Evidence map›Paper›PMID 30182223›Full record

Observational studyClinical and experimental nephrology2019

Safety and effectiveness of long-term use of darbepoetin alfa in non-dialysis patients with chronic kidney disease: a post-marketing surveillance study in Japan.

Tetsuhiro Tanaka, Masaomi Nangaku, Enyu Imai, Yoshiharu Tsubakihara, Masatoshi Kamai, Michihito Wada, Shinji Asada, Tadao Akizawa

Erratum issuedOpen access · hybridAbstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Clinical and experimental nephrology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.1field-weighted citation impact, top 21% 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

4 citing papers in PubMed, 14 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Tetsuhiro TanakaDivision of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.
Masaomi NangakuDivision of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Bunkyo-ku, Tokyo, Japan.
Enyu ImaiInternal Medicine of Nakayamadera Imai Clinic, Takarazuka, Hyogo, Japan.
Yoshiharu TsubakiharaGraduate School of Health Care Sciences, Jikei Institute, Yodogawa-ku, Osaka, Japan.
Masatoshi KamaiPharmacovigilance Department, Kyowa Hakko Kirin Co., Ltd., Chiyoda-ku, Tokyo, Japan.
Michihito WadaMedical Affairs Department, Kyowa Hakko Kirin Co., Ltd., Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan.
Shinji AsadaMedical Affairs Department, Kyowa Hakko Kirin Co., Ltd., Otemachi Financial City Grand Cube, 1-9-2 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan. shinji.asada@kyowa-kirin.co.jp.
Tadao AkizawaShowa University, Shinagawa-ku, Tokyo, Japan.
Kyowa Kirin (Japan) · JPThe University of Tokyo · JPGraduate School of Health Care Sciences, Jikei Institute · JPShowa University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis post-marketing surveillance (PMS) study evaluated the safety and effectiveness of long-term darbepoetin alfa (darbepoetin) for the treatment of renal anemia in Japanese non-dialysis chronic kidney disease patients.

methodsPatients were treated with darbepoetin and followed up for 3 years. Adverse events (AEs), adverse drug reactions (ADRs), hemoglobin (Hb) levels, and renal function were assessed. Patients were stratified by Hb level at the time of occurrence of cardiovascular-related AEs. Statistical analyses were performed to explore factors affecting the occurrence of AEs, cardiovascular-related AEs, and composite renal endpoints.

resultsIn the safety analysis set (5547 patients), AEs and ADRs occurred in 44.4 and 7.1% of patients, respectively. Cardiovascular-related AEs were observed in 12.6% of the overall population. The proportion of patients who presented cardiovascular-related AEs was lower among those with a higher Hb level at the time of occurrence. In the effectiveness analysis set (5024 patients), mean Hb levels remained between 10.0 and 10.6 g/dL (Weeks 4-156). Three months after darbepoetin administration, patients with Hb ≥ 11 g/dL presented fewer composite renal endpoints than those with Hb < 11 g/dL (p = 0.0013), and the cumulative proportion of renal survival was higher in those with Hb ≥ 11 g/dL vs. Hb < 11 g/dL (p < 0.0001).

conclusionsThis PMS study showed the safety and effectiveness of long-term use of darbepoetin in a large number of patients. Patients with Hb ≥ 11 g/dL presented fewer composite renal endpoints than those with Hb < 11 g/dL, without an increase in the incidence of cardiovascular-related AEs.

Indexed as

AgedAged, 80 and overAnemiaBiomarkersDarbepoetin alfaDrug Administration ScheduleFemaleHematinicsHemoglobinsHumansJapanKidneyMaleMiddle AgedPatient SafetyProduct Surveillance, PostmarketingBiomarkersDarbepoetin alfaHematinicsHemoglobinsCardiovascular-related adverse eventsComposite renal endpointsDarbepoetin alfaNon-dialysis chronic kidney diseasePost-marketing surveillance

Identifiers

PMID30182223
PMCPMC6510805
OpenAlexW2891220559

What OpenQuestion holds

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LicenceCC BY
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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.