Heartdrug : excellence in cardiovascular trials最新文献

{"title":"Review of Cardiovascular Disease in Women: Awareness, Prevention, and Psychosocial Characteristics","authors":"Sara Mobasseri, P. Liebson, L. Klein","doi":"10.1159/000075705","DOIUrl":"https://doi.org/10.1159/000075705","url":null,"abstract":"In the United States, cardiovascular disease remains the leading cause of death in postmenopausal women. Despite these alarming trends in the prevalence, the magnitude of the problem is still underappreciated. Women traditionally have been underrepresented in clinical trials with poor enrollment, and information for prevention and treatment of coronary heart disease (CHD) is extrapolated from populations of men. In addition to biologic risk factors for CHD, psychosocial risk factors have also been studied more in men than women. Both traditional coronary and psychosocial risk factors are reviewed as to how they uniquely affect women. A comprehensive approach, encompassing life-style changes, coping strategies and pharmacologic interventions for both prevention and treatment of CHD in women is emphasized.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"21 1","pages":"191 - 202"},"PeriodicalIF":0.0,"publicationDate":"2003-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000075705","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65205385","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A New Class of Lipid-Lowering Drugs: Ezetimibe","authors":"U. Keller","doi":"10.1159/000075707","DOIUrl":"https://doi.org/10.1159/000075707","url":null,"abstract":"Ezetrol® (Ezetimibe) is the first substance of a new class of selective cholesterol absorption inhibitors; it was registered in Switzerland in 2002. Ezetimibe is glucuronidised and recirculated in the enterohepatic circulation. It acts exclusively in the intestinal lumen, but has no effect on the absorption of bile acids and liposoluble vitamins. When given as monotherapy, the standard dose of 10 mg/day lowers the serum LDL cholesterol by about 15–20%. Combined therapy with statins is particularly useful, because in this way the adaptive increase in cholesterol synthesis is prevented; with this combination, the LDL cholesterol level can be lowered by up to 58%. The effect of ezetimibe is also pronounced in combination with low doses of statins. In contrast to the bile acid binders, ezetimibe slightly lowers the triglycerides and slightly raises the HDL cholesterol level. Other combinations have not been investigated in detail; up till now, side effects and drug interactions have scarcely been observed. Ezetimibe is suitable for use in the treatment of primary hypercholesterolaemia, in which monotherapy with statins has an inadequate effect on the target LDL cholesterol values. This is the case especially with severe familial (genetic) hypercholesterolaemia and/or hypercholesterolaemia in which treatment with statins has led to side effects or intolerance. Long-term studies with ezetimibe, investigating the cardiovascular morbidity or other long-term effects, have not been carried out to date.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"25 1","pages":"214 - 216"},"PeriodicalIF":0.0,"publicationDate":"2003-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000075707","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65205046","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Polymorphisms in the Apolipoprotein(a) Gene, Plasma Lp(a) and Cardiovascular Risk","authors":"P. Beneš","doi":"10.1159/000075708","DOIUrl":"https://doi.org/10.1159/000075708","url":null,"abstract":"Increased plasma concentration of lipoprotein(a) [Lp(a)] represents an established risk factor for coronary artery disease (CAD). The plasma Lp(a) level is relatively stable during life and it is more than 90% genetically determined by the apolipoprotein(a) [apo(a)] gene. Numerous polymorphisms have been identified in the apo(a) gene. The extreme apo(a) protein size polymorphism, based on the variable number of so-called kringle IV type 2 repeats (KIV-2), accounts for a large portion of variability of plasma Lp(a) levels. Moreover, it has been shown that several other apo(a) sequence changes, both in the coding and regulatory sequences, influence plasma Lp(a) levels and/or Lp(a) prothrombogenic properties. Associations between some of them and the increased risk of CAD have also been reported. However, the existence of strong linkage disequilibria in the apo(a) locus represents a serious problem to identify a real effect of single polymorphism on Lp(a) phenotype. Large and complex association and family studies in different populations, together with in vitro expression and functional studies, should clarify the importance of so far identified positive apo(a) polymorphism-plasma Lp(a) associations in the future. In addition, standardization of measurement of Lp(a) is necessary to allow comparison of results obtained with different immunoassays.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"3 1","pages":"217 - 224"},"PeriodicalIF":0.0,"publicationDate":"2003-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000075708","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65205280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Pulmonary Vein Isolation on Quality of Life in Patients with Paroxysmal Atrial Fibrillation","authors":"B. Nilsson, Xu Chen, J. Svendsen","doi":"10.1159/000075704","DOIUrl":"https://doi.org/10.1159/000075704","url":null,"abstract":"Background: Recent studies have demonstrated that delivering radiofrequency energy to isolate the pulmonary veins (PVs) can cure patients with paroxysmal atrial fibrillation (PAF). Objective: To quantify the effects of radiofrequency catheter isolation of PVs on quality of life (QoL), symptom burden and non-scheduled visiting to physicians in patients with PAF. Methods: Thirty consecutive patients referred for radiofrequency ablation of PAF were included. Questionnaires were administered retrospectively, 6.3 months after the ablation procedure. QoL was measured by the SF-36 (a measure of general health status) and symptoms and health care utilization by a locally constructed questionnaire. Results: Before ablation, patients with PAF had significantly lower scores on all SF-36 subscales with the exception of the pain subscale, compared with a healthy control group. Apart from bodily pain all subscales significantly improved after PV isolation. Twenty patients had an improvement in their total health perception. PV isolation significantly reduced the frequency of episodes of atrial fibrillation (AF) and the proportion of nonscheduled contacts to physicians for AF. Conclusion: QoL in patients with PAF is significantly impaired. PV isolation improves the QoL and reduces the frequency and severity of symptoms and non-scheduled contacts to physicians.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"3 1","pages":"173 - 179"},"PeriodicalIF":0.0,"publicationDate":"2003-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000075704","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65205326","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"New Insights into Molecular Mechanisms of Atrial Fibrillation: Are We Approaching Possible Novel Pharmacological Principles for Treating This Disorder?","authors":"A. Goette, U. Lendeckel","doi":"10.1159/000073239","DOIUrl":"https://doi.org/10.1159/000073239","url":null,"abstract":"Atrial fibrillation (AF) is associated with significant electrophysiological, structural and molecular alterations of atrial tissue. Some of these changes (e.g. interstitial fibrosis, atrial dilation) provide a proarrhythmogenic substrate which favors the occurrence of AF, although not all of these changes are primarily induced by the arrhythmia itself. Activation of several tissue proteases seems to be of particular importance for the development of structural atrial changes. An increased activation of the atrial angiotensin II system contributes to the development of interstitial atrial fibrosis, which induces proarrhythmic alterations in atrial conduction. Thus, inhibition of the angiotensin-converting enzyme or blockage of angiotensin II receptors may offer a novel antiarrhythmic approach to prevent AF, in particular in patients with concomitant cardiovascular diseases. This review will describe the role and regulation of the atrial angiotensin II system and other molecular signal transduction systems which may have the potential to provide new pharmacological targets for the therapy of AF.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"290 1","pages":"180 - 190"},"PeriodicalIF":0.0,"publicationDate":"2003-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000073239","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65183756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cardiac Resynchronization Therapy for Heart Failure: Here to Stay","authors":"W. Abraham","doi":"10.1159/000073836","DOIUrl":"https://doi.org/10.1159/000073836","url":null,"abstract":"Accessible online at: www.karger.com/hed In this issue of Heart Drug, Piepoli et al. review data concerning the role of atrial-synchronized biventricular pacing, or cardiac resynchronization therapy, for the treatment of heart failure and pose the question: ‘Is it here to stay?’ As they point out, results from mechanistic studies of cardiac resynchronization have demonstrated improved cardiac function and enhanced hemodynamics determined either echocardiographically or by invasive techniques. In addition, observational clinical studies have shown improvements in quality of life, functional status, and exercise capacity in heart failure patients treated with resynchronization therapy. Of course, such data alone cannot support the broad application of such a therapy in clinical practice. Thus, a series of randomized controlled trials of resynchronization therapy including more than 4,000 patients have been completed, and the weight of evidence supporting the routine use of cardiac resynchronization for patients with moderate-to-severe chronic systolic heart failure and ventricular dysynchrony is now overwhelming. Results from these trials have consistently demonstrated significant improvements in quality of life, functional status, and exercise capacity in NYHA class III and IV heart failure patients assigned to active resynchronization therapy [1–4]. In these patients, cardiac resynchronization has also been shown to improve cardiac structure and function, while significantly reducing the risk of worsening heart failure [1, 2]. In 2001, the first resynchronization device became commercially available in the United States. The next year, two devices which combine biventricular pacing capability with implantable cardioverter defibrillators (ICDs) were approved for use by the US Food and Drug Administration. Recently updated ACC/ AHA/NASPE Pacemaker and ICD Guidelines included cardiac resynchronization therapy as a Class IIA recommendation for pacing [5]. Since that time, preliminary results from another large-scale trial have suggested a significant reduction in the combined endpoint of all-cause mortality and all-cause hospitalization with cardiac resynchronization therapy in an advanced heart failure population [6]. Thus, cardiac resynchronization therapy not only makes heart failure patients feel better, it also helps them to live longer. Given these favorable effects on subjective as well as objective outcomes in heart failure patients, cardiac resynchronization therapy is here to stay.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"3 1","pages":"120 - 121"},"PeriodicalIF":0.0,"publicationDate":"2003-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000073836","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65190433","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Blinded End Point Adjudication in the ‘Danish Multicenter Randomized Study on Fibrinolytic Therapy versus Acute Coronary Angioplasty in Acute Myocardial Infarction’ (DANAMI-2 Trial)","authors":"N. Vejlstrup, P. Clemmensen, E. Steinmetz, L. Krusell, K. N. Hansen, I. Christiansen, P. Hansen, H. Andersen","doi":"10.1159/000073837","DOIUrl":"https://doi.org/10.1159/000073837","url":null,"abstract":"Background: Allocation concealment in trials that compare interventional procedures with medical therapy is impossible. Bias introduced by the investigators when end points are adjudicated is a methodological problem in such trials. Objective: To develop and test a novel method of blinded end point adjudication in open trials. Method: In the DANAMI-2 trial, a randomised open trial comparing primary angioplasty to fibrinolytic treatment of acute myocardial infarction, end points were evaluated by an independent end point committee (EPC). The cardiologists who presented the clinical end point data to the EPC were asked not to disclose any information on the randomised treatment, in order for the EPC to pass a truly blinded end point adjudication. The EPC categorised their evaluation of each end point as evaluated blinded or evaluated not blinded. Results: Blinded end point adjudication was possible in 84% of cases. All deaths reported by local investigators were confirmed by the EPC. Local investigators reported 78 cases of reinfarction and 31 (40%) of these events were rejected by the EPC, whereas the EPC discovered 35 unreported cases of reinfarction. Thirty-one strokes were reported by local investigators of which 2 (6%) were rejected by the EPC which, however, included 2 previously unreported strokes. A total of 383 cases of bleeding were reported of which 115 (30%) were rejected, whereas the EPC included 16 another cases of unreported bleedings. Blinded end point adjudication therefore contributed significantly to the final number of end points. Conclusion: Blinded end point adjudication is feasible in open randomised trials and is likely to reduce bias.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"3 1","pages":"127 - 133"},"PeriodicalIF":0.0,"publicationDate":"2003-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000073837","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65190533","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Atrial Fibrillation: Rhythm or Rate Control?","authors":"M. Landolina, G. D. de Ferrari, F. Cantú, B. Petracci, L. Tavazzi","doi":"10.1159/000072741","DOIUrl":"https://doi.org/10.1159/000072741","url":null,"abstract":"Atrial fibrillation is the most common sustained cardiac arrhythmia. Its prevalence increases with age, reaching 5% among subjects over 65 years of age. Recently, evaluation of the best therapeutic approach to patients with atrial fibrillation has been the object of two multicenter clinical trials that have compared a strategy of rhythm control and one of rate control. The Atrial Fibrillation Follow-up Investigation of Rhythm Management trial enrolled a total of 4,060 patients with a mean age of 69.7 years. After a mean follow-up of 5 years, total mortality was 24% in the rhythm control group and 21% in the rate control group, leading to a hazard ratio of 1.15 (p = 0.08). Similar results were found in the smaller Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation study. The two studies clearly indicate that rate control is not inferior to rhythm control in the general population of patients with atrial fibrillation and that the restoration of sinus rhythm should not be pursued aggressively. The data also suggest the opportunity for adequate anticoagulation among patients assigned to the rhythm control strategy. The characteristics of the patients enrolled as well as the analysis of subgroups suggest that the preference toward a rate control strategy may not apply to young patients who are moderately or highly symptomatic for atrial fibrillation, nor to patients with heart failure, in whom the arrhythmia may contribute to the progression of the disease. For these two classes of patients, rhythm control may still be an attractive option.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"3 1","pages":"164 - 170"},"PeriodicalIF":0.0,"publicationDate":"2003-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000072741","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65180131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment of Chronic Heart Failure by Biventricular Pacing: Is It Here to Stay?","authors":"M. Piepoli, G. Villani, A. Capucci","doi":"10.1159/000071026","DOIUrl":"https://doi.org/10.1159/000071026","url":null,"abstract":"In patients with advanced chronic heart failure, characterised by prolonged QRS duration and impaired cardiac contractility, decreasing dyssynchrony by biventricular pacing seems to improve exercise tolerance (6-min walk distance), symptoms (New York Health Association class) and quality-of-life scores. Although the results of several reports have been consistent, the numbers of patients studied were small, and many of the changes were trends that did not reach statistical significance. The availability of a non-pharmacological treatment that improves exercise capacity and quality of life would be a major advance. However, further studies will need to address the question of mortality and morbidity benefits of such intervention.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"3 1","pages":"147 - 152"},"PeriodicalIF":0.0,"publicationDate":"2003-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000071026","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65166186","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A New Emerging Risk Factor for Cardiovascular Disease: Apo(a) Polymorphism","authors":"C. Gazzaruso, P. Fratino, A. Garzaniti","doi":"10.1159/000071028","DOIUrl":"https://doi.org/10.1159/000071028","url":null,"abstract":"Apolipoprotein(a) [apo(a)], the specific apolipoprotein of lipoprotein(a), is characterized by a high degree of genetic polymorphism. Recent studies have shown that apo(a) polymorphism may represent a powerful independent cardiovascular risk factor. Indeed, an association between apo(a) polymorphism and coronary artery disease (CAD) has been documented both in the general population and among subjects at high cardiovascular disease risk, such as hypertensive, uremic, hypercholesterolemic, and diabetic patients. In addition, apo(a) polymorphism seems to correlate well with age of onset and severity of CAD. Nevertheless, at present, some problems prohibit the utilization of apo(a) polymorphism in clinical practice. Indeed, apo(a) phenotyping methods are not standardized, and there is not a cutoff of apo(a) polymorphism for clinical purposes. Moreover, large prospective studies should confirm the predictive value of apo(a) polymorphism for CAD. When the above problems are solved, apo(a) polymorphism could be a reliable tool to discriminate subjects with genetic predisposition to CAD among people with a family history of CAD and among patients with diseases representing a high cardiovascular risk, such as hypercholesterolemia, hypertension, diabetes, and uremia.","PeriodicalId":87985,"journal":{"name":"Heartdrug : excellence in cardiovascular trials","volume":"3 1","pages":"159 - 163"},"PeriodicalIF":0.0,"publicationDate":"2003-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000071028","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"65166336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}