ORLANDO, FL, Nov. 5 /CNW/ - Pfizer announced today that post-stroke or
post-TIA (transient ischemic attack) patients treated with Lipitor(R)
(atorvastatin calcium) Tablets 80 mg had stabilization or improvement in
kidney function. These results were demonstrated in patients with or without
chronic kidney disease, metabolic syndrome or type 2 diabetes. This post-hoc
analysis of the landmark Stroke Prevention by Aggressive Reduction of
Cholesterol Levels (SPARCL) study, was presented at the Annual Scientific
Sessions of the American Heart Association.
Data from the SPARCL study show that stroke patients with type 2
diabetes, metabolic syndrome or chronic kidney disease are at increased risk
of additional cardiovascular events, compared to patients without these
Analysis of Changes in Kidney Function in the SPARCL study
In this new post-hoc analysis (planned after the study closed) of the
SPARCL study, kidney function was evaluated by estimated glomerular filtration
rate (eGFR, mL/min/1.73m(2)), a standard test to measure how well the kidneys
Post-stroke or TIA mini-stroke patients without chronic kidney disease,
with chronic kidney disease and with metabolic syndrome treated with Lipitor
80 mg had significantly improved kidney function compared to placebo.
In post-stroke or mini-stroke patients with type 2 diabetes, those
treated with Lipitor demonstrated stabilized kidney function, while patients
receiving placebo had significantly declined kidney function during the course
of the trial.
"These results are especially significant for post-stroke diabetic
patients because they are more likely to develop progressive kidney disease,"
said Dr. Vito Campese, chief of the division of nephrology/hypertension at the
University of Southern California. "With Lipitor we were able to stabilize
patients' kidney function, and given the established relationship between
progressive kidney disease and cardiovascular outcome, this may contribute to
reducing cardiovascular events. These results are similar to findings from the
Treating to New Targets study which found that patients with coronary heart
disease treated with Lipitor had stabilized and even improved kidney
Post-stroke or mini-stroke patients treated with Lipitor 80 mg had:
- Significantly improved kidney function compared to placebo in those
2,671 patients without chronic kidney disease (change in eGFR during
the trial 2.22 vs. 0.22 mL/min/1.73m(2), p less than 0.0001).
- Significantly improved kidney function compared to placebo in those
1,315 patients with chronic kidney disease (change in eGFR during the
trial of 3.15 vs. 1.82 mL/min/1.73m(2),p equals 0.017).
- Significantly improved kidney function, measured as change in
estimated glomerular filtration rate, compared to placebo in those
593 patients with metabolic syndrome (change in eGFR during the trial
of 2.39 vs. 0.24 mL/min/1.73m(2), respectively p equals 0.012).
- Stabilized kidney function compared to placebo in those 730 patients
with type 2 diabetes (change in eGFR of -0.735 vs. -4.016
mL/min/1.73m(2), p less than 0.001).
Additional Analysis of Cardiovascular Outcomes in Patients with Chronic
In the SPARCL study, patients with chronic kidney disease had higher risk
of stroke (27 per cent) or major coronary events (70 per cent) compared to
patients without chronic kidney disease.
- In patients with chronic kidney disease, Lipitor 80 mg significantly
reduced the risk of major coronary events (including cardiovascular
death, non-fatal heart attack, resuscitated cardiac arrest) by 39 per
cent compared to placebo, however there was no difference in the risk
of stroke compared to placebo.
About the SPARCL Study
The SPARCL study (n equals 4,731), published in the New England Journal
of Medicine in 2006, is the only study to date evaluating the benefits of a
statin solely in patients with a prior stroke or mini-stroke. Lipitor 80 mg
reduced the risk of an additional stroke by 16 per cent and major coronary
events by 35 per cent compared with placebo.
In SPARCL, Lipitor was well-tolerated. The rate of side effects such as
elevated liver enzymes, muscle weakness or rhabdomyolysis were low and
consistent with the known safety profile.
About Stroke, Kidney Disease and Cardiovascular Disease
Cardiovascular disease is the number one cause of death globally and is
projected to remain the leading cause of death. Every year, an estimated
15 million people worldwide suffer strokes. Stroke is the fourth leading cause
of death in Canada and accounts for seven per cent of all deaths each year.(1)
Approximately 300,000 Canadians are living with the effects of stroke,
including paralysis and impaired cognitive functioning.(2) Often, those who
have had a stroke are at increased risk for stroke recurrence.
An estimated 2.0 million Canadians have chronic kidney disease, or
permanent kidney damage due to injury or disease.(3) Patients with chronic
kidney disease do not effectively filter toxins from the blood. When chronic
kidney disease progresses to kidney failure, either dialysis or a kidney
transplant is needed. Chronic kidney disease recently has been recognized as
an important risk factor for cardiovascular disease, the leading cause of
death and illness in patients with kidney disease. People with chronic kidney
disease are more likely to die from heart disease than to develop kidney
failure. Various illnesses may lead to chronic kidney disease, including high
blood pressure and diabetes, the number-one cause of kidney failure.
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.
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.
(1) Heart and Stroke Foundation. Understanding Transient Ischemic Attack
(TIA). June 2006.
(3) The Kidney Foundation of Canada. Facing the Facts. Winter 2007.
For further information:
For further information: Laura Espinoza, Edelman, (416) 979-1120, ext.
245, firstname.lastname@example.org; Christian Marcoux, Pfizer Canada Inc., (514)