Comparison of the efficacy and safety of a combination tablet of niacin extended-release and XXXX with @entity3413 80 mg monotherapy: the SEACOAST II (high-dose) study.

@entity1 @entity1671 @entity3413 @entity2299 @entity1674 @entity156 @entity1670 @entity165
BACKGROUND: The number of @entity1 with @entity156 is increasing. Lipid treatment guidelines are established for low-density lipoprotein @entity165 (LDL-C) and non-high-density lipoprotein @entity165 (non-HDL-C). The importance of treating HDL-C and @entity1674 is gaining recognition. OBJECTIVE: To determine, in @entity1 who had been treated previously with @entity3413 40 mg/day, the efficacy, safety, and tolerability of two regimens of a combination of proprietary @entity1670 , extended-release core, coated with 40 mg/day @entity3413 (NER/S), compared to 80 mg/day @entity3413 monotherapy (S80). METHODS: High-risk @entity1 (n = 343) with @entity2299 were treated for 24 weeks with NER/S (1000/40 mg/day or 2000/40 mg/day) or S80. RESULTS: Median percentage change from baseline to week 24 in non-HDL-C in either NER/S group was noninferior to S80 (-11.3%, -17.1%, and -10.1%, respectively). Changes in LDL-C were comparable (-8.6%, -11.6%, and -12.7%, respectively). Doubling the dose of @entity3413 (S80) did not alter HDL-C, @entity1674 , or lipoprotein(a); however, both NER/S doses resulted in significant improvements in all three parameters (+21.9%, -31.8%, and -21.0%, respectively, for NER/S 2000/40 mg/day). The safety of NER/S was consistent with the safety profile of each individual component. Treatment with both doses of NER/S was well tolerated; 59% of @entity1 experienced @entity1671 , 78% of @entity1671 was mild or moderate in intensity, 49% of those who flushed during dose titration did not flush during weeks 13 to 24, and only 4.6% of @entity1 discontinued because of @entity1671 . CONCLUSION: NER/S provides similar reductions in non-HDL-C and LDL-C compared to doubling the @entity3413 dose to 80 mg; however, only NER/S resulted in improvements in HDL-C, @entity1674 , and lipoprotein(a).
