Papers by ester marina cela
Evidence-based medicine, 2014
anticoagulation within 3 days postoperatively, which may have conferred both antithrombotic benef... more anticoagulation within 3 days postoperatively, which may have conferred both antithrombotic benefit and increased bleeding risk. Of seven safety outcomes evaluated, major bleeding was the only to reach significance, with no differences in life-threatening bleeding or significant hypotension. Major bleeding was powered for a safety outcome and had a small absolute but significant difference between groups. Although the risk of perioperative bleeding was equivalent between groups, it is likely that the benefit would favour aspirin in high-risk patients. However, in a post hoc analysis, a composite of major or lifethreatening bleeding demonstrated a significant increased risk for up to 7 days postoperatively in the aspirin group. POISE-2 demonstrates that perioperative bleeding risks outweigh any antithrombotic benefit in patients not on lifelong aspirin for an appropriate indication and aspirin should likely be held preoperatively in this group. However, considering patients at high risk for a perioperative thrombotic complication (those requiring lifelong aspirin for an appropriate primary or secondary indication), POISE-2's study design mutes the antiplatelet treatment effect between the placebo and aspirin groups. It is still not possible to conclude whether temporary aspirin cessation for surgery is safe in high-risk patients. Aside from during closed-space procedures, aspirin should be continued perioperatively in high-risk patients until a trial specifically designed to examine perioperative outcomes in this population suggests otherwise.
Journal of Hepatology, 2010
Background & Aims: The benefit of individualizing treatment for patients with genotype 3 HCV infe... more Background & Aims: The benefit of individualizing treatment for patients with genotype 3 HCV infection on the basis of viral clearance at week 4 (wk4-R) has not been firmly established. Methods: Four hundred and fourteen patients received Peginterferon alpha-2b plus 1000-1200 mg of ribavirin daily according with body weight > or <75 kg. Patients were randomized to standard 24 weeks (Std24) or to a 12 or 36 weeks variable treatment duration (Var12/36). In the variable treatment arm, patients with or without wk4-R were allocated to either 12 or 36 weeks duration. Results: At treatment week 4, HCV RNA was undetectable in 262 patients (63.3%), 136 in the Std24, and 126 in the Var12/36 group (p = 0.41). In patients with wk4-R, end-of-treatment (EOT) responses were 80.4% (CI 85.4-95.3) and 97.6% (CI 94.9-99.9) in the two arms, respectively (p = 0.019). In patients without wk4-R, corresponding rates were 61.9% (50.6-73.2) and 75.3% (CI 65.9-84.6) (p = 0.08). SVR was attained in 302 patients, 71.4% (CI 65.3-77.6) in the St24 group and 74.3% (CI 58.4-80.3) in the variable 12/36 arm. Among patients with wk4-R, SVR was 81.6% (CI 75.1-88.1) and 82.5% (75.9-89.1), respectively. In patients without wk4-R, SVR amounted to 52.1% (CI 40.4-63.7) and 61.7 (CI 51.1-72.3) in the two arms (p = 0.25). Conclusions: HCV genotype 3 patients with week4-R may be treated safely with 12 weeks of therapy, provided that sufficiently high doses of ribavirin are administered. For patients still viremic at treatment week 4, SVR rates were numerically higher after 36 weeks of treatment than after the currently recommended 24 weeks.
Uploads
Papers by ester marina cela