Trial reportDrugs in R&D2013
Efficacy and safety of a fixed combination of irbesartan/hydrochlorothiazide in Chinese patients with moderate to severe hypertension.
Trial report in Drugs in R&D, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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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.
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.
Who cites it
5 citing papers in PubMed, 13 citations in OpenAlex.
- A randomized controlled trial on home blood pressure monitoring and quality of care in stage 2 and 3 hypertension.Hypertension research : official journal of the Japanese Society of Hypertension · 2021Trial
- Comparison of clinical efficacy of metoprolol combined with irbesartan and hydrochlorothiazide and non-invasive ventilator in the emergency treatment of patients with severe heart failure.Experimental and therapeutic medicine · 2018Article
- A rare case of hypokalemia-induced rhabdomyolysis.Journal of geriatric cardiology : JGC · 2018Article
- Chinese Hypertension Guidelines.Pulse (Basel, Switzerland) · 2015Review
- Comprehensive overview: efficacy, tolerability, and cost-effectiveness of irbesartan.Vascular health and risk management · 2013Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesIn a multi-center, single-arm, prospective study, we investigated the efficacy and safety of the fixed irbesartan/hydrochlorothiazide combination in Chinese patients with moderate to severe hypertension.
methodsEligible patients were aged 18-75 years, with a blood pressure of 160-199 mmHg systolic or 100-119 mmHg diastolic during a 1-week wash-out phase off antihypertensive medication. The enrolled patients started antihypertensive treatment with irbesartan/hydrochlorothiazide 150 mg/12.5 mg once daily, with the possible addition of irbesartan 150 mg once daily and up-titration to irbesartan/hydrochlorothiazide 300 mg/25 mg once daily at 4 and 8 weeks of follow-up, respectively. The primary efficacy variable was the goal blood pressure-attaining rate at 12 weeks of follow-up (<140/90 mmHg, or <130/80 mmHg in patients with diabetes mellitus).
resultsIn the intention-to-treat analysis (n = 501) at 12 weeks of follow-up, the goal blood pressure-attaining rate was 57.3%, and the mean change in blood pressure from baseline was 27.8 mmHg [95% confidence interval (CI) 26.4-29.1 mmHg; p < 0.001] systolic and 13.5 mmHg (95% CI 12.6-14.4 mmHg; p < 0.001) diastolic. Similar findings were observed in the per-protocol analysis (n = 449). The prevalence of microalbuminuria and left ventricular hypertrophy significantly (p ≤ 0.01) decreased from 33.4% (150/449) and 50.4% (215/427) at baseline to 23.4% (105/447) and 41.3% (176/427) at the end of follow-up, respectively. Four patients (2.0%) reported a serious adverse event.
conclusionThe fixed irbesartan/hydrochlorothiazide combination may control blood pressure to the target level in about 60% of Chinese patients with moderate to severe hypertension, with an acceptable safety profile.
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