Hypertensive Patients Taking On Amlodipine Besylate Experience Cardiovascular Benefits

Landmark hypertension study stopped earlier than expected due to significant outcomes for patients

London, Wednesday 8 December 2004: 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, Istin (amlodipine besylate) experienced favourable cardiovascular benefits.1

Funded by Pfizer, the Anglo-Scandinavian Cardiac Outcomes Trial (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, ASCOT was designed to compare the effects of an amlodipine-based regimen versus a standard beta blocker-based regimen in reducing cardiac events in patients with hypertension and multiple cardiovascular risk factors.2 In the amlodipine-based regimen, patients received the ACE-inhibitor perindopril as add-on therapy. Patients receiving the beta blocker-based regimen atenolol, received a diuretic as add-on therapy. Both arms then received doxazosin GITS, if required.2 As a result of the favourable benefits demonstrated by patients in the amlodipine-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 amlodipine-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 amlodipine’s clinical evidence. We look forward to receiving the fully analysed results.”

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 regardless of their cholesterol levels. In September 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 atorvastatin-treated patients.3

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 approximately 16 million people in the UK.4 It is a leading risk factor for cardiovascular disease-the leading cause of death in the UK. 5 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.