The FDA approved another new weight loss medication, Contrave which is a combination of Bupropion and Naltrexone in extended release formulation for the treatment of obesity and weight management, including for weight loss and maintenance of weight loss, used in conjunction with lifestyle modification. Obesity is a rapidly growing epidemic among adults, adolescents, and children in the United States.
Diet and exercise is the mainstay of weight management and generally precedes other measures. Unfortunately, diet and exercise alone yield mostly limited and transient weight loss, with many individuals finding it difficult to adhere to such regimens. The strategy to implement pharmacotherapeutic or surgical approaches in addition to diet and exercise depends upon the patient’s BMI as well as the presence of obesity-related comorbidities. However, unlike the situation for other metabolic diseases such as hypertension and type 2 diabetes, there are very limited obesity pharmacotherapies available.
All four Phase 3 studies showed statistically significant improvement in each co-primary endpoint relative to placebo.
Patients may experience elevated blood pressure or pulse during Contrave treatment; the risk may be greater during the initial 3 months of therapy.
All four Phase 3 Contrave studies demonstrated statistically significant and clinically meaningful weight loss following up to 56 weeks of treatment with Contrave compared with placebo. The average percent weight loss from baseline observed with NB treatment across the four studies corresponded to between approximately 5 and 9 kg (11 to 22 pounds).
Patients with type 2 diabetes in Contrave Study showed the smallest degree of weight loss, although a significantly greater proportion of Contrave-treated patients benefitted with at least 5% weight loss at endpoint compared to placebo. Clinically meaningful weight loss was apparent early in treatment, and was greater than that observed with either naltrexone or bupropion alone. Patients with type 2 diabetes benefitted from weight loss, improvements in waist circumference, HDL and triglycerides, and clinically significant improvements in glycemic control (particularly decreased HbA1c). Greater proportions of NB-treated patients reported clinically meaningful improvements in weight-related quality of life compared with placebo, providing further evidence of the range of clinical benefits that can be derived from NB treatment. The use of NB was generally well-tolerated, with the frequency and distribution of safety findings being consistent with the established profiles for naltrexone and bupropion. Common AEs such as nausea and vomiting tended to occur early in treatment (during the dose-escalation phase), were mostly mild to moderate in severity, and were generally self-limiting. The incidence of treatment-emergent SAEs overall was low; the vast majority of SAEs in NB-treated patients were considered unrelated to study drug.
Initiation of treatment with NB was associated with transient increases from baseline of approximately 1 mm Hg in mean blood pressure, followed by small reductions below baseline.
The incidence of major cardiovascular events (cardiovascular death, myocardial infarction and cerebrovascular accident) and revascularization procedures were low and comparable between NB- and placebo-treated patients, although the number of events is too low to draw firm conclusions. Seizures occurred infrequently at a rate that is consistent with that observed for the lowest approved dose of bupropion SR. Treatment with NB in the target patient population does not appear to be associated with an increased risk for depression or suicidality. Clinical laboratory evaluations were generally unremarkable, and values outside of normal ranges tended to be sporadic and unrelated to dose.


Neither bupropion nor naltrexone has historically been associated with prolongation of QTc intervals, and review of QT, QTc and the other ECG parameters in patients during long-term NB treatment revealed no noteworthy findings.
The distributor of Contrave offers one of the best manufacturer sponsored discount coupons for a new weight loss drug available for patients with a non-government issued insurance (certain limitations and exclusions apply). The distributor of Contrave, Takeda Pharmaceuticals has a program called Scale Down which provides a smart scale that interacts with your smart phone by sending your weight loss progress to your smart phone with customized messages to suit your needs and is included free when you activate the contrave complete discount card! In summary, the benefits of NB outweigh the risks given the clinically meaningful weight loss and improvement in multiple markers of cardiometabolic risk and patient-reported quality of life. Overall, the NB safety profile is well-understood, with known risks that are predictable and manageable via appropriate risk mitigation approaches. Disclaimer* W8MD medical weight loss centers of America is designed to provide general information on our insurance physician weight loss program locations, and general weight loss information.
Thanks to the Affordable Care Act that mandates insurance coverage for obesity, you can now lose weight and have your insurance cover the cost of the W8MD physician weight loss physician visits! Weight Loss Doctor AppointmentsGreater Philadelphia Weight Loss DoctorAppointments, call (215)676-2334. Ever since Fen-Phen was taken off the market, I (and every other weight conscious person on the planet) have been searching for another miraculous replacement. According to an article in Natural Foods Merchandiser, “And the biggest cheerleader of these products is the market-making Dr. A meta-analysis of green coffee bean extract studies concluded that “the magnitude of the effect is moderate and promising,” although more research, as always is needed.  Sounds good, good doctor. It should be noted that these results are modest because, as in the case with such thermogenic ingredients, people will gain muscle as they lose fat.  Because muscle weighs more than fat, while the pounds lost may smaller, the shape of the body improves and the belt tightens a few notches. Finding the magic pill to lose weight without the discomfort of effort is the secret desire of overweight Americans from coast to coast.  Ever since the most magic pill of all—ephedra combined with aspirin and caffeine—was taken off the market by the Food and Drug Administration in 2004, the market has clamored for the next thing.
Although orlistat is approved for long-term use and provides efficacy beyond that usually achievable using diet and exercise alone, it is not tolerated well by some patients. The most commonly reported side effects (those that occurred at a ?5% incidence in the Total NB group and greater than the incidence in the placebo group) for patients treated with NB are displayed in the table below. Weight loss was on average sustained, and those patients who continued treatment through 56 weeks experienced the most substantial weight loss.
A lower proportion of NB-treated patients required adjustments to their antidiabetic medications due to poor glycemic control. These increases are consistent with the known hemodynamic effects of bupropion and were attenuated by weight loss in patients who responded to therapy, although mean blood pressure reductions with NB were always less than that observed with comparable placebo patients. Bupropion has been extensively prescribed since its original approval more than 20 years ago, and has a long history of safe use even in populations considered at risk for CV disease. These benefits in aggregate are expected to be greater in general clinical practice, as proposed labeling would lead to discontinuation of treatment for patients not experiencing at least a 5% decrease from baseline in body weight.
Orexigen is developing a plan for additional clinical studies to assess: 1) prescription utilization patterns, 2) physician and patient adherence to labeling, and 3) the impact of Contrave on cardiovascular outcomes.


Tumpati, I can't thank you enough for helping transform my daughter Erin (lost 64 lbs*) into a much happier young lady and she looks amazing and also thanks for helping me lose 25 pounds I feel great - Lisa, Erin's mom. W8MD medical weight loss website or any of our affiliated weight loss blogs is not intended to diagnose, treat, cure, or prevent any disease. The pills that have appeared have been plant-based formulations that I have to admit, I have been skeptical about.  When America’s favorite doctor, Dr. Oz referred to raspberry ketones as a “miracle fat burner in a bottle to help boost your metabolism and burn excess body fat.”  Where did he get the idea?  From a 2010 petri dish study in which raspberry ketones were found to increase the breakdown of fat cells. Oz mentioned a placebo-controlled study finding 1 pound of weight lost per week while “doing nothing extra”—no exercise or anything.
Oz said on his show, as he ignited a piece of prop filament balloon to expose simulated hard muscle underneath. Achieving 5% weight loss is not only an FDA guidance efficacy benchmark, but this degree of weight loss is known to confer significant cardiometabolic benefit. As patients with hypertension or a history of hypertension may be at increased risk of blood pressure elevations, care should be exercised when initiating treatment with Contrave in such patients.
The efficacy of NB was observed across all demographic and clinical subgroups evaluated, including patients with hypertension, dyslipidemia, history of cardiovascular disease, type 2 diabetes, impaired fasting glucose, or history of depression. The small elevations in heart rate seen with NB treatment (compared with decreases with placebo) are also consistent with known bupropion effects. Benefits are observed across a range of overweight and obese patient subgroups and in various treatment settings. So far I have lost 42 pounds with 18 to go before by youngest daughter's 21st birthday trip to Hawaii.
I would highly recommend him to anyone that is serious about not only losing weight but improving their overall health , gaining knowledge about their bodies and nutrition and developing a healthier lifestyle.
Mehmet Oz, would mention a new product to assist us in fat-burning and losing those extra pounds – people jumped on it and the products would be top sellers in stores and online. The only green coffee bean extract worth discussing is Svetol, a branded ingredient standardized to 45 percent chlorogenic acid.  A 2012 human clinical study that followed 50 people ages 19 to 75 for 60 days found that those who took 400 mg of Svetol daily lost an average of 10 pounds and increased their lean-mass-to-fat-mass ration by more than 4 percent. In the face of such limited options, patients often resort to the use of off-label medications or dietary supplements that may be ineffective or unsafe.
Of note, the population of patients receiving currently approved bupropion-containing therapies has important similarities to patients enrolled in the NB clinical program, as well as the population of patients who receive currently marketed obesity pharmacotherapy. In this context, agents such as Contrave, a combination of Naltrexone and Bupropion(NB), may offer viable alternatives for many obese patients.
In addition, clinical experience and investigation in relevant patient populations, including those with cardiovascular risk factors or established cardiovascular disease, have not identified specific safety signals for clinical cardiovascular events.



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