November 22nd, 2011

Long-Term Follow-up of HPS Shows Extended Benefits of Statins

Long-term follow-up of patients enrolled in the Heart Protection Study (HPS) demonstrates continued benefits in the group originally randomized to receive simvastatin instead of placebo. The main results of the HPS, published in 2002, showed a significant 23% reduction at 5.3 years in major vascular events associated with simvastatin treatment among the 20,536 patients with coronary disease enrolled in the trial.

Now the HPS investigators report the follow-up results after a mean of 11 years in a paper published online in the Lancet. After the trial ended, statin use and, consequently, LDL levels were similar between the two groups. In the first post-trial year, patients who had been randomized to simvastatin during the trial had an additional 14% reduction in events compared with patients who had been randomized to placebo (p=0.05). After the first post-trial year, there were no further additional differences between the former groups, but the relative difference between the two groups remained unchanged.

Overall during the post-trial period, there were no significant differences between the two original randomized groups: 21.7% and 22.5% of the patients originally allocated to simvastatin and placebo, respectively, had a first event (RR 0.95, CI 0.89-1.02, p=0.17). The incidence of cancer was the same in both groups: 17%. No other safety signals emerged during the 11 years.

In an accompanying comment, Payal Kohli and Christopher Cannon write that the long-term results of the HPS “suggest that the early benefit of statins is likely to be followed by a prolonged legacy period, with benefit maintained over time” and “that extended use of statins is safe with respect to possible risk of cancer and non-vascular mortality.”

3 Responses to “Long-Term Follow-up of HPS Shows Extended Benefits of Statins”

  1. There continue to be people who question the long-term safety of statins, as a means of not recommending them for primary prevention. This study should help assuage their fears (or misguided excuse).

    Competing interests pertaining specifically to this post, comment, or both:
    Research grants/support from the following companies:


    Advisory Board (but funds donated to charity)
    Bristol-Myers Squibb/Sanofi

    Honoraria for independent educational programs: AstraZeneca, Pfizer

    Clinical Advisor, equity in Automedics Medical Systems.

  2. The same is true for use of statins in women (including in primary prevention). A recent meta-analysis of 18 clinical trails with >40,000 women showed a 19% RRR in women, regardless of baseline risk.

  3. Stewart Mann, DM (Oxon), FRCP(UK), FRACP says:

    … but if baseline risk is very low (as in many healthy women), absolute risk reduction may be negligible (a judgement that should be determined by the fully informed patient).