Association Between Niacin-ER Use, Safety, and Cardiovascular Events. A Single Center Experience.

Abstract

Background/Synopsis

Studies reveal increased incidences of cardiovascular events such as heart attacks and strokes in patients with elevated lipoprotein(a) levels. Niacin-ER has shown to lower lipoprotein(a) levels by approximately 30% though unknown if niacin-ER reduces cardiovascular events in this population. This single center study evaluates 129 patients with a personal or family history of a premature cardiovascular event whose lipoprotein(a) levels were greater than 75nmol/L and prescribed niacin-ER.

Objective/Purpose

Identify patients with personal or family history of premature cardiovascular events through history and screen patients for baseline serum lipoprotein(a); levels greater than or equal to 75nmol/L were included. Patients were monitored for incidences of cardiovascular events, elevation of liver enzymes, and side-effects of niacin-ER.

The study is an effort to determine if niacin-ER can reduce cardiovascular events. While current ASO-RNA and siRNA studies are undergoing trials, niacin-ER may be a less costly alternative.

Methods

The study followed 129 adult patients seen by a Board Certified Lipidologist/Cardiologist from 2014-2024 with baseline lipoprotein(a) greater than 75 nmol/L. Patients were started on 1000 mg-2000 mg (mean 1713 mg) of niacin-ER and a high intensity statin. In the study, 118 patients were prescribed niacin-ER, while 11 were a better fit for PCSK-9 therapy. Of the 118 patients, 36 could not tolerate the flushing, despite mitigating strategies. Patients’ hospital and outpatient records were reviewed for cardiovascular events.

Results

The average baseline value of lipoprotein(a) was 221.59 nmol/L, higher than 35-70 nmol/L in AIM-HIGH and HPS2-THRIVE trials. Current trials with siRNA and ASO-RNA therapies set inclusion criteria at >150 nmol/L. The average lipoprotein(a) after starting niacin-ER amounted to 157.71 nmol/L, a 33.68% reduction.

Fifteen patients laboratory tests resulted in non-prohibitive mildly elevated liver function tests (LFTs), with maximum ALT and AST of 85 U/L and 68 U/L, respectively, after starting niacin.

All patients were on high-intensity statin.

Conclusions

Niacin-ER reduced lipoprotein(a) levels by 33.68%, comparable to published data of 30%.

Niacin-ER continues to be shown as safe and well-tolerated with no incidences of strokes, infections, gastrointestinal symptoms, or rhabdomyolysis; there was a non-significant elevation in LFTs.

In the 83 patients taking niacin-ER, there were no subsequent cardiovascular events up to ten years follow up.

Reduction in cardiovascular events could not be observed with the low sample size. The study reinforces the need to further assess the effectiveness of niacin-ER on cardiovascular events while prospective therapies continue through trials.