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    "textoCompleto" => "<p class="elsevierStylePara">INTRODUCTION<br></br><br></br>Bone mineral disease associated to chronic kidney disease &#40;BMD-CKD&#41; is an integral component of stage 5 D chronic kidney disease &#40;CKD&#41; in any of the dialysis techniques that conditions the clinical course&#44; complications&#44; and survival of patients&#46;1 Changes in bone mineral metabolism promote vascular calcification and cardiovascular &#40;CV&#41; risk by mechanisms that are starting to be elucidated&#46; Since publication in 2003 of the K&#47;DOQI guidelines2 including recommendations for diagnostic management and treatment objectives&#44; several studies have shown how far we are from reaching such standards&#46; 3 The advent of new treatment strategies based on use of Cinacalcet&#174; has improved results in some fields&#46;4 However&#44; virtually all studies available have been conducted in patients on hemodialysis&#46;5 Only one of the randomized clinical trials enrolled 34 patients on peritoneal dialysis &#40;PD&#41; with an efficacy follow-up period of only 10 weeks&#44; who were jointly analyzed with a large series of patients on HD&#46;6<br></br><br></br>The purpose of this study was to assess the efficacy of Cinacalcet &#174; in patients with moderate to severe hyperparathyroidism &#40;HPTH&#41; resistant to conventional treatment on PD&#46;<br></br><br></br>METHODS<br></br><br></br>This was a prospective&#44; observational&#44; cohort study using pretreatment values as reference&#46; The primary objective was to assess compliance with K&#47;DOQI recommendations&#44; and secondary objectives included evaluation of compliance with suboptimal metabolic standards&#44; tolerability and occurrence of side effects&#44; and an estimation of the time required to reach those results&#46;<br></br><br></br>Selected patients had to meet the following criteria&#58; moderate to severe HPTH &#40;PTH &#62; 500 pg&#47;mL with normal or elevated serum calcium levels&#41; resistant to conventional treatment with diet&#44; binders&#44; and vitamin D&#44; or impossibility to use vitamin D due to hyperphosphoremia &#40;&#62; 5&#46;5 mg&#47;dL&#41; or hypercalcemia &#40;&#62; 10&#46;5 mg&#47;dL&#41;&#46; All patients should have been monitored for at least 6 months on specific treatment by a nephrologist and should have been on PD with adequate efficacy for at least 4 months&#46; No patient had hypocalcemia &#40;calcium levels &#60; 8&#46;5 mg&#47;dL&#41;&#46;<br></br><br></br>Treatment was started with Cinacalcet-Mimpara&#174; &#40;AMGEN&#41; 30 mg&#44; and the dose was titrated monthly based on<br></br>the targets reached&#46; Oral 1&#44;25 OH vitamin D&#191;Rocaltrol&#174; &#40;ROCHE&#41; was used according to the criteria recommended in clinical guidelines&#46;2 Calcium-based binders were prescribed without exceeding 1&#44;500 mg&#47;day of elemental calcium&#44; as well as non-metallic binders &#40;Sevelamer-Renagel&#174; GENZYME&#41;&#46; For cost studies&#44; the selling price excluding VAT of each product according to the 2007 price list was imputed&#46; The initial calcium concentration in peritoneal fluid bags was 1&#46;75 mEq&#47;L&#46; Use of calcium concentrations of 1&#46;25 mEq&#47;L was allowed depending on response and clinical course&#46;<br></br><br></br>Clinical and laboratory data were collected from 4 months before treatment start to the end of follow-up&#46; Two initial<br></br>two-weekly controls were performed&#44; followed by monthly controls&#46; Such controls included levels of at least calcium&#44; phosphorus&#44; alkaline phosphatase&#44; albumin&#44; and PTH&#46; The same laboratory test methods were used throughout followup&#46; Phosphorus and calcium were measured by UV spectrometry &#40;normal ranges&#44; 2&#46;7-4&#46;5 mg&#47;dL and 8&#46;6-10&#46;4 mg&#47;dL respectively&#41;&#44; and PTH by immunoluminescence &#40;normal range&#44; 10-65 pg&#47;mL&#41;&#46; Calcium was corrected for serum albumin levels&#46; Adjustments for PD efficacy and all other metabolic parameters were evaluated every two months and peritoneal equilibrium tests every 6 months&#44; according to the standard protocol&#46; A dietary survey&#44; dietary counseling&#44; and a specific survey for common side effects were done at each visit&#46; Only patients more than 9 months on treatment were included in the analysis shown in the tables&#46;<br></br><br></br>The targets used were those recommended by the NKFK&#47;DOQI clinical guidelines for CKD 5D&#58;2 PTH levels ranging<br></br>from 150 and 300 pg&#47;mL&#59; corrected serum calcium levels ranging from 8&#46;4 and 9&#46;5 mg&#47;dL&#44; phosphorus levels ranging from 3&#46;5-5&#46;6 mg&#47;dL&#44; and CaxP &#60; 55 mg2&#47;dL2&#46; For the analysis of suboptimal targets&#44; the previously published references of PTH &#60; 350 pg&#47;mL&#44;4 phosphorus &#60; 6 mg&#47;dL&#44; or calcium &#163; 10&#46;4 mg&#47;dL &#40;the normal value at our laboratory&#41; were used&#44; provided the CaxP product was simultaneously &#60; 55 mg2&#47;dL2&#46; The proportion of patients within the ranges of each optimal or suboptimal target are indicated at each time&#46; The proportion of<br></br>patients meeting all optimal and suboptimal targets at each time point of follow-up is also indicated&#46;<br></br><br></br>Data are given as mean and standard deviation &#40;SD&#41; or as percentage of patients depending on the nature of the variables&#46; Medications are given as daily mg of Cinacalcet-Mimpara &#174; &#40;AMGEN&#41; and elemental calcium&#44; number of Sevelamer &#174; 800 mg tablets &#40;Renagel&#174;&#59; Genzyme&#41; per day&#44; and micrograms of 1&#44;25 OH Vit D &#40;Rocaltrol&#174;&#59; Roche&#41; per week&#46; Data were entered into a SPSS 11&#46;0 database for statistical analysis&#46; The laboratory values in each period were compared to baseline values using a non-parametric Wilcoxon test&#46; A value of p &#60; 0&#46;05 was considered statistically significant&#46; The date of the first value on target was considered as the event date in a Kaplan-Meier analysis&#46; The median time to achievement of optimal or suboptimal control of all targets was calculated&#46;<br></br><br></br>RESULTS<br></br><br></br>Cohort description&#58; Eighteen patients &#40;80&#46;0&#37; males&#41; with a mean age at study start of 57&#46;70 years &#40;SD 9&#46;22&#41; were enrolled&#46; The most relevant etiologies included diabetes mellitus &#40;8&#46;3&#37;&#41;&#44; polycystic renal disease &#40;25&#46;0&#37;&#41;&#44; glomerular &#40;25&#46;0&#37;&#41;&#44; interstitial &#40;8&#46;3&#37;&#41;&#46; At the start of treatment with Cinacalcet &#174;&#44; patients had been on PD for a mean time of 15&#46;56 months &#40;SD 0&#46;78&#41;&#46; Patients received adequate APD &#40;8&#47;18&#41; or CAPD &#40;10&#47;18&#41; to reach appropriate efficacy levels &#40;Kt&#47;V 2&#46;29 &#91;SD 0&#46;65&#93;&#44; CCr 72&#46;4&#41; that were maintained during follow-up&#46;<br></br><br></br>PD bags with two calcium concentrations &#40;1&#46;25 and 1&#46;75 mEq&#47;L&#41; were available&#46; The 1&#46;75 mEq&#47;L calcium concentration was used at treatment start in 84&#46;6&#37; of cases&#44; at 3 months in 83&#46;3&#37;&#44; at 6 months in 66&#46;7&#37;&#44; at 9 months in 66&#46;7&#37;&#44; and at one year in 75&#37;&#44; with a mean calcium value during the whole follow-up of 1&#46;66 mEq&#47;L &#40;SD 0&#46;19&#41;&#46; Mean follow-up time on Cinacalcet&#174; treatment was 11&#46;9 months &#40;range&#44; 3-24&#46;83 months&#41;&#46; Two patients discontinued the study for transplant and one patient died from stroke&#46;<br></br><br></br>Table I details the changes over time in laboratory values related to BMD-CKD in patients with longer than 9 months of treatment and the medication prescribed at the different follow-up time points&#46;<br></br><br></br>No patient met the targets in the guidelines during the four months planned at the start of treatment with Cinacalcet&#174;&#44; as they all had PTH levels 3 500 pg&#47;mL&#46; Changes over time in the proportion of patients meeting each of the K&#47;DOQI targets and the suboptimal targets described are shown in Table II&#46; At the start&#44; no patient met the aggregate of all K&#47;DOQI targets or the proposed suboptimal targets&#46; The mean starting dose of Cinacalcet&#174; was 30 mg in all cases&#44; and the subsequent mean doses were 36&#46;4 mg at 1 month&#44; 44 mg at 3 months&#44; 43&#46;5 mg at 6 months&#44; and 28&#46;5 mg at one year&#46; Compliance with medication was verified in all patients&#44; and frequent non compliance was only found in one patient &#40;in whom optimal control of biochemical values was not achieved&#41;&#46; Mean monthly costs of the whole medication for treatment of HPTH is detailed in Table I&#46; Mean monthly cost of<br></br>Cinacalcet&#174; was 270 e per patient at month 3 and 175 e per patient at month 12&#46;<br></br><br></br>The mean time required to reach a PTH value on the K&#47;DOQI range was 2&#46;33 months &#40;95&#37; CI 1&#46;35-3&#46;32&#41;&#44; while<br></br>the time to reach all suboptimal targets was 4&#46;03 months &#40;95&#37; CI 2&#46;25-5&#46;82&#41;&#44; and the time required to reach all optimal targets was 16&#46;94 months &#40;95&#37; CI 11&#46;38-22&#46;5&#41;&#46; Curves are detailed in figure 1&#46;<br></br><br></br>Dyspepsia was recorded in two patients&#44; self-limited diarrhea in one&#44; gynecomastia in one&#44; and 3 patients experienced pruritus from the start&#44; but this disappeared in all cases when calcium and phosphorus levels were controlled&#46; Dose reduction was only required in one patient due to side effects &#40;painful gynecomastia&#41;&#44; and discontinuation of Cinacalcet&#174; administration was not required in any patient&#46; Only 3 cases of mild hypocalcemia ranging from 7&#46;5 and 8 mg&#47;dL&#44; all of them asymptomatic&#44; were recorded&#46;<br></br><br></br>DISCUSSION<br></br><br></br>This is the first specific study of systematic treatment with Cinacalcet in patients on PD&#46; Overall&#44; Cinacalcet was safe<br></br>and effective&#44; and allowed for controlling biochemical markers in a majority of patients resistant to conventional treatment&#46;<br></br><br></br>The approach to HPTH has evolved in recent years&#44; with attention being now focused on the vascular field&#44; beyond its effects on bone&#46;7 The K&#47;DOQI initiative attempted to unify the strategies of the different scientific societies around the world&#46;8 Along these same lines&#44; a change in nomenclature reinforcing this concept has been proposed&#46;9 Indeed&#44; there is evidence from observational studies of the relationship between the control level of BMD-CKD and the general course of patients&#46; Data showing the relationship between hyperphosphoremia in HPTH and mortality and that failure to meet the objectives proposed by K&#47;DOQI is associated to a poorer prognosis are available&#46;1 A recent study has even shown that phosphorus reduction improves vital prognosis&#46;10<br></br><br></br>Some recent European studies found the same prevalence of HPTH in incident patients on HD and PD&#44; with very similar calcium and phosphorus levels and target achievement data for both procedures&#46;1 However&#44; a majority of the epidemiological data discussed&#44; as well as Cinacalcet&#174; studies&#44; come from HD patients&#46;5&#44;11&#44;12 In fact&#44; we have found no specific study about treatment with Cinacalcet&#174; in PD&#46; Only a clinical trial enrolled 34 patients on PD together with a much greater number of patients on HD&#46; Use of PD in Spain is increasing&#44; but only reaches 15&#37; of patients and is distributed in small units&#46; The mean maintenance time on the procedure is less than 4 years&#46;13 All these factors&#44; combined with a decreased patient accessibility because it is a home procedure&#44; reduce the interest of sponsors in enrolling these patients in clinical trials and hinder the initiatives directly promoted by nephrologists&#46;<br></br><br></br>Patients on PD have some relevant differences in management of Cinacalcet&#174;&#46; First&#44; very few cases of hypocalcemia have been found&#44; and none of them was severe and&#47;or symptomatic&#46; The continuous presence of intra-abdominal fluid with adequate calcium levels may equilibrate this imbalance and protect patients from problems&#46; On the other hand&#44; Cinacalcet&#174; doses higher than 60 mg&#47;day were received by 3 patients only&#44; and dose titration was more gradual than in the schemes recommended in clinical trials published&#44;12 in which the dose was increased every month if objectives had not been reached&#46; A slower titration taking into account the trend in laboratory tests may allow for a safer control&#44; even if takes a longer time&#46;<br></br><br></br>This is the first study to estimate the time required to reach adequate control values&#46; Fifty percent of patients resistant to conventional treatment reached the PTH target in only 70 days&#46; However&#44; medication could only be temporally suspended in some patients&#44; and long-term maintenance doses are required&#46; There is only one report about the course with Cinacalcet &#174; beyond the first year of treatment&#46;14<br></br><br></br>Another significant subject is the trend to the adynamic forms of BMD&#46; Some series report a greater prevalence of adynamia in PD as compared to HD&#46; Adynamia should be avoided because of its harmful effects&#46;15 In fact&#44; the factors associated to an increased risk of adynamic forms include the presence of diabetes&#44; use of aluminium-based binders&#44; overtreatment with high calcium levels and vitamin D&#44; and PD itself&#46;16<br></br><br></br>Guidelines themselves recommend that elevation of PTH levels is allowed by reducing aggressiveness of treatment<br></br>when PTH levels are below 100 pg&#47;mL&#46;2<br></br><br></br>We used the concept of suboptimal target compliance&#44; encompassing a wider tolerance margin of PTH &#40;350 pg&#47;mL&#41;&#44;<br></br>previously used by other authors&#44;4 calcium levels within the normal ranges at our laboratory&#44; and phosphorus levels increased by 0&#46;5 mg&#47;dL&#46; In addition&#44; the CaxP product should not be higher than 55 mg2&#47;dl2&#46; We think that outside a clinical trial with strict titration protocols&#44; the clinician has a certain tolerance with these borderline values&#46; Considering these margins&#44; target control increased to 66&#46;7&#37; at 12 months&#46;<br></br><br></br>However&#44; the value of PTH as an accurate&#44; single marker of bone metabolism is increasingly controversial&#46;17 Indeed&#44; no good agreement exists between the different laboratory tests&#44;18 and all evidence about the correlation between PTH levels and bone biopsy comes from data collected using a currently unavailable PTH kit&#46;<br></br><br></br>Cinacalcet&#174; therefore appears to be as effective in PD as in HD and to be even better tolerated&#44; according to a comparison with data from a recent meta-analysis&#46;5<br></br><br></br>Patients on PD have a greater tendency to anorexia and abdominal discomfort&#44; as they have an intra-abdominal occupation&#46; The presence of calcium sensor receptors in the gastrointestinal tract justifies that the most common side effect is intolerance due to nausea or dyspepsia&#46;19 However&#44; the rate of gastrointestinal adverse effects is similar to that seen in patients on HD&#44;20 and in no patient was treatment discontinued for this reason&#46; The recommendation of taking the drug with food may have had an influence on this&#46;<br></br><br></br>The real challenge in treatment of BMD-CKD are not biochemical markers&#44; but evaluation of their effect on mortality<br></br>and vascular calcification&#46;21&#44;22 It is reasonable to assume that if HPTH and hyperphosphoremia are associated to a poorer prognosis&#44; any measure that improves these intermediate markers will have a positive effect&#46; However&#44; neither our study nor other previously published reports have been able to show this hypothesis&#46;<br></br><br></br>As added effects to HPTH control&#44; control of phosphorus levels&#44; that had increased by up to 60&#37; at 6 months&#44; and a<br></br>15&#37; reduction in use of binders such as Sevelamer&#174; were achieved&#46; The cost attributable to direct use of Cinacalcet&#174; was 175 e&#47;month at the end of follow-up&#44; and was partially compensate by the decreased Sevelamer&#174; use&#46; On the other hand&#44; as these were patients selected for their high treatmentresistant PTH levels&#44; the long-term benefits on reduction of parathyroidectomies&#44;23 CV events as a result of calcification&#44; and so on should be considered&#46; However&#44; the design of our study did not allow for making such calculations&#46; Previous studies have shown the treatment with Cinacalcet&#174; is cost-effective as compared to parathyroidectomy&#44; but the opposite occurs after 15 months of cumulative treatment&#46; Based on this&#44; Cinacalcet&#174; would be particularly indicated for patients<br></br>candidates to kidney transplant within two years&#44; a very common profile in patients on PD&#46;23<br></br><br></br>Limitations of this study include its small sample size and its observational design&#46; However&#44; study conduct at a single center&#44; with a prior protocol and no exclusion criteria&#44; ensures consistency in therapeutic management and reflects use in the real world&#46; Further specific studies in PD are required to understand whether management is exactly the same as in HD&#46; Studies intended to verify the true effect on vascular calcification&#44; bone biopsy&#44; and patient mortality are particularly required&#46;<br></br><br></br>To sum up&#44; use of Cinacalcet&#174; in patients on PD with HPTH resistant to conventional treatment was found to be<br></br>safe and effective and allowed for an improved compliance with targets in clinical guidelines&#46; Additional studies in PD specifically intended to study the impact of the drug on mortality&#44; vascular calcifications&#44; and quality of life are needed&#46;<br></br><br></br>ACKNOWLEDGEMENT<br></br><br></br>Center included as a clinical group in REDinREN &#40;Instituto Carlos IIII de Investigaci&#243;n&#44; Red 06&#47;0016&#41;&#46;<br></br></p>"
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        "resumen" => "Objetivos&#58; Estudiar la eficacia de Cinacalcet&#174; en el cumplimiento de las recomendaciones K&#47;DOQI en pacientes en di&#225;lisis peritoneal &#40;DP&#41; y estimar el tiempo necesario para alcanzarlos&#46; M&#233;todos&#58; Estudio observacional prospectivo de cohorte&#44; con pacientes con hiperparatiroidismo-HPTH moderadosevero &#40;PTH &#62; 500 pg&#47;ml&#41; con m&#225;s de 4 meses en DP resistentes a tratamiento convencional con dieta&#44; quelantes y vitamina D&#46; Los objetivos &#243;ptimos son los recomendados por las Gu&#237;as NKF-K&#47;DOQI para ERC-5D y para el an&#225;lisis de objetivos sub&#243;ptimos se utilizan las referencias de PTH &#60; 350 pg&#47;ml&#46;&#59; f&#243;sforo &#60; 6 mg&#47;dl o calcio &#60; 10&#44;4 mg&#47;dl &#40;siempre que simult&#225;neamente CaxP &#60; 55 mg2&#47;dl2&#41;&#46; Resultados&#58; Al inicio del tratamiento con Cinacalcet&#174; los 18 pacientes llevaban 15&#44;56 meses &#40;DE 0&#44;78&#41; en DP&#44; todos ten&#237;an una PTH &#62; 500 pg&#47;ml&#44; y ninguno cumpl&#237;a los objetivos K&#47;DOQI ni los sub&#243;ptimos propuestos&#46; El seguimiento medio en tratamiento con Cinacalcet&#174; fue de 12 meses&#46; El porcentaje de pacientes con PTH &#60; 350 pg&#47;ml fue de 66&#44;7&#37; a los 3 meses 60&#37; a los 6 y 100&#37; al a&#241;o&#46; A los tres meses el 33&#44;3&#37; cumplen todos los objetivos sub&#243;ptimos&#44; a los 6 meses el 33&#44;3&#37; y al a&#241;o el 66&#44;7&#37;&#46; El tiempo medio necesario para alcanzar un valor de PTH en rango fue de 2&#44;33 meses IC al 95&#37; &#91;1&#44;35-3&#44;32&#93; y para alcanzar todos los objetivos &#243;ptimos de 16&#44;94 meses &#91;11&#44;38-22&#44;5&#93;&#46; La tolerancia a la medicaci&#243;n ha sido buena&#44; no se suspendi&#243; Cinacalcet&#174; en ning&#250;n caso y s&#243;lo en uno se redujo la dosis por efectos secundarios&#46; Conclusi&#243;n&#58; La utilizaci&#243;n de Cinacalcet&#174; en pacientes en DP con HPTH resistente a tratamiento convencional ha resultado eficaz y segura y ha permitido mejorar el cumplimiento de objetivos de las gu&#237;as&#46;"
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        "resumen" => "Background&#58; Cinacalcet&#174; has improved the management of hyperparathiroidism &#40;HPTH&#41; in hemodialysis&#46; To our knowledge there are no specific studies on peritoneal dialysis &#40;PD&#41;&#46; Aim&#58; The aim of the present study was to evaluate the efficacy of Cinacalcet&#174; on the achievement of optimal and suboptimal targets on treatment of hyperparathiroidism &#40;HPTH&#41; in PD patients&#46; As secondary objectives we have studied the safety of treatment and estimate the mean time to reach these targets&#44; and evaluate economic cost&#46; Methods&#58; Eighteen patients undergoing more than 4 months on PD with a severe HPTH &#40;PTH &#62; 500 pg&#47;ml&#41; resistant to conventional treatment with diet&#44; chelants and vitamin D were included in this prospective open-label study&#46; We have used the targets of K&#47;DOQITM-clinical guidelines as optimal target&#46; We have selected as suboptimal targets&#58; PTH &#60; 350 pg&#47;ml&#44; phosphorus &#60; 6 mg&#47;dl and calcium &#60; 10&#46;4 mg&#47;dl &#40;only when simultaneous CaxP was under 55 mg2&#47;dl2&#41;&#46; Oral Cinacalcet&#174; was given with main meal in a single daily start dose of 30 mg and titrated thereafter monthly&#46; We considered the first value on target as an event and used a Kaplan-Meyer survival analysis to estimate mean time to reach target&#46; Results&#58; On inclusion all patients have at least two previous PTH values over 500 pg&#47;ml&#44; PTH mean 695&#46;3 &#40;SD 96&#41; and they were on PD with an appropriate efficacy during a mean of 15&#46;56 months &#40;SD 0&#46;78&#41;&#46; Mean follow-up time under Cinacalcet &#174; treatment was 12 months&#46; The percentage of patients with a PTH under 350 pg&#47;ml was 66&#46;7&#37; on month 3&#44; 60&#37; on month 6 and 100&#37; after 1 year&#46; The percentage of patients that reach an aggregate of all suboptimal targets &#40;PTH &#60; 350 pg&#47;ml and calcium &#60; 10&#46;4 mg&#47;dl and phosphorus &#60; 6 mg&#47;dl and CaxP &#60; 55 mg2&#47;dl2&#41; was 33&#46;3&#37; on month 6 and 66&#46;7&#37; after 1 year&#46; The mean time to reach PTH target was 2&#46;33 months with a 95&#37; confident interval &#91;1&#44;35-3&#44;32&#93; and to reach the aggregate of all target was 16&#46;94 months &#91;11&#44;38-22&#44;5&#93;&#46; Cinacalcet &#174; has been well tolerated&#44; we reduced the dose in a single patient due to secondary effects&#44; but treatment was not discontinued in any case&#46; Conclussion&#58; In summary the addition of Cinacalcet&#174; to conventional treatment in PD patients with resistant HPTH has improved the achievement of targets&#44; and has been reasonably safe in our patients&#46;"
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                  "referenciaCompleta" => "(9) Moe S, Drueke T, Cunningham J, Goodman W, Martin K, Olgaard K et al. Definition, evaluation, and classification of renal osteodystrophy: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int 2006; 69(11):1945-1953."
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Cinacalcet in patients on peritoneal dialysis with moderate to severe hyperparathyroidism resistant to conventional treatment. A one-year, prospective study
Cinacalcet en pacientes en diálisis peritoneal con hiperparatiroidismo moderado-severo resistentes a tratamiento convencional. Estudio prospectivo a un año.
Jose Portolésa, Ana Tatoa, Paula López-Sáncheza, Enrique Grussa, Fernando Cavaa, Almudena Ortigosaa, Mª Dolores Molanoa
a S. Nefrologia y S. Análisis Clínicos, Hospital Universitario Fundación Alcorcón Madrid, Madrid, España,
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    "titulo" => "Cinacalcet in patients on peritoneal dialysis with moderate to severe hyperparathyroidism resistant to conventional treatment&#46; A one-year&#44; prospective study"
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        "titulo" => "Cinacalcet en pacientes en di&#225;lisis peritoneal con hiperparatiroidismo moderado-severo resistentes a tratamiento convencional&#46; Estudio prospectivo a un a&#241;o&#46;"
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    "textoCompleto" => "<p class="elsevierStylePara">INTRODUCTION<br></br><br></br>Bone mineral disease associated to chronic kidney disease &#40;BMD-CKD&#41; is an integral component of stage 5 D chronic kidney disease &#40;CKD&#41; in any of the dialysis techniques that conditions the clinical course&#44; complications&#44; and survival of patients&#46;1 Changes in bone mineral metabolism promote vascular calcification and cardiovascular &#40;CV&#41; risk by mechanisms that are starting to be elucidated&#46; Since publication in 2003 of the K&#47;DOQI guidelines2 including recommendations for diagnostic management and treatment objectives&#44; several studies have shown how far we are from reaching such standards&#46; 3 The advent of new treatment strategies based on use of Cinacalcet&#174; has improved results in some fields&#46;4 However&#44; virtually all studies available have been conducted in patients on hemodialysis&#46;5 Only one of the randomized clinical trials enrolled 34 patients on peritoneal dialysis &#40;PD&#41; with an efficacy follow-up period of only 10 weeks&#44; who were jointly analyzed with a large series of patients on HD&#46;6<br></br><br></br>The purpose of this study was to assess the efficacy of Cinacalcet &#174; in patients with moderate to severe hyperparathyroidism &#40;HPTH&#41; resistant to conventional treatment on PD&#46;<br></br><br></br>METHODS<br></br><br></br>This was a prospective&#44; observational&#44; cohort study using pretreatment values as reference&#46; The primary objective was to assess compliance with K&#47;DOQI recommendations&#44; and secondary objectives included evaluation of compliance with suboptimal metabolic standards&#44; tolerability and occurrence of side effects&#44; and an estimation of the time required to reach those results&#46;<br></br><br></br>Selected patients had to meet the following criteria&#58; moderate to severe HPTH &#40;PTH &#62; 500 pg&#47;mL with normal or elevated serum calcium levels&#41; resistant to conventional treatment with diet&#44; binders&#44; and vitamin D&#44; or impossibility to use vitamin D due to hyperphosphoremia &#40;&#62; 5&#46;5 mg&#47;dL&#41; or hypercalcemia &#40;&#62; 10&#46;5 mg&#47;dL&#41;&#46; All patients should have been monitored for at least 6 months on specific treatment by a nephrologist and should have been on PD with adequate efficacy for at least 4 months&#46; No patient had hypocalcemia &#40;calcium levels &#60; 8&#46;5 mg&#47;dL&#41;&#46;<br></br><br></br>Treatment was started with Cinacalcet-Mimpara&#174; &#40;AMGEN&#41; 30 mg&#44; and the dose was titrated monthly based on<br></br>the targets reached&#46; Oral 1&#44;25 OH vitamin D&#191;Rocaltrol&#174; &#40;ROCHE&#41; was used according to the criteria recommended in clinical guidelines&#46;2 Calcium-based binders were prescribed without exceeding 1&#44;500 mg&#47;day of elemental calcium&#44; as well as non-metallic binders &#40;Sevelamer-Renagel&#174; GENZYME&#41;&#46; For cost studies&#44; the selling price excluding VAT of each product according to the 2007 price list was imputed&#46; The initial calcium concentration in peritoneal fluid bags was 1&#46;75 mEq&#47;L&#46; Use of calcium concentrations of 1&#46;25 mEq&#47;L was allowed depending on response and clinical course&#46;<br></br><br></br>Clinical and laboratory data were collected from 4 months before treatment start to the end of follow-up&#46; Two initial<br></br>two-weekly controls were performed&#44; followed by monthly controls&#46; Such controls included levels of at least calcium&#44; phosphorus&#44; alkaline phosphatase&#44; albumin&#44; and PTH&#46; The same laboratory test methods were used throughout followup&#46; Phosphorus and calcium were measured by UV spectrometry &#40;normal ranges&#44; 2&#46;7-4&#46;5 mg&#47;dL and 8&#46;6-10&#46;4 mg&#47;dL respectively&#41;&#44; and PTH by immunoluminescence &#40;normal range&#44; 10-65 pg&#47;mL&#41;&#46; Calcium was corrected for serum albumin levels&#46; Adjustments for PD efficacy and all other metabolic parameters were evaluated every two months and peritoneal equilibrium tests every 6 months&#44; according to the standard protocol&#46; A dietary survey&#44; dietary counseling&#44; and a specific survey for common side effects were done at each visit&#46; Only patients more than 9 months on treatment were included in the analysis shown in the tables&#46;<br></br><br></br>The targets used were those recommended by the NKFK&#47;DOQI clinical guidelines for CKD 5D&#58;2 PTH levels ranging<br></br>from 150 and 300 pg&#47;mL&#59; corrected serum calcium levels ranging from 8&#46;4 and 9&#46;5 mg&#47;dL&#44; phosphorus levels ranging from 3&#46;5-5&#46;6 mg&#47;dL&#44; and CaxP &#60; 55 mg2&#47;dL2&#46; For the analysis of suboptimal targets&#44; the previously published references of PTH &#60; 350 pg&#47;mL&#44;4 phosphorus &#60; 6 mg&#47;dL&#44; or calcium &#163; 10&#46;4 mg&#47;dL &#40;the normal value at our laboratory&#41; were used&#44; provided the CaxP product was simultaneously &#60; 55 mg2&#47;dL2&#46; The proportion of patients within the ranges of each optimal or suboptimal target are indicated at each time&#46; The proportion of<br></br>patients meeting all optimal and suboptimal targets at each time point of follow-up is also indicated&#46;<br></br><br></br>Data are given as mean and standard deviation &#40;SD&#41; or as percentage of patients depending on the nature of the variables&#46; Medications are given as daily mg of Cinacalcet-Mimpara &#174; &#40;AMGEN&#41; and elemental calcium&#44; number of Sevelamer &#174; 800 mg tablets &#40;Renagel&#174;&#59; Genzyme&#41; per day&#44; and micrograms of 1&#44;25 OH Vit D &#40;Rocaltrol&#174;&#59; Roche&#41; per week&#46; Data were entered into a SPSS 11&#46;0 database for statistical analysis&#46; The laboratory values in each period were compared to baseline values using a non-parametric Wilcoxon test&#46; A value of p &#60; 0&#46;05 was considered statistically significant&#46; The date of the first value on target was considered as the event date in a Kaplan-Meier analysis&#46; The median time to achievement of optimal or suboptimal control of all targets was calculated&#46;<br></br><br></br>RESULTS<br></br><br></br>Cohort description&#58; Eighteen patients &#40;80&#46;0&#37; males&#41; with a mean age at study start of 57&#46;70 years &#40;SD 9&#46;22&#41; were enrolled&#46; The most relevant etiologies included diabetes mellitus &#40;8&#46;3&#37;&#41;&#44; polycystic renal disease &#40;25&#46;0&#37;&#41;&#44; glomerular &#40;25&#46;0&#37;&#41;&#44; interstitial &#40;8&#46;3&#37;&#41;&#46; At the start of treatment with Cinacalcet &#174;&#44; patients had been on PD for a mean time of 15&#46;56 months &#40;SD 0&#46;78&#41;&#46; Patients received adequate APD &#40;8&#47;18&#41; or CAPD &#40;10&#47;18&#41; to reach appropriate efficacy levels &#40;Kt&#47;V 2&#46;29 &#91;SD 0&#46;65&#93;&#44; CCr 72&#46;4&#41; that were maintained during follow-up&#46;<br></br><br></br>PD bags with two calcium concentrations &#40;1&#46;25 and 1&#46;75 mEq&#47;L&#41; were available&#46; The 1&#46;75 mEq&#47;L calcium concentration was used at treatment start in 84&#46;6&#37; of cases&#44; at 3 months in 83&#46;3&#37;&#44; at 6 months in 66&#46;7&#37;&#44; at 9 months in 66&#46;7&#37;&#44; and at one year in 75&#37;&#44; with a mean calcium value during the whole follow-up of 1&#46;66 mEq&#47;L &#40;SD 0&#46;19&#41;&#46; Mean follow-up time on Cinacalcet&#174; treatment was 11&#46;9 months &#40;range&#44; 3-24&#46;83 months&#41;&#46; Two patients discontinued the study for transplant and one patient died from stroke&#46;<br></br><br></br>Table I details the changes over time in laboratory values related to BMD-CKD in patients with longer than 9 months of treatment and the medication prescribed at the different follow-up time points&#46;<br></br><br></br>No patient met the targets in the guidelines during the four months planned at the start of treatment with Cinacalcet&#174;&#44; as they all had PTH levels 3 500 pg&#47;mL&#46; Changes over time in the proportion of patients meeting each of the K&#47;DOQI targets and the suboptimal targets described are shown in Table II&#46; At the start&#44; no patient met the aggregate of all K&#47;DOQI targets or the proposed suboptimal targets&#46; The mean starting dose of Cinacalcet&#174; was 30 mg in all cases&#44; and the subsequent mean doses were 36&#46;4 mg at 1 month&#44; 44 mg at 3 months&#44; 43&#46;5 mg at 6 months&#44; and 28&#46;5 mg at one year&#46; Compliance with medication was verified in all patients&#44; and frequent non compliance was only found in one patient &#40;in whom optimal control of biochemical values was not achieved&#41;&#46; Mean monthly costs of the whole medication for treatment of HPTH is detailed in Table I&#46; Mean monthly cost of<br></br>Cinacalcet&#174; was 270 e per patient at month 3 and 175 e per patient at month 12&#46;<br></br><br></br>The mean time required to reach a PTH value on the K&#47;DOQI range was 2&#46;33 months &#40;95&#37; CI 1&#46;35-3&#46;32&#41;&#44; while<br></br>the time to reach all suboptimal targets was 4&#46;03 months &#40;95&#37; CI 2&#46;25-5&#46;82&#41;&#44; and the time required to reach all optimal targets was 16&#46;94 months &#40;95&#37; CI 11&#46;38-22&#46;5&#41;&#46; Curves are detailed in figure 1&#46;<br></br><br></br>Dyspepsia was recorded in two patients&#44; self-limited diarrhea in one&#44; gynecomastia in one&#44; and 3 patients experienced pruritus from the start&#44; but this disappeared in all cases when calcium and phosphorus levels were controlled&#46; Dose reduction was only required in one patient due to side effects &#40;painful gynecomastia&#41;&#44; and discontinuation of Cinacalcet&#174; administration was not required in any patient&#46; Only 3 cases of mild hypocalcemia ranging from 7&#46;5 and 8 mg&#47;dL&#44; all of them asymptomatic&#44; were recorded&#46;<br></br><br></br>DISCUSSION<br></br><br></br>This is the first specific study of systematic treatment with Cinacalcet in patients on PD&#46; Overall&#44; Cinacalcet was safe<br></br>and effective&#44; and allowed for controlling biochemical markers in a majority of patients resistant to conventional treatment&#46;<br></br><br></br>The approach to HPTH has evolved in recent years&#44; with attention being now focused on the vascular field&#44; beyond its effects on bone&#46;7 The K&#47;DOQI initiative attempted to unify the strategies of the different scientific societies around the world&#46;8 Along these same lines&#44; a change in nomenclature reinforcing this concept has been proposed&#46;9 Indeed&#44; there is evidence from observational studies of the relationship between the control level of BMD-CKD and the general course of patients&#46; Data showing the relationship between hyperphosphoremia in HPTH and mortality and that failure to meet the objectives proposed by K&#47;DOQI is associated to a poorer prognosis are available&#46;1 A recent study has even shown that phosphorus reduction improves vital prognosis&#46;10<br></br><br></br>Some recent European studies found the same prevalence of HPTH in incident patients on HD and PD&#44; with very similar calcium and phosphorus levels and target achievement data for both procedures&#46;1 However&#44; a majority of the epidemiological data discussed&#44; as well as Cinacalcet&#174; studies&#44; come from HD patients&#46;5&#44;11&#44;12 In fact&#44; we have found no specific study about treatment with Cinacalcet&#174; in PD&#46; Only a clinical trial enrolled 34 patients on PD together with a much greater number of patients on HD&#46; Use of PD in Spain is increasing&#44; but only reaches 15&#37; of patients and is distributed in small units&#46; The mean maintenance time on the procedure is less than 4 years&#46;13 All these factors&#44; combined with a decreased patient accessibility because it is a home procedure&#44; reduce the interest of sponsors in enrolling these patients in clinical trials and hinder the initiatives directly promoted by nephrologists&#46;<br></br><br></br>Patients on PD have some relevant differences in management of Cinacalcet&#174;&#46; First&#44; very few cases of hypocalcemia have been found&#44; and none of them was severe and&#47;or symptomatic&#46; The continuous presence of intra-abdominal fluid with adequate calcium levels may equilibrate this imbalance and protect patients from problems&#46; On the other hand&#44; Cinacalcet&#174; doses higher than 60 mg&#47;day were received by 3 patients only&#44; and dose titration was more gradual than in the schemes recommended in clinical trials published&#44;12 in which the dose was increased every month if objectives had not been reached&#46; A slower titration taking into account the trend in laboratory tests may allow for a safer control&#44; even if takes a longer time&#46;<br></br><br></br>This is the first study to estimate the time required to reach adequate control values&#46; Fifty percent of patients resistant to conventional treatment reached the PTH target in only 70 days&#46; However&#44; medication could only be temporally suspended in some patients&#44; and long-term maintenance doses are required&#46; There is only one report about the course with Cinacalcet &#174; beyond the first year of treatment&#46;14<br></br><br></br>Another significant subject is the trend to the adynamic forms of BMD&#46; Some series report a greater prevalence of adynamia in PD as compared to HD&#46; Adynamia should be avoided because of its harmful effects&#46;15 In fact&#44; the factors associated to an increased risk of adynamic forms include the presence of diabetes&#44; use of aluminium-based binders&#44; overtreatment with high calcium levels and vitamin D&#44; and PD itself&#46;16<br></br><br></br>Guidelines themselves recommend that elevation of PTH levels is allowed by reducing aggressiveness of treatment<br></br>when PTH levels are below 100 pg&#47;mL&#46;2<br></br><br></br>We used the concept of suboptimal target compliance&#44; encompassing a wider tolerance margin of PTH &#40;350 pg&#47;mL&#41;&#44;<br></br>previously used by other authors&#44;4 calcium levels within the normal ranges at our laboratory&#44; and phosphorus levels increased by 0&#46;5 mg&#47;dL&#46; In addition&#44; the CaxP product should not be higher than 55 mg2&#47;dl2&#46; We think that outside a clinical trial with strict titration protocols&#44; the clinician has a certain tolerance with these borderline values&#46; Considering these margins&#44; target control increased to 66&#46;7&#37; at 12 months&#46;<br></br><br></br>However&#44; the value of PTH as an accurate&#44; single marker of bone metabolism is increasingly controversial&#46;17 Indeed&#44; no good agreement exists between the different laboratory tests&#44;18 and all evidence about the correlation between PTH levels and bone biopsy comes from data collected using a currently unavailable PTH kit&#46;<br></br><br></br>Cinacalcet&#174; therefore appears to be as effective in PD as in HD and to be even better tolerated&#44; according to a comparison with data from a recent meta-analysis&#46;5<br></br><br></br>Patients on PD have a greater tendency to anorexia and abdominal discomfort&#44; as they have an intra-abdominal occupation&#46; The presence of calcium sensor receptors in the gastrointestinal tract justifies that the most common side effect is intolerance due to nausea or dyspepsia&#46;19 However&#44; the rate of gastrointestinal adverse effects is similar to that seen in patients on HD&#44;20 and in no patient was treatment discontinued for this reason&#46; The recommendation of taking the drug with food may have had an influence on this&#46;<br></br><br></br>The real challenge in treatment of BMD-CKD are not biochemical markers&#44; but evaluation of their effect on mortality<br></br>and vascular calcification&#46;21&#44;22 It is reasonable to assume that if HPTH and hyperphosphoremia are associated to a poorer prognosis&#44; any measure that improves these intermediate markers will have a positive effect&#46; However&#44; neither our study nor other previously published reports have been able to show this hypothesis&#46;<br></br><br></br>As added effects to HPTH control&#44; control of phosphorus levels&#44; that had increased by up to 60&#37; at 6 months&#44; and a<br></br>15&#37; reduction in use of binders such as Sevelamer&#174; were achieved&#46; The cost attributable to direct use of Cinacalcet&#174; was 175 e&#47;month at the end of follow-up&#44; and was partially compensate by the decreased Sevelamer&#174; use&#46; On the other hand&#44; as these were patients selected for their high treatmentresistant PTH levels&#44; the long-term benefits on reduction of parathyroidectomies&#44;23 CV events as a result of calcification&#44; and so on should be considered&#46; However&#44; the design of our study did not allow for making such calculations&#46; Previous studies have shown the treatment with Cinacalcet&#174; is cost-effective as compared to parathyroidectomy&#44; but the opposite occurs after 15 months of cumulative treatment&#46; Based on this&#44; Cinacalcet&#174; would be particularly indicated for patients<br></br>candidates to kidney transplant within two years&#44; a very common profile in patients on PD&#46;23<br></br><br></br>Limitations of this study include its small sample size and its observational design&#46; However&#44; study conduct at a single center&#44; with a prior protocol and no exclusion criteria&#44; ensures consistency in therapeutic management and reflects use in the real world&#46; Further specific studies in PD are required to understand whether management is exactly the same as in HD&#46; Studies intended to verify the true effect on vascular calcification&#44; bone biopsy&#44; and patient mortality are particularly required&#46;<br></br><br></br>To sum up&#44; use of Cinacalcet&#174; in patients on PD with HPTH resistant to conventional treatment was found to be<br></br>safe and effective and allowed for an improved compliance with targets in clinical guidelines&#46; Additional studies in PD specifically intended to study the impact of the drug on mortality&#44; vascular calcifications&#44; and quality of life are needed&#46;<br></br><br></br>ACKNOWLEDGEMENT<br></br><br></br>Center included as a clinical group in REDinREN &#40;Instituto Carlos IIII de Investigaci&#243;n&#44; Red 06&#47;0016&#41;&#46;<br></br></p>"
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        "resumen" => "Objetivos&#58; Estudiar la eficacia de Cinacalcet&#174; en el cumplimiento de las recomendaciones K&#47;DOQI en pacientes en di&#225;lisis peritoneal &#40;DP&#41; y estimar el tiempo necesario para alcanzarlos&#46; M&#233;todos&#58; Estudio observacional prospectivo de cohorte&#44; con pacientes con hiperparatiroidismo-HPTH moderadosevero &#40;PTH &#62; 500 pg&#47;ml&#41; con m&#225;s de 4 meses en DP resistentes a tratamiento convencional con dieta&#44; quelantes y vitamina D&#46; Los objetivos &#243;ptimos son los recomendados por las Gu&#237;as NKF-K&#47;DOQI para ERC-5D y para el an&#225;lisis de objetivos sub&#243;ptimos se utilizan las referencias de PTH &#60; 350 pg&#47;ml&#46;&#59; f&#243;sforo &#60; 6 mg&#47;dl o calcio &#60; 10&#44;4 mg&#47;dl &#40;siempre que simult&#225;neamente CaxP &#60; 55 mg2&#47;dl2&#41;&#46; Resultados&#58; Al inicio del tratamiento con Cinacalcet&#174; los 18 pacientes llevaban 15&#44;56 meses &#40;DE 0&#44;78&#41; en DP&#44; todos ten&#237;an una PTH &#62; 500 pg&#47;ml&#44; y ninguno cumpl&#237;a los objetivos K&#47;DOQI ni los sub&#243;ptimos propuestos&#46; El seguimiento medio en tratamiento con Cinacalcet&#174; fue de 12 meses&#46; El porcentaje de pacientes con PTH &#60; 350 pg&#47;ml fue de 66&#44;7&#37; a los 3 meses 60&#37; a los 6 y 100&#37; al a&#241;o&#46; A los tres meses el 33&#44;3&#37; cumplen todos los objetivos sub&#243;ptimos&#44; a los 6 meses el 33&#44;3&#37; y al a&#241;o el 66&#44;7&#37;&#46; El tiempo medio necesario para alcanzar un valor de PTH en rango fue de 2&#44;33 meses IC al 95&#37; &#91;1&#44;35-3&#44;32&#93; y para alcanzar todos los objetivos &#243;ptimos de 16&#44;94 meses &#91;11&#44;38-22&#44;5&#93;&#46; La tolerancia a la medicaci&#243;n ha sido buena&#44; no se suspendi&#243; Cinacalcet&#174; en ning&#250;n caso y s&#243;lo en uno se redujo la dosis por efectos secundarios&#46; Conclusi&#243;n&#58; La utilizaci&#243;n de Cinacalcet&#174; en pacientes en DP con HPTH resistente a tratamiento convencional ha resultado eficaz y segura y ha permitido mejorar el cumplimiento de objetivos de las gu&#237;as&#46;"
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        "resumen" => "Background&#58; Cinacalcet&#174; has improved the management of hyperparathiroidism &#40;HPTH&#41; in hemodialysis&#46; To our knowledge there are no specific studies on peritoneal dialysis &#40;PD&#41;&#46; Aim&#58; The aim of the present study was to evaluate the efficacy of Cinacalcet&#174; on the achievement of optimal and suboptimal targets on treatment of hyperparathiroidism &#40;HPTH&#41; in PD patients&#46; As secondary objectives we have studied the safety of treatment and estimate the mean time to reach these targets&#44; and evaluate economic cost&#46; Methods&#58; Eighteen patients undergoing more than 4 months on PD with a severe HPTH &#40;PTH &#62; 500 pg&#47;ml&#41; resistant to conventional treatment with diet&#44; chelants and vitamin D were included in this prospective open-label study&#46; We have used the targets of K&#47;DOQITM-clinical guidelines as optimal target&#46; We have selected as suboptimal targets&#58; PTH &#60; 350 pg&#47;ml&#44; phosphorus &#60; 6 mg&#47;dl and calcium &#60; 10&#46;4 mg&#47;dl &#40;only when simultaneous CaxP was under 55 mg2&#47;dl2&#41;&#46; Oral Cinacalcet&#174; was given with main meal in a single daily start dose of 30 mg and titrated thereafter monthly&#46; We considered the first value on target as an event and used a Kaplan-Meyer survival analysis to estimate mean time to reach target&#46; Results&#58; On inclusion all patients have at least two previous PTH values over 500 pg&#47;ml&#44; PTH mean 695&#46;3 &#40;SD 96&#41; and they were on PD with an appropriate efficacy during a mean of 15&#46;56 months &#40;SD 0&#46;78&#41;&#46; Mean follow-up time under Cinacalcet &#174; treatment was 12 months&#46; The percentage of patients with a PTH under 350 pg&#47;ml was 66&#46;7&#37; on month 3&#44; 60&#37; on month 6 and 100&#37; after 1 year&#46; The percentage of patients that reach an aggregate of all suboptimal targets &#40;PTH &#60; 350 pg&#47;ml and calcium &#60; 10&#46;4 mg&#47;dl and phosphorus &#60; 6 mg&#47;dl and CaxP &#60; 55 mg2&#47;dl2&#41; was 33&#46;3&#37; on month 6 and 66&#46;7&#37; after 1 year&#46; The mean time to reach PTH target was 2&#46;33 months with a 95&#37; confident interval &#91;1&#44;35-3&#44;32&#93; and to reach the aggregate of all target was 16&#46;94 months &#91;11&#44;38-22&#44;5&#93;&#46; Cinacalcet &#174; has been well tolerated&#44; we reduced the dose in a single patient due to secondary effects&#44; but treatment was not discontinued in any case&#46; Conclussion&#58; In summary the addition of Cinacalcet&#174; to conventional treatment in PD patients with resistant HPTH has improved the achievement of targets&#44; and has been reasonably safe in our patients&#46;"
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ISSN: 20132514
Original language: English
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