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Using Shared Decision Making to Improve Erik's Hospital Stay, Part 3: Statins
August 21, 2016
Statin cholesterol medicines have become a mainstay in treating coronary artery disease (CAD). There is ample evidence that the use of statins in people with known CAD can reduce death and subsequent heart attack. According to large studies, after five years of statin use in people with CAD, regardless of a person’s cholesterol, 12/1000 deaths are averted (See BRCT on the left) and 26/1000 heart attacks are averted in people who take statins compared to people who do not. Since Erik now has known CAD, his annual benefit of taking a statin is a 2.4/1000 benefit of averting death, and a 5.2/1000 benefit of averting another heart attack. It is unclear if those benefits extend progressively beyond 5 years, but since Erik is healthy and expects to live many years, he looked at those numbers and felt that the benefit of statins made sense for him.
A recent study looking at compliance with post-MI guidelines, including both use of statins and use of ACE inhibitors (which does not apply to Erik as he has normal heart function and his blood pressure is too low, negating the benefit of ACE inhibitors in his case), there was a reduction in major cardiac events (heart attack, death) and an insurance savings. A year after MI in this large cohort, there were a very large number of adverse events: 95/1000 in those who took statins and Ace inhibitors, and 131/1000 in those who did not take the medicines, meaning that 36/1000 people who took these medicines benefit in a year. There was a $900/year savings to insurance companies among those patients who were fully compliant with therapy compared to those who were noncompliant. At least some of this improvement is related to statin use, but not all of it.
In the hospital Erik’s doctors presented him with two other declarations regarding statin use. First, that it was important to start statins immediately at the time of the MI. The immediacy of statin use prevented any meaningful discussion between Erik and his medical team as to whether he wanted to take statins. Second, Erik was told that he needed to be on high dose statins. Consequently, Erik’s doctors put him on a very high dose statin (Atorvastatin 80mg), insisting that such mega-dosing was far more advantageous than standard doses and that he needed to be on that medicine for the rest of his life. They did not discuss the risks and benefits of this approach. Are high dose statins more beneficial than normal doses, and did the statins have to be given to him immediately?
One caveat in this discussion relates to Erik’s cholesterol level. In many studies, statins are helpful after heart attack despite a person’s cholesterol level, and people are prone to heart attacks whether they have high or low cholesterol levels. In fact, there is a great deal of controversy as to whether cholesterol itself is a substantial risk factor at all and whether it should even be measured in assessing risk. Similarly, there is a very sharp divide within the cardiology community as to whether the level of cholesterol (LDL) reduction has any significant correlation to outcome. In other words, some studies suggest that pushing down LDL very far with high dose statins with or without other cholesterol medicines will improve outcome, and some studies do not support that approach. Therefore, while the use of statins does improve outcome in virtually all studies, the utility of cholesterol as a marker of statin efficacy is uncertain.
The benefit of statins given immediately after a heart attack, compared to starting statins later, has been studied. By a Cochrane analysis, there is a 0/1000 benefit (see BRCT) of giving immediate statins compared to giving them later in people with an MI. It was not necessary for Erik’s doctors to put him on a statin before first having a discussion and ascertaining whether statins would be appropriate for Erik or if he even wanted to take them. This discussion could have even occurred as an outpatient if Erik chose to wait.
Why not just start a statin? Because these medicines do have side effects and interactions, and thus their use needs to be individualized. All statins cause muscle damage, and every study of statins finds that 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 (see BRCT) who are active, and 750/1000 marathoners, can get symptomatic pain or weakness with statins impacting their exercise capacity, and it is reasonable to assume (although not studied) that older people prone to falls could have an increase in weakness that leads to more falls and disability. Another study showed that up to 400/1000 people on statins say they are more tired than 1000 people on placebo, a question that is not asked of people in most statin studies. 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 (see BRCT below).
Thus there are potential side effects from statins that should have been discussed with Erik before simply putting him on the pills.
While many studies do not show significant increase in side effects among 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 no significant benefits were found with high dose statin use. A recent study of high vs standard dose statins in people Erik’s age (over 75) who have known CAD found no benefit in high dose use (0/1000 benefit when compared to standard dose statin therapy, as shown in BRCT above). There is no data about side effects in this study, but given that older people are generally excluded from high dose statin studies, there remains uncertainly as to whether the high dose atorvastatin given to Erik would have led to more weakness, fatigue, or even the chance of his getting diabetes.
In the end, Erik and I discussed the risks and benefits of statins and high dose statins after his discharge. Given the fact he was extremely weak and fatigued after returning home, and looking at the data, we cut Erik’s statin dose from 80mg to 20mg, with a subsequent reduction of his muscle fatigue. There is no reason to believe that Erik would have been better protected from subsequent death or heart attack if he stayed on the high dose statin, and an uncertainty as to whether he would have been prone to more side effects, but as an active person it seemed reasonable to cut his dose to enable him to feel well and continue his vibrant lifestyle, especially given how poorly he felt. Again, a discussion of this issue in the hospital using BRCTs could have allowed Erik to leave the hospital on a dose of statins most appropriate for him and a better understanding of his risks and benefits.