Innovative pharmaceutical interventions in cardiovascular disease: Focusing on the contribution of non-HDL-C/LDL-C-lowering versus HDL-C-raisingA systematic review and meta-analysis of relevant preclinical studies and clinical trials

2015 ◽  
Vol 763 ◽  
pp. 48-63 ◽  
Author(s):  
Susan Kühnast ◽  
Marta Fiocco ◽  
José W.A. van der Hoorn ◽  
Hans M.G. Princen ◽  
J. Wouter Jukema
2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
E D’Andrea ◽  
S Hey ◽  
C L Ramirez ◽  
A Kesselheim

Abstract Background Niacin remains a therapeutic option for patients with cardiovascular disease, but recent studies have called into question the effectiveness of other HDL-C-raising drugs. We evaluated the evidence supporting current FDA-approved uses of niacin in cardiovascular prevention settings. Methods The systematic review included clinical trials involving niacin as a treatment for cardiovascular disease. The meta-analysis included randomized clinical trials reporting niacin’s effect on at least one long-term outcome: cardiovascular disease, coronary heart disease mortality, acute coronary syndrome, stroke, revascularization, major adverse cardiac events (MACE). Databases were searched up to October 2017. Study-level data were extracted and inverse-variance weighted methods were used to produce pooled risk ratios using random-effects models for between-study heterogeneity. Meta-regression analysis was used to assess the association between change in HDL-C and the log risk ratio of the pooled results. Results Out of 119 clinical trials, 17 documented niacin’s effect on at least one cardiovascular disease outcome. The meta-analysis covered 35,760 patients with history of cardiovascular disease or dyslipidemia. Cumulative evidence found no preventive effect of niacin on cardiovascular outcomes in secondary prevention. Stratified meta-analysis showed an association between niacin monotherapy and reduction of some cardiovascular events (acute coronary events, RR 0.74, 95%CI 0.58-0.96; stroke, RR 0.74, 95%CI 0.59-0.94; revascularization, RR 0.51, 95%CI 0.37-0.72). These results were mainly driven by two trials conducted in the 1970s and 1980s. Conclusions Niacin might have some use in lipid control for secondary prevention as monotherapy, perhaps in patients intolerant to statins, but evidence is from older studies on a population potentially not representative of current-day patients. Key messages Niacin might have some use for cardiovascular secondary prevention in patients intolerant to statins, but evidence is from older studies on a population not representative of current-day patients. The FDA has to review the approved indications for Niacin in cardiovascular secondary prevention.


Sign in / Sign up

Export Citation Format

Share Document