Evidence map›Paper›PMID 31079189›Full record

Trial reportWorld journal of urology2020

Impact of disease progression on individual IPSS trajectories and consequences of immediate versus delayed start of treatment in patients with moderate or severe LUTS associated with BPH.

Salvatore D'Agate, Timothy Wilson, Burkay Adalig, Michael Manyak, Juan Manuel Palacios-Moreno, Chandrashekhar Chavan, Matthias Oelke, Claus Roehrborn, Oscar Della Pasqua

Open access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in World journal of urology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
2.4field-weighted citation impact, top 12% 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, 3 syntheses or guidelines pooled it, 23 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Review
  7. Article
  8. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 7 institutions in 5 countries.

Salvatore D'AgateClinical Pharmacology and Therapeutics Group, University College London, London, UK.
Timothy WilsonPAREXEL International, Durham, NC, USA.
Burkay AdaligClassic and Established Products, GSK, Istanbul, Turkey.
Michael ManyakClassic and Established Products, GSK, Washington, DC, USA.
Juan Manuel Palacios-MorenoClassic and Established Products, GSK, Madrid, Spain.
Chandrashekhar ChavanClassic and Established Products, GSK, Worli, Mumbai, India.
Matthias OelkeDepartment of Urology, St. Antonius Hospital, Gronau, Germany.
Claus RoehrbornDepartment of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
Oscar Della PasquaClinical Pharmacology and Therapeutics Group, University College London, London, UK. oscar.e.della-pasqua@gsk.com.ORCID http://orcid.org/0000-0002-6211-1430
Geological Society of London · GBGlaxoSmithKline (India) · INGlaxoSmithKline (Spain) · ESPAREXEL International (United States) · USSt.-Antonius-Hospital Gronau · DEThe University of Texas Southwestern Medical Center · USUniversity College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeDespite superiority of tamsulosin-dutasteride combination therapy versus monotherapy for lower urinary tract symptoms due to benign prostatic hyperplasia (LUTS/BPH), patients at risk of disease progression are often initiated on α-blockers. This study evaluated the impact of initiating tamsulosin monotherapy prior to switching to tamsulosin-dutasteride combination therapy versus immediate combination therapy using a longitudinal model describing International Prostate Symptom Score (IPSS) trajectories in moderate/severe LUTS/BPH patients at risk of disease progression.

methodsClinical trial simulations (CTS) were performed using data from 10,238 patients from Phase III/IV dutasteride trials. The effect of varying disease progression rates was explored by comparing profiles on- and off-treatment. CTS scenarios were investigated, including a reference (immediate combination therapy) and six alternative virtual treatment arms (delayed combination therapy of 1-24 months). Clinical response (≥ 25% IPSS reduction relative to baseline) was analysed using log-rank test. Differences in IPSS relative to baseline at various on-treatment time points were assessed by t tests.

resultsDelayed combination therapy initiation led to significant (p < 0.01) decreases in clinical response. At month 48, clinical response rate was 79.7% versus 74.1%, 70.3% and 71.0% and IPSS was 6.3 versus 7.6, 8.1 and 8.0 (switchers from tamsulosin monotherapy after 6, 12 and 24 months, respectively) with immediate combination therapy. More patients transitioned from severe/moderate to mild severity scores by month 48.

conclusionsCTS allows systematic evaluation of immediate versus delayed combination therapy. Immediate response to α-blockers is not predictive of long-term symptom improvement. Observed IPSS differences between immediate and delayed combination therapy (6-24 months) are statistically significant.

Indexed as

Time-to-Treatment5-alpha Reductase InhibitorsAgedAzasteroidsDisease ProgressionDouble-Blind MethodDrug Therapy, CombinationDutasterideHumansLower Urinary Tract SymptomsMaleMiddle AgedProstatic HyperplasiaTreatment Outcome5-alpha Reductase InhibitorsAzasteroidsDutasterideBenign prostatic hyperplasiaClinical trial simulationDrug–disease modellingDutasterideLower urinary tract symptomsTamsulosin

Identifiers

PMID31079189
PMCPMC6994451
OpenAlexW2944057527

What OpenQuestion holds

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LicenceCC BY
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.