Efficacy and safety of cinacalcet for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney disease before initiation of regular dialysis.
OBJECTIVE
To evaluate the compassionate use of cinacalcet for the management of secondary hyperparathyroidism in patients who are not on dialysis.


METHODS
Patients with stage 4-5 chronic kidney disease (CKD) who were not on dialysis, had an intact parathyroid hormone (iPTH) level greater than 300 pg/mL, and had not responded satisfactorily to treatment with phosphate binders and vitamin D were prospectively studied. Patients received 6 months of compassionate treatment with cinacalcet, which was initiated at a dose of 30 mg/day orally and flexibly dosed thereafter based on iPTH levels.


RESULTS
Twenty-six patients with a mean age±standard deviation (SD) of 58.8±16.1 years were enrolled in the study and included in the statistical analysis. The mean percentage change in iPTH levels from baseline after 6 months of treatment was -67.9±17.0%, with 92.3% (95% confidence interval (CI), 75.9-97.9) of patients showing an iPTH level within the limits recommended by Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines. The mean serum calcium concentrations had decreased significantly at the end of the study (-8.0±6.9%), while the mean serum phosphorus concentration had significantly increased (+8.3±17.0%).


CONCLUSIONS
Our results suggest that cinacalcet may be a useful alternative for the treatment of secondary hyperparathyroidism in pre-dialysis patients who are unresponsive to other treatments. The hypocalcemia and hyperphosphatemia reported in previous studies may not occur if a moderate dose of calcimimetics is used in patients with marginal glomerular filtration rates, especially if combined with vitamin D analogues and calcium-based phosphate binders.
Nephrology Department, Galdakao-Usansolo Hospital, Galdakao, Vizcaya, Spain. jesus.montenegromartinez@osakidetza.net
Jesús
J
Montenegro
Iñaki
I
Cornago
Isabel
I
Gallardo
Paula
P
García-Ledesma
Ainhoa
A
Hernando
Isabel
I
Martinez
Rosa I
RI
Muñoz
Marco A
MA
Romero
D000328:Adult; D000368:Aged; D057966:Calcimimetic Agents / Q000008:administration & dosage / Q000009:adverse effects; D002118:Calcium / Q000097:blood / Q000627:therapeutic use; D002908:Chronic Disease; D000069449:Cinacalcet; D057176:Compassionate Use Trials; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism / Q000503:physiopathology; D007674:Kidney Diseases / Q000150:complications* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009281:Naphthalenes / Q000008:administration & dosage / Q000009:adverse effects; D010281:Parathyroid Hormone / Q000097:blood*; D010758:Phosphorus / Q000097:blood; D012720:Severity of Illness Index; D016896:Treatment Outcome; D014807:Vitamin D / Q000097:blood / Q000627:therapeutic use
D057966:Calcimimetic Agents; D009281:Naphthalenes; D010281:Parathyroid Hormone; D014807:Vitamin D; D010758:Phosphorus; D002118:Calcium; D000069449:Cinacalcet