Evidence map›Paper›PMID 26289089›Full record

Trial reportJournal of thrombosis and thrombolysis2016

Detrimental effects of niacin/laropiprant on microvascular reactivity and red cell deformability in patients with elevated lipoprotein(a) levels.

Gabriele Cioni, Lucia Mannini, Alessandrello Agatina Liotta, Giovanna D'Alessandri, Cinzia Fatini, Brunella Bandinelli, Maria Costanzo, Rosanna Abbate, Rossella Marcucci

Abstract readClinical TrialLetter
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In one paragraph

Trial report in Journal of thrombosis and thrombolysis, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors.

Gabriele CioniDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50132, Florence, Italy. gabriele.cioni@unifi.it.
Lucia ManniniDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50132, Florence, Italy.
Alessandrello Agatina LiottaDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50132, Florence, Italy.
Giovanna D'AlessandriSIMT, USL 3, Pistoia, Italy.
Cinzia FatiniDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50132, Florence, Italy.
Brunella BandinelliDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50132, Florence, Italy.
Maria CostanzoDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50132, Florence, Italy.
Rosanna AbbateDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50132, Florence, Italy.
Rossella MarcucciDepartment of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50132, Florence, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Several studies have found a beneficial effect of nicotinic acid on lipid profile, but there remains a limitation in the clinical use of nicotinic acid due to its side effects. In this study, 46 (F/M = 22/24, age = 58.74 ± 10.02 years) patients with Lp(a) ≥500 mg/L and with a previous arterial thrombotic event were treated with nicotinic acid/laropiprant (Tredaptive®). We found a significant reduction in the Lp(a) values at T1 (after 12 months), with a decrease of 32.3 % from baseline levels. At T1, 11 patients (23.9 %) showed Lp(a) levels to be <500 mg/L. PAT values were significantly decreased after treatment (2.13 ± 0.81 vs 1.74 ± 0.42, p = 0.001), showing a worsening of endothelial function in 27 (58.6 %) patients. A significantly higher number of patients had RHI <1.5 after the treatment [18 (39.1 %) vs 8 (17.4 %)]. Blood rheology worsened as ED was impaired (p < 0.0001) after 12 months, whereas WHV, plasma viscosity, and red cell aggregation did not show any significant differences in comparison to baseline. Patients with a worsening in microvascular reactivity in comparison to baseline showed a marked impairment in ED (0.3327 ± 0.037 vs 0.3091 ± 0.0351; p < 0.0001), while others showed only a mild, even though significant, reduction (0.3347 ± 0.0299 vs 0.3272 ± 0.0235; p = 0.044). In the light of the results of HPS2-THRIVE study, we may hypothesize that the addition of laropiprant to niacin might be responsible for these negative effects. In turn, these effects might explain, at least in part, the lack of a clinical net benefit of niacin/laropiprant in the trial.

Indexed as

AgedErythrocyte DeformabilityFemaleHumansIndolesLipoprotein(a)MaleMicrocirculationMiddle AgedNiacinIndolesLipoprotein(a)MK-0524NiacinMicrovascular reactivityNiacin/laropiprantPeripheral arterial tonometryRed cell deformability

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.