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

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.