Hypertension and nephrology

[Monitoring of effectiveness of ramipril-amlodipine fixed combination in metabolic syndrome, a non-interventional trial (The RAMSES Study)]


MARCH 20, 2015

Hypertension and nephrology - 2015;19(01)

[Hypertension is a cardiovascular risk factor. The 6th Cardiovascular Consensus Conference has recommended metabolic syndrome in high-risk category. In diabetic patients hypertension is observed in most cases. Aims: Monitoring the effectiveness and safety of the fix combination of ra - mipril/amlodipine therapy in patients with metabolic syndrome suffering from mild or moderate hypertension despite current antihypertensive treatment. Patients and methods: Open, prospective, phase IV clinical observational study, which involved known metabolic syndrome patients (age over 18 years) with mild or mode - rate hypertension. Ramipril/amlodipine fixed combination (5/5, 5/10, 10/5 or, 10/10 mg) were administered or titrated in 3 visits, during the 6 months of trial period. The doses of the fixed combination drugs were determined individually during the visits by physicians involved in the study. The target blood pressure value was 140/90 mmHg and <140/85 mmHg in diabetic patients. Results: 63% of total patient (9,052) have fulfilled the protocol during the four month of trial (5,707 patients). The age of patients was 61.3±11.97 (mean±SD) years, 2.736 (47.9%) men and 2,971 (52.1%) women. 74.0% of total metabolic patients has reached target blood pressure at the end of 6th month (primary end point). The blood pressure has decreased significantly from 158.7±8.97/91.9±7.30 mmHg (1. visit) to 131.6±7.73/79.8±12.20 mmHg (-27.1±10.43 /12.1±13.38 mmHg) to the 6th month (3. visit) (p<0.0001). Patients with hypertension in metabolic syndrome have tolerated the various fixed combination of ramipril/amlodipine well. ]



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[Antihipertensive therapy in the complex treatment of diabetes mellitus, obesity and lipid metabolism disorder was discussed, which also means the fight against the emergence of cardiometabolic syndrome and chronic renal failure as well. Angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor antagonists (ARBs), calcium channel blockers (CCB), b-blockers and thiazid diuretics with “A” level of evidence reduce cardiovascular morbidity and mortality. The main effect of CCBs is effective antihipertensive vasodilatation, which is the basis of anti-ischaemic, anti-anginal and antihipertensive agents for use in everyday practice. Based on the database of the National Health Insurance, we analyzed changes in the turnover of CCBs between 2007 and 2013 the examined period among CCBs ordered with TB support amlodipin is the most frequently used active ingredient. In December 2007 almost 75% of the prescriptions was amlodipin. That increased to 87,12% by December 2013. CCBs ordered in monotherapy not changed in the examined period, while combinations increased continuously Among CCBs between 2007 and 2013 the fix dosage combinations available with TB support are: statins (atorvastatin + amlodipin), ACE inhibitors (ramipril + felodipin, lisinopril + amlodipin, perindopril + amlodipin, ramipril + amlodipin, verapamil + trandolapril) and b-blockers (metoprolol + felodipin). Using the assigned CCB monotherapy decreased steadily during the study period, while the use of combination formulations induced gradually increased. At the end of the examined seven year period more than 40% of the prescribed boxes were CCB in fix combination. Use of the combination of amlodipin + perindopril increased while amlodipin + lisinopril continuously reduced. The use of the combination of felodipin + ramipril also decreased.]

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