Can a patient stop taking statins (HMG-CoA reductase inhibitors) after making lifestyle changes and how is cardiovascular disease risk assessed?

Statin Discontinuation After Lifestyle Changes

Patients should not stop statins solely because they have made lifestyle changes, as statin discontinuation is associated with worse cardiovascular outcomes than never starting statins at all, including increased cardiovascular events and mortality. 1, 2

Why Statins Should Not Be Stopped

• Statin discontinuation, particularly after acute events, causes harmful effects on cardiovascular outcomes and all-cause mortality—patients who stopped statins had worse outcomes than those never prescribed statins, suggesting a biological rebound phenomenon. 1

• Non-adherence and discontinuation significantly increased cardiovascular and cerebrovascular events as well as all-cause mortality in high-risk patients across both primary and secondary prevention settings. 2

• Lifestyle changes are beneficial and should be intensified, but they complement rather than replace statin therapy—the guidelines emphasize that crossing the threshold to conditions like diabetes does not reduce the expected benefits of statins and reinforces the need for continued ASCVD risk reduction. 3

The Role of Lifestyle Changes

• Lifestyle modifications (weight loss, increased physical activity, dietary changes) are useful for preventing diabetes and reducing cardiovascular risk, but should be implemented alongside—not instead of—statin therapy. 3

• Studies show that while patients may recall receiving lifestyle advice when starting statins, this does not translate into significant sustained changes in diet or physical activity at 3-month follow-up. 4

• The decision to start a statin is based on 10-year ASCVD risk calculation and should involve shared decision-making, but once initiated for appropriate indications, statins should be continued unless contraindicated. 3

When Reassessment May Be Appropriate

• For patients who were borderline candidates for statin therapy (10-year ASCVD risk 5-7.5%), a trial of intensive lifestyle modifications for 3-6 months before initiating statins is reasonable, with reassessment of 10-year ASCVD risk using updated lipid values. 5

• However, this approach applies only to patients not yet started on statins—it does not support stopping statins already initiated. 5

• The shared decision-making process may span multiple encounters before initiating therapy, but once started, discontinuation requires careful clinical justification. 3

Common Patient Concerns About Continuing Statins

• Fear of side effects and perceived side effects are the most common reasons patients cite for declining or discontinuing statins. 6

• Patients who declined or discontinued statins were less likely to believe statins are safe (36.9-37.4% vs. 70.4% of current users) or effective (67.4-69.1% vs. 86.3% of current users). 6

• Reassurance can be provided that severe muscle damage is extremely rare, and muscle complaints are usually no more common in statin-treated patients than those given placebo in clinical trials. 3

• Most patients who develop myalgias can tolerate a statin when rechallenged, especially at lower doses or less frequent dosing schedules. 3

• Statin-induced cognitive impairment is exceedingly rare, if it exists at all. 3

Managing Statin-Associated Symptoms

• Moderate to severe symptoms that are progressive or concerning should prompt temporary cessation until clinical evaluation occurs, but this is for symptom evaluation—not permanent discontinuation. 3

• After symptom resolution, rechallenge with an alternative statin or alternative regimen (reduced dose, less frequent dosing) is appropriate. 3

• Post-treatment lipid and safety evaluations should occur 3-12 weeks after statin initiation and at intervals thereafter to monitor adherence and address concerns. 3

---

Best Methods to Assess Cardiovascular Disease Risk

The pooled cohort equations (PCE) to calculate 10-year ASCVD risk is the primary tool for adults aged 40-75 years, supplemented by coronary artery calcium (CAC) scoring when risk status remains uncertain after considering risk-enhancing factors. 3

Primary Risk Assessment Tool

• Calculate 10-year ASCVD risk using the pooled cohort equations for adults 40-75 years of age without clinical ASCVD or diabetes who have LDL-C 70-189 mg/dL (1.8-4.9 mmol/L). 3

• Risk should be estimated every 4-6 years in this population. 3

• Either fasting or nonfasting plasma lipid profiles are effective for screening and estimating ASCVD risk. 3

• The pooled cohort equations should not be used to re-estimate risk in statin-treated patients or after a short course of lifestyle change. 3

Risk-Enhancing Factors for Personalized Assessment

When 10-year risk falls in intermediate range (7.5-19.9%), evaluate these risk-enhancing factors to refine risk assessment: 3

• Family history of premature ASCVD (men <55 years, women <65 years)
• LDL-C ≥160 mg/dL (4.1 mmol/L)
• Metabolic syndrome
• Chronic kidney disease (eGFR 15-59 mL/min/1.73m²)
• History of preeclampsia or premature menopause (<40 years) in women
• Chronic inflammatory disorders (rheumatoid arthritis, psoriasis, HIV/AIDS)
• High-risk ethnicity (South Asian ancestry)
• Persistently elevated triglycerides >175 mg/dL (2.0 mmol/L)
• If measured: apolipoprotein B (especially useful if triglycerides >200 mg/dL), high-sensitivity C-reactive protein ≥2.0 mg/L, lipoprotein(a) >50 mg/dL (125 nmol/L), or reduced ankle-brachial index (<0.9)

Presence of risk-enhancing factors in patients at intermediate risk favors statin therapy. 3

Coronary Artery Calcium Scoring for Uncertain Cases

• In adults 40-75 years with LDL-C 70-189 mg/dL and 10-year risk 7.5-19.9% who remain uncertain about statin benefit after risk discussion, CAC scoring may help resolve uncertainty. 3

CAC Score Interpretation:

• CAC score = 0 Agatston units: Statin therapy may be withheld or delayed, except in cigarette smokers, those with strong family history of premature ASCVD, or diabetes. 3

• CAC score 1-99 units: Favors statin therapy, especially in patients >55 years. 3

• CAC score ≥100 units or ≥75th percentile: Statin therapy is indicated unless deferred by clinician-patient risk discussion. 3

• If CAC scoring is performed and score is zero in intermediate-risk patients, reassess CAC in 5-10 years. 3

• CAC scoring should be performed in facilities with current technology delivering the lowest radiation possible. 3

Special Populations Requiring Clinical Judgment

Patients <40 Years Old:

• Prioritize discussion about lifetime risk rather than 10-year risk. 3
• Focus on family history of premature ASCVD and LDL-C ≥160 mg/dL. 3

Patients ≥75 Years Old:

• The pooled cohort equations are not validated for this age group. 3
• Pay particular attention to potential adverse effects and drug-drug interactions. 3
• For those already on statins with good response, it is reasonable to continue without frequent monitoring. 7

Patients with Diabetes:

• Adults 40-75 years with diabetes and LDL-C 70-189 mg/dL should generally receive statin therapy regardless of calculated 10-year risk. 3
• Chronic kidney disease not treated with dialysis is a risk-enhancing factor. 3

Monitoring After Risk Assessment and Treatment Initiation

• Measure LDL cholesterol 4-12 weeks after initiating or adjusting statin therapy to assess therapeutic response and medication adherence. 8

• High-intensity statin therapy should achieve ≥50% LDL reduction; moderate-intensity should achieve 30-50% LDL reduction from baseline. 8

• Once stable dosing is achieved, monitor LDL cholesterol annually, or every 3-6 months if suboptimal response despite reported adherence. 8

• Adherence assessment should occur at every visit, as clinicians often underestimate non-adherence unless specific questions are asked. 3

Common Pitfalls to Avoid

• Do not use 10-year ASCVD risk calculation in isolation to prescribe statins—it must be part of a comprehensive clinician-patient risk discussion. 3

• Do not delay treatment excessively in very high-risk patients (established ASCVD, multiple risk factors) while pursuing lifestyle modifications. 5

• Do not assume lifestyle changes alone are sufficient for patients who meet criteria for statin therapy based on risk assessment. 3, 1

• For patients concerned about statins, use the risk discussion as an opportunity to address misconceptions about safety and efficacy rather than simply accepting discontinuation. 6