Contrave new weight loss medication now available
The Food and Drug Administration today approved Contrave (naltrexone hydrochloride and bupropion hydrochloride extended-release tablets) as an adjunct treatment option for long term weight management in those suffering from Obesity, overweight and any of the 50 different medication problems related to obesity in addition to a reduced-calorie diet.
Statistics on Obesity
Obesity is common, serious and costly
- According to the CDC, more than one-third (34.9% or 78.6 million) of U.S. adults are obese. [See abstract Journal of American Medicine (JAMA)]
- Obesity-related conditions include heart disease, stroke, type 2 diabetes and certain types of cancer, some of the leading causes of preventable death. [Read guidelines]
- The estimated annual medical cost of obesity in the U.S. was $147 billion in 2008 U.S. dollars; the medical costs for people who are obese were $1,429 higher than those of normal weight. [Read summary]
[Read abstract Journal of American Medicine (JAMA)]
- Non-Hispanic blacks have the highest age-adjusted rates of obesity (47.8%) followed by Hispanics (42.5%), non-Hispanic whites (32.6%), and non-Hispanic Asians (10.8%)
- Obesity is higher among middle age adults, 40-59 years old (39.5%) than among younger adults, age 20-39 (30.3%) or adults over 60 or above (35.4%) adults.
- Among non-Hispanic black and Mexican-American men, those with higher incomes are more likely to have obesity than those with low income.
- Higher income women are less likely to have obesity than low-income women.
- There is no significant relationship between obesity and education among men. Among women, however, there is a trend—those with college degrees are less likely to have obesity compared with less educated women.
Indications For Contrave
Contrave is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related comorbidities.
What is BMI?
BMI, which measures body fat based on an individual’s weight and height, is used to define the obesity and overweight categories.
Interpretation of BMI for adults
For adults 20 years old and older, BMI is interpreted using standard weight status categories that are the same for all ages and for both men and women. For children and teens, on the other hand, the interpretation of BMI is both age- and sex-specific.
According to the Centers for Disease Control and Prevention, more than one-third of adults in the United States are obese.
“Obesity continues to be a major public health concern,with significant cost to the individual and the nation. In fact, one study estimated the annual cost of ignoring obesity at $4,879 and $2,646 for women and men respectively!
How can Contrave help with weight loss?
Contrave is a combination of two extended release formulations of two FDA-approved drugs, naltrexone and bupropion.
What is Naltrexone used for?
Naltrexone is approved to treat alcohol and opioid dependence.
What is Bupropion used for?
Bupropion is approved to treat depression and seasonal affective disorder and as an aid to smoking cessation treatment.
How come the combination helps with weight loss?
Like many of the newer weight loss drugs, combination of two or more medications that block certain pathways in the brain that control appetite have shown to have superior effect compared to one alone. The other new weight loss medication that was FDA approved in 2011, Qsymia was a combination of Phentermine and Topiramate.
How effective is contrave for weight loss?
The effectiveness of Contrave was evaluated in multiple studies that included approximately 4,500 obese and overweight patients with and without significant weight-related conditions treated for one year. In addition to the drug Contrave, all patients received lifestyle modification that consisted of a reduced- calorie diet and regular physical activity.
Results from a clinical trial that enrolled patients without diabetes showed that patients had an average weight loss of 4.1 percent over treatment with placebo at one year. In this trial, 42 percent of patients treated with Contrave lost at least 5 percent of their body weight compared with 17 percent of patients treated with placebo. Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 2 percent over treatment with placebo at one year. In this trial, 36 percent of patients treated with Contrave lost at least 5 percent of their body weight compared with 18 percent of patients treated with placebo.
Assess in 12 weeks
Patients using Contrave at the maintenance dose should be evaluated after 12 weeks to determine if the treatment is working. If a patient has not lost at least 5 percent of baseline body weight, Contrave should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Because it contains bupropion, Contrave has a boxed warning to alert health care professionals and patients to the increased risk of suicidal thoughts and behaviors associated with antidepressant drugs. The warning also notes that serious neuropsychiatric events have been reported in patients taking bupropion for smoking cessation.
Contrave can cause seizures and must not be used in patients who have seizure disorders. The risk of seizure is dose-related. Contrave should be discontinued and not restarted in patients who experience a seizure while being treated with Contrave.
Contrave can also raise blood pressure and heart rate and must not be used in patients with uncontrolled high blood pressure. The clinical significance of the increases in blood pressure and heart rate observed with Contrave treatment is unclear, especially for patients with heart-related and cerebrovascular (blood vessel dysfunction impacting the brain) disease, since patients with a history of heart attack or stroke in the previous six months, life-threatening arrhythmias, or congestive heart failure were excluded from the clinical trials. Blood pressure and pulse should be measured prior to starting the drug and should be monitored at regular intervals, particularly among patients with controlled high blood pressure prior to treatment.
Other products containing bupropion should not be taken along with Contrave. The drug should not be used in patients who have eating disorders (bulimia or anorexia nervosa). Contrave should also not be taken by patients who are using opioids or treatments for opioid dependence, or who are experiencing acute opiate withdrawal. Patients undergoing an abrupt discontinuation of alcohol, benzodiazepines, barbiturates and antiepileptic drugs should not take Contrave. Women who are pregnant or trying to become pregnant should not take Contrave.
Comparison of Contrave with Phentermine and Topiramate
In studies, the combination of Phentermine and Topiramate was a bit superior to Contrave with 9% weight loss in those taking Phentermine and Topiramate (Qsymia) to that of 5% weight loss seen in patients taking Contrave. However, Contrave might be a bit easier to tolerate and might be more appropriate in certain sections of the population. Belviq(Lorcaserin), on the hand, helped lose 3% of weight in the same time period.
Side effects of Contrave
The most common adverse reactions reported with Contrave include nausea, constipation, headache, vomiting, dizziness, insomnia, dry mouth, and diarrhea.
Contrave is distributed by Takeda Pharmaceuticals America Inc. of Deerfield, Illinois for Orexigen Therapeutics, Inc. of La Jolla, California.
Doctors that offer Contrave for eligible patients
W8MD Medical Weight Loss Centers of America is one of the first to offer Contrave to eligible patients in all of its offices.
Philadelphia Insurance Weight Loss & Sleep Center: 1718, Welsh Rd, Philadelphia, PA, 19115 Ph: 1-215-676-2334
King Of Prussia Weight Loss & Sleep Center: 987 Old Eagle School Rd, Ste 712, Wayne, PA, 19087 Ph: 215-676-2334
NYC Insurance Weight Loss & Sleep Center: 2003, Bath Avenue, Brooklyn, NY, 11214 Ph: 1-718-946-5500.
W8MD weight loss program in New Jersey.
W8MD weight loss program at Vida Sleep Center of Dr. Felix Roque’s office at 543, 45th Street, Union City, New Jersey. 543 45th St, Union City, NJ 07087. Phone: (201) 766-6469
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Posted on October 30, 2014, in Weight Loss Articles and tagged Bupriopion Naltrexone, Contrave, contrave availability, contrave cost, contrave doctors, new weight loss drug, Weight Loss Articles. Bookmark the permalink. Leave a comment.