| アブストラクト | BACKGROUND: Case reports have signaled a possible association between tramadol, a weak opioid analgesic, and hyponatremia. The objective of this study was to determine whether the use of tramadol is associated with an increased risk of hyponatremia, when compared with codeine. METHODS: Using the UK Clinical Practice Research Datalink and Hospital Episodes Statistics database, a population-based cohort of 332,880 patients initiating tramadol or codeine was assembled from 1998 through 2012. Cox proportional hazards models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CIs) of hospitalization for hyponatremia associated with the use of tramadol, compared with codeine, in the first 30 days after initiation. A similar analysis was conducted within a highly restricted sub-cohort, which additionally excluded patients with any serum sodium level abnormality in the year before cohort entry. All models were adjusted for propensity score quintiles. RESULTS: The incidence rates of hospitalization for hyponatremia were 4.6 (95% CI, 2.4-8.0) and 1.9 (95% CI, 1.4-2.5) per 10,000 person-months for tramadol and codeine users, respectively. In the adjusted model, the use of tramadol was associated with a 2-fold increased risk of hospitalization for hyponatremia, compared with codeine (adjusted HR 2.05; 95% CI, 1.08-3.86). In the highly restricted sub-cohort, the use of tramadol was associated with an over 3-fold increased risk of hospitalization for hyponatremia, compared with codeine (adjusted HR 3.54; 95% CI, 1.32-9.54). CONCLUSIONS: In this first population-based study, the use of tramadol was associated with an increased risk of hyponatremia requiring hospitalization. |
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| 組織名 | Centre for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital,;Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics and;Occupational Health, McGill University, Montreal, Quebec, Canada.;Montreal, Quebec, Canada.;Department of Medicine, Division of Nephrology, Jewish General Hospital,;Laboratoire de Pharmacologie Medicale et Clinique, Equipe de;PharmacoEpidemiologie, Faculte de Medecine, Universite Paul Sabatier, Toulouse,;France; Service de Pharmacologie Clinique, Centre Midi-Pyrenees de;Pharmacovigilance, de PharmacoEpidemiologie et d'Information sur le Medicament,;Centre Hospitalier Universitaire de Toulouse, Toulouse, France.;Montreal, Quebec, Canada; Department of Oncology, McGill University, Montreal,;Quebec, Canada. Electronic address: laurent.azoulay@mcgill.ca. |
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