Benefits of Fixed Dose Combination of Ramipril/Amlodipine in Hypertensive Diabetic Patients： A Subgroup Analysis of RAMONA Trial  

作　　者：Gabor Simonyi 

机构地区：[1]Metabolic Center, Szent Imre University Teaching Hospital, H-1115 Budapest, Hungary

出　　处：《Chinese Medical Journal》2016年第10期1224-1228,共5页中华医学杂志（英文版）

摘　　要：Background： Combination of angiotensin-converting enzyme inhibitors and calcium channel blockers has been successfully used in the ant±hypertensive therapy for many years. Fixed dose combinations of ramipril/amlodipine have a benefit effect for patients to achieve target blood pressure （BP）. This study aimed to assess the efficacy and safety of fixed dose combinations oframipril and amlodipine （Egiramlon） in hypertensive diabetic patients. Methods： Hypertensive diabetic patients who were enrolled into the RAMONA trial were included in this open, prospective, Phase Ⅳ observational clinical study. Patients had mild-to-moderate hypertension and failed to reach target BP levels through their previous therapy. During the four months of observation, patients took part in three visits （1 st day - visit 1, 1 st month = visit 2, and 4th month = visit 3） where they received a fixed dose combination of 5/5, 5/10, 10/5, or 10/10 nag ramipril/amlodipine, respectively, with the possibly required dose titrations, based on the decision of their attending physician. Target BP for diabetic patients was 〈 140/85 mmHg. BP levels were measured in all visits, by taking two readings at 2-min interval. Laboratory tests including full blood count, renal function test, electrolytes, blood glucose, serum cholesterol, uric acid, triglycerides, liver function test, creatinine kinase, and midstream urinalysis were performed at visit 1 and visit 3. Results： The 6423 patients completed the study. Among these patients, 1276 （19.9%） patients suffered from type 2 diabetes mellitus. The mean age of these diabetic patients was 64.2 ±10.0 years; 707 （55.4%） patients were males. Target BP was achieved by 891 （69.8%） of diabetic patients at visit 3 （primary endpoint）. BP decreased from 157.5/91.3 ±9.6/7.6 mmHg （visit 1） to 130.9/79.6 ± 7.4/5.8 mmHg （visit 3）. As for the secondary endpoint of the study, total cholesterol decreased from 5.50 ±1.13 mmol/L （visit 1 ） to 5.20 ±0.95 mmol/L （P = 0.000�Background： Combination of angiotensin-converting enzyme inhibitors and calcium channel blockers has been successfully used in the ant±hypertensive therapy for many years. Fixed dose combinations of ramipril/amlodipine have a benefit effect for patients to achieve target blood pressure （BP）. This study aimed to assess the efficacy and safety of fixed dose combinations oframipril and amlodipine （Egiramlon） in hypertensive diabetic patients. Methods： Hypertensive diabetic patients who were enrolled into the RAMONA trial were included in this open, prospective, Phase Ⅳ observational clinical study. Patients had mild-to-moderate hypertension and failed to reach target BP levels through their previous therapy. During the four months of observation, patients took part in three visits （1 st day - visit 1, 1 st month = visit 2, and 4th month = visit 3） where they received a fixed dose combination of 5/5, 5/10, 10/5, or 10/10 nag ramipril/amlodipine, respectively, with the possibly required dose titrations, based on the decision of their attending physician. Target BP for diabetic patients was 〈 140/85 mmHg. BP levels were measured in all visits, by taking two readings at 2-min interval. Laboratory tests including full blood count, renal function test, electrolytes, blood glucose, serum cholesterol, uric acid, triglycerides, liver function test, creatinine kinase, and midstream urinalysis were performed at visit 1 and visit 3. Results： The 6423 patients completed the study. Among these patients, 1276 （19.9%） patients suffered from type 2 diabetes mellitus. The mean age of these diabetic patients was 64.2 ±10.0 years; 707 （55.4%） patients were males. Target BP was achieved by 891 （69.8%） of diabetic patients at visit 3 （primary endpoint）. BP decreased from 157.5/91.3 ±9.6/7.6 mmHg （visit 1） to 130.9/79.6 ± 7.4/5.8 mmHg （visit 3）. As for the secondary endpoint of the study, total cholesterol decreased from 5.50 ±1.13 mmol/L （visit 1 ） to 5.20 ±0.95 mmol/L （P = 0.000�

关 键 词：Diabetes Mellitus HYPERTENSION Ramipril/Amlodipine Fixed Dose Combination 

分 类 号：S828.5[农业科学—畜牧学] Q75[农业科学—畜牧兽医]