Abstract 19139: Effect of HDL-C Raising and/or Triglyceride Lowering on Cardiovascular Outcomes and All-Cause Mortality in the AIM-HIGH Trial
Background: Published reports have questioned the benefit of serum HDL-cholesterol (HDL-C) raising and/or triglycerides (TG) lowering for patients at risk for cardiovascular (CV) events.
Methods: AIM-HIGH (NCT00120289) patient-level data were reanalyzed to evaluate the effects of HDL-C raising and TG lowering treatment strategies (background statin ± extended-release niacin therapy) on major adverse CV events (MACE: a composite of MI, stroke, and CV death) and all-cause mortality. Four groups, based on percent change from baseline to 6 months in HDL-C and TG due to antidyslipidemic therapy, were compared (Table 1). Time-to-first event analyses were performed, with a multivariate analysis used to adjust for group, age, gender, history of diabetes, and estimated glomerular filtration rate [eGFR].
Results: Kaplan-Meier curves showed a significant difference for MACE (log-rank p<0.05) among the four groups (Figure 1). Surprisingly, a 49%-increased risk of MACE (unadjusted HR 1.49; 95% CI 1.14 to 1.98, p<0.01), was seen in the group with the greatest drug response (Group 1) compared to that with the least (Group 4). Subjects at increased risk were older, male, and had an eGFR ≤60 mL/min (Group 1 vs. 4: adjusted HR 1.47; 95% CI 1.10 to 1.94, p<0.01). There was no difference in risk of MACE between Group 2 (predominantly HDL-C raising) or Group 3 (predominantly TG lowering) compared to Group 4 (least changes in HDL-C and TG), or in all-cause mortality among the 4 groups.
Conclusions: Post hoc analyses showed that Group 1, which had the greatest HDL-C and TG response, had an unexpected increase in MACE risk. Further study is warranted to clearly define lipid thresholds associated with MACE.
Author Disclosures: T. Patel: None. B. Tesfaldet: None. J. Chen: None. J. Fleg: None. G. Csako: None. G. Sopko: None. L. Cooper: None. E. Navarro: None. C. Gandotra: None. R. Kirby: None. H. Sviglin: None. K. Burkhart: None. S. Coady: None. H. Chang: None. P. Desvigne-Nickens: None. M. Fennessy: None. L. Liu: None. E. Leifer: None. F. Pucino: None. S. Raman: None. Y. Rosenberg: None. A. Hasan: None.
- © 2016 by American Heart Association, Inc.