56-OR: Impact of Delays in Statin Therapy Due to Statin Nonacceptance on Cardiovascular Outcomes in Patients with Diabetes

Introduction: Many patients with diabetes do not accept their clinicians’ statin therapy recommendations. Long-term clinical sequalae of statin non-acceptance are unknown.

Methods: We conducted a retrospective cohort study of patients with diabetes without ASCVD treated at Mass General Brigham in 2000-2018. We analyzed the relationship between delay in statin therapy due to statin non-acceptance by patients and the incidence of CV events (MI or ischemic stroke). Information about statin non-acceptance and baseline characteristics was obtained from the electronic medical records and a previously validated Natural Language Processing tool.

Results: The mean age of 7,239 study patients was 55.0 (SD 11.9) years; 3,769 (52.1%) were female. Their mean baseline LDL-C was 138 (SD 28) mg/dl and the mean HbA1c was 7.5% (SD 1.9). A total of 1,280 (17.7%) of patients delayed statin therapy (by a mean of 2.7 (SD 3.1) years during which they had a mean of 4.6 (SD 9.1) provider visits) due to initial non-acceptance. These patients then continued on statin therapy for a mean of 7.1 (SD 4.8) years. Over the mean follow-up time of 8.2 (SD 4.6) years, 455 (6.3%) of patients had a CV event.

Accounting for all-cause death as a competing risk, 6.4% (95% CI 5.6-7.2) of patients who accepted vs. 8.5% (95% CI 6.8-10.5) of patients who initially declined statin therapy recommendation experienced a CV event at 10 years (p = 0.001). In a multivariable Cox analysis that adjusted for patients’ demographic characteristics and comorbidities and clustering within providers, initial non-acceptance of statin therapy was associated with increased risk of a CV event (HR 1.49, 95% CI 1.16-1.91, p = 0.002).

Conclusions: Our study shows that patients with diabetes without ASCVD who delay statin therapy due to statin non-acceptance have an increased risk of CV events. This finding identifies a previously unexplored gap in care that increases cardiovascular burden in this already high-risk population.