Jan Galle, Werner Kleophas, Frank Dellanna, Volkmar H R Schmid, Claudia Forkel, Gerhard Dikta, Vera Krajewski, Winfried Fuchs, Thomas Forst, Andreas Pfützner
{"title":"在标准胰岛素治疗的基础上给予吡格列酮与安慰剂对需要血液透析的2型糖尿病患者的效果比较:来自PIOren研究的结果","authors":"Jan Galle, Werner Kleophas, Frank Dellanna, Volkmar H R Schmid, Claudia Forkel, Gerhard Dikta, Vera Krajewski, Winfried Fuchs, Thomas Forst, Andreas Pfützner","doi":"10.1159/000337334","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients with type 2 diabetes mellitus and advanced kidney disease are usually treated with insulin. However, the prolonged pharmacokinetic insulin profile in patients with delayed renal insulin elimination impairs a successful therapy. Due to its hepatic metabolism, pioglitazone is a potential candidate for additional administration. The aim of this study was to investigate the effect of pioglitazone versus placebo on total daily insulin requirements and several pleiotropic factors in type 2 diabetes patients requiring hemodialysis.</p><p><strong>Methods: </strong>The effect of pioglitazone (30 mg) versus placebo was explored in this prospective, randomized, double-blind parallel multicenter phase II study analyzing data from 36 patients with type 2 diabetes mellitus currently under hemodialysis (25 male, 11 female, aged 69.2 ± 7.9 years, baseline HbA1c 7.6 ± 0.9%). The most important efficacy parameters collected before dialysis and after an overnight fast at baseline and after 6 months were: total daily insulin dose, HbA1c, fasting blood glucose, adiponectin, HDL, LDL, triglycerides, NT-proBNP, and ultrafiltrate volume.</p><p><strong>Results: </strong>Application of pioglitazone resulted in a significant decrease of the daily insulin dose by 35% versus baseline (placebo: -10%, n.s.), improvement in HbA1c (-0.60 ± 0.87%, p = 0.015; placebo: 0.21 ± 1.1%, n.s.) and adiponectin (7.33 ± 4.80 mg/l, p < 0.001; placebo: -1.37 ± 2.56 mg/l, n.s.). Slight improvements or no changes were seen with fasting glucose, triglycerides, HDL, LDL and NT-proBNP. There was no indication of increased hypoglycemia risk and volume overload by the addition of pioglitazone.</p><p><strong>Conclusions: </strong>Addition of pioglitazone to insulin in patients with late-stage kidney failure requiring hemodialysis is a well-tolerated treatment option that improves glycemic control with simultaneous insulin-sparing potential.</p>","PeriodicalId":56356,"journal":{"name":"Nephron Extra","volume":"2 1","pages":"104-14"},"PeriodicalIF":0.0000,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1159/000337334","citationCount":"9","resultStr":"{\"title\":\"Comparison of the Effects of Pioglitazone versus Placebo when Given in Addition to Standard Insulin Treatment in Patients with Type 2 Diabetes Mellitus Requiring Hemodialysis: Results from the PIOren Study.\",\"authors\":\"Jan Galle, Werner Kleophas, Frank Dellanna, Volkmar H R Schmid, Claudia Forkel, Gerhard Dikta, Vera Krajewski, Winfried Fuchs, Thomas Forst, Andreas Pfützner\",\"doi\":\"10.1159/000337334\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Patients with type 2 diabetes mellitus and advanced kidney disease are usually treated with insulin. However, the prolonged pharmacokinetic insulin profile in patients with delayed renal insulin elimination impairs a successful therapy. Due to its hepatic metabolism, pioglitazone is a potential candidate for additional administration. The aim of this study was to investigate the effect of pioglitazone versus placebo on total daily insulin requirements and several pleiotropic factors in type 2 diabetes patients requiring hemodialysis.</p><p><strong>Methods: </strong>The effect of pioglitazone (30 mg) versus placebo was explored in this prospective, randomized, double-blind parallel multicenter phase II study analyzing data from 36 patients with type 2 diabetes mellitus currently under hemodialysis (25 male, 11 female, aged 69.2 ± 7.9 years, baseline HbA1c 7.6 ± 0.9%). The most important efficacy parameters collected before dialysis and after an overnight fast at baseline and after 6 months were: total daily insulin dose, HbA1c, fasting blood glucose, adiponectin, HDL, LDL, triglycerides, NT-proBNP, and ultrafiltrate volume.</p><p><strong>Results: </strong>Application of pioglitazone resulted in a significant decrease of the daily insulin dose by 35% versus baseline (placebo: -10%, n.s.), improvement in HbA1c (-0.60 ± 0.87%, p = 0.015; placebo: 0.21 ± 1.1%, n.s.) and adiponectin (7.33 ± 4.80 mg/l, p < 0.001; placebo: -1.37 ± 2.56 mg/l, n.s.). Slight improvements or no changes were seen with fasting glucose, triglycerides, HDL, LDL and NT-proBNP. There was no indication of increased hypoglycemia risk and volume overload by the addition of pioglitazone.</p><p><strong>Conclusions: </strong>Addition of pioglitazone to insulin in patients with late-stage kidney failure requiring hemodialysis is a well-tolerated treatment option that improves glycemic control with simultaneous insulin-sparing potential.</p>\",\"PeriodicalId\":56356,\"journal\":{\"name\":\"Nephron Extra\",\"volume\":\"2 1\",\"pages\":\"104-14\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2012-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1159/000337334\",\"citationCount\":\"9\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Nephron Extra\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1159/000337334\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2012/5/4 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nephron Extra","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1159/000337334","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2012/5/4 0:00:00","PubModel":"Epub","JCR":"","JCRName":"","Score":null,"Total":0}
Comparison of the Effects of Pioglitazone versus Placebo when Given in Addition to Standard Insulin Treatment in Patients with Type 2 Diabetes Mellitus Requiring Hemodialysis: Results from the PIOren Study.
Background: Patients with type 2 diabetes mellitus and advanced kidney disease are usually treated with insulin. However, the prolonged pharmacokinetic insulin profile in patients with delayed renal insulin elimination impairs a successful therapy. Due to its hepatic metabolism, pioglitazone is a potential candidate for additional administration. The aim of this study was to investigate the effect of pioglitazone versus placebo on total daily insulin requirements and several pleiotropic factors in type 2 diabetes patients requiring hemodialysis.
Methods: The effect of pioglitazone (30 mg) versus placebo was explored in this prospective, randomized, double-blind parallel multicenter phase II study analyzing data from 36 patients with type 2 diabetes mellitus currently under hemodialysis (25 male, 11 female, aged 69.2 ± 7.9 years, baseline HbA1c 7.6 ± 0.9%). The most important efficacy parameters collected before dialysis and after an overnight fast at baseline and after 6 months were: total daily insulin dose, HbA1c, fasting blood glucose, adiponectin, HDL, LDL, triglycerides, NT-proBNP, and ultrafiltrate volume.
Results: Application of pioglitazone resulted in a significant decrease of the daily insulin dose by 35% versus baseline (placebo: -10%, n.s.), improvement in HbA1c (-0.60 ± 0.87%, p = 0.015; placebo: 0.21 ± 1.1%, n.s.) and adiponectin (7.33 ± 4.80 mg/l, p < 0.001; placebo: -1.37 ± 2.56 mg/l, n.s.). Slight improvements or no changes were seen with fasting glucose, triglycerides, HDL, LDL and NT-proBNP. There was no indication of increased hypoglycemia risk and volume overload by the addition of pioglitazone.
Conclusions: Addition of pioglitazone to insulin in patients with late-stage kidney failure requiring hemodialysis is a well-tolerated treatment option that improves glycemic control with simultaneous insulin-sparing potential.
期刊介绍：
An open-access subjournal to Nephron. ''Nephron EXTRA'' publishes additional high-quality articles that cannot be published in the main journal ''Nephron'' due to space limitations.
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