Evidence map›Paper›PMID 38616722›Full record

ArticleLower urinary tract symptoms2024

Long-term safety of desmopressin orally disintegrating tablets in men with nocturia due to nocturnal polyuria: Interim results of a specified drug use-results survey in Japan.

Yoshimasa Ogawa, Shujiro Murata, Kiyotoshi Kuramoto, Atsushi Nakano

Open access · hybridAbstract read
In one paragraph

Article in Lower urinary tract symptoms, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.7field-weighted citation impact, top 16% 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, 4 citations in OpenAlex.

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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

4 authors at 2 institutions in 2 countries.

Yoshimasa OgawaPost-Marketing Surveillance, Medical Affairs, Ferring Pharmaceuticals Co. Ltd., Tokyo, Japan.ORCID https://orcid.org/0009-0008-2466-545X
Shujiro MurataMedical Affairs, Ferring Pharmaceuticals Co. Ltd., Tokyo, Japan.
Kiyotoshi KuramotoPharmacovigilance & Post-Marketing Surveillance, Kissei Pharmaceutical Co., Ltd., Tokyo, Japan.
Atsushi NakanoMedical Affairs, Ferring Pharmaceuticals Co. Ltd., Tokyo, Japan.
Ferring Pharmaceuticals (Switzerland) · CHKissei Pharmaceutical (Japan) · JP

Funding

Post-Marketing Surveillance, Medical Affairs, Ferring Pharmaceuticals Co. Ltd., Tokyo, Japan
6 · The paper itself

Abstract

objectivesThis interim report presents the 12-week results of a post-marketing surveillance evaluating the safety of desmopressin orally disintegrating tablets 25 and 50 μg in Japanese men with nocturia due to nocturnal polyuria.

methodsOf the planned study population of 1000 Japanese men receiving desmopressin for the first time for nocturia due to nocturnal polyuria, 971 cases were enrolled. In this interim analysis, 9 cases, including 6 registry violations and 3 cases of unconfirmed desmopressin dosing, were excluded from the 354 case report forms collected and fixed by the end of December 2021, and data up to 12 weeks after administration in 345 cases were defined as the safety analysis set.

resultsThe mean age was 74.5 ± 9.9 years and 88.7% of the survey participants were aged ≥65 years. Desmopressin was started at a dose of 25 μg in 153 cases (44.3%). There were 102 adverse drug reactions (ADRs) reported in 71 cases, including 6 serious ADRs in 3 cases (0.9%). The most common ADR was hyponatremia occurring in 29 cases (8.4%). Eight of the hyponatremic cases were asymptomatic. Symptoms were resolved or slightly improved within 4 weeks of onset in 13 of 29 cases of hyponatremia. In addition, hyponatremia occurred in 11 of 217 cases (5.1%), with a serum sodium level before the administration of desmopressin of ≥140 mmol/L, and in 13 of 87 cases (14.9%), with a level of 135-139 mmol/L, and was not measured in 5 hyponatremia cases. Patient characteristics that showed significant differences in the occurrence of hyponatremia included body weight, body mass index, renal function, and pretreatment serum sodium level. Regular monitoring of serum sodium is necessary for early detection of hyponatremia.

conclusionsHyponatremia was the most common ADR when desmopressin orally disintegrating tablets were used to treat nocturia due to nocturnal polyuria over a 12-week period.

Indexed as

Drug-Related Side Effects and Adverse ReactionsHyponatremiaNocturiaSubstance-Related DisordersAgedAged, 80 and overDeamino Arginine VasopressinHumansJapanMaleMiddle AgedPolyuriaSodiumTabletsDeamino Arginine VasopressinSodiumTabletsdesmopressinHyponatremiaMINIRINMELTnocturiapost‐marketing surveillance

Identifiers

PMID38616722
PMCPMC11500684
OpenAlexW4394818138

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.