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阿伐那非片(Stendra,AVANAFIL ,zepeed)(二)
besity finally have another important tool to help address their weight and related co-morbidities," added Joe Nadglowski, Obesity Action Coalition President and CEO.
Obesity and Losing Weight
Many factors contribute to excess weight gain. These include environmental factors, genetics, health conditions or certain medications, emotional factors and other behaviors.
All this contributes to more than 110 million Americans being obese or overweight with at least one weight-related comorbidity. Excess weight increases the risk of conditions including type 2 diabetes, high cholesterol, high blood pressure, heart disease, sleep apnea, stroke and osteoarthritis.
According to the National Institutes of Health (NIH), losing just 10% of body weight may help obese patients reduce the risk of developing other medical conditions, while making a meaningful difference in health and well-being.
About Qsymia
The safety and efficacy of Qsymia were eva luated in two multicenter, phase 3 trials that included more than 3,700 patients: severely obese patients (the EQUIP study) and overweight or obese patients with at least two weight-related comorbidities, such as hypertension, hypertriglyceridemia, type 2 diabetes or central adiposity (the CONQUER study). The average weight loss in EQUIP was 10.9% on Qsymia 15 mg/92 mg and 1.6% for placebo (ITT-LOCF, p<0.0001). The average weight loss in CONQUER was 9.8% on Qsymia 15 mg/92 mg, 7.8% on Qsymia 7.5 mg/46 mg and 1.2% for placebo (ITT-LOCF, p<0.0001).
The most common adverse reactions for patients treated with Qsymia included tingling sensation of hands and feet, dizziness, altered taste, insomnia, constipation and dry mouth.
The Qsymia REMS program is intended to inform prescribers and female patients of reproductive potential about the following: an increased risk of orofacial clefts in infants exposed to Qsymia during the first trimester of pregnancy; the importance of pregnancy prevention for females of reproductive potential receiving Qsymia; and the need to discontinue Qsymia immediately if pregnancy occurs.
For more information about Qsymia, go to www.Qsymia.com. For full prescribing information go to http://vivus.com/docs/QsymiaPI.pdf.
Important Safety Information
Qsymia™ (phentermine and topiramate extended-release) capsules CIV 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 to sympathomimetic amines, topiramate, or any of the inactive ingredients in Qsymia.
Qsymia can cause fetal harm. 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.
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.
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.
About STENDRA
STENDRA is a prescription medicine used to treat erectile dysfunction (ED). STENDRA ( |
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