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A randomised, double-blind, placebo-controlled, 3 parallel group efficacy and safety study of linagliptin 2.5 mg twice daily versus 5 mg once daily over 12 weeks as add-on therapy to a twice daily dosing regimen of metformin in patients with type 2 diabetes mellitus and insufficient glycaemic control

开始日期2009-11-12

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Boehringer Ingelheim Korea Ltd.

100 项与 Boehringer Ingelheim Korea Ltd. 相关的临床结果

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2023-01-31·Diabetes & Metabolism Journal

Safety and Effectiveness of Empagliflozin in Korean Patients with Type 2 Diabetes Mellitus: Results from a Nationwide Post-Marketing Surveillance

Article

作者: Jeong, In-Kyung ; Lee, Sun Woo ; Kim, Nan Hee ; Lee, Dong Woo ; Mok, Ji-Oh ; Lee, Soon Hee ; Cho, Jinhong ; Won, Kyu Chang ; Cho, Jae Hyoung ; Moon, Jun Sung ; Na, Jin Oh ; Kim, Nam Hoon ; Chung, Dong Jin

Background: To evaluate the safety and effectiveness of empagliflozin in routine clinical settings, we collected and assessed the clinical profiles of Korean patients with type 2 diabetes mellitus.Methods: This was a post-marketing surveillance study of empagliflozin 10 and 25 mg. Information on adverse events and adverse drug reactions (ADRs) was collected as safety data sets. Available effectiveness outcomes, including glycosylated hemoglobin (HbA1c) level, fasting plasma glucose, body weight, and blood pressure, were assessed.Results: The incidence rate of ADRs was 5.14% in the safety dataset (n=3,231). Pollakiuria, pruritis genital, and weight loss were the most common ADRs. ADRs of special interest accounted for only 1.18%, and there were no serious events that led to mortality or hospitalization. In the effectiveness data set (n=2,567), empagliflozin significantly reduced the mean HbA1c level and body weight during the study period by –0.68%±1.39% and –1.91±3.37 kg (both P<0.0001), respectively. In addition, shorter disease duration, absence of dyslipidemia, and higher baseline HbA1c levels were identified as the clinical features characteristic of a “responder” to empagliflozin therapy.Conclusion: Empagliflozin is a safe and potent glucose-lowering drug in routine use among Korean patients with type 2 diabetes mellitus. It is expected to have better glycemic efficacy in Korean patients with poorly controlled type 2 diabetes mellitus.

2021-12-01·BMC Cancer2区 · 医学

An open-label expanded access program of afatinib in EGFR tyrosine kinase inhibitor-naïve patients with locally advanced or metastatic non-small cell lung cancer harboring EGFR mutations

2区 · 医学

ArticleOA

作者: Märten, Angela ; Kim, Joo-Hang ; Kang, Jin-Hyoung ; Jin, Jong-Youl ; Kim, Miyoung ; Cho, Eun Kyung ; Park, Keunchil ; Kim, Jin-Soo ; Kim, Hoon-Gu ; Kim, Young-Chul

AbstractBackgroundAfatinib is approved globally for EGFR-TKI treatment-naïve patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). In this Korean expanded access program, we evaluated its ‘real-world’ safety and efficacy.MethodsEGFR-TKI treatment-naïve patients with EGFR mutation-positive NSCLC received afatinib 40 mg/day until disease progression or other withdrawal criteria. Dose reductions were permitted for adverse events (AEs). The primary endpoint was the number of patients with AEs (CTCAE version 3.0). Other endpoints included progression-free survival (PFS), overall response rate (ORR), duration of response (DOR), and changes in investigator-assessed cancer-related symptoms.ResultsEighty-eight patients received afatinib, including 27 (31%) with brain metastases and 16 (18%) with uncommon EGFR mutations. Median PFS was 17.0 months (95% confidence interval [CI] 12.9–23.3 months). Grade 3 treatment-related AEs (TRAEs) were reported in 51 (58%) patients; the most common were diarrhea (22%) and rash/acne (20%). No grade > 3 TRAEs were reported. AEs leading to dose reduction occurred in 49 (56%) patients. Treatment discontinuation due to TRAEs occurred in 4 (5%) patients. ORR was 81% overall, 89% in patients with brain metastases, and 55% in patients with uncommon mutations (excluding T790M/exon 20 insertions). Median DOR was 15.1 months (95% CI 12.4–21.4 months). Cancer-related symptoms were improved/unchanged/worsened in 34–66%/36–66%/0–3% of patients over the first year.ConclusionsNo unexpected safety signals for afatinib were observed. AEs were manageable; the treatment discontinuation rate was low. Afatinib showed encouraging efficacy in a broad patient population including those with brain metastases or tumors harboring uncommon EGFR mutations.Trials registrationClinicalTrials.gov NCT01931306; 29/08/2013.

2021-05-01·TP40. TP040 COPD CLINICAL TRIALS AND THERAPIES

Assessing the Escalation Time to Open Triple Therapy from Initiation of LAMA vs ICS/LABA in COPD Management; Findings from Comparing the Incidence of Tiotropium and ICS/LABA in Real-World Use in South Korea (CITRUS Study)

作者: Lee, S.E. ; Yoo, K.H. ; Kim, Y. ; Hwang, Y.I. ; Rhee, C.K. ; Park, Y.B.

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