NEW YORK, Dec. 8 /PRNewswire-FirstCall/ -- Pfizer Inc said today that early results from a major clinical trial showed that patients receiving a treatment regimen based on its calcium channel blocker, Norvasc (amlodipine besylate) experienced favorable cardiovascular benefits.
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.
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. 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. As a result of the favorable benefits demonstrated by patients in the Norvasc-based regimen, the independent ASCOT steering committee has decided to stop the trial early so that ASCOT investigators and patients can discuss their optimum hypertension treatment moving forward.
"The early stopping of this trial clearly confirms the benefits of blood- pressure lowering with a Norvasc-based treatment regimen for hypertensive patients who have additional cardiovascular risk factors," said Dr. Joseph Feczko, president of Worldwide Development at Pfizer. "This new information, along with the long-term results from the ALLHAT, VALUE and CAMELOT clinical studies further strengthens Norvasc's clinical evidence and underscores that a Norvasc-based regimen may represent optimal care for hypertensive patients."
In addition to treatment for high blood pressure, a sub-set of patients in ASCOT who also had normal or slightly elevated cholesterol levels, and usually not considered for lipid lowering treatment, received Lipitor (atorvastatin calcium) or placebo to evaluate the cardiovascular benefits of lowering cholesterol levels regardless of their cholesterol levels. In October 2002, the lipid lowering arm of ASCOT was also stopped earlier than expected due to a significant benefit in the reduction of heart attacks and stroke in Lipitor- treated patients.
"ASCOT highlights that these hypertensive patients may benefit from a treatment regimen including both Norvasc and Lipitor. With Caduet, physicians now have the option to offer patients a single therapy regimen," Dr. Feczko said. "We look forward to receiving the fully analyzed results."
The ASCOT steering committee has notified patients and investigators in the study to inform them of the appropriate follow-up with their physicians as well as to ensure that patients remain on their present therapy until the final study visit where the need for a potential modification of the treatment will be evaluated.
High blood pressure affects more than 50 million Americans and approximately one billion people worldwide. It is a leading risk factor for heart disease-one of the 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.
Since its introduction fourteen years ago, the safety and efficacy of Norvasc has been supported through an extensive clinical trial program with about 400 completed trials involving more than 600,000 patients.
Norvasc is indicated for high blood pressure and angina. In clinical trials, the most common side effects for Norvasc versus placebo were edema, headache, fatigue and dizziness.
Lipitor is a prescription drug. It is used to reduce the risk of heart attack, and, with a low-fat diet to lower cholesterol.
Caduet is indicated for patients for whom treatment with Lipitor and Norvasc is appropriate.
Caduet and Lipitor are contraindicated in patients with hypersensitivity to any component of this medication; Caduet and Lipitor are contraindicated in patients with active liver disease or unexplained persistent elevation of serum transaminases; in women during pregnancy and in nursing mothers. With any statin, promptly report muscle pain, tenderness, or weakness. This could be a sign of serious side effects.
The most common side effects of Lipitor are gas, constipation, stomach pain and heartburn. The side effects of Caduet are similar to those of Norvasc and Lipitor. 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 or Lipitor should tell their doctor if they feel any new muscle pain or weakness which could be a sign of serious side effects.
For more information, please go to http://www.ascotstudy.org/.
DISCLOSURE NOTICE: The information contained in this release is as of December 8, 2004. The Company assumes no obligation to update any forward- looking statements contained in this release as a result of new information or future events or developments.
This release contains forward-looking information about the Company's products that involves substantial risks and uncertainties. A description of these risks and uncertainties can be found in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2003 and in its reports on Forms 10-Q and 8-K.
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