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Träfflista för sökning "WFRF:(Budaj Andrzej) srt2:(2010-2014);pers:(Held Claes 1956)"

Sökning: WFRF:(Budaj Andrzej) > (2010-2014) > Held Claes 1956

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1.
  • Becker, Richard C, et al. (författare)
  • Bleeding complications with the P2Y12 receptor antagonists clopidogrel and ticagrelor in the PLATelet inhibition and patient Outcomes (PLATO) trial
  • 2011
  • Ingår i: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 32:23, s. 2933-2944
  • Tidskriftsartikel (refereegranskat)abstract
    • AimsMore intense platelet-directed therapy for acute coronary syndrome (ACS) may increase bleeding risk. The aim of the current analysis was to determine the rate, clinical impact, and predictors of major and fatal bleeding complications in the PLATO study.Methods and resultsPLATO was a randomized, double-blind, active control international, phase 3 clinical trial in patients with acute ST elevation and non-ST-segment elevation ACS. A total of 18 624 patients were randomized to either ticagrelor, a non-thienopyridine, reversibly binding platelet P2Y(12) receptor antagonist, or clopidogrel in addition to aspirin. Patients randomized to ticagrelor and clopidogrel had similar rates of PLATO major bleeding (11.6 vs. 11.2%; P = 0.43), TIMI major bleeding (7.9 vs. 7.7%, P = 0.56) and GUSTO severe bleeding (2.9 vs. 3.1%, P = 0.22). Procedure-related bleeding rates were also similar. Non-CABG major bleeding (4.5 vs. 3.8%, P = 0.02) and non-procedure-related major bleeding (3.1 vs. 2.3%, P = 0.05) were more common in ticagrelor-treated patients, primarily after 30 days on treatment. Fatal bleeding and transfusion rates did not differ between groups. There were no significant interactions for major bleeding or combined minor plus major bleeding between treatment groups and age ≥75 years, weight <60 kg, region, chronic kidney disease, creatinine clearance <60 mL/min, aspirin dose >325 mg on the day of randomization, pre-randomization clopidogrel administration, or clopidogrel loading dose.Conclusion Ticagrelor compared with clopidogrel was associated with similar total major bleeding but increased non-CABG and non-procedure-related major bleeding, primarily after 30 days on study drug treatment. Fatal bleeding was low and did not differ between groups.
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2.
  • Vedin, Ola, et al. (författare)
  • Tooth loss is highly prevalent and associated with cardiovascular risk factors in patients with chronic coronary heart disease in the global stability trial
  • 2013
  • Ingår i: Journal of the American College of Cardiology. - 0735-1097 .- 1558-3597. ; 61:10, s. E1368-E1368
  • Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)abstract
    • BackgroundSeveral reports have proposed a link between periodontal disease (PD) and coronary heart disease (CHD). However, knowledge regarding PD in patients with established CHD is scarce. Therefore, we investigated the prevalence of self-reported PD and its relation to cardiovascular (CV) risk factors in high-risk patients with CHD participating in the ongoing STABILITY study, a global clinical trial evaluating the lipoprotein phospho-lipase A2 inhibitor darapladib.MethodsAt study baseline, 15,828 study participants from 39 countries reported their remaining number of teeth (none, 1-14, 15-19, 20-25 or 26-32) and frequency of gum bleeds (never/rarely, sometimes, often or always). Data on CV risk factors were also obtained. Statistical analyses were performed using linear and logistic regression, adjusting for age, smoking, diabetes and education.ResultsApproximately 40 % of participants had < 15 teeth and 16 % had no teeth; 25 % of subjects reported gum bleeds. For every decrease in number of teeth category we observed increasing levels of Lp-PLA2 activity (+1.98 mmol/L/min), hs-CRP (+0.07 g/L), LDL cholesterol (+0.015 mmol/L), fasting plasma glucose (+0.015 mmol/L), systolic blood pressure (+0.41 mmHg) and waist circumference (+0.52 cm) (p < 0.0001 for all), as well as a higher probability of having diabetes (odds increasing by 11% for every decrease in number of teeth category), being a current or former smoker vs. being a non-smoker (+39% and +21%, respectively), and having a lower education (p < 0.0001 for all). Gum bleeds were associated with increasing LDL cholesterol and systolic blood pressure, as well as a greater probability of being a non-smoker and having a higher education (p < 0.0001 for all).ConclusionTooth loss was highly prevalent in this global CHD population and was associated with several traditional CV risk factors and inflammatory markers, including the novel Lp-PLA2 activity. Gum bleeding was less common and associations to CV risk factors were less evident compared to tooth loss. These findings require confirmation in large independent populations to elucidate whether PD can be used as a clinically useful risk marker for CHD.
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3.
  • White, Harvey D., et al. (författare)
  • Survival with Cardiac-Resynchronization Therapy in Mild Heart Failure
  • 2014
  • Ingår i: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 370:18, s. 1702-1711
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Elevated lipoprotein-associated phospholipase A(2) activity promotes the development of vulnerable atherosclerotic plaques, and elevated plasma levels of this enzyme are associated with an increased risk of coronary events. Darapladib is a selective oral inhibitor of lipoprotein-associated phospholipase A(2). Methods: In a double-blind trial, we randomly assigned 15,828 patients with stable coronary heart disease to receive either once-daily darapladib (at a dose of 160 mg) or placebo. The primary end point was a composite of cardiovascular death, myocardial infarction, or stroke. Secondary end points included the components of the primary end point as well as major coronary events (death from coronary heart disease, myocardial infarction, or urgent coronary revascularization for myocardial ischemia) and total coronary events (death from coronary heart disease, myocardial infarction, hospitalization for unstable angina, or any coronary revascularization). Results: During a median follow-up period of 3.7 years, the primary end point occurred in 769 of 7924 patients (9.7%) in the darapladib group and 819 of 7904 patients (10.4%) in the placebo group (hazard ratio in the darapladib group, 0.94; 95% confidence interval [CI], 0.85 to 1.03; P=0.20). There were also no significant between-group differences in the rates of the individual components of the primary end point or in all-cause mortality. Darapladib, as compared with placebo, reduced the rate of major coronary events (9.3% vs. 10.3%; hazard ratio, 0.90; 95% CI, 0.82 to 1.00; P=0.045) and total coronary events (14.6% vs. 16.1%; hazard ratio, 0.91; 95% CI, 0.84 to 0.98; P=0.02). ConclusionsIn patients with stable coronary heart disease, darapladib did not significantly reduce the risk of the primary composite end point of cardiovascular death, myocardial infarction, or stroke. (Funded by GlaxoSmithKline; STABILITY ClinicalTrials.gov number, NCT00799903.)
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4.
  • White, Harvey, et al. (författare)
  • Study design and rationale for the clinical outcomes of the STABILITY Trial (STabilization of Atherosclerotic plaque By Initiation of darapLadIb TherapY) comparing darapladib versus placebo in patients with coronary heart disease
  • 2010
  • Ingår i: American Heart Journal. - : Elsevier BV. - 0002-8703 .- 1097-6744. ; 160:4, s. 655-661.e2
  • Tidskriftsartikel (refereegranskat)abstract
    • Background Elevated plasma levels of lipoprotein-associated phospholipase A(2) (Lp-PLA(2)) are associated with increased risk of cardiovascular (CV) events. Direct inhibition of this proinflammatory enzyme with darapladib may benefit CV patients when given as an adjunct to standard of care, including lipid-lowering and antiplatelet therapies. Methods STABILITY is a randomized, placebo-controlled, double-blind, international, multicenter, event-driven trial. The study has randomized 15,828 patients with chronic coronary heart disease (CHD) receiving standard of care to darapladib enteric-coated (EC) tablets, 160 mg or placebo. Results The primary end point is the composite of major adverse cardiovascular events (MACE): CV death, nonfatal myocardial infarction, and nonfatal stroke. The key secondary end points will include major coronary events, total coronary events, individual components of MACE, and all-cause mortality. Prespecified substudies include 24-hour ambulatory blood pressure monitoring, albuminuria progression, changes in cognitive function, and pharmacokinetic and biomarker analyses. Health economic outcomes and characterization of baseline lifestyle risk factors also will be assessed. The study will continue until 1,500 primary end points have occurred to achieve 90% power to detect a 15.5% reduction in the primary end point. The median treatment duration is anticipated to be 2.75 years. Conclusions STABILITY will assess whether direct inhibition of Lp-PLA(2) with darapladib added to the standard of care confers clinical benefit to patients with CHD.
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