title: PTH-dependence of the effectiveness of cinacalcet in hemodialysis patients with secondary hyperparathyroidism.
abstract: Cinacalcet lowers parathyroid hormone levels. Whether it can prolong survival of people with chronic kidney disease (CKD) complicated by secondary hyperparathyroidism (SHPT) remains controversial, in part because a recent randomized trial excluded patients with iPTH <300 pg/ml. We examined cinacalcet's effects at different iPTH levels. This was a prospective case-cohort and cohort study involving 8229 patients with CKD stage 5D requiring maintenance hemodialysis who had SHPT. We studied relationships between cinacalcet initiation and important clinical outcomes. To avoid confounding by treatment selection, we used marginal structural models, adjusting for time-dependent confounders. Over a mean of 33 months, cinacalcet was more effective in patients with more severe SHPT. In patients with iPTH ≥ 500 pg/ml, the reduction in the risk of death from any cause was about 50% (Incidence Rate Ratio [IRR] = 0.49; 95% Confidence Interval [95% CI]: 0.29-0.82). For a composite of cardiovascular hospitalization and mortality, the association was not statistically significant, but the IRR was 0.67 (95% CI: 0.43-1.06). These findings indicate that decisions about using cinacalcet should take into account the severity of SHPT.
authors.affiliation: Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
authors.forename: Tadao
authors.initials: T
authors.lastname: Akizawa
authors.affiliation: Department of Innovative Research and Education for Clinicians and Trainees (DiRECT), Fukushima Medical University Hospital, Fukushima, Japan.|Center for Innovative Research for Communities and Clinical Excellence (CIRC2LE), Fukushima Medical University, Fukushima, Japan.|Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto, Japan.|Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Noriaki
authors.initials: N
authors.lastname: Kurita
authors.affiliation: Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan.
authors.forename: Masahide
authors.initials: M
authors.lastname: Mizobuchi
authors.affiliation: Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine, Isehara, Japan.
authors.forename: Masafumi
authors.initials: M
authors.lastname: Fukagawa
authors.affiliation: Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto, Japan.
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Onishi
authors.affiliation: Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto, Japan.|Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.
authors.forename: Takuhiro
authors.initials: T
authors.lastname: Yamaguchi
authors.affiliation: Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Tokyo, Japan.
authors.forename: Alan R
authors.initials: AR
authors.lastname: Ellis
authors.affiliation: Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto, Japan.|Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan.|Institute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital, Kyoto, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Fukuma
authors.affiliation: Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill, Tokyo, Japan.|Department of Epidemiology, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Tokyo, Japan.
authors.forename: M
authors.initials: M
authors.lastname: Alan Brookhart
authors.affiliation: Department of Innovative Research and Education for Clinicians and Trainees (DiRECT), Fukushima Medical University Hospital, Fukushima, Japan.|Center for Innovative Research for Communities and Clinical Excellence (CIRC2LE), Fukushima Medical University, Fukushima, Japan.|Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto, Japan.|Division of Nephrology, Department of Internal Medicine, Showa University Fujigaoka Hospital, Yokohama, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Hasegawa
authors.affiliation: National Graduate Institute for Policy Studies, Tokyo, Japan.
authors.forename: Kiyoshi
authors.initials: K
authors.lastname: Kurokawa
authors.affiliation: Center for Innovative Research for Communities and Clinical Excellence (CIRC2LE), Fukushima Medical University, Fukushima, Japan.|Department of Healthcare Epidemiology, School of Public Health in the Graduate School of Medicine, Kyoto University, Kyoto, Japan.
authors.forename: Shunichi
authors.initials: S
authors.lastname: Fukuhara
mesh_terms: D000368:Aged; D057966:Calcimimetic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000069449:Cinacalcet / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood*; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000628:therapy*
chemical_list: D057966:Calcimimetic Agents; D010281:Parathyroid Hormone; D000069449:Cinacalcet