Real-world evaluation of cinacalcet on hard outcomes in hemodialysis patients in Saudi Arabia

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BACKGROUND: Chronic Kidney Disease (CKD) complications, like cardiovascular complications, are one of the leading causes of mortality. Managing the biochemical profile is essential in slowing the progression of CKD and its associated consequences. This study aimed to assess the effect of cinacalcet add-on therapy on clinical outcomes in patients with End-Stage Renal Disease (ESRD) on Hemodialysis (HD) who developed Secondary Hyperparathyroidism and are receiving hemodialysis. METHOD: A mixed retrospective-prospective cohort multicenter study was conducted in three hospitals in Saudi Arabia between December 1st, 2019, and January 31st, 2021. RESULTS: One hundred and seventy-four subjects were analyzed; the incidence of the cardiovascular events and the first cardiovascular events in patients on cinacalcet was significantly decreased compared to the patients on the conventional therapy (p = 0.02 & 0.005, respectively). The incidence of coronary artery diseases was significantly decreased by 61% in the patients on cinacalcet (HR = 0.39, p = 0.04). Patients on Cinacalcet were 69% less in all-cause first hospitalization hazard ratio; HR = 0.31, 95% CI: 0.16–0.63, p = 0.001. There was no significant reduction in the risk of all-cause and cardiovascular mortality in the patients on Cinacalcet (p = 0.06 & 0.12, respectively), but patients with Hypertension and “Diabetes Mellitus & Hypertension” etiology had a lower mortality HR (Hypertension: HR = 0.46, 95% CI = 0.21-1.00, p = 0.05; “Diabetes Mellitus & Hypertension”: HR = 0.42, 95% CI = 0.2-1.00, p = 0.04). There was no significant difference in the frequency of incidence of bone fractures between the two groups (p = 0.26). CONCLUSION: Cinacalcet is superior in decreasing the frequency of cardiovascular events. However, it is not effective in reducing the risk of all-cause and cardiovascular mortality, except in patients with “Hypertension” and “Diabetes Mellitus & Hypertension” etiology, and it might offer a somewhat protective trend in males and older patients. CLINICAL TRIAL NUMBER: Not applicable.

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