Hypertension and nephrology

[Monitoring of effectiveness of ramipril-amlodipine fixed combination, a non-interventional trial (Ramona study). Subgroup analysis of patients with chronic kidney disease]

SIMONYI Gábor

DECEMBER 10, 2013

Hypertension and nephrology - 2013;17(05-06)

[Hypertension and chronic kidney disease are independent cardiovascular risk factors. The 5th Cardiovascular Consensus Conference has recommended chronic kidney disease in high-risk category. In chronic kidney disease hypertension is observed in most cases. In patients with chronic kidney disease blood pressure targets are as 140/90 mmHg blood pressure below must be achieved without overt proteinuria. In chronic kidney disease combined antihypertensive therapy treatment should be initiated according the Hungarian Society of Hypertension recommendations. Aims: Monitoring the effectiveness and safety of the fix combination of ramipril/amlodipine Egiramlon® therapy in chronic kidney disease suffering from mild or moderate hypertension despite antihypertensive treatment. Patients and methods: Open, prospective, phase IV clinical observational study, which involved known chronic kidney disease (age over 18 years) with mild or moderate hypertension. Ramipril/amlodipine fixed combination (5/5, 5/10, 10/5 or, 10/10 mg) were administered or titrated in three visits, during the 4 months of trial period. The doses of the fixed combination drugs were determined individually during the visits by the 923 physicians involved in the study. The target blood pressure value was <140/90 mmHg according the new guidelines of ESH/ESC. Results: 70.1% of total patient (9169) was fulfilled the protocol during the four month of trial (6423 patients). In this population 194 patients suffered from chronic kidney disease. The age of patients was 68.52±1.84 (mean±SD) years, 85 (43.8) women and 109 (56.2%) men. 74.74% of total patients with chronic kidney disease has reached target blood pressure at the end of 4th month (primary endpoint). The blood pressure has decreased significantly (all p<0.0001) from 158.04/90.46±9.97/8.30 mmHg (1. visit) to 138.77/82.12±10.68/7.21 mmHg 2. visit and to 130.40/78.59±7.56/5.75 at the and of trial (3. visit), it means -27.64/- 11.87 mmHg decrease from the beginning of the 4th Month (3. visit). eGFR level increased significantly from 46.3±16.49 ml/min/1,73m2 to 49.0±19.58 ml/min/1,73m2. Patients suffered from chronic kidney disease have tolerated well the various doses of fixed combination of ramipril/amlodipine, and adverse events have no occurred correlation of treatment.]

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