Six-Month Real-World Outcomes of Cinacalcet in Patients on Hemodialysis Who Have Secondary Hyperparathyroidism (SHPT) in Quito, Ecuador

Background: Secondary hyperparathyroidism (SHPT) is a serious complication in patients on HD, associated with CV events, vascular calcifications, fractures, and mortality. Cinacalcet has shown efficacy in controlling PTH levels, yet real-world evidence from Latin America is limited. This study evaluates the biochemical response to cinacalcet over 6 months in a cohort of HD patients in Quito-Ecuador. Methods: Prospective, single-cohort study in HD patients with SHPT in Quito. Inclusion criteria were at least two historical PTH values >500 pg/mL, patients with prior parathyroidectomy and PTH <500 pg/mL were excluded. Patients were followed monthly for six months, with clinical and biochemical monitoring of PTH, calcium, phosphorus, and alkaline phosphatase (ALP). Cinacalcet dosing was adjusted based on KDOQI targets. Neck ultrasound was performed to assess parathyroid nodular disease. Results: Of 100 patients (64 men, 36 women; mean age 51.6 years), 47% achieved a ≥50% reduction in PTH, with mean levels declining from 1151 to 535 pg/mL. Serum calcium and phosphorus remained within acceptable ranges (mean Ca: 9.0 to 8.2 mg/dL; P: 5.6 to 4.5 mg/dL). ALP decreased progressively from 427 to 340 U/L. Neck ultrasound identified nodular disease in 40% of patients, all of whom required dose escalation from 30 mg to 60 mg/day. Those with adenomas had the highest baseline PTH levels. Bone pain improved in most of the 52% who initially reported it, and fracture rate was 6%. Conclusion: Cinacalcet effectively reduced PTH levels over six months in chronic hemodialysis patients, including those with nodular parathyroid disease. These real-world results support its role in SHPT management in Latin American settings, where clinical data remain scarce.