posted by Andy Lazris & Erik Rifkin
on March 23, 2017
Overtreatment and undertreatment can occur when patients do not fully understand the implications of medical interventions. Studies show that patients can best comprehend medical data when it is: in a graphic form; free of numbers; uses a denominator of 1000; stated in absolute rather than relative values; and presented in a straight-forward and comprehensible format.
We have designed a universal decision aid that includes those characteristics and uses the familiar setting of a theater with 1,000 seats. Blackened seats designate the risks and/or benefits of medical interventions. We call it a Benefit-Risk Characterization Theater (BRCT). We will demonstrate how it works for statin cholesterol medicine.
Statin cholesterol medicines have become a mainstay in treating coronary artery disease (CAD), which occurs when people have blockages in their hearts or have had a heart attack. There is ample evidence that the use of statins in people with known CAD can reduce heart attack and subsequent death. According to robust studies, after five years of statin use by people with CAD, 46/1000 will avoid having a bad outcome (Figure 1) compared to people with CAD who do not take statins (including 12 deaths, 26 heart attacks, and 8 strokes). Patients can look at this BRCT and make a decision regarding the benefits of statin use based on how they determine what constitutes acceptable benefits and risks.
A recent study that looked at compliance with guidelines given to people after a heart attack determined the use of certain drugs, including statins, led to a reduction in heart attack and death. Per patient savings were $900/year among patients who took these drugs compared to those who were noncompliant. Given the large number of people who have heart attacks and other CAD, the savings can be substantial with a higher rate of statin compliance. Unfortunately, compliance with statins is not high; approximately half of people on statins stop taking them after a year, most citing side effects as the reason.
Why do people resist taking statins despite their benefit? Statin side effects are not trivial. All statins cause muscle damage, and every study of statins finds the extent of damage varies based on the patient. In the studies cited above, 100/1000 people had severe muscle damage, while many others get weak or tired muscles that can impact their function. Pain and weakness can be worse as people age and when they are more active.
One study suggested approximately 250/1000 people (Figure 2) who are active (and 750/1000 marathoners) can get pain or weakness with statins impacting their ability to exercise. Another study showed up to 400/1000 people on statins say they are more tired than 1000 people on placebo. Also, statins are a known cause of diabetes, and it is felt that about 10/1000 people who take statins will get diabetes compared to 1000 people who take placebo.
Lowering statin dose, or giving the medicine every other day, can possibly diminish the intensity and incidence of muscle pains and other side effects. While many studies do not show increased muscle damage in those taking high dose statins, there are more withdrawals among those taking high dose drugs, very few older people are enrolled in those studies, and there is no consensus as to whether high dose are more effective in real outcome measures.
A recent study of high vs standard dose statins in older people (over age 75) who have known CAD found no benefit in high dose use (0/1000 benefit when compared to standard dose statin therapy; Figure 3). Other studies have shown some improved outcome, but it is small. Certainly, even if there is a marginal benefit of higher dose statins over more moderate doses, the higher withdrawal rate makes their use suspect in people who report side effects.
Perhaps the most prudent way to help a patient remain complaint with statin treatment is to demonstrate the drug’s value while being upfront about the drug’s potential side effects. If patients understand there are side effects from the medicine, and that these side effects can be mitigated – by lowering dose or changing drugs – then patients and doctors can work together to find a statin regimen that is tolerable.
It is also important to know that statins have a much less proven benefit in people without known CAD. Thus, when attempting to achieve compliance with statin treatment, it is wise to focus on those people in whom these drugs have the most benefit. Overtreatment can very easily lead to higher rates of discontinuation. Showing people BRCTs, such as the ones in this article, can help them to decide if statins can help and understand their potential side effects. Such shared decision-making between doctors and patients can lead to better compliance with treatments and better health.
Andy Lazris, M.D., CMD, is author of Curing Medicare and co-author of Interpreting Health Benefits and Risks. Erik Rifkin, Ph.D, is Adjunct Associate Research Scientist in the Department of Environmental Health and Engineering at Johns Hopkins School of Public Health.