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

HanKyu Lee; So-Hyun Park; Shin-Young Oh; Yil-Seob Lee

doi:10.0000/jkscpt.2012.20.2.195

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Lee, Park, Oh, and Lee: Post-marketing Surveillance of the Safety and Effectiveness of Rosiglitazone/Metformin in Korean Patients with Type 2 Diabetes

Original Article

Journal of Korean Society for Clinical Pharmacology and Therapeutics

Journal of Korean Society for Clinical Pharmacology and Therapeutics 2012; 20(2): 195-204.

Published online: 31 December 2012

DOI: https://doi.org/10.0000/jkscpt.2012.20.2.195

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

HanKyu Lee, So-Hyun Park, Shin-Young Oh, Yil-Seob Lee

Glaxo SmithKline Korea, Seoul, Korea.

Corresponding author (Yil.S.Lee@gsk.com)

Received 20 November 2012 Revised 27 December 2012 Accepted 28 December 2012

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 ± 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: Rosiglitazone, Metformin, Post-marketing surveillance

Figures and Tables

Table 1

Baseline characteristics of patients

SD: Standard deviation; DM: Diabetes mellitus.

Table 2

Adverse events by expectedness and seriousness

Table 3

Reported adverse events and adverse drug reactions

Table 4

Adverse event rate by risk factors

AE: Adverse event; CI: confidence interval; DM: Diabetes mellitus. ^*P-value by chi-square test or Fisher's exact test.

Table 5

Effectiveness evaluation

^*Maintenance: in case within normal range before and after effectiveness assessment.

Table 6

Comparison of clinical data

^*SD: Standard deviation; FBG: Fasting blood glucose; PPG: Postprandial glucose; HbA1c: Hemoglobin A1c.

^*P-value by paired t-test.

Table 7

Effectiveness analysis by risk factors

^*P-value by chi-square test or Fisher's exact test.

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