Discontinuing statin use in patients with late-stage terminal illnesses is safe and may even be beneficial, according to research in JAMA Internal Medicine
published on 23 March 2015.
The researchers found that among patients with a life expectancy of less than one year and no active cardiovascular disease, the number of deaths was not significantly different when statins were stopped, but quality of life improved.
“This study provides evidence that suggests that survival is not affected when statins prescribed for primary or secondary prevention of cardiovascular disease are discontinued in this population,” the researchers say.
The team from the University of Colorado in Denver and Duke University in Durham, North Carolina, evaluated the safety and impact of taking patients off statins in the palliative care setting. Study participants had an estimated life expectancy of between one month and one year, were on statin therapy for three months or more, had recent deterioration in functional status, and had no recent active cardiovascular disease.
Of the 381 patients enrolled in the study, 189 were randomly assigned to discontinue statins and 192 to continue therapy. The proportion of participants in both groups who died within 60 days was not significantly different, comprising 23.8% of those who discontinued the therapy and 20.3% of those who continued it (90% confidence interval [CI], -3.5% to 10.5%; P=0.36). The median time to death for the two groups was similar at 229 days (90% CI, 186–332) and 190 days (90% CI, 170–257), respectively (P=0.60).
Patients in the discontinuation group also showed a reduction in the mean number of non-statin medications they were taking, the researchers note, adding, “it is possible that discontinuing statin therapy reduces the number of adverse effects and decreases the need for medications taken to treat those effects”.
The research team found that total quality of life was better for the group that had discontinued statin therapy (P=0.04). Just 13 participants in the discontinuation group and 11 participants in the continuation group experienced cardiovascular events.
Statins, which help to lower cholesterol and reduce the risk of heart attack or stroke, are among the most commonly prescribed medicines in the United States and the UK. The drugs typically take two years to reach their full effect, and can cause several adverse effects, including gastrointestinal symptoms and musculoskeletal pain.
Patients in their last year of life typically see a 50% increase in the number of medications they take, including those prescribed for chronic conditions, those specific to their disease, and those meant to relieve symptoms. A patient’s ability to metabolise medications and their susceptibility to side effects may also be altered by the effects of advanced diseases, the study’s authors say.
“[This research] is really positive and backs our clinical practice,” says Bisharat El-Khoury, a consultant in palliative medicine at Hayward House, a specialist palliative care unit at Nottingham University Hospitals NHS Trust. “Patients often struggle to take a large number of medications towards the end of their lives when they are often cachectic, frail and struggling to take in food and fluid. Having to take a high number of medications can have an impact on quality of life and affect adherence in terms of patients selecting which medications to prioritise when they are unable to take them all. ’’
El-Khoury adds that she and her colleagues continually review patients’ medication and discuss the benefits and adverse effects of treatments as part of an overall management plan.
“The whole focus of palliative medicine is patient-centred, holistic and individualised care for each person,” she says. “Our aim is to control symptoms and improve the quality of life for patients for however long they are going to live.”
The study co-authors note several limitations of the trial, including the fact that participants knew whether statin therapy was being continued or discontinued, which could create a bias towards identification of more side effects from discontinuing therapy; the team detected no such bias during the trial, they add. They also note that application of the trial results requires clinicians to make a difficult prognosis about the remaining survival time of patients.
Finally, the researchers observed that additional research is needed to investigate the use of other common medicines, such as anticoagulants and antihypertensives, in populations with limited life expectancies.
 Kutner JS, Blatchford PJ, Taylor DH et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Internal Medicine 2015. doi:10.100/jamainternmed.2015.0289.