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Alejandro Macchia,
Hugo Grancelli,
Sergio Varini,
Daniel Nul,
Nicolás Laffaye,
Javier Mariani,
Daniel Ferrante,
Raúl Badra,
Julio Figal,
Silvina Ramos,
Gianni Tognoni,
Hernán C Doval
Journal of the American College of Cardiology 04/2013; · 14.16 Impact Factor
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Journal of the American College of Cardiology 03/2013; · 14.16 Impact Factor
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ABSTRACT: Previous studies have suggested that n-3 polyunsaturated fatty acids (n-3 PUFAs) have antiarrhythmic effects on atrial fibrillation (AF). We aimed to assess the effects of therapy with n-3 PUFAs on the incidence of recurrent AF and on postoperative AF.
Electronic searches were conducted in Web of Science, Medline, Biological Abstracts, Journal Citation Reports, and the Cochrane Central Register of Controlled Trials databases. In addition, data from the recently completed FORωARD and OPERA trials were included. We included randomized controlled trials comparing treatment with n-3 PUFAs versus control to (1) prevent recurrent AF in patients who underwent reversion of AF or (2) prevent incident postoperative AF after cardiac surgery. Of identified studies, 12.9% (16 of 124) were included, providing data on 4677 patients. Eight studies (1990 patients) evaluated n-3 PUFA effects on AF recurrence among patients with reverted AF and 8 trials (2687 patients) on postoperative AF. Pooled risk ratios through random-effects models showed no significant effects on AF recurrence (RR, 0.95; 95% CI, 0.79 to 1.13; I(2), 72%) or on postoperative AF (0.86; 95% CI, 0.71 to 1.04; I(2), 53.1%). A funnel plot suggested publication bias among postoperative trials but not among persistent AF trials. Meta-regression analysis did not find any relationship between doses and effects (P=0.887 and 0.833 for recurrent and postoperative AF, respectively).
Published clinical trials do not support n-3 PUFAs as agents aimed at preventing either postoperative or recurrent AF.
URL: http://www.crd.york.ac.uk/PROSPERO. Unique Identifier: CRD42012002199.
Journal of the American Heart Association. 01/2013; 2(1):e005033.
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ABSTRACT: BACKGROUND: Combined treatment (CT) with statins and polyunsaturated fatty acids (n-3 PUFA) resulted in a reduction of death and major cardiovascular events when administered after a myocardial infarction (MI). However, recent data suggests that CT may be ineffective because patients are currently treated aggressively and the risk may not be further decreased. We aimed to study the prevalence and the results on major outcomes with CT among patients discharged with a MI in Italy. METHODOLOGYPRINCIPAL FINDINGS: Retrospective cohort study that used linked hospital discharge, prescription databases and vital statistics containing information on 14,704 patients who were discharged for MI between 1/2003 and 12/2003 in 117 hospitals in Italy. All analyses were time-dependent and adjusted for major confounders. Sensibility and paired matched analysis were conducted to further verify main results. A total of 11,532 (78.4%) filled a prescription for a statin. Of these, 4302 (37.3%) were on CT. There were 45,528 patients/years of follow-up. As compared with statins alone, CT was associated with an adjusted higher survival rate (HR = 0.59 [0.52-0.66], p<0.001), survival free of atrial fibrillation (HR = 0.78 [0.71-0.86], p<0.001) and survival free of new heart failure development (HR = 0.81 [0.74-0.88], p<0.001), but not with re-infarction (HR = 0.94 [0.86-1.02], p<0.127). Clinically this means that between 2 to 3 fewer events for each 100 patients/year were obtained in the group under CT. CONCLUSIONSSIGNIFICANCE: Among a representative sample of patients discharged with MI in Italy, we observed clinically significant synergism between the effects of statins and n-3 PUFA for most cardiovascular outcomes, including all cause mortality.
PLoS ONE 01/2013; 8(5):e62772. · 4.09 Impact Factor
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Alejandro Macchia,
Hugo Grancelli,
Sergio Varini,
Daniel Nul,
Nicolás Laffaye,
Javier Mariani,
Daniel Ferrante,
Raúl Badra,
Julio Figal,
Silvina Ramos,
Gianni Tognoni,
Hernán C Doval
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ABSTRACT: OBJECTIVES: The aim of this study was to evaluate the efficacy of polyunsaturated fatty acids (n-3 PUFA) for the prevention of recurrent atrial fibrillation (AF) in patients with normal sinus rhythm. BACKGROUND: Current pharmacological treatments to limit recurrent AF in patients with previous AF have limited efficacy and high rates of adverse events. Results of trials that tested the efficacy of n-3 PUFA provided heterogeneous results. METHODS: This was a prospective, randomized, double-blind, placebo-controlled, multicenter trial involving 586 outpatient participants with confirmed symptomatic paroxysmal AF that required cardioversion (n = 428), at least 2 episodes of AF in the 6 months before randomization (n = 55), or both (103). Patients were randomly allocated to n-3 PUFA (1 g/day) or placebo for 12 months. The primary endpoint was symptomatic recurrence of AF. RESULTS: There were no significant differences between patients allocated to placebo and those who received n-3 PUFA for the main outcome. At 12 months, 56 of 297 participants (18.9%) in the placebo group and 69 of 289 participants (24.0%) in the n-3 PUFA group had a recurrent symptomatic AF (hazard ratio: 1.28, 95% confidence interval: 0.90 to 1.83, p = 0.17). There was no difference between treatment with placebo and n-3 PUFA for any of the other pre-specified endpoints, including the composite of all-cause mortality, nonfatal stroke, nonfatal acute myocardial infarction, systemic embolism, heart failure development, or severe bleeding that occurred in 20 (6.7%) and 16 (5.5%) of patients randomized to placebo or n-3 PUFA, respectively (hazard ratio: 0.86, 95% confidence interval: 0.44 to 1.66, p = 0.65). CONCLUSIONS: Pharmacological supplementation with 1 g of n-3 PUFA for 1 year did not reduce recurrent AF. (Randomized Trial to Assess Efficacy of PUFA for the Maintenance of Sinus Rhythm in Persistent Atrial Fibrillation [FORWARD]; NCT00597220).
Journal of the American College of Cardiology 12/2012; · 14.16 Impact Factor
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Dariush Mozaffarian,
Roberto Marchioli, Alejandro Macchia,
Maria G Silletta,
Paolo Ferrazzi,
Timothy J Gardner,
Roberto Latini,
Peter Libby,
Federico Lombardi,
Patrick T O'Gara,
Richard L Page,
Luigi Tavazzi,
Gianni Tognoni
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ABSTRACT: CONTEXT Postoperative atrial fibrillation or flutter (AF) is one of the most common complications of cardiac surgery and significantly increases morbidity and health care utilization. A few small trials have evaluated whether long-chain n-3-polyunsaturated fatty acids (PUFAs) reduce postoperative AF, with mixed results. OBJECTIVE To determine whether perioperative n-3-PUFA supplementation reduces postoperative AF. DESIGN, SETTING, AND PATIENTS The Omega-3 Fatty Acids for Prevention of Post-operative Atrial Fibrillation (OPERA) double-blind, placebo-controlled, randomized clinical trial. A total of 1516 patients scheduled for cardiac surgery in 28 centers in the United States, Italy, and Argentina were enrolled between August 2010 and June 2012. Inclusion criteria were broad; the main exclusions were regular use of fish oil or absence of sinus rhythm at enrollment. INTERVENTION Patients were randomized to receive fish oil (1-g capsules containing ≥840 mg n-3-PUFAs as ethyl esters) or placebo, with preoperative loading of 10 g over 3 to 5 days (or 8 g over 2 days) followed postoperatively by 2 g/d until hospital discharge or postoperative day 10, whichever came first. MAIN OUTCOME MEASURE Occurrence of postoperative AF lasting longer than 30 seconds. Secondary end points were postoperative AF lasting longer than 1 hour, resulting in symptoms, or treated with cardioversion; postoperative AF excluding atrial flutter; time to first postoperative AF; number of AF episodes per patient; hospital utilization; and major adverse cardiovascular events, 30-day mortality, bleeding, and other adverse events. RESULTS At enrollment, mean age was 64 (SD, 13) years; 72.2% of patients were men, and 51.8% had planned valvular surgery. The primary end point occurred in 233 (30.7%) patients assigned to placebo and 227 (30.0%) assigned to n-3-PUFAs (odds ratio, 0.96 [95% CI, 0.77-1.20]; P = .74). None of the secondary end points were significantly different between the placebo and fish oil groups, including postoperative AF that was sustained, symptomatic, or treated (231 [30.5%] vs 224 [29.6%], P = .70) or number of postoperative AF episodes per patient (1 episode: 156 [20.6%] vs 157 [20.7%]; 2 episodes: 59 [7.8%] vs 49 [6.5%]; ≥3 episodes: 18 [2.4%] vs 21 [2.8%]) (P = .73). Supplementation with n-3-PUFAs was generally well tolerated, with no evidence for increased risk of bleeding or serious adverse events. CONCLUSION In this large multinational trial among patients undergoing cardiac surgery, perioperative supplementation with n-3-PUFAs, compared with placebo, did not reduce the risk of postoperative AF. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00970489.
JAMA The Journal of the American Medical Association 11/2012; · 30.03 Impact Factor
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ABSTRACT: : Results from basic science and narrative reviews suggest a potential role of β-blockers in patients with sepsis. Although the hypothesis is physiologically appealing, it could be seen as clinically counterintuitive. We sought to assess whether patients previously prescribed chronic β-blocker therapy had a different mortality rate than those who did not receive treatment.
: Record linkage of administrative databases of Italian patients hospitalized for sepsis during years 2003-2008 were identified and followed up for all-cause mortality at 28 days.
: None.
: We identified 9,465 patients aged ≥40 yrs who were hospitalized in critical care units for sepsis. Of these, 1,061 patients were on chronic prescription with β-blockers and 8404 were not previously treated. Despite a higher risk profile, patients previously prescribed with β-blockers had lower mortality at 28 days (188/1061 [17.7%]) than those previously untreated (1857/8404 [22.1%]) (odds ratio 0.78; 95% confidence interval 0.66-0.93; p = .005 for unadjusted analysis, and odds ratio 0.81; 95% confidence interval 0.68-0.97; p = .025 for adjusted analyses). Sensitivity and pair-matched results confirm the primary findings.
: As far as we are aware, this pharmacoepidemiologic assessment is the largest to examine the potential association of previous β-blocker prescription and mortality in patients with sepsis. Chronic prescription of β-blockers may confer a survival advantage to patients who subsequently develop sepsis with organ dysfunction and who are admitted to an intensive care unit. Prospective randomized clinical trials should formally test this hypothesis.
Critical care medicine 07/2012; 40(10):2768-72. · 6.37 Impact Factor
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ABSTRACT: PurposeCurrent strategies for avoiding atrial fibrillation (AF) are of limited value. We aim to assess the relationship between omega-3
fatty acids (n-3 PUFA) and AF occurrence in post-myocardial infarction (MI) patients.
MethodsA population study, linking hospital discharge records, prescription databases, and vital statistics, was conducted and included
all consecutive patients with MI (ICD-9: 410) in six Italian local health authorities over a 3-year period. A propensity score
(PS)-based, 5-to-1, greedy 1:1 matching algorithm was used to check consistency of results. Sensitivity analysis was performed
to assess the robustness of findings.
ResultsN-3 PUFA reduced the relative risk of the hospitalization for AF [hazard ratio (HR) 0.19, 95% CI 0.07–0.51] and was associated
with a further and complementary reduction in all-cause mortality (HR 0.15, 95% CI 0.05–0.46). PS-based matched analysis and
sensitivity analysis confirmed the main results.
Conclusionn-3 PUFA reduced both all-cause mortality and incidence of 1-year AF in patients hospitalized with MI.
European Journal of Clinical Pharmacology 04/2012; 64(6):627-634. · 2.85 Impact Factor
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ABSTRACT: PurposeTo identify a cohort of subjects without treatment for any cardiovascular risk and analyze the potential causative role of
treatment for depression on the development of major cardiovascular outcomes during 2 years of follow-up.
MethodsWe carried out a record-linkage analysis of hospital discharge records, prescription databases and vital statistics for all
consecutive patients aged 30years or older in one Italian region during a 4-year period. Depression was defined in terms
of exposure to at least three prescriptions of antidepressant drugs within 1 year. Patients had no history of treatment with
cardiovascular or antidiabetic agents and had not been hospitalized with a diagnosis of any cardiovascular condition in the
preceding year. Follow-up was extended up to 2 years or to time to occurrence of major outcomes defined as either all-cause
mortality, hospitalization for any cardiovascular cause or chronic exposure to cardiovascular drugs (antihypertensive, statins,
antidiabetics). The results are expressed hazard ratios (HRs) and 95% confidence intervals (CIs) within age categories (30–49,
50–59, ≥60years).
ResultsA total of 105,573 persons without treated cardiovascular risk at baseline were identified, among whom 1,129 (1.1%) had been
chronically exposed to antidepressant treatment. Treated depression determined an increased risk of all cause-mortality (HR
1.88, 95% CI 1.33–2.66, p < 0.001) and of subsequent treatment with antidiabetic agents (HR 0.89, 95% CI 1.34–2.66, p < 0.001), statins (HR 1.87, 95% CI 1.53–2.29, p < 0.001) and antihypertensive drugs (HR 1.25, 95% CI 1.07–1.47, p = 0.006).
ConclusionAmong the general population without treated cardiovascular risk, pharmacologic treatment for depression was associated with
an increase in all-cause mortality and major cardiovascular outcomes.
European Journal of Clinical Pharmacology 04/2012; 65(11):1131-1138. · 2.85 Impact Factor
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ABSTRACT: Aims Epidemiological studies reported two contrasting trends: on one hand, a significant improvement in the use of evidence-based treatments of patients discharged with a myocardial infarction (MI). On the other hand, the increasing number of elderly and co-morbid patients who are usually less treated. The aim of this study is to examine whether improvements in the treatment of MI are homogeneously distributed throughout all subgroups of patients. Methods and results Based on record linkage of administrative registers, 21 423 patients discharged with MI in three different periods (2003, 2005, and 2007), were identified and followed up for major clinical events up to 1 year. Using as a reference temporal category those patients discharged in 2003 (odds ratios, 95% confidence intervals) and as a demographic category male patients aged ≤75 years (1.00), the study identified: in-hospital mortality significantly decreased in all periods and in all groups of patients; out-of-hospital mortality decreased only in younger patients and not in older patients; prescription of evidence-based treatments increased in all periods for all patients; however, the magnitude of improvement was mostly concentrated in younger patients. Conclusion Although there was a mean improvement in the treatment and outcome of patients discharged from an MI, most of these benefits were strongly concentrated in younger, healthier patients. Old and co-morbid populations-although representing a substantial proportion of the burden of disease-received significant less attention and barely improved their survival.
European Heart Journal 11/2011; 33(4):515-22. · 10.48 Impact Factor
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ABSTRACT: The evidence of individual studies in acute cardiogenic pulmonary edema (ACPE) supporting noninvasive ventilation (NIV) is still inconclusive, particularly regarding noninvasive positive pressure ventilation (NIPPV).
We carried out a meta-analysis. We searched in the Embase, Medline, Cinahl, Dare, Coch, Central, and CNKI databases and congress abstracts for trials comparing continuous positive airway pressure (CPAP) or NIPPV with standard therapy (ST). To assess treatment effects, we carried out direct comparison using a random effects model and adjusted indirect comparison.
At total of 34 studies (3,041 patients) were included. In direct comparisons, both CPAP and NIPPV reduced the risk of death (relative risk [RR] 0.64, 95% CI 0.44-0.93; RR 0.80, 95% CI 0.58-1.10; respectively) compared with ST, although only CPAP had a significant effect. There were no significant differences between NIPPV and CPAP. Pooled results of direct and adjusted indirect comparisons showed that compared with ST, both CPAP and NIPPV significantly reduced mortality (RR 0.63, 95% CI 0.44-0.89; RR 0.73, 95% CI 0.55-0.97; respectively).
Our findings suggest that among ACPE patients, NIV delivered through either NIPPV or CPAP reduced mortality.
Journal of cardiac failure 10/2011; 17(10):850-9. · 3.25 Impact Factor
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ABSTRACT: Background: The impact of treatment with vasodilators on the survival of patients with pulmonary arterial hypertension (PAH) remains uncertain. Despite several clinical trials have been carried out in the last 15 years, their primary objective was not to assess mortality but the changes on surrogate end points. Methods and results: We reviewed the results of all clinical trials with vasodilators in PAH and the main results of different metaanalysis. Clinical trials and systematic reviews confirm that vasodilator therapies in patients with PAH who are non-vasoreactive produce a consistent, statistically significant but a marginal effect on exercise capacity assessed by the six-minute walk test. The weighted mean difference (95% CI) achieved with epoprostenol (EPO) or other prostacyclin analogues (PCA), endothelin receptor antagonists (ETRA) and phosphodiesterase-type-5 inhibitors (PDE5-I) was 35.4 m (17.3-53.5), 46.1 m (38.1-54.2) and 33.8 m (24.8-42.7), respectively. When considering the cumulative effects within each drug family, no class of drug produced a statistically significant reduction in all cause mortality. The relative risk rates (95% CI) conferred by EPO or PCA, ETRA and PDE5-I were 0.66 (0.36-1.21), 0.48 (0.19-1.23) and 0.65 (0.16-2.67), respectively. Interpretation: Further trials utilizing similar classes of drugs, and following similar trial designs are unlikely to yield different results or offer any more clinical benefits. Given that PAH is a fatal disease this raises concerns about whether they are ethical to conduct or not. Future trials will need to utilize clinical endpoints rather than the ones that are easy to administer and will need to include longer durations of study and other strategies to test the durability of effect.
Reviews on Recent Clinical Trials 08/2011; 6(3):228-234.
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Dariush Mozaffarian,
Roberto Marchioli,
Tim Gardner,
Paolo Ferrazzi,
Patrick O'Gara,
Roberto Latini,
Peter Libby,
Federico Lombardi, Alejandro Macchia,
Richard Page,
Massimo Santini,
Luigi Tavazzi,
Gianni Tognoni
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ABSTRACT: Postoperative atrial fibrillation/flutter (PoAF) commonly complicates cardiac surgery, occurring in 25% to 60% of patients. Postoperative atrial fibrillation/flutter is associated with significant morbidity, higher long-term mortality, and increased health care costs. Novel preventive therapies are clearly needed. In experiments and short-term trials, seafood-derived long-chain ω-3 polyunsaturated fatty acids (PUFAs) influence several risk factors that might reduce risk of PoAF. A few small and generally underpowered trials have evaluated effects of ω-3-PUFAs supplementation on PoAF with mixed results. The OPERA trial is an appropriately powered, investigator-initiated, randomized, double-blind, placebo-controlled, multinational trial to determine whether perioperative oral ω-3-PUFAs reduces occurrence of PoAF in patients undergoing cardiac surgery. Additional aims include evaluation of resource use, biologic pathways and mechanisms, postoperative cognitive decline, and safety. Broad inclusion criteria encompass a "real-world" population of outpatients and inpatients scheduled for cardiac surgery. Treatment comprises a total preoperative loading dose of 8 to 10 g of ω-3-PUFAs or placebo divided over 2 to 5 days, followed by 2 g/d until hospital discharge or postoperative day 10, whichever comes first. Based on anticipated 30% event rate in controls, total enrollment of 1,516 patients (758 per treatment arm) will provide 90% power to detect 25% reduction in PoAF. The OPERA trial will provide invaluable evidence to inform biologic pathways; proof of concept that ω-3-PUFAs influence cardiac arrhythmias; and potential regulatory standards and clinical use of this simple, inexpensive, and low-risk intervention to prevent PoAF.
American heart journal 07/2011; 162(1):56-63.e3. · 4.65 Impact Factor
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ABSTRACT: The impact of treatment with vasodilators on the survival of patients with pulmonary arterial hypertension (PAH) remains uncertain. Despite several clinical trials have been carried out in the last 15 years, their primary objective was not to assess mortality but the changes on surrogate end points.
We reviewed the results of all clinical trials with vasodilators in PAH and the main results of different metaanalysis. Clinical trials and systematic reviews confirm that vasodilator therapies in patients with PAH who are non-vasoreactive produce a consistent, statistically significant but a marginal effect on exercise capacity assessed by the six-minute walk test. The weighted mean difference (95% CI) achieved with epoprostenol (EPO) or other prostacyclin analogues (PCA), endothelin receptor antagonists (ETRA) and phosphodiesterase-type-5 inhibitors (PDE5-I) was 35.4 m (17.3-53.5), 46.1 m (38.1-54.2) and 33.8 m (24.8-42.7), respectively. When considering the cumulative effects within each drug family, no class of drug produced a statistically significant reduction in all cause mortality. The relative risk rates (95% CI) conferred by EPO or PCA, ETRA and PDE5-I were 0.66 (0.36-1.21), 0.48 (0.19-1.23) and 0.65 (0.16-2.67), respectively.
Further trials utilizing similar classes of drugs, and following similar trial designs are unlikely to yield different results or offer any more clinical benefits. Given that PAH is a fatal disease this raises concerns about whether they are ethical to conduct or not. Future trials will need to utilize clinical endpoints rather than the ones that are easy to administer and will need to include longer durations of study and other strategies to test the durability of effect.
04/2011; 6(3):228-34. · 1.07 Impact Factor
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ABSTRACT: Earlier reviews have found that the proportion of inverse associations between socioeconomic status and obesity increased according to the level of development of the studied country. Based on this finding, it has been hypothesized that in low- to middle- income countries the burden of obesity shifts to disadvantaged groups as a country develops.
CARMELA is a cross-sectional, population-based observational study that sampled 11,550 women and men age 25-64 from seven major Latin American cities. We analyzed by gender the association of educational attainments (as proxy of socioeconomic status) with body mass index, waist circumference and metabolic syndrome. Participating cities were divided by country Human Development Index (HDI). An inverse gradient between socioeconomic status and body mass index in women was uniformly present in High HDI cities (Buenos Aires, Santiago, Mexico) but not in Medium HDI group (Barquisimeto, Bogota, Lima, Quito), where two cities showed an inverse gradient and two cities did not. In men, no clear socioeconomic gradients were found. Findings regarding waist circumference and metabolic syndrome closely mirrored those about body mass index.
In women but not men, these results give support to the hypothesis of obesity shifting to the poor and extend it to the related concepts of abdominal obesity and metabolic syndrome. Obesity should be considered as a socially-generated disease and an indicator of socioeconomic disadvantage, to be approached by comprehensive strategies that bear in mind this perspective.
European journal of cardiovascular prevention and rehabilitation: official journal of the European Society of Cardiology, Working Groups on Epidemiology & Prevention and Cardiac Rehabilitation and Exercise Physiology 01/2011; 18(4):550-6. · 2.51 Impact Factor
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ABSTRACT: The purpose of this study was to assess the rate of death and hospitalization for heart failure (HF) 1 and 3 years after a randomized trial of telephone intervention aimed to improve education and compliance in stable patients with HF ended.
The long-term effects of HF programs are not well known.
In all, 1,518 patients with HF were randomized into the DIAL (Randomized Trial of Phone Intervention in Chronic Heart Failure). After completion of the trial, patients were followed up to 3 years to assess major outcomes. Compliance with diet, weight control, and treatment was evaluated. The effect of the intervention on mortality and HF hospitalizations was assessed using relative risk (RR), relative risk reduction, and Cox proportional hazards model for adjusting by potential confounders.
The rate of death or hospitalization for HF was lower in the intervention group (37.2% vs. 42.6%, RR: 0.81, 95% confidence interval [CI]: 0.69 to 0.96; p = 0.013) 1 and 3 years (55.7% vs. 57.5%, RR: 0.88, 95% CI: 0.77 to 1.00; p = 0.05) after the intervention ended. This benefit was mainly caused by a reduction in admission for HF (28.5% vs. 35.1% after 3 years, RR: 0.72, 95% CI: 0.60 to 0.87; p = 0.0004). Patients who showed improvement in 1 or more of 3 key compliance indicators (diet, weight control, and medication) had lower risks of events.
The benefit observed during the intervention period persisted and was sustained 1 and 3 years after the intervention ended. This effect may be explained by the impact of the educational intervention on patients' behavior and habits.
Journal of the American College of Cardiology 07/2010; 56(5):372-8. · 14.16 Impact Factor
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Journal of the American College of Cardiology 07/2010; 56(2):159-60; author reply 160. · 14.16 Impact Factor
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ABSTRACT: In a previous meta-analysis on the approved treatments for pulmonary hypertension, we reported that all therapies caused small changes in 6-minute walk distance over a short period, with minimal effects on hemodynamics and no effect on survival. Since that last review, 10 new clinical trials with about 1,500 patients have been published, which has increased the statistical power of our observations.
A systematic review of all clinical trials in pulmonary arterial hypertension was done.
The pooled effect of all treatments strategies (relative risk [95% CI], P) now shows a significant reduction of 39% (2%-62%, P = .041) in all-cause mortality. The benefits were confined only to patients with advanced disease for 16 weeks, regardless of which class of drug is used. When considering the effects within each drug family, no class of drug produced a statistically significant reduction in all-cause mortality. The improved survival bore no relationship with the change in 6-minute walk, the primary end point in most of the trials.
The impact of vasodilators on long-term survival in pulmonary arterial hypertension remains uncertain. Future trials need to (a) adopt new trial designs that can better address clinical benefits, (b) use new end points that incorporate our best understanding of the disease rather than the ones that are easy to administer, and (c) include longer durations of study and other strategies to clarify if survival is affected.
American heart journal 02/2010; 159(2):245-57. · 4.65 Impact Factor
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Rafael Hernández-Hernández,
Honorio Silva,
Manuel Velasco,
Fabio Pellegrini, Alejandro Macchia,
Jorge Escobedo,
Raul Vinueza,
Herman Schargrodsky,
Beatriz Champagne,
Palmira Pramparo,
Elinor Wilson
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ABSTRACT: Little information is available regarding hypertension, treatment, and control in urban population of Latin America.
We aimed to compare blood pressure (BP) distribution, hypertension prevalence, treatment, and control in seven Latin American cities following standard methodology.
The Cardiovascular Risk Factor Multiple Evaluation in Latin America (CARMELA) study was a cross-sectional, epidemiologic study assessing cardiovascular risk factors using stratified multistage sampling of adult populations (aged 25-64 years) in seven cities: Barquisimeto (Venezuela; n = 1848); Bogotá (n = 1553); Buenos Aires (n = 1482); Lima (n = 1652); Mexico City (n = 1720); Quito (n = 1638); and Santiago (n = 1655). The prevalence of hypertension and high normal BP were determined based on 2007 European Society of Hypertension and European Society of Cardiology definitions.
BP increased with age in men and women; pulse pressure increased mainly in the upper age group. The hypertension prevalence ranged from 9% in Quito to 29% in Buenos Aires. One-quarter to one-half of the hypertension cases were previously undiagnosed (24% in Mexico City to 47% in Lima); uncontrolled hypertension ranged from 12% (Lima) to 41% (Mexico City). High normal BP was also evident in a substantial number of each city participants (approximately 5-15%). Majority of population has other cardiovascular risk factors despite hypertension; only 9.19% of participants have no risk factors apart from hypertension.
From 13.4 to 44.2% of the populations of seven major Latin American cities were hypertensive or had high normal BP values. Most hypertensive patients have additional risk factors. Public health programs need to target prevention, detection, treatment, and control of total cardiovascular risk in Latin America.
Journal of hypertension 10/2009; 28(1):24-34. · 4.02 Impact Factor
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ABSTRACT: To identify a cohort of subjects without treatment for any cardiovascular risk and analyze the potential causative role of treatment for depression on the development of major cardiovascular outcomes during 2 years of follow-up.
We carried out a record-linkage analysis of hospital discharge records, prescription databases and vital statistics for all consecutive patients aged 30 years or older in one Italian region during a 4-year period. Depression was defined in terms of exposure to at least three prescriptions of antidepressant drugs within 1 year. Patients had no history of treatment with cardiovascular or antidiabetic agents and had not been hospitalized with a diagnosis of any cardiovascular condition in the preceding year. Follow-up was extended up to 2 years or to time to occurrence of major outcomes defined as either all-cause mortality, hospitalization for any cardiovascular cause or chronic exposure to cardiovascular drugs (antihypertensive, statins, antidiabetics). The results are expressed hazard ratios (HRs) and 95% confidence intervals (CIs) within age categories (30-49, 50-59, > or = 60 years).
A total of 105,573 persons without treated cardiovascular risk at baseline were identified, among whom 1,129 (1.1%) had been chronically exposed to antidepressant treatment. Treated depression determined an increased risk of all cause-mortality (HR 1.88, 95% CI 1.33-2.66, p < 0.001) and of subsequent treatment with antidiabetic agents (HR 0.89, 95% CI 1.34-2.66, p < 0.001), statins (HR 1.87, 95% CI 1.53-2.29, p < 0.001) and antihypertensive drugs (HR 1.25, 95% CI 1.07-1.47, p = 0.006).
Among the general population without treated cardiovascular risk, pharmacologic treatment for depression was associated with an increase in all-cause mortality and major cardiovascular outcomes.
European Journal of Clinical Pharmacology 07/2009; 65(11):1131-8. · 2.85 Impact Factor
