Identification of risk factors and development of detection algorithm for denosumab-induced hypocalcaemia

Autor: Takuya Imatoh, Masato Karayama, Katsunori Segawa, Michio Kimura, Yoshiro Saito, Kimie Sai, Junichi Kawakami, Katsuhito Hori, Kazuki Furuhashi, Mayu Takeyama
Rok vydání: 2018
Předmět:
Zdroj: Journal of clinical pharmacy and therapeutics. 44(1)
ISSN: 1365-2710
Popis: WHAT IS KNOWN AND OBJECTIVE This study used electronic medical records to identify risk factors and establish a detection algorithm for denosumab-induced hypocalcaemia. METHODS We identified 201 patients with cancer who were initially prescribed denosumab. Hypocalcaemia was defined as an adjusted serum calcium level of ≤2.13 mmol/L. A diagnosis of denosumab-induced hypocalcaemia was confirmed by two physicians after reviewing patient medical records. We evaluated patient characteristics as potential screening factors. Moreover, a retrospective cohort study was conducted to identify risk factors for denosumab-induced hypocalcaemia. Odds ratios (ORs) were estimated using logistic regression analysis. RESULTS We analysed 164 patients with a low risk of hypocalcaemia. Among these, 29 (17.7%) patients were suspected to have denosumab-induced hypocalcaemia. The times to onset of definitive hypocalcaemia were shorter among these patients than among patients with non-denosumab-induced hypocalcaemia. Based on receiver operating characteristic curve analysis, we used time to onset of hypocalcaemia of ≤90 days as a second screening factor. The positive predictive value of this factor was 87.5%. In the retrospective cohort study, a significant difference was observed among patients with serum alkaline phosphatase (ALP) levels of >5.95 μkat/L before initial prescription (P
Databáze: OpenAIRE