Intensive Lipitor Therapy Significantly Reduced hsCRP Levels Further
Than Low-Dose Lipitor
KIRKLAND, QC, Feb. 3 /CNW/ - Patients treated with Lipitor(R)
(atorvastatin calcium) 80 mg had a significant 55 percent reduction in levels
of high-sensitivity C-reactive protein (hsCRP), while those taking Lipitor 10
mg had a significant 21 percent reduction in hsCRP levels at the end of 26
weeks compared to baseline, according to the results from the primary endpoint
of a new study. Patients in this study had stable coronary artery disease,
normal to mildly elevated cholesterol levels and chronic low-grade
inflammation as indicated by elevated levels of hsCRP, which studies suggest
may play a role in determining cardiovascular risk. The findings, from the
Comparative Atorvastatin Pleiotropic effects (CAP) study, were recently
published in Clinical Therapeutics.
"These findings support results from prior clinical trials suggesting
that, in addition to lowering LDL cholesterol levels, Lipitor may help reduce
hsCRP, which reflects the systemic inflammation that might contribute to
increased risk for cardiovascular events," said Dr. Jean Davignon, director of
the hyperlipidemia and atherosclerosis research group at the Clinical Research
Institute of Montreal and a principal investigator of the trial. "Even more
encouraging was the fact that further reductions in hsCRP were observed with
intensive Lipitor therapy versus a lower dose."
The CAP trial was a prospective, randomized, double-blind, 26-week study
designed to examine the effects of low-dose versus high-dose Lipitor on hsCRP
levels in men and women under the age of 80 with stable coronary artery
disease, normal to mildly elevated cholesterol levels and chronic low-grade
inflammation as indicated by elevated levels of hsCRP. The mean baseline hsCRP
concentration was 3.1 mg/L and 3.6 mg/L in the Lipitor 10 mg and Lipitor 80 mg
treatment groups, respectively. Coronary artery disease was defined by at
least one of the following: history of heart attack, stable angina, coronary
narrowing of at least 50 percent, history of unstable angina and history of
coronary artery bypass grafting or coronary angioplasty.
A total of 340 patients were treated with either low-dose Lipitor 10 mg
or intensive Lipitor 80 mg therapy. The primary endpoint of the study was the
percent change in hsCRP after 26 weeks of treatment with Lipitor 10 mg or 80
mg. Comparisons of hsCRP levels at five weeks were pre-determined secondary
After five weeks of therapy, patients treated with Lipitor 10 mg had a
significant 25 percent reduction in hsCRP levels compared to baseline, and
hsCRP levels remained stable at study end (21 percent reduction). Patients
treated with Lipitor 80 mg for five weeks had a significant 36 percent
reduction in hsCRP levels compared to baseline. These levels were reduced
further at study end to a total reduction of 55 percent. The effects of
Lipitor on changes in hsCRP levels were dose dependent; high-dose Lipitor was
associated with significantly greater reductions.
Reductions in hsCRP were largely independent of the significant
reductions in LDL cholesterol that were also observed in both treatment
groups. At 26 weeks, those treated with Lipitor 80 mg had significantly
greater reductions in LDL cholesterol compared to those who received Lipitor
10 mg (51 percent versus 35 percent, respectively).
Both doses of Lipitor (10 mg and 80 mg) were generally well tolerated.
The prevalence of adverse events considered by the investigators to be
treatment-related was 8.2 percent in the 10 mg group and 11.8 percent in the
80 mg group. The most common adverse events, reported with an incidence
greater than 1 percent in either the 10 mg or 80 mg group, were asthenia (1.8
percent and 1.8 percent, respectively), increased creatinine kinase (1.8
percent and 0.6 percent), myalgia (1.2 percent and 2.4 percent), constipation
(1.2 percent and 1.8 percent), increased aspartate aminotransferase (0 percent
and 1.2 percent) and insomnia (0 percent and 1.2 percent). The majority of
adverse events in both treatment groups were mild to moderate in intensity,
with only 1.2 percent of patients in each group reporting severe side effects.
The study was sponsored by Pfizer and led by a joint Canadian/French
steering committee. Patients were recruited from 65 sites in seven countries.
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.
In addition, 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
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.
About Pfizer Canada
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 Canada's
commitment to helping Canadians live happier, healthier and longer lives
extends beyond medication. To learn more about Pfizer Canada's More Than
Medication philosophy and programs, visit www.morethanmedication.ca.
For further information:
For further information: Carolyn Santillan, Edelman, (416) 979-1120,
ext. 351, email@example.com; Christian Marcoux, Pfizer Canada Inc,
(514) 426-6985, firstname.lastname@example.org