Clinical efficacy of pioglitazone: generic vs. original product.
Author(s): Temboonkiat S, Satyapan N, Benjasuratwong Y, Patarakitvanit S, Tunkanitlert J,
Vudhironarit T, Klangkalya B.
Affiliation(s): Department of Pharmacology, Phramongkutklao College of Medicine, Bangkok,
Thailand.
Publication date & source: 2012, J Med Assoc Thai. , 95 Suppl 5:S58-62
BACKGROUND: Pioglitazone, an oral antidiabetic agent in the class of
thiazolidinediones (TZDs), was widely used in the case of insulin tolerance as it
provided more benefit to patients with type 2 diabetes. However, the original
product is costly while some generic products are available at the substantial
lower cost in Thailand. The objective of the present study was to assess
bioequivalence in terms of efficacy between generic and original pioglitazone
products.
MATERIAL AND METHOD: A randomized double blind, crossover controlled trial was
performed on 60 patients with type 2 diabetes at the Endocrine Unit, Department
of Medicine, Phramongkutklao Hospital, Thailand. All subjects were randomly
selected for group A and B (30 volunteers in each group). Duration of observation
for efficacy of treatment with pioglitazone (both generic and original products)
was totally 24 weeks. The dose of pioglitazone was 15 mg once daily.
RESULTS: Finally, 22 males and 37 females remained in the trial. The reduction in
means of HbA1c in group A and group B were 0.7% and 0.6% respectively. The least
squares means of the HbA1c reduction of the generic and original group were 0.75%
and 0.79%, respectively. There was no significant difference in HbA1c reduction
between both groups. The average equality of HbA1c in all subjects in both groups
was 100.7% (87.9-113.5%) at 90% confidence interval.
CONCLUSION: These findings indicated that both formulations were bioequivalent as
their efficacy or therapeutic effects in reduction ofHbA1c in the type 2 diabetic
subjects were statistically the same.
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