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

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

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

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

  • Received : 2012.11.20
  • Accepted : 2012.12.28
  • Published : 2012.12.31
⟨ Previous Next ⟩

Abstract

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.

Keywords

Acknowledgement

Supported by : GSK

References

  1. Kim DJ. The epidemiology of diabetes in Korea. Diabetes Metab J, 2011;35(4):303-308. https://doi.org/10.4093/dmj.2011.35.4.303
  2. Holman RR, Paul SK, Bethel MA, Matthews DR, Neil HA. 10-year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med, 2008;359(15):1577-1589. https://doi.org/10.1056/NEJMoa0806470
  3. Ko KD, Kim BH, Oh SI, Um CS, Shin DW, Lee HW. What are patient factors associated with the quality of diabetes care?: results from the Korean National Health and Nutrition Examination Survey. BMC public health, 2012;12(1):689. https://doi.org/10.1186/1471-2458-12-689
  4. Miller RA, Birnbaum MJ. An energetic tale of AMPK-independent effects of metformin. J Clin Invest, 2010;120(7):2267-2270. https://doi.org/10.1172/JCI43661
  5. Bourg CA, Phillips BB. Rosiglitazone, myocardial ischemic risk, and recent regulatory actions. Ann Pharmacother, 2012;46(2):282-289. https://doi.org/10.1345/aph.1Q400
  6. Ko SH, Kwon HS, Song KH, Ahn YB, Yoon KH, Yim HW, Lee WC, Park YM. Long-term changes of the prevalence and control rate of hypertension among Korean adults with diagnosed diabetes: 1998-2008 Korean National Health and Nutrition Examination Survey. Diabetes Res Clin Pract, 2012;97(1):151-157. https://doi.org/10.1016/j.diabres.2012.04.004
  7. Handelsman Y, Mechanick JI, Blonde L, Grunberger G, Bloomgarden ZT, Bray GA, Dagogo-Jack S, Davidson JA, Einhorn D, Ganda O, Garber AJ, Hirsch IB, Horton ES, Ismail-Beigi F, Jollinger PS, Jones KL, Jovanovic L, Lebovitz H, Levy P, Moghissi ES, Orzeck EA, Vinik AI, Wyne KL. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for developing a diabetes mellitus comprehensive care plan. Endocrine Practice, 2011;17 Suppl 2:1-53.
  8. Hong JS, Kang HC. Relationship between oral antihyperglycemic medication adherence and hospitalization, mortality, and healthcare costs in adult ambulatory care patients with type 2 diabetes in South Korea. Med Care, 2011;49(4): 378-384.
  9. Bell DS. Combine and conquer: advantages and disadvantages of fixed-dose combination therapy. Diabetes, Obes Metab, 2012.
  10. Choi NK, Park BJ. Adverse drug reaction surveillance system in Korea. J Prev Med Public Health, 2007;40(4):278-284. (Korean) https://doi.org/10.3961/jpmph.2007.40.4.278
  11. Kahn SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravilz BG, Lachin JM, O'Neill MC, Zinman B, Viberti G. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. N Engl J Med, 2006;355(23):2427-2443. https://doi.org/10.1056/NEJMoa066224
  12. Kim HA. Attitude and knowledge of community pharmacists to adverse drug reaction reporting. Kor J Clin Pharm, 2009;19(2):159-166. (Korean)
  13. Lee HR, Kim YS, Sung S et al. Post-marketing surveillance for the safety and efficacy of irbesartan in patients with hypertension. JPERM, 2009;2(1):30-37. (Korean)