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Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): Effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients
Background: Previous evidence indicates that pioglitazone may improve dyslipidemia in patients with Type 2 diabetes mellitus (T2DM). Aim: The primary objective of this study was to evaluate the effect of either pioglitazone or placebo with metformin on levels of serum HDL cholesterol (HDL-C) in pati...
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| Published in: | Journal of endocrinological investigation 2013-09, Vol.36 (8), p.606-616 |
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| container_end_page | 616 |
| container_issue | 8 |
| container_start_page | 606 |
| container_title | Journal of endocrinological investigation |
| container_volume | 36 |
| creator | Genovese, S. Passaro, A. Brunetti, P. Comaschi, M. Cucinotta, D. Egan, C. G. Chinea, B. Bravi, F. Di Pietro, C. |
| description | Background:
Previous evidence indicates that pioglitazone may improve dyslipidemia in patients with Type 2 diabetes mellitus (T2DM).
Aim:
The primary objective of this study was to evaluate the effect of either pioglitazone or placebo with metformin on levels of serum HDL cholesterol (HDL-C) in patients with T2DM. A secondary objective evaluated changes in metabolic syndrome (MS)-specific parameters.
Subjects and Methods:
This multicenter, double-blind, randomized study was performed in patients with T2DM treated with metformin and hemoglobin A1c (HbA
1c
) levels between 6–8%, central obesity and reduced HDL-C. MS was evaluated from global changes in parameter values and expressed as a single factorial score following multivariate analysis of each parameter. 213 patients (110 in the pioglitazone group and 103 in the placebo group) were available for intention-to-treat analysis.
Results:
Pioglitazone-treated patients showed a significant increase in HDL-C compared to placebo group (6.3 mg/dl
vs
3.0 mg/dl;
p |
| doi_str_mv | 10.3275/8895 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_proquest_miscellaneous_1443389775</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1443389775</sourcerecordid><originalsourceid>FETCH-LOGICAL-p171t-34ff6d4bf70efb6204e20c46b53917962bd8adbf63fb816146a67f6ac6381daf3</originalsourceid><addsrcrecordid>eNpNkcFO3DAQhq2qqGyBV6h8QYJDqB07tsMNLbSstAjEwjmy4zE1Suw0dkDbF-nrNitA6mmkmU-fZuZH6JCSM1bK6rtSdfUJLagsSaGYEp_RgrCaFpzUch99TemZECaZkl_QfskqSkvOF-jvnY9Pnc_6TwyA73WwsfcJLF5l3Xkd8CZPdotjwDeQtYmdb_FmG-wYe8And_erzc3F6Tm-cg7ajKPDw_--V59_4R6yi2Pvw85yfbkulriDF-gSnlsP2wFwia3XBvLsHnT2EHI6RHtOdwmO3usBevxx9bC8Lta3P1fLi3UxUElzwbhzwnLjJAFnREk4lKTlwlTz6bIWpbFKW-MEc0ZRQbnQQjqhW8EUtdqxA3Ty5h3G-HuClJv5_Ba6TgeIU2oo54ypWspqRr-9o5PpwTbD6Hs9bpuPZ87A8RuQ5lF4grF5jtMY5vUbSppdSM0uJPYPLF6BdA</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1443389775</pqid></control><display><type>article</type><title>Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): Effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients</title><source>Springer Link</source><creator>Genovese, S. ; Passaro, A. ; Brunetti, P. ; Comaschi, M. ; Cucinotta, D. ; Egan, C. G. ; Chinea, B. ; Bravi, F. ; Di Pietro, C.</creator><creatorcontrib>Genovese, S. ; Passaro, A. ; Brunetti, P. ; Comaschi, M. ; Cucinotta, D. ; Egan, C. G. ; Chinea, B. ; Bravi, F. ; Di Pietro, C. ; PRISMA study group</creatorcontrib><description>Background:
Previous evidence indicates that pioglitazone may improve dyslipidemia in patients with Type 2 diabetes mellitus (T2DM).
Aim:
The primary objective of this study was to evaluate the effect of either pioglitazone or placebo with metformin on levels of serum HDL cholesterol (HDL-C) in patients with T2DM. A secondary objective evaluated changes in metabolic syndrome (MS)-specific parameters.
Subjects and Methods:
This multicenter, double-blind, randomized study was performed in patients with T2DM treated with metformin and hemoglobin A1c (HbA
1c
) levels between 6–8%, central obesity and reduced HDL-C. MS was evaluated from global changes in parameter values and expressed as a single factorial score following multivariate analysis of each parameter. 213 patients (110 in the pioglitazone group and 103 in the placebo group) were available for intention-to-treat analysis.
Results:
Pioglitazone-treated patients showed a significant increase in HDL-C compared to placebo group (6.3 mg/dl
vs
3.0 mg/dl;
p
<0.01) in addition to a greater reduction in the extent of MS (−13.2
vs
−4.9;
p
=0.0055). Upon study completion, patients treated with pioglitazone had lower levels of HbA
1c
(6.41±0.65
vs
6.96±0.74%;
p
<0.001) and homeostasis model assessment-insulin resistance (HOMA-IR) (2.88±1.95
vs
4.68±3.63;
p
=0.013) and a reduction of the atherogenic LDL subfraction (pattern B) (−5.7%).
Conclusions:
The beneficial effects observed in pioglitazone-treated patients in the present study, (i.e. the increase in HDL-C and the reduction of insulin resistance and atherogenic LDL subfractions), support findings from the PROactive trial, where pioglitazone showed pleiotropic effects and reduced death, fatal myocardial infarction (MI) and non-fatal MI in T2DM patients with MS. Furthermore, medication used in this study showed good tolerability.</description><identifier>ISSN: 0391-4097</identifier><identifier>EISSN: 1720-8386</identifier><identifier>DOI: 10.3275/8895</identifier><identifier>PMID: 23511244</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Adult ; Aged ; Cholesterol, HDL - blood ; Diabetes Mellitus, Type 2 - blood ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - metabolism ; Double-Blind Method ; Drug Combinations ; Endocrinology ; Female ; Glycated Hemoglobin A - metabolism ; Homeostasis ; Humans ; Insulin Resistance ; Male ; Medicine ; Medicine & Public Health ; Metabolic Diseases ; Metabolic Syndrome - drug therapy ; Metabolic Syndrome - metabolism ; Metformin - administration & dosage ; Middle Aged ; Models, Biological ; Original Article ; Placebos ; Thiazolidinediones - administration & dosage</subject><ispartof>Journal of endocrinological investigation, 2013-09, Vol.36 (8), p.606-616</ispartof><rights>Italian Society of Endocrinology (SIE) 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-p171t-34ff6d4bf70efb6204e20c46b53917962bd8adbf63fb816146a67f6ac6381daf3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23511244$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Genovese, S.</creatorcontrib><creatorcontrib>Passaro, A.</creatorcontrib><creatorcontrib>Brunetti, P.</creatorcontrib><creatorcontrib>Comaschi, M.</creatorcontrib><creatorcontrib>Cucinotta, D.</creatorcontrib><creatorcontrib>Egan, C. G.</creatorcontrib><creatorcontrib>Chinea, B.</creatorcontrib><creatorcontrib>Bravi, F.</creatorcontrib><creatorcontrib>Di Pietro, C.</creatorcontrib><creatorcontrib>PRISMA study group</creatorcontrib><title>Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): Effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients</title><title>Journal of endocrinological investigation</title><addtitle>J Endocrinol Invest</addtitle><addtitle>J Endocrinol Invest</addtitle><description>Background:
Previous evidence indicates that pioglitazone may improve dyslipidemia in patients with Type 2 diabetes mellitus (T2DM).
Aim:
The primary objective of this study was to evaluate the effect of either pioglitazone or placebo with metformin on levels of serum HDL cholesterol (HDL-C) in patients with T2DM. A secondary objective evaluated changes in metabolic syndrome (MS)-specific parameters.
Subjects and Methods:
This multicenter, double-blind, randomized study was performed in patients with T2DM treated with metformin and hemoglobin A1c (HbA
1c
) levels between 6–8%, central obesity and reduced HDL-C. MS was evaluated from global changes in parameter values and expressed as a single factorial score following multivariate analysis of each parameter. 213 patients (110 in the pioglitazone group and 103 in the placebo group) were available for intention-to-treat analysis.
Results:
Pioglitazone-treated patients showed a significant increase in HDL-C compared to placebo group (6.3 mg/dl
vs
3.0 mg/dl;
p
<0.01) in addition to a greater reduction in the extent of MS (−13.2
vs
−4.9;
p
=0.0055). Upon study completion, patients treated with pioglitazone had lower levels of HbA
1c
(6.41±0.65
vs
6.96±0.74%;
p
<0.001) and homeostasis model assessment-insulin resistance (HOMA-IR) (2.88±1.95
vs
4.68±3.63;
p
=0.013) and a reduction of the atherogenic LDL subfraction (pattern B) (−5.7%).
Conclusions:
The beneficial effects observed in pioglitazone-treated patients in the present study, (i.e. the increase in HDL-C and the reduction of insulin resistance and atherogenic LDL subfractions), support findings from the PROactive trial, where pioglitazone showed pleiotropic effects and reduced death, fatal myocardial infarction (MI) and non-fatal MI in T2DM patients with MS. Furthermore, medication used in this study showed good tolerability.</description><subject>Adult</subject><subject>Aged</subject><subject>Cholesterol, HDL - blood</subject><subject>Diabetes Mellitus, Type 2 - blood</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - metabolism</subject><subject>Double-Blind Method</subject><subject>Drug Combinations</subject><subject>Endocrinology</subject><subject>Female</subject><subject>Glycated Hemoglobin A - metabolism</subject><subject>Homeostasis</subject><subject>Humans</subject><subject>Insulin Resistance</subject><subject>Male</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metabolic Diseases</subject><subject>Metabolic Syndrome - drug therapy</subject><subject>Metabolic Syndrome - metabolism</subject><subject>Metformin - administration & dosage</subject><subject>Middle Aged</subject><subject>Models, Biological</subject><subject>Original Article</subject><subject>Placebos</subject><subject>Thiazolidinediones - administration & dosage</subject><issn>0391-4097</issn><issn>1720-8386</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><recordid>eNpNkcFO3DAQhq2qqGyBV6h8QYJDqB07tsMNLbSstAjEwjmy4zE1Suw0dkDbF-nrNitA6mmkmU-fZuZH6JCSM1bK6rtSdfUJLagsSaGYEp_RgrCaFpzUch99TemZECaZkl_QfskqSkvOF-jvnY9Pnc_6TwyA73WwsfcJLF5l3Xkd8CZPdotjwDeQtYmdb_FmG-wYe8And_erzc3F6Tm-cg7ajKPDw_--V59_4R6yi2Pvw85yfbkulriDF-gSnlsP2wFwia3XBvLsHnT2EHI6RHtOdwmO3usBevxx9bC8Lta3P1fLi3UxUElzwbhzwnLjJAFnREk4lKTlwlTz6bIWpbFKW-MEc0ZRQbnQQjqhW8EUtdqxA3Ty5h3G-HuClJv5_Ba6TgeIU2oo54ypWspqRr-9o5PpwTbD6Hs9bpuPZ87A8RuQ5lF4grF5jtMY5vUbSppdSM0uJPYPLF6BdA</recordid><startdate>20130901</startdate><enddate>20130901</enddate><creator>Genovese, S.</creator><creator>Passaro, A.</creator><creator>Brunetti, P.</creator><creator>Comaschi, M.</creator><creator>Cucinotta, D.</creator><creator>Egan, C. G.</creator><creator>Chinea, B.</creator><creator>Bravi, F.</creator><creator>Di Pietro, C.</creator><general>Springer International Publishing</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7X8</scope></search><sort><creationdate>20130901</creationdate><title>Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): Effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients</title><author>Genovese, S. ; Passaro, A. ; Brunetti, P. ; Comaschi, M. ; Cucinotta, D. ; Egan, C. G. ; Chinea, B. ; Bravi, F. ; Di Pietro, C.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p171t-34ff6d4bf70efb6204e20c46b53917962bd8adbf63fb816146a67f6ac6381daf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Cholesterol, HDL - blood</topic><topic>Diabetes Mellitus, Type 2 - blood</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - metabolism</topic><topic>Double-Blind Method</topic><topic>Drug Combinations</topic><topic>Endocrinology</topic><topic>Female</topic><topic>Glycated Hemoglobin A - metabolism</topic><topic>Homeostasis</topic><topic>Humans</topic><topic>Insulin Resistance</topic><topic>Male</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metabolic Diseases</topic><topic>Metabolic Syndrome - drug therapy</topic><topic>Metabolic Syndrome - metabolism</topic><topic>Metformin - administration & dosage</topic><topic>Middle Aged</topic><topic>Models, Biological</topic><topic>Original Article</topic><topic>Placebos</topic><topic>Thiazolidinediones - administration & dosage</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Genovese, S.</creatorcontrib><creatorcontrib>Passaro, A.</creatorcontrib><creatorcontrib>Brunetti, P.</creatorcontrib><creatorcontrib>Comaschi, M.</creatorcontrib><creatorcontrib>Cucinotta, D.</creatorcontrib><creatorcontrib>Egan, C. G.</creatorcontrib><creatorcontrib>Chinea, B.</creatorcontrib><creatorcontrib>Bravi, F.</creatorcontrib><creatorcontrib>Di Pietro, C.</creatorcontrib><creatorcontrib>PRISMA study group</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of endocrinological investigation</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Genovese, S.</au><au>Passaro, A.</au><au>Brunetti, P.</au><au>Comaschi, M.</au><au>Cucinotta, D.</au><au>Egan, C. G.</au><au>Chinea, B.</au><au>Bravi, F.</au><au>Di Pietro, C.</au><aucorp>PRISMA study group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): Effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients</atitle><jtitle>Journal of endocrinological investigation</jtitle><stitle>J Endocrinol Invest</stitle><addtitle>J Endocrinol Invest</addtitle><date>2013-09-01</date><risdate>2013</risdate><volume>36</volume><issue>8</issue><spage>606</spage><epage>616</epage><pages>606-616</pages><issn>0391-4097</issn><eissn>1720-8386</eissn><abstract>Background:
Previous evidence indicates that pioglitazone may improve dyslipidemia in patients with Type 2 diabetes mellitus (T2DM).
Aim:
The primary objective of this study was to evaluate the effect of either pioglitazone or placebo with metformin on levels of serum HDL cholesterol (HDL-C) in patients with T2DM. A secondary objective evaluated changes in metabolic syndrome (MS)-specific parameters.
Subjects and Methods:
This multicenter, double-blind, randomized study was performed in patients with T2DM treated with metformin and hemoglobin A1c (HbA
1c
) levels between 6–8%, central obesity and reduced HDL-C. MS was evaluated from global changes in parameter values and expressed as a single factorial score following multivariate analysis of each parameter. 213 patients (110 in the pioglitazone group and 103 in the placebo group) were available for intention-to-treat analysis.
Results:
Pioglitazone-treated patients showed a significant increase in HDL-C compared to placebo group (6.3 mg/dl
vs
3.0 mg/dl;
p
<0.01) in addition to a greater reduction in the extent of MS (−13.2
vs
−4.9;
p
=0.0055). Upon study completion, patients treated with pioglitazone had lower levels of HbA
1c
(6.41±0.65
vs
6.96±0.74%;
p
<0.001) and homeostasis model assessment-insulin resistance (HOMA-IR) (2.88±1.95
vs
4.68±3.63;
p
=0.013) and a reduction of the atherogenic LDL subfraction (pattern B) (−5.7%).
Conclusions:
The beneficial effects observed in pioglitazone-treated patients in the present study, (i.e. the increase in HDL-C and the reduction of insulin resistance and atherogenic LDL subfractions), support findings from the PROactive trial, where pioglitazone showed pleiotropic effects and reduced death, fatal myocardial infarction (MI) and non-fatal MI in T2DM patients with MS. Furthermore, medication used in this study showed good tolerability.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>23511244</pmid><doi>10.3275/8895</doi><tpages>11</tpages></addata></record> |
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| issn | 0391-4097 1720-8386 |
| language | eng |
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| subjects | Adult Aged Cholesterol, HDL - blood Diabetes Mellitus, Type 2 - blood Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - metabolism Double-Blind Method Drug Combinations Endocrinology Female Glycated Hemoglobin A - metabolism Homeostasis Humans Insulin Resistance Male Medicine Medicine & Public Health Metabolic Diseases Metabolic Syndrome - drug therapy Metabolic Syndrome - metabolism Metformin - administration & dosage Middle Aged Models, Biological Original Article Placebos Thiazolidinediones - administration & dosage |
| title | Pioglitazone Randomised Italian Study on Metabolic Syndrome (PRISMA): Effect of pioglitazone with metformin on HDL-C levels in Type 2 diabetic patients |
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