Zosia Chustecka

June 05, 2014

CHICAGO — Stopping statins is safe in patients with a life expectancy of less than a year, according to a new study in which half of the patients had advanced cancer.

For the first time, researchers showed that discontinuation of the cholesterol-lowering medications did not affect overall survival and improved overall quality of life, with a trend toward fewer symptoms. The survival data will be encouraging for oncologists, in particular. Previous studies have suggested that cancer patients taking statins have improved survival, so there has been a concern that their discontinuation could have an adverse effect.

There were also substantial cost savings. The researchers estimate that stopping statins in every American patient with less than a year's life expectancy would save more than $600 million, said study lead author Amy Pickar Abernethy, MD, PhD, medical oncologist and palliative care specialist at the Duke University Medical Center in Durham, North Carolina.

She presented the study results here at the 2014 Annual Meeting of the American Society of Clinical Oncology®.

It seems like common sense to stop medications that are taken for prevention of chronic disease, but there is also worry about "rocking the boat" at this stage of life, said Dr. Abernathy. "We have no guidance on what medicines to stop and when to do so," she added.

"It's a very unique piece of work. There's very little work that looks at the benefit of withdrawing pills," commented Allen J. Taylor, MD, professor of medicine at the Georgetown University School of Medicine and chief of the cardiology division at the MedStar Heart Institute in Washington, DC. He was not involved in the study, and was approached for comment.

"The strength of this work is that it's a randomized trial," Dr. Taylor said. "The authors focus on the important outcomes like quality of life and cardiovascular events. It gives confidence when making decisions that these issues have been examined in a scientific way so patients and doctors can make these individualized decisions."

"The idea here is to individualize decision-making, and it may be very reasonable to withdraw statins and, for that matter, other preventive cardiovascular medications," he added. Dr. Abernethy noted that her group intends to study anticoagulants next.

"It's also worth pointing out that statins have never been tested in people with cancer, and people with less than a year of survival are often excluded from trials that validate the benefit of these medicines. So we don't even know if they provide benefit in that particular patient population for that period of time," Dr. Taylor commented. Also, as the patient's illness progresses, the risk/benefit ratio changes. For example, kidney and liver function change, and this can affect the metabolism of those drugs and alter the safety profile, he added.

First Randomized Trial

The study enrolled patients with life-threatening illnesses (49% with advanced cancer), about whom the treating physician "would not be surprised if they died within a year," Dr. Abernethy commented. However, patients also had to have a life expectancy of more than a month, and a recent deterioration in performance status (within 3 months). Exclusions included known cardiovascular disease or high risk for cardiovascular events, so that the patients who participated were taking statins for primary or secondary prevention; 69% had been taking the statin for more than 5 years. The median age was 74 years, and 75% were Medicare patients.

The study randomized 381 patients; 189 to discontinue statins and 192 to continue on the drugs. At 6 months, there were no significant differences in the rate of death (23.8% in the discontinuation groups vs 20.3%; P = .36), the overall survival (229 days vs 190 days; P  =.06), or in the cardiovascular events (13% vs 11%).

At the same time, there was an improvement in total quality of life and a trend toward fewer symptoms and improved satisfaction.

There was also a substantial cost saving. The researchers calculated that the statin was costing $3.37 per patient per day (which would be $2.97 if generics were used instead, but for the most part they were not; most patients were on branded medications, Dr. Abernethy commented).

The average survival on study was 212 days, so the cost saved per patient during the trial was $714.46 ($629.30 with generics).

Extrapolating these figures to the 2014 population estimate, the researchers calculated that stopping statins in all patients with less that a year's life expectancy could save $603 million ($529 million with generics).

2014 Annual Meeting of the American Society of Clinical Oncology (ASCO): Abstract LBA9514. Presented June 3, 2014.

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