7 research outputs found
Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates
DOSE ADJUSTMENT PRACTICES OF PEGINESATIDE VS. EPOETIN IN EMERALD 1 AND 2 PIVOTAL TRIALS
Peginesatide (P) is a synthetic, pegylated, peptide-based ESA approved for treatment of anemia due to chronic kidney disease in adult patients (pts) on dialysis. P demonstrated noninferiority to epoetin (E) in maintenance of Hb levels in hemodialysis (HD) pts in two Phase 3 randomized, active-controlled, open-label trials (EMERALD 1,2). A large dialysis organization (LDO) recently reported an ESA dose adjustment rate of 12.1/pt-year (Bond et al, ISPOR 2012). This post hoc analysis evaluated dosing practices for maintaining Hb with P vs E.
Pooled data from the two trials compared P (1x monthly; N=1066) with E (1-3x wkly; N=542) in HD pts previously on stable doses of E. Hb was measured during screening, at baseline and wkly (evaluation period, wks 29-36) or every 2 wks (all other periods). Dose adjustments were not to be made more frequently than every 4 wks, unless required for safety purposes. Dose adjustments (defined as change >±20% from last dose) were evaluated during the titration (wks 0-28), evaluation, and long-term follow-up (LT, wks 36-52) periods. Dose postponements were defined as >35d for P; for E, they were >4d, 6d, or 9d for TIW, BIW, and QW, respectively.
Across the entire study period, P doses were adjusted ∼3 times less frequently and held ∼8 times less than P (Table).
P (per pt-year)
E (per pt-year)
E/P ratio
Total Dose Adjustments
3.5
10.3
2.9
Dose Increases
1.7
5.3
3.0
Dose Decreases
1.8
5.0
2.8
Dost Postponements
0.6
5.0
8.3
Within each treatment arm, dose adjustment and postponement rates (including corresponding E/P ratios) were similar across titration, evaluation, and LT periods.
E dose adjustment rate was similar to that of real world practice in an LDO. E doses were adjusted and held more frequently than P despite similar protocol specifications for dose alteration and Hb maintenance
Recommended from our members
Telavancin in the Treatment of Concurrent Staphylococcus aureus Bacteremia: A Retrospective Analysis of ATLAS and ATTAIN Studies
<p>Article
full text</p>
<p>The full text of this
article can be found <a href="https://link.springer.com/article/10.1007/s40121-017-0162-1"><b>here</b>.</a></p>
<p>Provide
enhanced content for this article</p>
<p>If you are an author
of this publication and would like to provide additional enhanced content for
your article then please contact <a href="http://www.medengine.com/Redeem/âmailto:[email protected]â"><b>[email protected]</b></a>.</p>
<p>The journal offers a
range of additional features designed to increase visibility and readership.
All features will be thoroughly peer reviewed to ensure the content is of the
highest scientific standard and all features are marked as ‘peer reviewed’ to
ensure readers are aware that the content has been reviewed to the same level
as the articles they are being presented alongside. Moreover, all sponsorship
and disclosure information is included to provide complete transparency and
adherence to good publication practices. This ensures that however the content
is reached the reader has a full understanding of its origin. No fees are
charged for hosting additional open access content.</p>
<p>Other enhanced
features include, but are not limited to:</p>
<ul>
<li>Slide decks</li>
<li>Videos and animations</li>
<li>Audio abstracts</li>
<li>Audio slides</li>
</ul
Assessment of Minimum Inhibitory Concentrations of Telavancin by Revised Broth Microdilution Method in Phase 3 Hospital-Acquired Pneumonia/Ventilator-Associated Pneumonia Clinical Isolates
<p>Article
full text</p>
<p>The full text of this
article can be found <b><a href="https://link.springer.com/article/10.1007/s40121-016-0133-y">here.</a></b></p>
<p>Provide
enhanced content for this article</p>
<p>If you are an author
of this publication and would like to provide additional enhanced content for
your article then please contact <a href="http://www.medengine.com/Redeem/âmailto:[email protected]â"><b>[email protected]</b></a>.</p>
<p>The journal offers a
range of additional features designed to increase visibility and readership.
All features will be thoroughly peer reviewed to ensure the content is of the
highest scientific standard and all features are marked as ‘peer reviewed’ to
ensure readers are aware that the content has been reviewed to the same level
as the articles they are being presented alongside. Moreover, all sponsorship
and disclosure information is included to provide complete transparency and
adherence to good publication practices. This ensures that however the content
is reached the reader has a full understanding of its origin. No fees are
charged for hosting additional open access content.</p>
<p>Other enhanced
features include, but are not limited to:</p>
<ul>
<li>Slide decks</li>
<li>Videos and animations</li>
<li>Audio abstracts</li>
<li>Audio slides</li>
</ul