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Norvasc (Amlodipine Besylate) Appears to Achieve Superior Blood Pressure Control with Fewer Heart Attacks: Presented at ESH

KIRKLAND, QC -- June 16, 2004 -- Patients taking Pfizer's blood pressure-lowering medicine Norvasc (amlodipine besylate) achieved superior blood pressure control and had significantly fewer heart attacks, according to findings from a major new clinical trial presented at the annual meeting of the European Society of Hypertension, on June 14, in Paris, France.

The four-year, 15,245-patient trial compared the calcium channel blocker Norvasc with the angiotensin-receptor blocker valsartan. Norvasc patients reached lower blood pressure levels earlier, and maintained better blood pressure control throughout the trial compared with valsartan patients. In addition, Norvasc patients were treated with fewer add-on medications than Diovan patients.

The Valsartan Antihypertensive Long-term Use Evaluation (VALUE) trial was conducted in 31 countries worldwide. The trial was sponsored by Novartis, which manufactures Diovan (valsartan).

"Patients in this study taking Norvasc achieved significantly better blood pressure levels particularly within the first few months of beginning therapy," said Dr. Joseph Feczko, Pfizer's executive vice president of Global Research and Development and president of Worldwide Development. "This important study confirms findings from numerous clinical trials, which demonstrate that Norvasc effectively and safely reduces blood pressure while helping to improve patients' cardiovascular health."

The purpose of the VALUE trial was to determine if at the same blood pressure levels Diovan would have a greater reduction of cardiac events and mortality. The results of the study, which were also published in the June 14 edition of The Lancet, could not prove its hypothesis and showed no significant difference in cardiac mortality/morbidity overall or tolerability between patients treated with either Norvasc or Diovan. VALUE showed that "blood pressure was reduced by both treatments, but the effects of the amlodipine-based regimen were more pronounced, especially in the early period (blood pressure 4.0/2.1 mm Hg lower in Norvasc than Diovan group after one month)." VALUE also showed that consistent with this more pronounced blood pressure lowering, patients taking Norvasc had significantly fewer heart attacks.

The study investigators concluded that the findings "emphasise the importance of prompt blood-pressure control in hypertensive patients at high cardiovascular risk."

"These results clearly show the importance in treating blood pressure early and controlling levels to reduce cardiovascular outcomes," said Dr. Feczko. "Aggressively managing blood pressure to goal levels should be a number one priority for physicians, especially when treating high risk patients."

High blood pressure affects approximately five million Canadians and is a leading risk factor for heart disease and stroke - which are leading causes of death. Despite the abundance of available treatments, the majority of patients have not reached their recommended blood pressure goals. If left untreated, high blood pressure can lead to stroke, atherosclerosis, heart attack, congestive heart failure, kidney failure and blindness.
The 2004 Canadian Hypertension Society (CHS) recommendations indicate threshold blood pressure values for monitoring of anti-hypertensive therapy. They also recommend that hypertension be managed in the context of cardiovascular risk.

Risk factors for developing high blood pressure include age, family history, blood pressure in the high-normal range, lack of exercise, obesity, high intake of alcohol and ethnicity.

Since its global introduction, Norvasc has become the world's most-prescribed branded antihypertensive therapy. Norvasc has been studied in over 400,000 patients and has achieved more than 30 billion patients-days of therapy worldwide.

Norvasc is indicated in the treatment of mild to moderate essential hypertension and chronic stable angina. The adverse events observed in VALUE were consistent with those described in current Norvasc labeling.


SOURCE: Edelman

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