New Studies Shed Light on Statin Side Effect Concerns

By Kim Smiley

Usage surveys have found that the majority of people prescribed statins in the United States discontinue using them within a year. The number one reason stated by patients for stopping statin use is concern with side effects.

This issue can be analyzed by building a Cause Map, a visual method for performing a root cause analysis.  The first step in the Cause Mapping process is to define the problem by filling an Outline with the basic background information (who, what, when, where, etc.).  Additionally, the Outline is used to capture how the problem impacts the goals so that the magnitude of the problem is well understood.   Once the Outline is complete, the analysis is done by building a Cause Map by asking “why” questions to find the causes that contribute to an issue.

For this example, the fact that patients aren’t taking prescribed statins is an impact to the patient goal.  This occurs because patients were prescribed statins and they are not using them.  Looking at each cause individually, let’s first ask why patients were prescribed statins.  A physician wrote a prescription for statins because the patient was considered at risk for heart disease and statins can reduce the risk of heart disease.  Statins have been shown to reduce cholesterol levels in the blood and high cholesterol can lead to blocked arties that can contribute to heart disease.  Cholesterol is reduced because statins inhibit an enzyme in the liver that controls cholesterol production in the body and the majority of cholesterol is produced by the liver.

So the question that still needs to be answered is why aren’t patients taking their statins if they can reduce their risk of heart disease?  The most significant reason that patients are discontinuing statin use is because they are concerned about side effects and the concerns haven’t been adequately addressed. Patients are concerned about side effects because they believe they have experienced side effects or they are generally worried about potential side effects.

Like most other medications, statins can have serious side effects, such as liver injury, cognitive impairment and potential for muscle damage (especially when combined with certain other medications.  According to the U.S. Food and Drug Administration, the value of statins in preventing heart disease has clearly been established and the benefits outweigh the risks, but one of the reasons that patients are concerned about side effects is that there are very outspoken critics of statins that do not agree with this assessment.  For the purpose of this example, we will assume that the FDA is correct that patients would benefit from taking statins if they are prescribed and that it is in fact a problem if patients discontinue using stating when their physicians have recommended them.

The final step in the Cause Mapping process is to come up with solutions that can be implemented to help reduce the risk of a problem occurring in the future. So how can the risk that patients will discontinue statins be reduced?  One possible solution would be to give patients reliable information that shows that statins are relatively safe and are effective at reducing the risk heart disease.  If patients believe that the benefits of statins outweigh the risks, they will be significantly more likely to take them.  More information is becoming available as researchers continue to study the benefits of statins and the frequency and severity of side effects.  For example, a recent study that used 83,000 patients and randomized statin therapy and a placebo found that “only a small minority of symptoms reported on statins are genuinely due to the statins: almost all would occur just as frequently on placebo”.  With more data about the effectiveness of statins and the accurate information the risks associated with them patients can make decisions based on real data and better determine if they should keep taking the statins.

To view the Outline and Cause Map, please click “Download PDF” above.