Association of the 2013 Blood Cholesterol Guidelines and Generic Statin Availability with Statin Treatment in the U.S. Population

Abstract

Background: The 2013 cholesterol guideline was a paradigm shift in lipid management. Many have studied its impact, but few have considered generic availability and trend changes over time.

Objective: To evaluate if the 2013 guideline release was associated with changes in statin-related outcome trends.

Methods: Four 2013 guideline statin benefit groups were included in a retrospective study between atorvastatin and rosuvastatin generic dates in the U.S. Trend changes in statin use, guideline adherence, statin adherence, LDL-C reduction, and MACE survival were evaluated using interrupted time series analysis.

Results: 197,021 patients were included in the study (10% ASCVD, 17% High-LDL, 70% Diabetic, and 3% High-ASCVD-Risk Group). Positive trend reversal of Diabetic Group MACE survival in 5 years, +4.8 percentage points (pp) acceleration of guideline adherence in ASCVD, and -1.22pp slowdown in ASCVD Group 1-Year MACE survival were found to be significantly associated with the 2013 guideline release (P=<0.01, <0.01, 0.04). No other structural breaks were detected but moderate improvements were found: Statin use in ASCVD and High-LDL Groups accelerated (+2.54pp, +1.10pp change); Guideline adherence for all groups was higher and sped up by +3.4pp on average; LDL-C reduction accelerated in slope overall while statin adherence increments were stagnant in all but enhanced by +1.95pp in ASCVD Group. Meanwhile, MACE survival rates in one and five years were consistent for most benefit groups.

Conclusions: The 2013 guideline is associated with higher-intensity statins adoption, especially in ASCVD, but most patient-related outcomes did not have direct associations.