Case Evaluation

Avandia: Avandia Clinical Trials - Adverse Effects - Objectives

 The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product. Before prescribing any product mentioned in this Register, healthcare professionals should consult prescribing information for the product approved in their country.

Study No: 49653/177(AVA-177/2000)
Title: AVA-177: Avandia? in daily practice.
Rationale: The aim of the study was to describe safety, tolerability, efficacy, and usage of RSG in daily practice.
Phase: IV
Study Period: 17 July 2000 to 24 January 2002
Study Design: A multicenter, open-label, non-randomized, non-comparative, observational, audited, post-marketing-surveillance study
Centers: 6,420 centers in Germany
Indication: T2DM
Treatment: RSG as prescribed by the investigator (70% subjects were treated with 4mg RSG)
Objectives: To describe the safety, tolerability, efficacy, and usage of RSG in daily practice.
Primary Outcome/Efficacy Variable: Glycosylated haemoglobin(HbA1c)
Secondary Outcome/Efficacy Variables: Fasting blood glucose (FBG), responder rates (HbA1c, FBG), blood pressure (BP), body weight measured at baseline and end of study plus anti-diabetic therapy.
Statistical Methods: An audited observational cohort study (AOCS) is limited to the documentation of risks and effectiveness within the frame of the approved, intended application of the medicine. Therefore, only simple, descriptive statistics (n, mean, median, standard deviation [SD], %) were evaluated.
Study Population: All observed subjects to describe safety and tolerability: all efficacy evaluable subjects to document efficacy. Exclusion criteria from the efficacy evaluable population included missing HbA1c values at baseline (BL) or at end of the study (EOS), or treatment duration <120 days. RSG was newly initiated in these subjects at the beginning of the observational period.
Number of Subjects:
Total
Planned, N
30,000
Entered, N
22,808
Completed, n (%)
20,013 (88)
Total Number Subjects Withdrawn, n (%) [Multiple Reasons Possible]
2,795 (12)
Withdrawn Due To Adverse Events, n (%)
231 (1)
Withdrawn Due To Lack of Efficacy, n (%)
1,159 (5)
Withdrawn For Other Reasons, n (%)
1715 (8)
Changeover to Insulin, n (%)
1,173 (5)
Efficacy Evaluable, n (%)
19,962 (88)
Reasons For Not Being Efficacy Evaluable, n (%)
No HbA1c value at BL
882 (4)
No HbA1c value at EOS
1,216 (5)
Treatment <120 days
748 (3)
Demographics
Efficacy Evaluable
N (Efficacy Evaluable):
19,962
Females: Males : Not reported
9,943: 9,950: 69
Mean Age, Years (SD)
62.4 (11.0)
Race, n (%)
Not Available
Mean Diabetes Duration, Years (SD)
6.3 (5.2)
Mean Body Mass Index (BMI), Kg/m2 (SD)
29.5 (4.9)

 

 

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