Press Release, Bayer Pharmaceuticals, re CCB

ANAHEIM, Calif., Nov. 16, 1995

In response to the debate at the American Heart Association annual meeting between Drs. Franz Messerli and Curt Furberg (Calcium Antagonists: Friend or Foe?), Bayer Corporation Pharmaceutical Division and Bayer AG issued the following statement:

As Dr. Franz Messerli conclusively documented in today's debate, Dr. Furberg's data suggesting an increased risk of death in patients treated with calcium channel blockers contain a significant number of errors and flaws. These theoretical conclusions should not be used to guide doctors in counseling their patients.

One issue that all participants in the debate agreed to was the need to increase the number of adequately treated patients with high blood pressure. Of the 50 million patients believed to have hypertension, only 21 percent are currently adequately treated. Once daily calcium channel blockers like long-acting nifedipine are important therapies for the treatment of hypertension, and should facilitate current public health efforts to increase the proportion of hypertensive patients being adequately treated.

No new evidence was presented today that should alter physicians' selection of long-acting calcium antagonists.

Bayer Corporation maintains that its nifedipine products, both in long- and short-acting formulations, are safe and effective in the treatment of cardiovascular disease when they are used as indicated in their product labeling. Bayer bases this belief on its 20 years of experience with nifedipine and a worldwide data base of 70,000 patients who have been included in clinical trials.

The only valuable answers on the long-term role of calcium channel blockers and other cardiovascular therapies will come from government and industry sponsored studies -- and these will take time. Bayer has initiated a 6,500 patient, double-blind randomized, placebo-controlled study that has been approved by ethical committees and is conducted by internationally recognized experts. INSIGHT, the International Nifedipine Study-Intervention as a Goal in Hypertension Treatment, has as its goal to determine the effects of long-acting nifedipine on morbidity among high risk hypertensives when compared to diuretics. Bayer began enrolling patients in this study last year, well in advance of the current controversy, and now approach inclusion of 5,000 patients. With the INSIGHT study Bayer is demonstrating its commitment for further research to support Adalat.

CONTACT: Donald R. Hyman of Bayer Corporation, 203-498-6545; or Dr. Franz-Josef Bohle of Bayer AG, 49-0214-30-3010

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