Trial reportCurrent medical research and opinion2013
Effects of demographics on the antihypertensive efficacy of triple therapy with amlodipine, valsartan, and hydrochlorothiazide for moderate to severe hypertension.
Trial report in Current medical research and opinion, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00327587 (An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.), which is not on this map. Cited by 9 papers, 2 of them syntheses that pooled 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.
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.
An 8-week, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of Valsartan/HCTZ/Amlodipine Compared to Valsartan/HCTZ, Valsartan/Amlodipine, and HCTZ/Amlodipine in Patients With Moderate to Severe Hypertension.
Who cites it
9 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.
- Calcium channel blockers versus other classes of drugs for hypertension.The Cochrane database of systematic reviews · 2022Pooled it
- Calcium channel blockers versus other classes of drugs for hypertension.The Cochrane database of systematic reviews · 2021Pooled it
- "The impact of statins addind to the fixed combination antihypertensive therapy on the arterial stiffness in patients with moderate and severe hypertension".International journal of cardiology. Cardiovascular risk and prevention · 2023Article
- Amlodipine/Valsartan (Avsar®): Efficacy in Hypertensive Patients - A Real World Observational Study (ALERT).Cureus · 2020Article
- Triple-combination therapy in the treatment of hypertension: a review of the evidence.Journal of human hypertension · 2017Review
- Real-life Effectiveness and Safety of Amlodipine/Valsartan Single-pill Combination in Patients with Hypertension in Egypt: Results from the EXCITE Study.Drugs - real world outcomes · 2016Article
- Real-world effectiveness of amlodipine/valsartan and amlodipine/valsartan/hydrochlorothiazide in high-risk patients and other subgroups.Vascular health and risk management · 2015Observational
- The comparative efficacy and safety of the angiotensin receptor blockers in the management of hypertension and other cardiovascular diseases.Drug safety · 2015Review
- Candesartan cilexetil 32 mg/hydrochlorothiazide 25 mg in unselected patients with high or very high cardiovascular risk: efficacy, safety, and metabolic impact.Clinical drug investigation · 2014Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 3 institutions in 3 countries.
Funding
Abstract
objectiveTo compare the antihypertensive efficacy and safety of once-daily triple therapy with amlodipine (Aml) 10 mg, valsartan (Val) 320 mg, and hydrochlorothiazide (HCTZ) 25 mg versus dual-therapy combinations of these components in patients with moderate to severe hypertension. RESEARCH
designSubgroup analysis of a multinational, randomized, double-blind, parallel-group, active-controlled trial.
methodsAfter antihypertensive washout and a placebo run-in of up to 4 weeks, 2271 patients were randomly allocated in a 1:1:1:1 ratio to receive Aml/Val/HCTZ triple therapy or dual therapy with Val/HCTZ, Aml/Val, or Aml/HCTZ for 8 weeks. Forced titration to the full dose was done over the first 2 weeks of treatment. Efficacy and safety parameters were determined by age group (<65 vs. ≥65 years), gender, race (White vs. Black), ethnicity (Hispanic/Latino vs. non-Hispanic/Latino), and body mass index (BMI, <30 vs. ≥30 kg/m²).
main outcome measuresChange from baseline to endpoint in mean sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP); blood pressure (BP) control rate <140/90 mmHg.
resultsTriple therapy was numerically superior and, for the majority of comparisons, statistically superior to each dual therapy in reducing MSSBP and MSDBP and in improving BP control rates in all subgroups. Across subgroups, triple therapy reduced MSSBP by 5.7-10.7 mmHg more than Val/HCTZ, 3.4-8.3 mmHg more than Aml/Val, and 4.4-9.4 mmHg more than Aml/HCTZ. Triple therapy was well tolerated across all subgroups. Limitations of our analysis included the lack of stratification of patients by subgroup at randomization and the small sample size of some subgroups (e.g., Blacks, elderly).
conclusionsTriple therapy with Aml/Val/HCTZ is effective and well tolerated in patients with moderate to severe hypertension regardless of age, gender, race, ethnicity, or BMI. TRIAL REGISTRATION NUMBER: NCT00327587.
Indexed as
Identifiers
What OpenQuestion holds
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.