Deprescribing statins “safe”

THE decision about which medications should be continued or deprescribed among elderly patients at the end of life is a difficult balance for GPs, according to a leading general practice expert.

Professor Mark Nelson, professional research fellow at the Menzies Institute for Medical Research, Hobart, and chair of general practice at the University of Tasmania, told MJA InSight that a common catalyst for GPs having to make this choice was when a patient moved into a nursing home.
    
“This is when the main purpose of medication changes, and it becomes more about maintaining quality of life.”

Professor Nelson was responding to a randomised controlled trial published last week in JAMA Internal Medicine, which assessed the safety, clinical and cost impacts of discontinuing statin medications for patients in a palliative care setting. (1)

The US study, conducted between 2011 and 2013, included 381 patients with a mean age of 74.1 years. Patients were eligible for the trial if they had an estimated life expectancy of between 1 month and 1 year, had been on statin therapy for 3 months or more, had recent deterioration in functional status, and no recent active cardiovascular disease. The participants included 22% with cognitive impairment and 48.8% with cancer.

The patients were randomised to either discontinue or continue statin therapy, and were monitored monthly for up to a year. Outcomes measured included death within 60 days, survival, cardiovascular events, quality of life (QoL), symptoms and cost savings.

The authors found that the proportion of participants in the discontinuation and continuation groups who died within 60 days was not significantly different, and did not meet the non-inferiority end point.

Total QoL was better for the group who discontinued statin therapy, and few participants experienced cardiovascular events.

“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 authors wrote.

They recommended that the choice to continue or stop therapy with statin medications merited patient-centred decision making between the physician and patient.

However, an accompanying commentary said that although the study was a great starting point for further research, there were several practical issues to overcome before the results could be incorporated into practice. (2)

These included when to have discussions about medication discontinuation with patients and their caregivers, and the time required to engage in shared decision making on deprescribing preventive medication therapy.

Professor Nelson told MJA InSight that when it came to deprescribing medication in older patients, treatments generally fell into two categories which required careful consideration and patient-focused decision making.

“Firstly, there are medications that provide symptomatic relief, and you have to consider whether stopping these [medications] will greatly exacerbate symptoms and cause the patient discomfort. This could happen with a PPI (proton-pump inhibitor).”

However, decisions to discontinue preventive medications were more complex.

“If these medications are stopped, it might lead to a non-fatal catastrophic event, like a stroke, which could leave the patient disabled for the last 6 months of their life”, he said.

Associate Professor Leon Simons, professor of medicine and director of the lipid research department at the University of NSW, told MJA InSight that the study provided valuable reassurance to both doctor and patient that deprescribing statin therapy was safe in a palliative care setting, because “for people with a limited life expectancy, statin therapy can be both costly and burdensome”.

However, he said it would be premature to apply these findings to other medications, such as antihypertensives or oral diabetes medication, without further research.

Professor Simons also warned against broadening the implications of the results, saying that recent research on statin therapy had already been misrepresented in the media.

“This is a nice piece of research, but it is a small study on a specific group of people — those with limited life expectancy”, he said.

“We shouldn’t go extrapolating these findings and apply them to all elderly patients, because the mean age in the study was only 74.”

Professor Sarah Hilmer, conjoint professor of geriatric pharmacology medicine at the University of Sydney’s Northern Clinical School, is part of a research team attempting to broaden Australia’s data on deprescribing in older patients in nursing homes.

Professor Hilmer told MJA InSight the results of her research would provide vital information to GPs about the safety of deprescribing a range of medications in these patients.

“It will be 2 years before the results are published, but we hope to have data on more than 1000 people in nursing homes”, Professor Hilmer said.

1. JAMA Internal Medicine 2015; Online 23 March
2. JAMA Internal Medicine 2015; Online 23 March

Also in MJA InSight this week, Associate Professor Leon Simons discusses the link between statins and diabetes — click here