Abstract
BackgroundCalcimimetic treatment of secondary hyperparathyroidism in chronic dialysis patients is often followed by hypocalcemia.MethodsWe investigated the frequency, predictors, consequences and therapeutic responses following cinacalcet-induced hypocalcemia in an incident European hemodialysis cohort of 1068 patients with a cinacalcet prescription.ResultsOf 905 normocalcemic patients initiating cinacalcet, 67% developed hypocalcemia within 12 months: 68% mild, 23% moderate, 9% severe. Compared to persistently normocalcemic patients, those with severe hypocalcemia were more often diabetic, overweight, had cardiovascular disease, shorter dialysis vintage, used a catheter dialysis access, had fewer active vitamin-D sterols, and exhibited higher CRP and iPTH and lower calcium levels. Multivariate predictors of hypocalcemia included a catheter for vascular access, low albumin and high iPTH. Generally, no therapeutic intervention to prevent hypocalcemia was taken prior to cinacalcet initiation. After the hypocalcemic event, the most common clinical response was no change of the dialysis or medical regimen. Following the hypocalcemic event, iPTH remained low even in those with severe hypocalcemia. The number of deaths and cardiovascular events did not differ between patients with and without hypocalcemia within six months following cinacalcet initiation.ConclusionTwo-thirds of cinacalcet initiated patients experienced hypocalcaemia with 9% being severe. Hypocalcemia was mostly asymptomatic, transient (with and without targeted intervention to correct it) and not associated with an increase in cardiovascular events or deaths.
Highlights
IntroductionSecondary hyperparathyroidism (sHPT) is common in patients on chronic hemodialysis (HD)
Secondary hyperparathyroidism is common in patients on chronic hemodialysis (HD)
Longitudinal anonymised individual-level data on medical history, laboratory (albumin, calcium, c-reactive protein (CRP), ferritin, hemoglobin, phosphate, and parathyroid hormone (PTH)), dialysis, and medication data, plus ICD-10 coded hospitalisation and death data are available for patients who enrolled in AROii between 1 January 2007 and 31 December 2009 and were followed-up to end of 2014
Summary
Secondary hyperparathyroidism (sHPT) is common in patients on chronic hemodialysis (HD). As recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) chronic kidney disease-mineral bone disorder (CKD-MBD) Guideline, therapeutic approaches for dialysis patients with sHPT who have PTH levels above the target range include calcimimetics, calcitriol and active vitamin D sterols, or, in advanced cases, parathyroidectomy [2]. Use of active vitamin D sterols for patients with advanced sHPT can lead to hypercalcemia and/or exacerbation of hyperphosphatemia Calcimimetics, such as cinacalcet, may be the treatment of choice since they do not increase serum calcium or phosphate in contrast to active vitamin D sterols. Compared to persistently normocalcemic patients, those with severe hypocalcemia were more often diabetic, overweight, had cardiovascular disease, shorter dialysis vintage, used a catheter dialysis access, had fewer active vitamin-D sterols, and exhibited higher CRP and iPTH and lower calcium levels. Hypocalcemia was mostly asymptomatic, transient (with and without targeted intervention to correct it) and not associated with an increase in cardiovascular events or deaths
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