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EVOLVE: Difference between revisions
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==Guidelines== | ==Guidelines== | ||
'''KDIGO CKD-BMD''' (2009, adapted)<ref name="kdigo/ | '''KDIGO CKD-BMD''' (2009, adapted)<ref name="kdigo"/> | ||
''These guidelines reflect the outcomes of the EVOLVE trial. The working group of the 2013 KDIGO Controversies Conference did not make changes to the 2009 recommendations.''<ref name="ketteler">[http://www.kdigo.org/ControConf/CKD-MBD%202013/KDIGO%202013%20CKD-MBD%20Controversies%20Conf%20Report%20AOP.pdf Ketteler M, et al. "Revisiting KDIGO clinical practice guideline on chronic kidney disease—mineral and bone disorder: a commentary from a Kidney Disease: Improving Global Outcomes controversies conference." ''Kidney International. ''2014.]</ref> | ''These guidelines reflect the outcomes of the EVOLVE trial. The working group of the 2013 KDIGO Controversies Conference did not make changes to the 2009 recommendations.''<ref name="ketteler">[http://www.kdigo.org/ControConf/CKD-MBD%202013/KDIGO%202013%20CKD-MBD%20Controversies%20Conf%20Report%20AOP.pdf Ketteler M, et al. "Revisiting KDIGO clinical practice guideline on chronic kidney disease—mineral and bone disorder: a commentary from a Kidney Disease: Improving Global Outcomes controversies conference." ''Kidney International. ''2014.]</ref> | ||
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* Primary outcome: Composite of death or CV event | * Primary outcome: Composite of death or CV event | ||
==Population== | ==Population<ref name="design"/>== | ||
===Inclusion Criteria=== | ===Inclusion Criteria=== | ||
* Age ≥18 years | * Age ≥18 years | ||
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* Ca × P ≥45mg²/dL² (3.63 mmol²/L²) | * Ca × P ≥45mg²/dL² (3.63 mmol²/L²) | ||
===Exclusion Criteria=== | ===Exclusion Criteria=== | ||
* Parathyroidectomy ≤12 weeks prior to informed consent | * Parathyroidectomy ≤12 weeks prior to informed consent | ||
* Severe concomitant disease | * Severe concomitant disease | ||
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* Anticipated parathyroidectomy within 6 months after randomization | * Anticipated parathyroidectomy within 6 months after randomization | ||
===Baseline Characteristics=== | ===Baseline Characteristics<ref name="baseline"/>=== | ||
''Significant differences were reported between mean diastolic BP and prior TIA rate.'' | ''Significant differences were reported between mean diastolic BP and prior TIA rate.'' | ||
==== Demographics ==== | ====Demographics==== | ||
''From the cinacalcet group.'' | ''From the cinacalcet group.'' | ||
* Age: 55 years | * Age (mean): 55 years | ||
* Female: | * Female: 42% | ||
* Race: 58% white, 21%black, 21% other | * Race: 58% white, 21% black, 21% other | ||
* BMI: 26 | * BMI (mean): 26 | ||
* Dialysis duration: | * Dialysis vintage (duration): 45 months | ||
* Blood pressure: 140/80 | * Blood pressure: 140/80 | ||
* Medical history: | * Medical history: | ||
** Diabetes | ** Diabetes mellitus: 34% (T2DM in 30%) | ||
** Cardiovascular disease: 95% | ** Cardiovascular disease: 95% | ||
*** Hypertension: | *** Hypertension: 93% | ||
*** Heart failure: 23% | *** Heart failure: 23% | ||
*** Peripheral vascular disease: 16% | *** Peripheral vascular disease: 16% | ||
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*** Atrial fibrillation: 10% | *** Atrial fibrillation: 10% | ||
====Biochemical==== <!-- need to | ====Biochemical====<!-- need to verify these--> | ||
* Hemoglobin: 11.8 g/dL | * Hemoglobin: 11.8 g/dL | ||
* BUN: 61.9 mg/dL) | * BUN: 61.9 mg/dL) | ||
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<references> | <references> | ||
<ref name="kdigo">[http://www.kdigo.org/clinical_practice_guidelines/pdf/CKD/KDIGO%20CKD-MBD%20GL%20KI%20Suppl%20113.pdf Kidney Disease: Improving Global Outcomes (KDIGO) CKD–MBD Work Group. "KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD–MBD)." ''Kidney International.'' 2009; 76 (Suppl 113): S1–S130.]</ref> | <ref name="kdigo">[http://www.kdigo.org/clinical_practice_guidelines/pdf/CKD/KDIGO%20CKD-MBD%20GL%20KI%20Suppl%20113.pdf Kidney Disease: Improving Global Outcomes (KDIGO) CKD–MBD Work Group. "KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD–MBD)." ''Kidney International.'' 2009; 76 (Suppl 113): S1–S130.]</ref> | ||
<ref name="design">[http://ndt.oxfordjournals.org/content/27/7/2872.long Design]</ref> | |||
<ref name="guidelines">[http://cjasn.asnjournals.org/content/2/5/898.full Guidelines]</ref> | |||
</references> | </references> | ||