Clinical efficacy of pioglitazone: generic vs. original product.

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.

Herbal medicine: affecting factors and prevalence of use among Thai population in Bangkok.

BACKGROUND: Remarkable growth in use of herbal medicines has recently been noted. In Thailand, eight items of herbal medicines with single composition are currently placed on the National List of Essential Medicines (EM). This study was to clarify the actual state of factors affecting the usage and knowledge of these herbal medicines, as the study concerning with these aspects was infrequently performed. MATERIAL AND METHOD: A descriptive and cross-sectional research was conducted by using self-administered questionnaires. Six hundred and thirty-one subjects were randomly sampling and the data were analyzed by the Statistic Package for the Social Sciences software program. RESULTS: The finding revealed that 28.6% of total subjects had experienced on herbal medicine treatment, especially eight items listed in EM. The elderly and government officers usually purchased the drugs from hospital and drugstore, while housewife purchased them from supermarket. Subjects with positive attitude towards herbal medicine use usually were government officers. Almost all of herbal medicines were well-known about their indications by less than 55% of total subjects. Among all well-known indications, the relief of gastric distress by Zingiber officinale was the most well-known one (73.2%). On the other hand, high percentage of media exposure (55-70%) was found in majority of the subjects which indicated that media was more likely to influence consumer's knowledge and behavior. CONCLUSION: Only 28.6% of total subjects had experienced on herbal medicines listed in EM, despite of high percentage of media exposure. Therefore, the providing proper information of herbal medicines on various medias and integrated education about herbal medicine in medical curricula could effectively help increase appropriate drug use and consumers' safety.

Adverse effect of pioglitazone in military personnel and their families: a preliminary report.

BACKGROUND: Thiazolidinediones (rosiglitazone and pioglitazone) whether administered alone or in combination with metformin, sulfonylurea, or insulin, are often accompanied by an increase in weight and/or plasma volume. Several studies have shown the adverse effect of weight gain and edema with rosiglitazone. But there was less data with pioglitazone, especially in military personnel and their families. MATERIAL AND METHOD: The authors prospectively recorded the adverse events in 40 patients with type 2 diabetes mellitus who underwent administration with pioglitazone 15 mg once daily between June 2005 to May 2007. RESULTS: Weight gain was reported in 30/40 of patients (75%). The mean weight gain was 2.25 +/- 2.23 kg and the median was 2 kg. The slightly lower proportion of patients, 21/40 (52.5%) developed edema and some of them were associated with weight gain. CONCLUSION: Pioglitazone was associated with a significant increase in body weight and edema. This finding may lead to increase the risk of myocardial infarction in military personnel and their families, especially those who had underlying disease of congestive heart failure, which was not included in the present study.

Development of a Novel AAV Gene Therapy Cassette with Improved Safety Features and Efficacy in a Mouse Model of Rett Syndrome.

Rett syndrome (RTT), caused by loss-of-function mutations in the MECP2 gene, is a neurological disorder characterized by severe impairment of motor and cognitive functions. The aim of this study was to investigate the impact of vector design, dosage, and delivery route on the efficacy and safety of gene augmentation therapy in mouse models of RTT. Our results show that AAV-mediated delivery of MECP2 to Mecp2 null mice by systemic administration, and utilizing a minimal endogenous promoter, was associated with a narrow therapeutic window and resulted in liver toxicity at higher doses. Lower doses of this vector significantly extended the survival of mice lacking MeCP2 or expressing a mutant T158M allele but had no impact on RTT-like neurological phenotypes. Modifying vector design by incorporating an extended Mecp2 promoter and additional regulatory 3' UTR elements significantly reduced hepatic toxicity after systemic administration. Moreover, direct cerebroventricular injection of this vector into neonatal Mecp2-null mice resulted in high brain transduction efficiency, increased survival and body weight, and an amelioration of RTT-like phenotypes. Our results show that controlling levels of MeCP2 expression in the liver is achievable through modification of the expression cassette. However, it also highlights the importance of achieving high brain transduction to impact the RTT-like phenotypes.