The early addition of Lipitor (atorvastatin calcium) tablets to effective blood pressure lowering treatment maintained a significant 36 per cent reduction in the relative risk of fatal or non-fatal heart attacks over five years, says a new study on Lipitor, the details of which were released by its maker, Pfizer .
This was a post-hoc analysis (designed and completed following the closure of the trial) of the lipid-lowering arm of the Anglo-Scandinavian cardiac outcomes trial (ASCOT-LLA) follow-up period. A majority of patients who were treated with Lipitor or placebo during a three-year study went on to receive Lipitor during two years of post-study follow up.
Funded by Pfizer, ASCOT was an investigator-led trial coordinated by an independent steering committee.
However, Pfizer has cautioned that Lipitor is not for everyone and definitely not for those with liver problems, women who are nursing, pregnant or may become pregnant. Lipitor is a prescription medication, prescribed for patients with multiple risk factors for heart disease such as family history, high blood pressure, age, low HDL ("good" cholesterol) or smoking to reduce the risk of a heart attack and stroke, certain kinds of heart surgery and chest pain.
At the start of the study, patients had high blood pressure and additional cardiovascular risk factors but no coronary heart disease. ASCOT-LLA is one of the first studies to explore the benefit of controlling more than one cardiovascular risk factor at a time.
"These important results show that early initiation of Lipitor with an effective blood pressure lowering drug regimen may have significant clinical implications for reducing the risk of heart attacks," said Professor Peter Sever, study principal investigator, professor of clinical pharmacology and therapeutics, International Centre for Circulatory Health at London's Imperial College. "It is vital that physicians use the right combination of treatments from the start to maximize the reduction in the risk of heart attacks and coronary heart disease death."
The results were published online in the European Heart Journal.
"Patients with high blood pressure and other risk factors for cardiovascular disease are usually treated with blood pressure lowering medications first," said Professor Bryan Williams, professor of medicine, University Hospitals NHS Trust, Leicester, United Kingdom, and chairman of the British Hypertension Society Guidelines working party.
"It is important to note, however, that many people with high blood pressure are also at sufficient risk of cardiovascular disease to benefit from statin therapy," he said. "Even if patients are prescribed statins in this context, they are generally only treated with statins after lifestyle modifications have failed.
"This study highlights the importance of initiating medical treatment for both blood pressure and cholesterol as soon as possible, and raises questions about medical guidelines that do not focus on early intensive treatment of multiple risk factors, notably blood pressure and cholesterol, in patients with moderate cardiac risk," he said.
The ASCOT study was one of the largest hypertension trials ever conducted with 19,342 patients in Europe. It compared the calcium channel blocker anti-hypertensive Norvasc- based regimen versus a beta blocker-based regimen in reducing cardiac events in patients with high blood pressure and additional cardiovascular risk factors but without coronary heart disease.
Patients in ASCOT-LLA had normal to mildly elevated cholesterol levels (n=10,000), were not candidates for lipid-lowering treatment at the time of the study initiation, and received Lipitor 10 mg or placebo at the outset of the trial.
The ASCOT-LLA part of the trial was expected to last five years, but was stopped early after three years due to a highly significant 36 per cent lower risk of death from heart disease and non-fatal heart attack in patients treated with Lipitor versus patients taking placebo.
At the end of the follow-up period, LDL-C levels were similar in both groups as a result of Lipitor treatment and the average blood pressure level was significantly reduced from 164/95 mmHg to 137/78 mmHg with the blood pressure lowering therapy.