Evidence map›Paper›PMID 25879524›Full record

Trial reportHealth and quality of life outcomes2015

Health-related quality of life impact of a triple combination of olmesartan medoxomil, amlodipine besylate and hydrochlorotiazide in subjects with hypertension.

Pedro Marques da Silva, Uwe Haag, Julian F Guest, John E Brazier, Marco Soro

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Health and quality of life outcomes, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00923091 (Randomised, Double-Blind, Parallel-Group Study Evaluating Efficacy and Safety of Co-Administration of Triple Combinations of Olmesartan Medoxomil, Amlodipine Besylate, and Hydrochlorothiazide Compared With Corresponding Olmesartan - Amlodipine Combination in Subjects With Hypertension), which is not on this map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.3field-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.

NCT00923091 phase3completednot on this map

Randomised, Double-Blind, Parallel-Group Study Evaluating Efficacy and Safety of Co-Administration of Triple Combinations of Olmesartan Medoxomil, Amlodipine Besylate, and Hydrochlorothiazide Compared With Corresponding Olmesartan - Amlodipine Combination in Subjects With Hypertension

TypeinterventionalSponsorDaiichi SankyoRan2009 to 2011Enrolled2,689ConditionsEssential HypertensionArmsolmesartan medoxomil + amlodipine + hydroclororthiazide + placebo, Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo, olmesartan medoxomil + amlodipine + hydroclororthiazide, olmesartan medoxomil + amlodipine
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Single-Pill Combination with Three Antihypertensive Agents to Improve Blood Pressure Control in Hypertension: Focus on Olmesartan-Based Combinations.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2023
    Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Observational
  10. Article
  11. Article
  12. 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

5 authors at 4 institutions in 3 countries.

Pedro Marques da SilvaArterial Investigation Unit, Medicine 4, Santa Marta's Hospital, CHLC, Lisbon, Portugal. pmarques.silva@sapo.pt.
Uwe HaagHaaPACS GmbH, Schriesheim, Germany. uwe.haag@haapacs.com.
Julian F GuestCatalyst Health Economics Consultants, Northwood, UK. julian.guest@catalyst-health.com.
John E BrazierHealth Economics and Decision Science (HEDS), School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK. j.e.brazier@sheffield.ac.uk.
Marco SoroHealth Economics & Outcomes Research Department, Daiichi-Sankyo Europe, Munich, Germany. marco_soro@virgilio.it.
Catalyst Health Economics Consultants Ltd · GBDaiichi Sankyo (Germany) · DEHospital de Santa Marta · PTUniversity of Sheffield · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA post-hoc analysis was performed on the data from a 54 weeks phase III study (ClinicalTrials.gov identifier: NCT00923091) to measure changes in the health-related quality of life (HRQoL) of 2,690 patients aged ≥18 with moderate-to-severe hypertension who received one of six doses of olmesartan/amlodipine/hydrochlorothiazide (OLM/AML/HCTZ), using the MINICHAL and EQ-5D instruments.

methodsDescriptive statistics were used to assess blood pressure and HRQoL scores over the study period. Analysis of covariance (ANCOVA) was used to identify those factors that could possibly have influenced HRQoL. Linear regression was used to assess the relationship between changes in blood pressure and HRQoL scores.

resultsPatients' baseline MINICHAL mood and somatic domains scores were 5.5 and 2.6. Over the study period HRQoL improved as both MINICHAL scores decreased by 31-33%. Patients' baseline EQ-5D index and VAS scores were 0.9 and 73.4 respectively, increasing by 6% and 12% over the study period. Patients' QALY gain over the 54 weeks study period was estimated to be 0.029 QALYs. The ANCOVA showed that changes in patients' HRQoL was likely to have been influenced by patients' achievement of blood pressure control, the amount of concomitant medication and patients' last used dosage strength of antihypertensive. Linear regression showed that blood pressure improvement may have been associated with improved HRQoL.

conclusionsThis study showed that OLM/AML/HCTZ reduced blood pressure and significantly increased blood pressure control whilst improving patients' HRQoL. Achieving blood pressure control, amount of concomitant medication and dosage strength of antihypertensive impacted on patients' HRQoL.

Indexed as

AdultAgedAmlodipineAnalysis of VarianceAntihypertensive AgentsDrug CombinationsFemaleHumansHydrochlorothiazideHypertensionImidazolesMaleMiddle AgedOlmesartan MedoxomilQuality of LifeTetrazolesAmlodipineAntihypertensive AgentsDrug CombinationsHydrochlorothiazideImidazolesolmesartanOlmesartan MedoxomilTetrazoles

Identifiers

PMID25879524
PMCPMC4339651
OpenAlexW2140478837

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.