Hyperparathyroidism In Dialysis Patients Research Articles

Secondary Hyperparathyroidism in Dialysis Patients: Short- and Long-Term Outcomes of Conservative Parathyroidectomy

Secondary Hyperparathyroidism in Dialysis Patients: Short- and Long-Term Outcomes of Conservative Parathyroidectomy

Active Vitamin D Use and Fractures in Hemodialysis Patients: Results from the International DOPPS.

Active vitamin D is commonly used to control secondary hyperparathyroidism in dialysis patients, but it is unknown whether active vitamin D directly improves bone strength, independently of its ability to suppress parathyroid hormone (PTH). We analyzed the association between the prescription of active vitamin D and incidence of any fracture and hip fracture in 41,677 in-center hemodialysis patients from 21 countries in phases 3 to 6 (2005 to 2018) of the Dialysis Outcomes and Practice Patterns Study (DOPPS). We used Cox regression, adjusted for PTH and other potential confounders, and used a per-protocol approach to censor patients at treatment switch during follow-up. We also used a facility preference approach to minimize confounding by indication. Overall, 55% of patients were prescribed active vitamin D at study enrollment. Event rates (per patient-year) were 0.024 for any fracture and 0.010 for hip fracture. The adjusted hazard ratio (95% confidence interval) comparing patients prescribed versus not prescribed active vitamin D was 1.02 (0.90 to 1.17) for any fracture and 1.00 (0.81 to 1.23) for hip fracture. In the facility preference approach, there was no difference in fracture rate between facilities with higher versus lower active vitamin D prescriptions. Thus, our results do not suggest a PTH-independent benefit of active vitamin D in fracture prevention and support the current KDIGO guideline suggesting the use of active vitamin D only in subjects with elevated or rising PTH. Further research is needed to determine the role of active vitamin D beyond PTH control. © 2023 American Society for Bone and Mineral Research (ASBMR).

Risk factors associated with the development of secondary hyperparathyroidism in dialysis patients.

Aim To determine risk factors associated with the development and severity of secondary hyperparathyroidism in dialysis patients. Methods A cross-sectional study at the Clinical Centre of the University of Tuzla (March 2022) included 104 adult patients (males 51.9%, females 48.1%) with chronic kidney diseases under dialysis treatment. Based on parathyroid hormone (PTH) values, patients were divided into two groups: study group (45/104, PTH >792pg/mL) and control group (59/104, PTH 176-792 pg/ mL). The analysis aimed to resolve whether there was a connection between the duration of dialysis, the type of therapy treatment administered, the underlying kidney disease, and the presence of comorbidities with the values of PTH, and a wide spectrum of monitored laboratory parameters. Results The most common causes of chronic renal failure were undefined kidney diseases (32.7%), followed by diabetic nephropathy (18.3%) and chronic glomerulonephritis (16.3%). In the examined biochemical parameters, a significant difference was found in mean values of alkaline phosphatase (p<0.001). The correlation was proved between the duration of dialysis (p=0.028), the values of phosphorus (p=0.031), and alkaline phosphatase (p<0.001) with absolute values of PTH. The most common present comorbidity was hypertension (78.8%), followed by cardiovascular diseases (40.4%) and diabetes (22.1%). Conclusion A number of factors contribute to the development and severity of SHPT. Modulation of therapy and better control of risk parameters can prolong and reduce the frequency of SHPT in dialysis patients, as well as the occurrence of comorbidities.

Efficacy and safety of radiofrequency ablation versus parathyroidectomy for secondary hyperparathyroidism in dialysis patients: a single-center retrospective study

We compared the efficacy and safety of ultrasound (US)-guided radiofrequency ablation (RFA) and parathyroidectomy (PTX) for the treatment of secondary hyperparathyroidism (SHPT). In this single-center retrospective study, we divided patients into PTX (n = 53) and RFA (n = 47) groups. The primary outcome was the proportion of patients who achieved the target intact parathyroid hormone (iPTH) concentration range (≤ 300 pg/mL). Secondary outcomes were the differences in the changes in iPTH, calcium, and phosphorus levels over time and prognosis. iPTH concentrations of 82.1% and 64.1% in the PTX and RFA groups, respectively, were within the recommended range at the endpoint (P = 0.07). iPTH concentrations in the PTX and RFA groups dropped sharply after treatment (82 ± 163 pg/mL and 280 ± 307 pg/mL, respectively, P < 0.001). There was no difference in the trends of iPTH, calcium, and phosphorus levels between the two groups (P > 0.05). Survival analysis revealed no differences in all-cause mortality and cumulative response rate between the two groups (P = 0.90, P = 0.14, respectively). Notably, the incidence of infection and length of the hospital stay in the RFA group were significantly lower. The preoperative bone-specific alkaline phosphatase concentration was a risk factor for postoperative hypocalcemia. US-guided RFA is minimally invasive and compared to PTX in terms of long-term efficacy and complications in the treatment of severe SHPT in maintenance dialysis patients. It may be used as an alternative technique to PTX; however, further studies are needed.

Surgical management of secondary hyperparathyroidism in dialysis patients in Senegal.

Secondary hyperparathyroidism (SHPT) is a common complication of end-stage renal disease. Surgical management occurs in severe forms and/or unresponsive medical treatment. The aim of this study was to outline the indications of parathyroidectomy and its evolution after surgical approach. It was a five-year multicenter backward study in Otorhinolaryngology Department of Fann Hospital and four dialysis centers in Dakar. We include all patients with SHPT who underwent surgery. Preoperative clinical and paraclinical parameters, clinical-biological evolution, and histology findings of the resected parathyroid specimen were collected. Out of 58 patients with hyperparathyroidism, 18 patients required parathyroidectomy, corresponding to a prevalence of 31%. Mean age of patients was 46.6 ± 15.29 years and sex ratio 0.61. Mean duration on dialysis was 44.4 ± 30 months. Ten patients (55.56%) had bone pain and nine patients (50%) had joint pain. Mean serum calcium was 97.27 ± 8.66 mg/L. Mean blood phosphorus levels were 40.47 ± 9.99 mg/L. Mean iPTH rate was 1493.22 ± 1014.93 ng/mL, with a maximum of 5000 ng/mL (77N). Mean value of 25-OH Vitamin D was 32.89 ± 16.02 ng/mL. Parathyroidectomy was indicated after failure of medical treatment with persistence of a serum intact parathyroid hormone concentration above 800 μg/mL in all patients. Subtotal parathyroidectomy (7/8) was performed in 11 patients (61.1%). Two patients (11.11%) benefited from a selective parathyroidectomy (3/4). Evolution was favorable for 13 patients, corresponding to a success rate of 72.2%. It was unfavorable in five patients including one patient with hypoparathyroidism and four patients with recurrent hyperparathyroidism. Surgery for patients with renal hyperparathyroidism in the era of calcimimetics continues to play an important role in selected patients and achieves efficient control of hyperparathyroidism in developing countries.

Increasing rates of parathyroidectomy to treat secondary hyperparathyroidism in dialysis patients with Medicare coverage

BackgroundSecondary hyperparathyroidism affects nearly all patients with renal failure on dialysis. Medical treatment of secondary hyperparathyroidism has considerably evolved over the past 2 decades, with parathyroidectomy reserved for severe cases. The primary objective of our study was to understand how trends in medical treatments affected parathyroidectomy rates in patients with secondary hyperparathyroidism on dialysis. MethodsWe used the United States Renal Data System to identify 379,835 adult patients (age ≥18) who were on maintenance dialysis in the United States between 2006 and 2016 with Medicare as the primary payor and ascertained treatment for secondary hyperparathyroidism. Adjusted rate ratios for rates of parathyroidectomy were calculated using multivariable-adjusted Poisson regression. ResultsOf 379,835 secondary hyperparathyroidism patients, 4,118 (1.1%) underwent parathyroidectomy, 39,835 (10.5%) received cinacalcet, 243,522 (64.1%) received phosphate binders, 17,571 (4.6%) received vitamin D analogs, and 86,899 (22.9%) received no treatment during the 10 years of follow-up. Over the entire study period, there was a 3.5-fold increase in the use of calcimimetics and a 3.4-fold increase in rates of parathyroidectomy. Compared to 2006 through 2009, utilization of parathyroidectomy increased 52% (adjusted rate ratio = 1.52, 95% confidence interval: 1.39–1.65) between 2010 and 2013 and by 106% (adjusted rate ratio = 2.06, 95% confidence interval: 1.90–2.24) between 2014 and 2016. The greatest increase in parathyroidectomy utilization occurred in younger patients (age 18–64 years), Black patients, female patients, those living in higher poverty neighborhoods, those listed for kidney transplant, and those who live in the Southern region of the United States. ConclusionDespite the evolution of medical treatments and an increase in the use of calcimimetics to treat secondary hyperparathyroidism, parathyroidectomy rates have been steadily increasing among dialysis patients with Medicare coverage.

Implementation of a Nurse-Led Etelcalcetide Protocol at the Outpatient Dialysis Unit: A Quality Improvement Project

This quality improvement project was implemented to improve renal hyperparathyroidism in patients with end stage kidney disease who are on hemodialysis through the implementation of a nurse-led etelcalcetide protocol. Results showed that the post-intervention group had a 16.7% increase of the intact parathyroid hormone (iPTH) range within the target goal compared to the 3-month pre-intervention assessment (95% CI; 20.3% to 48.1%). The odds of being in the PTH target range were 1.73 times higher after the 3-month intervention than measurements obtained before starting the intervention (95% CI for the odds ratio: 0.29 to 10.3). Despite the lack of statistical significance (p = 0.688) due to a small sample size, there was an improvement in reaching goal PTH levels. Further studies are needed to analyze the effectiveness of nurse-led protocols in treating renal hyperparathyroidism in dialysis patients.

Hungry Bone Syndrome after Surgical Treatment of Hyperparathyroidism in Dialysis Patients: About Two (2) Cases in Senegal

Hungry Bone Syndrome after Surgical Treatment of Hyperparathyroidism in Dialysis Patients: About Two (2) Cases in Senegal

Subtotal Parathyroidectomy vs Total Parathyroidectomy with Autotransplantation for Secondary Hyperparathyroidism in Dialysis Patients: Short- and Long-Term Outcomes

Two operations are performed for management of secondary hyperparathyroidism, subtotal parathyroidectomy (SPTX) and total parathyroidectomy with autotransplantation (TPTX-AT). There is no consensus among endocrine surgeons about which operation is the preferred treatment. This study compares the short- and long-term outcomes of SPTX and TPTX-AT for dialysis patients with secondary hyperparathyroidism. This is a retrospective review of 46 dialysis patients undergoing PTX from 2006 to 2017 at a 719-bed tertiary care hospital. Calcium on postoperative day 1 was 7.7 ± 0.8 mg/dL for SPTX and 7.9 ± 1.3 mg/dL for TPTX-AT (p= 0.49). Parathyroid hormone values on postoperative day 1 were 32.6 ± 26.0 pg/mL for SPTX and 9.5 ± 4.2 pg/mL for TPTX-AT (p ≤ 0.05). Hospital length of stay was 3.7 ± 1.9 days for SPTX and 4.4 ± 3.5 days for TPTX-AT (p= 0.46). The required doses of calcium and calcitriol at discharge did not differ significantly. Reoperation for recurrence or persistence of disease was required in 6 SPTX patients and 2 TPTX-AT patients (p= 0.12). Parathyroid hormone values <15 pg/mL at long-term follow-up occurred in 5.6% of SPTX patients and 26.7% of TPTX-AT patients (p= 0.09). Parathyroid hormone values >200 pg/mL at long-term follow-up occurred in 38.9% of SPTX patients vs 6.7% of the TPTX-AT patients (p ≤ 0.05). Calcium supplementation at more than 6 months was required for 36.8% of SPTX and 71.4% of TPTX-AT patients (p < 0.05). The long-term control of parathyroid hormone elevation and avoidance of recurrent disease is improved with TPTX-AT, but carries a higher risk of long-term hypocalcemia.

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

Paricalcitol and calcitriol are widely used for the treatment of secondary hyperparathyroidism in dialysis patients. We conducted a systematic review and meta-analysis to compare the efficacy and safety of paricalcitol and calcitriol for secondary hyperparathyroidism in dialysis patients. PubMed, EMbase, Web of Science, EBSCO, and Cochrane library databases were systematically searched. Randomized controlled trials (RCT) assessing the efficacy of paricalcitol and calcitriol for secondary hyperparathyroidism in dialysis patients are included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. Meta-analysis was carried out using the random-effect model. Six randomized controlled trials are included in the meta-analysis. Overall, compared with calcitriol treatment for secondary hyperparathyroidism in dialysis patients, paricalcitol treatment has comparable ≥50% reduction of parathyroid hormone (risk ratio [RR] = 1.33; 95% CI = 0.93-1.91; P = 0.12), calcium concentration (standard mean difference [Std. MD] = -0.21; 95% CI = -0.94 to 0.52; P = 0.58), phosphate concentration (Std. MD = -0.17; 95% CI = -0.58 to 0.24; P = 0.42), calcium phosphate (Std. MD = -0.08; 95% CI = -0.49-0.34; P = 0.71), alkaline phosphatase (Std. MD = -0.21; 95% CI = -0.73-0.31; P = 0.43), hypercalcemia (RR = 1.43; 95% CI = 0.51 to 3.98; P = 0.49), adverse events (RR = 0.79; 95% CI = 0.42-1.49; P = 0.47), and serious adverse events (RR = 0.78; 95% CI = 0.47-1.30; P = 0.33). Paricalcitol and calcitriol result in similar ≥50% reduction of parathyroid hormone, calcium concentration, phosphate concentration, calcium phosphate, alkaline phosphatase, hypercalcemia, adverse events, and serious adverse events for secondary hyperparathyroidism in dialysis patients.

Evocalcet in the management of secondary hyperparathyroidism in dialysis patients

Use of calcimimetics will be influenced not only by assessment of benefits and harms in individual patients but also by cost and by national guidelines. The Japanese Society for Dialysis Therapy has a lower PTH threshold for PTH control than other countries. The current RCT, despite its limitations, provides a rationale for use of evocalcet in the management of secondary hyperPTH.

Novel treatment options for secondary hyperparathyroidism in end-stage kidney disease patients on hemodialysis therapy

Pathogenesis of secondary hyperparathyroidism is based on D-hormone deprivation, leading to bone remodeling impairment, increase in FGF-23, PTH levels, changes in blood calcium and phosphorus levels. Taken together with alteration of calcium-sensing receptor (CaSR) sensitivity, these changes result in alteration of bone structure and cardiovascular complications. CaSR agonists are one of the most important medications for treatment of secondary hyperparathyroidism in dialysis patients. Until recently, there was only one CaSR agonist with proven effectiveness – cinacalcet, which is administered per os, daily. Now, a new drug is registered in US, Europe and Russia – etelcalcetide, which is administered intravenously 3 times a week. In this review we focus on results of clinical trials regarding etelcalcetide effectiveness and possible compliance benefits.

Short- and Long-Term Impact of Subtotal Parathyroidectomy on the Achievement of Bone and Mineral Parameters Recommended by Clinical Practice Guidelines in Dialysis Patients: A 12-Year Single-Center Experience

Background/Aims: The short- and long-term impact of parathyroidectomy (PTX) on the parameters of mineral bone disease in dialysis patients with severe secondary hyperparathyroidism (HPT) remains unclear. Methods: A retrospective chart review of 401 consecutive dialysis patients who underwent subtotal PTX by one surgeon was performed. We checked serum levels of calcium (Ca), phosphorus (P), and intact parathyroid hormone (iPTH) for 3 consecutive days, and then monthly for Ca, P, and tri-monthly for iPTH postoperatively. Patients with available laboratory data within the 1st to 6th postoperative months were included in the short-term follow-up group and those with at least 6 months available data were in the long-term follow-up one. Results: Patients (short-term group, n = 401, and long-term group, n = 94) had severely uncontrolled serum iPTH levels, Ca, P and Ca × P before PTX. In the short-term group, percentages of cases achieving K/DOQI targets for serum Ca, Ca × P, and iPTH and KDIGO ones for serum Ca, P, and iPTH after PTX, significantly improved compared with those before operation (all p < 0.05). In the long-term group (mean follow-up of 43 ± 29 months), the percentage of achieved targets for serum iPTH in both guidelines and for serum Ca and Ca × P in the K/DOQI recommendation also improved postoperatively (all p < 0.05). Conclusions: Achievements of K/DOQI recommended values for serum Ca, Ca × P, iPTH and KDIGO recommendations for iPTH can be successfully reached by subtotal PTX in medically refractory, secondary HPT in dialysis patients both during short- and long-term follow-ups.

Trends and Variations in Intravenous Vitamin D Use among Hemodialysis Patients in the United States

Injectable vitamin D agents are commonly used to manage secondary hyperparathyroidism in dialysis patients. Yet, there are few data documenting the trends and geographic variations in the use of these agents in large, representative samples. We sought to describe patterns and variations in the use of vitamin D formulations (calcitriol, paricalcitol, and doxercalciferol) in hemodialysis patients. We studied patients in the United States Renal Data System between January1999 and December 2008 with Medicare as a primary payer. Annual percentages of patients treated with each type of formulation were tabulated by race, sex, and age at dialysis initiation. The geographical distribution of vitamin D dose per patient was mapped at the state level. Intravenous vitamin D use has increased sharply from 1999 to 2008 with 83.9% of patients treated with any vitamin D formulation in 2008. The use of calcitriol has declined since 1999, going from being administered in 58.6% of patients in 1999 to 1.8% in 2008. Paricalcitol was found to be the overwhelmingly preferred formulation during the study years. In 2008, the average dose among black patients was 84% greater than among white patients (136 mcg vs. 73.6 mcg). Higher doses of vitamin D were administered to patients in the southern region of the country. Vitamin D use has increased and parallels the rise in use of paricalcitol and doxercalciferol. Given the variations in use and known pharmacologic differences in vitamin D formulations, future research should focus on whether the formulations differentially affect patient outcomes.

Clinical utilization of cinacalcet in hypercalcemic conditions

Introduction: Cinacalcet has recently been introduced as a treatment for secondary hyperparathyroidism in dialysis patients and for parathyroid carcinoma. However, there has been an increasing interest in finding out whether cinacalcet can be used as a treatment for other parathyroid hormone (PTH)-dependent hypercalcemic conditions also.Areas covered: The article reports the most relevant recent contributions dealing with calcium sensing receptor (CaSR) physiology as well as cinacalcet pharmacokinetics and pharmacodynamics. It also looks at the different hypercalcemic conditions where the use of cinacalcet has been proposed. This article was researched using clinical trials, case reports and outstanding basic research published in the last 3 years (MEDLINE database up to 31 November 2010). It provides the reader with an insight into the many unaddressed issues regarding cinacalcet that need to be resolved before it can be used in newly proposed fields.Expert opinion: Since cinacalcet may not only have an effect on parathyroid CaSR but also on CaSR expressed at bone and renal levels, it can currently only be considered a good alternative to parathyroidectomy in PTH-dependent hypercalcemic conditions when surgical intervention is burdened by a high failure rate or when it can be considered a risky procedure. At present, cinacalcet cannot be considered the first choice treatment in asymptomatic primary hyperparathyroidism or in mild-to-moderate forms of familial hypocalciuric hypocalcemia.

Cinacalcet Treatment for Secondary Hyperparathyroidism in Dialysis Patients: An Observational Study in Routine Clinical Practice

Background: Cinacalcet reduces intact parathyroid hormone (iPTH), Ca and P serum levels in patients with secondary hyperparathyroidism (SHPT). Methods: This Spanish, multicenter, observational, retrospective study collected data from SHPT dialysis patients 12 weeks before and up to 72 weeks after starting cinacalcet in clinical practice. Results: Data from 428 patients with uncontrolled SHPT despite receiving standard of care (29% with baseline iPTH 501–800 pg/ml; 51% with >800 pg/ml) were collected. Percentages of patients within National Kidney Foundation Kidney Disease Outcomes Quality Initiative targets at baseline and 72 weeks were: iPTH, 0 versus 32.5% (p < 0.05); Ca, 40.1 versus 50% (p < 0.05); P, 47.7 versus 53.8% (p = 0.162). Vitamin D sterol use decreased from 53.3% at baseline to 36.7% at 72 weeks (p < 0.05). The mean ± SD cinacalcet dose at 72 weeks was 44.0 ± 25.8, 51.7 ± 31.3 and 57.1 ± 37.0 mg for patients with baseline iPTH 301–500, 501–800 or >800 pg/ml, respectively. The main adverse reactions were nausea (5.4%), dyspepsia (5.1%) and vomiting (3.7%). Conclusions: The introduction of cinacalcet improved the routine clinical management of SHPT in a large cohort of Spanish dialysis patients. Cinacalcet is effective and well tolerated regardless of disease severity, and maintains its efficacy over 72 weeks.

Continuation of cinacalcet immediately after renal transplantation: a prospective cohort study

Cinacalcet is used for treating secondary hyperparathyroidism in dialysis patients, but it is currently unknown whether it can safely be continued immediately after renal transplantation. We prospectively studied renal transplant recipients with secondary hyperparathyroidism who were receiving cinacalcet before transplantation and continued treatment afterwards (n = 29) at a dose of 30 mg/day. Cinacalcet dose was titrated to serum calcium. Patients were followed for 6 months. Incidence of hypercalcemia, serum calcium and intact PTH (iPTH) were analyzed. Tacrolimus levels, acute rejection rate and renal function were compared with an age and sex matched control group. In 16 patients hypercalcemia was observed after transplantation. Severe hypercalcemia (>= 2.87 mmol/l) (n = 4) and hypocalcemia (n = 2) were infrequent. No difference in acute rejection rate or renal function between the cinacalcet and the control group was found. There also was no clinically relevant influence of cinacalcet on tacrolimus levels. Our study shows that cinacalcet can safely be continued immediately after renal transplantation. Studies are needed to determine if continuation of cinacalcet is better than early withdrawal. Also, the optimum dose of cinacalcet and the long-term effects of cinacalcet after renal transplantation must be defined.

Effect of paricalcitol and cinacalcet on serum phosphate, FGF-23, and bone in rats with chronic kidney disease

Calcimimetics activate the calcium-sensing receptor (CaR) and reduce parathyroid hormone (PTH) by increasing the sensitivity of the parathyroid CaR to ambient calcium. The calcimimetic, cinacalcet, is effective in treating secondary hyperparathyroidism in dialysis patients [chronic kidney disease (CKD 5)], but little is known about its effects on stage 3-4 CKD patients. We compared cinacalcet and paricalcitol in uremic rats with creatinine clearances "equivalent" to patients with CKD 3-4. Uremia was induced in anesthetized rats using the 5/6th nephrectomy model. Groups were 1) uremic control, 2) uremic + cinacalcet (U+Cin; 15 mg x kg(-1) x day(-1) po for 6 wk), 3) uremic + paricalcitol (U+Par; 0.16 microg/kg, 3 x wk, ip for 6 wk), and 4) normal. Unlike U+Par animals, cinacalcet promoted hypocalcemia and marked hyperphosphatemia. The Ca x P in U+Cin rats was twice that of U+Par rats. Both compounds suppressed PTH. Serum 1,25-(OH)(2)D(3) was decreased in both U+Par and U+Cin rats. Serum FGF-23 was increased in U+Par but not in U+Cin, where it tended to decrease. Analysis of tibiae showed that U+Cin, but not U+Par, rats had reduced bone volume. U+Cin rats had similar bone formation and reduced osteoid surface, but higher bone resorption. Hypocalcemia, hyperphosphatemia, low 1,25-(OH)(2)D(3), and cinacalcet itself may play a role in the detrimental effects on bone seen in U+Cin rats. This requires further investigation. In conclusion, due to its effects on bone and to the hypocalcemia and severe hyperphosphatemia it induces, we believe that cinacalcet should not be used in patients with CKD without further detailed studies.

Assessment of adherence to cinacalcet by prescription refill rates in hemodialysis patients

Secondary hyperparathyroidism is common among dialysis patients and leads to numerous complications including cardiovascular disease and renal osteodystrophy. Cinacalcet, an oral daily calcimimetic agent that sensitizes the calcium receptor to serum calcium, is approved for treatment of secondary hyperparathyroidism in dialysis patients. We identified 101 patients who received their first cinacalcet prescription between November 2004 and April 2005. All patients were participating in a Missouri state-funded pharmacy program providing free or low cost medications. We tracked the cinacalcet refill rate and refills for another control medication prescribed to each patient. The average cinacalcet refill rate over the first 12 months was 56% vs. 64% for the control medication (P=0.02). Good adherence, defined as >80% medication possession ratio over the 12 months, was 29% for cinacalcet and 33% for the control medication (P=0.68). Additionally, the refill rate for cinacalcet fell significantly over five quarterly periods from 53% in the first quarter to 37% in the 5th quarter. We conclude that dialysis patients' adherence to medications, including cinacalcet, is poor even when medications are provided at a nominal cost. Poor cinacalcet adherence would be expected to impair long-term control of SHPT. In a reimbursement system where injectable, but not oral medications, are bundled with dialysis payments there may be pressure to move patients to oral medications. The poor compliance found in this study highlights the potential adverse effects of movement toward self-administered oral therapy.

Cinacalcet Use Patterns and Effect on Laboratory Values and Other Medications in a Large Dialysis Organization, 2004 through 2006

Cinacalcet was introduced in mid-2004 to treat secondary hyperparathyroidism in dialysis patients. We aimed to characterize adult patients who received cinacalcet prescriptions and to determine (1) dosage titration and effects on laboratory values, active intravenous vitamin D use, and phosphate binder prescriptions and (2) percentage who achieved National Kidney Foundation Kidney Disease Outcomes Quality Initiative targets for serum parathyroid hormone, calcium, and phosphorus and experienced biochemical adverse effects. This observational study evaluated 45,487 prevalent patients from a dialysis organization database linked with the Centers for Medicare and Medicaid Services End-Stage Renal Disease database. Patient characteristics, laboratory values (albumin, parathyroid hormone, calcium, phosphorus), intravenous vitamin D, and oral medication (cinacalcet, phosphate binders) prescriptions were evaluated for cinacalcet patients. By June 2006, almost 32% of patients had received cinacalcet prescriptions. Mean baseline corrected calcium was 9.8 mg/dl and phosphorus was 6.3 mg/dl, and median parathyroid hormone was 577 pg/ml, versus 9.5 mg/dl, 5.3 mg/dl, and 215 pg/ml, respectively, for noncinacalcet patients. Patients with cinacalcet prescriptions for > or =6 mo had corrected calcium reduced by 4.2%, phosphorus by 7.0%, and parathyroid hormone by 29.9% by 12 mo. More cinacalcet patients attained Kidney Disease Outcomes Quality Initiative targets with less hyperparathyroidism, hypercalcemia, and hyperphosphatemia but more hypoparathyroidism and hypocalcemia. Over 12 mo, vitamin D use and use consistency increased, phosphate binder dosages increased, and mean cinacalcet daily dosage reached 55 mg. Patients with cinacalcet prescriptions exhibited more severe hyperparathyroidism and hyperphosphatemia than noncinacalcet patients. Positive effects were less dramatic than in Phase III clinical trials, possibly as a result of modest, slow dosage titration.