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Back To Vidyya Results Of Lipitor® Trial Demonstrate Significant Reduction In Stroke For Certain Heart Patients

Study Appears In The 4 April 2001 Issue Of The Journal Of The American Medical Association

Pfizer Inc. reported yesterday that newly published results of a clinical study showed that patients treated with Lipitor (atorvastatin calcium) upon hospital admission for an acute coronary syndrome (ACS) were significantly (59%) less likely to experience a non-fatal stroke within the following four months. New findings from the MIRACL (Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering) study were published in the 4 April 2001 issue of the Journal of the American Medical Association.

The ACS (also known as mild heart attack or severe cardiac chest pain) patients were 50% less likely to experience either a fatal or non-fatal stroke (12 patients in the Lipitor group, compared with 24 patients in the placebo group; p=0.045). Nine of the ACS patients experienced non-fatal stroke in the Lipitor group, compared with 22 in the placebo group (59% risk reduction; p=0.02).

"The most interesting and unexpected observation in the study was that the drug reduced by 50% the number of strokes in these patients within just four months," said Gregory Schwartz, M.D., Ph.D., Chief of Cardiology, Denver Veterans Affairs Medical Center, and a Principal Investigator in MIRACL. "And these were patients who were hospitalized with warning symptoms of a heart attack, not a stroke. Therefore the significant reduction in strokes within such a short period of time is notable."

The MIRACL study involved 3,086 patients who received either Lipitor (80 mg daily) or placebo for 16 weeks, both with dietary education and counseling, initiated between 24 to 96 hours of an ACS. Patients ordinarily experience a high rate of death and secondary ischemic events within this four-month period.

The reductions in strokes observed in MIRACL occurred in patients regardless of age, gender, baseline cholesterol levels or whether they had other risk factors such as high blood pressure or diabetes. Study participants' LDL-cholesterol levels declined from an average of 123 mg/dL (3.2 mmol/L) at baseline to 72 mg/dL (1.9 mmol/L) during treatment with Lipitor. Therefore, treatment lowered LDL-cholesterol to levels well below the current recommended guideline of 100 mg/dL (2.6 mmol/L).

Initial results of the MIRACL trial were presented last fall at the 73rd Annual Scientific Sessions of the American Heart Association (AHA) in New Orleans. MIRACL data showed that study participants treated with Lipitor experienced a significant reduction (16%; p=0.048) in the risk of the primary combined endpoint of death, non-fatal acute MI (heart attack), cardiac arrest with resuscitation, or recurrent symptomatic myocardial ischemia requiring emergency rehospitalization. The reduction in the combined endpoint was primarily due to a favorable effect of Lipitor on recurrent symptomatic myocardial ischemia -- or oxygen deprivation to the heart resulting in chest tightness -- which was reduced by 26% (p=0.02).

MIRACL is the first trial that demonstrated a clinical benefit of aggressive lipid-lowering therapy administered within one-to-four days following an acute coronary event. Previous trials with other statins have established the benefit of conventional lipid-lowering therapy in reducing death and non-fatal events in patients with stable coronary heart disease over periods of years.

One hospital survey revealed that many coronary heart disease patients admitted for events do not receive lipid-lowering medication. Specifically only 41% of patients received lipid-lowering medication during hospitalization and only 39% received it at discharge.

No serious adverse events occurred with a frequency >1% in either the atorvastatin or placebo group. Three patients in the atorvastatin group were hospitalized with hepatitis (elevated liver transaminases associated in two cases with jaundice and/or fever). In each case, these abnormalities resolved upon discontinuation of the drug. There were no documented cases of myositis, a rare but severe adverse event associated with statin use.

Atorvastatin is indicated as an adjunct to diet to reduce elevated total- C, LDL-C, Apo B, and TG and to increase HDL-C levels in patients with primary hypercholesterolemia and mixed dyslipidemia. The recommended starting dose of atorvastatin is 10 mg once daily. The dosage range is 10 mg to 80 mg once daily. Atorvastatin is generally well tolerated. Adverse reactions usually have been mild and transient, with fewer than 2% of patients being discontinued from clinical trials due to side effects related to atorvastatin. This rate of discontinuation was comparable to that of placebo. The most frequent adverse effects of atorvastatin are constipation, flatulence, dyspepsia, and abdominal pain. It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of therapy and any elevation of dose, and periodically thereafter. The effects of atorvastatin on cardiovascular morbidity and mortality have not been demonstrated. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation of creatine phosphokinase (CPK).


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Editor: Susan K. Boyer, RN
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