Clear Evidence for Nifedipine GITS in High Risk Patients with CAD and Hypertension

(I-Newswire) March 22, 2005 - Reduction of death and cardiovascular events

52 % of the nearly 8,000 patients enrolled in ACTION were found to be hypertensive, although 88 % of these were already on blood pressure lowering therapy. The analysis of this large subgroup demonstrates that adding nifedipine GITS to existing best practice therapy results in a significant 13 % reduction in the combined rate of death from any cause and cardiovascular events.

Remarkable heart failure and stroke findings

Especially striking are a 38 % reduction in new overt heart failure, a 33 % reduction in debilitating stroke and a 16 % reduction in the need for coronary angiography. Since these patients were already receiving best practice therapy (aspirin, ß-blockers, ACE inhibitors, ARBs, diuretics or statins), the findings strongly suggest that current management of these patients can be improved.

"If you have angina and hypertension you should be taking a calcium antagonist like nifedipine GITS. ACTION shows that this is safe and reduces the risk of future events", commented Professor Philip Poole-Wilson, London, Chairman of the independent steering committee of the ACTION study.

The fact that 52 % of the 7,665 patients enrolled in ACTION were hypertensive at baseline was striking, and suggests that the prevalence of hypertension in CAD patients may be much higher than previously believed, according to Professor Peter Meredith, Senior Lecturer at the University of Glasgow.

Major primary and secondary endpoints met

Patients enrolled in ACTION suffered from stable angina pectoris and were randomized to two groups receiving, in addition to their best practice therapies, either nifedipine GITS or a placebo. The patients in the hypertension analysis were followed-up in the trial for at least four years. In addition to the significant reduction in the primary endpoint (combined incidence of all-cause mortality, myocardial infarction, refractory angina, heart failure, stroke and peripheral revascularization) in this subgroup analysis, and the proven safety, nifedipine GITS also significantly reduced the secondary endpoint "any CV event" by 17 % in the hypertensive population. Death and any CV event or procedure was reduced by 10 % and any vascular event or procedure was reduced by 11 %.

The results of ACTION support data from INSIGHT and ENCORE providing further evidence of the double mode of action of nifedipine GITS. According to Professor Meredith, the blood pressure lowering properties of nifedipine GITS are considered to be the major contributors to the reduction in stroke. The striking reduction in heart failure and the reduction in angiography and by-pass surgery may in part reflect the reduction in blood pressure, but this is unlikely to account for all of the benefit. The residual effect probably reflects the vascular protective properties, said Meredith. Patients with coronary artery disease often have hard-to-manage hypertension. The fact that so many of the hypertensive patients in ACTION reached their blood pressure goals is also a clear demonstration of the excellent anti-hypertensive properties of nifedipine GITS.

"ACTION has demonstrated a substantial reduction in coronary procedures, coronary angiograms and by-pass surgery", comments Professor Poole-Wilson. He emphasizes the benefit of using additional medication in these patients before they need these types of invasive procedures. In addition to the costs related to hospitalization and procedures, Poole-Wilson also points out quality of life aspects for the patient. "If I were a patient I wouldn't want those things done to me".

The data from the ACTION Hypertension Subgroup Analysis will be published in the March 2005 issue of Journal of Hypertension (vol. 23, pages 641-648).

Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.

The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.

Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.

Forward-looking statements

This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

http://www.press.bayer.com

Company Contact Information