A CDU

According to the Carvedilol or Metoprolol European Trial (COMET), chronic heart failure (CHF) patients treated with the beta blocking agent carvedilol had a significant survival benefit 17% better than those taking the selective beta blocker metoprolol. The COMET findings were released last month during the European Society of Cardiology's (Sophia Antipolis, France) Heart Failure 2003 meeting in Strasbourg, France.

Also published in the July 5 issue of The Lancet, the COMET findings "provide clear evidence of the superior survival benefits of carvedilol over metoprolol in the treatment of chronic heart failure and suggest that carvedilol prolongs the life of patients by 1.4 years compared to metoprolol," according to Professor Philip Poole-Wilson, chairman of the COMET Steering Committee. "Carvedilol's significant survival benefit could mean thousands of lives saved each year," he said, adding that the results "will have a major impact on clinical practice."

Beta blocking agents are recommended in the guidelines of such major cardiovascular societies as the European Society of Cardiology, the American Heart Association (Dallas, Texas) and the American College of Cardiology (Bethesda, Maryland) for the treatment of mild, moderate and severe CHF. They also have been clinically proven in a number of major clinical trials.

With more than 14,000 patient years of follow-up, COMET is the largest and longest study in CHF and the first head-to-head survival study comparing two beta blocking agents in such patients. The study was focused on determining whether carvedilol was superior in terms of survival to metoprolol in the treatment of CHF patients. Although both are classified as beta blockers, these two drugs have different properties. Carvedilol provides not only Beta-1 receptor blockade, but also blocks Beta-2 and Alpha-1 receptors and displays additional ancillary properties.

Experts in the field suggest that there may be more than 10 million people with CHF in Europe alone. Prognosis for such patients is generally poor, with around half of all of those diagnosed dying within three to five years.

The COMET trial enrolled 3,029 patients from 15 European countries with mild to moderate to severe (New York Heart Association class II-IV) CHF. All were followed up for more than 45 months.

The trial was jointly sponsored by F. Hoffmann-La Roche (Basel, Switzerland) and GlaxoSmithKline (London). Carvedilol is marketed worldwide by Roche under various trade names. It is marketed in North America by GlaxoSmithKline under the name Coreg and in Japan by Daiichi under the trade name Artist.

Direct UK sales force for AED maker

Cardiac Science (Irvine, California) said in June that it has established a direct sales operation in the United Kingdom through the acquisition of LifeTec Medical Ltd. (Timperley, UK), which had been the principal distributor of the company's automated external defibrillator (AED) products in that country.

The financial terms of the all-cash transaction were not disclosed.

Raymond Cohen, president and CEO of Cardiac Science, said that to date, "our UK network has been competing with direct sales efforts of our competitors and we feel that establishing a direct sales and sales management presence is warranted to ensure that we increase our share of this market." He said that he "is confident in our ability to grow that business more rapidly and more profitably by taking the operation in house."

Stuart Hildage, who had been managing director of LifeTec, will continue as managing director of the new Cardiac Science (UK) sales organization. Cardiac Science said that under Hildage's leadership, LifeTec had captured an estimated 20% share of the AED market in the UK for the company's Powerheart AED. Cohen referred to the customer base and "rich pipeline of prospects established by LifeTec under Mr. Hildage's leadership" as "valuable assets" for Cardiac Science as it grows its UK business.

While the new Cardiac Science (UK) sales organization will operate from Lifetec's existing offices in Timperley, the company said all other functions would be relocated to its international headquarters in Copenhagen, Denmark, in order to leverage the existing operational and administrative infrastructure.

In addition to Powerheart AEDs, Cardiac Science manufactures Diascope brand patient monitors and the Powerheart CRM, which it describes as "the only FDA-cleared therapeutic patient monitor that instantly and automatically treats hospitalized cardiac patients who suffer life-threatening heart rhythms."

CARDS study halt validates Lipitor

The Collaborative AtoRvastatin Diabetes Study (CARDS) Steering Committee announced last month that a major UK trial studying the reduction of cardiovascular disease (CVD) risk in Type 2 diabetes patients using the cholesterol-lowering medicine Lipitor (atorvastatin) has been stopped early.

The decision to stop the CARDS trial early was made because results collected showed a significant benefit to patients receiving atorvastatin in reducing primary endpoints of major coronary events, stroke or coronary revascularization procedures. The interim results are significant and beyond the early termination threshold agreed for the interim analyses, the steering committee said.

The CARDS study was carried out in the UK and Ireland, involved 2,838 patients and was designed to compare the effectiveness of the lipid-lowering drug, for the primary prevention of cardiovascular disease in diabetic patients with some additional risk factors for CVD. Those given atorvastatin 10 mg were found to have significant reductions in primary endpoints compared to those receiving placebo.

The trial, a collaboration between Diabetes UK, the UK Department of Health and Pfizer UK (Surry, UK), was terminated early because interim analyses confirmed the benefit of treatment. All patients are being notified and will have appropriate study follow-up arranged.

"Stopping this study early is an exciting development," said Moira Murphy, MD, director of research at Diabetes UK. "Diabetes UK co-sponsored this work in recognition of its potentially critical importance for people with diabetes. We look forward to seeing the analyzed data later this year and hope that it will add to the existing evidence of the benefit statins can have for people with diabetes. People with the condition are up to five times more likely to develop cardiovascular disease, and we should look at the best ways to prevent this."

"This is the second major atorvastatin trial in the last 12 months which has stopped earlier than anticipated due to benefits over placebo," said Michael Zaiac, MD, deputy medical director at Pfizer UK.

It is estimated that 1.4 million people in the UK have been diagnosed with diabetes, a figure set to double by 2010. Cardiovascular complications, such as coronary artery disease and stroke, are the principle cause of death in up to 75% of patients with Type 2 diabetes.

Atorvastatin is currently not licensed for the prevention of coronary or cardiovascular events and is a prescription-only medicine.