Treatment of Hypertensive Patients With Diabetes and Microalbuminuria With Combination Indapamide SR/Amlodipine: Retrospective Analysis of NESTOR

Am J Hypertens. 2015 Aug;28(8):1064-71. doi: 10.1093/ajh/hpu297. Epub 2015 Jan 26.

Abstract

Background: Combination treatments for hypertension most often include a renin-angiotensin-aldosterone system (RAAS) inhibitor. However, systolic blood pressure (SBP) remains difficult to control. Non-RAAS-inhibiting strategies such as calcium channel blocker/thiazide-like diuretic combinations may offer effective alternatives.

Methods: Hypertensive diabetic patients with microalbuminuria were included in this retrospective, post-hoc analysis of the Natrilix SR Versus Enalapril Study in Hypertensive Type 2 Diabetics With MicrOalbuminuRia (NESTOR) trial if they were uncontrolled on monotherapy (indapamide slow release (SR) 1.5 mg or enalapril 10mg) and had been given add-on amlodipine 5 mg. Patients uncontrolled with monotherapy/amlodipine 5mg were uptitrated to 10 mg.

Results: After 52 weeks, supine SBP/diastolic BP (DBP) decreased from baseline by 26±13/14±9 mm Hg in the indapamide SR/amlodipine group (n = 135) and by 21±14/11±9 mm Hg in the enalapril/amlodipine group (n = 156) (P = 0.006 for ΔSBP). In the amlodipine 10mg subgroup, SBP/DBP decreased from baseline by 26±13/13±9 mm Hg in the indapamide SR/amlodipine group (n = 62) and by 20±13/12±8 mm Hg in the enalapril/amlodipine group (n = 77) (P = 0.02 for ΔSBP). Treatment with indapamide SR/amlodipine was well tolerated. Few patients experienced edema, with no between-group differences. As expected with diuretics, slight changes in kalemia and in uricemia were observed in the indapamide SR/amlodipine group. Changes in fasting glucose, lipids, natremia, and creatinine clearance were similar between groups.

Conclusions: Indapamide SR/amlodipine results in superior SBP reduction with a safety profile in line with that of its components and tolerability equivalent to that of an angiotensin-converting enzyme inhibitor/amlodipine strategy.

Keywords: amlodipine; blood pressure; combination treatment; hypertension; indapamide SR..

Publication types

  • Clinical Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Albuminuria / etiology*
  • Amlodipine / therapeutic use*
  • Angiotensin-Converting Enzyme Inhibitors / therapeutic use
  • Antihypertensive Agents / therapeutic use*
  • Calcium Channel Blockers / therapeutic use
  • Delayed-Action Preparations
  • Diabetes Mellitus, Type 2 / complications*
  • Diuretics / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Enalapril / therapeutic use*
  • Female
  • Humans
  • Hypertension / complications
  • Hypertension / drug therapy*
  • Indapamide / therapeutic use*
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome

Substances

  • Angiotensin-Converting Enzyme Inhibitors
  • Antihypertensive Agents
  • Calcium Channel Blockers
  • Delayed-Action Preparations
  • Diuretics
  • Amlodipine
  • Enalapril
  • Indapamide