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. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-014-0107-y) contains supplementary material, which is available to authorized users.