204: Aspirin Use Prior to Initiation of Therapy with a Proprietary Niacin Extended-Release Reduces Discontinuation Rates Due to Flushing

Abstract

Synopsis: Niacin has beneficial effects across all elements of the lipid profile; however, flushing can limit long-term adherence to therapy. Aspirin (ASA) can mitigate niacininduced flushing. Purpose: To evaluate the effect of ASA use prior to initiation of niacin therapy on tolerability of a novel combination of a proprietary, niacin extended-release with simvastatin (NER/S) as determined by discontinuation rates due to flushing. Methods: Data from 403 patients, who reported aspirin use prior to randomization to NER/S 1000/20, 2000/20, 1000/40, or 2000/40 mg/d for 24 weeks from two international studies, SEACOAST I and II, were pooled for this analysis. All patients had mixed dyslipidemia, including elevated cardiac risk-adjusted non-HDL-C, and were niacin-treatment-naive. After the end of the study, patients were retrospectively categorized based on ASA use prior to randomization: (1) those taking any dose of ASA (ASA ) at randomization and (2) those not taking ASA (ASA ). Results: The ASA subgroup included 192 of the 403 patients (47.6%), of whom 40 patients (9.9%) used 325 mg/d ASA, 101 (25.1%) used 81 or 100 mg/d ASA, and 51 (12.7%) used other doses. Most ASA patients reported that the ASA was being taken for cardiovascular disease prevention, therefore, frequency of ASA use at baseline differed based on coronary heart disease (CHD) risk (p 0.001 compared with ASA ). Of 271 patients with CHD or its risk equivalent, 164 (60.5%) used ASA; 24 of 100 patients (24.0%) with 2 risk factors used ASA; and 4 of 32 patients (12.5%) with 0 –1 risk factors used ASA. During NER/S treatment, fewer ASA than ASA patients experienced 1 flushing episode, 54.2% and 62.1%, respectively. Discontinuation rates due to flushing at week 24 were lower in ASA versus ASA patients, 4.2% and 7.6%, respectively. Of the 40 patients using 325 mg/d ASA at baseline, only one (2.5%) discontinued NER/S due to flushing. Treatment-emergent adverse events classified within the gastrointestinal system-organ class occurred with similar frequency in ASA and ASA patients (17.7% and 13.3%, respectively; p 0.27); no individual gastrointestinal adverse events occurred more frequently in ASA versus ASA patients (all p 0.1). Conclusions: Flushing and discontinuation due to flushing tended to be reduced in subjects reporting use of cardioprotective ASA before niacin therapy, suggesting that prior experience with ASA improves niacin tolerability. Relationships between ASA use and niacin persistence should be further explored in prospective studies.