Sometimes diet and exercise are not enough to help the 100 million Americans with obesity lose weight and prevent health conditions, including heart disease.
That’s why doctors are encouraging adults and adolescents with obesity to consider taking prescription medicine in combination with making lifestyle changes, including a reduced-calorie diet and more physical activity.
Maria knows the struggle to lose weight. “I have tried all types of diets through my adult life, workouts, everything known to man,” she said. “I eat very healthy and always have.”
It wasn’t until her doctor prescribed a weight loss drug, Qsymia®, that she was able to lose 60 pounds. She’s been taking the oral, non-injectable medicine for 22 months and has kept the weight off. She says she hasn’t experienced side effects.
“This is the only thing I have been able to maintain weight loss on,” she said, explaining she’s “satisfied and happy” with her weight loss. “My blood work has been excellent, and I look and feel great.”
To learn more, visit QSYMIA.com
Obesity
The CDC reports 2 in 5 adults are obese, which means they have a body mass index (BMI) of 30 or higher. The chronic disease costs $173B a year in added medical expenses.[1]
Dr. Pamela R. Rama
Cardiologist, Baptist Heart Specialists (Jacksonville Beach, Florida); Consultant, Vivus LLC
“Obesity is a chronic inflammatory state,” said Vivus LLC consultant Dr. Pamela R. Rama, a cardiologist at Baptist Heart Specialists in Jacksonville Beach, Florida.
People with obesity are at greater risk for health challenges like coronary artery disease, which is a buildup of plaque in the arteries, as well as diabetes, high blood pressure, cancer, stroke, and more.[2]
Obesity is also a health challenge for young Americans. The CDC says 22% of youth ages 12-19 are obese.[3] Experts predict that 80% of obese adolescents will continue to be obese in adulthood.[4]
Dr. Suzanne Cuda
Pediatric Obesity Specialist (San Antonio, Texas); Consultant, Vivus LLC
“Seek evaluation for the child as early as you think you see an issue,” said Dr. Suzanne Cuda, a pediatric obesity specialist in San Antonio. “Really be proactive for your child, because this is a disease.”
Dr. Cuda, a consultant for Vivus LLC, says managing chronic weight loss can help youth in all aspects of their lives, including improving their self-esteem. It may also help reduce their risk of chronic metabolic diseases like diabetes and heart disease.
Lifestyle changes and weight loss drugs
Losing weight can lower a person with obesity’s risk of heart disease and other chronic conditions. Typically, the first treatment for people with obesity is reducing caloric intake and increasing activity. But if that doesn’t work or doesn’t work well enough, doctors can prescribe weight loss drugs to their patients. Combining medicine with lifestyle changes can be an effective and sustainable approach to weight loss and chronic weight management.
Qsymia phentermine and topiramate extended-release capsules, manufactured by Vivus LLC, have been FDA-approved for over a decade for use in patients with obesity who have a BMI of 27 or higher and have at least one weight-related medical condition, such as high blood pressure.
Qsymia, pronounced Kyoo-sim-ee-uh, is informally known as obesity medicine experts’ best-kept weight loss secret. Studies support the non-injection weight loss drug’s efficacy. A two-year study found adults receiving the top dose lost 10.5% of their body weight, while those receiving the mid-dose lost 9.3%, compared to the placebo group, which lost 1.8%.[5] Another study shows it reduced systolic blood pressure, a cardiovascular disease risk factor, in patients who were overweight or obese.[6]
Since 2022, Qsymia has been FDA-approved for treating obesity in adolescents ages 12-17 who have a (BMI) in the 95th percentile or greater.
A study published in the New England Journal of Medicine reported that in a 56-week, randomized, double-blind trial, adolescents with obesity who received mid and top doses of Qsymia had a statistically significant reduction in BMI and improved cholesterol levels.[7]
“The great majority of kids do great; they tolerate the medications,” Dr. Cuda said. “Their families are good about modifying the diet and helping to increase activity.”
Effectiveness
In comparison to high profile weight-loss drugs, like Semaglutide and other GLP-1 medications, Qsymia stands out in both affordability and effectiveness. In a report in The Institute for Clinical and Economic Review (ICER), Qsymia has the lowest annual net price of $1,465, a big savings compared to the price of semaglutide, which has an annual net price of $13,618.[8]
It’s also one of the most effective weight-loss medications. The same report found “greater weight loss was seen with semaglutide and with phentermine/topiramate” than other weight-loss drugs.
Patient perspectives
Patients who’ve taken Qsymia praise the pill for helping them control their weight. For example, Michele, who gained 40 pounds during menopause, says she couldn’t lose weight even though she was eating healthy. “I’ve already lost 35 pounds since being on it,” she said, calling the weight loss medicine “wonderful.”
Other patients say the drug helps them manage their weight while they’re also managing chronic health conditions. Pamela, who has athyroid condition, has been taking Qsymia for a year and has lost 20 pounds. “I finally feel better and in control of my weight.”
Another patient, Stephanie, has struggled with her weight for most of her life, especially after she was diagnosed with an autoimmune disease. She’s been taking Qsymia on and off for four years and credits it with helping her manage her cravings. “I wasn’t always hungry, and lost weight and maintained it,” she said. “This journey is not as easy as some people think. It’s a battle each and every day.”
Promising therapies
With obesity on the rise — researchers project that nearly half of all Americans will have obesity by 2030 — it’s more important than ever to have effective treatments.[9]
“It looks like there’s a light at the end of the tunnel that we’re finally being able to treat these patients and reverse this disease,” said Dr. Rama, who has been treating patients with obesity for over 20 years.
To learn more, visit QSYMIA.com
What is Qsymia?
QSYMIA is a combination of phentermine, a sympathomimetic amine anorectic, and topiramate, indicated as an adjunct to 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 BMI in the 95th percentile or greater standardized for age and sex.
Limitations of Use:
- The effect of QSYMIA on cardiovascular morbidity and mortality has not been established
- The safety and effectiveness of QSYMIA in combination with other products intended for weight loss, including prescription and over-the-counter drugs, and herbal preparations, have not been established
IMPORTANT SAFETY INFORMATION
Qsymia can cause serious side effects, including:
• Birth defects (cleft lip/cleft palate). Patients who are pregnant must not take Qsymia. If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away.
• Qsymia may slow the increase in height in children 12 years and older, when used for a long time.
• Increases in heart rate.
• Suicidal thoughts or actions. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity and talking (mania); other unusual changes in behavior or mood.
• Serious eye problems, which include any sudden decrease in vision, with or without eye pain and redness, or a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These problems can lead to permanent vision loss if not treated.
Do not get pregnant while taking Qsymia. Do not drink alcohol while taking Qsymia. Do not drive a car or operate heavy machinery, or do other dangerous activities until you know how Qsymia affects you.
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 as it may cause death or harm them.
QSYMIA may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson Syndrome). Qsymia may also cause a rash with blisters and peeling skin over much of the body that may be life-threatening (Toxic Epidermal Necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.
Common side effects of Qsymia in adults include numbness or tingling in the hands, arms, feet, or face (paraesthesia); dizziness; change in the way foods taste or loss of taste (dysgeusia); trouble sleeping (insomnia); constipation; and dry mouth. Common side effects in pediatric patients aged 12 years and older include depression, dizziness, joint pain, fever, flu, and ankle sprain.
These are not all of the possible side effects of Qsymia.
Call your doctor for medical advice about side effects. You may report side effects to VIVUS at 1-888-998-4887 or FDA at 1-800-FDA-1088.
References
[1] “Adult Obesity Facts.” Centers for Disease Control and Prevention, www.cdc.gov/obesity/php/data-research/adult-obesity-facts.html.
[2] “About Coronary Artery Disease (CAD).” Centers for Disease Control and Prevention, https://www.cdc.gov/heart-disease/about/coronary-artery-disease.html.
[3] “Childhood Obesity Facts.” Centers for Disease Control and Prevention, https://www.cdc.gov/obesity/php/data-research/childhood-obesity-facts.html.
[4] Simmonds M, Llewellyn A, Owen CG, Woolacott N. “Predicting adult obesity from childhood obesity: a systematic review and meta-analysis.” Obes, https://pubmed.ncbi.nlm.nih.gov/26696565/.
[5] Garvey WT, Ryan DH, Look M, Gadde KM, Allison DB, Peterson CA, Schwiers M, Day WW, Bowden CH. “Two-year sustained weight loss and metabolic benefits with controlled-release phentermine/topiramate in obese and overweight adults (SEQUEL): a randomized, placebo-controlled, phase 3 extension study” Am J Clin Nutr, https://pubmed.ncbi.nlm.nih.gov/22158731/.
[6] Bays HE, Hsia DS, Nguyen LT, Peterson CA, Varghese ST. “Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study.” Obesity Pillars, https://doi.org/10.1016/j.obpill.2024.100099.
[7] Kelly AS, Bensignor MO, Hsia DS, Shoemaker AH, Shih W, Peterson C, Varghese ST. “Phentermine/Topiramate for the Treatment of Adolescent Obesity.” NEJM, https://evidence.nejm.org/doi/10.1056/EVIDoa2200014.
[8] “Report at a Glance: Obesity Management.” Institute for Clinical and Economic Review, https://icer.org/wp-content/uploads/2022/10/Obesity-RAAG_October-2022.pdf.
[9] Ward ZJ, Bleich SN, Cradock AL, Barrett JL, Giles CM, Flax C, Long MW, Gortmaker SL. “Projected U.S. State-Level Prevalence of Adult Obesity and Severe Obesity.” NEJM, https://www.nejm.org/doi/full/10.1056/NEJMsa1909301.
Disclosure Statements
Drs. Rama and Cuda are Vivus LLC consultants.
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