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Impact of cinacalcet introduction on MBD management: the MBD-5D study in Japan
Shingo Fukuma1, Noriaki Kurita2, Masafumi Fukagawa3
1Department of Healthcare Epidemiology, School of Public Health at Graduate School of Medicine, Kyoto University , Kyoto, Japan ; Institute for Advancement of Clinical and Translational Science (iACT), Kyoto University Hospital , Kyoto, Japan ; Institute for Health Outcomes and Process Evaluation Research (iHope International) , Tokyo, Japan.
Insights
Cinacalcet significantly improved mineral and bone disorder (CKD-MBD) markers in Japanese hemodialysis patients with secondary hyperparathyroidism (SHPT). Combination therapy with vitamin D receptor activators (VDRAs) offers tailored treatment strategies for managing CKD-MBD.
Area of Science:
- Nephrology
- Endocrinology
- Pharmacology
Background:
- Chronic kidney disease-mineral and bone disorder (CKD-MBD) is linked to adverse clinical outcomes, including fractures, cardiovascular disease, and mortality in dialysis patients.
- Effective management of CKD-MBD is crucial in dialysis practice, necessitating real-world evidence for treatment decisions.
- Cinacalcet has altered prescription patterns for secondary hyperparathyroidism (SHPT) management, showing different effects on mineral and bone disorder markers compared to active vitamin D derivatives.
Approach:
- The Mineral and Bone Disorder Outcomes Study for Japanese CKD Stage 5D Patients (MBD-5D) was a 3-year observational study.
- The study involved prevalent hemodialysis patients diagnosed with secondary hyperparathyroidism (SHPT).
- The study reviewed cinacalcet's impact on MBD markers and explored combination therapies with vitamin D receptor activators (VDRAs).
Key Points:
- Three years post-introduction, cinacalcet is used by 40% of hemodialysis patients with SHPT, leading to significant improvements in intact parathyroid hormone (PTH), phosphorus, and calcium levels.
- Combination therapy with cinacalcet and VDRAs allows for personalized prescription patterns based on patient characteristics and treatment goals.
- Starting cinacalcet with an increased VDRA dose showed an additive effect on improving intact PTH control, while combining cinacalcet with a decreased VDRA dose improved serum phosphorus and calcium target achievement.
Conclusions:
- Cinacalcet has demonstrably improved the management of key mineral and bone disorder markers in Japanese hemodialysis patients with SHPT.
- The combination of cinacalcet and VDRAs provides flexible therapeutic options for optimizing SHPT treatment.
- Further research is warranted to investigate the impact of various SHPT treatment prescription patterns on clinical outcomes.
Abstract:
Chronic kidney disease-mineral and bone disorder (CKD-MBD) has recently attracted attention in light of its association with clinical outcomes, such as fracture, cardiovascular disease, and mortality. Management of CKD-MBD has therefore come to have a central role in dialysis practice. Cinacalcet, a newly developed drug, has changed prescription patterns in many centers based on different changes in MBD markers than those observed with active vitamin D derivatives. As physicians require real-world evidence to guide their treatment decisions with respect to MBD management, we conducted the Mineral and Bone Disorder Outcomes Study for Japanese CKD Stage 5D Patients (MBD-5D), a 3-year observational study involving prevalent hemodialysis patients with secondary hyperparathyroidism (SHPT). Here, we review the results from the MBD-5D and discuss issues of MBD management in the cinacalcet era. Three years since the introduction of cinacalcet, 40% of hemodialysis patients with SHPT have come to use cinacalcet, enjoying marked improvement in management of circulating MBD markers, such as intact parathyroid hormone (PTH), phosphorus, and calcium. Combination therapy with cinacalcet and a vitamin D receptor activator (VDRA) may allow physicians to choose more suitable prescription patterns based on patient characteristics and therapeutic purposes. We observed an additive association between 'starting cinacalcet' and 'increased VDRA dose,' with marked improvement in the control of intact PTH levels. Further, the combination pattern of 'starting cinacalcet' and 'decreased VDRA dose' was associated with better achievement of target serum phosphorus and calcium levels. Future studies should examine the effect of different prescription patterns for SHPT treatment on clinical outcomes.
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