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Effects of early treatment with zofenopril in patients with myocardial infarction and metabolic syndrome: the SMILE Study
Full text linkTo evaluate the clinical efficacy of the early administration of zofenopril in a group of patients with and without metabolic syndrome (MS+ and MS-) and anterior myocardial infarction enrolled in the Survival of Myocardial Infarction Long-Term Evaluation (SMILE) Study
Zofenopril and ramipril in patients with left ventricular systolic dysfunction after acute myocardial infarction: A propensity analysis of the Survival of Myocardial Infarction Long-term Evaluation (SMILE) 4 study
Full text linkIntroduction: This was a propensity score analysis of the prospective, randomized, double-blind Survival of Myocardial Infarction Long-term Evaluation (SMILE) 4 study in which one-year treatment with zofenopril 60 mg plus acetylsalicylic acid (ASA) 100 mg gave superior results compared to ramipril 10 mg plus ASA in terms of death or hospitalization for cardiovascular causes in patients with acute myocardial infarction (AMI) complicated by left ventricular dysfunction (LVD). Materials and methods: A total of 716 patients of the intention-to-treat population were divided into homogeneous propensity quintiles (Q) using a logistic regression model (QI: best risk profile; QV: worst risk profile). Results: Treatment was associated with a similar low rate of major cardiovascular events in any Q. However, the efficacy of zofenopril was better than that of ramipril in QII, QV, and particularly QIII (odds ratio (OR) and 95% confidence interval: 0.43 (0.21-0.87), p<0.05]. This result was primarily attributed to a decrease in the risk of cardiovascular hospitalization, particularly striking in the QIII (OR: 0.40, 0.19-0.85; p<0.05). Mortality rate did not significantly differ between the two treatments in any Q. Conclusions: In the SMILE-4 study the propensity analysis confirmed the efficacy of zofenopril in the prevention of longterm cardiovascular outcomes irrespective of the cardiovascular risk profile of post-AMI patients
Cardioprotective role of zofenopril in patients with acute myocardial infarction: a pooled individual data analysis of four randomised, double-blind, controlled, prospective studies
No full textEarly administration of zofenopril following acute myocardial infarction (AMI) proved to be prognostically beneficial in the four individual randomised, double-blind, parallel-group, prospective SMILE (Survival of Myocardial Infarction Long-term Evaluation) studies. In the present analysis, we evaluated the cumulative efficacy of zofenopril by pooling individual data from the four SMILE studies
Efficacy of zofenopril in combination with thiazide diuretics in patients with acute myocardial infarction: A pooled individual data analysis of four randomized, double-blind, controlled, prospective studies
No full textBackground: In the Survival of Myocardial Infarction Long-Term Evaluation (SMILE) studies, early administration of zofenopril after acute myocardial infarction (AMI) was prognostically beneficial as compared to placebo and other angiotensin-converting enzyme inhibitors (ACEIs), such as lisinopril and ramipril. Here, we investigated whether zofenopril efficacy could be affected by a concomitant use of thiazide diuretics (TDs). Methods: This was a post hoc analysis of pooled individual patient data from the SMILE studies. Patients treated with other diuretics than TDs were excluded. The primary study endpoint was the 1-year combined occurrence of death or hospitalization for CV causes, with or without TD. Results: Among 2,995 patients, 263 (8.8%) were treated with a combination including a TD (TD+), whereas 2,732 (91.2%) were not treated with any diuretic (TD-). Proportions of subjects who were treated with TD were equally distributed (p=0.774) within the placebo, zofenopril, and other ACEIs groups. The 1-year risk of major cardiovascular events was similar in TD+ (18.3%) and TD-(16.8%) patients (hazard ratio [HR] 1.04; 95% CI 0.74–1.45; p=0.838). After stratifying per concomitant treatment and TD, the 1-year risk of CV events was significantly lower with zofenopril than with placebo (HR 0.70; 95% CI 0.55–0.88; p=0.002) and other ACEIs (HR 0.58; 95% CI 0.46–0.74; p=0.0001). Treatment with ACEIs and TD as concomitant therapy was associated with a larger blood pressure (BP) reduction (p=0.0001 for systolic BP and p=0.045 for diastolic BP). Conclusion: In post AMI patients, zofenopril maintained its positive impact on prognosis compared to placebo or other ACEIs, regardless concomitant TD administration. In this setting, TD shows advantages in managing the most difficult hypertensive patients
Trends in blood pressure control and antihypertensive treatment in clinical practice: the Brisighella Heart Study
No full textOBJECTIVES:
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)]
Early Treatment with Zofenopril and Ramipril in Combination with Acetyl Salicylic Acid in Patients with Left Ventricular Systolic Dysfunction after Acute Myocardial Infarction: Results of a 5-Year Follow-up of Patients of the SMILE-4 Study
No full textThe SMILE-4 study showed that in patients with left ventricular dysfunction (LVD) after acute myocardial infarction, early treatment with zofenopril plus acetyl salicylic acid is associated with an improved 1-year survival, free from death or hospitalization for cardiovascular (CV) causes, as compared to ramipril plus acetyl salicylic acid. We now report CV outcomes during a 5-year follow-up of the patients of the SMILE-4 study. Three hundred eighty-six of the 518 patients completing the study (51.2%) could be tracked after the study end and 265 could be included in the analysis. During the 5.5 (±2.1) years of follow-up, the primary endpoint occurred in 27.8% of patients originally randomized and treated with zofenopril and in 43.8% of patients treated with ramipril [odds ratio (OR) and 95% confidence interval, 0.65 (0.43-0.98), P = 0.041]. Such a result was achieved through a significantly larger reduction in CV hospitalization under zofenopril [OR: 0.61 (0.37-0.99), P = 0.047], whereas reduction in mortality rate with zofenopril did not achieve statistical significance versus ramipril [OR: 0.75 (0.36-1.59), P = 0.459]. These results were in line with those achieved during the initial 1-year follow-up. Benefits of early treatment of patients with LVD after acute myocardial infarction with zofenopril are sustained over many years as compared to ramipril
Efficacy of Zofenopril Compared with Placebo and Other Angiotensin-converting Enzyme Inhibitors in Patients with Acute Myocardial Infarction and Previous Cardiovascular Risk Factors: A Pooled Individual Data Analysis of 4 Randomized, Double-blind, Controlled, Prospective Studies
No full textIn the Survival of Myocardial Infarction Long-term Evaluation (SMILE) 1, 3, and 4 studies, early administration of zofenopril in acute myocardial infarction showed to be prognostically beneficial versus placebo or ramipril. The SMILE-2 showed that both zofenopril and lisinopril are safe and showed no significant differences in the incidence of major cardiovascular (CV) complications. In this pooled analysis of individual data of the SMILE studies, we evaluated whether the superior efficacy of zofenopril is maintained also in patients with 1 CV risk factor (CV+, n = 2962) as compared to CV2 (n = 668). The primary study end point was set to 1-year combined occurrence of death or hospitalization for CV causes. The risk of CV events was significantly reduced with zofenopril versus placebo either in the CV+ (237%; hazard ratio: 0.63; 95% confidence interval: 0.51-0.78; P = 0.0001) or in the CV2 group (255%; hazard ratio: 0.45; 0.26-0.78; P = 0.004). Also, the other angiotensinconverting enzyme inhibitors reduced the risk of major CV outcomes, though the reduction was not statistically significant versus placebo (CV+: 0.78; 0.58-1.05; P = 0.107; CV2: 0.71; 0.36-1.41; P = 0.334). The benefit was larger in patients treated with zofenopril than other angiotensin-converting enzyme inhibitors, with a statistically significant difference for CV+ (0.79; 0.63-0.99; P = 0.039) versus CV2 (0.62; 0.37-1.06; P = 0.081). In conclusion, zofenopril administered to patients after acute myocardial infarction has a positive impact on prognosis, regardless of the patient's CV risk profile
Efficacy and Safety of Zofenopril Versus Ramipril in the Treatment of Myocardial Infarction and Heart Failure: A Review of the Published and Unpublished Data of the Randomized Double-Blind SMILE-4 Study
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