Evidence map›Paper›PMID 32144791›Full record

SynthesisBritish journal of clinical pharmacology2020

Model-based meta-analysis of individual International Prostate Symptom Score trajectories in patients with benign prostatic hyperplasia with moderate or severe symptoms.

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

Abstract readMeta-Analysis
In one paragraph

Synthesis in British journal of clinical pharmacology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Review
  4. Article
  5. Article
  6. Article
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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

9 authors.

Salvatore D'AgateClinical Pharmacology and Therapeutics Group, University College London, London, UK.ORCID 0000-0001-5328-4834
Timothy WilsonPAREXEL International, Durham, NC, USA.
Burkay AdaligClassic & Established Products, GSK, Istanbul, Turkey.
Michael ManyakClassic & Established Products, GSK, Washington, DC, USA.
Juan Manuel Palacios-MorenoClassic & Established Products, GSK, Madrid, Spain.
Chandrashekhar ChavanClassic & 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.ORCID 0000-0002-6211-1430

Funding

GlaxoSmithKline
6 · The paper itself

Abstract

aimsInternational Prostate Symptom Score (IPSS) is a marker of lower urinary tract symptoms (LUTS) deterioration or improvement in benign prostate hyperplasia (BPH). Whereas changes in IPSS relative to baseline have been used as endpoints in clinical trials, little attention has been given to the time course of symptoms. The current investigation aimed to develop a drug-disease model to describe individual IPSS trajectories in moderate and severe BPH patients.

methodsA model-based meta-analytical approach was used including data from 10 238 patients enrolled into Phase III and IV studies receiving placebo, tamsulosin, dutasteride or combination therapy over a period of up to 4 years. Model predictive performance was assessed using statistical and graphical criteria. Subsequently, simulations were performed to illustrate the implications of treatment with drugs showing symptomatic and disease-modifying properties in patients with varying disease progression rates.

resultsImprovement and worsening of IPSS could be characterized by a model including a sigmoid function which disentangles drug effects from placebo and varying disease progression rates on IPSS. Mean estimate (95% confidence intervals) for the disease progression rate was 0.319 (0.271-0.411) month

conclusionsThe availability of a drug-disease model enables the evaluation of interindividual differences in disease progression rate, deterioration of symptoms and treatment effects on LUTS/BPH.

Indexed as

Prostatic HyperplasiaAzasteroidsDrug Therapy, CombinationHumansMaleSulfonamidesTreatment OutcomeAzasteroidsSulfonamidesbenign prostatic hyperplasiadisease modellingdisease progressiondutasterideInternational Prostate Symptoms Scorelower urinary tract symptomstamsulosin

Identifiers

PMID32144791
PMCPMC7373698

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LicenceCC BY-NC-ND
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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.