How should I react when a patient says they cannot tolerate a statin?
Before deeming a patient intolerant to statins, gather more detail for what intolerance means to that patient and/or the patient’s prescriber. Keep in mind that if a patient reports intolerance and has only tried moderate- or high-intensity statins, there is evidence that low-intensity statins or less-than-daily statin doses provide benefit.4
Best practices for addressing statin intolerance include:
- Examine prescription history or confirm with the patient/prescriber to see how many statins that patient has tried in the past.
- If the patient has switched between multiple statins, ask why those changes were made.
- Explain that even if one statin causes muscle pain or a specific side effect, that does not mean another statin would do the same.
- Consider proposing the following options if the patient has experienced muscle pain or other side effects:
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- Try a lower dose of the same statin
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- Try an alternative statin (e.g., pravastatin and rosuvastatin are less lipophilic & therefore, less likely to cause muscle pain)
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- Try intermittent dosing with long half-life statins (e.g., rosuvastatin dosed 2-3 times per week)
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- Consider examining patient’s vitamin D levels, as some studies have shown vitamin D deficiency can lead to statin-induced muscle pain and correcting that vitamin D deficiency can potentially resolve statin-induced muscle pain.5
For more information, refer to Statin Intolerance3 and Section 5 of the ACC/AHA Guidelines on the Management of Blood Cholesterol.4
How should I respond when a patient says they do not need a statin because they do not have high cholesterol?
Reference benefits of statin therapy related to that patient’s specific condition(s). One recommended approach is to:
- Verify the medical condition that prompted the need for statin initiation (e.g., diabetes, CAD, CVD, stroke/TIA).
- Explain how that condition raises their risk for serious complications.
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- Example: “Your [insert specific condition] increases your risk for serious complications in the future, such as a heart attack or a stroke. Even if your cholesterol levels are not high right now, there is still a risk that cholesterol will build up over time and potentially cause a blockage in an artery. Statin therapy is recommended for people with [insert specific condition] to prevent or lessen the risk of those serious events happening to you.”
For more information, refer to Figure 3 in Section 4.3 in the ACC/AHA Guidelines on the Primary Prevention of Cardiovascular Disease. This section explains the 4 Statin Benefit Groups, for which the potential for an ASCVD risk reduction benefit clearly exceeds the potential for adverse effects in adults.1
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- Note: If a patient has a diagnosis of both ASCVD and diabetes, low-intensity statin therapy is not preferred.
Click here for an ASCVD Risk Calculator.
Best practice: Enter any relevant notes specific to the patient’s ASCVD risk within your recommendation on the prescriber fax.
Which statins and doses are considered high-intensity, moderate-intensity and low-intensity?
High-, Moderate- and Low-Intensity Statin Therapy4*
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High-Intensity Statin Therapy |
Moderate-Intensity Statin Therapy |
Low-Intensity Statin Therapy |
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Daily dose lowers LDL-C on average, |
Daily dose lowers LDL–C on average, by approximately 30% to 49%
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Daily dose lowers LDL–C on average, |
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Atorvastatin (40 mg‡)–80 mg Rosuvastatin 20 mg (40 mg) |
Atorvastatin 10 mg (20 mg) Rosuvastatin (5 mg) 10 mg Simvastatin 20–40 mg§ Pravastatin 40 mg (80 mg) Lovastatin 40 mg (80 mg) Fluvastatin XL 80 mg Fluvastatin 40 mg BID Pitavastatin 1–4 mg |
Simvastatin 10 mg Pravastatin 10–20 mg Lovastatin 20 mg Fluvastatin 20–40 mg
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Percent LDL-C reductions with the primary statin medications used in clinical practice (atorvastatin, rosuvastatin, simvastatin) were estimated using the median reduction in LDL-C from the VOYAGER database. Reductions in LDL-C for other statin medications (fluvastatin, lovastatin, pitavastatin, pravastatin) were identified according to FDA approved product labeling in adults with hyperlipidemia, primary hypercholesterolemia, and mixed dyslipidemia. Boldface type indicates specific statins and doses that were evaluated in RCTs, and the Cholesterol Treatment Trialists’ 2010 meta-analysis. All these RCTs demonstrated a reduction in major cardiovascular events.
*Percent reductions are estimates from data across large populations. Individual responses to statin therapy varied in the RCTs and should be expected to vary in clinical practice.
‡Evidence from 1 RCT only: down titration if unable to tolerate atorvastatin 80 mg in the IDEAL (Incremental Decrease through Aggressive Lipid Lowering) study.
Although simvastatin 80 mg was evaluated in RCTs, initiation of simvastatin 80 mg or titration to 80 mg is not recommended by the FDA because of the increased risk of myopathy, including rhabdomyolysis. BID indicates twice daily; FDA, U.S. Food and Drug Administration; LDL-C, low-density lipoprotein cholesterol; RCT, randomized controlled trial; VOYAGER, an individual patient data meta-analysis of statin therapy in At risk Groups: Effects of Rosuvastatin, atorvastatin and simvastatin; and XL, extended release.
Best Practices
When talking with the prescriber:
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- Use the clinical guidelines and supporting evidence provided in the TIP overview.
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- Have your recommendation ready, “Based on the other medications the patient is taking, I’d like to recommend (name of medication).”
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- Keep the patient’s health at the center of the conversation−be prepared to defend your recommendation!
When talking with the patient:
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- Discuss the benefits of using the suggested medication.
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- Approach this as an “opportunity to improve your drug therapy” rather than a chance to “fix a mistake the prescriber has made.”
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- Communicate the change to the patient after receiving the prescriber’s approval, “Here is a new medication your doctor has ordered for you”
- Communicate the change to the patient after receiving the prescriber’s approval, “Here is a new medication your doctor has ordered for you”
Other Supporting Documentation for Statin Initiation
- JUPITER Trial - For those treated with a statin vs those not treated with a statin, results showed:6
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- 44% reduction in the trial primary end point of all vascular events (P<0.00001)
- 54% reduction in myocardial infarction (P=0.0002)
- 48% reduction in stroke (P=0.002)
- 46% reduction in need for arterial revascularization (P<0.001)
- 20% reduction in all-cause mortality (P=0.02)
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- Improvement of endothelial dysfunction
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- Increased bioavailability of nitric oxide
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- Antioxidant effects
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- Inhibition of inflammatory responses
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- Stabilization of atherosclerotic plaques
Resources:
- Arnett DK. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease. September 2019.
- Davignon J, Jean Davignon From the Hyperlipidemia and Atherosclerosis Research Group, Davignon Cto J. Beneficial cardiovascular pleiotropic effects of statins. Circulation. June 2004.
https://www.ahajournals.org/doi/10.1161/01.cir.0000131517.20177.5a#:~:text=Pleiotropic%20effects%20of%20statins%20include ,and%20stabilization%20of%20atherosclerotic%20plaques
- Fitchett, DH, et al. Statin Intolerance Circulation. 2015;131:e389-e391.
http://circ.ahajournals.org/content/131/13/e389#T4.
- Grundy SM. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Blood Cholesterol: A Report of the American College of Cardiology/ American Heart Association Task Force on the Clinical Practice Guidelines. November 2018.
https://www.jacc.org/doi/10.1016/j.jacc.2018.11.003
- Khayznikov M, Hemachrandra K, Pandit R, Kumar A, Wang P, Glueck CJ. Statin intolerance because of myalgia, myositis, myopathy, or myonecrosis can in most cases be safely resolved by vitamin D supplementation. North American journal of medical sciences. March 2015.
- Ridker PM, Paul M Ridker From the Center for Cardiovascular Disease Prevention, Ridker Cto P. The jupiter trial. Circulation: Cardiovascular Quality and Outcomes. May 2009.
https://www.ahajournals.org/doi/10.1161/circoutcomes.109.868299