When I was enrolled in a weight-loss clinical trial that compared then investigative lorcaserin (Belviq) with placebo, there were no guarantees, but there were also few alternatives for me as my weight approached 300 pounds.
Through the 12 months of the study, I didn't know if the pills I took each day were the "real thing" or placebo, but as pounds melted off my obese frame, my primary care physician declared that I had to be on the active drug.
My friends were also convinced it had to be a drug effect.
The proof was there every day on the scale, and I, too, was fairly certain that I was taking lorcaserin twice a day.
But it was not until June 27 when the FDA approved lorcaserin for treatment of obesity, that my suspicions were confirmed -- indeed, I was on lorcaserin. The 55-pound weight loss was not due just to lifestyles changes and the placebo effect.
More importantly, I can say that the weight loss that occurred in the trial has not been regained. I'm still more than 50 pounds lighter than I was in those dark days in late 2007 when weight loss seemed impossible.
During the year I participated in Arena Pharmaceutical's BLOOM-DM study my weight dropped from 293 pounds on my primary care physician's scales to 238 pounds.
My treatment progress was documented in a series of articles and videos published by 番茄社区 from January 2008 through January 2009.
WATCH: January 2008 video | February 2008 video | November 2008 video | February 2009 video
When the FDA approved the drug last month, it marked the end of a 6-year long clinical trial program, said Christen M. Anderson, MD, the former vice president of Arena and medical director for development of the drug.
"Yes, Ed, you definitely were on lorcaserin," she said in a telephone interview.
She also told me that Arena officials had followed the articles I wrote about my progress.
Although Arena did not establish an extension trial, Anderson said that the company plans further trials, possibly combining lorcaserin with other medications to enhance its impact.
"While your experience in losing weight was remarkable," she said, "the drug did not work as well for others."
Anderson, who retired from Arena a couple of weeks before the drug was approved, said she believes that once labeling and other technical issues with the approval process are resolved the drug will be rolled out, but probably without a lot of fanfare.
She said that Arena licensed the drug to Eisai Pharmaceuticals for sale in the U.S. Eisai did not respond to requests for when they expect to roll out the drug.
Although I have maintained my weight loss, my battle of bulge is not yet over.
At 6 feet, 1.5 inches, my body mass index is still 30.5, which still puts me in the obesity level. That compares with my trial baseline body mass index of 38.1. Moreover, keeping my diabetes under control remains a struggle.
"I can tell you for sure that things would be a whole lot worse if you hadn't lost that weight in the clinical trial," my primary care doctor, Derek Vigil, MD, associate clinical professor of medicine at University of Miami/Florida Atlantic University School of Medicine, Boca Raton, told me.
Since the trial ended, Vigil has asked me at every check-up if lorcaserin had been approved, the last time actually on the day that the FDA gave its go-ahead.
"I am very interested in prescribing lorcaserin for my patients, like you, who were overweight and diabetic," Vigil said. "I will usually wait for the drug to be on the market for 6 months to a year before offering it to my patients, in case there are some late issues," he explained. "But we do not have a good weight-loss medication that can be used for long term. We really need something."
Vigil has been my doctor since 2002, and had constantly urged me to lose weight -- yet, every time I appeared at his office, my weight had increased. That led to increases in medicines to treat blood pressure, hypercholesterolemia and, of course, diabetes.
"I was truly impressed at how you were able to lose weight in the clinical trial," he said. "As you know, you had been my patient for at least 3 years before you entered the trial and we had never been successful in getting you to lose weight," Vigil said.
Moreover, he said that my experience with the drug -- significant weight loss with no adverse events -- eased his concerns about safety.
"However, as you have experienced, weight loss by itself may not be enough to control diabetes and we may have to consider other diabetic medicine," he told me, explaining that both my age and my weight made my diabetes more difficult to control.
Although Arena did not establish an extension trial, Anderson said that the company plans further trials, possibly combining lorcaserin with other medications to enhance its impact.
"While your experience in losing weight was remarkable," she said, "the drug did not work as well for others."
While in the study, I was required to monitor my blood sugar at least twice daily -- but I routinely checked my glucose about four times a day. I also wore a pedometer to measure physical activity.
Each patient was put on a calorie restriction regimen -- in my case, it was 2,100 calories and I was required to keep a food diary.
I had few problems with any of these requirements with the exception of exercise -- I was never able to achieve the exercise goals given to me.
Like the other study participants, I also had monthly dietary and nutritional counseling.
At baseline, all study participants underwent dual energy x-ray absorptiometry (DXA) scanning, and a second DXA was performed after 12 months to track the impact of treatment on bone structure.
Everyone also had echocardiography at baseline, 6 months, and 12 months to determine what effect -- if any -- the drug had on heart valves.
And all participants were evaluated for changes in sleep patterns, dreaming, or suicidal ideation -- all problems that have been observed with other diet drugs.
In my case, I had no changes in the psychological testing, no apparent changes in heart valves, and no apparent impact on bones. The DXA scan, however, did reflect the weight loss I experienced. In the baseline scan, my body habitus -- i.e., my fatty body -- slightly extended outside the scan frame; at the trial's end, my body habitus fit easily in the picture.
Anderson said that same phenomenon was seen in many patients in the trial.
Lorcaserin targets receptors in the brain as a way to boost a person's will power to change eating habits. In my case, it spilled over to other habits as well -- I stopped biting my nails -- a compulsive behavior I had for about 60 years. Despite some bouts of recidivism in that respect, I still require -- happily -- regular visits to a manicurist to trim the nails.
Anderson said that other trial participants also reported favorable changes in habits, and there is a possibility that the company will undertake clinical trials to determine if the drug can be used in those areas.
Finally, the lorcaserin trial was a good experience for me, but I am still fat. I need to lose at least another 20 pounds.
And my next conversation with my primary care doctor may be about a lorcaserin prescription.
Disclosures
Susman had no disclosures.
Anderson is a former employee of Arena Pharmaceuticals.
Vigil had no disclosures.