6/28/23, 10:07 PM EVOLVE Pathway Feedback Search Clinical Topics Home Studies EVOLVE EVOLVE Disease Disease Chronic kidney disease Chronic kidney disease-mineral Trial question What is the effect of cinacalcet on CVD in patients undergoing dialysis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 41.0% female N = 3883 59.0% male 3883 patients (1578 female, 2305 male) Inclusion criteria: patients with moderate-to-severe secondary hyperparathyroidism (median level of intact PTH, 693 pg/mL) who were undergoing hemodialysis Key exclusion criteria: unstable medical condition, parathyroidectomy in the 12 weeks before the date of informed consent, severe concomitant disease, history of seizure within 12 weeks prior to randomization, scheduled date for kidney transplant from a known living donor, anticipated parathyroidectomy within 6 months after randomization, or pregnancy or breast feeding Interventions N=1948 cinacalcet (at a starting dose of 30 mg daily with dose adjustment up to 180 mg daily) N=1935 placebo (matching placebo) Primary outcome https://web.pathway.md/studies/recpEcH7Na3OmzpKO 1/2 6/28/23, 10:07 PM EVOLVE Pathway Death, myocardial infarction, hospitalization for unstable angina, heart failure, or a peripheral vascular event 49.2 % 49.2 48.2 36.9 % 24.6 % 12.3 % No significant difference 0.0 % Cinacalcet Placebo No significant difference in death, myocardial infarction, hospitalization for unstable angina, HF, or a peripheral vascular event (48.2% vs. 49.2%; HR 0.93, 95% CI 0.85 to 1.02) Secondary outcomes No significant difference in cardiovascular death (377 vs. 391; HR 0.92, 95% CI 0.8 to 1.07) No significant difference in adjudicated stroke (115 vs. 102; HR 1.07, 95% CI 0.82 to 1.4) Safety outcomes Significant difference in hypocalcemia (12.4% vs. 1.7%) and gastrointestinal adverse events (75.2% vs. 47.9%). Conclusion In patients with moderate-to-severe secondary hyperparathyroidism (median level of intact PTH, 693 pg/mL) who were undergoing hemodialysis, cinacalcet was not superior to placebo with respect to death, myocardial infarction, hospitalization for unstable angina, HF, or a peripheral vascular event. Reference EVOLVE Trial Investigators, Chertow GM, Block GA et al. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. N Engl J Med. 2012 Dec 27;367(26):2482-94. Open reference URL https://web.pathway.md/studies/recpEcH7Na3OmzpKO 2/2