Qsymia (15 mg phentermine plus 92 mg topiramate) lost 8.9% more than with placebo

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Wednesday, July 18, 2012 3:40 pm Email this article

Subjects given the higher doses of Qsymia (15 mg phentermine plus 92 mg topiramate extended-release) lost 8.9% of their body weight more than those given a placebo.

Two studies lasting one-year with the drug

Two studies lasting one-year with a total of 3700 people

“The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials that included approximately 3,700 obese and overweight patients with and without significant weight-related conditions treated for one year,” notes the FDA press release.

“All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity.”

Reference

FDA. FDA approves weight-management drug Qsymia. July 17, 2012.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312468.htm

More Info

More info about Qsymia here

Drug companies website:

• Qsymia’s home page
• Information about Qsymia for patients
• About Qsymia
• Is This Qsymia Right for Me?
• FAQs about Qsymia
• report
• Qsymia full prescribing information
• Qsymia medication guide
• Qsymia home page for Health Care Providers
• Qsymia Indication and Usage for Health Care Providers
• Risk Evaluation and Mitigation Strategy about Qsymia
• Important Safety Information about Qsymia
• Qsymia (phentermine and topiramate extended-release) Healthcare Provider Training Program
• Risk of Birth Defects with Qsymia
• FDA-Required Risk Evaluation and Mitigation Strategy (REMS) required for Qsymia
• Qsymia Prescriber Dosing and Management Checklist
• Healthcare Provider Counseling Tool for Females of Reproductive Potential with the use of Qsymia

Other Articles

Other articles about Qsymia (formerly Qnexa)

• Qsymia side effects: Paresthesia (tingling in hands, feet, or face,) in 14% to 20% of patients
• Qsymia side effects: Dry Mouth in 14% to 19% of patients
• Qsymia side effects: Constipation in 15% to 16% of patients
• Qsymia side effects: Dizziness in 7% to 9% of patients
• Qsymia side effects: Altered taste or bad taste (dysgeusia) in 7% to 9% of patients
• Qsymia side effects: Cognitive disorders (problems with concentration, memory) in 7.6% of patients
• Qsymia side effects: Anxiety in 4% of patients
• Qsymia side effects: Depression in 4% of patients
• Qsymia side effects: Reduced sense of touch (hypoesthesia) in 4% of patients
• Qsymia side effects: Irritability in 3% to 4% of patients
• Qsymia side effects: Hair loss (alopecia) in 3% to 4% of patients
• Qsymia side effects: Disturbance in attention in 2% to 4% of patients
• Qsymia side effects: Low potassium levels (hypokalemia) in 2% to 3% of patients
• Qsymia (phentermine / topiramate) dosage and administration
• Qsymia (phentermine / topiramate) contraindications
• Qsymia (phentermine / topiramate) warnings and precautions
• Qsymia (phentermine / topiramate) drug interactions
• Qsymia (phentermine / topiramate), possibility of Suicidal Behavior and Ideation
• Qsymia (phentermine / topiramate), possibility of Myopia (nearsightedness) and Glaucoma
• Qsymia (phentermine / topiramate) can cause anxiety, depression and insomnia
• Qsymia (phentermine / topiramate) can cause Cognitive Impairment
• Qsymia (phentermine and topiramate) approved by US FDA on July 17, 2012
• Qsymia (phentermine and topiramate) should NOT be used during pregnancy
• Qsymia (7.5 mg phentermine plus 46 mg topiramate) lost 6.7% more than with placebo
• Qsymia (15 mg phentermine plus 92 mg topiramate) lost 8.9% more than with placebo
• Those who don’t lose at least 3% in 3 months with Qsymia (phentermine plus topiramate)
• Qsymia (phentermine plus topiramate) must not be used in patients with glaucoma
• Qsymia (phentermine plus topiramate) must not be used in patients with hyperthyroidism
• Qsymia (phentermine / topiramate) can increase heart rate; risk of heart attack and stroke not known
• Qsymia (phentermine/topiramate) most common side effects: tingling of hands and feet, dizziness, etc
• 3.75 mg of phentermine plus 23 mg of topiramate caused weight loss of 5.1% vs 1.6% with placebo
• 15 mg of phentermine plus 92 mg of topiramate caused weight loss of 10.9% vs 1.6% with placebo
• Most common side effects with phentermine plus topiramate: paresthesia, dry mouth, constipation
• Depression-related events more common in those given 15 mg phentermine + 92 mg Topamax: 7.3% vs 3.8%
• Anxiety-related events more common in those given 15 mg phentermine + 92 mg Topamax: 7.7% vs 2.8%
• Attention problems more common in those given 15 mg phentermine + 92 mg Topamax: 3.5% vs 0.7%
• Kidney stones 5 times more common in those given 15 mg of phentermine plus 92 mg of Topamax
• 7.5 mg of phentermine plus 46 mg of Topamax caused weight loss of 17.8 lbs vs 3.1 lbs with placebo
• 15 mg of phentermine plus 92 mg of Topamax caused weight loss of 22.4 lbs vs 3.1 lbs with placebo
• Most common side effects of phentermine plus Topamax were paraesthesia, dry mouth, constipation
• Qnexa (phentermine plus Topamax) causes woman to lose 55 lbs, man 73 lbs
• 2.1% to 2.6% of patients given Qnexa (phentermine + Topamax) dropped out due to cognitive effects
• High-dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes weight loss of 10.4% vs 1.8% w/placebo
• Mid-dose Qnexa: 7.5 mg Phentermine plus 46 mg Topamax causes weight loss of 8.4% vs 1.8% w/placebo
• High-dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes weight loss of 11% vs 1.6% w/placebo
• Low-dose Qnexa: 3.75 mg Phentermine plus 23 mg Topamax causes weight loss of 5.1% vs 1.6% w/placebo
• Qnexa (Phentermine/Topamax) side effects dry mouth, tingling, constipation, altered taste, insomnia
• Qnexa side effects (phentermine plus Topamax): 20% paresthesia, 18% dry mouth, 15% altered taste
• Low dose Qnexa: 7.5 mg Phentermine plus 46 mg Topamax causes weight loss of 8.5% vs 1.7% w/ placebo
• Full dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes weight loss of 9.2% vs 1.7% w/ placebo
• Low dose Qnexa: 7.5 mg Phentermine plus 46 mg Topamax causes 5% weight loss in 62% of people vs 15%
• Full dose Qnexa: 15 mg Phentermine plus 92 mg Topamax causes 5% weight loss in 66% of people vs 15%
• 43-year-old man loses 50 lbs in 4 months on phentermine plus Topamax (topiramate) - update
• 43-year-old man loses 44 lbs in 3 months on phentermine plus Topamax (topiramate)
• Qnexa: Phentermine-Topriamate drug combo causes half of patients to lose an average of 25 pounds

Articles on the same subject can be found here:

• Qsymia (phentermine and topiramate) (formerly Qnexa)