EVOLVE: Difference between revisions

EVOLVE (view source)

46 bytes added , 26 August 2015

no edit summary

495

edits

@@ Line 207: / Line 207: @@
 * High drug discontinuation rates (66.7% vs. 70.5%)
 * High drop-in rates in the placebo group (use of commercial cinacalcet)
-* Under the initial assumption of a 20% treatment effect, the study power dropped to 54%<ref name=":2">[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983668/pdf/nihms568937.pdf Moe SM, Thadhani R. "What have we learned about CKD-MBD From the EVOLVE and PRIMO trials?" ''Curr Opin Nephrol Hypertens''. 2013; 22(6): 651–655.]</ref>
+* Under the initial assumption of a 20% treatment effect, the presumed study power of 90% to 54% secondary to crossovers and drop-outs<ref name=":2">[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3983668/pdf/nihms568937.pdf Moe SM, Thadhani R. "What have we learned about CKD-MBD From the EVOLVE and PRIMO trials?" ''Curr Opin Nephrol Hypertens''. 2013; 22(6): 651–655.]</ref>
 * Combination of atherosclerotic and non-atherosclerotic cardiovascular endpoints
 ** Cinacalcet hypothesized to primarily effect non-atherosclerotic endpoints (slowing arterial calcification, reducing myocardial calcium accumulation)<ref>[http://www.ncbi.nlm.nih.gov/pubmed/25404192 Wheeler DC, et al. "Effects of Cinacalcet on Atherosclerotic and Nonatherosclerotic Cardiovascular Events in Patients Receiving Hemodialysis: The EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) Trial". ''J Am Heart Assoc. ''2014;3:e001363.]</ref>