Effectiveness of Cinacalcet in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Not Receiving Dialysis

Abstract

BackgroundSecondary hyperparathyroidism (SHPT) is a common complication in chronic kidney disease (CKD) patients. Cinacalcet could be a therapeutic option although its use is controversial in patients not receiving dialysis. Thus, the aim of this study is to assess the effectiveness and safety of cinacalcet in patients with CKD and SHPT without renal replacement treatment (RRT) and without renal transplantation (RT).MethodsA retrospective observational study was conducted. Patients were included if they had collected cinacalcet, under off-label use, during 2010 and 2011. Patients selected were followed from the beginning of cinacalcet therapy for one year of treatment.ResultsA total of 37 patients were included with CKD stage 3 (38%), 4 (51%) and 5 (11%). Baseline mean PTH value was 400.86 ± 168.60 mg/dl. At 12 months, a 67% of patients achieved at least a 30% reduction in their PTH value (p<0.001; CI 49.7–83.6), and the overall mean reduction of PTH values was 38% (p< 0.001; IC -49.1, -27.5). A 28% of the patients achieved KDOQI PTH goals (p = 0.003, CI 12%-50%). At 12 months, mean serum calcium values decreased by 6% and mean serum phosphorus values increased by 13%. A 19% of patients experienced hypocalcemia episodes while an increase of 24% in hyperphosphatemia episodes was observed. A 25% of patients finished cinacalcet before a year of treatment. Main withdrawal reasons were: gastrointestinal and other discomfort (8%), hypocalcaemia (8%), non-compliance (3%), interactions (3%) and excess of efficacy (3%).ConclusionsCinacalcet was effective in patients with CKD and SHPT not receiving dialysis. Electrolytic imbalances could be managed with administration of vitamin D and analogues or phosphate binders.

Long-term effectiveness of cinacalcet in non-dialysis patients with chronic kidney disease and secondary hyperparathyroidism

“…More worryingly, it increased phosphorus serum levels by 21.4% [8]. Similar or greater reductions in PTH levels were also observed in other clinical practice studies [10–16].…”

“…An analytical, retrospective, observational, non-placebo-controlled and multi-center lead-in study was conducted and previously reported elsewhere [10,11]. The lead-in study followed patients for up to 12 months.…”

“…Individualized dosage adjustments were made as needed based on each patient’s biochemical values. Patients first received standard treatment if their serum calcium levels allowed it [10,11]. The Clinical Research Ethics Committees of the Vall d’Hebron University Hospital and Bellvitge University Hospital approved this study (approval no.…”

Electrolyte and Acid-Base Disorders in Chronic Kidney Disease and End-Stage Kidney Failure

“…Cinacalcet, a calcimimetic agent, has been approved by the FDA to treat secondary hyperparathyroidism in dialysis patients. A recent observational study has shown beneficial effects of cinacalcet in lowering PTH, calcium and phosphate in non-dialysis CKD patients [111]. For patients with tertiary hyperparathyroidism (autonomous PTH production), therapeutic options are limited to cinacalcet or subtotal parathyroidectomy [112].…”

Comparison of Paricalcitol and Calcitriol in Dialysis Patients With Secondary Hyperparathyroidism: A Meta‐Analysis of Randomized Controlled Studies

“…Secondary hyperparathyroidism is a common complication in dialysis patients, and can result in renal osteodystrophy, an increased risk of bone fractures, and a higher cardiovascular and overall mortality of patients . Reduced synthesis of calcitriol in the kidneys, hypocalcemia, and hyperphosphatemia commonly occur in development of secondary hyperparathyroidism . Active forms of vitamin D are used to treat secondary hyperparathyroidism in dialysis patients through binding with greater or lesser selectivity to vitamin D receptors distributed throughout the entire body .…”