| 1. |
- Zannad, F., et al.
(författare)
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Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document
- 2013
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Ingår i: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 15:10, s. 1082-1094
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Tidskriftsartikel (refereegranskat)abstract
- Endpoint selection is a critically important step in clinical trial design. It poses major challenges for investigators, regulators, and study sponsors, and it also has important clinical and practical implications for physicians and patients. Clinical outcomes of interest in heart failure trials include all-cause mortality, cause-specific mortality, relevant non-fatal morbidity (e.g. all-cause and cause-specific hospitalization), composites capturing both morbidity and mortality, safety, symptoms, functional capacity, and patient-reported outcomes. Each of these endpoints has strengths and weaknesses that create controversies regarding which is most appropriate in terms of clinical importance, sensitivity, reliability, and consistency. Not surprisingly, a lack of consensus exists within the scientific community regarding the optimal endpoint(s) for both acute and chronic heart failure trials. In an effort to address these issues, the Heart Failure Association of the European Society of Cardiology (HFA-ESC) convened a group of expert heart failure clinical investigators, biostatisticians, regulators, and pharmaceutical industry scientists (Nice, France, 12-13 February 2012) to evaluate the challenges of defining heart failure endpoints in clinical trials and to develop a consensus framework. This report summarizes the group's recommendations for achieving common views on heart failure endpoints in clinical trials.
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| 2. |
- Dobre, D., et al.
(författare)
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Heart rate: a prognostic factor and therapeutic target in chronic heart failure. The distinct roles of drugs with heart rate-lowering properties
- 2014
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Ingår i: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 16:1, s. 76-85
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Tidskriftsartikel (refereegranskat)abstract
- Heart rate not only predicts outcome but may also be a therapeutic target in patients with chronic heart failure. Several classes of pharmacological agents can be used to modulate heart rate, including beta-blockers, ivabradine, digoxin, amiodarone, and verapamil. Choice of agent will depend on heart rhythm, co-morbidities, and disease phenotype. Beneficial and harmful interactions may also exist. The aim of this paper is to summarize the current body of knowledge regarding the relevance of heart rate as a prognostic factor (risk marker) and particularly as a therapeutic target (risk factor) in patients with chronic heart failure, with a special focus on ivabradine, a novel agent that is currently the only available purely bradycardic agent.
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| 3. |
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| 4. |
- Shewan, Louise G., et al.
(författare)
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A statement on ethical standards in publishing scientific articles in the International Journal of Cardiology family of journals
- 2014
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Ingår i: International Journal of Cardiology. - : Elsevier. - 0167-5273 .- 1874-1754. ; 170:3, s. 253-254
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Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
- All authors of manuscripts in the International Journal of Cardiology family of journals: The International Journal of Cardiology, IJC Heart & Vessels and IJC Metabolic & Endocrine are required to make a binding statement that they as authors adhere to the following principles: 1. That the corresponding author has the approval of all other listed authors for the submission and publication of all versions of the manuscript, that all authors have made a significant independent contribution and that no one who justifies being an author has been omitted from authorship 2. That the work has not been published nor is under consideration for publication elsewhere other than in oral, poster or abstract format, and that appropriate attribution and citation is given for any material reproduced from any other source including the authors' prior publications 3. That the material in the manuscript has been acquired according to modern ethical standards and has been approved by the legally appropriate ethical committee(s) 4. That all material conflicts of interest have been declared including the use of paid medical writers and their funding source. 5. That the manuscript will be maintained on the servers of the journals and held to be a valid publication by the journals only as long as all statements in these principles remain true, and that the authors have a duty to notify the journal editors immediately if any of the statements above ceases to be true withdrawn.
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| 5. |
- Yoshida, H., et al.
(författare)
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Sex differences in effects of valsartan administration on cardiovascular outcomes in hypertensive patients: findings from the Jikei Heart Study
- 2010
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Ingår i: Journal of Hypertension. - 0263-6352. ; 28:6, s. 1150-1157
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: The randomized Jikei Heart Study has demonstrated that the addition of valsartan to conventional treatments prevents more cardiovascular events in Japanese patients with hypertension. This substudy analyses the sex difference in cardiovascular disease risk reduction in the Jikei Heart Study. METHODS: Treatment effects were evaluated by sex (1038 women and 2043 men) as hazard ratios with 95% confidence intervals (CIs) using Cox regression models adjusted for age, BMI, smoking, dyslipidemia, diabetes, antihypertensives, and statin use at baseline. RESULTS: Women were older, had higher SBP, total and low-density lipoprotein cholesterol but were less frequently smokers or diabetics, and had a lower DBP and incidence of coronary artery disease. A greater incidence of primary endpoint, a composite of cardiovascular events, occurred in men versus women [hazard ratio 1.37 (95% CI 1.02-1.85)]. Men in the valsartan group had a significant reduction in the primary endpoint [hazard ratio 0.6 (95% CI 0.44-0.82), P = 0.001], whereas a nonsignificant effect was found in women [hazard ratio 0.64 (95% CI 0.39-1.06), P = 0.075]. However, statistical heterogeneity of this valsartan effect was not found between sexes, and women of at least 55 years of age, mostly after menopause, in the valsartan group showed a significant risk reduction for the primary endpoint [hazard ratio 0.60 (95% CI 0.36-0.99)]. CONCLUSION: The valsartan effect was significant in men and in elderly women but consistent in both sexes. A potential cardiovascular protection by valsartan therapy might be attributed to the cardiovascular risk level but not to the sex difference.
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