Evidence map›Paper›PMID 25653511›Full record

Trial reportClinical interventions in aging2015

Multicenter, prospective, comparative cohort study evaluating the efficacy and safety of alfuzosin 10 mg with regard to blood pressure in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia with or without antihypertensive medications.

Li Tao Zhang, Sung Won Lee, Kwangsung Park, Woo Sik Chung, Sae Woong Kim, Jae Seog Hyun, Doo Geon Moon, Sang-Kuk Yang, Ji Kan Ryu, Dae Yul Yang and 3 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical interventions in aging, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.3field-weighted citation impact, top 20% 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

4 citing papers in PubMed, 6 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 2 countries.

Li Tao ZhangDepartment of Urology, Chonbuk National University, Medical School and Biomedical Research Institute and Clinical Trial Center for Medical Devices of Chonbuk National University Hospital, Jeonju, Republic of Korea.
Sung Won LeeDepartment of Urology, College of Medicine, Sungkyunkwan University, Seoul, Republic of Korea.
Kwangsung ParkDepartment of Urology, College of Medicine, Chonnam National University, Gwangju, Republic of Korea.
Woo Sik ChungDepartment of Urology, College of Medicine, Ewha Woman's University, Seoul, Republic of Korea.
Sae Woong KimDepartment of Urology, College of Medicine, Catholic University, Seoul, Republic of Korea.
Jae Seog HyunDepartment of Urology, College of Medicine, Kyungsang National University, Jinju, Republic of Korea.
Doo Geon MoonDepartment of Urology, College of Medicine, Korea University, Seoul, Republic of Korea.
Sang-Kuk YangDepartment of Urology, Chungju Hospital, College of Medicine, Konkuk University, Chungju, Republic of Korea.
Ji Kan RyuDepartment of Urology, College of Medicine, Inha University, Incheon, Republic of Korea.
Dae Yul YangDepartment of Urology, College of Medicine, Hallym University, Seoul, Republic of Korea.
Ki Hak MoonDepartment of Urology, College of Medicine, Youngnam University, Daegu, Republic of Korea.
Kweon Sik MinDepartment of Urology, College of Medicine, Inje University, Busan, Republic of Korea.
Jong Kwan ParkDepartment of Urology, Chonbuk National University, Medical School and Biomedical Research Institute and Clinical Trial Center for Medical Devices of Chonbuk National University Hospital, Jeonju, Republic of Korea.
Catholic University of Korea · KRChonnam National University · KRInha University · KRInje University · KRKorea University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe objective of this study was to assess the efficacy and safety of alfuzosin 10 mg monotherapy or combined antihypertensive medication on blood pressure (BP) in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS) with or without antihypertensive medication.

methodsThis was a 3-month, multicenter, randomized, open-label study in 335 patients aged ≥45 years with a clinical diagnosis of BPH/LUTS by medical history and clinical examination, a total International Prostatic Symptom Score (IPSS) ≥8 points, a maximum flow rate >5 mL/sec and ≤15 mL/sec, and a voided volume ≥120 mL. Eligible subjects were randomized to receive alfuzosin 10 mg as monotherapy (group 1) or alfuzosin 10 mg + antihypertensive combination therapy (group 2). Based on baseline BP and hypertensive history with or without antihypertensive medications at first medical examination, group 1 was divided into two subgroups of normotensive and untreated hypertensive patients, and group 2 into two subgroups of controlled hypertensive and uncontrolled hypertensive patients. The primary study outcomes were change in IPSS, BP, and heart rate from baseline. Secondary outcomes were change in IPSS-quality of life score, maximum flow rate, average flow rate, voided volume, and post-voided volume.

resultsThe overall BP change was not significantly different between groups 1 and 2 (systolic BP, P=0.825; diastolic BP, P>0.999). In patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or combined with antihypertensive therapy significantly decreased systolic and diastolic BP. The mean difference in total IPSS and IPSS-quality of life scores from baseline between groups 1 and 2 was 0.45 (95% CI: -1.26, 2.16) and 0.12 (95% CI: -0.21, 0.45), respectively (both P>0.05). Maximum flow rate, average flow rate, voided volume, and post-voided volume at endpoint were numerically, but not significantly, changed from baseline (all P>0.05).

conclusionThis study shows that alfuzosin 10 mg is effective and well tolerated in patients with BPH/LUTS with or without antihypertensive medications. However, in patients with uncontrolled or untreated hypertension, alfuzosin 10 mg alone or in combination with antihypertensive medication appears to decrease systolic and diastolic BP, and these patients should be warned about a decrease in BP on initiation of therapy.

Indexed as

AgedAntihypertensive AgentsBlood PressureDrug Therapy, CombinationHumansHypertensionLower Urinary Tract SymptomsMaleMiddle AgedProspective StudiesProstatic HyperplasiaQuality of LifeQuinazolinesUrological AgentsalfuzosinAntihypertensive AgentsQuinazolinesUrological Agentsalfuzosinantihypertensive medicationbenign prostatic hyperplasiablood pressurelower urinary tract symptoms

Identifiers

PMID25653511
PMCPMC4303366
OpenAlexW2084882661

What OpenQuestion holds

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LicenceCC BY-NC
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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.