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| |  Initial results from the 4S trial, discussed at the American Heart Association meeting last November, showed that treatment with simvastatin over the 5.4 years of the trial significantly reduced all-cause mortality and morbidity in patients with coronary heart disease (CHD). It reduced the risk of coronary events by 34% and the risk of stroke and transient ischemic attacks by 30%. The 4S trial is the first study to show such conclusive results. At the American College of Cardiology meeting in New Orleans this week, Drs. Terje Pedersen and John Kjekshus provided further important findings from this study. Reduced need for hospital care In his analysis of resource utilisation, Kjekshus noted that treatment with simvastatin significantly reduced need for and duration of hospitalisation. The number of hospitalisations for CHD was reduced by 32% in the treatment group. In the placebo group, 1,076 acute coronary hospitalisations occurred compared with 730 in the simvastatin group. The total number of days spent in hospital for CHD was reduced by 36%. Patients in the placebo group spent 6,407 days in hospital for cardiovascular illnesses compared with 4,083 days for patients taking simvastatin. Subjects treated with simvastatin also benefited from a 32% reduction in the need for intervention such as coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA). In the placebo group, 413 CABGs or PTCAs were performed in contrast to 279 in the treatment group. Consistency of benefit According to Pedersen, lipid-lowering with simvastatin is beneficial across typical subgroups of cardiac patients. The 4S trial demonstrated reductions in total mortality and major coronary events regardless of age; likewise, men and women were equally affected by treatment. Results were also consistent for subjects with and without hypertension. Those with MI or angina benefited equally, and the 20% of subjects who had angina previous to the trial had a better prognosis if treated. Subjects who continued smoking after entering the trial experienced slightly less - but still substantial - benefits. In a Q&A session after the presentation, the panellists indicated that diabetic patients also derived benefits; they will release more detailed information later in the year. Many patients who are candidates for cholesterol lowering are already treated with drugs other than HMG-CoA reductase inhibitors. Results from 4S indicate that the beneficial effects of cholesterol lowering with simvastatin are independent of concomitant medications such as acetylsalicylic acid (ASA), b-blockers, and calcium-channel blockers. Changing clinical practice Discussion after the presentation focused on the need for convincing physicians to rapidly incorporate new knowledge into clinical practice. Dr. Robert Vogel of the University of Maryland noted that many physicians are slow to react to significant findings from trials such as 4S (which he called "the smoking gun" of the cholesterol hypothesis) because "they're too simple... We like to do the most expensive, most sexy things." Dr. Salim Yusuf of McMaster University, who said that results from 4S on total mortality are "comparable or better" to those from currently accepted therapies, commented that medical education is usually problem-oriented rather than evidence-based and thus contributes to the slowness in changing clinical practice. Prof. Sanford Schwartz, executive director of the Leonard Davis Institute of Health Economics at the University of Pennsylvania, commented in an earlier interview that "simvastatin provides substantial health benefits at very modest cost and may even save money in some patient groups... What we need to focus on as a medical community is how to use this therapy more frequently and more effectively." |
