LDL-C and TC lowering was significantly greater in the evening dose than in the morning dose in case of short-acting statins .
Besides slight but significant effect on LDL-C , the efficacy of long-acting statins was equivalent for both regimens .
BACKGROUND Evidence about the optimal time of day at which to administer statins is lacking .
OBJECTIVE The objective of this study is to synthesize evidence about effects of morning vs evening statin administration on lipid profile .
Comparison of the efficacy and safety profile of morning administration of controlled-release simvastatin versus evening administration of immediate-release simvastatin in chronic kidney disease patients with dyslipidemia.
PURPOSE Evening administration of the conventional immediate-release ( IR ) formulation of simvastatin is recommended because of its short half-life ( 1.9 hours ) . In a healthy population , morning administration of a controlled-release ( CR ) formulation of simvastatin was shown to have equivalent lipid-lowering efficacy and a safety profile similar to that of evening doses of IR simvastatin . The present study aim ed to verify noninferiority and to compare the safety of morning administration of CR simvastatin with that of evening administration of IR simvastatin in patients with chronic kidney disease ( CKD ) who have dyslipidemia . METHODS The present study was a prospect i ve , multicenter , double-blind , Phase IV trial with an active comparator . We r and omly assigned 122 patients with CKD and dyslipidemia to 1 of 2 drug administration groups : morning administration of CR simvastatin 20 mg ( test group ) and evening administration of IR simvastatin 20 mg ( control group ) . After 8 weeks , the treatment outcomes and adverse effects of the 2 treatments were compared . FINDINGS The mean ( SD ) percentage of change in serum LDL-C at the end of treatment was -35.1 % ( 15.7 % ) for the test group and -35.6 % ( 14.6 % ) for the control group . The difference between the 2 groups was not significant ( P = 0.858 ) . The 95 % CI of the difference in the percentage of change of LDL-C between the test and control groups was -6.0 to 5.0 . There was no difference in the percentage of change of total cholesterol ( -24.3 % [ 12.5 % ] vs -26.5 % [ 12.0 % ] , P = 0.317 ) , triglyceride ( -10.6 % [ 35.1 % ] vs -12.4 % [ 33.2 % ] , P = 0.575 ) and HDL-C ( 10.2 % [ 20.7 % ] vs 4.5 % [ 11.4 % ] , P = 0.064 ) . Treatment-related adverse events were similar in both groups ( 10 events in the test group vs 8 events in the control group , P = 0.691 ) . IMPLICATION S The efficacy of morning administration of CR simvastatin was noninferior to evening administration of IR simvastatin in patients with CKD . Furthermore , the safety profile analysis showed no significant difference between the 2 treatments . Morning administration of CR simvastatin is expected to increase patient compliance and therefore better control of dyslipidemia in CKD patients
LDL-C and TC lowering was significantly greater in the evening dose than in the morning dose in case of short-acting statins .
Besides slight but significant effect on LDL-C , the efficacy of long-acting statins was equivalent for both regimens .
BACKGROUND Evidence about the optimal time of day at which to administer statins is lacking .
OBJECTIVE The objective of this study is to synthesize evidence about effects of morning vs evening statin administration on lipid profile .