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R&D news in brief

Our weekly round-up of R&D news in brief

Statins boost five-year survival
A fresh look at previously published data from a clinical trial involving more than 450 heart patients has cast light on the potential benefits imbued by taking statins. Of 458 patients with nonischaemic dilated cardiomyopathy (an enlarged heart with reduced pumping ability), one quarter were taking statins to control their cholesterol and these individuals were shown subsequently to have a 78 per cent greater chance of five-year survival, compared with those not on statins. The trial was originally designed to assess the benefits of implantable cardio defibrillators and it was only on re-examination of the data that researchers at Northwestern University noticed the survival benefits in the patients taking statins.

Better access to trial data
It is getting easier for more people around the world to access information and data online about the pharmaceutical industry's clinical trials, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), which has reaffirmed its support of transparency in drug development. The first stage of the IFPMA Clinical Trials Portal (www.ifpma.org/clinicaltrials), launched in September last year, has been improved upon with a more user-friendly, multi-lingual advanced search function, launched in March this year. Welcoming the World Health Organisation's consideration of recommendations for a global approach to clinical trial registration, the IFPMA's new online search function operates in English as well as French, Spanish, German and Japanese, and can access information on more than 30,000 ongoing clinical trials and in excess of 5000 completed trials for drugs already marketed.

Anti-arrhythmia drugs beaten by ablation - study
The use of tissue ablation was shown to have a 75 per cent success rate in preventing arrhythmias in patients for whom at least one drug regimen had failed, compared with a success rate of just 6 per cent through the use of drugs alone. These findings, from a year-long, 112-patient trial, were presented earlier this week at a Heart Rhythm Society meeting in Boston, US. The results are notable, according to lead researcher Dr Pierre Jais, a cardiologist at France's Haut-Leveque Hospital, because the majority of cardiologists still believe regimens of anti-arrhythmia drugs to be the best form of treatment. ìPeople who are performing ablation will tell you that ablation works better than drugs, but these are a minority of cardiologists,î he said. ìMost are not convinced.î

Trial hints at extra indication for AZ drug
AstraZeneca's schizophrenia treatment, Seroquel (quetiapine) may have potential as a monotherapy for acute bipolar depression, according to results reported on Tuesday this week from a trial called BOLDER II. The atypical anti-psychotic is already approved and established as a treatment for the manic phases of bipolar disorder, but not yet for bipolar depression, which could be a new indication for the product. In a randomised trial completed by approximately 300 people, improvements in the severity of depressive symptoms were shown to be significantly greater in patients on Seroquel 300mg/d amd 600mg/d, compared with those taking placebo. These improvements, as measured on the Montgomery-Asberg Depression Rating Scale), were seen to continue unto week eight of the trial. The drug was well tolerated in this setting, with a low rate of serious adverse event rates, but which included constipation, dizziness, dry mouth, sedation and somnolence.

30th September 2008

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