Statins: Worth the Risk?

For reasons that are not always quite clear, HMG-CoA reductase inhibitors (i.e. statins) are a group of medications that receive a great deal of criticism despite the beneficial clinical outcomes that have been shown in countless trials.  Certainly much has been learned regarding safe and appropriate use since they were first introduced.  Changing clinical guidelines, monitoring recommendations, and removal of specific statins from the market (i.e. cerivastatin/Baycol) have left impressions that the class as a whole has inherent dangers.  Negative media stories, the internet, and experiences from family and friends aren’t helpful either, sometimes disseminating less than factual information regarding some of the risks of these medications.  Often in daily practice, patients and/or their healthcare providers may erroneously blame statins for reported ailments.  As a result, discontinuation rates of statin therapy on average are higher in the United States versus other countries (~10% versus 2-4%).   Inappropriate discontinuation eliminates the cardiovascular benefits of these medications, resulting in higher risk of myocardial infarction and cardiovascular disease.

To try and dispel some of the concerns that may exist, the American Heart Association (AHA) has published a Scientific Statement to accurately address the issue.  The objective of this publication was to “provide a rigorous examination of statin safety and tolerability.”  Although the review is meant to review the statins as a class, they do address specific statins when pertinent differences exist.  The comprehensive (forty-four page) statement is broken into six areas of emphasis:

1. Assessment of Adverse Events
2. Adverse Events
3. Drug-Drug Interactions
4. Demographic Considerations
5. Patients with Specific Diseases
6. Summary and Conclusions

What may provide the most compelling information to both patients and providers can be found in Table 7, which reviews the risk/benefit of statin therapy for those on therapy for five years who achieved a 77mg/dL reduction in LDL cholesterol.  On average, these patients saw a:

• 5% reduction in primary cardiovascular events
• 10% reductions in secondary cardiovascular events

For this same group of patients, “commonly reported” adverse events seen in practice where found to be quite low:

• Approximately 1% were newly diagnosed with diabetes
• Less than 1% had muscle symptoms without CK increase
• Less than 0.05% experienced myopathy (unexplained muscle pain or weakness accompanied by CK elevation >10x ULN) or rhabdomyolysis
• Less than 0.01% were found to have liver toxicity

To review the AHA Scientific Statement in its entirety,click here.

The publication contains a wealth of information.  However, the above figures gives a little perspective of how the benefits do appear to overshadow the risks.

References:

1. Newman CB, Preiss D, Tobert J, Jacobson T, Page II Robert, et al.  Statin Safety and Associated Adverse Events: A Scientific Statement From the American Heart Association.  Arterioscler Thromb Vasc Biol.  2018;38:e00-e00. DOI: 10.1161/ATV.0000000000000073.