First Global Atrial Fibrillation Registry, RecordAF, Shows Rhythm-Control Strategy With Current Therapies Achieves Improved Disease Control but not Clinical Outcomes

October 19th, 2009 MONTREAL - New results from ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation), the largest clinical trial ever performed in patients with type 2 diabetes worldwide, provide important insights into the therapeutic strategy to adopt for efficient and safe blood glucose control aimed at the reduction of severe diabetes complications.(1) The new data from ADVANCE, presented today at the International Diabetes Federation (IDF) Congress, show that the efficacy and safety of intensive blood glucose control using gliclazide modified release (MR) (Diamicron MR)-based regimen is maintained across a broad range of patients in different clinical settings.(1) ADVANCE demonstrated that intensive glucose control with a gliclazide MR-based treatment regimen in people with type 2 diabetes reduces the combined risk of microvascular and macrovascular events, primarily through reductions in the risk of diabetic nephropathy.(2) "Intensive glucose control with a gliclazide MR-based regimen was effective in lowering HbA1C, irrespective of age, duration of diabetes, sex, body mass index, or HbA1C at study entry, and also irrespective of initial glucose lowering treatment," said ADVANCE Study Investigator Sophia Zoungas from The George Institute for International Health, Australia. "The gliclazide MR-based regimen was well-tolerated with very low rates of severe hypoglycemia and no weight gain." ADVANCE showed a positive trend toward a reduction of major cardiovascular events in diabetes patients who received intensive glucose control.(2) This finding was supported in a recent collaborative meta-analysis of 4 trials of intensive glucose lowering, including ADVANCE and ACCORD, which demonstrated a significant 9% reduction in major cardiovascular events, primarily reflecting a 15% reduction in myocardial infarction.(3) On the basis of observational data, several national registers (including more than 70,000 patients with type 2 diabetes),have recently reported that glucose lowering regimens that included gliclazide were associated with lower risks of mortality compared to other therapeutic strategies.(4,5) "ADVANCE is a huge reservoir of valuable clinical information," concluded ADVANCE Principal Investigator Professor John Chalmers from The George Institute for International Health, Australia.

September 24th, 2009 PARIS - Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has adopted a positive opinion recommending to grant a marketing authorization in the European Union for Multaq(R) (dronedarone - 400mg Tablets). The CHMP has recommended the approval of Multaq(R) in adult clinically stable patients with history of, or current non-permanent atrial fibrillation (AF) to prevent recurrence of AF or to lower ventricular rate.

August 29th, 2009 BARCELONA, Spain - - Six-year GARFIELD Registry to prospectively follow 50,000 AF patients worldwide - The Thrombosis Research Institute (TRI) - an affiliated institute of Queen Mary University of London - today announced the launch of GARFIELD (Global Anticoagulant Registry in the Field), an innovative research initiative to understand the burden of atrial fibrillation (AF) on a global scale. Atrial fibrillation is a common condition in which the two small upper chambers of the heart (the atria) quiver rather than beat rhythmically and can lead to life-threatening complications, including stroke.

July 14th, 2009 BOSTON and EDISON, New Jersey - -- Pharmacokinetic Analysis of Atrial Fibrillation Study May Explain Bleeding Rate Difference between Once-Daily and Twice-Daily Dosing Regimens with Same Total Exposure of Factor Xa Inhibitor -- A sub-analysis of a Phase IIb multinational study(1) with edoxaban(2) -- an investigational oral Factor Xa inhibitor - provides insights into why patients with non-valvular atrial fibrillation (AF) receiving edoxaban once daily (OD) experienced fewer bleeding events than patients given edoxaban twice a day (BID). The analysis finds that bleeding associated with edoxaban is most closely correlated with minimum concentration levels of the drug in the blood, and that these trough levels may best predict bleeding events, rather than total exposure or maximum concentration levels.

July 1st, 2009 PARIS - - Multaq(R) Approved to Reduce the Risk of Cardiovascular Hospitalization in Patients With Atrial Fibrillation or Atrial Flutter - U.S Commercial Launch Planned for the Summer of 2009 Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the U.S. Food and Drug Administration (FDA) has approved Multaq(R) (dronedarone) 400 mg Tablets.

June 7th, 2009 LONDON - Survey Shows Many Doctors Find the Management of Atrial Fibrillation Difficult and Patients are Unaware of the Risks, Complexities and Treatment for This Most Common of Heart Rhythm Disorders Four leading patient and medical associations announced today the formation of AF AWARE (Atrial Fibrillation AWareness And Risk Education), a joint initiative to highlight and address issues that contribute to the growing burden of atrial fibrillation (AF) worldwide. AF is a common yet under-recognised and poorly understood abnormal heart rhythm that is associated with poor quality of life, substantial numbers of hospitalisations, increased risk of severe and potentially fatal cardiovascular complications such as stroke, as well as death.

June 4th, 2009 SYDNEY - Australian researchers have developed gene expression biomarkers which can accurately discriminate pre-cancerous and cancerous colorectal growths from non-cancerous controls. Being presented today at the Digestive Disease Week conference in Chicago, the preliminary findings are the result of a collaborative study - involving CSIRO, Flinders University and Australian healthcare company, Clinical Genomics Pty Ltd - designed to develop an improved screening/diagnostic test for detecting bowel cancer and significant pre-cancer lesions.

June 2nd, 2009 SUNNYVALE, California - Radiofrequency ablation is durable after 2 years, compares favorably with endoscopic resection for advanced disease, and reduces the risk for cancer progression Results from a number of clinical trials were presented during the Digestive Disease Week (DDW) in Chicago this week, revealing new outcomes data related to endoscopic radiofrequency ablation using the HALO ablation system for eradicating a pre-cancerous esophageal condition known as Barrett's esophagus. Among them, reports included durability outcomes from a randomized sham-controlled trial, safety and efficacy outcomes from a large U.S.

April 5th, 2009 LEIDEN, The Netherlands - The Dutch Orphan Disease Registry Consortium is set up in order to build a disease registry framework to collect information on rare diseases, encourage drug development and optimize patient care. The consortium focuses on inborn errors of metabolism as target group of diseases.

March 26th, 2009 MUNICH - Edoxaban (DU-176b) is a direct Factor Xa inhibitor and is developed to prevent thromboembolic events such as stroke and pulmonary embolism. The Phase II Edoxaban programme has been successfully completed for orthopaedic and cardiological indications.

April 4th, 2009 WASHINGTON - Older men who were big during their 20s are at an increased risk of suffering from atrial fibrillation, or abnormal heart rhythm, says a new study. According to the new research from the Sahlgrenska Academy, University of Gothenburg, Sweden, being big includes height and weight.

July 9th, 2009 Merck, Portola in $420M deal for anticlotting drugWHITEHOUSE STATION, N.J. — Merck & Co.

June 3rd, 2009 WASHINGTON - An international team of researchers has discovered an enzyme that plays a crucial role in inflammatory bowel disease (IBD). The researchers hope that the new finding could potentially lead to therapies to help those affected by ulcerative colitis and Crohn's disease, collectively referred to as IBD.

August 31st, 2009 LONDON - A new drug developed as an alternative to popular drug warfarin, also used as rat poison, has been found to significantly reduce stroke risk. Generally, patients at risk of stroke are given warfarin to prevent blood clotting, but the treatment is risky and requires regular monitoring.

August 30th, 2009 Study shows experimental drug cuts stroke riskBARCELONA, Spain — An experimental drug reduces the stroke risk in patients with irregular heartbeats by nearly four times, compared with the popular drug warfarin — but possibly at a cost, according to new research released Sunday. Patients taking the new drug dabigatran etexilate, made by German pharmaceutical Boehringer Ingelheim, also were slightly more likely to have heart attacks or stomach pain, according to the research presented at the European Society of Cardiology meeting in Barcelona.

March 16th, 2009 WASHINGTON - Researchers have come by additional evidence that aspirin seems to reduce the risk of death in women who have heart disease or have had a stroke. The new study also provides fresh insight into aspirin dosing for women, suggesting that a lower dose of aspirin (81 mg) is as effective as a higher dose (325 mg).

September 30th, 2009 House passes registry for convicted arsonistsWASHINGTON — The House has passed a bill sought by California lawmakers that would create a national registry of convicted arsonists. The House passed a similar bill two years ago, but the effort stalled in the Senate.

October 3rd, 2009 WASHINGTON - A new analysis of climate risk has shown that even moderate carbon-reduction policies now can substantially lower the risk of future climate change. To illustrate the findings of their model, MIT (Massachusetts Institute of Technology) researchers created a pair of 'roulette wheels.' This wheel depicts their estimate of the range of probability of potential global temperature change over the next 100 years if no policy change is enacted on curbing greenhouse gas emissions.

May 6th, 2009 HYDERABAD - MakroCare, a global clinical services firm, provides clinical research support to pharmaceutical, biotechnology, and medical device industries, is taking a lead in the training of professionals for the clinical research industry by providing series of informational through workshop and seminars. Advanced GCP workshop will be held at CHITRAMAYEE Auditorium, State Arts Gallery, Kavuri Hills, Madhapur, Hyderabad on May 15.

March 6th, 2009 NEW DELHI - An NGO, working for tuberculosis patients, has initiated a study to know steps taken by parliamentarians to control the disease in their constituencies. 'With nearly 1,000 people dying of tuberculosis everyday in India despite several high quality drugs and well established programmes, it become important to know what people's representatives are doing to control and spread awareness about it,' said Bobby John of the NGO Advocacy to Control TB Internationally (Action) Thursday.