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Pharmaceutical antagonism of the mineralocorticoid receptor (MR) can protect against organ damage caused by elevated aldosterone levels in patients experiencing heart failure (HF), chronic kidney disease (CKD), primary aldosteronism, and hypertension. While traditional steroid-based MR antagonists effectively reduce mortality rates and extend patient survival, their broad application has been limited by significant side effects, most notably hyperkalaemia. Recently, finerenone (BAY 94-8862) has emerged as a next-generation non-steroidal dihydropyridine-based MR antagonist designed to minimize off-target effects while maintaining potent efficacy. In this review, the outcomes of finerenone therapy in several diseases associated with MR activity are explored. The (pre-) clinical efficacy of finerenone is compared with that of traditional steroid-based MR antagonists. Finally, recent and ongoing clinical trials using finerenone to treat chronic HF, CKD, and diabetic nephropathy are discussed. Taken together, pre-clinical and clinical evidence suggests that finerenone may achieve equivalent organ-protective effects with reduced levels of electrolyte disturbance compared with traditional steroid-based MR antagonists. This supports further clinical development of finerenone for the treatment of cardiovascular and renal disease., (© 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiology.)

Hypertension in the elderly is a major risk factor for cardiovascular disease. We aimed to analyze determinants of blood pressure (BP) control across different age groups. Population of a large global survey on hypertension treatment and control including 18927 patients was analyzed. A logistic regression analysis was conducted to estimate BP control rates and the prevalence of antihypertensive drug usage according to age. Systolic BP control decreased from 29.6% (95% confidence intervals (CI) 26.0;33.5) at 18-40 years to 22.4% (20.8;24.2) at >75 years (P<0.0001), and diastolic BP control increased from 31.6% (27.9;35.6) to 57.3% (55.2;59.3), respectively (P<0.0001). BP control was worse in diabetic patients, but did not differ substantially with co-morbid conditions, except for a better control in patients with myocardial infarction (MI) (P<0.05). The use of ≥ 3 antihypertensive drugs increased with age from 16.1 to 37.8% (P<0.0001) due to a more frequent use of loop diuretics (P<0.0001), thiazides (P<0.0001), angiotensin-converting enzyme (ACE) inhibitors (P<0.0001) and calcium channel blockers (P<0.0001). About one third of patients received non-guideline-recommended drug-drug combinations. BP control is largely unsuccessful with increasing age. Owing to frequent inadequacies in the combination of antihypertensive drugs, future guidelines and educational programs should devote increased attention to the choice of optimal drug-drug combinations in the elderly.

Aims: Microalbuminuria (MAU) is a marker for endothelial dysfunction and a predictor of increased cardiovascular risk. Physical activity improves endothelial function. This analysis aims to explore the impact of regular physical exercise on the prevalence and the degree of MAU in hypertensive individuals at high cardiovascular risk., Methods and Results: The International Survey Evaluating microAlbuminuria Routinely by Cardiologists in patients with Hypertension (I-SEARCH) studied the prevalence of MAU in 20,786 hypertensive patients at high cardiovascular risk. Herein, we investigated the relationship between self-reported physical activity and MAU in relation to the number of cardiovascular risk factors, medication and co-morbidities. A total of 7123 patients (34.3%) performed regular physical exercise (moderate or strenuous, at least 4 hours per week). The prevalence of MAU was significantly lower in active than in inactive patients (54% vs 61%; P < 0.0001). This association was observed in all classes of blood pressure and heart rate and was similar in patients with and without diabetes mellitus. Urinary albumin excretion (UAE) was lower in active than in inactive patients (UAE 80 mg/l: 11.6% vs 13.5%, P < 0.0001; UAE 150 mg/l: 7.5% vs 10%; P < 0.0001). In a multivariate analysis adjusted for age, gender, blood pressure, heart rate, renal function, medication and comorbidities, regular physical activity was associated with a 25% lower risk for MAU (odds ratio (OR) 0.75; 95% confidence interval (CI), 0.67-0.84; P < 0.0001). Risk reduction for MAU was more pronounced in strenuously active (OR 0.66; 95%CI, 0.47-0.95; P < 0.05) than in moderately active patients (OR 0.76; 95%CI, 0.68-0.85; P < 0.0001)., Conclusion: In hypertensive patients at high cardiovascular risk, physical activity is an independent predictor for a decreased risk of microalbuminuria.

Background: Microalbuminuria (MAU) is a marker for endothelial dysfunction and a predictor of cardiovascular events. Cardiovascular risk and mortality are mainly influenced by associated morbidities and risk factors., Methods and Results: The present analysis aimed to investigate the relationship between the number of cardiovascular comorbidities and both the prevalence of MAU and the extent of albuminuria (measured as urinary albumin excretion, UAE) in 21,867 high-risk hypertensive patients included in the I-SEARCH study. A total of 6,945 patients (32 %) suffered from at least one comorbidity, out of which 5,437 patients (25 %) had one cardiovascular comorbidity, 1,163 (5 %) patients had two, and 345 (2 %) had ≥3. The prevalence of MAU increased from 54 % in patients without cardiovascular comorbidity to 74 % in the presence of ≥3 comorbidities (p < 0.01). In a multivariate analysis, the presence of ≥3 cardiovascular comorbidities nearly doubled the risk for MAU (HR 1.79, CI 1.07-2.68, p = 0.025). Compared to other comorbidities, patients with left ventricular hypertrophy had the highest prevalence of MAU (68 %, p < 0.01). The extent of UAE was related to the number of concomitant disease and increased significantly in patients with ≥3 comorbidities compared to patients with no comorbidity (UAE of 80 mg/L: 12-22 %, p < 0.01; UAE of 150 mg/L: 8-19 %, p < 0.01)., Conclusions: In hypertensive patients at high cardiovascular risk, both the prevalence of MAU and the extent of albuminuria increase with the number of comorbidities.

Background: In Germany, an estimated 20-25 million patients suffer from hypertension. Blood pressure control rates are, however, lower than in many other European countries and the USA. The present analysis reports blood pressure treatment and control rates in Germany in patients with hypertension treated by cardiologists., Methods: The present analysis reports data from a German subgroup analysis of a large, multinational, observational survey i-SEARCH that recruited patients in 2005/2006. It reports blood pressure readings, drug utilization and control rates in cardiology practice., Results: A total of 4,982 patients were documented at 417 sites. Mean systolic/diastolic blood pressure (SBP/DBP) was 152 ± 19.5/88.4 ± 11.5 mmHg. SBP was 1.3 mmHg higher in men than in women (p = 0.021). The majority of patients had an SBP between 141 and 160 mmHg and 31.4% of patients had normal SBP. Overall blood pressure control rate was only 11.6% [95% CI 10.7-12.6] in treated patients. It was different in men [10.2%; 95% CI 9.0-11.6] than in women [8.1%; 95% CI 7.1-9.4; p = 0.008] and higher in patients without diabetes [12.7%; 95% CI 11.6-14.0] than in those with diabetes [4.3%; 95% CI 3.4-5.4; p < 0.0001]. One-third of patients received either monotherapy or dual therapy, or three and more drugs, respectively; 42.2% of patients received guideline-recommended dual combination therapy. A combination of beta-blockers + ACE inhibitors was most frequently prescribed (30.8%)., Conclusions: Our data indicate a low level of blood pressure control, especially in patients at an increased risk for cardiovascular events, such as those with diabetes or cardiovascular comorbidities. Major efforts are required to improve hypertension management as recommend by current treatment guidelines.

Background: Microalbuminuria (MAU) is a marker of endothelial dysfunction and a predictor of cardiovascular events. The effects of cigarette smoking on the prevalence of MAU in a high-risk population with arterial hypertension are unclear., Methods: The International Survey Evaluating Microalbuminuria Routinely by Cardiologists in patients with Hypertension (I-SEARCH) documented the clinical profile of 20,364 patients with arterial hypertension and cardiovascular risk factors. In this population, 13,690 patients had no history of smoking, 4,057 patients were former smokers and 2,617 patients were current smokers., Results: The prevalence of MAU was associated with the smoking status. Consumption of 1-20 cigarettes per day leads to an increase of 6.8% in the prevalence of MAU compared to non-smokers (P < 0.001). Smoking of >20 cigarettes per day was associated with a 12.5% higher prevalence of MAU compared to non-smokers, while former smokers had a 4.7% higher prevalence of MAU. Multivariable analysis revealed that smoking was independently associated with MAU [odds ratio (OR) smoking vs. non-smoking 1.16; 95% confidence interval (CI) 1.01-1.33; P < 0.05]. Particularly, a consumption of >20 cigarettes per day was associated with high odds for MAU (OR 1.33; CI 1.01-1.75; P < 0.05). Interestingly, independently of blood pressure, the use of an angiotensin receptor blocker and an ACE was associated with significantly reduced odds ratio for MAU in the smoking group, while there was no significant association in the non-smoking group., Conclusion: The prevalence of MAU in hypertensive patients is higher in smokers than in non-smokers with a strong dose dependency.

Hypertensive patients with cardiovascular (CV) comorbidities are at increased risk, and cardiologists' care should put particular emphasis on controlling blood pressure. Data on blood pressure treatment and control and drug utilization on a global scale, however, are scarce. Aiming to resolve this lack of information, the authors analyzed the data of International Survey Evaluating Microalbuminuria Routinely by Cardiologists in Patients With Hypertension (i-SEARCH) to gain further insights into national and regional blood pressure control and antihypertensive pharmacotherapy prescribed in cardiology practice. A total of 22,282 patients with hypertension from 26 countries were enrolled in 2005/2006. A total of 18,652 patients were treated (mean age, 63.0±11.4 years; 52.2% male; mean body mass index, 28.9 kg/m2). Mean systolic blood pressure was 148.2±19.8 mm Hg and diastolic blood pressure was 86.7±11.6 mm Hg. Blood pressure was controlled in 8.3% of diabetic and 25.3% of nondiabetic patients (21.2% overall), with particularly good control rates in North and Latin America (28.0% and 30.6%, respectively). A total of 31.2% of patients were treated with 1, 39.7% with 2, and 29.1% with ≥3 drugs. β-blockers were being used most frequently (47.9%), in both monotherapy and combination therapy despite low numbers of patients with respective compelling indications for their use. The present data illustrate the potential for an improvement of blood pressure treatment and control in daily cardiology practice., (© 2010 Wiley Periodicals, Inc.)

Cardiovascular death represents the single largest cause of mortality in women with 70% of deaths attributable to modifiable risk factors, such as hypertension. This analysis aims at evaluating, whether there are gender disparities in antihypertensive drug usage and blood pressure (BP) control. We included 18 017 patients with arterial hypertension from the International Survey Evaluating Microalbuminuria Routinely by Cardiologists in patients with Hypertension (I-SEARCH). The study was conducted between September 2005 and March 2006 in 26 countries, and data on patient demographics, cardiovascular disease and risk factors, BP, and cardiovascular drug treatment were collected. Mean systolic blood pressure (SBP) was 2.1 mm Hg higher in women (150.6+/-0.35 mm Hg, n=8357/18 017) than in men (148.5+/-0.35 mm Hg; P<0.0001, n=9526/18 017), whereas no difference in diastolic BP was seen (88.2+/-0.20 vs 88+/-0.20 mm Hg; P=0.198). Gender differences in SBP were more pronounced in diabetic as compared with non-diabetic patients (3.5 vs 1.7 mm Hg, n=4272 vs n=13 611; P<0.0001) and became evident at an age 55 years old. Overall BP-control rate was 33.6% in men and 30.6% in women (P<0.0001) and was lower in diabetic as compared with non-diabetic patients. In all, 30% of patients used one, 40% used two and 30% used > or = 3 drugs without gender differences. Response rates to different drug regimens appeared to be similar. However, women received more frequently thiazides and beta-blockers, and less frequently ACE-inhibitors as monotherapy. Major efforts are required to improve BP-management, especially in women.

Question Under Study: The aim of this study was to determine the prevalence of microalbuminuria (MAU) in hypertensive patients attending an office or hospital based cardiologist or internist. An additional aim was to describe associations between MAU and cardiovascular risk factors as well as to investigate the role of pharmacotherapy., Methods: International, observational, cross-sectional study of 22282 patients with 5605 attendees in Germany and Switzerland at 444 cardiology centers. Inclusion criteria were male and female outpatients, aged > or =18 years with currently treated or newly diagnosed hypertension (> or =140/90 mm Hg at rest on the day of the study visit) and no reasons for false positive dip stick tests. The main outcome measures were the prevalence of MAU, co-morbid cardiovascular risk factors or disease and their association with the presence of MAU, and the role of pharmacotherapy in modulating prevalence of MAU., Results: Prevalence of MAU in Germany and Switzerland (53.1%) was high, but lower when compared to the prevalence in "other countries" (OC, 60.2%). Routine MAU measurement was performed in 52.9% of the practices only (32.9% OC), although physicians regarded MAU to be important for risk assessment and therapeutic decisions. MAU is highly correlated with a wide variety of cardiovascular risk factors and co-morbid cardiovascular conditions including high waist circumference (55.1% [95%CI 56.0; 59.7]), diabetes (59.1% [56.8; 61.3]), atrial fibrillation (62.3% [57.4; 66.9]) and peripheral arterial disease (67.1% [61.6; 72.2]). Angiotensin receptor blockers (ARBs) appeared to be associated with the lowest risk of MAU (52.1%). Calcium channel blockers (CCBs) were used more frequent in patients with MAU (28.7%) than without (23.4%)., Conclusions: Patients with MAU are common in clinical cardiology and its presence is associated with a wide variety of cardiovascular risk factors and co-morbid cardiovascular conditions. A more aggressive multi-factorial treatment might help to reduce this risk constellation.

Aims: To investigate the relationship between microalbuminuria (MAU) and atrial fibrillation (AF) and to further evaluate whether the heart rate dependency of MAU in patients without AF is maintained in patients with a history of AF., Methods and Results: The International Survey Evaluating Microalbuminuria Routinely by Cardiologists in patients with Hypertension (I-SEARCH) included 18,900 patients without and 1705 patients with a history of AF suffering from hypertension and other risk factors for cardiovascular disease in 26 countries worldwide from September 2005 to March 2006. Heart rate, blood pressure, urinary albumin excretion, and an estimated glomerular filtration rate were determined among other parameters. The prevalence of MAU was higher at higher heart rate in both patients with and without a history of AF. Prevalence of MAU was about 10% higher in patients with a history of AF (P < 0.001). Male gender, the presence of diabetes mellitus, a higher heart rate, and a higher diastolic blood pressure were independently associated with increased odds for MAU in patients without and with a history of AF., Conclusion: The prevalence of MAU in hypertensive patients with cardiovascular risk factors is related to heart rate and significantly higher in patients with a history of AF.

Background: Overweight and obesity are frequently associated with preventable death and have emerged as a major challenge to public health. There is an ongoing debate on the role of abdominal obesity and its value in predicting cardiovascular and renal outcomes. The present analysis evaluates the prevalence of microalbuminuria (MAU) and conventional cardiovascular risk factors in relation to measures of general and abdominal obesity., Methods: In this multinational, observational study, 20828 hypertensive out-patients from 26 countries including Europe, North and Latin America, Middle East, and Asia were analyzed. Urinary dipstick screening for MAU was performed as well as data on patient demographics, anthropometric measures, cardiovascular risk factors, comorbid conditions, and cardiovascular drug therapy collected. MAU prevalence was determined by a stepwise logistic regression analysis with cardiovascular risk factors as univariate., Results: In the univariate analysis, MAU prevalence systematically increased with body mass index (BMI) from 54.4% (1st tertial) to 62.1% (3rd tertial) (p < 0.0001), an increase which was also observed for waist circumference (WC). At any level of BMI, MAU increased with WC from 53.5%, 54.8%, and 55.0% (1st tertial of WC in all three BMI tertials) to 61.4%, 62.1%, and 64.0% (3rd tertial of WC in all BMI tertials) (p < 0.0001). In the multivariate analysis, WC, but not BMI was independently associated with MAU. Furthermore, overweight/obesity were associated with the presence of modifiable and nonmodifiable risk factors., Conclusion: An abnormal WC, but not BMI appears to be independently associated with MAU, an early marker of cardiovascular and renal risk. Increasing WC confers an incremental risk for MAU at any level of BMI, underlining the prognostic importance of abdominal fat accumulation beyond general obesity.

Objectives: To define the prevalence of microalbuminuria (MAU) in hypertensive outpatients attending a cardiologist or internist (i-SEARCH A) and to compare hypertensive outpatients with or without coronary artery disease (CAD; i-SEARCH B). A secondary objective was to establish a correlation between MAU and known cardiovascular risk factors., Methods: i-SEARCH was an international, observational study. which enrolled consecutive outpatients with hypertension. Patients with reasons for a false-positive MAU test were excluded. Main outcome measures were the prevalence of MAU as assessed using a dipstick test, hypertension co-morbidities, co-medication and presence of known cardiovascular risk factors., Results: A total of 21,050 patients, from 26 countries, were included in the primary analysis. Overall prevalence of MAU was 58.4% (men > women), although there was considerable variation in prevalence across countries and continents (maximum 71% in Vietnam/Indonesia; minimum 53% in Germany/Switzerland). In multivariate analyses, predictors of MAU were identified to be male gender, high waist circumference, systolic blood pressure >or= 120 mmHg, diastolic blood pressure >or= 100 mmHg, creatinine clearance >or= 50 ml/min, and the presence of diabetes, congestive heart failure, CAD, history of cerebral pathology, peripheral arterial disease, dyspnoea or palpitations. MAU was present more often in patients with CAD than in patients without., Conclusions: MAU is extremely common in hypertensive outpatients worldwide, especially in patients with known cardiovascular risk factors. Given its importance as a strong, early and independent marker of increased cardiovascular risk in hypertension, the results of i-SEARCH mandate more rigorous MAU screening of hypertensive patients in clinical practice.

Background: Cardiovascular risk markers like microalbuminuria (MAU), highly sensitive C-reactive protein (hsCRP) and brain natriuretic peptide (BNP) currently gain importance to estimate risk in trials and clinical practice. Blockade of the renin-angiotensin system (RAS) has been shown to reduce some of these risk markers in clinical trials, but validation of their time course and role in clinical practice is still pending., Design: To fill this gap, the design of a nationwide registry study was chosen in which patients attending their cardiologist were observed for 12 months and the effect of blocking the RAS with the angiotensin II receptor blocker irbesartan was documented. Primary question: risk for mortality and the incidence of cardiovascular events in relation to baseline values of MAU, hsCRP, and BNP. Secondary questions: correlations between cardiovascular risk markers (1) amongst each other with respect to cardiovascular events, (2) with clinical findings (echocardiography, electrocardiogram), (3) with the heart rate, (4) with further metabolic parameters (blood sugar, HbA(1c), etc.), and (5) with blood pressure control., Results: Until April 1, 2006, 2,149 patients were recruited in 305 centers in Germany. Patients had a mean age of 61.4 (+/- 11.3) years. Waist circumference was 103.6 (+/- 13.5) cm. 95.1% of all patients had arterial hypertension at inclusion (> or = 140/90 mmHg). The mean value for albumin/creatinine was 68.9 (+/- 307.5) mg/g (n = 2,100), for hsCRP 4.6 (+/- 8.3) mg/l (n = 2,136), and for proBNP 236.5 (+/- 557.3) pg/ml (n = 2,138)., Conclusion: The present register will elucidate the time course and the interdependence of the cardiovascular risk markers MAU, hsCRP and proBNP as well as their prediction of cardiovascular endpoints in hypertensive individuals. In addition, the role of RAS-blocking agents will be evaluated. A valuable contribution to estimate risk and to optimize care for cardiovascular high-risk patients in clinical practice can be expected.

Objectives: The metabolic syndrome is a cluster of cardiovascular risk factors leading to an increased risk for the subsequent development of diabetes and cardiovascular morbidity and mortality. Blocking the renin-angiotensin system has been shown to prevent cardiovascular disease and delay the onset of diabetes. Irbesartan is an angiotensin receptor blocker (ARB) which has been shown to possess peroxisome proliferator-activated receptor gamma (PPARgamma) activating properties, and to have a favorable metabolic profile. Current discussion is whether the addition of small doses of hydrochlorothiazide changes this profile. Therefore the efficacy, safety and metabolic profile of Irbesartan either as monotherapy or in combination therapy was assessed in patients with the metabolic syndrome in a large observational cohort in primary care., Research Design and Methods: Multicenter, prospective, two-armed, post authorization study over 9 months in 14,200 patients with uncontrolled hypertension with and without the metabolic syndrome (doctors' diagnosis based on the Adult Treatment Panel III criteria 2001). Blood pressure was measured sphygmomanometrically and cardiovascular risk factors making up the criteria for the metabolic syndrome were assessed., Main Outcome Measures: Systolic (SBP) and diastolic (DBP) blood pressure reduction, response, and normalization (systolic and diastolic), changes in fasting glucose, waist circumference (abdominal obesity), serum triglycerides and HDL cholesterol as well as the proportion of patients fulfilling the criteria for the metabolic syndrome. Number and nature of adverse events (AEs)., Results: After 9 month the use of Irbesartan in monotherapy resulted in a significant reduction of blood pressure (SBP: -26.3 +/- 10.1 mmHg/DBP-13.0 +/- 6.6 mmHg, both p < 0.0001) in patients with the metabolic syndrome. This was accompanied by a reduction in cardiovascular risk factors: HDL cholesterol (+3.6 +/- 7.2 mg/dl in men, +3.8 +/- 6.5 mg/dl in women, both p < 0.0001), serum triglycerides (-28.6 +/- 52.1 mg/dl, p < 0.0001), fasting blood glucose (-8.4 +/- 25.1 mg/dl, p < 0.0001) and waist circumference (-2.4 +/- 11.9 cm in men, -1.2 +/- 14.2 in women, both p < 0.0001) were significantly improved. Irbesartan combination therapy (12.5 mg HCTZ) in patients with the metabolic syndrome: blood pressure reduction (SBP: -27.5 +/- 10.1 mmHg/DBP: -14.1 +/- 6.6 mmHg, both p < 0.0001), improvement in HDL cholesterol (+4.0 +/- 6.8 mg/dl in men, +3.4 +/- 6.8 in women, both p < 0.0001), triglycerides (-34.1 +/- 52.6 mg/dl, p < 0.0001), fasting blood glucose (-10.0 +/- 24.7, p < 0.0001) and waist circumference (-3.2 +/- 12.7 cm in men, -1.7 +/- 14.4 in women, both p < 0.0001). Tolerability was excellent: only 0.6% of patients experienced an AE., Conclusion: There was a significant improvement in blood pressure and metabolic risk factors as a result of Irbesartan treatment. There was no evidence of a difference between monotherapy and combination therapy with regard to the cardiovascular risk profile.

Objective: High blood pressure (BP) is a leading risk factor for cardiovascular morbidity and mortality. Effective antihypertensive pharmacotherapy is available but recognition and proper management of hypertension and BP goal achievement is still poor. Therefore, it was hypothesized that physicians' attitude towards high BP, as well as patients' perception and knowledge, may influence actual management of hypertension., Research Design and Methods: Telephone interviews were carried out with a random sample of 1259 primary care physicians in 17 countries worldwide from 12 December 2005 to 13 January 2006 using a central computer assisted telephone interview methodology (CATI)., Results: (1) Physicians believed that 62 +/- 21% of their patients had their BP controlled. (2) They were mostly in line with guideline recommended BP goals and 96% were aware of the elevated cardiovascular risk of hypertension, but 41% aimed to reduce BP to acceptable levels only. (3) Physicians indicated that in 41% of patients monotherapy controls BP and 71% would escalate to combination therapy after monotherapy failure. (4) 54% regard hypertension management as difficult. (5) Physicians estimated that between 60 and 70% of patients know their BP goal but thought that there was still room for improvement of hypertension management on the patient side., Conclusion: Although many effective treatment options for arterial hypertension exist, BP goal achievement worldwide is suboptimal, leaving patients at an unnecessary cardiovascular risk. An increase in patients' awareness and compliance together with an increased adherence of physicians to current guidelines should help in reducing the long term cardiovascular consequences of hypertension.

Background and Objective: Despite the fact that high BP is a leading risk factor for cardiovascular morbidity and mortality, BP goals are achieved in less than 10-30% of hypertensive patients. Irbesartan alone or in combination with hydrochlorothiazide has been shown to control BP in >70% of hypertensive patients in clinical trials. We set out to investigate the role in clinical practice of irbesartan in improving BP in uncontrolled hypertensive patients with a particular focus on patients with the metabolic syndrome through analysis of data from a post-marketing surveillance study., Methods: A multicentre, prospective, post-marketing surveillance study was conducted over 9 months in 14 200 patients aged > or =18 years with previously uncontrolled hypertension (either receiving therapy or newly diagnosed), paying particular attention to a subgroup of patients receiving irbesartan/hydrochlorothiazide as first-line combination therapy. BP was measured by a sphygmomanometer. The main outcome measures were systolic BP (SBP) and diastolic BP (DBP) reduction, response rate (DBP reduction of > or =10mm Hg or to <90 mm Hg), and BP normalisation (SBP <140 and DBP <90 mm Hg) in patients treated with irbesartan alone or in combination with hydrochlorothiazide. Analyses per patient subgroup, previous medication and whether treatment was initiated by the treating physician as first-line combination therapy were conducted. The number and nature of adverse events were documented., Results: Use of irbesartan 300 mg/day as monotherapy in previously uncontrolled patients resulted in a significant reduction in SBP/DBP (-26.8/-13.3mm Hg, p < 0.0001), which was comparable to the subgroup of patients with the metabolic syndrome (-26.3/-13.0mm Hg, p < 0.0001 vs baseline). Combination therapy (irbesartan 300 mg/hydrochlorothiazide 12.5mg once daily) lowered BP by -27.9/-14.2mm Hg (p < 0.0001) in previously uncontrolled patients; again the subgroup of patients with the metabolic syndrome achieved a comparable BP reduction (-27.5/-14.1mm Hg, p < 0.0001 vs baseline). Overall, no linear dose-response relationship was observed. Use of irbesartan/hydrochlorothiazide as first-line combination therapy was effective (BP normalisation rates between 65.7% and 78.6%) and safe. The mean number of antihypertensive tablets taken was reduced and after a mean period of 9 months, 92% of patients were still taking irbesartan therapy., Conclusion: The study demonstrates that treatment with an irbesartan-based regimen for 9 months results in a strong BP reduction and is feasible as first-line combination therapy. Similar BP reductions were observed in the subgroup of patients with the metabolic syndrome. Compliance with treatment is particularly good, with >90% of patients continuing with treatment after 9 months.

Objective: Obese patients often present with multiple co-morbid conditions, including hypertension, which are associated with an increased cardiovascular (CV) risk. We aimed to assess the risk factor profiles of primary-care patients with obesity and hypertension in order to estimate their fatal CV risk in total and according to use of various antihypertensive drugs., Methods: This was a post-hoc analysis of data from a recent observational study involving 72 479 hypertensive patients in 6989 general practices across Germany. Almost all patients (92.3%) were overweight or obese. The 10-year risk for fatal CV events was determined using the SCORE algorithm as published by the European Society of Cardiology., Results: Overall, 68% of patients had one or more diseases or conditions in addition to obesity and hypertension. The 10-year fatal CV risk was lowest in the youngest normal weight group (1.7%), and highest in the oldest obese group (26%). Men had a higher risk than women, and risk rose with increasing age. The risk factor profile appeared to differ between patients treated with various antihypertensive classes, e.g. angiotensin II type 1 receptor antagonists were associated with lower risk, diuretics with higher risk. There were moderate differences within drug classes., Conclusions: According to this cross-sectional data, fatal CV risk is strongly increased in obese patients, especially in men and in older age groups. While there were strong associations between use of certain drugs and metabolic risk markers and overall fatal CV risk, the causality of these associations remains to be determined.