Evidence map›Paper›PMID 33247951›Full record

SynthesisBritish journal of clinical pharmacology2021

Model-based meta-analysis of the time to first acute urinary retention or benign prostatic hyperplasia-related surgery in patients with moderate or severe symptoms.

Salvatore D'Agate, Chandrashekhar Chavan, Michael Manyak, Juan Manuel Palacios-Moreno, Matthias Oelke, Martin C Michel, Claus G Roehrborn, Oscar Della Pasqua

Open access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 2 pooled it
1.5field-weighted citation impact, top 17% 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

8 citing papers in PubMed, 2 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
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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 8 institutions in 6 countries.

Salvatore D'AgateClinical Pharmacology & Therapeutics Group, University College London, London, WC1H 9JP, UK.ORCID 0000-0001-5328-4834
Chandrashekhar ChavanGlobal Medical Urology, GlaxoSmithKline, Mumbai, Maharashtra, 400093, India.
Michael ManyakGlobal Medical Urology, GlaxoSmithKline, Philadelphia, PA, 19112, USA.
Juan Manuel Palacios-MorenoGlobal Medical Urology, GlaxoSmithKline, Tres Cantos, 28760, Spain.
Matthias OelkeDepartment of Urology, St Antonius Hospital, Gronau, D-48599, Germany.
Martin C MichelDepartment of Pharmacology, Johannes Gutenberg University, Mainz, 55131, Germany.
Claus G RoehrbornDepartment of Urology, Texas Southwestern Medical Center, Dallas, TX, 75390, USA.
Oscar Della PasquaClinical Pharmacology & Therapeutics Group, University College London, London, WC1H 9JP, UK.ORCID 0000-0002-6211-1430
GlaxoSmithKline (France) · FRGlaxoSmithKline (India) · INGlaxoSmithKline (United States) · USJohannes Gutenberg University Mainz · DESouthwestern Medical CenterSt.-Antonius-Hospital Gronau · DESystem Simulation (United Kingdom) · GBUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsCombination therapy of 5α-reductase inhibitor and α-blocker is a guideline-endorsed therapeutic approach for patients with moderate-to-severe lower urinary tract symptoms or benign prostatic hyperplasia (LUTS/BPH) who are at risk of disease progression. We aimed to disentangle the contribution of clinical and demographic baseline characteristics affecting the risk of acute urinary retention or BPH-related surgery (AUR/S) from the effect of treatment with drugs showing symptomatic and disease-modifying properties.

methodsA time-to-event model was developed using pooled data from patients (n = 10 238) enrolled into six clinical studies receiving placebo, tamsulosin, dutasteride or tamsulosin-dutasteride combination therapy. A parametric hazard function was used to describe the time to first AUR/S. Covariate model building included the assessment of relevant clinical and demographic factors on baseline hazard. Predictive performance was evaluated by graphical and statistical methods.

resultsAn exponential hazard model best described the time to first AUR/S in this group of patients. Baseline International Prostate Symptom Score, prostate-specific antigen, prostate volume and maximum urine flow were identified as covariates with hazard ratio estimates of 1.04, 1.08, 1.01 and 0.91, respectively. Dutasteride monotherapy and tamsulosin-dutasteride combination therapy resulted in a significant reduction in the baseline hazard (56.8% and 66.4%, respectively). By contrast, the effect of tamsulosin did not differ from placebo.

conclusionsOur analysis showed the implications of disease-modifying properties of dutasteride and tamsulosin-dutasteride combination therapy for the risk of AUR/S. It also elucidated the contribution of different baseline characteristics to the risk of these events. The use of tamsulosin monotherapy (symptomatic treatment) has no impact on individual long-term risk.

Indexed as

Prostatic HyperplasiaUrinary RetentionAzasteroidsDrug Therapy, CombinationHumansMaleSulfonamidesTreatment OutcomeAzasteroidsSulfonamidesacute urinary retentionbaseline risk factorsbenign prostatic hyperplasiadisease-modifying propertiesdutasteridelower urinary tract symptomstamsulosintime-to-event modelling

Identifiers

PMID33247951
PMCPMC8359386
OpenAlexW3109960362

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.