A new drug from Sanofi-Aventis reduced significantly episodes of atrial fibrillaton or irregular heart beat in two clinical studies released on Sunday.
The trials showed that patients given dronedarone went, on average, 2.3 and 2.7 times longer than those on placebo before experiencing heart flutter. The risk of a first occurrence was also reduced significantly, by 21.6 and 27.5 percent, over a one-year period. There was, however, no significant reduction on mortality in the Phase III studies, which involved a total of 1,507 patients. “The results of the ADONIS and EURIDIS trials appear to position dronedarone as a promising option for cardiac space and rate control in atrial fibrillation,” Stefan Hohnloser of JW Goethe University in Frankfurt told the annual meeting of the European Society of Cardiology. Dronedarone is an improved version of an earlier drug called amiodarone, which is now off patent and which has been linked to organ toxicity. Because of its problems, many doctors have been reluctant to use amiodarone except as a second-line therapy. Hohnloser, an investigator on the EURIDIS trial, said dronedarone showed no such problems. Industry analysts view dronedarone as an interesting product but not all are convinced it has blockbuster potential. Some are concerned that the drug’s improved side effect profile may have been achieved at the expense of lower efficacy. Dronedarone suffered a setback in another trial last year when it failed to demonstrate benefit in patients with congestive heart failure, delaying its path to market and reducing its overall sales potential. Newly merged Sanofi-Aventis is keen to demonstrate the potential of its new drug pipeline, especially given patent uncertainties surrounding its top-selling blood thinner Plavix. Most attention is focused on its promising anti-obesity and anti-smoking drug Acomplia, or rimonabant, which is a major talking point at this week’s cardiology meeting.(Source: Reuters Health News: August 2004.)