JACC in a Flash | Despite the established benefits of statin therapy for secondary prevention after acute coronary syndromes (ACS), registry data shows substantial underutilization of and non-adherence to prescriptions, according to a new review paper published July 6 in JACC.

In the review, the authors led by Laurence S. Sperling, MD, FACC, examined data demonstrating the lack of optimal statin use despite the proven benefits. In the recently published IMPROVE-IT trial, up to 40% of patients discontinued statins prematurely and registry data have demonstrated even higher non-adherence rates. Additional data has found higher mortality rates following the discontinuation of statin therapy after ACS.

The authors also cite a recent JACC study that used data from the ACC’s PINNACLE® Registry database to assess the impact of the 2013 ACC/AHA cholesterol guidelines on current cardiovascular practice. Nearly one third of statin-eligible patients did not receive them—with 2.9% receiving only nonstatin therapy and 27.9% receiving no lipid-lowering medications—suggesting a lack of optimized lipid management. Finally, a paper from the National Health and Nutrition Examination Survey found that while statin use in the U.S. increased from 36% in 1999 to nearly 73% in 2012, opportunities exist to improve risk reduction and lipid lowering for the 27% of patients not taking statins after ACS.

The authors also express concern about the dosage of statins prescribed after ACS, pointing to findings that many patients are not taking high-intensity statins. They write that the failure to maximize statin intensity suggests a lack of knowledge regarding the benefits of high-dose statin-therapy over moderate or low dose statin-therapy. Fragmented care and poor communication between community-care providers and specialists may limit statin therapy or dose optimization. The authors suggest the need for alternative guidelines and nurse-managed protocols to address concerns about possible medication interactions to improve decision-making and statin utilization for older patients with multiple comorbidities.

The lack of adherence from patients in the IMPROVE-IT trial is similar to those in other large studies. Previous trials have found patient and physician preference to be the main reason for statin discontinuation, with a lower percentage being due to adverse experiences or events, side effects, or laboratory abnormalities. Real-world registry data have found adherence to be even lower than clinical trials, reaching up to 50% at 1 year. The authors encourage an in-depth focus on the rationale behind these discontinuations, adding that “statin non-adherence is among the most important determinations of outcome.” Statin adherence is inversely associated with low-density lipoprotein cholesterol levels and mortality after ACS.

Measuring non-adherence is challenging, and many health providers often fail to recognize or inquire about it. Current measurement practices, such as questioning patients, counting pills or refills, and electronic monitoring, can be unreliable, objective, and costly. Reliable measurement and implementation of adherence improvements measures will require strong clinical care partnerships between multiple providers, pharmacies, caregivers and patients, according to the authors.

Factors that may influence adherence include demographics and socioeconomic factors, lifestyle habits, time since last provider visits, adverse effects of therapy, and complex medication regiments. Those with lower incomes, black or Hispanic women, those without access to a caregiver, and patients with higher copays are more likely to discontinue statin treatment. However, there are interventions that may improve adherence among these patient groups. Educational programs and materials—such as instructional checklists, drug fact pamphlets and national campaigns promoting disease awareness—have proven to be beneficial in the past. The authors also encourage providing information in the patient’s native language. Additionally, policy changes such as full coverage for preventative medications after MI have shown improved adherence. Other patient barriers to care include belief systems, forgetfulness, expectations of treatment, and lack of noticeable benefits, while health-system barriers include access to appointments, continuity of care, limited prescription refills, and priorities of comorbidities.

To counteract these barriers, Sperling and colleagues recommend that providers gather data on the patient’s insurance coverage, social support and the role of the caregiver. They should assess the risk for medication non-adherence, evaluate any reasons for forgetfulness, and consider the expectation of the treatment outcome that is more important to the patient. Team-based approaches may be necessary to gather this information if there are time constraints. Outpatient nurse-management protocols and pharmacy outreach programs may also help with medication monitoring and adherence.

Lifestyle factors associated with non-adherence include obesity, smoking, alcohol consumption, and the presence of comorbidities. It is important for providers, health care systems, and family members to support and facilitate necessary behavior changes. Cardiac rehabilitation has shown to have significant impact on morbidity and mortality following MI and revascularization. Not only to patients show improved physical activity and nutrition, they also demonstrate a >30% improvement in statin therapy adherence. Depression may also lead to a lack of statin adherence, so it is therefore important to be mindful of signs and symptoms. The quality of the patient-provider relationship is also important as it can lead to improved communication and trust.

As adherence is greatest 5 days prior to and following a doctor’s appointment—a phenomenon dubbed “white coat adherence”—Sperling and colleagues suggest that surveillance through electronic prescription-filing records and the use of reminder trigger systems, like cell phone alerts and text messages, may increase adherence by reminding patients not only to take their medications, but also to remind them to fill their prescriptions.

Many patients resist statin therapy over worries of adverse side effects. However, trials have shown only a slight increase in side effects when compared to placebo. For those who do demonstrate statin intolerance, simple strategies such as re-challenging with the same or different statin, reduced dosing, or alternate-day-dosing have proven effecting for 92.2% of patients. Pill burden has also proven to contribute to non-adherence. Fixed-dose combination therapy or the polypill may be helpful to those who take numerous pills a day.

The authors conclude the paper, writing that “guidelines, enhanced quality metrics, coordination of care, and outreach programs offer mechanisms to improve implementation of system-based approaches to optimal prescribing. Strategies that incorporate strong clinical are partnerships to address non-adherence to smoking cessation, hypertension control, exercise program, and lipid management will result in improved outcomes after ACS.” They add that the best way to improve clinical outcomes of ACS patients may be by “improving provider awareness of guideline-driven high-intensity statin utilization and patient adherence to all forms of therapy.”

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Hirsh BJ, Smilowitz NR, Rosenson RS, et al. J Am Coll Cardiol. 2015;66(2) 184-92.

Keywords: CardioSource WorldNews, ACC Publications, PINNACLE Registry, Acute Coronary Syndrome, Prescriptions, Secondary Prevention

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