NEW YORK, Jan. 17 /CNW/ - The early addition of Lipitor(R) (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, according to a new analysis.
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. 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 starting 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 Center 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.
Pfizer offers physicians and patients the option of Lipitor or a
combination medication known as Caduet(R) (amlodipine besylate/atorvastatin
calcium) that includes Lipitor and Norvasc(R) (amlodipine besylate).
ABOUT THE STUDY
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 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.
Funded by Pfizer, ASCOT was an investigator-led trial coordinated by an
independent steering committee.
Lipitor is the most extensively studied and most prescribed
cholesterol-lowering therapy in the world, with nearly 144 million
patient-years of experience. Lipitor is supported by an extensive clinical
trial program involving more than 400 ongoing and completed trials with more
than 80,000 patients.
Lipitor is a prescription drug indicated to lower LDL cholesterol and
other fats in the blood (such as triglycerides) when response to diet and
other lifestyle measures alone have been inadequate, in both adults and
pediatric patients (boys and postmenarchal girls, 10 to 17 years of age, with
heterozygous familial hypercholesterolemia). Lipitor is also indicated to
reduce the risk of myocardial infarction in adult hypertensive patients
without clinically evident coronary heart disease, but with at least three
additional risk factors (such as 55 years and older, smoking and type 2
diabetes) for coronary heart disease.
Lipitor is also indicated to reduce the risk of myocardial infarction and
stroke in adult patients with type 2 diabetes mellitus and hypertension
without clinically evident coronary heart disease, but with other risk factors
such as age (55 years and older) retinopathy, albuminuria or smoking.
In addition, Lipitor is indicated to reduce the risk of myocardial
infarction in patients with clinically evident coronary heart disease.
Lipitor is generally well-tolerated. Adverse reactions have usually been
mild and transient. The most common adverse events were gastrointestinal
complaints, headache, pain, muscle pain and fatigue.
Caduet is a prescription drug that combines two medicines, Lipitor
(atorvastatin calcium) and Norvasc (amlodipine besylate), which have been
extensively studied in clinical trials. It is a single-pill therapy that
reduces global cardiovascular risk in hypertensive patients with risk factors
for cardiovascular disease such as smoking, physical inactivity, being
overweight, high blood pressure and diabetes.
Norvasc is a prescription drug indicated in the treatment of mild to
moderate essential hypertension. Norvasc is also indicated for the management
of chronic stable angina (effort-associated angina) in patients who remain
symptomatic despite adequate dose of beta blockers and/or organic nitrates or
who cannot tolerate those agents.
ABOUT PFIZER CANADA INC.
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., the world's
leading pharmaceutical company. Pfizer discovers, develops, manufactures and
markets prescription medicines for humans and animals. Pfizer's ongoing
research and development activities focus on a wide range of therapeutic areas
following our guiding aspiration: working for a healthier world. For more
information, visit www.pfizer.ca.
For further information:
For further information: Laura Espinoza, Edelman, (416) 979-1120, ext.
245, firstname.lastname@example.org; Christian Marcoux, Pfizer Canada Inc., (514)