Experimental Weight Loss Pill Accomplia (Rimonabant) Really Works
Latest results in Phase III studies of the experimental weight-loss drug Accomplia (rimonabant) created growing excitement over this potentially major breakthrough in treating obesity. Over 3,000 patients took part in this two-year study in which roughly half took a 20 mg dose of Accomplia, and half the placebo (fake) pill.
The results published in a February 2006 Journal of the American Medical Association (JAMA) article indicated that Accomplia helped obese people lose significant weight (11.7 pounds on average for those taking Accomplia, compared to 3 pounds in the control group). All participants experienced weight loss and reduced caloric intake by about 600 calories.
In addition to weight loss, waist circumference was reduced by 2 inches for the study group, versus 0.7 inches for the placebo or control group. In other positive measures, Accomplia raised good cholesterol, lowered triglicerides, and reduced other cardiac risk factors. In studies of obese diabetics, Accomplia reduced their all-important HbA1c level – a measure of blood sugar control.
Results of four clinical trials totaling 6,000 participants (RIO-Diabetes trial, RIO-North American, RIO Europe, and RIP Lipids) have been submitted to the U.S. Food and Drug Administration and European regulators. Researchers hope to gain approval to market Accomplia widely by summer 2006. This development is exciting news for millions of obese and seriously overweight Americans and Europeans.
Side effects of the Accomplia were mainly mild and occurred during the first few weeks of starting the drug therapy, after which they usually disappeared. Nausea (12 percent), dizziness (9 percent), diarrhea (7 percent), vomiting (6 percent), low blood sugar (5 percent), fatigue (5 percent) and anxiety (5 percent) were among the symptoms that caused a small number of participants to leave the study (about 3 percent on the high dose of Accomplia and 0.9 percent in the placebo group left the study before completion.)
Accomplia is the first of a new line of medications that affect the body’s cannabinoid receptors. In most persons, these receptors act much as marijuana does, altering the mood and increasing the appetite. Because the new drug targets these receptors that elevate mood, some people taking Accomplia became somewhat depressed.
Despite feeling a bit down, they continued the drug, completed the study, lost weight and kept it off as long as they remained on the drug. Study investigators point out that Accomplia is for chronic treatment and patients need to stay on it indefinitely to maintain weight loss and other benefits.
Richard Kahn, chief scientific and medical officer of the American Diabetes Association, noted that the drug has created excitement, but “the real issue is post marketing surveillance.” The true test of Accomplia’s safety will take place when persons taking the drug number in the hundreds of thousands.
The results published in a February 2006 Journal of the American Medical Association (JAMA) article indicated that Accomplia helped obese people lose significant weight (11.7 pounds on average for those taking Accomplia, compared to 3 pounds in the control group). All participants experienced weight loss and reduced caloric intake by about 600 calories.
In addition to weight loss, waist circumference was reduced by 2 inches for the study group, versus 0.7 inches for the placebo or control group. In other positive measures, Accomplia raised good cholesterol, lowered triglicerides, and reduced other cardiac risk factors. In studies of obese diabetics, Accomplia reduced their all-important HbA1c level – a measure of blood sugar control.
Results of four clinical trials totaling 6,000 participants (RIO-Diabetes trial, RIO-North American, RIO Europe, and RIP Lipids) have been submitted to the U.S. Food and Drug Administration and European regulators. Researchers hope to gain approval to market Accomplia widely by summer 2006. This development is exciting news for millions of obese and seriously overweight Americans and Europeans.
Side effects of the Accomplia were mainly mild and occurred during the first few weeks of starting the drug therapy, after which they usually disappeared. Nausea (12 percent), dizziness (9 percent), diarrhea (7 percent), vomiting (6 percent), low blood sugar (5 percent), fatigue (5 percent) and anxiety (5 percent) were among the symptoms that caused a small number of participants to leave the study (about 3 percent on the high dose of Accomplia and 0.9 percent in the placebo group left the study before completion.)
Accomplia is the first of a new line of medications that affect the body’s cannabinoid receptors. In most persons, these receptors act much as marijuana does, altering the mood and increasing the appetite. Because the new drug targets these receptors that elevate mood, some people taking Accomplia became somewhat depressed.
Despite feeling a bit down, they continued the drug, completed the study, lost weight and kept it off as long as they remained on the drug. Study investigators point out that Accomplia is for chronic treatment and patients need to stay on it indefinitely to maintain weight loss and other benefits.
Richard Kahn, chief scientific and medical officer of the American Diabetes Association, noted that the drug has created excitement, but “the real issue is post marketing surveillance.” The true test of Accomplia’s safety will take place when persons taking the drug number in the hundreds of thousands.
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