Obesity has become an epidemic, sweeping the nation and metastasizing into a global issue. The World Health Organization (WHO), has stated that over 200 million adults are classified as obese (having a BMI over 30 kg/m2). This problem taxing our already overburdened health system, and will continue on through younger generations if it is not stopped.
Not only does obesity take its toll physically, but emotionally as well. The emotional component can make it very difficult for obese patients to lose weight in the long run. Worse than that, obesity brings with it other comorbid diseases, such as type 2 diabetes, osteoarthritis, high blood pressure, sleep apnea, heart attack, stroke, coronary artery disease, and some cancers.
If mortality risks of obesity alone weren’t enough, the addition of these comorbidities raises those risks even further. Many patients feel helpless, often turning to their doctors for help.
Over the years, many weight loss medications have been tested, with a few approved. The standards are rigorous, so a drug must show marked effectiveness in order to gain such approval. In 2012, the FDA approved Belviq after revealing promising data from several clinical trials, making Belviq the first weight loss medication available in 13 years.
There are many factors that affect the development of a patient’s obesity, from outside influences such as behavior, socioeconomic status, and environmental conditions, to inherent influences such as sex, metabolic rate, and genetic predisposition. This makes obesity a tough disease to treat, as it requires a weight loss program tailored to the individual patient.
The results of these programs always vary between patients, especially when factoring in the many comorbidities related to their condition, making it difficult to establish an appropriate weight loss program. Such programs require major changes to the patient’s habits, including modifying the diet and increasing activity and exercise. For patients who struggle with these changes, medications like Belviq can be a helpful tool on their weight loss journey.
Belviq is the trade name for the drug lorcaserin HCI (lorcaserin hydrochloride) that is produced by Arena Pharmaceuticals.
Sometimes doctors may prescribe a drug like lorcaserin HCI to patients with comorbidities, but that drug does little if lifestyle changes are not made. As a selective serotonin receptor antagonist, lorcaserin hydrochloride can reduce the appetite, and assist in weight loss.
Serotonins have been the target of weight loss studies since the 1970s, but only recently did researchers find a serotonergic agent that wouldn’t activate the other receptors at the same time (which could cause bad reactions). Upon the heels of this finding, three clinical trials of lorcaserin hydrochloride have been completed, with more underway.
Of those three completed trials, the first two centered on the outcomes of obese patients with at least one other comorbidity, who are taking Belviq. The third study focused on Belviq’s effect on type 2 diabetes patients who also have hypertension. The optimistic outcomes of the three studies combined led to the FDA approval of Belviq.
The first trial for Belviq, referred to as BLOOM, lasted 2 years and was conducted as a randomized blind clinical trial with a placebo control group. Researchers prescribed 10 mg of lorcaserin to half of the 3,182 participants, to be taken twice daily. The other half of the patients took the placebo twice daily. None of the subjects knew if they were receiving the placebo or the lorcaserin. In addition, subjects were instructed to exercise daily and were put on a low calorie diet of healthy foods.
The clinical trial evaluated the subjects after 52 weeks, and 47.5 percent of the subjects who followed the lorcaserin regimen lost in excess of 5 percent of their body weight, on average, with abut 22 percent of subjects losing 10 percent or more. This makes for an average of 6 kg lost by those using Belviq.
Of the placebo subjects, 20.3 percent of participants lost 5 percent or more of their body weight, with an average of abut 2 kg lost, and 7.7 percent of those patients lost in excess of 10 percent of their body weight.
Following the evaluation at 52 weeks into the trial, the researchers put 573 random subjects on lorcaserin for another 52 weeks, while another 283 patients were chosen at random were switched to the placebo. The patients were unaware of the change.
At the end of that year, 67.9 percent of the subjects who stayed on Belviq continued to lose weight, while only 50.3 percent of placebo subjects lost more weight. In addition to the weight loss, those on lorcaserin had a markedly reduced BMI, LDL cholesterol level, and blood pressure, and saw a drop in waist measurements.
The second study was the BLOSSOM clinical trial. More than 4,000 patients were divided at random into 3 groups, at a ratio of 2:1:2, with the first group taking lorcaserin at a dose of 10 mg twice daily, the second group taking the drug once daily, and the last group taking the placebo.
Unlike the first study, for BLOSSOM, patients who had heart valve disorders or diseases were admitted. Also, during the study period additional doses were assigned to subjects randomly.
By the end of the BLOSSOM trial, 47.2 percent of the twice-daily lorcaserin subjects were able to lose more than 5 percent of their starting body weight, while only 40.2 percent of the once-daily lorcaserin patients and 25 percent of the placebo patients achieved this milestone. Subjects in both of the lorcaserin group showed improvement in their cardiovascular health.
The final study completed so far was the BLOOM-DM trial, which focused on patients with diabetes mellitus. The purpose of the study was to determine the effect of Belviq over the course of a year on obese diabetes patients who were already on prescriptions of either sulfonylurea or metformin.
604 patients took part in the clinical trial, and were divided equally at random between 3 groups: those who took Belviq at 10 mg twice daily, those who took Belviq at 10 mg once daily, and those who took a placebo.
The results of BLOSSOM-DM were similar to the first two studies, as 37 percent of the twice-daily group lost 5 percent or more of their original body weight, 44.7 percent of the once-daily group lost as much, and 16 percent of the placebo group lost the same 5 percent or more of body weight. The study also confirmed that lorcaserin was safe, led to weight loss, and provided effective control over blood sugar levels.
The statistically significant results were similar in all three studies, showing a clear indication that Belviq can be a helpful tool in losing weight, even with comorbidities present. The amount of weight lost is dependent upon the diet regimen chosen, and the patient’s compliance with the diet along with the consistent taking of the medication. But it’s important to remember that although a patient may experience improvement in their blood sugar and blood pressure, it doesn’t mean a patient can abandon their prescribed diabetes treatment.
Up to about 90% of lorcaserin hydrochloride is taken up by our bodies, and it is absorbed quickly and distributed throughout our system. After being metabolized in the liver, the drug is excreted by the kidneys. This cycle is completed, from the taking of the drug to its elimination from the body, in approximately 11 hours.
Lorcaserin is typically prescribed to patients with a BMI (body mass index) of more than 30, along with at least one comorbidity. It is only approved for use by patients 18 and older.
Although Belviq may be easily absorbed, it’s not appropriate for all patients. There are life-threatening contraindications for some patients. Patients should let their doctors know if they are pregnant, lactating, taking antidepressants or have diabetes, heart failure, a heart valve disorder, sickle cell anemia, kidney or liver disease, leukemia or myeloma, or a physical deformity of the penis.
Unpleasant side effects have been reported by many of the subjects who took lorcaserin, including unusual changes in mood or behavior, thoughts of suicide, hallucinations, heart problems, severe nervous system reactions, and more. Patients may need to stop taking the drug as a result.
Since Belviq is able to activate the body’s serotonin receptors, it may be addictive, and therefore the potential for abuse of Belviq exists. Because of the potential for abuse, Belviq is classified as a controlled substance, and is only available by prescription and only in the United States. Not available in Australia as of writing this, so the best bet for us Aussies still remains – Phen375, available without prescriptions.
It’s important to consider that the longest clinical trial lasted only two years, and therefore it’s unclear what the long-term effects Belviq might have.
While Belviq might not be right for every patient, for those obese patients who meet the qualifications, it could be a useful tool, along with diet and exercise, for weight loss.