Study no:

GSK medicine : rosiglitazone/metformin
Study No.: 105709
Title : An open label, multi-centre, non-interventional post-marketing surveillance to monitor the
safety and/or efficacy of Avandamet® administered in Korean Diabetic patients according to the
prescribing information
Rationale : This PMS collected routine clinical data in the local target population (600
subjects) as per the requirement of Korean Food and Drug Administration (KFDA).
Objectives:
The objective of this post-marketing surveillance (PMS) is to monitor safety and
efficacy of Avandamet® under the real clinical setting after launch.
Indication: Non-insulin-dependent diabetes mellitus(Type II Diabetes Mellitus)
Study investigators/Centers : GSK conducted study, 8 centres & 10 investigators in South
Korea
Research Methods :
Data source : Standardized hard copy Case Report Form(CRF)
Study Design : Open label, multi-center, non-interventional post-marketing surveillance.
Study population : Male and female subjects who were considered appropriate to prescribe
Avandamet® according to the prescribing information were eligible for this study. Subjects who had previously been treated with Avandamet® were not eligible for this study.
Planned, N (according to the legal requirement by KFDA) Total Number Subjects Withdrawn, n (%)11(1.5%) Withdrawn due to Lack of Efficacy n (%)0 (0.0%) Study Exposures, Outcomes : Primary outcome/ Efficacy Variable(s): observed incidence of adverse events in Korean Type II DM patients treated with Avandamet® based on prescribing information under the real clinical setting .
Secondary Outcome//Efficacy Variable(s): to identify risk factors associated with the occurrence of adverse events. ‘Ex pected’ was that adverse events were described in the locally approved label by KFDA at the time the Korean PMS was ended. ‘Un expected’ included events which
were not described in the locally approved label by KFDA at the time of surveillance completion.
Data Analysis Methods : Since this study was not designed to test any statistical hypothesis,
basically descriptive statistics were presented. Data were summarized using simple summary
statistics for example means and counts, at each individual. Adverse events were coded by using WHOART (preferred term level) according to the local regulation. The cumulative incidence of adverse event was estimated with 95% confidence interval. In addition, the incidence of unexpected adverse event and the incidence of serious adverse events were computed. Chi-square test or Fisher’s exact test were performed to identify risk factor
associated with the occurrence of adverse events.
Limitations : As being observation study, there was no comparison group.
Study Results :
Demographics
N (ITT safety population)
Primary Results: (ITT Safety population)
Overall incidence of adverse events, n (%)
Exact 95% Confidence interval for overall (3.00, 6.07) Secondary Outcome Variable(s): (Safety ITT population)
Summary of risk factors by incidence of Adverse events, n(%)
adverse events
Covariates
32 (4.57%)
668 (95.43%)
Safety Results:
Most Frequent Adverse Events – On- Avandamet®(N=706)
Therapy, n(%)
Subjects with any AE(s), n(%)
HEADACHE
Serious Adverse Events – On-Therapy
Avandamet®(N=706)
n(%), [n considered by the investigator to
be related to study medication]
Subjects with any SAE(s), n(%) [includes SAE 0 (0.00%), [0(0.00%)]
related to Avandamet®]
Conclusion: 34 Adverse events were reported in 32 subjects, the most frequent being Oedema.
The overall incidence of adverse events was 4.53% (95% CI: 3.00-6.07). A total of 12
unexpected adverse events were reported in 11 subjects. The incidence of unexpected adverse events was 1.56%. There was no serious adverse event in the surveillance.

Source: http://gsk.sylogent.com/files/23176.pdf

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