Daytime systolic ambulatory blood pressure with a direct switch between candesartan monotherapy and the fixed-dose combination olmesartan/amlodipine in patients with uncontrolled essential hypertension (SEVICONTROL-1)

J Clin Hypertens (Greenwich). 2013 Nov;15(11):815-9. doi: 10.1111/jch.12202. Epub 2013 Sep 16.

Abstract

A direct switch of candesartan to the fixed-dose combination olmesartan/amlodipine in uncontrolled hypertension is a frequent clinical requirement but is not covered by current labeling. An open-label, prospective, single-arm phase IIIb study was performed in patients with 32 mg candesartan followed by olmesartan/amlodipine 40/10 mg. The primary endpoint was change in mean daytime systolic blood pressure (BP). Mean daytime systolic BP was reduced by 9.2±12.6 mm Hg (P<.0001) after substituting candesartan for olmesartan/amlodipine (baseline BP 140.2±9.7 mm Hg). The reduction in office BP was 9.4±18.4/4.0±9.6 mm Hg; P<.002). Overall, 61.3% of patients achieved a target BP <140/90 mm Hg using office BP and <135/85 mm Hg using ambulatory BP measurement. There were 8 adverse events with a possible relation to study drug and 1 unrelated serious adverse events. In conclusion, patients with uncontrolled moderate arterial hypertension being treated using candesartan monotherapy achieve a further reduction of BP when switched directly to a fixed-dose combination of olmesartan 40 mg/amlodipine 10 mg.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study

MeSH terms

  • Aged
  • Amlodipine / administration & dosage
  • Amlodipine / pharmacology
  • Amlodipine / therapeutic use*
  • Angiotensin Receptor Antagonists / administration & dosage
  • Angiotensin Receptor Antagonists / pharmacology
  • Angiotensin Receptor Antagonists / therapeutic use*
  • Antihypertensive Agents / administration & dosage
  • Antihypertensive Agents / pharmacology
  • Antihypertensive Agents / therapeutic use
  • Benzimidazoles / administration & dosage
  • Benzimidazoles / pharmacology
  • Benzimidazoles / therapeutic use*
  • Biphenyl Compounds
  • Blood Pressure / drug effects
  • Blood Pressure / physiology*
  • Calcium Channel Blockers / administration & dosage
  • Calcium Channel Blockers / pharmacology
  • Calcium Channel Blockers / therapeutic use*
  • Circadian Rhythm / physiology
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Therapy, Combination
  • Essential Hypertension
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Hypertension / physiopathology
  • Imidazoles / administration & dosage
  • Imidazoles / pharmacology
  • Imidazoles / therapeutic use*
  • Male
  • Middle Aged
  • Prospective Studies
  • Systole / drug effects
  • Systole / physiology
  • Tetrazoles / administration & dosage
  • Tetrazoles / pharmacology
  • Tetrazoles / therapeutic use*
  • Treatment Outcome

Substances

  • Angiotensin Receptor Antagonists
  • Antihypertensive Agents
  • Benzimidazoles
  • Biphenyl Compounds
  • Calcium Channel Blockers
  • Imidazoles
  • Tetrazoles
  • Amlodipine
  • olmesartan
  • candesartan