Pfizer's Norvasc reduces cardiovascular events

Our News Bureau - Mumbai

A study by Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) show that patients with high blood pressure and additional cardiovascular risk factors, who received Pfizer's calcium channel blocker Norvasc (marketed in India as Amlogard), experienced reductions in cardiovascular death, all-cause mortality and other cardiovascular events, including heart attacks and strokes. The results were published in the The Lancet.

“The results of ASCOT clearly demonstrate that a Norvasc-based anti-hypertensive regimen can reduce the risk of cardiovascular death and a broad range of cardiovascular events in patients with hypertension who have additional risk factors,” said Professor Peter Sever, ASCOT Principal Investigator, Clinical Pharmacology and Therapeutics, International Centre for Circulatory Health at London's Imperial College.

The five-year ASCOT Study, which was one of the largest hypertension trials ever conducted, involved over 19,000 patients in Europe who had high blood pressure. The trial compared the cardivascular effects of a Norvasc-based regimen versus a standard beta-blocker based regimen in reducing cardiac events in patients with hypertension and multiple cardiovascular risk factors. In the Norvasc-based regimen, patients received the ACE inhibitor perindopril and the alpha-blocker Cardura XL (doxazosin GITS) as add-on therapy if   additional blood pressure control was needed. Patients receiving the beta-blocker based regimen of atenolol, received a diuretic (thiazide) and Cardura XL (doxazosin GITS), if needed.

The final results of ASCOT confirmed data safety and monitoring board decision to stop the trial early due to an 11 percent reduction in total mortality shown in patients taking the Norvasc-based regimen. These patients also experienced a 23 percent reduction in fatal and non-fatal strokes and a 24 percent reduction in cardiovascular death, compared to patients taking the beta-blocker-based regimen. In addition, these patients experienced a reduction in the primary endpoint (fatal coronary heart disease and non-fatal heart attack) of 10 percent which did not reach statistical significance.

In addition to treatment for high blood pressure, 10,000 patients in ASCOT, who had normal to mildly elevated cholesterol levels (not typical candidates for lipid-lowering treatment), received Lipitor 10mg (atorvastatin calcium) or placebo to evaluate the cardiovascular benefits of lipid-lowering therapy. In October 2002, the lipid-lowering arm of ASCOT was stopped earlier than expected due to a significant benefit in the reduction of heart attacks and stroke in Lipitor-treated patients.

The results of the lipid lowering arm of ASCOT provided critical information in the development of national guidelines including the National Cholesterol Education Program and the Joint European Guidelines, which now call for more aggressive lipid lowering in patients who have elevated cardiovascular risk, including those with high blood pressure.