Stopping statins may benefit terminally ill patients

Results presented May 30 2014 at the 50th Annual Meeting of the American Society for Clinical Oncology (ASCO) and June 6 at the European Association of Palliative Care Research Conference show that stopping statins for cholesterol management in the late stages of cancer or other terminal illnesses may offer quality-of-life and even life-extending benefits. The results highlight the larger question of when, if ever, it is appropriate in patients with life-limiting illnesses to discontinue medications prescribed for other conditions that will likely not lead to their death.

Researchers from the University of Colorado Cancer Center and the Palliative Care Research Cooperative Group report that discontinuing statins in patients with advanced illnesses resulted in improved overall quality of life, lower costs and no increased deaths. In fact, the patients who stopped taking statins appeared to live slightly longer.

"Based on the study, for patients that are on medications for primary or secondary prevention – for example, those who have not just had a stroke or heart attack – and have a limited life expectancy of less than one year, I would recommend discussing with their physicians the potential to stop taking statins," says Jean Kutner, MD, MSPH, CU Cancer Center investigator and professor of medicine at the University of Colorado School of Medicine.

"We tend to be so focused on which medications are effective to start but there's no research on if and when to stop them. It's a new line of investigation. Especially in the context of end-of-life care, we believe there are many situations in which preventative drugs may be doing more harm than good," Kutner says.

Kutner points to medicines taken to prevent osteoporosis, blood clots, high blood pressure, and diabetes as candidates for future study. These are things people take to prevent something or treat a chronic illness. But particularly in the advanced cancer population, they may not be achieving the intended benefits," Kutner says.

The study enrolled 381 patients who faced the likelihood of dying within a year. All patients had been taking statins for at least three months; roughly half were randomized to continue taking the drug, the other half to discontinuing it.

The researchers followed the patients for up to a year to monitor survival, cardiovascular events and changes in quality of life.

Among the 192 study patients who continued statins, the median survival was 190 days; the 192 participants who stopped taking the drugs had a median survival of 229 days.

Those who discontinued the drugs reported a better overall quality of life, particularly in their psychological wellbeing, and saved money: $716 per person over the course of the trial for name-brand drugs, and $629 for generics.

Using U.S. population estimates, the researchers reported that as much as $603 million a year could be saved if patients in the late stages of fatal illnesses were to cut out statins.

"One thing we found during the study was clinicians saying, 'hey I never thought about stopping people's statins.' The study raised awareness. Here's a setting in which these drugs may not be doing most patients any good any more and bringing up the subject of stopping unneeded medications offers the opportunity for shared decision-making. There's power in individual choice," Kutner says.

How can modern medicine help dying patients achieve a 'good' death?

"Fear of dying is something almost every patient with advanced cancer or other life-threatening illness faces, and helping them, to achieve a "good death" is an important goal of palliative care," says Dr. Sarah Hales, Coordinator of Psychiatry Services, Psychosocial Oncology & Palliative Care, Princess Margaret Cancer Centre. "We know a lot about disease and the physical symptoms that it may produce, but only recently have we focused on approaches to relieve the fear of death in patients and families and to address the emotional, spiritual and existential concerns that support the quality of the dying experience."

Link to video of Dr. Sarah Hales: https://www.youtube.com/watch?v=ecYCvLF9M1w

Understanding the multiple dimensions of the dying process has helped us better care for patients and families at this stage of life, says Dr. Rodin, Head of the Department of Psychosocial Oncology and Palliative Care at the Princess Margaret Cancer Centre. "We have found that individuals evaluate differently the dimensions of the experience, which include symptom control, the sense of life closure and facing the end of life without overwhelming fear. The perspectives of patients on these issues at the end of life may differ from those of their family and health care providers."

The study, entitled "The Quality of Dying and Death in Cancer and Its Relationship to Palliative Care and Place of Death," is in press but on-line in the prestigious Journal of Pain and Symptom Management, with Dr. Sarah Hales, Lecturer, Department of Psychiatry, University of Toronto as lead author, as well as Drs. Camilla Zimmerman, Head of Palliative Care at the Princess Margaret, and Gary Rodin, Professor of Psychiatry at the University of Toronto and Academic Director of the Kensington Hospice.

Thirty-nine percent (39%) of the sample scored in the "good' to "almost perfect" range of a scale measuring the dying experience, with 61% of the sample scoring in the "neither good nor bad" range of the scale. Better scores were linked to older patients, high social support (most patients were not living alone), older caregiver age, English as the primary language of the caregiver, greater length of relationship between the caregiver and patient, less caregiver bereavement distress (i.e. grief, stress-response, and depressive symptoms) and home death.

The study examined 402 deaths of cancer patients between 2005 and 2010 in the three acute care hospitals of University Health Network and from the Tammy Latner Centre for Palliative Care, a home palliative care program at Mount Sinai Hospital in Toronto. Caregivers of the patients who spoke and read English were contacted and, those who agreed, were interviewed about the quality of death and dying using the Quality of Dying and Death (QODD) questionnaire, the most widely used and best validated tool to assess the dying experience.

The questionnaire includes 31 items covering symptoms and personal care, treatment preferences, time with family, whole person concerns, preparation for death, and the moment of death, with special attention to four key domains: Symptom Control, Preparation (i.e. visiting with spiritual advisor, avoiding life support, having funeral arrangements in order), Connectedness (i.e. spending time with family and friends), Transcendence (i.e. feeling unafraid of dying, feeling at peace with dying, feeling untroubled about strain on loved one). A total score on all variables was calculated from 0 to 100.

About one-third of all the cancer deaths occurred at home, while 40% occurred in an inpatient hospice/palliative care unit and 28% in an acute care hospital.

Receiving late or no palliative care was most common amongst those dying in a hospital, followed by those dying in a hospice/palliative care unit and least common amongst those dying at home. A late or no referral did not contribute to a worse overall quality of dying and death, but the authors state that this may mean that oncologists and family physicians provide good end-of- life care and that those who have more complicated illnesses are more likely to be referred to palliative care.

Home deaths were linked to better overall scores on the death experience, along with better Symptom Control and Preparation scores than dying in an acute-care or hospice setting. Surprisingly, home death with briefer palliative care was linked to better preparation and overall quality of dying than home death with longer palliative care involvement (i.e. greater than seven days).

In another surprise finding, there was no significant difference between a death in a hospice or palliative care setting and an acute care hospital. "You can have a good death in a hospice or a hospital setting when there is high quality palliative care," says Dr. Hales. "Caregivers often feel incredibly guilty about their loved ones dying in hospital, but it may not always be possible to die at home. Complicated symptoms, lack of advanced care planning and caregivers who feel overwhelmed with the process could indicate that a hospice or hospital death might be better for the patient and the family."

Although the dying and death experience ratings were generally positive, for a substantial minority, symptom control and death-related distress at the end of life were problematic. Fifteen per cent (15%) of the sample scored in the "terrible" to "poor" range for symptom control, with 19 percent scoring in the same range for Transcendence – feeling unafraid of or making peace with dying. These could be areas in which further interventions are needed to improve outcomes, say the authors.