Evidence map›Paper›PMID 33768487›Full record

ArticleClinical pharmacokinetics2021

Effect of Varying Degrees of Renal Impairment on the Pharmacokinetics of Omecamtiv Mecarbil.

Ashit Trivedi, Rajneet K Oberoi, Pegah Jafarinasabian, Hanze Zhang, Stephen Flach, Siddique Abbasi, Sandeep Dutta, Edward Lee

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
2.2field-weighted citation impact, top 11% of its field
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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 17 citations in OpenAlex.

  1. Pooled it
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  3. Trial
  4. Trial
  5. Review
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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

8 authors at 2 institutions in 1 country.

Ashit TrivediAmgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA. ashitt@amgen.com.ORCID 0000-0002-5040-5722
Rajneet K OberoiAmgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Pegah JafarinasabianAmgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Hanze ZhangAmgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Stephen FlachCovance Inc., Madison, WI, USA.
Siddique AbbasiAmgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Sandeep DuttaAmgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Edward LeeAmgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA, 91320, USA.
Amgen (United States) · USCovance (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveOmecamtiv mecarbil is a novel selective cardiac myosin activator (myotrope) under investigation for the treatment of heart failure with reduced ejection fraction. The objective of this clinical study was to estimate the effect of varying degrees of renal impairment on the pharmacokinetics of omecamtiv mecarbil single dose (50 mg) under fasted conditions.

methodsThis phase I, open-label, non-randomized, parallel-group study evaluated the pharmacokinetics, safety, and tolerability of a single oral dose of omecamtiv mecarbil 50 mg in individuals with normal renal function or mild, moderate, and severe renal impairment, including end-stage renal disease requiring dialysis. Geometric least-squares mean ratios of maximum observed concentration (C

resultsThirty-one participants received treatment and completed the study. Geometric mean exposures were similar for participants with renal impairment (AUC

conclusionsOmecamtiv mecarbil pharmacokinetics were not meaningfully affected by renal function or hemodialysis, suggesting the same dosing strategy can be used in individuals with normal renal function or renal impairment. Oral administration of omecamtiv mecarbil was not associated with major tolerability findings. This study supports omecamtiv mecarbil for the treatment of heart failure in individuals with or without renal impairment.

Indexed as

Heart FailureUreaAdministration, OralArea Under CurveCardiac MyosinsHumansCardiac Myosinsomecamtiv mecarbilUrea

Identifiers

PMID33768487
PMCPMC8332597
OpenAlexW3137484214

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Registered trials

None linked

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.