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薬理と治療
Abstract
Objectives To examine the safety and efficacy of sucroferric oxyhydroxide(P-TOL® Chewable tablets)in clinical practice for treating patients with hyperphosphatemia in chronic kidney disease undergoing dialysis. Methods We performed a prospective special drug use surveillance study using a central registration method. Interim analysis was performed 3 months after the start of administration of sucroferric oxyhydroxide to determine patient characteristics and safety and efficacy. Results Our study included 2205 patients. Adverse reactions were observed in 402 patients (18.2%). The most common adverse reactions were gastrointestinal disorders, including diarrhea in 145 patients (6.58%), constipation in 38 patients(1.72%)and loose stools in 37 patients (1.68%). The serum phosphorus levels showed a significant decrease from 6.64 mg╱dL before administration of sucroferric oxyhydroxide to 5.54 mg╱dL at 1 month after administration, and the serum phosphorous levels continued to remain low until 3 months after the administration. Conclusions We observed no remarkable increase in the adverse reactions and no new safety concerns after 3 month administration of sucroferric oxyhydroxide. For the efficacy, serum phosphorus lowering effect was observed during 3 month administration of sucroferric oxyhydroxide. Surveillance will be continued until 18 months, and the final results will be reported in the future.
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