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Objective: In the four SMILE (Survival of Myocardial Infarction Long-Term Evaluation) studies, early administration of zofenopril in acute myocardial infarction (AMI) showed beneficial effects as compared to placebo and other angiotensin converting enzyme inhibitors (ACEIs). This study investigated whether the concomitant administration of the dihydropyridine calcium channel-blocker amlodipine may improve zofenopril efficacy to prevent cardiovascular events in post-AMI patients. Methods: This was a post-hoc analysis of pooled individual patient data from the four large randomized SMILE studies. The primary endpoint was the 1-year combined occurrence of death or hospitalization for cardiovascular causes. Results: In total, 3488 patients were considered, 303 (8.7%) treated with concomitant amlodipine. Baseline systolic blood pressure and prevalence of metabolic syndrome were higher in amlodipine treated patients. The 1-year occurrence of major cardiovascular outcomes was significantly reduced in patients receiving concomitant treatment with amlodipine (hazard ratio, HR = 0.66; and 95% confidence interval, CI = 0.44-0.98; p = .039). After accounting for treatment with amlodipine, the risk of cardiovascular events was significantly reduced with zofenopril compared to placebo (HR = 0.78; 95% CI = 0.63-0.97; p = .026]. Among ACEI-treated patients, the zofenopril plus amlodipine combination reduced the risk of cardiovascular events by 38%, compared to the combination of other ACEIs plus amlodipine [HR = 0.76; 95% CI = 0.61-0.94); p = .013). The prognostic benefit of concomitant treatment with zofenopril plus amlodipine was independent from blood pressure lowering. Conclusions: Zofenopril had a positive impact on prognosis in post-AMI patients, compared to other ACEIs. Concomitant administration of amlodipine may help to reduce the risk of cardiovascular events at 1 year.

Observational clinical studies have demonstrated that only 30-40 % of patients with arterial hypertension achieve the recommended blood pressure goals (below 140/90 mmHg). In contrast, interventional trials consistently showed that it is possible to achieve effective blood pressure targets in about 70 % of treated hypertensive patients with different cardiovascular risk profiles, especially through the use of rational, effective and well tolerated combination therapies. In order to bridge the gap between current and desired blood pressure control and to achieve more effective prevention of cardiovascular diseases, the Italian Society of Hypertension (SIIA) has developed an interventional strategy aimed at reaching nearly 70 % of treated controlled hypertensive patients by 2015. This ambitious goal can be realistically achieved by a more rational use of modern tools and supports, and also through the use of combination therapy in hypertension in daily clinical practice, especially if this approach can be simplified into a single pill (fixed combination therapy), which is a therapeutic option now also available in Italy. Since about 70-80 % of treated hypertensive patients require a combination therapy based on at least two classes of drugs in order to achieve the recommended blood pressure goals, it is of key importance to implement this strategy in routine clinical practice. Amongst the various combination therapies currently available for hypertension treatment and control, the use of those strategies based on drugs that antagonize the renin-angiotensin system, such as angiotensin II type 1 receptor antagonists (angiotensin receptor blockers) and ACE inhibitors, in combination with diuretics and/or calcium channel blockers, has been shown to significantly reduce the risk of major cardiovascular events and to improve patient compliance to treatment, resulting in a greater antihypertensive efficacy and better tolerability compared with monotherapy. The present document of the Italian Society of Arterial Hypertension (SIIA) aims to gather the main indications for the implementation of combination therapy in the treatment of hypertension, in order to improve blood pressure control in Italy. © 2013 Springer International Publishing Switzerland.

Background: Angiotensin-converting enzyme inhibitors (ACEIs) are largely employed for treating patients with left ventricular dysfunction (LVD), but their efficacy may be negatively affected by concomitant administration of acetylsalicylic acid (ASA), with some difference among the different compounds. Hypothesis: The interaction between ASA and the two ACEIs zofenopril and ramipril may result in a different impact on survival of cardiac patients, due to differences in the pharmacological properties of the two ACEIs. Methods: This phase IIIb, randomized, double-blind, parallel-group, multicenter, European study compared the safety and efficacy of zofenopril (60 mg/day) and ramipril (10 mg/day) plus ASA (100 mg/day), in 771 patients with LVD (clinical signs of heart failure or a left ventricular ejection fraction

Importanza della farmacoeconomia nella valutazione della terapia antiipertensiva: i metodi per la valutazione economica, i costi della malattia ed i contributi dei della terapia farmacologica.

Hypertension is responsible for a relevant burden of cardiovascular morbidity and mortality worldwide. Although several appropriate and integrated pharmacological strategies are available, blood pressure control still remains largely unsatisfactory. Failure to achieve effective blood pressure control in treated hypertensive patients may have a substantial impact on overall cardiovascular risk, since it significantly increases the risk of both macrovascular and microvascular complications. Hypertension is arbitrarily defined as "resistant" or "refractory" when recommended blood pressure goals (clinic blood pressure

Guidelines aim to present all the relevant evidence on a particular issue in order to help physicians to weigh the benefits and risks of a particular diagnostic or therapeutic procedure. They should be helpful in everyday clinical decision-making. A great number of guidelines have been issued in recent years by different organisations--European Society of Cardiology (ESC), American Heart Association (AHA), American College of Cardiology (ACC), and other related societies. By means of links to web sites of National Societies several hundred guidelines are available. This profusion can put at stake the authority and validity of guidelines, which can only be guaranteed if they have been developed by an unquestionable decision-making process. This is one of the reasons why the ESC and others have issued recommendations for formulating and issuing guidelines. In spite of the fact that standards for issuing good quality guidelines are well defined, recent surveys of guidelines published in peer-reviewed journals between 1985 and 1998 have shown that methodological standards were not complied with in the vast majority of cases. It is therefore of great importance that guidelines and recommendations are presented in formats that are easily interpreted. Subsequently, their implementation programmes must also be well conducted. Attempts have been made to determine whether guidelines improve the quality of clinical practice and the utilisation of health resources. In addition, the legal implications of medical guidelines have been discussed and examined, resulting in position documents, which have been published by a specific task force. The ESC Committee for practice guidelines (CPG) supervises and coordinates the preparation of new guidelines and expert consensus documents produced by task forces, expert groups or consensus panels. The Committee is also responsible for the endorsement of these guidelines or statements.

Background—Nonadherence to antihypertensive treatment is a common problem in cardiovascular prevention and may influence prognosis. We explored predictors of adherence to antihypertensive treatment and the association of adherence with acute cardiovascular events. Methods and Results—Using data obtained from 400 Italian primary care physicians providing information to the Health Search/Thales Database, we selected 18 806 newly diagnosed hypertensive patients 35 years of age during the years 2000 to 2001. Subjects included were newly treated for hypertension and initially free of cardiovascular diseases. Patient adherence was subdivided a priori into 3 categories— high (proportion of days covered, 80%), intermediate (proportion of days covered, 40% to 79%), and low (proportion of days covered, 40%)—and compared with the long-term occurrence of acute cardiovascular events through the use of multivariable models adjusted for demographic factors, comorbidities, and concomitant drug use. At baseline (ie, 6 months after index diagnosis), 8.1%, 40.5%, and 51.4% of patients were classified as having high, intermediate, and low adherence levels, respectively. Multiple drug treatment (odds ratio, 1.62; 95% CI, 1.43 to 1.83), dyslipidemia (odds ratio, 1.52; 95% CI, 1.24 to 1.87), diabetes mellitus (odds ratio, 1.40; 95% CI, 1.15 to 1.71), obesity (odds ratio, 1.50; 95% CI, 1.26 to 1.78), and antihypertensive combination therapy (odds ratio, 1.29; 95% CI, 1.15 to 1.45) were significantly (P0.001) associated with high adherence to antihypertensive treatment. Compared with their low-adherence counterparts, only high adherers reported a significantly decreased risk of acute cardiovascular events (hazard ratio, 0.62; 95% CI, 0.40 to 0.96; P0.032). Conclusions—The long-term reduction of acute cardiovascular events associated with high adherence to antihypertensive treatment underscores its importance in assessments of the beneficial effects of evidence-based therapies in the population. An effort focused on early antihypertensive treatment initiation and adherence is likely to provide major benefits. (Circulation. 2009;120:1598-1605.)

Background and purpose Hypertension is known to be highly prevalent among patients with diabetes and associated with an increased risk of cardiovascular damage. In contrast, relatively few investigations have addressed the prevalence of diabetes among patients with hypertension. The purpose of the present study was to examine the prevalence of type 2 diabetes, the effectiveness of hypertension and diabetes control and the association with other cardiovascular risk factors and previous cardiovascular diseases in a cohort of patients with hypertension referred to 30 hospital outpatient clinics for the treatment of hypertension. Methods and patients Patients were considered as having diabetes if they were already on an antidiabetic treatment either with diet or medications. All other patients had fasting plasma glucose measured on two separate occasions and were classified as having diabetes if both values were at least 140 mg/dl (7.8 mmol/l) and as not having diabetes if both values were less than 110 mg/dl (6.1 mmol/l). In patients with a single determination of at least 110 mg/dl, the final diagnosis of diabetes was established according to the result of an oral glucose tolerance test. A secondary definition of diabetes was also used, that is two fasting plasma glucose values of at least 126 mg/dl (7.0 mmol/l). In all patients, serum total, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol, fasting serum triglycerides, serum creatinine and urinary albumin were also evaluated. Results and conclusion Among the 1397 recruited patients, 242 (17.3%) were diagnosed as having diabetes according to the primary definition and 244 (17.5%) according to the secondary definition. In 195 out of the 242 (14%), the diagnosis was already known whereas, in the remaining 47 (3.3%), it was made de novo. In 61.4% of those already having diabetes, plasma glucose was at least 140 mg/dl (7.8 mmol/l), whereas only in 8.4% of them was it less than 110 mg/dl (6.1 mmol/l). Patients with diabetes were older, heavier and with a greater familiar predisposition. Patients with diabetes had higher values of systolic blood pressure than individuals without diabetes (150W17 vs. 144W16mmHg, respectively; P

BACKGROUND: A number of patients with chronic heart failure (CHF) have diastolic but not systolic dysfunction. This occurs particularly in the elderly and in hypertension, but the prevalence of diastolic dysfunction in elderly hypertensives without CHF has never been investigated systematically. METHODS AND RESULTS: The Assessment of PRevalence Observational Study of Diastolic Dysfunction (APROS-diadys) project was a cross-sectional observational study on elderly (age >/= 65 years) hypertensives without systolic dysfunction [left ventricular ejection fraction (LVEF) >/= 45%] consecutively attending hospital outpatient clinics in Italy, in order to establish the prevalence of echocardiographic signs of diastolic dysfunction according to various criteria, and to correlate them with a number of demographic and clinical characteristics. Primary criteria for diastolic dysfunction was an E/A ratio (ratio between transmitral peak velocities of E and A waves) < 0.7 or > 1.5 on echocardiographic Doppler examination. Secondary criteria were: E/A < 0.5 and deceleration time (DT) > 280 ms, or isovolumic relaxation time (IVRT) > 105 ms or pulmonary vein (PV) peak systolic/peak diastolic flow (S/D) ratio > 2.5 or PV atrial retrograde flow (PV A) > 35 cm/s. Throughout Italy, 27 447 patients were screened in 107 clinics, with 24 141 excluded according to protocol. Among the remaining 3336 patients, 754 (22.6%) had signs of CHF. After exclusion of 37 protocol violators, 2545 patients (49.0% men, mean age 70.3 years, 95.4% under antihypertensive treatment) were studied ultrasonographically. Diastolic dysfunction (primary criteria) was found in 649 (25.8%) patients. Multiple logistic regression analysis found age, gender, left ventricular mass, systolic and pulse pressures and midwall shortening fraction as significant covariates. Using secondary criteria, the prevalence of diastolic dysfunction was higher (45.6%), mostly because of IVRT > 105 ms or PVA flow > 35 cm/s. CONCLUSION: CHF and diastolic dysfunction are highly prevalent in elderly hypertensives attending hospital

For several years the European Society of Hypertension (ESH) and the European Society of Cardiology (ESC) decided not to produce their own guidelines on the diagnosis and treatment of hypertension but to endorse the guidelines on hypertension issued by the World Health Organization (WHO) and International Society of Hypertension (ISH)1,2 with some adaptation to reflect the situation in Europe. However, in 2003 the decision was taken to publish ESH/ESC specific guidelines3 based on the fact that, because the WHO/ISH Guidelines address countries widely varying in the extent of their health care and availability of economic resource, they contain diagnostic and therapeutic recommendations that may be not totally appropriate for European countries. In Europe care provisions may often allow a more in-depth diagnostic assessment of cardiovascular risk and organ damage of hypertensive individuals as well as a wider choice of antihypertensive treatment. The 2003 ESH/ESC Guidelines3 were well received by the clinical world and have been the most widely quoted paper in the medical literature in the last two years.4 However, since 2003 considerable additional evidence on important issues related to diagnostic and treatment approaches to hypertension has become available and therefore updating of the previous guidelines has been found advisable. In preparing the new guidelines the Committee established by the ESH and ESC has agreed to adhere to the principles informing the 2003 Guidelines, namely 1) to try to offer the best available and most balanced recommendation to all health care providers involved in the management of hypertension, 2) to address this aim again by an extensive and critical review of the data accompanied by a series of boxes where specific recommendations are given, as well as by a concise set of practice recommendations to be published soon thereafter as already done in 2003; …

BACKGROUND: No data are available on the clinical efficacy of the early administration (

In Monte Carlo a Round Table focused on topics of great clinical-practical interest related to the treatment of arterial hypertension was held last January, in the light of the 2003 European Society of Hypertension European Society of Cardiology Guidelines for the Management of Arterial Hypertension. During this scientific event, attended by number of opinion leaders belonging to different specialities, the main topics discussed were: 1) diagnostic procedures for subclinical target-organ damage evaluation, 2) intervention strategies in diabetic hypertensives with and without cardiovascular complications, 3) the diabetes-inducing effect of the "traditional" anti -hypertensive medications, 4) the problem of insufficient blood pressure control in the daily clinical practice.

The impact of hypertension on left ventricular (LV) and vascular structure and the relation of left ventricular hypertrophy (LVH) with vascular changes in untreated essential hypertensives has not been fully explored. This study investigated the prevalence of structural abnormalities of LV and carotid arteries and their determinants in a large population of untreated, uncomplicated essential hypertensive patients. The Assessment of Prognostic Risk Observational Survey was a multicentre (44 centres) prospective study including 1142 untreated hypertensives classified as low or medium cardiovascular risk on the basis of the routine diagnostic work-up recommended by the 1999 World Health Organization/International Society of Hypertension guidelines. All patients underwent ultrasound examinations of the heart and carotid arteries. LVH and carotid structural changes were diagnosed when: (1) LV mass index exceeded 125 g/m(2) in men and 110 g/m2 in women; (2) there was at least one plaque (focal thickening >41.3 mm) in any segment of either carotid artery or a diffuse common carotid intima media thickness (IMT) (average of IMT greater than or equal to0.8 mm) was present. Overall, 1074 patients (504 women, mean age 48.1+/-11.4 years) completed the study with ultrasonographic examinations of good technical quality. The prevalences of LVH and LV concentric remodelling in the total population were 26.8 and 10.7%, respectively. Eccentric hypertrophy was more prevalent than concentric hypertrophy (15.2 vs 11.6%). One or more carotid plaques or thickening were present in 27.4% of the patients. A stepwise increase in IM thickness occurred from the lowest values in patients with normal cardiac mass and geometry (0.68 mm) to intermediate in those with LV remodelling (0.76 mm) and eccentric LVH (0.81 mm) and to the highest level in patients with concentric LVH (0.87 mm). Patients with LV concentric remodelling and concentric LVH had a significantly greater relative carotid wall thickness than those with normal geometry and eccentric LVH (0.25 and 0.26 vs 0.18 and 0.19, respectively, P