Evidence map›Paper›PMID 27114197›Full record

ArticleThe journal of sexual medicine2016

Efficacy of Continuous Dosing of Tadalafil Once Daily vs Tadalafil On Demand in Clinical Subgroups of Men With Erectile Dysfunction: A Descriptive Comparison Using the Integrated Tadalafil Databases.

Gerald Brock, Xiao Ni, Matthias Oelke, John Mulhall, Matt Rosenberg, Allen Seftel, Deborah D'Souza, Jane Barry

Open access · hybridAbstract readComparative Study
In one paragraph

Article in The journal of sexual medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Canadian Urological Association guideline: Erectile dysfunction.Canadian Urological Association journal = Journal de l'Association des urologues du Canada · 2021
    Article
  5. Review
  6. Article
  7. Erectile Dysfunction: A Primer for in Office Management.Medical sciences (Basel, Switzerland) · 2019
    Review
  8. Article
  9. Article
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 7 institutions in 4 countries.

Gerald BrockWestern University, Canadian Urological Association, London, ON, Canada.
Xiao NiEli Lilly and Company, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.
Matthias OelkeDepartment of Urology, Hannover Medical School, Hannover, Germany.
John MulhallUrology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Matt RosenbergMid Michigan Health Centers, Jackson, MI, USA.
Allen SeftelCooper Medical School of Rowan University, Camden, NJ, USA.
Deborah D'SouzainVentiv Health Company, LLC, Indianapolis, IN, USA.
Jane BarryEli Lilly and Company, Basingstoke, Hampshire, UK. Electronic address: jbarry@lilly.com.
Canadian Urological Association · CACooper Medical School of Rowan University · USEli Lilly (United Kingdom) · GBEli Lilly (United States) · USHannover Re (Germany) · DEinVentiv Health Clinical · CANew York Proton Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

introductionVarious factors play a role in the development of erectile dysfunction (ED).

aimTo provide a descriptive comparison of erectile function response for tadalafil on-demand (PRN) and once-daily (OAD) dosing regimens in patients with common comorbid conditions, treatments, or risk factors that can be considered when treating ED.

methodsIn total, 17 PRN and 4 OAD placebo-controlled studies were included in the integrated database in these pooled analyses. Data were analyzed from patients treated with placebo, tadalafil 10 mg (low dose), and 20 mg (high dose) for the PRN studies and placebo, tadalafil 2.5 mg (low dose), and 5 mg (high dose) for the OAD studies.

main outcome measuresThe effects of tadalafil were measured using the International Index of Erectile Function administered from baseline to week 12. A descriptive comparison of the efficacy of tadalafil PRN vs OAD was examined in the clinical populations.

resultsBaseline characteristics of 4,354 men were comparable between the PRN and OAD groups, with differences seen only in the variables of race, body mass index (BMI) of at least 30 kg/m(2), and alcohol use. Tadalafil was efficacious at improving erectile function for all clinical populations, except for the low-dose OAD group, which demonstrated a weaker effect vs placebo than the high-dose OAD group, and the low- and high-dose PRN groups vs placebo for patients with BMI of at least 30 kg/m(2) for patients without a cardiovascular disorder, smokers, patients with ED duration shorter than 1 year, and patients without previous phosphodiesterase type 5 inhibitor use. Tadalafil was efficacious for patients with or without diabetes mellitus, arterial hypertension, hyperlipidemia, and alcohol use at baseline.

conclusionTadalafil OAD and PRN regimens showed efficacy in patients with ED. No clinical populations of patients with ED seemed to benefit overwhelmingly from one dose regimen over the other.

Indexed as

Patient PreferenceAdultDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleErectile DysfunctionHumansMaleMiddle AgedPenile ErectionPhosphodiesterase 5 InhibitorsTadalafilTreatment OutcomePhosphodiesterase 5 InhibitorsTadalafilData PoolingErectile DysfunctionPhosphodiesterase Type 5 InhibitorsTadalafilTreatment Efficacy

Identifiers

PMID27114197
PMCPMC5411983
OpenAlexW2338804784

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.