No abstract available.
Chromans ; Thiazolidinediones

No abstract available.
Animals ; Inflammation ; Rats ; Thiazolidinediones

No abstract available.
Animals ; Inflammation ; Rats ; Thiazolidinediones

No abstract available.
Diabetes Mellitus, Type 2 ; Humans ; Metformin ; Thiazolidinediones

No abstract available.
Thiazolidinediones ; Urinary Bladder ; Urinary Bladder Neoplasms

No abstract available.
Thiazolidinediones ; Urinary Bladder ; Urinary Bladder Neoplasms

No abstract available.
Thiazolidinediones ; Urinary Bladder ; Urinary Bladder Neoplasms

No abstract available.
Thiazolidinediones ; Urinary Bladder ; Urinary Bladder Neoplasms

Type 2 diabetes is rapidly increasing worldwide, and there have been many advances in the care of diabetic patients. Nevertheless, less than half of the patients are achieving the glycemic goal of HbA1c < 7%. This shows that current therapeutic modalities have limitations, and the need for continued development of new antidiabetic drugs is clear. In 2007, a meta-analysis focusing on the thiazolidinedione drug rosiglitazone suggested an unacceptably high cardiovascular risk for this newly approved drug, prompting changes in regulations for antidiabetic drug development. The FDA guidance for Diabetes Mellitus-Evaluation of Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes was released as a draft in Feb 2008, and the final form was published in December 2008. The guidance, though not a regulation, requires developers to demonstrate that all new antidiabetic agents have an acceptable cardiovascular risk. The European Medicine Agency (EMA) also published a draft guideline in January 2010 on the clinical investigation of medicinal products for the treatment of diabetes mellitus which included a cardiovascular safety assessment component. Considering the increased CV risk in type 2 diabetic patients, antidiabetic drugs should not result in an unacceptable increase in cardiovascular risk. The FDA has offered guidelines for the assessment of cardiovascular safety for antidiabetic drugs. Careful prospective planning of clinical trials (choice of study type, subject selection, and meta-analysis) and thorough preclinical safety assessment (choice of cardiovascular endpoints: MACE, endpoint adjudication) are needed to assess possible cardiovascular risk.
Diabetes Mellitus ; Humans ; Hypoglycemic Agents ; Social Control, Formal ; Thiazolidinediones

BACKGROUND: The aim of this multicenter, randomized, double-blind study was to examine the effect of lobeglitazone, a novel thiazolidinedione, on the changes in bone mineral density (BMD) in patients with type 2 diabetes mellitus. METHODS: A 24-week, double-blinded phase was followed by a 28-week, open-label phase, in which the placebo group also started to receive lobeglitazone. A total of 170 patients aged 34 to 76 years were randomly assigned in a 2:1 ratio to receive lobeglitazone 0.5 mg or a matching placebo orally, once daily. BMD was assessed using dual-energy X-ray absorptiometry at week 24 and at the end of the study (week 52). RESULTS: During the double-blinded phase, the femur neck BMD showed decreasing patterns in both groups, without statistical significance (−0.85%±0.36% and −0.78%±0.46% in the lobeglitazone and placebo groups, respectively). The treatment difference between the groups was 0.07%, which was also not statistically significant. Further, minimal, nonsignificant decreases were observed in both groups in the total hip BMD compared to values at baseline, and these differences also did not significantly differ between the groups. During the open-label phase, the BMD was further decreased, but not significantly, by −0.32% at the femur neck and by −0.60% at the total hip in the lobeglitazone group, and these changes did not significantly differ compared with the original placebo group switched to lobeglitazone. CONCLUSION: Our results indicate that treatment with lobeglitazone 0.5 mg over 52 weeks showed no detrimental effect on the BMD compared to the placebo.
Absorptiometry, Photon ; Bone Density* ; Diabetes Mellitus, Type 2* ; Double-Blind Method ; Femur Neck ; Hip ; Humans ; Thiazolidinediones