Patient Autonomy and Statin Therapy Adherence (PASTA) Trial

Abstract

Introduction: Adherence to statin therapy is suboptimal in the primary prevention population, despite extensive data regarding efficacy and safety. Hypothesis: Introducing autonomy in the decision-making process will increase statin adherence and reduce perceived side effects. Goals: Compare six-month rate of statin adherence and perceived side effects in patients who initially decline atorvastatin, between those given reassurance and those offered a supplement trial prior to statin therapy. Methods: Patients > 40 years without a history of ASCVD at a moderate ASCVD risk who decline statin therapy underwent block randomization. The control group was provided education and reassurance regarding the statin therapy and prescribed 30mg atorvastatin. The intervention group was offered a trial of red yeast rice extract 20mg and a goal LDL-C 100 mg/dL. After 2 months those not at the goal LDL-C were then prescribed 30mg atorvastatin (Figure 1). The primary endpoint was the number of monthly pharmacy refills at 6 months. The secondary endpoints were rates of self-reported myalgias, fatigue, mental fog, and gastrointestinal upset at 6 months. The Wilcoxon rank sum test and the Chi-square test was used to assess the primary and secondary endpoints, respectively. Results: The final analysis included 276 patients; baseline demographics, labs and lipid profiles were similar between the two groups. Statin prescriptions filled was higher in the intervention group (Figure 2). The intervention group had lower rates of fatigue and mental fog, but not myalgias or gastrointestinal upset (Figure 3). Conclusion: Introducing autonomy in the decision-making process improved adherence to atorvastatin therapy and reduced the rate of perceived side effects.