8th Mar 2005 15:21
Initial Results of Large Hypertension Study Reaffirms Norvasc's Therapeutic Benefits to Patients, Pfizer Says Landmark Hypertension Study Stopped Earlier Than Expected Due to Reductions in Cardiovascular Death and All Cause Mortality in Patients Taking Norvasc-Based Regimen ORLANDO, Fla., March 8 -- Pfizer Inc said today that preliminary results of a large hypertension clinical trial showed that patients receiving treatment based on its calcium channel blocker Norvasc (amlodipine besylate) experienced significant reductions in cardiovascular mortality and all cause mortality, and also had significantly fewer heart attacks and strokes. These initial data reaffirm the cardiovascular benefits of Norvasc, and were presented today at the annual American College of Cardiology meeting in Orlando, Florida. Involving nearly 20,000 patients with high blood pressure, the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT) was designed to compare the 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. The trial was stopped early because preliminary data showed that patients receiving the Norvasc based regimen demonstrated a 25 percent reduction in cardiovascular death and a 15 percent reduction in total mortality. 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, they showed significant reductions in stroke, coronary events and they were also less likely to develop diabetes compared to patients taking the beta-blocker based regimen. 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 atenolol, received a diuretic and Cardura XL (doxazosin GITS), if needed. Funded by Pfizer, ASCOT is an investigator-initiated trial coordinated by an independent steering committee. The study began in 1998 and enrolled patients in the United Kingdom, Ireland, Sweden, Norway, Denmark, Finland and Iceland. In December 2004, the independent ASCOT steering committee endorsed the recommendation to stop the trial early due to favorable benefits demonstrated by patients in the Norvasc-based regimen. "It is clear, based on these preliminary ASCOT results as well as previous studies that a Norvasc based blood-pressure lowering treatment regimen results in cardiovascular benefits for patients with high blood pressure" said Dr. Joseph Feczko, Pfizer's chief medical officer. "We look forward to seeing the final study results." ASCOT also included a lipid lowering arm. In October 2002, the lipid lowering arm was also stopped earlier than expected due to a significant benefit in the reduction of heart attacks in patients treated with Lipitor (atorvastatin calcium). This sub-set of patients in ASCOT also had normal to slightly elevated cholesterol levels, and would usually not be considered for lipid lowering treatment. Patients received Lipitor, or placebo to evaluate the cardiovascular benefits in hypertensive patients regardless of their cholesterol levels. "ASCOT highlights the benefits that both Norvasc and Lipitor can provide to patients with high blood pressure and other risk factors. With Caduet, physicians have the option to offer patients the benefits of Norvasc and Lipitor in a single pill treatment," said Dr. Feczko. Norvasc (amlodipine besylate) is indicated for high blood pressure and angina. In clinical trials, the most common side effects for Norvasc versus placebo were edema (8.3% vs 2.4%), headache (7.3% vs 7.8%), fatigue (4.5% vs 2.8%), and dizziness (3.2% vs 3.4%). Caduet (amlodipine besylate/atorvastatin calcium) is a prescription drug used with diet and exercise to treat high blood pressure, high cholesterol and angina, and reduces the risk of heart attacks. Caduet is not for everyone. It is not for those with liver problems or for women who are nursing, pregnant, or may become pregnant. The most common side effects are swelling, headache and dizziness. They tend to be mild and often go away. Patients should talk to their doctor about all medicines they are taking to help avoid serious drug interactions. Doctors may do blood tests to check liver function before and during treatment. Patients treated with Caduet should tell their doctor if they feel any new muscle pain or weakness which could be a sign of serious side effects. SOURCE Pfizer Inc 03/08/2005 /CONTACT: Vanessa Aristide, +1-212-733-3784, for Pfizer, Inc/ /Photo: A free corporate logo to accompany this story is available immediately via Wieck Photo Database to any media with telephoto receiver or electronic darkroom, PC or Macintosh, that can accept overhead transmissions. To retrieve a logo, please call 972-392-0888./ /Web site: http://www.pfizer.com / ENDPFIZER INCRelated Shares:
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