Denosumab and osteonecrosis of the jaw. A systematic analysis of events reported in clinical trials

Clinical Oral Implants Research - Tập 27 Số 3 - Trang 367-375 - 2016
Ana Boquete‐Castro1, Gerardo Gómez‐Moreno2, José Luís Calvo‐Guirado3, Antonio Aguilar‐Salvatierra4, Rafael Delgado‐Ruiz5
1Department of Pharmacological Research in Dentistry Faculty of Dentistry University of Granada Granada Spain
2Department of Pharmacological Research in Dentistry, Periodontology and Implant Dentistry, Special Care in Dentistry, Faculty of Dentistry, University of Granada, Granada, Spain
3Department of Implant Dentistry Implant Dentistry and Biomaterials School of Medicine and Dentistry University of Murcia Murcia Spain
4Department of Pharmacological Research in Dentistry, Periodontology and Implant Dentistry, Faculty of Dentistry, University of Granada, Granada, Spain
5School of Dental Medicine, Stony Brook University, Stony Brook, NY, USA

Tóm tắt

AbstractObjectivesThe aims of this meta‐analysis were (i) to perform a systematic review of the relation between treatment with denosumab and the incidence of osteonecrosis of the jaw (ONJ) and (ii) to obtain information on dosage, first event apparition, and treatment approaches for patients with ONJ related to denosumab.Materials and methodsA systematic review and meta‐analysis of relevant literature was performed in the PubMed, MEDLINE, Embase, and Cochrane databases, identifying randomized clinical trials that evaluate the adverse effects of denosumab. The overall incidence rates and 95% confidence intervals (CI) for ONJ were calculated employing fixed‐ and random‐effects models, according to the heterogeneity of the studies included.ResultsA total of 8963 patients with a variety of solid tumors reported in seven randomized controlled trials (RCTs) were included in the systematic analysis. The overall incidence of ONJ in patients with cancer receiving denosumab was 1.7% [95% CI: 0.9–3.1%]. The use of denosumab was associated with a significantly increased risk of ONJ in comparison with bisphosphonates (BPs)/placebo treatment (RR 1.61, 95% CI: 1.05–2.48, P = 0.029). Subgroup analysis based on controlled therapies demonstrated an increased risk of ONJ in denosumab therapy, when compared with BPs (RR 1.48, 95% CI: 0.96–2.29, P = 0.078) or placebo (RR 16.28, 95% CI: 1.68–158.05, P = 0.017). Similar results were observed for prostate cancer (RR 3.358, 95% CI: 1.573–7.166, P = 0.002).ConclusionsDenosumab combined with risk factors such as dental extraction, poor oral hygiene, use of removable apparatus, and chemotherapy may favor the development of ONJ.

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Clinical Oral Implants Research

Tập 27 Số 3

367-375

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