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Biomedical subjects

Ettore Ambrosioni

Publications and source records attributed to Ettore Ambrosioni.

At least 19 recordsLinked to original sources

Effects of early angiotensin-converting enzyme inhibition in patients with non-ST-elevation acute anterior myocardial infarction.

BACKGROUND: No data are available on the clinical efficacy of the early administration (<24 hours from onset of chest pain) of angiotensin-converting enzyme inhibitors in non-thrombolysed patients with non-ST-elevation myocardial infarction (NSTEMI). We have addressed this issue in a subgroup of NSTEMI patients enrolled in the SMILE trial. METHODS: Of the overall population of 1556 patients, 526 (33.8%) had an anterior wall NSTEMI, defined as an ST elevation <1 mm or an ST depression in at least two contiguous precordial leads with or without new abnormal Q waves. No patient of the SMILE Study received thrombolytic therapy or was reperfused. Patients were randomized, double-blind, to zofenopril (n = 253) or placebo (n = 273) for 6 weeks. The primary end point was the effect of treatment on the 6-week combined occurrence of death and severe congestive heart failure (CHF). Secondary end points included the evaluation of the 6-week rate of severe CHF as well as the 1-year mortality rate. RESULTS: After 6 weeks of treatment, zofenopril significantly reduced both the incidence of the primary end point (risk reduction 65%, 95% CI 20-80, 2P = .003) and the 6-week incidence of severe CHF (84%, 95% CI 33-97, 2P = .006) in NSTEMI patients. One-year mortality was also significantly reduced by zofenopril treatment (43%, 95% CI 14-57, 2P = .036). CONCLUSIONS: Results of this post hoc analysis of the SMILE Study strongly suggest the benefit of the early administration of zofenopril even in patients with an anterior wall NSTEMI.

Aged↗

Hypertension prevalence, awareness, control and association with metabolic abnormalities in the San Marino population: the SMOOTH study.

BACKGROUND: The aim of the SMOOTH (San Marino Observational Outlooking Trial on Hypertension) study was to explore hypertension awareness, treatment and control and the associated metabolic abnormalities and risk factors in the population of San Marino, a small state in the Mediterranean area, for which limited evidence is available. METHODS: Nine general practitioners enrolled 4590 consecutive subjects (44% of the San Marino population age 40-75 years), seen in their office by collecting history, physical and laboratory data and office blood pressure (BP) measurements. RESULTS: Of these subjects, 2446 were normotensive and 2144 hypertensive; 62.3% of hypertensive patients were aware of their condition, 58.6% were treated (monotherapy 31.5%, combination therapy 27.1%), and 21.7% were controlled. Hypertension awareness and treatment were more frequent above age 50 and in females; BP control was similarly low in both genders. As compared to normotensives, hypertensive subjects were less frequently smokers (20.1 versus 27.8%), had greater body mass index (28.1 +/- 4.5 versus 25.8 +/- 3.7 g/m), and a higher prevalence of diabetes mellitus (15.8 versus 6.3%), lower high-density lipoprotein (HDL) cholesterol and higher prevalence of increased blood total cholesterol (66.1 versus 51.3%), triglycerides and serum uric acid. Values of subjects with 'high-normal' blood pressure were closer to those of hypertensive subjects. The prevalence of metabolic syndrome was higher in hypertensive than in normotensive subjects, and in treated than in untreated hypertensives. CONCLUSIONS: Even in a small Mediterranean country with high health-care standards, hypertension awareness, treatment and control are inadequate and hypertension clusters with metabolic abnormalities and risk factors as in non-Mediterranean areas.

Adult↗

Blood pressure control and risk of stroke in untreated and treated hypertensive patients screened from clinical practice: results of the ForLife study.

OBJECTIVES: Stroke has a high prevalence in Italy, and is the third cause of death worldwide. Hypertension is the most important risk factor contributing to the risk of stroke. The aims of this study were to assess the risk of stroke in a large cohort of hypertensive patients, and to determine the percentage with controlled blood pressure, to establish the contribution of this factor to the risk of stroke. METHODS: The study involved general practitioners to make it representative of clinical practice. They were asked to recruit 10 consecutive hypertensive patients, treated and untreated. Data collection included a full medical history and a physical examination. The 10-year absolute risk of stroke was calculated by an algorithm derived, with some modification, from the Framingham study. RESULTS: Most untreated hypertensive patients were grade 1 or 2. In treated hypertensive patients, controlled blood pressure values occurred in 18.4%, the percentage being less in patients with left ventricular hypertrophy and diabetes. In diabetic hypertensive patients the more stringent blood pressure control recommended by the guidelines was achieved in only 3.0% of cases. The average 10-year stroke risk was 17%, a greater risk being more common in elderly patients, diabetic individuals and in those with left ventricular hypertrophy. CONCLUSION: Current antihypertensive treatment achieved blood pressure control in a limited fraction of hypertensive patients seen by general practitioners. The risk of stroke in hypertensive patients is by no means negligible, which emphasizes the need for more attention to be paid to the prevention of this disease.

Aged↗

Trends in blood pressure control and antihypertensive treatment in clinical practice: the Brisighella Heart Study.

OBJECTIVES: To assess trends in blood pressure (BP) awareness, control, treatment and use of different antihypertensive medications in a cohort of hypertensive patients. DESIGN: This study summarizes the results of a 12-year observation (1984-1996) of a cohort of 940 hypertensive patients from the population of 2329 participants to the Brisighella Heart Study (BHS). Primary outcome measures were the extent of BP control (systolic/diastolic BP < 140/90 mmHg) and prevalence of the use of various antihypertensive medications. RESULTS: From 1984 to 1996 the proportion of patients aware of elevated BP and treated for hypertension rose from 73 to 88% and from 43.8 to 50.3% in men, and from 77 to 87% and from 50 to 56.6% in women (P < 0.001 for all). The rate of BP control increased from 7.5 to 17.4% in men (P < 0.001) and from 7.3 to 18.5% in women (P < 0.001). This occurred with increased use of combination therapy (+0.2 drugs/person) and with a decline in the use of diuretics (-38.2% men and -28% women; P < 0.001) and an increase in use of calcium-channel blockers (CCBs) (24.2% in men and 12.2% in women; P < 0.001) and angiotensin-converting enzyme (ACE) inhibitors (30.7% in men and 30.8% in women; P < 0.001) as first-line drugs. The improved BP control was associated with a lower rate of fatal and non-fatal cardiovascular (CV) events. CONCLUSIONS: The results of this observational study confirm that the rate of BP control can be improved in daily clinical practice by increasing the use of drug combinations, as well as by the first-line prescription of ACE inhibitors and CCBs [and probably angiotensin II receptor inhibitors (ARBs)].

Aged↗

A review of the angiotensin-converting enzyme inhibitor, zofenopril, in the treatment of cardiovascular diseases.

Based on preclinical and clinical findings, zofenopril appears to be an angiotensin-converting enzyme (ACE) inhibitor with high potency, significant tissue selectivity and a long duration of action. Its ancillary properties, such as antioxidant activity and cardiovascular (CV) protection, make this drug potentially suitable for the treatment, and possibly prevention, of several CV diseases. There is a large body of evidence that support a complex interaction between ACE inhibitors and CV disease. A review of the preclinical profile of zofenopril clearly suggest that such interaction can be even more complex and could involve some drug-specific properties directly involved in the definition of the overall clinical profile of zofenopril as emerged from randomised clinical trials. In particular, zofenopril combines the feature of an effective ACE inhibitor, with plasma and tissue activity, along with that of an antioxidant compound, and both these characteristics can contribute to its capacity of controlling hypertension and improving the prognosis of patients with coronary artery disease. The results of The Survival of Myocardial Infarction Long term Evaluation (SMILE) trials have demonstrated that the early administration of zofenopril to patients with acute myocardial infarction is associated with a significant reduction in the 6-week occurrence of major CV events (death and congestive heart failure) in high-risk patients with anterior non-thrombolysed myocardial infarction, and this effect is enhanced in some higher-risk subgroups of patients, such as those with a history of diabetes or arterial hypertension.

Angiotensin-Converting Enzyme Inhibitors↗

Double-blind comparison between zofenopril and lisinopril in patients with acute myocardial infarction: results of the Survival of Myocardial Infarction Long-term Evaluation-2 (SMILE-2) study.

BACKGROUND: Angiotensin-converting enzyme (ACE) inhibitors have been reported to be effective in placebo-controlled trials in various subsets of patients with acute myocardial infarction (MI). However, no direct comparisons have been performed between different ACE inhibitors in the same patient population. METHODS: This phase III, double-blind, parallel-group, multicenter study compared the safety and efficacy of zofenopril and lisinopril in 1024 thrombolyzed patients with acute MI. Patients, aged 18 to 75 years, were randomized to receive oral zofenopril (30-60 mg/day) or lisinopril (5-10 mg/day), starting within 12 hours of completion of thrombolytic therapy and continuing for 42 days. The primary study end point was the incidence of severe hypotension (systolic blood pressure <90 mm Hg), either cumulative or drug-related. Secondary end points included additional safety and efficacy parameters. RESULTS: The overall incidence of severe hypotension was slightly 5 more reduced with zofenopril (10.9%) than with lisinopril (11.7%, P =.38). The incidence of drug-related severe hypotension was slightly but significantly lower with zofenopril than with lisinopril (6.7 vs 9.8%, 2-tailed P =.048). The 6-week mortality rate was 3.2% in the zofenopril group and 4.0% in the lisinopril group (P =.38), and no significant differences were observed in the incidence of major cardiovascular complications or any safety variables between the 2 ACE inhibitors. CONCLUSIONS: The SMILE-2 study demonstrates that both zofenopril and lisinopril are safe and associated with a rather low rate of severe hypotension when given in accordance with a dose-titrated scheme to thrombolyzed patients with acute MI. These findings could have a positive clinical impact and increase the proportion of patients with acute MI who can be safely treated with ACE inhibitors.

Adolescent↗

Improved tolerability of the dihydropyridine calcium-channel antagonist lercanidipine: the lercanidipine challenge trial.

The objective of this 8-week open-label study was to compare the tolerability of lercanidipine, a dihydropyridine calcium-channel antagonist (CA), with that of other CAs in the treatment of hypertension. Subjects already taking amlodipine, felodipine, nifedipine gastrointestinal therapeutic system (GITS), or nitrendipine and experiencing CA-specific adverse effects (AEs) were switched to lercanidipine for 4 weeks and then rechallenged with their initial treatment for 4 weeks. Results showed that at comparable levels of BP, lercanidipine was associated with a significantly lower incidence of ankle edema, flushing, rash, headache and dizziness compared with other CAs (p < 0.001). After 4 weeks of lercanidipine, mean systolic blood pressure (SBP)/diastolic blood pressure (DBP) was 142.1/86.7 mmHg. After rechallenge with other CAs for 4 weeks, mean SBP/DBP was 141.1/86.7 mmHg. In this open-label study, lercanidipine compared with other CA seems to provide a significant improvement in tolerability with comparable antihypertensive effect.

Aged↗

European guidelines on cardiovascular disease prevention in clinical practice: third joint task force of European and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of eight societies and by invited experts).

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.

Adult↗

Effects of the early ACE inhibition in diabetic nonthrombolyzed patients with anterior acute myocardial infarction.

OBJECTIVE: The aim of the present study was to evaluate the clinical efficacy of the ACE inhibitor zofenopril in a cohort of diabetic patients with nonthrombolyzed anterior acute myocardial infarction who were enrolled in the Survival of Myocardial Infarction Long-Term Evaluation (SMILE) trial. RESEARCH DESIGN AND METHODS: Among the overall population of 1,512 patients, 303 (20.0%) had diabetes. The primary end point of this study was the effect of treatment on the 6-week combined occurrence of death and severe congestive heart failure (CHF). Secondary end points included the evaluation of the 6-week rate of major cardiovascular events as well as the 1-year survival rate. RESULTS: After 6 weeks of double-blind treatment, zofenopril significantly reduced both the incidence of the primary end point (8.6 vs. 18.3%; P = 0.019) and the 6-week incidence of severe CHF (0 vs. 7.3%; P = 0.001) in diabetic patients, and the effect was greater than that observed in nondiabetic patients. Conversely, 1-year mortality was significantly reduced among nondiabetic patients (9.1 vs. 13.8%; P = 0.010), whereas in the diabetic population, the decrease did not reach statistical significance (13.7 vs. 16.5%; P = 0.52). CONCLUSIONS: The present data suggest that the clinical outcome of patients with diabetes and myocardial infarction can be significantly improved by early treatment with zofenopril. The lesser effect on 1-year mortality seems to suggest that long-term treatment is probably needed to maintain the benefits of the early ACE inhibition in patients with diabetes.

Aged↗

Clinical role of Natrilix SR in the treatment of at-risk hypertensive patients.

Although recent trials have shown that antihypertensive treatment can bring about a reduction in stroke, coronary heart disease, heart failure and renal disease, the situation is no longer improving. This is due to the fact that the percentage of hypertensive patients with satisfactory blood pressure is still very poor. International guidelines on hypertension indicate the importance of assessing the absolute risk of patients and the use of a lower dose of drugs to improve the efficacy-tolerability profile. Diuretics used at lower dosage than in the past are effective in reducing morbidity and mortality and continue to be drugs of first choice in the treatment of hypertension. Indapamide sustained release (Natrilix SR) 1.5 mg has an antihypertensive effect equivalent to indapamide immediate release 2.5 mg with a 50% reduction in incidence of serum potassium levels <3.4 mmol/l. Natrilix SR has proved to have a neutral effect both on lipid and glucose profiles and to reduce microalbuminuria in diabetic hypertensive patients. Recent multicentre European clinical trials have shown that Natrilix SR decreases diastolic blood pressure to <90 mmHg in about 75% of patients treated for 1 year. In elderly patients with isolated systolic hypertension, Natrilix SR has been proven to be as effective as amlodipine 5 mg and significantly more effective than hydrochlorothiazide 25 mg. Natrilix SR produces regression of left ventricular hypertrophy which, in the Left ventricular hypertrophy: Indapamide Versus Enalapril study was greater than that induced by enalapril. Natrilix SR represents an appropriate choice not only as a first-line drug in many hypertensive patients but also in at-risk patients like the elderly, subjects with other cardiovascular risk factors, target organ damage, diabetes, or impaired renal function.

Delayed-Action Preparations↗

Do ACE inhibitors or angiotensin II antagonists reduce total mortality and arrhythmic mortality? A critical review of controlled clinical trials.

ACE-inhibitors (ACE-I) represent effective drugs more and more widely used in acute myocardial infarction (AMI) patients, in post AMI patients and mainly, today, in CHF patients.A complete review of the scientific literature and of all the randomized controlled clinical trials (RCTs), where ACE-I have been tested directly or in association with other drugs, have been performed. ACE-I effects on total mortality (TM) and arrhythmic mortality (AM) and other composite clinical endpoints have been evaluated. It is well known that frequent ventricular arrhythmias (VA) and a high incidence of sudden death (SD) can be documented in CHF patients; nevertheless a direct relationship between VA, TM, and AM has not been clearly demonstrated; neither beneficial effects, on the same endpoints, of the treatment and suppression of ambient VA in CHF. Conversely, sometimes clear negative effects on both TM and AM have been observed. According to individual studies and two recent complete and large metanalysis, ACE-I were unable to reduce AM, but they reduced TM. Furthermore, they can affect and modify many, if not all, of the triggering factors of VA and SD in this context. Differently from ACE-I, betablockers (BB) have been clearly associated with a reduction in TM and AM, in the same context. Thus, at present time, ACE-I, with or without BB, should be considered the standard therapy in all patients with CHF, if not contraindicated. Angiotensin II antagonists (AII-a) probably represent a comparably effective treatment, in all CHF patients and mainly in those patients, suffering from side effects or showing intolerance to ACE-I, but we are still lacking definitive data from RCTs. In many RCTs, conducted with traditional antiarrhythmic drug therapy (ADT), these drugs have been widely used, contributing probably, in a consistent way, to some of the positive results of these studies. All primary and some secondary implantable defibrillators (ICD) RCTs, in the prevention of SD, have included these drugs as the standard treatment of the underlying cardiac disease, with or without CHF. The same therapeutical strategy is regularly applied in all biventricular pacing (BP) RCTs, with or without the ICD. These trials are supposed to assess the reduction in TM and AM, preventing deterioration or progression of CHF and improving the quality of the patients' s life.Finally, according to these clinical evidences, in the last part of the review, we stress the need for a more widespread implementation of ACE-I and AII-a in treating CHF patients.

Adrenergic beta-Antagonists↗

Role of echocardiography and carotid ultrasonography in stratifying risk in patients with essential hypertension: the Assessment of Prognostic Risk Observational Survey.

BACKGROUND: Echocardiography and carotid ultrasonography, by providing a more accurate assessment of cardiac and vascular damage related to hypertension, may lead to a more precise stratification of the global cardiovascular risk. However, current guidelines do not recommend systematic use of ultrasound examination of heart and large arteries in evaluating the cardiovascular risk in patients with hypertension. OBJECTIVE: To assess the impact of echocardiography and carotid ultrasonography on global risk stratification in hypertensive patients classified as being at low or medium risk according to routine clinical work-up as suggested by current hypertension guidelines. METHODS: Among 8502 consecutive patients screened at 44 outpatient hypertension hospital clinics in different parts of Italy, 1074 untreated individuals with low-to-medium risk essential hypertension were identified on the basis of the diagnostic routine procedures suggested by 1999 World Health Organization/International Society of Hypertension guidelines: medical history, physical examination and clinic blood pressure measurement; routine blood chemistry and urine analysis; electrocardiogram. The extent of risk for the 1074 individuals was reassessed by adding the results of ultrasound examinations of heart and carotid arteries: left ventricular hypertrophy (defined as left ventricular mass index > 120 g/m(2) in men and > 100 g/m(2) in women), carotid intima-media thickening (defined as diffuse thickening if >or= 0.8 mm), and presence of plaque (defined as focal thickening > 1.3 mm). RESULTS: According to routine classification, 18.7% (n = 201) of the 1074 patients were considered at low risk and 81.3% (n = 873) at medium risk. A marked change in risk stratification was obtained when ultrasound markers of target-organ damage were taken into consideration: the proportion of low-risk patients decreased to 11.1%, and that of medium risk patients to 35.7%, whereas more than 50% of the patients previously classified at low-medium risk were found to be at high absolute risk. According to a multivariate analysis, age, grade of hypertension, male sex, and serum cholesterol concentration were the variables with the greatest impact on risk class change. CONCLUSIONS: Ultrasound assessment of the heart and carotid wall helps to obtain a more valid assessment of global cardiovascular risk in hypertensive patients without evidence of target-organ damage after routine examination.

Adult↗