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13.10.2014, admin  
Category: Muscle Magazine

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. Your doctor will be able to help with advice on how to lose weight and perhaps even prescribe weight loss medication as well. Some types will work in more than one way, but it is important that if you are prescribed any weight loss medication that you follow the instructions set by your doctor. Unfortunately if you are obese you are not going to get back down to the weight you were in your teenage years. Even if you could skin will be an issue as it will probably be stretched and loose, which may affect your confidence levels. Your weight will not drop dramatically overnight, it may take many months to any significant results.
If you are relying solely on weight loss medication for your results then you are likely to be disappointed by the results you experience. Instead try eating more fresh fruits and vegetables as they are low in calories, but contain all of the nutrients your body requires. You should also consider eating fibre and protein-rich foods too, as these can help fill you up and keep you feeling full. To ensure you are seeing the right kind of results from the use of the weight loss medication it is important that you keep in contact with your doctor. They should be monitoring your progress, and if you are not seeing the results you should then they may suggest alternatives. If you value your health then it is no good continuing with a form of medication that does not work. Weight Loss Apps Worthless Experts ClaimDespite their popularity and claims that they could ..
Qsymia will be used for people who have a BMI of 30 or greater, or for people who have a BMI of 27 with at least one co-morbid condition such as diabetes or hypertension. Patients with recent or unstable heart disease or stroke are not good candidates for Qsymia according to the FDA.
For some people, the use of weight loss medications is another method to help with controlling their excess weight.
Patients who use Qsymia or any anti-obesity drug should be utilizing a comprehensive weight management program which involves dietary change, exercise, behavior modification in addition to the medical monitoring by a physician. 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. This amount of weight loss could help to ward off the dangers of conditions such as diabetes. To start I would suggest going for a short walk once a day, and to try and build up the amount you do.
It is actually a combination of two medications known to help with weight loss: phentermine and topiramate. 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. Phentermine is a stimulant that suppresses the appetite and topirimate is an anticonvulsant that makes people feel more satisfied after eating.
This compares to the 5% weight loss shown with the other newly FDA approved anti-obesity medication, Belviq.
Also, there is a risk of birth defects if taken by pregnant women, so pregnancy tests are a necessity during the treatment.
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.
As with all medications, patients should be individually evaluated before beginning on these medications.
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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