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Comparison of hypoglycaemia episodes in people with type-2 diabetes fasting in Ramazan, treated with vildaglipton or sulphonylurea: results of the Pakistani cohort of the VIRTUE study
To assess the effect of vildagliptin in comparison to sulphonylurea (SU) on hypoglycaemia in Muslim patients with type 2 diabetes mellitus fasting during Ramadan. VIRTUE was a multicenter, prospective, observational study, which enrolled 244 patients from Pakistan who were re-analysed. All included...
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Published in: | Journal of the Pakistan Medical Association 2014-11, Vol.64 (11), p.1297-1302 |
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creator | Mahar, Saeed Ahmed Hasan, Mohammad Imtiaz Khan, Mohammad Imran Hasan Fawwad, Asher Hussain, Shakir Maheshwary, Neeta Kumar, Kishore Siddiqi, Ahson Khan, Muhammad Athar |
description | To assess the effect of vildagliptin in comparison to sulphonylurea (SU) on hypoglycaemia in Muslim patients with type 2 diabetes mellitus fasting during Ramadan.
VIRTUE was a multicenter, prospective, observational study, which enrolled 244 patients from Pakistan who were re-analysed. All included patients were treated with vildagliptin (n=121) or SU (n=121) as add-on to metformin or as monotherapy for 16 weeks. The primary outcome of interest was to compare the proportion of patients with ≥1 hypoglycaemic event (HE) during fasting between vildagliptin and SU cohort. Changes in HbA1c and body weight and treatment adherence were also measured.
Of the 244 patients enrolled, 120 patients in the vildagliptin cohort (99.2%) and 119 patients in the SU cohort (98.3%) completed the study. Patients experiencing at least one HE were fewer with vildagliptin when compared with SUs (5.8% vs. 14.2%; p |
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VIRTUE was a multicenter, prospective, observational study, which enrolled 244 patients from Pakistan who were re-analysed. All included patients were treated with vildagliptin (n=121) or SU (n=121) as add-on to metformin or as monotherapy for 16 weeks. The primary outcome of interest was to compare the proportion of patients with ≥1 hypoglycaemic event (HE) during fasting between vildagliptin and SU cohort. Changes in HbA1c and body weight and treatment adherence were also measured.
Of the 244 patients enrolled, 120 patients in the vildagliptin cohort (99.2%) and 119 patients in the SU cohort (98.3%) completed the study. Patients experiencing at least one HE were fewer with vildagliptin when compared with SUs (5.8% vs. 14.2%; p<0.033). The reduction in HbA1c was 0.3% with vildagliptin from a baseline of 7.6% and 0.1% with SU from a baseline of 7.4% (between-treatment difference: -0.1% p<0.054). A reduction of 0.3 kg was seen with vildagliptin treatment vs. 0.2 kg weight gain in the SU group. Adverse events were experienced by 15.7% in the vildagliptin cohort and 17.4% in the SU group.
The treatment with vildagliptin was associated with fewer hypoglycaemic events compared with SUs and was well tolerated with good glycaemic and weight control in patients with T2DM fasting during Ramadan.</description><identifier>ISSN: 0030-9982</identifier><identifier>PMID: 25831650</identifier><language>eng</language><publisher>Pakistan: Knowledge Bylanes</publisher><subject>Adamantane - analogs & derivatives ; Adamantane - therapeutic use ; Adult ; Aged ; Care and treatment ; Cohort Studies ; Comparative analysis ; Diabetes mellitus ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - ethnology ; Fasting ; Female ; Humans ; Hypoglycemia - epidemiology ; Hypoglycemic Agents - therapeutic use ; Islam ; Male ; Middle Aged ; Nitriles - therapeutic use ; Pakistan ; Pharmaceutical industry ; Pyrrolidines - therapeutic use ; Sulfonylurea Compounds - therapeutic use</subject><ispartof>Journal of the Pakistan Medical Association, 2014-11, Vol.64 (11), p.1297-1302</ispartof><rights>COPYRIGHT 2014 Knowledge Bylanes</rights><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/25831650$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mahar, Saeed Ahmed</creatorcontrib><creatorcontrib>Hasan, Mohammad Imtiaz</creatorcontrib><creatorcontrib>Khan, Mohammad Imran Hasan</creatorcontrib><creatorcontrib>Fawwad, Asher</creatorcontrib><creatorcontrib>Hussain, Shakir</creatorcontrib><creatorcontrib>Maheshwary, Neeta</creatorcontrib><creatorcontrib>Kumar, Kishore</creatorcontrib><creatorcontrib>Siddiqi, Ahson</creatorcontrib><creatorcontrib>Khan, Muhammad Athar</creatorcontrib><title>Comparison of hypoglycaemia episodes in people with type-2 diabetes fasting in Ramazan, treated with vildaglipton or sulphonylurea: results of the Pakistani cohort of the VIRTUE study</title><title>Journal of the Pakistan Medical Association</title><addtitle>J Pak Med Assoc</addtitle><description>To assess the effect of vildagliptin in comparison to sulphonylurea (SU) on hypoglycaemia in Muslim patients with type 2 diabetes mellitus fasting during Ramadan.
VIRTUE was a multicenter, prospective, observational study, which enrolled 244 patients from Pakistan who were re-analysed. All included patients were treated with vildagliptin (n=121) or SU (n=121) as add-on to metformin or as monotherapy for 16 weeks. The primary outcome of interest was to compare the proportion of patients with ≥1 hypoglycaemic event (HE) during fasting between vildagliptin and SU cohort. Changes in HbA1c and body weight and treatment adherence were also measured.
Of the 244 patients enrolled, 120 patients in the vildagliptin cohort (99.2%) and 119 patients in the SU cohort (98.3%) completed the study. Patients experiencing at least one HE were fewer with vildagliptin when compared with SUs (5.8% vs. 14.2%; p<0.033). The reduction in HbA1c was 0.3% with vildagliptin from a baseline of 7.6% and 0.1% with SU from a baseline of 7.4% (between-treatment difference: -0.1% p<0.054). A reduction of 0.3 kg was seen with vildagliptin treatment vs. 0.2 kg weight gain in the SU group. Adverse events were experienced by 15.7% in the vildagliptin cohort and 17.4% in the SU group.
The treatment with vildagliptin was associated with fewer hypoglycaemic events compared with SUs and was well tolerated with good glycaemic and weight control in patients with T2DM fasting during Ramadan.</description><subject>Adamantane - analogs & derivatives</subject><subject>Adamantane - therapeutic use</subject><subject>Adult</subject><subject>Aged</subject><subject>Care and treatment</subject><subject>Cohort Studies</subject><subject>Comparative analysis</subject><subject>Diabetes mellitus</subject><subject>Diabetes Mellitus, Type 2 - complications</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - ethnology</subject><subject>Fasting</subject><subject>Female</subject><subject>Humans</subject><subject>Hypoglycemia - epidemiology</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Islam</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nitriles - therapeutic use</subject><subject>Pakistan</subject><subject>Pharmaceutical industry</subject><subject>Pyrrolidines - therapeutic use</subject><subject>Sulfonylurea Compounds - therapeutic use</subject><issn>0030-9982</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><recordid>eNptkdGK1TAQhnuhuOvqK0hAEC-spE2b03i3HFZdWFDW1dsybSZtNE1ikq7UF_P1zOHsggsyFxn-fP_kZ_KoOKWU0VKIrj4pnsb4ndKat5Q-KU7qtmNV7k-LP3u3eAg6OkucIvPm3WS2EXDRQNBnXWIk2hKPzhskv3SaSdo8ljWRGgZM-VpBTNpOB-waFvgN9g1JASGhPBputZEwGe3T4ZlA4mr87Oxm1ky9IwGzkOIhQJqRfIYfOiawmoxudiHd698ur2--XpCYVrk9Kx4rMBGf351nxZf3Fzf7j-XVpw-X-_OrcmJUpLJBJdq6ZdjIZmw5o4hNNXCxo6rtqpF3I-atMFQjVcOO8bqph0HuOqEaEJKdFa-PU31wP1eMqV90HNEYsOjW2Feci46JioqMvjyiExjstVUuBRgPeH_e0FrUvKp4pt7-h8ol88JHZ1HprD8wvPrHMCOYNEdn1qSdjQ_BF3dR12FB2fugFwhbf__V7C953KWv</recordid><startdate>20141101</startdate><enddate>20141101</enddate><creator>Mahar, Saeed Ahmed</creator><creator>Hasan, Mohammad Imtiaz</creator><creator>Khan, Mohammad Imran Hasan</creator><creator>Fawwad, Asher</creator><creator>Hussain, Shakir</creator><creator>Maheshwary, Neeta</creator><creator>Kumar, Kishore</creator><creator>Siddiqi, Ahson</creator><creator>Khan, Muhammad Athar</creator><general>Knowledge Bylanes</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>20141101</creationdate><title>Comparison of hypoglycaemia episodes in people with type-2 diabetes fasting in Ramazan, treated with vildaglipton or sulphonylurea: results of the Pakistani cohort of the VIRTUE study</title><author>Mahar, Saeed Ahmed ; Hasan, Mohammad Imtiaz ; Khan, Mohammad Imran Hasan ; Fawwad, Asher ; Hussain, Shakir ; Maheshwary, Neeta ; Kumar, Kishore ; Siddiqi, Ahson ; Khan, Muhammad Athar</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-g309t-4ef95253e4d4c5630ee41b6970f581c68ce0023efc0fb736242bbd789f4a9d3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Adamantane - analogs & derivatives</topic><topic>Adamantane - therapeutic use</topic><topic>Adult</topic><topic>Aged</topic><topic>Care and treatment</topic><topic>Cohort Studies</topic><topic>Comparative analysis</topic><topic>Diabetes mellitus</topic><topic>Diabetes Mellitus, Type 2 - complications</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - ethnology</topic><topic>Fasting</topic><topic>Female</topic><topic>Humans</topic><topic>Hypoglycemia - epidemiology</topic><topic>Hypoglycemic Agents - therapeutic use</topic><topic>Islam</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nitriles - therapeutic use</topic><topic>Pakistan</topic><topic>Pharmaceutical industry</topic><topic>Pyrrolidines - therapeutic use</topic><topic>Sulfonylurea Compounds - therapeutic use</topic><toplevel>online_resources</toplevel><creatorcontrib>Mahar, Saeed Ahmed</creatorcontrib><creatorcontrib>Hasan, Mohammad Imtiaz</creatorcontrib><creatorcontrib>Khan, Mohammad Imran Hasan</creatorcontrib><creatorcontrib>Fawwad, Asher</creatorcontrib><creatorcontrib>Hussain, Shakir</creatorcontrib><creatorcontrib>Maheshwary, Neeta</creatorcontrib><creatorcontrib>Kumar, Kishore</creatorcontrib><creatorcontrib>Siddiqi, Ahson</creatorcontrib><creatorcontrib>Khan, Muhammad Athar</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 the Pakistan Medical Association</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mahar, Saeed Ahmed</au><au>Hasan, Mohammad Imtiaz</au><au>Khan, Mohammad Imran Hasan</au><au>Fawwad, Asher</au><au>Hussain, Shakir</au><au>Maheshwary, Neeta</au><au>Kumar, Kishore</au><au>Siddiqi, Ahson</au><au>Khan, Muhammad Athar</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparison of hypoglycaemia episodes in people with type-2 diabetes fasting in Ramazan, treated with vildaglipton or sulphonylurea: results of the Pakistani cohort of the VIRTUE study</atitle><jtitle>Journal of the Pakistan Medical Association</jtitle><addtitle>J Pak Med Assoc</addtitle><date>2014-11-01</date><risdate>2014</risdate><volume>64</volume><issue>11</issue><spage>1297</spage><epage>1302</epage><pages>1297-1302</pages><issn>0030-9982</issn><abstract>To assess the effect of vildagliptin in comparison to sulphonylurea (SU) on hypoglycaemia in Muslim patients with type 2 diabetes mellitus fasting during Ramadan.
VIRTUE was a multicenter, prospective, observational study, which enrolled 244 patients from Pakistan who were re-analysed. All included patients were treated with vildagliptin (n=121) or SU (n=121) as add-on to metformin or as monotherapy for 16 weeks. The primary outcome of interest was to compare the proportion of patients with ≥1 hypoglycaemic event (HE) during fasting between vildagliptin and SU cohort. Changes in HbA1c and body weight and treatment adherence were also measured.
Of the 244 patients enrolled, 120 patients in the vildagliptin cohort (99.2%) and 119 patients in the SU cohort (98.3%) completed the study. Patients experiencing at least one HE were fewer with vildagliptin when compared with SUs (5.8% vs. 14.2%; p<0.033). The reduction in HbA1c was 0.3% with vildagliptin from a baseline of 7.6% and 0.1% with SU from a baseline of 7.4% (between-treatment difference: -0.1% p<0.054). A reduction of 0.3 kg was seen with vildagliptin treatment vs. 0.2 kg weight gain in the SU group. Adverse events were experienced by 15.7% in the vildagliptin cohort and 17.4% in the SU group.
The treatment with vildagliptin was associated with fewer hypoglycaemic events compared with SUs and was well tolerated with good glycaemic and weight control in patients with T2DM fasting during Ramadan.</abstract><cop>Pakistan</cop><pub>Knowledge Bylanes</pub><pmid>25831650</pmid><tpages>6</tpages></addata></record> |
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subjects | Adamantane - analogs & derivatives Adamantane - therapeutic use Adult Aged Care and treatment Cohort Studies Comparative analysis Diabetes mellitus Diabetes Mellitus, Type 2 - complications Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - ethnology Fasting Female Humans Hypoglycemia - epidemiology Hypoglycemic Agents - therapeutic use Islam Male Middle Aged Nitriles - therapeutic use Pakistan Pharmaceutical industry Pyrrolidines - therapeutic use Sulfonylurea Compounds - therapeutic use |
title | Comparison of hypoglycaemia episodes in people with type-2 diabetes fasting in Ramazan, treated with vildaglipton or sulphonylurea: results of the Pakistani cohort of the VIRTUE study |
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