Evidence map›Paper›PMID 28251822›Full record

Trial reportCancer medicine2017

Tolvaptan use in cancer patients with hyponatremia due to the syndrome of inappropriate antidiuretic hormone: a post hoc analysis of the SALT-1 and SALT-2 trials.

Richard J Gralla, Fatima Ahmad, Jaime D Blais, Joseph Chiodo, Wen Zhou, Linda A Glaser, Frank S Czerwiec

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.1field-weighted citation impact, top 8% 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

13 citing papers in PubMed, 24 citations in OpenAlex.

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  10. Evidence for Effective Multiple KFrontiers in pharmacology · 2019
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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

7 authors at 3 institutions in 1 country.

Richard J GrallaAlbert Einstein College of Medicine, Bronx, New York.
Fatima AhmadOtsuka Pharmaceutical Development & Commercialization Inc., Rockville, Maryland.
Jaime D BlaisOtsuka Pharmaceutical Development & Commercialization Inc., Rockville, Maryland.
Joseph ChiodoOtsuka Pharmaceutical Development & Commercialization Inc., Rockville, Maryland.
Wen ZhouOtsuka Pharmaceutical Development & Commercialization Inc., Rockville, Maryland.
Linda A GlaserCoastal Biomedical Research, Inc., Santa Monica, California.
Frank S CzerwiecOtsuka Pharmaceutical Development & Commercialization Inc., Rockville, Maryland.
Otsuka (United States) · USPharmaceutical Product Development (United States) · USAlbert Einstein College of Medicine · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Hyponatremia is a common electrolyte disorder in cancer patients and has been associated with poor prognosis. A frequent cause of cancer-related hyponatremia is the syndrome of inappropriate antidiuretic hormone (SIADH). This study was a post hoc subgroup analysis of the SALT-1 (Study of Ascending Levels of Tolvaptan in Hyponatremia) and SALT-2 clinical trials. Hyponatremic subjects with SIADH and cancer received the oral selective vasopressin V2-receptor antagonist tolvaptan (n = 12) or matching placebo (n = 16) once-daily for 30 days. The initial tolvaptan dose (15 mg) was titrated over 4 days to 30 or 60 mg per day, as needed, according to serum sodium level and tolerability. Baseline serum sodium levels in the SIADH/cancer cohort of the SALT trials was 130 and 128 mEq/L for tolvaptan and placebo, respectively. Mean change from baseline in average daily serum sodium AUC for tolvaptan relative to placebo was 5.0 versus -0.3 mEq/L (P < 0.0001) at day 4, and 6.9 versus 1.0 mEq/L (P < 0.0001) at day 30; the observed treatment effects were similar to those in the overall SIADH population (i.e., with and without cancer) at both time points. Serum sodium normalization was observed in 6/12 and 0/13 subjects at day 4 and 7/8 and 2/6 subjects at day 30 in the tolvaptan and placebo groups, respectively (P < 0.05 for both). Common treatment-emergent AEs for tolvaptan were consistent with previously reported results. In this post hoc study of the SALT trial population, oral tolvaptan was an effective and safe therapy for the treatment of hyponatremia in subjects with SIADH and cancer.

Indexed as

Administration, OralAgedAntidiuretic Hormone Receptor AntagonistsBenzazepinesDouble-Blind MethodFemaleHumansHyponatremiaInappropriate ADH SyndromeMaleMiddle AgedNeoplasmsSodiumTolvaptanTreatment OutcomeAntidiuretic Hormone Receptor AntagonistsBenzazepinesSodiumTolvaptanbreast cancerhead and neck cancer,Hyponatremia,lung cancer,renal cancersyndrome of inappropriate antidiuretic hormone (SIADH)tolvaptan

Identifiers

PMID28251822
PMCPMC5387121
OpenAlexW2593546409

What OpenQuestion holds

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LicenceCC BY
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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.