For patients with a body mass index (BMI)* of 30+† or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition.

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Study: CONQUER clinical trial

Overweight and obese 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) 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 endpoints1

  • 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

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Secondary metabolic parameters1

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

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Study Design1

  • Qsymia was specifically studied in overweight patients 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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Home Delivery Pharmacy

Doses include 6-week New Patient Packs, 6-week Titration Packs and all 30-day prescriptions. For cash patients only. Insurance claims will not be processed. Additional shipping and handling costs will apply. Limit of one New Patient Pack and one Titration Pack per patient for the duration of the program.

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 medical condition such as high blood pressure, type 2 diabetes, or high cholesterol

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
  • It is not known if Qsymia is safe and effective in children under 18 years old

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, include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.

Qsymia can cause fetal harm. 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). Females of reproductive potential should have a negative pregnancy test before treatment and monthly thereafter and use effective contraception consistently during Qsymia therapy. If a patient becomes pregnant while taking Qsymia, treatment should be discontinued immediately, and the patient should be informed of the potential hazard to the fetus.

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.

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.

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, Inc. 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 Females of Reproductive Potential for Qsymia.

*BMI (body mass index) measures the amount of fat in the body based on height and weight. BMI is measured in kg/m2.
Or a BMI of 27 or more with one weight-related medical condition.

Site References: 1. Qsymia Full Prescribing Information. Campbell, CA: VIVUS, Inc; 2018. 2. Data on file. VIVUS, Inc. 3. Contrave [package insert]. La Jolla, CA: Orexigen Therapeutics, Inc; 2014. 4. Saxenda [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2015. 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.

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.

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