2A.06: COMPARATIVE STUDY OF THE EFFICACY OF OLMESARTAN/AMLODIPINE VERSUS PERINDOPRIL/AMLODIPINE IN PERIPHERAL AND CENTRAL BP PARAMETERS AFTER MISSED DOSE IN TYPE 2 DIABETES. (June 2015)

• Record Type: Journal Article
• Authors: Redon, J.; Team, Missed Dose
• Is Part Of: Journal of hypertension. Volume 33(2015)Supplement 1
• Publication Date: 2015-06
• Subjects: Hypertension -- Periodicals; Hypertension -- Periodicals; 616.132005
• DOI: 10.1097/01.hjh.0000467404.79160.7e
• Languages: English
• ISSNs: 1473-5598

Abstract

Abstract : Objective: To determine whether the Olmesartan 20–40 mg + Amlodipine 5–10 mg combination is as effective as the Perindopril 4–8 mg + Amlodipine 5–10 mg combination in reducing ODBP after 24 weeks of treatment, at 48 hours from last administration (missed dose) in diabetes. Assessment of efficacy on OSBP and pulse pressure, on central BP and on the radial artery-derived hemodynamic indices, as well as safety are also evaluated. Design and method: Non-inferiority trial with randomized, double-blind, double dummy parallel groups. Type II diabetic patients, of both sexes with OSBP 140–179mmHg and DBP 90–109 are recruited. After 2 week running period with Amlodipine 5 mg, patients are randomised to the first 12 weeks of randomised double-blind double dummy treatment; combination of Olmesartan 20 mg + Amlodipine 5 mg (OLM/AML) once a day, or Perindopril 4 mg + Amlodipine 5 mg (PER/AML) once a day, in 1:1 ratio. In patients not normalized by treatment after 12 or 18 weeks, the doses of drug treatment are up-titrated until week 24. At the last visit, patients received placebo treatment in single-blind for 1 day. OBP, aortic BP as large vessels parameters are assessed. Results: From 335 screened subjects, 260 are randomized (FAS) and 215 evaluated per protocol (OLM/AML 107, PER/AML 108). No differences at baseline are present. Non-inferiority criteria, was reached. OLM/AML reduced hypertension, both ODBP and OSBP, more rapidly than PER/AML in initial treatment phases and OLM/AML effect was constant and longer lasting. After missed dose, decrease of the sitting ODBP value obtained after 24 weeks of treatment was kept after both treatments. OLM/AML treatment was more effective in maintaining the sitting ODBP values' reduction after missed dose, suggesting a longer lasting effect of OLM/AML. Secondary endpoints evaluated both after 24 weeks of study treatment administration and after missed dose indicated that OLM/AML was more effective than PER/AML and the trend of efficacy was in favour of OLM/AML administration in all performed evaluations. Conclusions: OLM/AML is safe, well tolerated and as effective as PER/AML in controlling essential hypertension in patients with diabetes mellitus, while the trend of efficacy is in favour of OLM/AML. Figure. No caption available.