Efficacy and Tolerability of Fixed-Dose Combination of Perindopril/Indapamide in Type 2 Diabetes Mellitus: PICASSO Trial

BACKGROUND: Hypertension and type 2 diabetes mellitus (T2DM) synergistically deteriorate the vascular environment, making blood pressure reduction challenging, and substantially increasing cardiovascular risk. METHODS: In the real-life, open-label, observational, PICASSO study, 9,257 hypertensive patients unsuccessfully treated with antihypertensives were switched to fixed-dose combination of perindopril 10 mg/indapamide 2.5 mg. In this subgroup analysis, we analyzed changes in blood pressure and laboratory parameters of 2,762 hypertensive patients with T2DM or pre-diabetes. RESULTS: After 3 months of treatment, significant decreases in office blood pressure were noted in the whole cohort (-27.0±14.8/-12.7±9.8 mmHg; p<0.001). Significant decreases were also recorded in patients with grade 1 hypertension (19.2±10.0/-9.4±7.9 mmHg), grade 2 (29.2±10.9/-13.3±8.7 mmHg) and grade 3 (-45.1±15.4/-21.5±11.2 mmHg). Significant decreases in ambulatory blood pressure were also noted (n=93). In patients previously treated with angiotensin-converting enzyme inhibitor±hydrochlorothiazide or angiotensin receptor blocker±hydrochlorothiazide, mean 24-h blood pressure decreased by 23.4±13.9/11.5±9.7 and 22.3±8.7/10.4±13.2 mmHg, respectively (p<0.001). Treatment was well tolerated and the switch to treatment with perindopril/indapamide was associated with improvements in laboratory parameters. CONCLUSIONS: Data from this diabetes subgroup analysis suggest that fixed combination of perindopril 10 mg/indapamide 2.5 mg should be routinely considered for the treatment of hypertension in diabetic patients who are unsuccessfully managed with other antihypertensive medications.