Winston
Yes, yes, Winston, I have heard about the new medication approved by the FDA. It has been heralded as the first drug approved for the treatment of Obstructive Sleep Apnea. “Is it so?” you ask. It is, but as an infamous man once said, “It all depends on what the definition of is, is.”
The approval is the FDA giving it an indication for use in obese patients with moderate to severe obstructive sleep apnea. With that approval, it becomes the first medication to have an indication for use in Obstructive Sleep Apnea. This is the fact that has been in multiple news outlets and led to many questions of sleep doctors by our patients. It is important to know more about the details.
The approval followed a multi-million dollar, manufacture sponsored study that was published in the New England Journal of Medicine (NEJM). The study focused on using the weight loss drug in obese individuals with Obstructive Sleep Apnea. Unsurprisingly, the weight loss induced by the medication resulted in improvement in the apnea condition. The treated patients were compared to those treated by diet alone who lost little weight during the study. It was not compared to other weight loss drugs. The article received wide acclaim and attention.
What was known about excessive body weight, weight loss and Obstructive Sleep Apnea before this study? I have an interest in the subject and have followed the work in the field since seeing my first patient with sleep apnea while serving in the Army. He was thin as a rail, by the way. Current knowledge is that we know slightly more than half of all newly diagnosed apnea patients have problems with their weight. We know that of those patients who experience significant weight loss, apnea is eliminated in 18-20% of the obese patients. The others are usually improved, but apnea is not eliminated.
My review of the NEJM article can be summarized briefly. The drug causes weight loss (previously known) and the weight loss improved apnea in many with it. Does it work any better than weight loss by any other means: diet, counseling or other weight loss drugs? Who knows? The study does not address the issue. Does it improve apnea over and above the effect of losing weight? Who knows? The study does not address the issue.
What did the article do? I don’t think it provided any new information. It most likely – I speculate here – influenced the FDA to add the Sleep Apnea with obesity indication to the medication’s approved usage. I suspect that the several million dollars spent for the study resulted in far more notoriety and media attention than any amount of advertising money could buy. Additional facts for you to consider are the cost of the medication and the duration of treatment it requires. A quick Internet search shows it to cost between 900 and 1,000 dollars a month on a well-known discount site. The duration of treatment is potentially life long.
No Winston, it is not proven to be a drug for apnea: just another very expensive drug for weight loss.
What has transpired? A modern, marketing miracle.