Qsymia treatment is recommended. If persistent elevations in creatinine occur while taking Qsymia, reduce the dose or discontinue Qsymia.
Serious skin reactions (Stevens-Johnson Syndrome [SJS] and Toxic Epidermal Necrolysis [TEN]) have been reported in patients receiving topiramate. Qsymia should be discontinued at the first sign of a rash, unless the rash is clearly not drug-related. If signs or symptoms suggest SJS/TEN, use of this drug should not be resumed and alternative therapy should be considered. Inform patients about the signs of serious skin reactions.
Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (e.g., sulfonylureas). 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. A reduction in the dose of antidiabetic medications which are non-glucose-dependent should be considered to mitigate the risk of hypoglycemia.
In hypertensive patients being treated with antihypertensive medications, weight loss may increase the risk of hypotension. 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.g., barbiturates, benzodiazepines, and sleep medications) with phentermine or topiramate may potentiate CNS depression or other centrally mediated effects of these agents. Therefore, avoid concomitant use of alcohol with Qsymia.
In situations where immediate termination of Qsymia is medically required, appropriate monitoring is recommended. Patients discontinuing Qsymia 15 mg/92 mg should be gradually tapered as recommended.
Adjust dose of Qsymia for patients with moderate or severe renal impairment. Qsymia has not been studied in patients with end-stage renal disease on dialysis. Avoid use of Qsymia in this patient population.
Adjust dose of Qsymia for patients with moderate hepatic impairment. Qsymia has not been studied in patients with severe hepatic impairment. Avoid use of Qsymia in this patient population.
Avoid the use of Qsymia with other drugs that inhibit carbonic anhydrase (e.g., zonisamide, acetazolamide or methazolamide). Use of topiramate by patients on a ketogenic diet may also result in a physiological environment that increases the likelihood of kidney stone formation. Increase fluid intake to increase urinary output which can decrease the concentration of substances involved in kidney stone formation.
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.
When prescribing Qsymia, patients should be monitored for hypokalemia. It is recommended that a blood chemistry profile is obtained at baseline and periodically during treatment.
Phentermine, a component of Qsymia, has known potential for abuse.
To report negative side effects, contact VIVUS LCC at 1-888-998-4887 or FDA at 1-800-FDA- 1088 or www.fda.gov/medwatch.
Please see the Important Safety Information, Full Prescribing Information, and Healthcare Provider Counseling Tool for Patients of Reproductive Potential for Qsymia.
Site References: 1. Qsymia Full Prescribing Information. Campbell, CA: VIVUS LLC; 2023. 2. Data on file. VIVUS LCC. 3. Contrave [package insert]. Brentwood, TN; CurraxTM Pharmaceuticals LLC; 2021. 4. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2022. 5. Hill AJ et al. Appetite. 1991;17(3):187-197. 6. Stubbs RJ et al. Physiol Behav. 2001;72(4):615-619. 7. Isaksson H et al. Food Nutr Res. 2008;52. 8. Pelchat ML. Appetite. 1997;28(2):103-113. 9. Hill AJ, Heaton-Brown L. J Psychosom Res.1994;38(8):801-814. 10. Garber, AJ, Abrahamson MJ, Barzilay Jl, et al. AACE comprehensive diabetes management algorithm 2013. Endocr Pract. 2013; 19(2):327-336. 11. Hampl SE, Hassink SG, Skinner AC, et al. Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity. Pediatrics. 2023;151(2):
Indication
Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management inadults with an initial body mass index (BMI)…
Important Safety Information
Qsymia is contraindicated in pregnancy; in patients with glaucoma; in hyperthyroidism; in patients receiving treatment or within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); or in patients with hypersensitivity or idiosyncrasy to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.