Randomized trial of an increased dose of calcium channel blocker or angiotensin II type 1 receptor blocker as an add-on intensive depressor therapy in type 2 diabetes mellitus patients with uncontrolled essential hypertension: the ACADEMIE Study

Heart Vessels. 2019 Apr;34(4):698-710. doi: 10.1007/s00380-018-1286-2. Epub 2018 Nov 8.

Abstract

There is a lack of data on how to treat hypertensive patients with diabetes when treatment with medium doses of calcium channel blocker and angiotensin II type 1 receptor blocker (ARB) is insufficient to achieve the target blood pressure (BP). A total of 121 participants with type 2 diabetes and uncontrolled essential hypertension, who were receiving medium doses of amlodipine (5 mg/day) and ARB, were enrolled. Participants were randomized to receive either a high dose of amlodipine (10 mg/day) plus a medium dose of ARB (high-AML) or a medium dose of amlodipine (5 mg/day) plus a high dose of ARB (high-ARB). The depressor effects of these two regimens were monitored using a telemonitoring home BP-measuring system. Fifty-four patients were excluded after an observation period, and the remaining 67 eligible participants were randomized into the two groups; 42 which had a record of their home BP for analysis. The change in morning home systolic and diastolic BP was greater in the high-AML than in the high-ARB (systolic BP; - 7.9 mmHg vs. + 2.7 mmHg; p = 0.0002, diastolic BP; - 3.9 mmHg vs. + 0.6 mmHg; p = 0.0007). In addition, the home systolic and diastolic BP before going to bed and office systolic BP were significantly reduced from week 0 only in the high-AML. An increased dose of amlodipine, but not ARB, reduced home morning BP in hypertensive patients with type 2 diabetes who were already receiving combination therapy with medium doses of amlodipine and ARB.

Keywords: Angiotensin II type 1 receptor blocker; Calcium channel blocker; Essential Hypertension; Home blood pressure; Type 2 diabetes mellitus.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Amlodipine / administration & dosage*
  • Angiotensin II Type 1 Receptor Blockers / administration & dosage*
  • Blood Pressure / drug effects
  • Blood Pressure / physiology*
  • Blood Pressure Monitoring, Ambulatory
  • Calcium Channel Blockers / administration & dosage
  • Diabetes Mellitus, Type 2 / complications*
  • Diabetes Mellitus, Type 2 / drug therapy
  • Dose-Response Relationship, Drug
  • Drug Therapy, Combination
  • Essential Hypertension / complications
  • Essential Hypertension / drug therapy*
  • Essential Hypertension / physiopathology
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Treatment Outcome

Substances

  • Angiotensin II Type 1 Receptor Blockers
  • Calcium Channel Blockers
  • Amlodipine