title: Safety and efficacy of low-dose pioglitazone (7.5 mg/day) vs. standard-dose pioglitazone (15 mg/day) in Japanese women with type 2 diabetes mellitus.
abstract: It is well known that pioglitazone, a potent thiazolidinedione, improves metabolic control. However, weight gain or peripheral edema may be of major clinical concern when using this agent. The purpose of our study was to prospectively evaluate the effects of low-dose pioglitazone (7.5 mg/day) on metabolic control, weight gain and the incidence of edema compared with a standard dose of pioglitazone (15.0 mg/day) in patients with type 2 diabetes mellitus (T2DM). Ninety-five Japanese female patients (mean age 58.4 +/- 10.4 years) with newly diagnosed T2DM were selected for this study. They were randomly divided into the following 2 groups according to therapy regimens, and examined every month for 6 months after diagnosis. Group A consisted of 54 patients treated with low-dose pioglitazone orally; Group B, the control-group, consisted of 41 patients treated with standard-dose pioglitazone orally. The incidence of peripheral edema was significantly much lower in group A (2/54) than in group B (11/41) (p = 0.0014). In addition, % change of body weight during the 6-month treatment in group A was significantly less than that in group B (p < 0.0001). On the other hand, the % change of biochemical parameters including HbA1c did not differ significantly between group A and group B, although glucose and lipid control significantly improved from baseline in both groups. Our results demonstrate the safety and efficacy of low-dose pioglitazone, suggesting that it could be another good choice of treatment for Japanese women with T2DM.
authors.affiliation: Department of Endocrinology and Metabolism, Rakuwakai Otowa Hospital, Kyoto, Japan.
authors.forename: Takafumi
authors.initials: T
authors.lastname: Majima
authors.forename: Yasato
authors.initials: Y
authors.lastname: Komatsu
authors.forename: Kentaro
authors.initials: K
authors.lastname: Doi
authors.forename: Michika
authors.initials: M
authors.lastname: Shigemoto
authors.forename: Chieko
authors.initials: C
authors.lastname: Takagi
authors.forename: Atsushi
authors.initials: A
authors.lastname: Fukao
authors.forename: Jerry
authors.initials: J
authors.lastname: Corners
authors.forename: Kazuwa
authors.initials: K
authors.lastname: Nakao
mesh_terms: D000284:Administration, Oral; D000368:Aged; D001786:Blood Glucose / Q000187:drug effects; D001794:Blood Pressure; D002784:Cholesterol / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004487:Edema / Q000139:chemically induced; D005215:Fasting / Q000097:blood; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D015994:Incidence; D007564:Japan; D008875:Middle Aged; D000077205:Pioglitazone; D045162:Thiazolidinediones / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014280:Triglycerides / Q000097:blood; D015430:Weight Gain / Q000187:drug effects
chemical_list: D001786:Blood Glucose; D002784:Cholesterol; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D000077205:Pioglitazone; D045162:Thiazolidinediones; D014280:Triglycerides