Impact of acarbose on carotid intima-media thickness in patients with newly diagnosed impaired glucose tolerance or mild type 2 diabetes mellitus: A one-year, prospective, randomized, open-label, parallel-group study in Japanese adults with established coronary artery disease

Masayoshi Koyasu, Hideki Ishii, Masato Watarai, Kenji Takemoto, Yasuya Inden, Kyosuke Takeshita, Tetsuya Amano, Daiji Yoshikawa, Tatsuaki Matsubara, Toyoaki Murohara

研究成果: Article査読

31 被引用数 (Scopus)

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Objective: This study examined the effect of acarbose therapy on carotid intima-media thickness (IMT) in patients with established coronary artery disease (CAD) who had been newly diagnosed with impaired glucose tolerance (IGT) or mild type 2 diabetes mellitus (T2DM).Methods: This was a 1-year, prospective, randomized, open-label, parallel-group study in patients with established CAD (≥50% stenosis on quantitative coronary angiography) who were newly diagnosed with IGT or mild T2DM. IGT was defined as 2-hour glucose concentrations of 140 to 199 mg/dL on the 75-g oral glucose tolerance test (OGTT). Mild T2DM was defined as a fasting plasma glucose concentration <126 mg/dL, 2-hour plasma glucose concentration on OGTT >200 mg/dL, and glycosylated hemoglobin (HbA1c) <6.5%. On the day after undergoing coronary angiography, patients were randomly allocated to receive either acarbose 150 mg/d or control (no treatment). Carotid IMT was measured by ultrasonography at baseline and at 12 months of follow-up. The changes in glucose profiles (75-g OGTT), HbA1c, and lipid profiles were also compared between baseline and follow-up. At visits every 2 months, data on adverse events, drug adherence, and changes in medication were collected. Adverse events were recorded based on spontaneous reports and questioning by the investigator. Clinical follow-up data on outcomes of interest were obtained from patients' hospital charts or from telephone interviews; these outcomes were the incidence of mortality, nonfatal myocardial infarction, repeat percutaneous coronary intervention for a treated coronary artery, and stroke.Results: Ninety Japanese patients were enrolled in the study (45 in each group). Two patients in the acarbose group discontinued therapy due to drug-related diarrhea, and 1 patient in each group was discontinued because of a newly diagnosed malignancy. Three patients in the control group were discontinued because they initiated treatment with fibrates, and 2 patients in the control group were lost to follow-up. Thus, complete baseline and follow-up data were available for 42 patients in the acarbose group and 39 in the control group. These 81 patients were predominantly male (74 [91.4%]), with a mean (SD) age of 66.3 (9.0) years, mean body weight of 65.9 (10.5) kg, and mean HbA1c of 5.57% (0.38%). Baseline characteristics appeared to be comparable between the 2 groups. In the acarbose group, IMT increased from a mean of 1.28 (0.53) mm at baseline to 1.30 (0.52) mm at 12-month follow-up (mean change, 0.02 [0.29] mm; P = NS), whereas in the control group, it increased from a mean of 1.15 (0.37) mm to 1.32 (0.46) mm (mean change, 0.17 [0.25] mm; P < 0.001 ). The difference between groups was statistically significant (P = 0.01). In addition, the acarbose group had significant reductions from baseline in 2-hour glucose concentrations on the 75-g OGTT (mean change, -24.8 [45.2] mg/dL; P = 0.001), fasting total cholesterol (mean change, -11.26 [26.1] mg/dL; P = 0.009), and fasting triglyceride concentrations (mean change, -30.4 [62.7] mg/dL; P = 0.003), whereas the corresponding changes were not significant in the control group (mean change, -8.5 [39.4], -6.22 [26.7], and -1.05 [74.2] mg/dL, respectively). Cardiovascular events requiring hospitalization occurred in 4 patients (9.5%) in the acarbose group and 4 patients (10.3%) in the control group. No deaths, nonfatal myocardial infarctions, or strokes occurred in either group over the follow-up period.Conclusion: In this small, open-label study in patients with established CAD who were newly diagnosed with IGT or mild T2DM, 12 months of treatment with acarbose was associated with a beneficial effect in terms of preventing the progression of carotid IMT compared with control, although it was not associated with a significant decrease in IMT from baseline. UMIN (University Hospital Medical Information Network) Clinical Trials Registry identifier: UMIN000000544.

本文言語English
ページ(範囲)1610-1617
ページ数8
ジャーナルClinical therapeutics
32
9
DOI
出版ステータスPublished - 08-2010
外部発表はい

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

フィンガープリント 「Impact of acarbose on carotid intima-media thickness in patients with newly diagnosed impaired glucose tolerance or mild type 2 diabetes mellitus: A one-year, prospective, randomized, open-label, parallel-group study in Japanese adults with established coronary artery disease」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

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