A randomized pilot study on the effect of niacin on pulmonary arterial pressureReport as inadecuate




A randomized pilot study on the effect of niacin on pulmonary arterial pressure - Download this document for free, or read online. Document in PDF available to download.

Trials

, 16:530

First Online: 21 November 2015Received: 05 March 2015Accepted: 15 October 2015DOI: 10.1186-s13063-015-1013-6

Cite this article as: McNamara, M.J., Sayanlar, J.J., Dooley, D.J. et al. Trials 2015 16: 530. doi:10.1186-s13063-015-1013-6

Abstract

BackgroundNiacin induces the release of vasodilating prostaglandins, for which receptors are present within the pulmonary arterial circulation. We hypothesized that immediate-release niacin would reduce right ventricular systolic pressure in patients with pulmonary hypertension in a randomized, double-blinded, single-dose provocation study.

MethodsWe recruited inpatient subjects with a Doppler echocardiogram showing a peak tricuspid regurgitation TR jet velocity of 2.7 m-s or greater, and who were free of known pulmonary vascular disease. Subjects were randomized in a 1:2:2 ratio to receive a single dose of either placebo, niacin 100 mg or niacin 500 mg, respectively. TR jet velocities were measured immediately before, and 1 hour post dose, corresponding to peak niacin absorption and prostaglandin release. The primary endpoint was the change in mean TR jet velocity measured over ten successive cardiac cycles.

ResultsThe baseline mean estimated right ventricular systolic pressure RVSP for all 49 subjects 25 male was 51.9 ± 12.1 mm Hg. The primary endpoint of mean change in TR jet velocity was 0.016 ± 0.065 m-s in the placebo group, compared to −0.017 ± 0.065 m-s with niacin 100 mg, and −0.063 ± 0.038 m-s with niacin 500 mg P = 0.63. The change in maximum estimated RVSP across the three drug groups was 0.2 ± 1.6 mm Hg, −1.3 ± 1.8 mm Hg and −2.2 ± 1.2 mm Hg P = 0.62. In exploratory pairwise analysis in the high-dose niacin group 500 mg, the reduction in mean RVSP was from 50.9 ± 9.4 mm Hg to 48.7 ± 10.0 mm Hg P = 0.09.

ConclusionsA single dose of immediate-release niacin 100 mg or 500 mg had no significant effect on RVSP 1 hour post administration. A nonsignificant dose-dependent trend for a modest reduction in RVSP, most notable in the 500 mg group, was noted.

ISRCTN number 12353191, registered April 23, 2015.

AbbreviationsANOVAanalysis of variance

ALTalanine transaminase

ASTaspartate transaminase

Bi-PAPbi-level positive airway pressure

GPR109AG-protein coupled receptor 109A

IVCinferior vena cava

MGUHMedStar Georgetown University Hospital

m-smeters-second

NPOnothing by mouth

NSAIDnonsteroidal anti-inflammatory drug

PAHpulmonary arterial hypertension

PGD2prostaglandin D2

PGI2prostacyclin or prostaglandin I2

RVSPright ventricular systolic pressure

TRtricuspid regurgitation

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-015-1013-6 contains supplementary material, which is available to authorized users.

Download fulltext PDF



Author: Martin J. McNamara - Jason J. Sayanlar - Daniel J. Dooley - Monvadi B. Srichai - Allen J. Taylor

Source: https://link.springer.com/







Related documents