People with a high body mass index who lose weight reduce the risk of health problems such as diabetes or heart disease.
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From Nature magazine
After 13 suspenseful years, the US Food and Drug Administration (FDA) has approved a pill that could help to fight the US obesity epidemic.
Belviq (lorcaserin) is no wonder drug, but it can help people to lose about 3–4% of their body weight when combined with a healthy diet and exercise. The drug has been approved for use by obese people with a body mass index (BMI) greater than 30, and for a subset of overweight people (with a BMI of more than 27) who have health conditions such as high blood pressure, elevated cholesterol and type 2 diabetes.
“It’s a start in the right direction,” says Abraham Thomas, head of endocrinology at the Henry Ford Hospital in Detroit, Michigan, who chairs the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee. “We don’t have the tools to really treat obesity.”
Developed by Arena Pharmaceuticals of San Diego, California, Belviq faced a high bar for safety. In 1997, the weight-loss drug fenfluramine was pulled from the market for causing heart-valve problems. In the past two years, the FDA has rejected a total of three obesity drugs because of concerns over safety or lack of efficacy. The FDA advisory committee recommended in March that all obesity drugs should go through tests for cardiovascular risks, which would extend already lengthy clinical trials.
The FDA had already rejected Arena’s first application for approval of Belviq in September 2010 because the compound seemed to produce tumours in rats and because the company could not statistically rule out an increase in the risk of heart-valve problems. Similar to fenfluramine, Belviq suppresses food cravings by mimicking the effects of serotonin in the brain, making people eat less and feel full. However, Belviq seems to activate only the serotonin 2C receptor in the brain, not the serotonin 2B receptor that is present in heart muscle.
The FDA’s turnaround this week came after Arena performed echocardiograms in nearly 8,000 people to measure heart-valve function, which revealed that there was no increase in heart-valve abnormalities among those taking the drug. The firm has agreed to run six post-marketing studies, including a long-term cardiovascular trial, and patients with congestive heart failure are advised not to take the drug.
“I felt the benefits outweighed the risk,” says Ida Johnson Spruill, the consumer representative on the FDA advisory committee and a diabetes specialist at the Medical University of South Carolina in Charleston. One-third of adults in the United States are obese, so regulators must balance the risks of a new weight-loss drug with the health consequences of obesity, including rising diabetes rates.
Weighing the benefits
Compared to the placebo, Belviq’s efficacy is about the same as that of orlistat, which was first approved in 1999 and blocks the uptake of fat calories. A 90-kilogram patient on Belviq loses, on average, an extra 3 kilograms (6–7 pounds) or so after a year. “The good minimum weight loss would be in the 10–15-pound range,” notes endocrinologist Peter Savage of the National Heart, Lung, and Blood Institute in Bethesda, Maryland, “That doesn’t mean that people who lose 5–8 pounds don’t do well.”
It would also be a mistake to reject a drug that works well for a subset of the patient population, says Thomas. About 20% of people on the drug lost 10% or more of their body weight. The FDA recommends that patients who have not lost 5% of body weight by week 12 stop taking the drug.
Belviq has also shown promise for people with type 2 diabetes, who were twice as likely to keep their blood sugars under control than those on the placebo.
“No medication works by itself,” says Patrick O’Neil, a clinical psychologist at the Medical University of South Carolina and lead author of the diabetes study. “It’s not a replacement for diet, exercise, and lifestyle modification, but it can augment such programmes.”
This article is reproduced with permission from the magazine Nature. The article was first published on July 2, 2012.
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12 Comments
Add CommentI am aware that the obesity problem is not always just "calories in-calories out. However I tend to agree with SimpleAtheist in that for the vast majority of obese persons the problem is nothing more than laziness and gluttony. Perhaps a "Reality Pill" would be more appropriate.
Reply | Report Abuse | Link to thisThere is still a problem with changes in metabolism as you grow older. This has little to do with eating disorders. I eat little and exercise daily but I at least 50 lbs overweight (6'4" and 285 lbs) and wish I could get rid of the weight. I do not eat sweets, eat lots of veggies but cannot lose the weight. It is amazing how everyone seems to think I am some sort of glutton when I am not. This type of drug may not help me though since it blocks food cravings which is not my problem. My cholesterol is low (around 120) and I do not have diabetes. I need something to safely increase my metabolism, not suppress my food cravings.
Reply | Report Abuse | Link to thisI am sure your metabolism is fine. There is no healthy variation of metabolism that would let a guy die from starvation while still having fat. Not losing it means your body has no need to.
Reply | Report Abuse | Link to thisIf you had a health condition which has obesity side effect, trust me you would know about it. And obesity would be the least of your problems.
I did not see any sign that these are not just excuses. To eat little food and lots of veggies means to eat lots of food; 20 sit-ups every morning is better than nothing but that's no exercise; enough beer daily can negate almost any effort; and if you've only started trying a month ago, what did you expect.
BillR, you say that you exercise every day, and yet you see little progress. It might help if instead you exercise only three days a week, arranged so that twice a week you have two consecutive days of rest.
Reply | Report Abuse | Link to thisWith two days of rest, your muscles get time to recover well, and, after this recovery, time to grow. This way, in a few months you'll probably have much more muscle mass. Muscles consume more energy, so your metabolism improves.
When you exercise, it's not the exercise itself that improves your muscles. On the contrary, the exercise is mildly damaging. During recovery from this damage, there's a process of rebuilding, and this rebuilding overcompensates for the damage, adding some extra growth. With a few months of repeated damage, rebuilding and overcompensation you get a substantial improvement. But this is possible only if you have fully sufficient time for rebuilding and overcompensation.
However, the type and amount of rest that is needed varies hugely among individuals. Two days is slightly too little for some and a bit more than necessary for some. Some can exercise mildly during those two days, some should avoid all exercise. Some can get the desired effect by exercising every day while working different muscles each day, letting those muscles that worked yesterday rest today, others can't get any good effect this way.
(Working different muscles every day is quite popular, but I suspect it's unhealthy, since this way your heart, lungs etc. never get their two days of recovery.)
There's a lack of strictly scientific facts about all this. Apparently it's difficult to research this subject stringently -- or maybe individual variations are just too great. But if you experiment along these lines, with luck you may achieve great progress.
Unfortunately, you'll need lots of patience, since, once you hit the regimen that is best for you, progress might take a couple of months. Of course, the time that this takes also varies hugely among individuals.
I believe that two consecutive days with no exercise twice a week works very well for most people, and is therefore a very good starting point. Later you can refine it to find what works best for you.
Also, make sure you eat some protein and fat, so your body gets the building blocks it needs for building muscle.
Kasym says: "I did not see any sign that these are not just excuses."
Reply | Report Abuse | Link to thisDid you see any sign that they are excuses? Or are you just guessing?
That kind of guessing is called prejudice. Whether prejudice happens to fit reality or not in the individual case is a matter of pure, random chance.
Kasym... Actually, when I said "little food", I included the veggies. It is just that 50-60% of what I eat are low carb vegetables. I control the amount of fat and salt as well and really do not like eating out but once a month and definitely NOT at fast food places. My doctor wants me to eat stuff high in cholesterol because my "good" cholesterol is too low so I eat fish and shrimp (and lobster when I can afford it). I eat little red meat but I do eat chicken and turkey. And usually a hand full of nuts and dried fruit as a snack in the evening.
Reply | Report Abuse | Link to thisMy exercise regime is between a half hour to an hour of speed walking three times a week and some exercises in the pool on the off days to try to keep limber. I am 60 years old so I do not expect to turn into some sort of hunk. I just want my wife to stop bugging me to lose weight. She wants me to look like the governor of California in his younger days. Of course, I wish she could look like a super model but I do not entertain unreasonable expectations. She looks pretty good for 68 but could loose a few pounds as well (but I refuse to tell her that).
The rule that FDA won't give an OK for a new weight loss product, at least one made of two products in a single pill, if the product doesn't give a 5% weight loss within a fixed term is alive and well, or this is a different issue? Fats do burn in the carbohydrate's furnace, and around 80% of body energy use is independent from how much the person exercises.
Reply | Report Abuse | Link to thisYour numbers are wrong. The following are taken directly from the BLOSSOM and BLOOM-DM trials, respectively:
Reply | Report Abuse | Link to thisBLOSSOM Trial
"Lorcaserin was highly effective in helping patients achieve significant weight loss using multiple measurements. Patients treated with 10 mg of lorcaserin dosed twice daily (BID) who completed the 52-week trial according to protocol demonstrated the benefit of long-term treatment with lorcaserin:
-- 63.2% of patients lost at least 5% of their body weight (p<0.0001);
-- 35.1% of patients lost at least 10% of their body weight (p<0.0001);
-- Patients lost an average of 17.0 pounds, or 7.9% of their body weight;
and
-- The quartile of lorcaserin patients with the greatest weight loss (among
those with a Week 52 weight recorded) lost an average of 35.1 pounds, or
16.3% of their body weight.
Of the placebo patients who completed the trial, 34.9% and 16.1% achieved at least 5% and 10% weight loss, respectively, and the average weight loss was 8.7 pounds, or 3.9%. The top quartile of lorcaserin patients lost 36% more body weight than the top quartile of placebo patients."
http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=410040
BLOOM-DM Trial (For those with Type 2 Diabetes)
"The three primary efficacy endpoints at Week 52 were as follows: the proportion of patients who lose at least 5% of their baseline body weight; change from baseline in body weight; and the proportion of patients who lose at least 10% of their baseline body weight. Using Modified Intent-to-Treat Last Observation Carried Forward (MITT-LOCF) analysis, lorcaserin 10 mg BID met the three primary efficacy endpoints by producing statistically significant weight loss compared to placebo (p<0.0001). At Week 52, 37.5% of patients treated with lorcaserin 10 mg BID achieved at least 5% weight loss, more than double the 16.1% of patients taking placebo. Patients treated with lorcaserin 10 mg BID achieved mean weight loss of 4.5% (4.7 kg), compared to 1.5% (1.6 kg) for placebo. Also, at Week 52, 16.3% of lorcaserin 10 mg BID patients achieved at least 10% weight loss, compared to 4.4% of patients taking placebo."
http://invest.arenapharm.com/releasedetail.cfm?ReleaseID=528113
as far as I'm concerned lossing weight is one of the most challanging things for human.I think in most of the obeas people overweighting is the result of a bad trade off between input and output energy. in such cases , I think It doesnt need any kind of drug . It should be better to exercise, to have a suitable diet and etc. but in some cases obeasity is the result of a metabolism disorder. this chaotic situation must have a biologic solution and we should try to find the cause of chaos in conjunction with a good diet and exercise.
Reply | Report Abuse | Link to thisHi Ehsan,
Reply | Report Abuse | Link to thisThanks for your well-expressed comment. Please see below to see modified version of your writing and notice the differences both in terms of grammar, spelling and punctuation marks.
Good Luck,
M.K.
\/ \/ \/ \/ \/ \/ \/ \/ \/ \/ \/ \/ \/ \/ \/ \/ \/
As far as I'm concerned, losing weight is one of the most challenging things for human. I think in most of the obese people, over-weighting is the result of a bad trade off between input and output energy. In such cases, I think it doesn't need any kind of drug. It should be better to exercise, have a suitable diet, etc. But in some cases obesity is the result of a metabolism disorder. This chaotic situation must have a biological solution and we should try to find the cause of chaos in conjunction with a good diet and exercise.
/\ /\ /\ /\ /\ /\ /\ /\ /\ /\ /\ /\ /\ /\ /\ /\ /\ /\
@123456 - Just because the magazine has American in the name doesn't mean only Americans read it. It wasn't hard to understand what Ehsan meant and seriously, if Ehsan wanted an English lesson then most likely Ehsan would have asked for correction.
Reply | Report Abuse | Link to thisWhile it is possible that Ehsan is simply an American with terrible writing skills, it is more likely that English is Ehsan's second, third or possibly higher language. This forum is for the exchange and discussion of ideas. Grammar Nazis have other avenues of nitpicking.
Hello mark,
Reply | Report Abuse | Link to thisYeah the weight loss drugs are being approved but why dont try to use the Well no, i’m afraid not. It is however possible to lose 20 pounds in 30 days by following the 5 rules and as mentioned in the title none of the rules will order you to workout at the gym, or go on a ridiculously long jog!
http://howtolose20poundsinaweek.org