A Randomized Controlled Clinical Study Of Lipids Regulating Effects Of Extended-release Niacin Tablet In The Old Patients With Lipids Abnormity

Objective: To evaluate the lipids regulating effects and the safety of extended-release niacin tablet in the old patients.Methods: sixty one hyperlipidemia patients in the outpatient department of our hospital and some retired military officers in Beijing from November 2005 to January 2007 were enrolled in the study. The patients were randomized into the study group and the controlled group. There were 31 patients in the study group, of which 23 males and 8 females, the age was 76.9±7.5 years. There were 30 patients in the controlled group, of which 21 males and 9 females, the age was 75.7±7.0 years. All patients enrolled the study were told to have lower lipid diet during all the study period. Patients in the study group received extended-release niacin tablet 500mg orally at night from the 1st week to the 4th week, then 1000mg from the 5th week to the 12th week. Patients in the controlled group received fenobrate 200mg at morning once a day. TC, LDL-C, HDL-C, TG, Lp(a), Glucose, creatine kinase, liver function, renal function, Fig and CIMT were measured regularly before study and at the end of the study. Chief complaints were also recorded during follow-up. All statistical tests were performed with SPSS software (version 11.5). All data were expressed as mean± standard deviation (mean ± SD), students t test was used to explore statistical significance.Results: There were no remarkable statistic difference of all lipid markers between the two groups before treatment. After the treatment, TC, TG, LDL-C, Lp(a), TC/HDL,Fig decreased by 10 % and 14 %, 28 % and 53 %, 6 % and 7 %, 26% and 6%, 21%and15%, 15 % and 6 %, HDL-C increased by 15 % and 6 % . Decreasing of TC, TG, Lp(a) TC/HDL,Fig and increasing of HDL-C had statistic significance in the study group,and decreasing of TC, TG, TC/HDL,Fig in the controlled group had statistic significance.there was significant difference of TG, Lp(a),HDL-C and no statistic significance of TC, TG, LDL-C,TC/HDL and Fig between the two groups. There was no statistic significance of CIMT between the two groups. There was no significant difference of blood sugar between the baseline and at the end of the study in each group but there was significant difference of the blood sugar between the two groups at the end of the study.Conclusions: Extended-release niacin and fenobrate both can improve the blood lipid profile of the old patients with lipid abnormity significantly. Fenobrate is better than extended-release niacin in decreasing TG, but extended-release niacin is better than fenobrate in increasing HDL-C and decreasing Lp(a) levels. Extended-release niacin can also reduce blood fibrinogen which could prevent from thrombosis. Extended-release niacin can reduce the occurrence of the adverse effects such as flushing, Liver injury and so on significantly. It was effective and safe in treating the lipid abnormality in the old patients. Glucose level changing should be monitored during the treatment period. Further study should be done to evaluate whether extended-release niacin could retard the arteriosclerosis development.