Hypertension and nephrology

[Monitoring of the blood pressure lowering effectiveness of ramipril-amlodipine fix combination – a non-interventional trial (RAMONA study)]


JULY 20, 2013

Hypertension and nephrology - 2013;17(02)

[Purpose: Monitoring the effectiveness and safety of the fix combination formulation Egiramlon® therapy containing ramipril and amlodipin in patients, suffering from mild or moderate hypertension despite antihypertensive treatment. Patients and methods: Open, prospective, phase IV clinical observational study, which involved 9169 patients (age >18) with mild or moderate hypertension [TUKEB No: 16927- 1/2012/EKU (294/PI/12.)]. Ramipril/Amlodipin 5/5, 5/10, 10/5, 10/10 mg combinations were administered/ titrated in three visits, during the four months period according to the physician’s decision Blood pressure was measured by validated blood pressure sphygmomanometry and ABPM (Meditech, Hungary). The dosis of the fix combination formulation was determined individually during the visits by the 923 doctors involved in the study. The target blood pressure value was 140/90 mmHg, but in case of high risk patients population (diagnosed cardiovascular disease, diabetes), 130/90 mmHg target value was determined. Results: In 70.1% of the patients had no protocoll deviation. Patients data and examination results were processed according to this 6423 patient population. The average age of the patients were 60.2 year, in 50-50% sex distribution. The average duration of the treated hypertension was 9.8 years and the average blood pressure value was 157/91 mmHg. Till the end of the study, systolic blood pressure has decreased with 26.4 mmHg and diastolic pressure with 11.8 mmHg. An average 5.5 bpm heart rate frequency decreasing was observed at the end of the study. As a result of the treatment 52.4% of the patient population has reached the target blood pressure value.]



Further articles in this publication

Hypertension and nephrology

[Hypertension and diabetes mellitus]

SZEGEDI János, KISS István

[Hypertension and diabetes mellitus are endemics which affect large crowds; they play an important role in the morbidity and mortality of the population. Both diseases are cardiovascular risk factors, their co-occurrence increases the coronary risk. According to forecasts, there will be 60% increase in the number of hypertensive patients by 2025; it will affect 29% of the world’s adult population, 1.56 billion people. The number of patients with diabetes increases in all countries; 552 million diabetic patients should be expected by 2030. The simultaneous occurrence of both diseases may be a coincidence, but there is also causal relationship between the two diseases (diabetic nephropathy, metabolic syndrome). The two diseases often occur in endocrine diseases, and in connection with medicinal therapy (steroids, etc.). The simultaneous occurrence of these two diseases determines the therapeutic strategy. During the prevention and treatment of both diseases, the change in lifestyle has an important role (obesity, salt intake, physical activity).]

Hypertension and nephrology

[Goals, doubts and confidences in treatment of renal anemia]

KISS István, SZEGEDI János, KULCSÁR Imre, DEÁK György, KISS Zoltán, REMPORT Ádám, AMBRUS Csaba

[The authors sum up the physiology of erythropoiesis, the history of the erythropoietin’s discovery and the steps through which it became applicable to clinical adaptation. The biologically similar erythropoietin medicines and their application are reviewed. The setting of the target hemoglobin value and the weekly amount of erythropoietin needed for successful therapy are briefly surveyed. The authors draw attention to the fact that by increasing the dose the risk of mortality rises. Considering the other side effects they conclude based on international data and studies that “less is more” in this case namely the lower target value and erythropoietin dose can mean bigger therapeutic success. The erythropoietin treatment’s practice in Hungary is expressly efficient in the authors’ view.]

Hypertension and nephrology

[Practical aspects of therapy by erythropoiesis stimulating agents in renal anaemia]

DEÁK György, HERSZÉNYI Eszter, AMBRUS Csaba, KISS István

[Prevalence of renal anaemia due to insufficient production of erythropoietin increases progressively in the course of renal function deterioration. Renal anaemia is treated by erythropoesis stimulating agents (ESA). Outcomes of randomized clinical trials have taught us to avoid the strategy of normalization of hemoglobin (HGB) levels by ESA therapy as it may increase the risk of cardiovascular events and mortality. The Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guideline for Anaemia published in 2012 recommends to start ESA therapy in the 90-100 g/l HGB range and suggests to keep HGB concentrations below 115 g/l. It is an inappropriate strategy to aim at normalizing hemoglobin (HGB) levels by ESA therapy because it may lead to progressive escalation of ESA doses even in the presence of diminished ESA responsiveness. High ESA doses and diseases causing ESA hyporesponsiveness eg. infections, chronic inflammation, malnutrition, insufficient dose of dialysis, severe hyperparathyroidism, iron deficiency are related to increased risk of mortality. KDIGO Clinical Practice Guideline for Anaemia emphasizes the importance of assessing and treating causes of ESA hyporesponsiveness, limits ESA dose escalation and recommends gradually changing ESA doses to avoid high amplitude HGB oscillation.]

Hypertension and nephrology

[Health Protective Screening Program of Hungary 2010-2020. Metabolic syndrome - Results in 2010-2012]

KÉKES Ede, BARNA István, DAIKI Tenno, DANKOVICS Gergely, KISS István

[1 597 163 health assessments were performed on 65267 persons as a part of screening program. 132 964 participants were participated in our lifestyle advice program. The number of questionnaire responses for health statue were 3 717 480 during three years. This publication presents the results of metabolic disorders explored by screening. The metabolic syndrome was characterized by visceral obesity, abnormal glucose level and elevated blood pressure. Reasonable suspicion of metabolic syndrome was occured in 33-38% of subjects. Where the positive criteria was present, there were higher values of investigated parameters (waist, glucose, cholesterol, systolic blood pressure, uric acide level) compared with those of negative criteria.]

Hypertension and nephrology

[Managing hypertension using a fixed combination of an angiotensin converting enzyme inhibitor and a calcium channel blocker]

E. Chazova, G. Ratova, V. Nedogoda, M. Lopatin, B. Perepech, V. Tsoma

[The objective of the study was to compare the efficacy of a low-dose combination of an angiotensin-converting enzyme (lisinopril 10 mg) and a dihydropyridine calcium channel blocker (amlodipine 5 mg) (Ekvator, Gedeon Richter) (Group 1) and enalapril with or without hydrochlorothiazide (Group 2) in hypertension. Materials and methods: The study included 93 patients with hypertension (36% of men and 64% of women). The mean age was 52.6±12 years and the mean duration of hypertension was 7.5±6.1 years. The initial office blood pressure (BP) was 149.2±13.8/91.4±81 mmHg. Patients were randomized into two groups (Group 1, n=51 and Group 2, n=36). Results: The fixed-dose combination of amlodipine/lisinopril offered the potential to reduce the office BP by -28.9±11.3/-16.0±8.7 mmHg; p<0.0001. In Group 2 the office BP dropped by -22.9±17.9/-11.5±10.7 mmHg; p<0.0001. Patients in Group 1 achieved goal blood pressure more frequently than patients in Group 2 (94.1% versus 72.2% patients respectively; p=0.008). There were no significant changes in the heart rate in either group. The reduction of microalbuminuria (the reduction in urinary albumin excretion (UAE)) by -13.8±24.4 mg/24h (p<0.001) was observed only in patients from Group 1. The quality of life of patients from Group 2 improved. However, the quality of life improvements were more significant in Group 1 than in Group 2 (p=0.002). Conclusion: The fixed-dose combination of amlodipine/lisinopril offers the potential to achieve a target blood pressure in 94% of patients with hypertension, produces a nephroprotective effect and improves patients’ quality of life.]

All articles in the issue

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Lege Artis Medicinae

[Thiazide- or thiazide-like diuretics should be used in the treatment of patients with hypertension? Particularities of the situation in Hungary]


[Diuretics have remained the cornerstone of the antihypertensive treatment since their widespreading in the 1960s. According to the 2018 ESC/ESH Guidelines for the management of arterial hypertension, in the absence of evidence from direct comparator trials and recognizing that many of the approved single-pill combinations are based on hydrochlorothiazide, this drug and thiazide-like indapamide can be considered suitable antihypertensive agents. In the 2018 Hungarian guidelines indapamide is named as the most efficacious diuretic in the treatment of patients with hypertension. The aim of the publication is redefining thiazide- and thiazide-like diuretic use in the treatment of hypertensive patients, with particular attention to presently available hydrochlorothia­zide and indapamide, and their combination drugs in Hungary.]

Hypertension and nephrology

[Association between cyclothymic affective temperament and hypertension]


[Affective temperaments (cyclothymic, hypertymic, depressive, anxious, irritable) are stable parts of personality and after adolescent only their minor changes are detectable. Their connections with psychopathology is well-described; depressive temperament plays role in major depression, cyclothymic temperament in bipolar II disorder, while hyperthymic temperament in bipolar I disorder. Moreover, scientific data of the last decade suggest, that affective temperaments are also associated with somatic diseases. Cyclothymic temperament is supposed to have the closest connection with hypertension. The prevalence of hypertension is higher parallel with the presence of dominant cyclothymic affective temperament and in this condition the frequency of cardiovascular complications in hypertensive patients was also described to be higher. In chronic hypertensive patients cyclothymic temperament score is positively associated with systolic blood pressure and in women with the earlier development of hypertension. The background of these associations is probably based on the more prevalent presence of common risk factors (smoking, obesity, alcoholism) with more pronounced cyclothymic temperament. The scientific importance of the research of the associations of personality traits including affective temperaments with somatic disorders can help in the identification of higher risk patient subgroups.]

Hypertension and nephrology

[Sudden death – ECG – hypertension]


[Sudden death (HH) is not only associated with coronary heart disease or heart failure, but is also present in hypertension, primarily associated with left ventricular hypertrophy, systolic pressure, and age. Co-morbidities of hypertension (diabetes, coronary heart disease, heart failure and renal failure) contribute greatly to its development. HH occurs due to ventricular fibrillation, or asystole. The auther demonstrates depolarization and repolarization pathologies leading to HH and detectable on the ECG and their characteristic ECG patterns. He also emphasizes the importance of resting heart rate and heart rate variability.]

Hypertension and nephrology

[Prevalence and treatment of hypertension in patients with newly diagnosed familial hypercholesterolemia]

NÁDRÓ Bíborka, DIÓSZEGI Ágnes, KOVÁCS Beáta, PARAGH György, PÁLL Dénes, HARANGI Mariann

[Familial hypercholesterolemia (FH) is an inherited defect of cholesterol metabolism characterized by high plasma total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels and premature cardiovascular disease risk. Prevalence of hypertension in FH is not clarified, but its appearance is independent risk factor for the development of cardiovascular disease. Therefore, optimal treatment has a major priority in this high-risk population. We aimed to investigate the lipid parameters and evaluate the presence of hypertension and its treatment characteristics in 86 newly diagnosed, untreated heterozygous FH patients (27 males, 59 females, mean age 53.6±13.4 years). We diagnosed FH by using the Dutch Lipid Clinic Network criteria. The mean TC level was 8.49±1.7 mmol/l, the mean LDL-C level was 6.11±1.5 mmol/l, the mean high-density lipoprotein cholesterol (HDL-C) level was 1.62±0.5 mmol/l, while the median lipoprotein (a) level was 301 mg/l. We diagnosed 33 FH patients (38.4%) with hypertension. Beta blockers were used in 23, ACE-inhibitors in 13, ARBs in 12, calcium channel blockers in 9, and HCT in 11 cases. 11 patients was treated with monotherapy, for 10 patients double, for 11 patients triple, while for 1 patient quadruple combined antihypertensive therapy was administered. Based on our results, hypertension might be underdiagnosed in this specific patient population. Neither the types nor the combination patterns of blood pressure lowering agents are in line with current guidelines. Up to date screening and treatment of hypertension should be worth considering in this extremely high risk population with enhanced atherosclerosis.]

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]


[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.]