Efficacy and security of teriparatide in bisphosphonate-pretreated and treatment-naive sufferers with osteoporosis at excessive danger of fracture: Put up hoc evaluation of a potential observational research.
J Orthop Sci. 2017 Mar;22(2):330-338
Authors: Yoshiki F, Nishikawa A, Taketsuna M, Kajimoto Okay, Enomoto H
BACKGROUND: Teriparatide is the primary anabolic agent proven to cut back the danger of fractures in sufferers with osteoporosis. In Japan, teriparatide is prescribed to deal with sufferers at excessive danger of fracture. Provided that bisphosphonates are generally used previous to teriparatide as remedy for osteoporosis, info on the effectiveness and security of teriparatide with or with out earlier bisphosphonate remedy is useful for physicians in medical follow. This research goals to report the effectiveness and security of teriparatide in treatment-naive and bisphosphonate-pretreated sufferers in Japan as real-world proof.
METHODS: A put up hoc evaluation of a postmarketing surveillance research was carried out in Japanese sufferers with osteoporosis at excessive danger of fracture who acquired 24-month remedy of each day teriparatide. Modifications in bone turnover biomarkers and bone mineral density and incidence of latest fractures have been analyzed in treatment-naive in addition to bisphosphonate-pretreated sufferers.
RESULTS: The evaluation included 1433 sufferers (treatment-naive, n = 659; bisphosphonate-pretreated, n = 774). Bone mineral density elevated considerably from baseline at 24 months in each treatment-naive (lumbar backbone, 13.45%; femoral neck, 5.16%; whole hip, four.46%) and bisphosphonate-pretreated (lumbar backbone, 11.20%; femoral neck, 2.22%; whole hip, zero.67%) sufferers. The incidence charges of latest vertebral and nonvertebral fractures at 24 months have been 1.69% and three.37%, respectively, in treatment-naive sufferers and three.60% and 5.56%, respectively, in bisphosphonate-pretreated sufferers. The incidence of adversarial drug reactions was 6% in treatment-naive sufferers and 10% in bisphosphonate-pretreated sufferers. The most typical adversarial drug response in treatment-naive and bisphosphonate-pretreated sufferers was nausea (zero.91%) and hyperuricaemia (1.81%), respectively.
CONCLUSIONS: On this put up hoc evaluation, no new security issues and related effectiveness of teriparatide have been noticed in Japanese sufferers with osteoporosis at excessive danger of fracture, no matter their earlier remedy standing with bisphosphonates.
PMID: 28038880 [PubMed – indexed for MEDLINE]