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| |  Aggressive Cholesterol Lowering With Lipitor Reduces Cardiac Events TORONTO, ON -- July 8, 1999 -- For the first time, aggressively lowering low density lipoprotein cholesterol (LDL-C, also known as the bad cholesterol) to levels below the currently-accepted guidelines (less than or equal to 2.6 mmol/L) was shown to be as effective or more effective than angioplasty and usual care in reducing the incidence of cardiovascular events in patients with stable coronary artery disease (CAD), according to research published today in The New England Journal of Medicine. The landmark study, known as AVERT (Atorvastatin Versus Revascularization Treatments), is the first ever to determine the role of aggressive cholesterol reduction in a patient population who were originally candidates for angioplasty. In Canada, a total of seven trial centres were involved, representing almost one-third of patients (99 patients) who completed the study. Aggressive lipid lowering with Parke-Davis’ and Pfizer Inc.’s Lipitor(R) (atorvastatin calcium) tablets in these patients resulted in a 36 per cent reduction in the combined incidence of cardiovascular events, such as death, nonfatal heart attack, bypass surgery, revascularisation and worsening angina, as compared with patients receiving angioplasty followed by usual care. Although this difference did not reach the level of significance as adjusted for interim analyses, it did reach the conventional five per cent level of significance. In addition, patients who received Lipitor experienced a significant delay in time to the first cardiovascular event as compared with the angioplasty and usual care group. The study concluded that patients with stable CAD who are candidates for revascularisation should be offered the option of aggressive lipid lowering to reduce the incidence of ischemic events. "These findings should provide physicians with the confidence to more aggressively manage LDL-C reduction to below the current guidelines among patients with stable coronary artery disease to help optimise cardiovascular benefits," said Dr. Todd Anderson, clinical cardiologist at Foothills Hospital in Calgary. "This study supports the value of getting these patients to levels below 2.0 mmol/L." Patients randomised to Lipitor achieved a mean LDL-C value of 2.0 mmol/L, while patients in the angioplasty and usual care group achieved a mean value of 3.1 mmol/L. Importantly, AVERT represents the first major lipid-lowering study to achieve a mean of 2.0 mmol/L, demonstrating that such levels were effectively achieved and well tolerated. "These data suggest that effective management of patients with stable coronary artery disease should include long-term aggressive lipid lowering," Dr. Anderson said. "The results also show that Canadian patients with coronary heart disease can reach the more aggressive LDL-C target values as recently recommended by the Canadian Working Group on Hypercholesterolemia and Other Dyslipidemias [less than 2.5 mmol/L]." The 18-month trial included 341 patients with stable CAD from 37 centres in Canada, the United States and Europe, randomised either to 80 mg/day of Lipitor or to angioplasty (which may have included stents) followed by usual care (such as cholesterol lowering therapy). At the time of enrolment, patients in the AVERT trial had one or two coronary arteries with at least 50 per cent narrowing (mean 80 per cent), had no symptoms or mild to moderate chest pain, relatively normal left ventricular function and were candidates for angioplasty. Lipitor has been shown in clinical studies to produce reductions in LDL-C of 39 to 60 per cent in patients with elevated cholesterol across the dose range of 10 mg to 80 mg. Reductions in triglycerides of 19 per cent to 37 per cent were reported in clinical trials across the same dose range. Lipitor is indicated in Canada as an adjunct to diet for the reduction of elevated total cholesterol, LDL cholesterol, triglyceride and apolipoprotein B (apo B) in hyperlipidemic and dyslipidemic conditions, when response to diet and other nonpharmacological measures alone has been inadequate. Additionally, Lipitor has recently been approved for all of the following conditions: dysbetalipoproteinemia (Type III); hypertriglyceridemia (Type IV); and familial hypercholesterolemia (homozygous and heterozygous). The recommended starting dose of Lipitor is 10 mg once daily. The dosage range is 10 mg to 80 mg once daily. Lipitor is generally well tolerated. Adverse reactions usually have been mild and transient, with fewer than two per cent of patients being discontinued from clinical trials due to side effects related to Lipitor. This rate of discontinuation was comparable to that of placebo. The most frequent adverse effects of Lipitor are constipation, flatulence and dyspepsia. It is recommended that liver function tests be performed prior to the initiation of therapy, and periodically thereafter. Myopathy should be considered in any patient with diffuse myalgias, muscle tenderness or weakness and/or marked elevation of creatine phosphokinase (CPK), which may be more frequent when co-administered with drugs that inhibit the cytochrome P-450 metabolising enzyme system. Related Links: Lipitor, Pfizer Inc.
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