Belviq’s results and what to expect from the drug
It might seem that for FDA to approve an anti-obesity medication, it should take at least a miracle. So when a weight-loss drug receives such approval, it must mean that it has indeed shown great results. Belviq got its FDA approval for obesity management in late 2012, after 13 years of absolutely no weight-loss medication legally available on the market. Belviq has earned its approval by showing very promising results in several clinical trials, which we will break down to you further on.
Over the last decade, obesity has become a huge health problem and is treated not only as a metabolic, but also as a behavioral disorder. According to the WHO (World Health Organization), more than 200 million adult men and even more women are diagnosed as being obese (that is they have a body mass index higher than 30 kg/m2). Unfortunately, this health problem does not come alone. Obesity is known for contributing to development of many other diseases. Obese people are significantly more likely to develop high blood pressure (hypertension), osteoarthritis, type-2 diabetes, sleep apnea, heart problems (such as stroke and coronary heart disease) and even some types of cancer. These conditions, obviously, greatly increase the risks of patients’ mortality.
Because of the complexity of the disease and of the factors that contribute to its development (such as metabolic rate, sex, behavior, socioeconomic status, genetic predisposition, and environmental conditions), it is quite difficult to treat. There is no one way to treat obesity, as every patient needs a personalized weight-loss program. Moreover, the results of the treatment will differ from person to person, especially considering that many suffer from obesity-related comorbidities. The treatment itself includes significant modifications in patient’s lifestyle, which means changing one’s eating habits, as well as activity levels. In many cases, certain pharmacological agents (Belviq weight loss pill is one of them) can be prescribed as a helpful addition for patients who struggle with the treatment.
Although Lorcaserin HCI is prescribed to patients who suffer from obesity or to overweight patients with obesity-related health conditions, it does not mean that the respective lifestyle changes can be overlooked. The drug on its own will not do patients much good. Lorcaserin Hydrochloride is a selective serotonin receptor agonist, which can help decrease the daily food intake and therefore contribute to weight loss. The drug selectively activates 5-HT2C molecule in the5-HT receptor subfamily, which is responsible for one’s appetite, and which are expressed in the central nervous system.
The pharmacological effects of serotonin for weight loss have been the subject of researchers’ attention since 1970’s. However, only recently did they discover a serotonergic agent that would not cause the activation of other receptors in the family and, thus, cause undesirable reactions. Since the discovery, there have been three completed clinical trials of Lorcaserin Hydrochloride, and several more that are still being conducted.
The first two of the clinical trials have focused on the use and the effects of Belviq on weight loss in obese patients and overweight patients with at least one of the common comorbidities. The third study evaluated the usage of the drug and its effectiveness in patients with type-2 diabetes and high blood pressure. The results of the studies allowed the Belviq diet pill’s FDA approval.
The very first clinical trial, known as BLOOM (which stands for: Behavioral Modification and Lorcaserin for Overweight and Obesity Management), was placebo-controlled trial that lasted for 2 years. BLOOM was also randomized and the participants were not aware of which group the actually belonged to (a crucial factor in any study). At the beginning of the trial, the researchers have found 3182 participants that met the requirements, and have randomly prescribed Lorcaserin (10 mg twice a day) to roughly a half, and the placebo to the other half. Subjects were also required to maintain a healthy low-calorie diet and exercise regularly.
At the end of the 52 weeks, the participants were reexamined – 47.5 percent of the subjects that actually took lorcaserin have managed to lose more than 5 percent of the body weight (making Belviq’s average weight loss of around 6 kg). Moreover, nearly 22% of the subjects have lost more than 10 percent of the body weight. Meanwhile, the 20.3 percent of patients that took placebo have managed to achieve the result of losing more than 5 percent of body weight (the average weight loss around 2 kg), and 7.7 percent of patients have lost more than 10 percent.
After completion of this first year, 573 patients were randomly prescribed the drug for another year and another random 283 patients were converted to the placebo group (being unaware of that conversion, naturally). 67.9% of those who continued taking Belviq have increased the weight losses to a greater extend during the second year, compared to 50.3% of patients on placebo. Furthermore, the lorcaserin group has shown reduction in waist circumference, and significantly lower BMI, blood pressure, and LDL cholesterol levels.
The second clinical trial on Lorcaserin, BLOSSOM (Behavioral Modification and Lorcaserin Second Study for Obesity Management), was conducted over the period of one year. This time over 4000 patients that met the requirements of Belviq’s prescription, were randomly placed into 3 groups (with the 2:1:2 ratio of participants). The first group was required to take 10 mg of Lorcaserin twice a day, the second – 10 mg once a day and the third took placebo. This time, however, patients who suffered from a disease or disorder of the valves of the heart were also allowed to participate. Furthermore, additional doses of Lorcaserin Hydrochloride were randomly assigned throughout the study period.
According to the results of the BLOSSOM trial, the weight loss of more than 5 percent of the initial body weight was achieved by 47.2 percent of patients, who took lorcaserin twice a day, by 40.2 percent of patients who were assigned only 10 mg of drug a day, and just 25 percent of patients who were on placebo. Moreover, patients who were in both of the lorcaserin groups have improved their cardiovascular conditions.
Finally, the last completed study, referred to as BLOOM-DM (Behavioral Modification and Lorcaserin for Obesity and Overweight Management in Diabetes Mellitus),was focused on the effect of Belviq on patients with diabetes over a one year period. The participants were already taking either metformin or sulfonylurea. This time 604 patients were randomly assigned to 3 equal groups: the first took 10 mg Belviq tablets twice a day, the second – once a day, and the third was on placebo.
Similar to the results of the previous study, more patients in the first two groups managed to lose at least 5 percent of the baseline body weight: 37 percent from the first group, 44.7 percent from the second group, and 16 percent from the third. This trial confirmed the safety and the effectiveness of the Lorcaserin use in patients with diabetes for weight loss and blood sugar control.
Given the results of all three studies it is clear that Belviq is a very helpful supplement to the usual obesity treatment. So, how much weight one can lose on Belviq highly depends on one’s following the prescribed regimen, as well as consistency in taking the drug. It has also shown quite a positive effect on the blood pressure management and blood glucose. However, it does not mean that patients with diabetes can discontinue their usual diabetes treatment.
Lorcaserin hydrochloride is absorbed very quickly by our bodies (up to 90% of the drug is being absorbed) and is distributed throughout. It is then being metabolized in the liver, and afterwards is excreted with the help of kidneys. Usually, it takes about 11 hours for the drug to be eliminated.
Nevertheless, not all the patients meet the requirements of prescribing Belviq. Patients who are pregnant, lactating, or taking anti-depressants are not allowed to start the Belviq course, as it could be life-threatening. Moreover, many patients who do take Belviq experience unpleasant side effects and some need to discontinue the treatment because of that.
Furthermore, because of Belviq’s ability to activate serotonin receptors, it can be addictive and has a potential for abuse. It is therefore classified as a controlled substance and is only issued by prescription. However, once you have the prescription, it is very easy to buy Belviq, as it is widely available in pharmacies.
Lastly, it should also be noted, that the studies and the trials so far have not provided insight to the long-term effect of the medication, since the longest trial only took 2 years.