Statin Benefits Last, With No Cancer Risk

http://is.gd/nyYUsa


By Kristina Fiore, Staff Writer, MedPage Today
Published: November 22, 2011
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner
Action Points
Note that the objective of this large study was to assess effects of long term treatment with statins as compared to placebo. The mean in-trial follow-up was approximately five years and the post-trial follow-up of surviving patients when most patients received statins, lasted for approximately six more years.


Point out that the reduction in vascular mortality achieved in the statin group during the trial persisted largely unchanged during the next six years without any identifiable adverse effect thus supporting both early treatment and long-term continuation of statins in patients at increased cardiovascular risk.
Statins are safe and effective in the long run, providing lasting reductions in vascular events and no increased risk of cancer, researchers found.
In a randomized trial, initial reductions in vascular events persisted over 11 years of follow-up compared with placebo, Richard Bulbulia, MD, of the Heart Protection Study Group, and colleagues reported online in The Lancet.

They also found no differences in cancer deaths or cancer incidence at all sites or any particular site.

"Reassuringly, there was no evidence that any adverse effect on particular causes of non-vascular mortality or major morbidity, including site-specific cancer, was emerging during this prolonged follow-up period," they wrote.

The findings "provide further support for the prompt initiation and long-term continuation of statin treatment," they added.

Critics have argued that there is limited evidence regarding the long-term safety and efficacy of statin treatment. Some studies have even shown that lowering cholesterol may be tied to higher rates of certain types of cancer, though they have largely been observational.

So to assess the long-term safety and efficacy of these widely used drugs, the researchers conducted an extended follow-up of the Heart Protection Study, which enrolled 20,536 patients at high risk of vascular and non-vascular outcomes. They were between 40 and 80 years old.

Patients were randomized to 40 mg simvastatin (Zocor) daily or to placebo, and were followed for a mean of 5.3 years during the trial and for six years during a post-trial period.

During the latter period, statin use was comparable between groups.

During the initial trial, the researchers found that simvastatin yielded an average LDL reduction of 1 mmol/L, which was linked with a 23% decrease in major vascular events (P<0.0001).

They also found an 18% reduction in vascular mortality (P<0.0001).

After the initial trial period, when statin use and lipid concentrations were similar between groups, there were no further reductions in major vascular events or vascular mortality, they reported.

"As a result, the cumulative proportions of participants who had major vascular events diverged throughout the in-trial period, and this separation then persisted roughly unchanged throughout the post-trial period," researchers wrote.

Nor were there any differences in non-vascular mortality during either period -- particularly, there were no differences in cancer death or cancer incidence at all sites or any particular site, they reported.

In an accompanying editorial, Payal Kohli, MD, and Christopher Cannon, MD, of Brigham and Women's Hospital, who are also investigators of the TIMI Study Group, said the results, "provide contemporary and confirmatory evidence that extended use of statins is safe with respect to possible risk of cancer and non-vascular mortality."

They noted that the original concerns about statin safety were from observational data, which were likely "heavily confounded."

The balance of evidence now tips in favor of statins' safety and efficacy, and long-lasting benefits, even after stopping therapy, they said.

"For this reason," they concluded, "concerns should be put to rest and doctors should feel reassured about the long-term safety of this life-saving treatment for patients at increased cardiovascular risk."

The study was supported by the UK Medical Research Council, the British Heart Foundation, Merck & Co, and Roche Vitamins.

The Clinical Trial Service Unit has a staff policy of not accepting honoraria or other payments from the pharmaceutical industry, except for the reimbursement of costs to participate in scientific meetings. Members of the writing committee have, therefore, only had such costs reimbursed.

Cannon reported relationships with Accumetrics, AstraZeneca, GlaxoSmithKline, Merck, Takeda, Pfizer, Bristol-Myers Squibb/Sanofi, Novartis, Alnylam, and Automedics Medical Systems.

Kohli reported no conflicts of interest.