Malberti Fabio, Albertazzi Alberto, Garibotto Giacomo, Papagni Sergio, Sicurezza Elvira, Gambini Fabio, Piccolo Carmela
Divisione di Nefrologia e Dialisi, Azienda Ospedaliera Istituti Ospitalieri di Cremona, Cremona.
G Ital Nefrol. 2011 Mar-Apr;28(2):201-9.
Several studies have shown that, compared with standard therapy, cinacalcet reduces parathyroid hormone (PTH) as well as calcium and phosphorus levels in dialysis patients with secondary hyperparathyroidism (SHPT). The ECHO study evaluated cinacalcet use in actual clinical practice. ECHO enrolled 1865 patients treated with cinacalcet at 187 sites in 12 European countries. In Italy 263 patients were enrolled at 20 sites. The primary objective of the study was to evaluate K/DOQI target achievement in SHPT dialysis patients after the introduction of cinacalcet. Patients on cinacalcet treatment between July 2005 and October 2006 were enrolled and data were collected from 6 months prior to starting cinacalcet up to 12 months after. No treatment algorithm was provided to the investigators. Italian patients had suboptimally controlled SHPT at baseline according to K/DOQI targets (median PTH 760 pg/mL, P 5.4 mg/dL, Ca 9.7 mg/dL). After 1 year of cinacalcet treatment a reduction of PTH (-53.4%), Ca (-7.3%), P (-4.6%) and Ca x P (-14.4%) was observed. The proportion of patients that reached the K/DOQI targets after 1 year of cinacalcet treatment was higher compared to baseline for all parameters (PTH 32% vs 5%; Ca 48% vs 35%; P 59% vs 55%, Ca x P 82% vs 64%). The Italian ECHO data show that cinacalcet treatment increases the proportion of patients achieving the K/DOQI targets for PTH, Ca, P and Ca x P, confirming the effectiveness of cinacalcet in clinical practice in Italy. These findings are consistent with the phase III study results on cinacalcet use in dialysis patients in Europe.
多项研究表明,与标准疗法相比,西那卡塞可降低继发性甲状旁腺功能亢进(SHPT)透析患者的甲状旁腺激素(PTH)以及钙和磷水平。ECHO研究评估了西那卡塞在实际临床实践中的使用情况。ECHO在12个欧洲国家的187个地点招募了1865名接受西那卡塞治疗的患者。在意大利,20个地点招募了263名患者。该研究的主要目的是评估引入西那卡塞后SHPT透析患者达到K/DOQI目标的情况。纳入了2005年7月至2006年10月接受西那卡塞治疗的患者,并收集了从开始使用西那卡塞前6个月至使用后12个月的数据。未向研究人员提供治疗方案。根据K/DOQI目标,意大利患者在基线时SHPT控制欠佳(PTH中位数为760 pg/mL,磷5.4 mg/dL,钙9.7 mg/dL)。西那卡塞治疗1年后,观察到PTH(-53.4%)、钙(-7.3%)、磷(-4.6%)和钙×磷(-14.4%)降低。西那卡塞治疗1年后达到K/DOQI目标的患者比例在所有参数上均高于基线(PTH 32%对5%;钙48%对35%;磷59%对55%,钙×磷82%对64%)。意大利ECHO数据表明,西那卡塞治疗可提高达到PTH、钙、磷和钙×磷K/DOQI目标的患者比例,证实了西那卡塞在意大利临床实践中的有效性。这些发现与欧洲关于西那卡塞用于透析患者的III期研究结果一致。