scholarly journals Gastrointestinal Events in High-Dose vs Standard-Dose Influenza Vaccine Recipients

2018 ◽  
Vol 5 (6) ◽  
Author(s):  
H Keipp Talbot ◽  
Andrew J Dunning ◽  
Corwin A Robertson ◽  
Victoria A Landolfi ◽  
David P Greenberg ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Influenza Vaccine ◽  
Randomized Clinical Trial ◽  
Standard Dose ◽  
High Dose ◽  
Passive Surveillance ◽  
Prospective Randomized Clinical Trial ◽  
Gastrointestinal Events ◽  
Gastrointestinal Adverse Events

Abstract Passive surveillance data had signaled the possibility of gastrointestinal adverse events occurring after the administration of high-dose inactivated influenza vaccine (IIV-HD). However, in a large, prospective randomized clinical trial, rates of serious gastrointestinal events were no greater among IIV-HD recipients than among those who received a standard-dose influenza vaccine.

Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial

2019 ◽  
Author(s):  
Freddy Caldera ◽  
Luke Hillman ◽  
Sumona Saha ◽  
Arnold Wald ◽  
Ian Grimes ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Inflammatory Bowel Disease ◽  
Influenza Vaccine ◽  
Randomized Clinical Trial ◽  
Bowel Disease ◽  
Standard Dose ◽  
Interquartile Range ◽  
Antibody Concentration ◽  
High Dose ◽  
Inflammatory Bowel

Abstract Background Patients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor alpha (TNF) agents may have lower immune response to the influenza vaccine. We aimed to evaluate the immunogenicity of the high dose (HD) vs standard dose (SD) influenza vaccine in patients with IBD on anti-TNF monotherapy. Methods We performed a randomized clinical trial at a single academic center evaluating the immunogenicity of the HD vs SD influenza vaccine in patients with IBD on anti-TNF monotherapy. Influenza antibody concentration was measured at immunization, at 2 to 4 weeks postimmunization, and at 6 months. Results Sixty-nine patients with IBD were recruited into the study, 40 on anti-TNF monotherapy, and 19 on vedolizumab, along with 20 healthy controls (HC). Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003). The H1N1 postimmunization levels were not significantly higher in the HD influenza vaccine (320 [interquartile range 150 to 320] vs 160 [interquartile range 80 to 320]; P = 0.18). Patients with IBD receiving the HD influenza vaccine and those on vedolizumab who received SD had equivalent antibody concentrations to HC (H1N1 P = 0.85; H3N2 P = 0.23; B/Victoria P = 0.20 and H1N1 P = 0.46; H3N2 P = 0.21; B/Victoria P = 1.00, respectively). Conclusions Patients with IBD on anti-TNF monotherapy receiving the HD influenza vaccine had significantly higher postimmunization antibody levels compared with SD vaccine. Clinicaltrials.gov (#NCT02461758).

High-dose selenium substitution in sepsis: a prospective randomized clinical trial

2011 ◽  
Vol 37 (5) ◽  
pp. 808-815 ◽  
Author(s):  
Jiri Valenta ◽  
Helena Brodska ◽  
Tomas Drabek ◽  
Jan Hendl ◽  
Antonin Kazda
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
High Dose ◽  
Prospective Randomized Clinical Trial ◽  
Selenium Substitution

Efficacy and Safety of Patiromer in Hyperkalemia: A Systematic Review and Meta-Analysis

2017 ◽  
Vol 31 (1) ◽  
pp. 6-17 ◽  
Author(s):  
Saibal Das ◽  
Jayanta Kumar Dey ◽  
Sumalya Sen ◽  
Rishav Mukherjee
Keyword(s):  
Adverse Events ◽  
Treatment Period ◽  
Meta Analysis ◽  
High Dose ◽  
Efficacy And Safety ◽  
Active Comparator ◽  
Gastrointestinal Events ◽  
End Of Treatment ◽  
All Cause Mortality ◽  
Gastrointestinal Adverse Events

Background: Patients at the highest risk of hyperkalemia are those with chronic kidney disease (CKD) stages 3 and 4. Objective: To evaluate the efficacy and safety of patiromer in hyperkalemia in patients with heart failure or CKD. Methods: The Cochrane Renal Group’s Specialized Register was searched through contact with the Trials’ Search Coordinator. We aimed at including randomized controlled trials with patiromer in patients with developed or risks of developing hyperkalemia, comparing against an active comparator or placebo. Three studies matched our inclusion and exclusion criteria, which we included in the meta-analysis. All-cause mortality, reduction in hospitalization, episodes of hypokalemia or hyperkalemia, and cardiovascular and gastrointestinal adverse events during the treatment period were our primary outcomes. Serial change in serum potassium (K+) until end of treatment or follow-up during the trial period and all other reported adverse reactions during the treatment period were our secondary outcomes. Meta-analysis (RevMan version 5.3.5) and descriptive statistics were used. Results: There was a non-significant improvement in all-cause mortality and serious cardiovascular events with patiromer than placebo. Hospitalization data were unavailable. Although serious gastrointestinal events were more common with placebo, there was a significant reduction ( P = .02) in the risk of non-serious gastrointestinal events with placebo. Patiromer lowered serum K+ more than placebo, and there were more patients developing hyperkalemia with placebo. High-dose patiromer was associated with better efficacy in some parameters but with more adverse events. Conclusion: Although patiromer seems promising, more trials with active comparator are essential to finalize its indication and use in hyperkalemia.

scholarly journals Prospective randomized clinical trial comparing high-dose ifosfamide + GM-CSF vs high-dose cyclophosphamide + GM-CSF for blood progenitor cell mobilization

2000 ◽  
Vol 25 (11) ◽  
pp. 1141-1146 ◽  
Author(s):  
J Vela-Ojeda ◽  
F Tripp-Villanueva ◽  
L Montiel-Cervantes ◽  
E Sánchez-Cortés ◽  
M Ayala-Sánchez ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Progenitor Cell ◽  
High Dose ◽  
Prospective Randomized Clinical Trial ◽  
Gm Csf ◽  
Cell Mobilization
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