Discontinuing statins for patients near the end of life is safe, saves money, spares patients from swallowing yet another pill and from the symptoms associated with statins, and is generally welcomed by patients. That last bit might come as a surprise to some physicians who worry that discontinuing statins or other medications might signify that the physician is giving up on the patient. But most patients don’t see it that way, according to a survey conducted as part of a randomized study on continuing vs discontinuing statins for patients with a life expectancy of less than 1 year.

Presented at the 2014 ASCO Annual Meeting in Chicago by Amy P. Abernethy, MD, PhD, Professor of Medicine and Palliative Care Specialist at Duke University Medical Center in Durham, North Carolina, the study found that the rate of death within 60 days, the primary endpoint of the study, was not significantly different among those who discontinued statins and those who continued—20.3% vs 23.8%. The group discontinuing statins even had a longer median time to death—229 days vs 190 for those continuing statins—but it was not statistically significant, and there were several confounding factors, Dr. Abernethy noted.

“The number of pills in our pill cup doubles at the end of life: medicines to treat the illness, medicines for comorbidities that we have been taking for a very long time, medicines for symptom control, and other burdens,” Dr. Abernethy said at a press briefing held during the Annual Meeting. In an interview with The ASCO Post, she explained that patients in the palliative care setting “commonly specify that they like taking fewer medicines. Getting full early, bloating, and nausea are very common concerns. So when you don’t have to take as many pills, that is valuable.”

Patient and Physician Concerns Diverge

The study included 381 patients, 49% with cancer, with a life expectancy of no more than 1 year, recruited from 15 sites across the country. All patients were taking statin medications for primary or secondary prevention for at least 3 months, and 69% had used statins for more than 5 years.

Before patients were randomized, they were surveyed to see if they were worried about possibly having statins discontinued. “Some of the things that are commonly concerns for physicians are not concerns for patients,” Dr. Abernethy said. “For example, as physicians, we worry about stopping medicines because it might signify that the doctor is giving up on the patient, but less than 5% of patients said that that was a concern to them.”

Asked if stopping statins would signify that the previous use of statins had been a wasted effort, less than 15% agreed it would. “We asked them whether they worried about unintended consequences of discontinuing the medicine,” Dr. Abernethy said, and only 11% said yes. “Physicians get anxious about having this conversation,” Dr. Abernethy noted, but the survey showed that for patients it wasn’t such a big concern.

An article that Dr. Abernethy coauthored for the British Medical Journal² in 2004 “was really the starting point for this study,” she explained. “We described the need to more properly manage medicines in the palliative care setting.” This included basing decisions to adjust drugs on whole-body changes that occur in life-limiting illness, rather than just adverse events, and monitoring those changes with ongoing clinical assessments. At the editors’ request, the authors developed a table listing patients’ potential perceptions and clinicians’ potential responses when discussing changes in drug regimens near the end of life. Those questions formed the basis of the survey.

Discontinuation of Other Drugs

Before the study began, Dr. Abernethy and her colleagues had estimated that the average number of medicines the patients would be taking would be about 10. “When we originally said that, we got lots of pushback that the estimate was too high—people don’t take that many medicines—but it was exactly what the average was,” she noted. That included routine and as-needed prescription drugs but not nonprescription drugs or complementary medicine.

“Discontinuing statins led to the discontinuation of other medicines, too. We clearly saw this in the data,” Dr. Abernethy said. “The number of medicines in the pill cup other than statin medicines significantly decreased” for those who discontinued statins (10.1 vs 10.8, P = .034).

“We don’t know what the impetus was” for discontinuing other medicines, she acknowledged. “We don’t know if patients did it with or without their doctor’s input. But we do know that polypharmacy is quite detrimental, especially over time, as people start losing more and more weight and have more decline in their kidney and liver functions. The concoction of drugs becomes more potent and potentially harmful, just due to drug-drug interaction.”

Reflecting on her own situation, Dr. Abernethy said that it makes sense that patients would be amenable to discontinuing medications that were no longer necessary. “I’m always asking myself: Do I need to take whatever it is that I am taking right now? As my grandmother’s pill cup got more full with different types of medicines, I was more attentive to which ones we could get rid of.”

Sense of Relief

A previous study Dr. Abernethy coauthored in 2007 noted, “There is abundant literature about starting medications for comorbid illnesses but little guidance on reducing or stopping medications, especially in the setting of a life-limiting illness.”³

Before conducting the current study about discontinuing medicines for patients with a life expectancy ≤ 1 year, “we surveyed the palliative care community and asked if this was an important question, and we got a resounding yes. We asked, if we were going to study medication simplification, which medicines should we study? That is where we learned we should study statins. We also asked, do you use any statins in your own practice, and half said that they continued them and half discontinued them. So it was a place of great equipoise, where clinically, nobody knew what to do.”

Dr. Abernethy said that the study results and subsequent news reports about discontinuing medicines near the end of life were well received by her palliative care colleagues. “Among the palliative care physicians, I think there is a sense of relief,” she noted. “In the oncology community, there has been a general sense of, ‘Okay, as long as you don’t stop the chemotherapy,’” she added.

“We set this study up to be essentially a platform where we can now conduct a sequence of studies of additional medicines,” Dr. Abernethy said, nothing that the next study would probably be about stopping anticoagulants. “We originally were going to do bisphosphonates next,” she said, but she and her colleagues learned that the rheumatology community would likely be studying that issue, and they wanted to avoid duplication of effort.

Dr. Abernethy noted that the statin investigation “was the first study conducted by the Palliative Care Research Cooperative Group, which is a new national research network funded by funded by the National Institute of Nursing Research.”

Big Cost Savings

The study included overall cost estimates on how much money could be saved if all people with a life expectancy of 1 year or less—similar to the group involved in this study (49% with cancer and the remainder with heart disease, chronic obstructive pulmonary disease, and other illnesses)—were to discontinue statins. For 2014, an estimated $603 million could potentially be saved in the United States. This estimate was based on an average survival on the study of 212 days and $3.37 saved per patient day. Applying these results to 2040 population estimates, the potential savings would total $1 billion.

Dr. Abernethy said that when she brings up cost concerns with physicians, especially cardiologists, many respond that statins are so cheap. But that may not be true for brand name statins and for individual patients. Physicians may feel uncomfortable talking about cost-effectiveness “because they think that patients will assume doing something that is cost-effective is somehow slighting them of something that they need. In fact, patients make decisions about cost-effectiveness all day long,” she said.

“We work a lot with this concept of ‘financial toxicity’ and the decisions people make because of the financial implications of their health care. People are constantly making judgments and decisions about going to the doctor, what to do with their pills, and the trade-offs. For us to assume that they don’t want to be able to discuss it with us is paternalistic. The neat thing about this statin study is that we actually can talk about something that is good for patients and is cheaper.” ■

Disclosure: Dr. Abernethy reported no potential conflicts of interest.

References

1. Abernethy AP, Kutner, Blatchford PJ: Managing comorbidities in oncology: A multisite randomized controlled trial of continuing versus discontinuing statins in the setting of life-limiting illness. ASCO Annual Meeting. Abstract LBA9514. Presented June 3, 2014.

2. Stevenson J, Abernethy AP, Miller C, et al: Managing comorbidities in patients at the end of life. BMJ 329:909-912, 2004.

3. Currow DC, Stevenson JP, Abernethy AP, et al: Prescribing in palliative care as death approaches. J Am Geriatr Soc 55:590-595, 2007.