A Prospective Trial of Risk Factors for Sulfonylurea-Induced Hypoglycemia in Type 2 Diabetes Mellitus
CONTEXT.— Retrospective studies have identified oral sulfonylureas, age, and fasting as major risk factors for hypoglycemia in patients with type 2 diabetes. Sulfonylureas may be withheld from elderly patients out of concern for hypoglycemia. OBJECTIVE.— To evaluate the hypoglycemic effects of maxim...
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creator | Burge, Mark R Schmitz-Fiorentino, Kristen Fischette, Christine Qualls, Clifford R Schade, David S |
description | CONTEXT.— Retrospective studies have identified oral sulfonylureas, age, and fasting
as major risk factors for hypoglycemia in patients with type 2 diabetes. Sulfonylureas
may be withheld from elderly patients out of concern for hypoglycemia. OBJECTIVE.— To evaluate the hypoglycemic effects of maximum doses of once-daily
second-generation sulfonylureas administered to fasting elderly patients. DESIGN.— A prospective, randomized, double-blind clinical trial. SETTING.— The University of New Mexico General Clinical Research Center. PATIENTS.— Fifty-two sulfonylurea-treated subjects with type 2 diabetes with a
mean (SD) age of 65.1 (5.7) years. INTERVENTIONS.— Subjects were randomly assigned to glyburide or glipizide gastrointestinal
therapeutic system (GITS). Each subject participated in three 23-hour fasting
studies after the sequential administration of 1 week of placebo and 1 week
of 10 mg and 1 week of 20 mg of the assigned sulfonylurea. MAIN OUTCOME MEASURES.— Occurrence of hypoglycemia (defined as plasma glucose level |
doi_str_mv | 10.1001/jama.279.2.137 |
format | Article |
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as major risk factors for hypoglycemia in patients with type 2 diabetes. Sulfonylureas
may be withheld from elderly patients out of concern for hypoglycemia. OBJECTIVE.— To evaluate the hypoglycemic effects of maximum doses of once-daily
second-generation sulfonylureas administered to fasting elderly patients. DESIGN.— A prospective, randomized, double-blind clinical trial. SETTING.— The University of New Mexico General Clinical Research Center. PATIENTS.— Fifty-two sulfonylurea-treated subjects with type 2 diabetes with a
mean (SD) age of 65.1 (5.7) years. INTERVENTIONS.— Subjects were randomly assigned to glyburide or glipizide gastrointestinal
therapeutic system (GITS). Each subject participated in three 23-hour fasting
studies after the sequential administration of 1 week of placebo and 1 week
of 10 mg and 1 week of 20 mg of the assigned sulfonylurea. MAIN OUTCOME MEASURES.— Occurrence of hypoglycemia (defined as plasma glucose level <3.33
mmol/L [60 mg/dL]) and hormonal parameters during the final 9 hours of the
23-hour fast in patients who had taken sulfonylureas vs placebo. RESULTS.— No hypoglycemia was observed during 156 fasting studies. Plasma glucose
level was decreased (nadir, 4.9 mmol/L [88 mg/dL] for a 20-mg dose of glyburide
vs 8.3 mmol/L [150 mg/dL] for placebo; nadir, 5.8 mmol/L [105 mg/dL] for a
20-mg dose of glipizide GITS vs 8.7 mmol/L [157 mg/dL] for placebo), and serum
insulin was increased in the sulfonylurea studies compared with placebo (P<.001). Plasma glucose parameters did not differ between
the 2 sulfonylureas, but C peptide concentrations were increased in the glyburide
group compared with glipizide GITS in the 20-mg study (P=.05). Concentrations of epinephrine were increased in the sulfonylurea
studies compared with placebo (P<.001). Epinephrine
secretion increased when glucose concentration fell below the mean (SD) level
of 9.10 (2.66) mmol/L (164 [48] mg/dL) in the 10-mg study and 8.77 (2.83)
mmol/L (158 [51] mg/dL) in the 20-mg study. CONCLUSIONS.— Fasting was well tolerated among these elderly patients with type 2
diabetes treated with sulfonylureas. Older age should not be considered a
contraindication to sulfonylurea treatment for diabetes. Stimulation of epinephrine
secretion at normal or elevated plasma glucose levels appears to be the primary
mechanism of protection against hypoglycemia in this study.</description><identifier>ISSN: 0098-7484</identifier><identifier>EISSN: 1538-3598</identifier><identifier>DOI: 10.1001/jama.279.2.137</identifier><identifier>PMID: 9440664</identifier><identifier>CODEN: JAMAAP</identifier><language>eng</language><publisher>Chicago, IL: American Medical Association</publisher><subject>Age Factors ; Aged ; Analysis of Variance ; Biological and medical sciences ; Blood Chemical Analysis ; Blood Glucose - metabolism ; Clinical trials ; Diabetes ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Double-Blind Method ; Drug therapy ; Drug toxicity and drugs side effects treatment ; Epinephrine - blood ; Fasting ; Female ; Glipizide - administration & dosage ; Glipizide - adverse effects ; Glipizide - therapeutic use ; Glyburide - administration & dosage ; Glyburide - adverse effects ; Glyburide - therapeutic use ; Humans ; Hypoglycemia - chemically induced ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Insulin - blood ; Male ; Medical sciences ; Miscellaneous (drug allergy, mutagens, teratogens...) ; Older people ; Peptides - blood ; Pharmacology. Drug treatments ; Prospective Studies ; Risk Factors</subject><ispartof>JAMA : the journal of the American Medical Association, 1998-01, Vol.279 (2), p.137-143</ispartof><rights>1998 INIST-CNRS</rights><rights>Copyright American Medical Association Jan 14, 1998</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a492t-8487f52dfc85d23bc8438a444391a669e893664c6ef8d8d8040a890034a595cf3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://jamanetwork.com/journals/jama/articlepdf/10.1001/jama.279.2.137$$EPDF$$P50$$Gama$$H</linktopdf><linktohtml>$$Uhttps://jamanetwork.com/journals/jama/fullarticle/10.1001/jama.279.2.137$$EHTML$$P50$$Gama$$H</linktohtml><link.rule.ids>64,315,781,785,3341,27929,27930,76494,76497</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=2156965$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/9440664$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Burge, Mark R</creatorcontrib><creatorcontrib>Schmitz-Fiorentino, Kristen</creatorcontrib><creatorcontrib>Fischette, Christine</creatorcontrib><creatorcontrib>Qualls, Clifford R</creatorcontrib><creatorcontrib>Schade, David S</creatorcontrib><title>A Prospective Trial of Risk Factors for Sulfonylurea-Induced Hypoglycemia in Type 2 Diabetes Mellitus</title><title>JAMA : the journal of the American Medical Association</title><addtitle>JAMA</addtitle><description>CONTEXT.— Retrospective studies have identified oral sulfonylureas, age, and fasting
as major risk factors for hypoglycemia in patients with type 2 diabetes. Sulfonylureas
may be withheld from elderly patients out of concern for hypoglycemia. OBJECTIVE.— To evaluate the hypoglycemic effects of maximum doses of once-daily
second-generation sulfonylureas administered to fasting elderly patients. DESIGN.— A prospective, randomized, double-blind clinical trial. SETTING.— The University of New Mexico General Clinical Research Center. PATIENTS.— Fifty-two sulfonylurea-treated subjects with type 2 diabetes with a
mean (SD) age of 65.1 (5.7) years. INTERVENTIONS.— Subjects were randomly assigned to glyburide or glipizide gastrointestinal
therapeutic system (GITS). Each subject participated in three 23-hour fasting
studies after the sequential administration of 1 week of placebo and 1 week
of 10 mg and 1 week of 20 mg of the assigned sulfonylurea. MAIN OUTCOME MEASURES.— Occurrence of hypoglycemia (defined as plasma glucose level <3.33
mmol/L [60 mg/dL]) and hormonal parameters during the final 9 hours of the
23-hour fast in patients who had taken sulfonylureas vs placebo. RESULTS.— No hypoglycemia was observed during 156 fasting studies. Plasma glucose
level was decreased (nadir, 4.9 mmol/L [88 mg/dL] for a 20-mg dose of glyburide
vs 8.3 mmol/L [150 mg/dL] for placebo; nadir, 5.8 mmol/L [105 mg/dL] for a
20-mg dose of glipizide GITS vs 8.7 mmol/L [157 mg/dL] for placebo), and serum
insulin was increased in the sulfonylurea studies compared with placebo (P<.001). Plasma glucose parameters did not differ between
the 2 sulfonylureas, but C peptide concentrations were increased in the glyburide
group compared with glipizide GITS in the 20-mg study (P=.05). Concentrations of epinephrine were increased in the sulfonylurea
studies compared with placebo (P<.001). Epinephrine
secretion increased when glucose concentration fell below the mean (SD) level
of 9.10 (2.66) mmol/L (164 [48] mg/dL) in the 10-mg study and 8.77 (2.83)
mmol/L (158 [51] mg/dL) in the 20-mg study. CONCLUSIONS.— Fasting was well tolerated among these elderly patients with type 2
diabetes treated with sulfonylureas. Older age should not be considered a
contraindication to sulfonylurea treatment for diabetes. Stimulation of epinephrine
secretion at normal or elevated plasma glucose levels appears to be the primary
mechanism of protection against hypoglycemia in this study.</description><subject>Age Factors</subject><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Biological and medical sciences</subject><subject>Blood Chemical Analysis</subject><subject>Blood Glucose - metabolism</subject><subject>Clinical trials</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Drug toxicity and drugs side effects treatment</subject><subject>Epinephrine - blood</subject><subject>Fasting</subject><subject>Female</subject><subject>Glipizide - administration & dosage</subject><subject>Glipizide - adverse effects</subject><subject>Glipizide - therapeutic use</subject><subject>Glyburide - administration & dosage</subject><subject>Glyburide - adverse effects</subject><subject>Glyburide - therapeutic use</subject><subject>Humans</subject><subject>Hypoglycemia - chemically induced</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin - blood</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Miscellaneous (drug allergy, mutagens, teratogens...)</subject><subject>Older people</subject><subject>Peptides - blood</subject><subject>Pharmacology. Drug treatments</subject><subject>Prospective Studies</subject><subject>Risk Factors</subject><issn>0098-7484</issn><issn>1538-3598</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1998</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpd0c1L5DAYBvAgK-6oe_WwsBBEvLXms5McZXRUUBR39lzeSZMls21Tk1bof78BBw8mhxyeH8nDG4TOKCkpIfRqBx2UbKlLVlK-PEALKrkquNTqG1oQolWxFEp8R8cp7UheGR2hIy0EqSqxQPYav8SQBmtG_27xJnpocXD41ad_eA1mDDFhFyL-PbUu9HM7RQvFQ99Mxjb4fh7C33Y2tvOAfY8382Axwzcetna0CT_ZtvXjlE7RoYM22R_78wT9Wd9uVvfF4_Pdw-r6sQCh2VgooZZOssYZJRvGt0YJrkAIwTWFqtJWaZ5bm8o61eRNBAGlCeECpJbG8RN0-XHvEMPbZNNYdz6ZXAJ6G6ZU04pLRpnI8PwL3IUp9rlbzSjlikqiMvq1R9O2s009RN9BnOv98HJ-sc8hGWhdhN749MkYlZWuZGY_P1j-qc-Q5hc4V_w_I6CEmg</recordid><startdate>19980114</startdate><enddate>19980114</enddate><creator>Burge, Mark R</creator><creator>Schmitz-Fiorentino, Kristen</creator><creator>Fischette, Christine</creator><creator>Qualls, Clifford R</creator><creator>Schade, David S</creator><general>American Medical Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7QL</scope><scope>7QP</scope><scope>7TK</scope><scope>7TS</scope><scope>7U7</scope><scope>7U9</scope><scope>8FD</scope><scope>C1K</scope><scope>FR3</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>NAPCQ</scope><scope>P64</scope><scope>RC3</scope></search><sort><creationdate>19980114</creationdate><title>A Prospective Trial of Risk Factors for Sulfonylurea-Induced Hypoglycemia in Type 2 Diabetes Mellitus</title><author>Burge, Mark R ; Schmitz-Fiorentino, Kristen ; Fischette, Christine ; Qualls, Clifford R ; Schade, David S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a492t-8487f52dfc85d23bc8438a444391a669e893664c6ef8d8d8040a890034a595cf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1998</creationdate><topic>Age Factors</topic><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Biological and medical sciences</topic><topic>Blood Chemical Analysis</topic><topic>Blood Glucose - metabolism</topic><topic>Clinical trials</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Drug toxicity and drugs side effects treatment</topic><topic>Epinephrine - blood</topic><topic>Fasting</topic><topic>Female</topic><topic>Glipizide - administration & dosage</topic><topic>Glipizide - adverse effects</topic><topic>Glipizide - therapeutic use</topic><topic>Glyburide - administration & dosage</topic><topic>Glyburide - adverse effects</topic><topic>Glyburide - therapeutic use</topic><topic>Humans</topic><topic>Hypoglycemia - chemically induced</topic><topic>Hypoglycemic Agents - administration & dosage</topic><topic>Hypoglycemic Agents - adverse effects</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Insulin - blood</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Miscellaneous (drug allergy, mutagens, teratogens...)</topic><topic>Older people</topic><topic>Peptides - blood</topic><topic>Pharmacology. Drug treatments</topic><topic>Prospective Studies</topic><topic>Risk Factors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Burge, Mark R</creatorcontrib><creatorcontrib>Schmitz-Fiorentino, Kristen</creatorcontrib><creatorcontrib>Fischette, Christine</creatorcontrib><creatorcontrib>Qualls, Clifford R</creatorcontrib><creatorcontrib>Schade, David S</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>Physical Education Index</collection><collection>Toxicology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Environmental Sciences and Pollution Management</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Nursing & Allied Health Premium</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Genetics Abstracts</collection><jtitle>JAMA : the journal of the American Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Burge, Mark R</au><au>Schmitz-Fiorentino, Kristen</au><au>Fischette, Christine</au><au>Qualls, Clifford R</au><au>Schade, David S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Prospective Trial of Risk Factors for Sulfonylurea-Induced Hypoglycemia in Type 2 Diabetes Mellitus</atitle><jtitle>JAMA : the journal of the American Medical Association</jtitle><addtitle>JAMA</addtitle><date>1998-01-14</date><risdate>1998</risdate><volume>279</volume><issue>2</issue><spage>137</spage><epage>143</epage><pages>137-143</pages><issn>0098-7484</issn><eissn>1538-3598</eissn><coden>JAMAAP</coden><abstract>CONTEXT.— Retrospective studies have identified oral sulfonylureas, age, and fasting
as major risk factors for hypoglycemia in patients with type 2 diabetes. Sulfonylureas
may be withheld from elderly patients out of concern for hypoglycemia. OBJECTIVE.— To evaluate the hypoglycemic effects of maximum doses of once-daily
second-generation sulfonylureas administered to fasting elderly patients. DESIGN.— A prospective, randomized, double-blind clinical trial. SETTING.— The University of New Mexico General Clinical Research Center. PATIENTS.— Fifty-two sulfonylurea-treated subjects with type 2 diabetes with a
mean (SD) age of 65.1 (5.7) years. INTERVENTIONS.— Subjects were randomly assigned to glyburide or glipizide gastrointestinal
therapeutic system (GITS). Each subject participated in three 23-hour fasting
studies after the sequential administration of 1 week of placebo and 1 week
of 10 mg and 1 week of 20 mg of the assigned sulfonylurea. MAIN OUTCOME MEASURES.— Occurrence of hypoglycemia (defined as plasma glucose level <3.33
mmol/L [60 mg/dL]) and hormonal parameters during the final 9 hours of the
23-hour fast in patients who had taken sulfonylureas vs placebo. RESULTS.— No hypoglycemia was observed during 156 fasting studies. Plasma glucose
level was decreased (nadir, 4.9 mmol/L [88 mg/dL] for a 20-mg dose of glyburide
vs 8.3 mmol/L [150 mg/dL] for placebo; nadir, 5.8 mmol/L [105 mg/dL] for a
20-mg dose of glipizide GITS vs 8.7 mmol/L [157 mg/dL] for placebo), and serum
insulin was increased in the sulfonylurea studies compared with placebo (P<.001). Plasma glucose parameters did not differ between
the 2 sulfonylureas, but C peptide concentrations were increased in the glyburide
group compared with glipizide GITS in the 20-mg study (P=.05). Concentrations of epinephrine were increased in the sulfonylurea
studies compared with placebo (P<.001). Epinephrine
secretion increased when glucose concentration fell below the mean (SD) level
of 9.10 (2.66) mmol/L (164 [48] mg/dL) in the 10-mg study and 8.77 (2.83)
mmol/L (158 [51] mg/dL) in the 20-mg study. CONCLUSIONS.— Fasting was well tolerated among these elderly patients with type 2
diabetes treated with sulfonylureas. Older age should not be considered a
contraindication to sulfonylurea treatment for diabetes. Stimulation of epinephrine
secretion at normal or elevated plasma glucose levels appears to be the primary
mechanism of protection against hypoglycemia in this study.</abstract><cop>Chicago, IL</cop><pub>American Medical Association</pub><pmid>9440664</pmid><doi>10.1001/jama.279.2.137</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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ispartof | JAMA : the journal of the American Medical Association, 1998-01, Vol.279 (2), p.137-143 |
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source | MEDLINE; American Medical Association Journals |
subjects | Age Factors Aged Analysis of Variance Biological and medical sciences Blood Chemical Analysis Blood Glucose - metabolism Clinical trials Diabetes Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Double-Blind Method Drug therapy Drug toxicity and drugs side effects treatment Epinephrine - blood Fasting Female Glipizide - administration & dosage Glipizide - adverse effects Glipizide - therapeutic use Glyburide - administration & dosage Glyburide - adverse effects Glyburide - therapeutic use Humans Hypoglycemia - chemically induced Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Insulin - blood Male Medical sciences Miscellaneous (drug allergy, mutagens, teratogens...) Older people Peptides - blood Pharmacology. Drug treatments Prospective Studies Risk Factors |
title | A Prospective Trial of Risk Factors for Sulfonylurea-Induced Hypoglycemia in Type 2 Diabetes Mellitus |
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