The Role of Niacin in Cardiovascular Disease Prevention: A Systematic Review and Meta-analysis

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.

Sex Differences in Long-Term Survival after a First Stroke with Intravenous Thrombolysis: Ebrictus Study

Background: A number of large trials have confirmed the benefits of thrombolysis in acute stroke, but there are gender differences. We sought to examine the relationship between sex and outcome after thrombolysis. Methods: This was a prospective cohort study including 1,272 incident ischemic strokes (597 in women) from April 1, 2006 to December 31, 2014. Statistical approaches were used for analyzing survival outcomes and their relationship with thrombolysis therapy. Results: The death rates were lower (p = 0.003) in the thrombolysis therapy group with an incidence ratio of 0.57 (95% CI 0.39-0.83). 113 (8.8%) patients (53 women) received thrombolysis. They were significantly younger (69.2 ± 12.7 vs. 73.9 ± 12.5 years; p < 0.001), had higher NIHSS score (12.7 ± 6.3 vs. 7.3 ± 7.0; p < 0.001), spent more days in hospital (10.4 ± 8.3 vs. 8.3 ± 7.9; p < 0.001), and had a higher average Barthel score at discharge (85.5 ± 24.4 vs. 79.2 ± 28.6; p = 0.023). The male/female incidence ratio showed a significant decrease (p = 0.01) in the incidence of mortality in women and a better Barthel score. The thrombolysis improved the survival in the overall group with thrombolysis versus without thrombolysis (p = 0.028), in women versus in men with thrombolysis (p = 0.023), and in women with thrombolysis versus in those without thrombolysis (p < 0.001) but not in men with thrombolysis versus in those without thrombolysis (p = 0.743). The protective factors as regards mortality were thrombolysis therapy (95% CI 0.37-0.80; p = 0.002), Barthel score ≥60 (95% CI 0.81-0.94; p = 0.002), and cardiovascular secondary prevention 1 year after stroke (0.13, 95% CI 0.06-0.28). Conclusions: The stroke death rates were lower in women after thrombolysis treatment and suggest significant benefit for women in this setting. The overall benefit on survival of the patients treated with thrombolysis might be explained by the beneficial effect of the thrombolysis on the women.