Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis

Investigators, Evolve Trial; Chertow, Glenn M.; Block, Gilbert A.; Correa‐Rotter, Ricardo; Tb, Drüeke; Floege, Jürgen; Wg, Goodman; Ca, Herzog; Kubo, Yumi; Gm, London; Mahaffey, KW; Tc, Mix; Sm, Moe; Ml, Trotman; Wheeler, DC; Ps, Parfrey

doi:10.1056/nejmoa1205624

Cited by 774 publications

(281 citation statements)

References 39 publications

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“…Although there were numerically fewer primary composite endpoints (time to death or first non‐fatal cardiovascular event) in patients randomised to cinacalcet compared with those of placebo, this difference failed to reach statistical significance in unadjusted intention‐to‐treat analysis 24. Pre‐specified secondary and sensitivity analyses such as covariate adjustment and lag‐censoring, however, revealed a nominally significant 12–15% risk reduction with cinacalcet 24…”

Section: Methodsmentioning

confidence: 99%

“…Six‐month lag‐censoring was employed to match the pre‐specified lag‐censored analysis in the EVOLVE trial,24 but 0‐month lag‐censoring was also investigated. Patients who switched from non‐exposed to exposed were censored 0 or 6 months after cinacalcet initiation; cinacalcet patients with poorer persistence (defined as the first 90‐day period post‐initiation where prescriptions covered less than two‐thirds of the period) were censored 0 or 6 months after the time of reduced persistence.…”

Section: Methodsmentioning

confidence: 99%

“…The EVOLVE trial was a large, multi‐centre, double‐blind, placebo‐controlled RCT where 3883 HD patients with sHPT were randomly assigned cinacalcet or placebo 24. Although there were numerically fewer primary composite endpoints (time to death or first non‐fatal cardiovascular event) in patients randomised to cinacalcet compared with those of placebo, this difference failed to reach statistical significance in unadjusted intention‐to‐treat analysis 24.…”

Section: Methodsmentioning

confidence: 99%

“…We were more interested in the potential for treatment crossover to distort the estimated treatment effect of cinacalcet use on all‐cause mortality—and our ability to correct this form of bias—than estimation of the actual treatment effect itself. Findings were compared with treatment estimates for all‐cause mortality from the EVOLVE study24: an RCT designed to gain an insight into the long‐term clinical efficacy of cinacalcet.…”

Section: Introductionmentioning

confidence: 99%

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Propensity score matching and persistence correction to reduce bias in comparative effectiveness: the effect of cinacalcet use on all‐cause mortality

Gillespie

Floege

Gioni

et al. 2015

Pharmacoepidemiol Drug Saf

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PurposeThe generalisability of randomised controlled trials (RCTs) may be limited by restrictive entry criteria or by their experimental nature. Observational research can provide complementary findings but is prone to bias. Employing propensity score matching, to reduce such bias, we compared the real‐life effect of cinacalcet use on all‐cause mortality (ACM) with findings from the Evaluation of Cinacalcet Therapy to Lower Cardiovascular Events (EVOLVE) RCT in chronic haemodialysis patients.MethodsIncident adult haemodialysis patients receiving cinacalcet, recruited in a prospective observational cohort from 2007–2009 (AROii; n = 10,488), were matched to non‐exposed patients regardless of future exposure status. The effect of treatment crossover was investigated with inverse probability of censoring weighted and lag‐censored analyses. EVOLVE ACM data were analysed largely as described for the primary composite endpoint.ResultsAROii patients receiving cinacalcet (n = 532) were matched to 1790 non‐exposed patients. The treatment effect of cinacalcet on ACM in the main AROii analysis (hazard ratio 1.03 [95% confidence interval (CI) 0.78–1.35]) was closer to the null than for the Intention to Treat (ITT) analysis of EVOLVE (0.94 [95%CI 0.85–1.04]). Adjusting for non‐persistence by 0‐ and 6‐month lag‐censoring and by inverse probability of censoring weight, the hazard ratios in AROii (0.76 [95%CI 0.51–1.15], 0.84 [95%CI 0.60–1.18] and 0.79 [95%CI 0.56–1.11], respectively) were comparable with those of EVOLVE (0.82 [95%CI 0.67–1.01], 0.83 [95%CI 0.73–0.96] and 0.87 [95%CI 0.71–1.06], respectively).ConclusionsCorrecting for treatment crossover, we observed results in the ‘real‐life’ setting of the AROii observational cohort that closely mirrored the results of the EVOLVE RCT. Persistence‐corrected analyses revealed a trend towards reduced ACM in haemodialysis patients receiving cinacalcet therapy. © 2015 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Propensity score matching and persistence correction to reduce bias in comparative effectiveness: the effect of cinacalcet use on all‐cause mortality

Gillespie

Floege

Gioni

et al. 2015

Pharmacoepidemiol Drug Saf

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“…La probabilità di decesso tra i soggetti allo stadio CKD5 è stata dedotta dallo studio EVOLVE [22] per simulare il trattamento con cinacalcet, mentre per il braccio relativo a Zemplar ® , la probabilità di decesso tra i soggetti allo stadio CKD5 è stata modellata utilizzando i dati riportati dallo studio di Teng et al [23]. Per entrambe le alternative terapeutiche sono state utilizzate le probabilità riportate nello studio di Nuijten et al [21] per modellare le transizioni tra lo stato del trapianto e del post trapianto.…”

Section: Le Probabilità DI Transizione E La Popolazioneunclassified

Budget impact analysis of the use of paricalcitol for the treatment of secondary hyperparathyroidism in chronic kidney disease

Lorenzoni

Turchetti

2014

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Data la diffusione e la dimensione del fenomeno legata alla molteplicità di complicanze associate, tale patologia è attualmente riconosciuta come una vera e propria emergenza di salute pubblica a livello internazionale [1]. Negli ultimi anni la prevalenza della malattia renale cronica è progressivamente aumentata ed è destinata a crescere ulteriormente nel futuro in conseguenza dell'invecchiamento della popolazione e dell'aumento della prevalenza di fattori di rischio associati alla sua insorgenza quali il diabete, l'ipertensione e la sindrome metabolica in generale. INTRODUZIONELa malattia renale cronica (MRC) è una patologia caratterizzata da una progressiva e irreversibile diminuzione della funzionalità renale che porta all'insufficienza renale cronica (IRC) ed esita nella perdita completa dell'attività del rene e quindi nella necessità di trattamento dialitico o nel trapianto renale. La progressione dell'IRC comporta un elevato rischio di mortalità anche tra i pazienti allo stadio intermedio della malattia e si caratterizza per un'elevata presenza di complicanze a carico di tutto l'organismo. Corresponding authorGiuseppe Turchetti, PhD Istituto di Management, Scuola Superiore Sant'Anna g.turchetti@sssup.it DisclosureThe authors have no conflict of interest to report ABSTRACT OBJECTIVE: Evaluation of the budget impact of the use of paricalcitol (compared to alternative treatment) for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) when used at two different timing of therapy. METHODS: Two Markov models related to a different timing of treatment have been developed: the intermediate stage of chronic kidney disease (CKD3) and the dialysis stage. The analysis was conducted with the perspective of the Italian National Health System and over a 5-year time horizon. The clinical and economic data used in the model were derived from the literature and other assumptions were made based on the opinion of clinical experts. Univariate sensitivity analysis was conducted to test the robustness of the results. RESULTS: The base case shows that starting paricalcitol treatment from the dialysis stage (considering 13,311 possible candidates) is associated with a reduction in direct costs from € 1,782,921,351 to € 1,622,357,209 over 5 years. Furthermore, considering a collective of 1,000 subjects eligible and starting treatment with paricalcitol since the intermediate stages of the CKD, is associated with an overall cost saving of € 1,197,500. DISCUSSION AND CONCLUSIONS: Paricalcitol is expected to be cost-saving in patients with SHPT in Italy considering both the therapeutic indications of the drug. Moreover, despite the higher cost of using paricalcitol in pre-dialysis stage, an early treatment of SHPT determine an overall decrease in direct medical costs.

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Second Chances to Improve ESRD Outcomes With a Second-Generation Calcimimetic

Middleton

Wolf

2017

JAMA

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Effect of Cinacalcet on Cardiovascular Disease in Patients Undergoing Dialysis

Cited by 774 publications

References 39 publications

Propensity score matching and persistence correction to reduce bias in comparative effectiveness: the effect of cinacalcet use on all‐cause mortality

Propensity score matching and persistence correction to reduce bias in comparative effectiveness: the effect of cinacalcet use on all‐cause mortality

Budget impact analysis of the use of paricalcitol for the treatment of secondary hyperparathyroidism in chronic kidney disease

Second Chances to Improve ESRD Outcomes With a Second-Generation Calcimimetic

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