Acomplia produced disappointing results in slowing progression of coronary artery disease in patients and it significantly raised the risk of anxiety and depression, according to a report in the April 2 issue of the Journal of the American Medical Association.
More than 20 percent of patients who took rimonabant in the STRADIVARIUS trial developed psychiatric problems, the researchers reported.
While Acomplia is sold in European Union countries and some other nations, Sanofi Aventis pulled back its U.S. application last year after an FDA advisory panel recommended against approval of rimonabant because of concerns over psychiatric risks.
The researchers reported that the study failed to meet its main goal of reducing the Percent Atheroma Volume (PAV), a measure of plaque in a cross-section of the arteries, although it did reduce the Total Atheroma Volume (TAV), a measurement of total plaque in the coronary artery.
But more attention seems certain to be focused on this latest effort to assess the extent to which Acomplia carries with it an increased risk of psychiatric side effects.
The researchers in the STRADIVARIUS study included patients with a history of such problems, and reported that 23.4 percent of patients who got Acomplia suffered psychiatric side effects such as depression and anxiety compared to 18.4 percent of patients who were in the control group.
But despite that ,reserchers have also goosd news about Acomplia.They descovered why this amaizing diet pill has some side effects.
Acomplia, in addition to promoting weight loss by blocking the body’s CB-1 receptors, may also block a receptor in the brain called TRPV1, possibly explaining why the diet pill produces depression, anxiety and suicidal thoughts in some patients, according to researchers.
“It’s possible that when people are taking the drug rimonabant, and the dose range is correct, it may not affect TRPV1 at all,” A specialist said. “However, in some people, Acomplia could be hitting TRPV1 and may well have an effect on activating this receptor,so the solution could be here”
So with the right dosage Acomplia may not affect people at all,but now this great discovery people could use a higher dosage without any side effect.
This is a great news for all over weight people ,that need help to change their lifes,so all we can hope now is that reserchers use properlly this discovery and the FDA finally to aprove this amaizing pill,Acomplia .
Archive for April, 2008
What is??
Rimonabant works by blocking the CB1 receptor, one of two receptors found in a newly described physiological system called the Endocannabinoid System (EC System), believed to play a critical role in the regulation of food intake and energy expenditure and it also helping by normalizing the over-activation of the EC system and making hunger or cigarette pangs more manageable.
Taranabant is a highly selective blocker of the cannabinoid-1 receptor (CB1R), which is believed to be responsible for regulating weight by impacting appetite and food intake, satiation (the feeling of satisfaction or fullness after a meal), energy expenditure and cravings.
Trial results
Phase III multicentre Rimonabant In Obesity (RIO) trials: Sanofi-Aventis SA, the world’s third biggest drug maker, said its experimental anti-craving pill, rimonabant, helped obese patients to lose their weight about 27 pounds and trim 4.5 inches from their waists. Among patients, 44.2% of patients treated with rimonabant 5 mg/day lost more than 7% of their initial body weight, compared to 67.4% of patients in the 20 mg/day group. Where as 5.3% of patients on rimonabant 5 mg/day lost more than 15% of their initial body weight compared to 39% of those on 20 mg/day.The weight that was lost wasn’t gained back for the next 2 years.
Phase III study of Taranabant:In this study, patients taking taranabant 2 mg experienced more than double the amount of weight loss at 52 weeks compared to patients treated with placebo. Patients on taranabant 2 mg demonstrated a mean weight loss reduction from baseline of 4.6 kg (95 percent CI: 6.4 kg to 4.9 kg) compared to 1.8 kg (95 percent CI: 2.3 kg to 1.4 kg) for patients on placebo, which was statistically significant (p<0.001 vs. placebo), at 52 weeks. Maximum weight loss in this study was achieved by week 36 and was maintained throughout the next 16 weeks of the study in patients taking taranabant 2 mg.
Side effect
Rimonabant has some common side effects whitch are known to include:depression, anxiety, insomnia, disorientation, nausea, hallucinations, headache, hypertension, kidney and heart damage, heart attack, palpitations, strokes, and hyperphagia, dizziness and gastrointestinal discomfort.Another side effect of rimonabant are suicidal thoughts,but this appear only in patients that are on antidepressent drug also.
The result of Tarabant are worse than we expected,because by taking tarabant people are not lossing weight ,but they suffer major side effect. Analyst Aileen Salares, in a research report based on an abstract of data from the two-year Phase III trial of taranabant, said the diet pill did not live up to expectations and had worse psychiatric and neurological side effects than anticipated.She added that the safety profile of the 2 milligram dose of the drug was “not nearly as clean as expected” with twice as many participants dropping out of the trial because of psychiatric side effects as patients taking a placebo.
Other benefits
Rimonabant can be used also as a pill for helping people quit smoking. Althought Rimonabant has not officially been approved for use as a smoking cessation aid, its effects on smoking are quite encouraging. Acomplia helps people with other problems and diseases such as diabetics,cardiovascular risks and the newest one is resistens to alcohol fat building effect in the liver. Alcoholic fatty liver is a cause for more serious disease.
Taranabant:The one-year study involved 414 patients randomly assigned to take 2 milligrams of taranabant daily and 417 patients given placebo.Results showed that patients reached their lowest weight about nine months into the study. They were then able to maintain that weight for the rest of the year, Aronne says.Patients taking taranabant also experienced a rise in levels of HDL”good “ cholesterol and a drop in triglyceride levels.


