Comparative study of the efficacy of olmesartan/amlodipine vs. perindopril/amlodipine in peripheral blood pressure after missed dose in type 2 diabetes

Josep Redon, Gernot Pichler, Missed Dose Study Group, Giuseppe Lembo

Research output: Contribution to journalArticle

Abstract

INTRODUCTION: Combination therapy is needed to control blood pressure (BP) in a large number of hypertensive patients with diabetes mellitus. Adherence to treatment is a major clinical problem; therefore, the time duration of the antihypertensive action of a drug determines BP control when a dose is skipped.

OBJECTIVES: The aim was to determine whether the fixed-dose combination of olmesartan/amlodipine provides equal efficacy and safety as the perindopril/amlodipine combination when a drug dose is missed.

METHODS: In this noninferiority trial with a randomized, double-blind, double-dummy parallel group, controlled design, 260 patients received either olmesartan 20-40 mg/amlodipine 5-10 mg or perindopril 4-8 mg/amlodipine 5-10 mg for 24 weeks. The main outcome was the sitting office DBP after 24 weeks of treatment at 48 h from last administration.

RESULTS: The olmesartan/amlodipine combination reached noninferiority criteria in reduction of office DBP after 24 weeks of treatment and after the missed dose, compared with the perindopril/amlodipine combination (-11.7 and -10.5 mmHg, respectively). Office SBP and pulse pressure were significantly lower in both groups after 24 weeks of treatment and 48 h after the missed dose, observing a trend to greater SBP reduction in the olmesartan/amlodipine group.

CONCLUSIONS: The combination olmesartan/amlodipine is safe, well tolerated, and as effective as the combination of perindopril/amlodipine in the control of essential hypertension in patients with diabetes mellitus. A missed dose does not leave the patients unprotected in both treatments; however, a faster control with less dose increment is observed with olmesartan/amlodipine.

Original languageEnglish
Pages (from-to)359-67
Number of pages9
JournalJournal of Hypertension
Volume34
Issue number2
DOIs
Publication statusPublished - Feb 2016

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Amlodipine
Type 2 Diabetes Mellitus
Blood Pressure
Diabetes Mellitus
Therapeutics
Perindopril
olmesartan
perindopril drug combination amlodipine
Pharmaceutical Preparations
Antihypertensive Agents
Safety

Keywords

  • Adult
  • Aged
  • Amlodipine
  • Angiotensin II Type 1 Receptor Blockers
  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Blood Pressure
  • Calcium Channel Blockers
  • Diabetes Mellitus, Type 2
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Hypertension
  • Imidazoles
  • Male
  • Medication Adherence
  • Middle Aged
  • Perindopril
  • Tetrazoles
  • Treatment Outcome
  • Comparative Study
  • Journal Article
  • Randomized Controlled Trial

Cite this

Comparative study of the efficacy of olmesartan/amlodipine vs. perindopril/amlodipine in peripheral blood pressure after missed dose in type 2 diabetes. / Redon, Josep; Pichler, Gernot; Missed Dose Study Group ; Lembo, Giuseppe.

In: Journal of Hypertension, Vol. 34, No. 2, 02.2016, p. 359-67.

Research output: Contribution to journalArticle

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T1 - Comparative study of the efficacy of olmesartan/amlodipine vs. perindopril/amlodipine in peripheral blood pressure after missed dose in type 2 diabetes

AU - Redon, Josep

AU - Pichler, Gernot

AU - Missed Dose Study Group

AU - Lembo, Giuseppe

PY - 2016/2

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N2 - INTRODUCTION: Combination therapy is needed to control blood pressure (BP) in a large number of hypertensive patients with diabetes mellitus. Adherence to treatment is a major clinical problem; therefore, the time duration of the antihypertensive action of a drug determines BP control when a dose is skipped.OBJECTIVES: The aim was to determine whether the fixed-dose combination of olmesartan/amlodipine provides equal efficacy and safety as the perindopril/amlodipine combination when a drug dose is missed.METHODS: In this noninferiority trial with a randomized, double-blind, double-dummy parallel group, controlled design, 260 patients received either olmesartan 20-40 mg/amlodipine 5-10 mg or perindopril 4-8 mg/amlodipine 5-10 mg for 24 weeks. The main outcome was the sitting office DBP after 24 weeks of treatment at 48 h from last administration.RESULTS: The olmesartan/amlodipine combination reached noninferiority criteria in reduction of office DBP after 24 weeks of treatment and after the missed dose, compared with the perindopril/amlodipine combination (-11.7 and -10.5 mmHg, respectively). Office SBP and pulse pressure were significantly lower in both groups after 24 weeks of treatment and 48 h after the missed dose, observing a trend to greater SBP reduction in the olmesartan/amlodipine group.CONCLUSIONS: The combination olmesartan/amlodipine is safe, well tolerated, and as effective as the combination of perindopril/amlodipine in the control of essential hypertension in patients with diabetes mellitus. A missed dose does not leave the patients unprotected in both treatments; however, a faster control with less dose increment is observed with olmesartan/amlodipine.

AB - INTRODUCTION: Combination therapy is needed to control blood pressure (BP) in a large number of hypertensive patients with diabetes mellitus. Adherence to treatment is a major clinical problem; therefore, the time duration of the antihypertensive action of a drug determines BP control when a dose is skipped.OBJECTIVES: The aim was to determine whether the fixed-dose combination of olmesartan/amlodipine provides equal efficacy and safety as the perindopril/amlodipine combination when a drug dose is missed.METHODS: In this noninferiority trial with a randomized, double-blind, double-dummy parallel group, controlled design, 260 patients received either olmesartan 20-40 mg/amlodipine 5-10 mg or perindopril 4-8 mg/amlodipine 5-10 mg for 24 weeks. The main outcome was the sitting office DBP after 24 weeks of treatment at 48 h from last administration.RESULTS: The olmesartan/amlodipine combination reached noninferiority criteria in reduction of office DBP after 24 weeks of treatment and after the missed dose, compared with the perindopril/amlodipine combination (-11.7 and -10.5 mmHg, respectively). Office SBP and pulse pressure were significantly lower in both groups after 24 weeks of treatment and 48 h after the missed dose, observing a trend to greater SBP reduction in the olmesartan/amlodipine group.CONCLUSIONS: The combination olmesartan/amlodipine is safe, well tolerated, and as effective as the combination of perindopril/amlodipine in the control of essential hypertension in patients with diabetes mellitus. A missed dose does not leave the patients unprotected in both treatments; however, a faster control with less dose increment is observed with olmesartan/amlodipine.

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KW - Diabetes Mellitus, Type 2

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KW - Drug Combinations

KW - Female

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KW - Imidazoles

KW - Male

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KW - Middle Aged

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KW - Tetrazoles

KW - Treatment Outcome

KW - Comparative Study

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KW - Randomized Controlled Trial

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JF - Journal of Hypertension

SN - 0263-6352

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