法德藥 Glyburide獲FDA學名藥藥證

法德藥:公告本公司學名藥產品-Glyburide獲得美國FDA正式核准 並取得藥證 鉅亨網新聞中心　(來源：台灣證券交易所)　2016-04-22 第三十四條第42款1.事實發生日:105/04/212.公司名稱:法德生技藥品股份有限公司3.與公司關係(請輸入本公司或聯屬公司):本公司4.相互持股比例(若前項為本公司，請填不適用):不適用5.發生緣由:本公司學名藥產品Glyburide 5/2.5/1.25mg Tablets已經 獲得美國FDA正式核可(Approval)並取得學名藥藥證，准許自即日起可在美國市場上市銷售。6.因應措施:本產品將透過本公司於美國當地之銷售夥伴進行銷售。7.其他應敘明事項:本學名藥之適應症為糖尿病。

The Use of Glyburide Compared With Other Sulfonylureas and the Risk of Cancer in Patients With Type 2 Diabetes/ Diabetes Care September 4, 2015

OBJECTIVE To determine whether the use of glyburide is associated with an increased risk of cancer compared with the use of other second-generation sulfonylureas among patients with type 2 diabetes. RESEARCH DESIGN AND METHODS The U.K. Clinical Practice Research Datalink was used to conduct a cohort study among 52,600 patients newly prescribed glyburide or other second-generation sulfonylureas between 1 January 1988 and 31 July 2013. A time-dependent Cox proportional hazards model was used to estimate adjusted hazard ratios (HRs) and 95% CIs of any cancer associated with the use of glyburide compared with the use of second-generation sulfonylureas. Secondary analyses were conducted to determine whether the association varied with cumulative duration of use and cumulative dose (expressed as defined daily dose [DDD]). RESULTS During 280,288 person-years of follow-up, 4,105 patients were given a new diagnosis of cancer (incidence rate 14.6 per 1,000 person-years). Overall, when compared with the use of other second-generation sulfonylureas, the use of glyburide was associated with a nonsignificant increased risk of any cancer (HR 1.09 [95% CI 0.98–1.22]). In secondary analyses, duration- and dose-response relationships were observed, with longer cumulative durations and cumulative doses associated with an increased risk of any cancer (>36 months: HR 1.21 [95% CI: 1.03–1.42]; >1,096 DDDs: HR 1.27 [95% CI 1.06–1.51]). CONCLUSIONS In this population-based cohort study, longer cumulative durations and higher cumulative doses of glyburide were associated with an increased risk of cancer.