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EVOLVE: Difference between revisions
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AKJD Blog: | AKJD Blog: | ||
http://ajkdblog.org/2012/11/04/kidney-week-2012-late-breaking-trials-evolve/ | http://ajkdblog.org/2012/11/04/kidney-week-2012-late-breaking-trials-evolve/ | ||
KDIGO PPT: | |||
http://www.kdigo.org/ControConf/CKD-MBD%202013/Presentations/EVOLVE%20and%20Other%20Outcome%20Trials%20in%20sHPT%20-%20G.%20Chertow.pdf | |||
==Guidelines== | ==Guidelines== | ||
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; Time to Death | ; Time to Death | ||
: Relative HR=0.94 (p=0.249) | |||
''After adjustment for baseline characteristics'' | ''After adjustment for baseline characteristics'' | ||
: Relative HR=0.86 (CI 0.78-0.96), P=0.006 | : Relative HR=0.86 (CI 0.78-0.96), P=0.006 | ||
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===Secondary Outcomes===<!-- remove when cleared by an editor --> | ===Secondary Outcomes===<!-- remove when cleared by an editor --> | ||
Secondary endpoints of stroke, death from cardiovascular diseases, parathyroidectomy, and fractures were not statistically significant. | Secondary endpoints of stroke, death from cardiovascular diseases, parathyroidectomy, and fractures were not statistically significant. | ||
=== Lag Censoring Analyses (Prespecified) ===<!-- remove when cleared by an editor --> | |||
''Censoring of data at six months after study-drug discontinuation was performed'' | |||
; Primary Composite Endpoint | |||
: HR=0.85 (CI 0.76-0.95; P=0.003) | |||
; Mortality | |||
: HR=0.83 (CI 0.73-0.96; P=0.009) | |||
=== Other Analyses ===<!-- remove when cleared by an editor --> | === Other Analyses ===<!-- remove when cleared by an editor --> | ||
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''Defined as MI, unstable angina hospitalizations, heart failure, peripheral vascular disease | ''Defined as MI, unstable angina hospitalizations, heart failure, peripheral vascular disease | ||
: 25.3 vs. 27.3 per 100 patient-years (P=0.02) | : 25.3 vs. 27.3 per 100 patient-years (P=0.02) | ||
; Censored Analysis: Post-Kidney Transplantation, Parathyroidectomy, Use of Commercially Available Cinacalcet | ; Censored Analysis: Post-Kidney Transplantation, Parathyroidectomy, Use of Commercially Available Cinacalcet | ||
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===Adverse Events===<!-- remove when cleared by an editor --> | ===Adverse Events===<!-- remove when cleared by an editor --> | ||
''Below statistics are per 100 patient-years'' | |||
* All AE: 273.2 vs. 217.8 (p<0.001) | |||
* Hypocalcemia: 6.7 vs. 0.9 (p<0.001) | |||
* Nausea: 18.3 vs. 9.1 (p<0.001) | |||
* Vomiting: 15.4 vs. 8.0 (p<0.001) | |||
* Hypocalcemia was 7 times more common in the cinacalcet group | * Hypocalcemia was 7 times more common in the cinacalcet group | ||
* Nausea and vomiting was 2 times more common in the cinacalcet group | * Nausea and vomiting was 2 times more common in the cinacalcet group | ||