Cholesterol Drug Study

Marylou McNally

Follow-up results from landmark LIPID study show that long-term cholesterol-lowering therapy has additional benefits in saving lives and preventing heart attacks and strokes.

  • The benefits of pravastatin therapy accumulate over time.
    Two-year follow-up data from LIPID study presented at the 73rd Scientific Sessions of the American Heart Association NEW ORLEANS, November 13 - Follow-up of patients after the landmark Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) study provides important new evidence for patients who have suffered a heart attack or unstable angina.

    The LIPID Cohort study:
    In the main LIPID trial (now completed), half the 9,014 heart disease patients received cholesterol-lowering pravastatin and half received placebo for an average of six years. When the trial was over and it was clear that patients on the active drug had benefited, all patients were offered continuing pravastatin treatment.

    Almost all remaining patients (7,680) opted to stay in the study. This whole cohort of patients was followed up closely to see whether long-term therapy was safe and effective. The first stage (which provides an extra two-years of follow-up) is now over, and the analysis shows that the benefits of cholesterol-lowering therapy accumulate over time.

    During these extra two years, patients who received pravastatin therapy during the entire eight-year period were less likely to die or suffer a recurrent heart attack or stroke than the patients who received the therapy only during the last two years. This benefit came during a time when all patients were essentially receiving the same treatment, showing the sustained benefit of earlier treatment.

    The detailed analysis, 'Prolonged and sustained reduction in total and coronary mortality in patients assigned pravastatin in the LIPID trial during two further years of follow-up", was presented today at the 73rd Annual Scientific Sessions of the American Heart Association (AHA) in New Orleans, Louisiana, by Professor John Simes of the University of Sydney.
    "The results of the LIPID Cohort study provide important evidence that patients on long-term pravastatin therapy have further benefits of less risk of death or of a recurrent myocardial infarction or stroke over the longer period, " said Professor Simes, LIPID investigator and director of the NHMRC Clinical Trials Centre at the University of Sydney.

  • Additional survival advantage from long-term therapy:
    Among the patients who had been on cholesterol-lowering therapy since the beginning, the rates of death and major cardiovascular events were lower than among patients who were originally in the placebo group. This was an extra survival advantage for the group of patients who had been taking pravastatin for a long time. It was particularly marked for death from heart disease: the rates were 2.8 per cent for patients on long-term therapy, but 3.6 per cent for patients who had started pravastatin at least six years later.

    The risk reduction with long-term pravastatin therapy was 18 per cent for death from any cause and 22 per cent for death from heart disease. A death was averted for every 26 patients treated over the initial six years. In other words, the benefit of treatment over the initial six years was still evident in this group after the placebo group had gone on to similar active treatment.

    "The data are consistent with both a sustained effect for a further one to two years as well as a delay in treatment effect in preventing deaths," Professor Simes said. "This also means that larger absolute benefits from the initial six years of treatment were seen with extended follow-up than estimated in the original trial. Over eight years of follow-up, the initial six years of pravastatin treatment resulted in fewer events: 38 deaths, 31 myocardial infarctions, 20 unstable angina events, 31 coronary revascularisations, or 10 strokes, for every 1,000 patients treated."

  • Benefits for patient groups:
    These results also attest to the consistency of treatment benefit across a broad range of patient groups: for example, the significant reduction of 19 per cent in the risk of death from coronary heart disease in patients whose initial cholesterol level was relatively low-under 5.5 mmol/L (or 212 mg/dL). These are patients who might be less inclined to seek cholesterol-lowering treatment.

  • Safety of pravastatin:
    The rate of death from cancer was lower, at 4.2 per cent, in the group of patients who had taken pravastatin for eight years, than in those who started out on placebo (4.5 per cent). The rates of death from trauma or suicide were 0.2 per cent and 0.4 per cent, respectively, a reassuring result. The differences were not significant, but were indicative of the safety of long-term treatment.

  • The future:
    The LIPID Cohort study will continue for a further three years, with the researchers continuing to observe the long-term effects and safety of pravastatin.
  • Background:
    The LIPID (Long-Term Intervention with Pravastatin in Ischaemic Disease) Study was conducted by an independent group of researchers and co-ordinated by the National Health and Medical Research Council's Clinical Trials Centre at the University of Sydney.

    The study was conducted under the auspices of the National Heart Foundation of Australia and funded by a grant from the pharmaceutical company, Bristol-Myers Squibb, manufacturers of pravastatin.

    The study involved 87 centres monitoring more than 9,000 patients throughout Australia and New Zealand.

    For further information or interviews please contact the Heart Foundation's National Corporate Affairs and Media Manager,
    Christopher Thomas,
    on 011-612-9219-2413.

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