New Weight Loss Drug on the Market

OverweightFor the last 13 years there have been no new medications designed specifically for weight reduction that have received FDA (Food and Drug Administration) approval. The long drought came on the heels of the reported adverse effects of the successful weight reduction combination of phentaramine and fenfluramine. While patients lost weight successfully on this combination of medications plus diet they additionally risked developing disease of the heart valves and its consequences. In July the FDA approved Belviq or lorcasrin HCl for weight reduction. Pharmaceutical manufacturer Vivus received approval for its weight reduction product Qsymia recently which is a combination of phentermine and topiramate. Topiramate has been on the market as a medicine to treat vascular and migraine type headaches and to treat seizures.

Vivus submitted data to the FDA involving 756 obese subjects, which showed that over seven months of treatment obese patients lost 10% or more of their body weight 38% of the time among those taking Qsymmia 7.5 /46 mg and 43% of the time when they used the higher dose of 15/92 mg. Patients taking placebo plus diet lost 10% of their body weight only 6.8%. The dose of topiramate in this combination drug is significantly lower than the starting dose for that drug when treating neurological issues. When the researchers looked at statistical significance the lower dose combination was actually more successful than the higher dose combination.

Adverse effects were more common in the higher dose group and included parasthesia (23%), dry mouth in 18.5%, headache and constipation. The drug was released to a limited number of pharmacies in April but has been slow to catch on. Its use is cautioned in individuals with existing heart, liver and kidney disease.

Obesity is epidemic in this country. Increased activity and dietary intervention are always our first line of therapy. Dietary counseling, organized diet programs with meal replacement therapy and bariatric surgery are available to help. Adding new medications to a difficult treatment problem is always a welcome step but will require that we closely watch their risk and side effect profile as the drugs become more popular and are used more frequently.

Bariatric Surgery Reverses Diabetes – But What About Seniors?

A recent well written article in the Fort Lauderdale Sun Sentinel discussed how bariatric surgery to treat extreme obesity was also now a formidable weapon against Type II Diabetes Mellitus.   Type II Diabetes Mellitus or adult onset diabetes occurs in older individuals and is closely related to weight gain, high blood pressure, elevated cholesterol, triglycerides and accelerated narrowing of arteries. The accelerated artery-narrowing results in premature and advanced coronary artery disease and peripheral arterial vascular disease.  A study published in the American Journal of Medicine in 2009 looked at 3,188 obese Type 2 diabetics who had bariatric surgery and lost weight.  Amazingly, 78% of them no longer met the criteria to be called diabetics.

Bariatric surgery includes minimally invasive surgery such as laparoscopic adjusted gastric banding to the more invasive re-routing of the intestines and reduction of stomach volume in the classic Roux-en-Y gastric bypass. Other procedures include open duodenal switch and vertical banded gastroplasty.  These types of procedures are only performed in the morbidly obese defined as those with a Body Mass Index (BMI) of 40 or greater.  The results in reversing Type II diabetes have been so impressive that experts are now considering reducing the BMI to 35 for consideration of candidacy to have these procedures.

Why these procedure reverse diabetes is a matter of debate. Weight loss is a traditional successful treatment for Type II diabetes. Some believe that the actual surgery on the gut stimulates hormones that help control the blood sugar. The positive result has led insurance companies to now start approving payment for these procedures because the $18,000- $30,000 cost is cheap compared to the $300,000 lifetime cost of treating a Type II diabetic.

With so many elderly obese patients with Type II Diabetes, and other metabolic and cardiovascular complications of obesity in the health system, is the procedure safe for the elderly?  A recent study by Robert B. Dorman M.D., at the University of Minnesota seemed to indicate that the surgery is safe.  He looked at 48,378 patients with a BMI above 35 who had bariatric surgery between 2005 and 2009.  He found that the mortality rate for seniors over 65 was higher than for younger patients but was still extremely low and rare for a death to occur. Longer hospital stays were noted for the elderly and were related to how heavy the patient was prior to surgery.  This study gives bariatric surgeons excellent figures on the risk of complications when performing bariatric surgery in the elderly.

As a primary care physician working with elderly Type II Diabetics, I will continue to stress lifestyle improvement with dietary improvement, weight reduction, increased exercise and activity as first line therapy.  Medication when necessary will be next. Bariatric surgery, now proven to be safe is a new weapon available to the proper patient.  Finding an experienced surgeon in performing the procedures (more than 200 of that procedure) will be paramount in reducing complications and mortality.

Dutch Diet Drink Reduces Hunger

Obesity is an epidemic negatively impacting our health in America and around the world.  According to the National Center for Health Statistics, over 68% of American adults are overweight or obese.  As we move away from a hard working agrarian society to a society which consumes fast food while getting less activity due, in part, to our technological advances, we are always looking for aids to keep our weight down.

In recent years the pharmacological approach has fallen on hard times due to the many significant side effects associated with diet medications.  Expensive surgery to reduce the stomach size and re-route the intestines has met with mixed success, high costs and adverse effects as well.

Last month, Harry Peters, a research manager of Unilever Research and Development in the Netherlands announced preliminary successful results of a prototype diet beverage. He and his staff concocted a chocolate flavored brew that stayed liquid and palatable when you drank it but firmed up into a thick gel when exposed to the acidic and digestive juices in the stomach.  The gel distended the stomach and produced a sense of satiety and fullness with a resultant decrease in appetite in the vast majority of the study participants. The research is quite preliminary but again presents hope to those of us fighting the battle of the bulge.

“Although the self-reported decreases in hunger are robustly reported in this study, further studies are needed to establish its implications for food intake, compliance to weight loss programs and long-term effects on weight loss or weight maintenance,” Peters and colleagues concluded.