Trial reportClinical drug investigation2009
Efficacy and safety of a stepped-care regimen using olmesartan medoxomil, amlodipine and hydrochlorothiazide in patients with moderate-to-severe hypertension: an open-label, long-term study.
Trial report in Clinical drug investigation, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 45 citations in OpenAlex.
- Personalised Single-Pill Combination Therapy in Hypertensive Patients: An Update of a Practical Treatment Platform.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2017Guideline
- LCZ696, a First-in-Class Angiotensin Receptor-Neprilysin Inhibitor: The First Clinical Experience in Patients With Severe Hypertension.Journal of clinical hypertension (Greenwich, Conn.) · 2016Trial
- Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized, Double-Blind, Multicenter Trial.American journal of cardiovascular drugs : drugs, devices, and other interventions · 2016Trial
- Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study).Journal of human hypertension · 2013Trial
- Safety and efficacy of aliskiren/amlodipine/hydrochlorothiazide triple combination in patients with moderate to severe hypertension: a 54-week, open-label study.Journal of clinical hypertension (Greenwich, Conn.) · 2012Trial
- Efficacy and safety of triple antihypertensive therapy with the olmesartan/amlodipine/hydrochlorothiazide combination.Clinical drug investigation · 2012Trial
- Long-term efficacy and safety of triple-combination therapy with olmesartan medoxomil and amlodipine besylate and hydrochlorothiazide for hypertension.Journal of clinical hypertension (Greenwich, Conn.) · 2012Trial
- Efficacy and safety of olmesartan medoxomil plus amlodipine in age, gender and hypertension severity defined subgroups of hypertensive patients.Journal of human hypertension · 2011Trial
- Moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy.Journal of hypertension · 2011Trial
- Hypertension Treatment with Angiotensin Receptor Blockers and Other Antihypertensive Agents: A Real-World Registry from a High-Volume Specialized Center Over TwoDecades.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2026Observational
- 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 · 2023Review
- Clinical Efficacy and Safety of Combination Therapy with Amlodipine and Olmesartan or an Olmesartan/Hydrochlorothiazide Compound for Hypertension: A Prospective, Open-Label, and Multicenter Clinical Trial in China.Current therapeutic research, clinical and experimental · 2019Article
- Triple Combination Therapies Based on Olmesartan: A Personalized Therapeutic Approach to Improve Blood Pressure Control.High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2017Review
- Olmesartan in the treatment of hypertension in elderly patients: a review of the primary evidence.Drugs & aging · 2013Review
- Modern clinical management of arterial hypertension: fixed or free combination therapies?High blood pressure & cardiovascular prevention : the official journal of the Italian Society of Hypertension · 2011Review
- Olmesartan medoxomil/amlodipine/hydrochlorothiazide: fixed-dose combination in hypertension.Drugs · 2011Review
- Olmesartan/amlodipine: a review of its use in the management of hypertension.Vascular health and risk management · 2011Review
- Rationale for triple-combination therapy for management of high blood pressure.Journal of clinical hypertension (Greenwich, Conn.) · 2010Review
- Role of olmesartan in combination therapy in blood pressure control and vascular function.Vascular health and risk management · 2010Review
- Critical appraisal of amlodipine and olmesartan medoxomil fixed-dose combination in achieving blood pressure goals.Integrated blood pressure control · 2010Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTreatment guidelines recommend combination therapy to control blood pressure (BP) in the majority of hypertensive patients. This long-term open-label study assessed a treatment algorithm based on olmesartan medoxomil (hereafter olmesartan), amlodipine and hydrochlorothiazide (HCTZ).
methodsPatients with moderate-to-severe hypertension who were inadequately controlled with amlodipine 5 mg/day monotherapy and who subsequently completed 16 weeks of double-blind combination treatment with olmesartan and amlodipine entered a 28-week open-label phase in which all patients initially received olmesartan/amlodipine 40/5 mg/day. After 4, 10 and 19 weeks, patients with inadequately controlled hypertension (seated trough diastolic [DBP] and systolic [SBP] BP >/=90 mmHg and >/=140 mmHg, respectively) had their doses increased in a step-wise manner to: (i) olmesartan/amlodipine 40/10 mg; (ii) olmesartan/amlodipine/HCTZ 40/10/12.5 mg; and (iii) olmesartan/amlodipine/HCTZ 40/10/25 mg.
resultsIn total, 692 patients entered the open-label phase (691 on olmesartan/amlodipine 40/5 mg). The majority of patients remained on olmesartan/amlodipine 40/5 mg without dose elevation, and, of these, 74.3% achieved goal BP at study completion or early termination. Additional patients achieved goal BP with each successive uptitration of therapy: in patients who finished the study on olmesartan/amlodipine 40/10 mg and olmesartan/amlodipine/HCTZ 40/10/12.5 mg, the respective proportions who reached goal BP were 59.0% and 47.1%. Overall, 66.9% of patients achieved the European guideline recommended goal BP of SBP <140 mmHg and DBP <90 mmHg for patients without diabetes mellitus, and SBP <130 mmHg and DBP <80 mmHg for patients with diabetes. Treatment was generally well tolerated, with no unexpected safety concerns.
conclusionsA treatment algorithm based on olmesartan/amlodipine (+/- HCTZ) provides a high degree of BP control in patients with moderate-to-severe hypertension. The open-label study design suggests similar results are obtainable in clinical practice.
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