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Postmarketing Surveillance of the Safety of Cyclic Etidronate
Author(s) -
Staa Tjeerd P.,
Leufkens Hubert,
Abenhaim Lucien,
Cooper Cyrus
Publication year - 1998
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1002/j.1875-9114.1998.tb03943.x
Subject(s) - postmarketing surveillance , medicine , etidronic acid , osteomalacia , osteoporosis , incidence (geometry) , adverse drug reaction , general practice , adverse effect , drug , family medicine , pharmacology , mathematics , geometry
To evaluate the safety of cyclic etidronate in routine clinical practice, we obtained information from 550 general practices in the United Kingdom that provide the medical records to the General Practice Research Database. A group of 7977 patients taking cyclic etidronate and two age‐, gender‐, and practice‐matched control groups, one with osteoporosis and one without, were analyzed. For the group taking cyclic etidronate, the average age was 71.6 years and follow‐up was 10,328 person‐years. Conditions that do not induce osteoporosis generally occurred in these patients at a rate comparable to that in the control groups. The incidence of osteomalacia was low and comparable between patients taking cyclic etidronate and controls with osteoporosis. No medically significant increases in frequency were observed among patients taking cyclic etidronate for a broad group of diseases that may potentially be induced by exposure to the drug. These data support the favorable risk:benefit ratio of cyclic etidronate.