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Advances in Therapy

, Volume 22, Issue 5, pp 513–526 | Cite as

Postmarketing surveillance study of nateglinide in Japan

  • Hiroto Taki
  • Toshio Maki
  • Takako Iso
  • Kenji Iwamoto
  • Taiichi Kajiura
Article

Abstract

Nateglinide is an oral antidiabetic medication that acts through rapid, short-term stimulation of insulin production. This study was undertaken to identify the incidence and nature of adverse effects of nateglinide and to assess its efficacy in clinical practice. Patients (n=3254) were recruited from 606 centers in Japan with a 12-week observation period. Pretreatment and posttreatment values were obtained for fasting blood glucose, postprandial blood glucose, hemoglobin A1c (HbA1c), triglycerides, cholesterol, and body mass index. All adverse events were reported, along with standard laboratory blood variables. The incidence of adverse events was 7.40%; hypoglycemia, including hypoglycemic symptoms, was reported as the most prevalent (1.62%). Adverse events were observed more frequently in patients with hepatic or renal dysfunction; no significant findings were noted in the remaining patient population. The efficacy rating determined by the treating physicians was 76.40%. HbA1c decreased by 0.81% from 7.70±1.53% to 6.89±1.22%, postprandial glucose decreased by 54.05 mg/dL from 228.91±73.69 mg/dL to 174.86±62.86 mg/dL, and fasting glucose decreased by 23.73 mg/dL from 164.15±51.42 mg/dL to 140.43±42.63 mg/dL. These effects were most marked in patients who were previously medication naïve or who had been diagnosed with diabetes for a short period. Mean body mass index decreased, and nateglinide was equally effective in obese patients. Nateglinide showed good therapeutic effect when used as the first choice in patients with a short duration of diabetes, and in those with no history of previous treatment. Moreover, nateglinide seemed to be useful for the treatment of elderly patients and obese patients.

Keywords

postmarketing surveillance study nateglinide treatment efficacy safety diabetes elderly obesity hyperglycemia 

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References

  1. 1.
    The DECODE Study Group. Glucose tolerance and mortality: comparison of WHO and American Diabetes Association diagnostic criteria. European Diabetes Epidemiology Group. Diabetes epidemiology: collaborative analysis of diagnostic criteria in Europe.Lancet. 1999;354:617–621.CrossRefGoogle Scholar
  2. 2.
    Ceriello A. Postprandial hyperglycemia and diabetes complications. Is it time to treat?Diabetes. 2005;54:1–7.PubMedCrossRefGoogle Scholar
  3. 3.
    Hanefeld M, Fischer S, Julius U, et al, for the DIS Group. Risk factors for myocardial infarction and death in newly detected NIDDM: the Diabetes Intervention Study, 11-year follow-up.Diabetologia. 1996;39:1577–1583.PubMedCrossRefGoogle Scholar
  4. 4.
    Kannel WB, McGee DL. Diabetes and cardiovascular diseases: the Framingham Study.JAMA. 1979:241:2035–2038.PubMedCrossRefGoogle Scholar
  5. 5.
    Ikenoue T, Akiyoshi M, Fujitani S. Hypoglycaemic and insulinotropic effects of a novel oral antidiabetic agent, (-)-N-(trans-4-isopropylcyclohexane-carbonyl)-D-phenylalanine (A-4166).Br J Pharmacol. 1997;120:137–145.PubMedCrossRefGoogle Scholar
  6. 6.
    Kosaka K, Kikuchi M, Tarui S, et al. Phase-III study of a novel hypoglycemic agent, AY4166, on NIDDM patients in Japan (1): α-glucosidase inhibitor, voglibose-controlled multicenter double blind study.Yakuri Rinsho. 1997;7:699–727. [Japanese]Google Scholar
  7. 7.
    Hanefeld M, Bouter KP, Dickinson S, Guitard C. Rapid and short-acting mealtime insulin secretion with nateglinide.Diabetes Care. 2000;23:202–207.PubMedCrossRefGoogle Scholar
  8. 8.
    Mine T, Miura K, Kitahara Y, Okano A, Kawamori R. Nateglinide suppresses postprandial hypertriglyceridemia in Zucker fatty rats and Goto-Kakizaki rats: comparison with voglibose and glibenclamide.Biol Pharma Bull. 2002;25:1412–1416.CrossRefGoogle Scholar
  9. 9.
    Saloranta C, Hershon K, Ball M, Dickinson S, Holmes D. Efficacy and safety of nateglinide in type 2 diabetic patients with modest fasting hyperglycemia.J Clin Endocrinol Metab. 2002;87: 4171–4176.PubMedCrossRefGoogle Scholar
  10. 10.
    Kosaka K, Kikuchi M, Kuzuya K, et al. Effect of a novel hypoglycemic agent, AY4166, on post-prandial blood glucose and pharmacokinetics of NIDDM patients.Yakuri Rinsho. 1997;7:653–668.[Japanese]Google Scholar
  11. 11.
    Uchino H, Niwa M, Shimizu T, et al. Impairment of early insulin response after glucose load, rather than insulin resistance, is responsible for postprandial hyperglycemia seen in obese type 2 diabetes: assessment using nateglinide, a new insulin secretagogue.Endocr J. 2000;47:639–641.PubMedCrossRefGoogle Scholar
  12. 12.
    O’Moore-Sullivan TM, Prins JB. Thiazolidinediones and type 2 diabetes: new drugs for old disease [review].Med J Aust. 2002;176:381–386.PubMedGoogle Scholar

Copyright information

© Health Communications Inc 2005

Authors and Affiliations

  • Hiroto Taki
    • 1
  • Toshio Maki
    • 1
  • Takako Iso
    • 2
  • Kenji Iwamoto
    • 2
  • Taiichi Kajiura
    • 2
  1. 1.Pharmaceutical Regulatory Affairs and Quality Assurance DepartmentAjinomoto Co., Inc.TokyoJapan
  2. 2.QA, RA, and Pharmacovigilance DivisionAstellas Pharma, Inc.TokyoJapan

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