Evidence mapPaperPMID 18681815Full record

Trial reportJournal of women's health (2002)

Efficacy and safety of fixed combinations of irbesartan/hydrochlorothiazide in hypertensive women: the inclusive trial.

Elizabeth O Ofili, Greg Cable, Joel M Neutel, Elijah Saunders

Open access · greenAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of women's health (2002). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 29% 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

6 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Epidemiology and management of hypertension in the Hispanic population: a review of the available literature.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2012
    Review
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

4 authors at 3 institutions in 1 country.

Elizabeth O OfiliMorehouse School of Medicine, Atlanta, Georgia 30310, USA. eofili@msm.edu
Greg Cable
Joel M Neutel
Elijah Saunders
Morehouse School of Medicine · USOrange County Research Center · USUniversity of Maryland, Baltimore · US

Funding

WARCEFP20RR011104 · MOREHOUSE SCHOOL OF MEDICINE · 1995 to 2005
$8.5M
RECRUITMENT COREU54RR014758 · MOREHOUSE SCHOOL OF MEDICINE · 1999 to 2004
$4.2M
NCATS NIH HHS UL1 TR000454NCRR NIH HHS 5P20RR11104NCRR NIH HHS 5U54RR14758-05NCRR NIH HHS P20 RR011104NCRR NIH HHS U54 RR014758NHLBI NIH HHS 1UO1HL084891NHLBI NIH HHS U01 HL084891
6 · The paper itself

Abstract

objectiveThis post hoc analysis of the Irbesartan/Hydrochlorothiazide Blood Pressure Reductions in Diverse Patient Populations (INCLUSIVE) trial evaluated the efficacy and safety of irbesartan/hydrochlorothiazide (HCTZ) in a diverse population of hypertensive women.

methodsINCLUSIVE was a multicenter, prospective, open-label, single-arm trial. Adult subjects had uncontrolled systolic blood pressure (SBP 140-159 mm Hg; 130-159 mm Hg for those with type 2 diabetes mellitus [T2DM]) after > or =4 weeks of antihypertensive monotherapy. Treatment was sequential: placebo (4-5 weeks), HCTZ 12.5 mg (2 weeks), irbesartan/HCTZ 150/12.5 mg (8 weeks), and irbesartan/HCTZ 300/25 mg (8 weeks). Mean changes from baseline to treatment end in SBP and diastolic blood pressure (DBP), BP goal attainment, and safety were assessed.

resultsTreatment with irbesartan/HCTZ was associated with significant mean reductions in BP (intent-to-treat population, n = 370; SBP/DBP: -22.9/-10.3 +/- 14.7/8.8 mm Hg). Improvements in SBP were observed in all subgroups (p < 0.001): Caucasian (n = 207) -23.5 +/- 13.5 mm Hg; African American (n = 93) -21.0 +/- 17.2 mm Hg; Hispanics/Latino (n = 66) -23.6 +/- 14.3 mm Hg; age <65 years (n = 281) -22.5 +/- 14.7 mm Hg; age > or =65 years (n = 89) -24.3 +/- 14.5 mm Hg; T2DM (n = 97) -19.0 +/- 15.1 mm Hg; and metabolic syndrome (n = 187) -22.1 +/- 14.6 mm Hg. Overall, 82% (95% confidence interval [CI] 78%-86%) of women achieved their SBP goal, 86% (95% CI 83%-90%) achieved their DBP goal, and 76% (95% CI 71%-80%) achieved their dual SBP/DBP goal. Treatments were well tolerated in all groups.

conclusionsIrbesartan/HCTZ treatment was effective and well tolerated in a diverse population of women whose BP was previously uncontrolled on monotherapy.

Indexed as

AdultAgedAntihypertensive AgentsBiphenyl CompoundsBlood PressureDiabetes Mellitus, Type 2Drug CombinationsFemaleHumansHydrochlorothiazideHypertensionIrbesartanMiddle AgedProspective StudiesTetrazolesAntihypertensive AgentsBiphenyl CompoundsDrug CombinationsHydrochlorothiazideIrbesartanTetrazoles

Identifiers

PMID18681815
PMCPMC2942752
OpenAlexW1973763650

What Socratic holds

Textmetadata
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 Socratic graph.