Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital, Faculty of Medicine, Toulouse, France.
Expert Opin Drug Saf. 2023 Jul-Dec;22(12):1283-1287. doi: 10.1080/14740338.2023.2247962. Epub 2023 Aug 21.
The association between dental problems and sublingual/buccal buprenorphine is unclear. We conducted an analysis of dental adverse drug reactions reported with sublingual/buccal buprenorphine in VigiBase®, the pharmacovigilance database of the World Health Organization.
We performed disproportionality analyses to compare the reporting rates of dental problems with sublingual/buccal buprenorphine, compared to other buprenorphine formulations and methadone. Significant signals were considered if the lower boundary of the 95% confidence interval of the Reporting Odds Ratio (ROR) was > 1; cases were ≥ 3 and p-value <0.05. We conducted sensitivity analyses by calculating the ROR according to the reporter's qualification and the reporting continent (United States of America and Europe).
We included 30,769 reports with all buprenorphine forms. We found 20 cases of dental problems with sublingual/buccal buprenorphine. Sublingual/buccal buprenorphine was associated with an overreporting of dental problems compared to other buprenorphine formulations (ROR = 15.10; 95% CI [7.50-30.39]; < 0.005) and compared to methadone (ROR = 6.02; 95% CI [3.21-11.30]; < 0.005). Overreporting of dental problems was consistent in sensitivity analyses, except in Europe compared with other buprenorphine formulations and with methadone.
Sublingual/buccal buprenorphine might increase the risk of reporting dental problems. However, these results do not modify the benefits of sublingual/buccal buprenorphine in the treatment of opioid use disorders.
牙齿问题与舌下/颊部丁丙诺啡之间的关联尚不清楚。我们对世界卫生组织药物警戒数据库 VigiBase®中舌下/颊部丁丙诺啡报告的药物不良反应进行了分析。
我们进行了比例失衡分析，以比较舌下/颊部丁丙诺啡与其他丁丙诺啡制剂和美沙酮相比，报告牙齿问题的比率。如果报告比值比（ROR）的 95%置信区间下限（LR）>1；病例数≥3且 p 值<0.05，则认为存在显著信号。我们根据报告人的资质和报告地区（美国和欧洲）计算 ROR 进行了敏感性分析。
我们纳入了所有丁丙诺啡制剂的 30769 例报告。我们发现舌下/颊部丁丙诺啡有 20 例牙齿问题。与其他丁丙诺啡制剂相比，舌下/颊部丁丙诺啡与牙齿问题的报告过多相关（ROR=15.10；95%CI[7.50-30.39]； <0.005），与美沙酮相比（ROR=6.02；95%CI[3.21-11.30]； <0.005）。敏感性分析中，除了在欧洲与其他丁丙诺啡制剂和与美沙酮相比，牙齿问题的报告过多不一致外，结果一致。
舌下/颊部丁丙诺啡可能会增加报告牙齿问题的风险。但是，这些结果并不会改变舌下/颊部丁丙诺啡在治疗阿片类药物使用障碍中的益处。
