임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

한국인 제2형 당뇨병 환자에서 로시글리타존/메트포르민의 안전성 및 유효성 평가를 위한 시판 후 조사

Post-marketing Surveillance of the Safety and Effectiveness of Rosiglitazone/Metformin in Korean Patients with Type 2 Diabetes

  • 투고 : 2012.11.20
  • 심사 : 2012.12.28
  • 발행 : 2012.12.31
⟨ 이전 논문 다음 논문 ⟩

초록

Background: To evaluate the safety and effectiveness of rosiglitazone/metformin in patients with type 2 (non-insulin-dependent) diabetes Methods: A total of 982 patients were enrolled by 19 physicians from November 2003 to November 2010. Patients treated with rosiglitazone/metformin at least once, were included in safety assessment. The incidences of adverse events (AEs) and serious adverse events (SAEs) were estimated. The effectiveness of rosiglitazone/metformin was evaluated through change in fasting blood glucose (FBG), 2-hour postprandial glucose (2hr PPG), Hemoglobin A1c (HbA1c). Results: Of the 982 patients, 713 patients with the mean age of $56.4{\pm}11.5$ years were included in the safety assessment. A total of 130 AEs were reported from 110 patients (15.4 %). The most frequent AEs were upper respiratory infection (2.4 %), oedema (2.2 %), gastritis (1.3 %), and weight increase (1.1 %). The incidence of unexpected AEs was 5.9 % (42/713, 47 AEs). Three SAEs such as bacterial pneumonia, hyperglycaemia, chest pain were reported in 2 patients. As it is about effectiveness, patients showed statistically significant reductions after treatment of rosiglitazone/metformin in FBG, 2hr PPG, and HbA1c (P<0.001 by paired t-test, for all). Conclusion: Our data suggest that rosiglitazone/metformin is well tolerated and effective in Korean patients with type 2 (non-insulin-dependent) diabetes.

키워드

과제정보

연구 과제 주관 기관 : GSK

참고문헌

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