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Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study
We investigated the efficacy of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes for 4 years in clinical practice. Between 2009 and 2010, we reviewed 1,178 patients with type 2 diabetes (HbA1c ≥7.5% or 58 mmol/mol) prescribed initial combination therapy wit...
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Published in: | PloS one 2015-06, Vol.10 (6), p.e0129477 |
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creator | Ku, Eu Jeong Jung, Kyong Yeon Kim, Yoon Ji Kim, Kyoung Min Moon, Jae Hoon Choi, Sung Hee Cho, Young Min Park, Kyong Soo Jang, Hak Chul Lim, Soo Ahrén, Bo |
description | We investigated the efficacy of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes for 4 years in clinical practice.
Between 2009 and 2010, we reviewed 1,178 patients with type 2 diabetes (HbA1c ≥7.5% or 58 mmol/mol) prescribed initial combination therapy with sitagliptin and metformin. After excluding 288 patients without a second follow-up, 890 individuals (age, 58.0 ± 12.5 years; BMI, 25.4 ± 3.5 kg/m2; HbA1c, 8.6 ± 1.1%) were followed up with every 3-6 months for 4 years. Homeostasis model assessments for insulin resistance and β-cell function (HOMA-β) were recorded at baseline. The response criterion was HbA1c reduction by ≥0.8% from baseline or attainment of the target HbA1c (≤7.0% or 53 mmol/mol). At the end of every year of treatment, changes in HbA1c from the baseline were assessed.
After 1 year, 72.2% of patients with initial combination therapy had responded, defined as HbA1c reduction ≥0.8% or attainment of the target HbA1c ≤7.0%. After 4 years, 35.4% of the patients still showed a response, with an HbA1c level of 7.0 ± 0.9%. A high HbA1c level at baseline was the most significant independent predictor of the long-term response (P |
doi_str_mv | 10.1371/journal.pone.0129477 |
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Between 2009 and 2010, we reviewed 1,178 patients with type 2 diabetes (HbA1c ≥7.5% or 58 mmol/mol) prescribed initial combination therapy with sitagliptin and metformin. After excluding 288 patients without a second follow-up, 890 individuals (age, 58.0 ± 12.5 years; BMI, 25.4 ± 3.5 kg/m2; HbA1c, 8.6 ± 1.1%) were followed up with every 3-6 months for 4 years. Homeostasis model assessments for insulin resistance and β-cell function (HOMA-β) were recorded at baseline. The response criterion was HbA1c reduction by ≥0.8% from baseline or attainment of the target HbA1c (≤7.0% or 53 mmol/mol). At the end of every year of treatment, changes in HbA1c from the baseline were assessed.
After 1 year, 72.2% of patients with initial combination therapy had responded, defined as HbA1c reduction ≥0.8% or attainment of the target HbA1c ≤7.0%. After 4 years, 35.4% of the patients still showed a response, with an HbA1c level of 7.0 ± 0.9%. A high HbA1c level at baseline was the most significant independent predictor of the long-term response (P<0.001). In addition, low HOMA-β was a significant predictor of a greater reduction in HbA1c. This treatment was generally well tolerated over the 4-year follow-up period, without any serious adverse events.
This real-world follow-up study shows a persistent glucose-reducing effect of initial combination therapy with sitagliptin and metformin for up to 4 years.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0129477</identifier><identifier>PMID: 26068661</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adult ; Aged ; Alcohol use ; Annan klinisk medicin ; Antidiabetics ; Body mass ; Care and treatment ; Clinical Medicine ; Combination therapy ; Diabetes ; Diabetes mellitus ; Diabetes mellitus (non-insulin dependent) ; Diabetes Mellitus, Type 2 - drug therapy ; Drug Therapy, Combination ; Durability ; Endocrinology and Diabetes ; Endokrinologi och diabetes ; FDA approval ; Female ; Glucose ; Hemoglobin ; Hemoglobin A - metabolism ; Homeostasis ; Humans ; Hypoglycemic Agents - administration & dosage ; Hypoglycemic Agents - adverse effects ; Hypoglycemic Agents - therapeutic use ; Insulin ; Insulin resistance ; Internal medicine ; Klinisk medicin ; Male ; Medical and Health Sciences ; Medical research ; Medicin och hälsovetenskap ; Medicine ; Metformin ; Metformin - administration & dosage ; Metformin - adverse effects ; Metformin - therapeutic use ; Middle Aged ; Other Clinical Medicine ; Patients ; Reduction ; Review boards ; Sitagliptin Phosphate - administration & dosage ; Sitagliptin Phosphate - adverse effects ; Sitagliptin Phosphate - therapeutic use ; Studies ; Systematic review ; Therapy ; Type 2 diabetes</subject><ispartof>PloS one, 2015-06, Vol.10 (6), p.e0129477</ispartof><rights>COPYRIGHT 2015 Public Library of Science</rights><rights>2015 Ku et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>2015 Ku et al 2015 Ku et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c761t-979b820b95f0cedf1295d5bb2e817a372c830ec044de2adb717e09d1cd5cbc0b3</citedby><cites>FETCH-LOGICAL-c761t-979b820b95f0cedf1295d5bb2e817a372c830ec044de2adb717e09d1cd5cbc0b3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/1687821797/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/1687821797?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,25753,27924,27925,37012,44590,53791,53793,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26068661$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://lup.lub.lu.se/record/7486652$$DView record from Swedish Publication Index$$Hfree_for_read</backlink></links><search><contributor>Sesti, Giorgio</contributor><creatorcontrib>Ku, Eu Jeong</creatorcontrib><creatorcontrib>Jung, Kyong Yeon</creatorcontrib><creatorcontrib>Kim, Yoon Ji</creatorcontrib><creatorcontrib>Kim, Kyoung Min</creatorcontrib><creatorcontrib>Moon, Jae Hoon</creatorcontrib><creatorcontrib>Choi, Sung Hee</creatorcontrib><creatorcontrib>Cho, Young Min</creatorcontrib><creatorcontrib>Park, Kyong Soo</creatorcontrib><creatorcontrib>Jang, Hak Chul</creatorcontrib><creatorcontrib>Lim, Soo</creatorcontrib><creatorcontrib>Ahrén, Bo</creatorcontrib><title>Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>We investigated the efficacy of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes for 4 years in clinical practice.
Between 2009 and 2010, we reviewed 1,178 patients with type 2 diabetes (HbA1c ≥7.5% or 58 mmol/mol) prescribed initial combination therapy with sitagliptin and metformin. After excluding 288 patients without a second follow-up, 890 individuals (age, 58.0 ± 12.5 years; BMI, 25.4 ± 3.5 kg/m2; HbA1c, 8.6 ± 1.1%) were followed up with every 3-6 months for 4 years. Homeostasis model assessments for insulin resistance and β-cell function (HOMA-β) were recorded at baseline. The response criterion was HbA1c reduction by ≥0.8% from baseline or attainment of the target HbA1c (≤7.0% or 53 mmol/mol). At the end of every year of treatment, changes in HbA1c from the baseline were assessed.
After 1 year, 72.2% of patients with initial combination therapy had responded, defined as HbA1c reduction ≥0.8% or attainment of the target HbA1c ≤7.0%. After 4 years, 35.4% of the patients still showed a response, with an HbA1c level of 7.0 ± 0.9%. A high HbA1c level at baseline was the most significant independent predictor of the long-term response (P<0.001). In addition, low HOMA-β was a significant predictor of a greater reduction in HbA1c. This treatment was generally well tolerated over the 4-year follow-up period, without any serious adverse events.
This real-world follow-up study shows a persistent glucose-reducing effect of initial combination therapy with sitagliptin and metformin for up to 4 years.</description><subject>Adult</subject><subject>Aged</subject><subject>Alcohol use</subject><subject>Annan klinisk medicin</subject><subject>Antidiabetics</subject><subject>Body mass</subject><subject>Care and treatment</subject><subject>Clinical Medicine</subject><subject>Combination therapy</subject><subject>Diabetes</subject><subject>Diabetes mellitus</subject><subject>Diabetes mellitus (non-insulin dependent)</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Durability</subject><subject>Endocrinology and Diabetes</subject><subject>Endokrinologi och diabetes</subject><subject>FDA approval</subject><subject>Female</subject><subject>Glucose</subject><subject>Hemoglobin</subject><subject>Hemoglobin A - metabolism</subject><subject>Homeostasis</subject><subject>Humans</subject><subject>Hypoglycemic Agents - administration & dosage</subject><subject>Hypoglycemic Agents - adverse effects</subject><subject>Hypoglycemic Agents - therapeutic use</subject><subject>Insulin</subject><subject>Insulin resistance</subject><subject>Internal medicine</subject><subject>Klinisk medicin</subject><subject>Male</subject><subject>Medical and Health Sciences</subject><subject>Medical research</subject><subject>Medicin och hälsovetenskap</subject><subject>Medicine</subject><subject>Metformin</subject><subject>Metformin - administration & dosage</subject><subject>Metformin - adverse effects</subject><subject>Metformin - therapeutic use</subject><subject>Middle Aged</subject><subject>Other Clinical Medicine</subject><subject>Patients</subject><subject>Reduction</subject><subject>Review boards</subject><subject>Sitagliptin Phosphate - administration & dosage</subject><subject>Sitagliptin Phosphate - adverse effects</subject><subject>Sitagliptin Phosphate - therapeutic use</subject><subject>Studies</subject><subject>Systematic review</subject><subject>Therapy</subject><subject>Type 2 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Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study</title><author>Ku, Eu Jeong ; Jung, Kyong Yeon ; Kim, Yoon Ji ; Kim, Kyoung Min ; Moon, Jae Hoon ; Choi, Sung Hee ; Cho, Young Min ; Park, Kyong Soo ; Jang, Hak Chul ; Lim, Soo ; Ahrén, Bo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c761t-979b820b95f0cedf1295d5bb2e817a372c830ec044de2adb717e09d1cd5cbc0b3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Alcohol use</topic><topic>Annan klinisk medicin</topic><topic>Antidiabetics</topic><topic>Body mass</topic><topic>Care and treatment</topic><topic>Clinical Medicine</topic><topic>Combination therapy</topic><topic>Diabetes</topic><topic>Diabetes mellitus</topic><topic>Diabetes mellitus (non-insulin dependent)</topic><topic>Diabetes Mellitus, 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Database</collection><collection>Materials science collection</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>Engineering collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>PubMed Central (Full Participant titles)</collection><collection>SwePub</collection><collection>SWEPUB Lunds universitet full text</collection><collection>SwePub Articles</collection><collection>SWEPUB Freely available online</collection><collection>SWEPUB Lunds universitet</collection><collection>SwePub Articles full text</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ku, Eu Jeong</au><au>Jung, Kyong Yeon</au><au>Kim, Yoon Ji</au><au>Kim, Kyoung Min</au><au>Moon, Jae Hoon</au><au>Choi, Sung Hee</au><au>Cho, Young Min</au><au>Park, Kyong Soo</au><au>Jang, Hak Chul</au><au>Lim, Soo</au><au>Ahrén, Bo</au><au>Sesti, Giorgio</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2015-06-12</date><risdate>2015</risdate><volume>10</volume><issue>6</issue><spage>e0129477</spage><pages>e0129477-</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>We investigated the efficacy of initial combination therapy with sitagliptin and metformin in patients with type 2 diabetes for 4 years in clinical practice.
Between 2009 and 2010, we reviewed 1,178 patients with type 2 diabetes (HbA1c ≥7.5% or 58 mmol/mol) prescribed initial combination therapy with sitagliptin and metformin. After excluding 288 patients without a second follow-up, 890 individuals (age, 58.0 ± 12.5 years; BMI, 25.4 ± 3.5 kg/m2; HbA1c, 8.6 ± 1.1%) were followed up with every 3-6 months for 4 years. Homeostasis model assessments for insulin resistance and β-cell function (HOMA-β) were recorded at baseline. The response criterion was HbA1c reduction by ≥0.8% from baseline or attainment of the target HbA1c (≤7.0% or 53 mmol/mol). At the end of every year of treatment, changes in HbA1c from the baseline were assessed.
After 1 year, 72.2% of patients with initial combination therapy had responded, defined as HbA1c reduction ≥0.8% or attainment of the target HbA1c ≤7.0%. After 4 years, 35.4% of the patients still showed a response, with an HbA1c level of 7.0 ± 0.9%. A high HbA1c level at baseline was the most significant independent predictor of the long-term response (P<0.001). In addition, low HOMA-β was a significant predictor of a greater reduction in HbA1c. This treatment was generally well tolerated over the 4-year follow-up period, without any serious adverse events.
This real-world follow-up study shows a persistent glucose-reducing effect of initial combination therapy with sitagliptin and metformin for up to 4 years.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>26068661</pmid><doi>10.1371/journal.pone.0129477</doi><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 1932-6203 |
ispartof | PloS one, 2015-06, Vol.10 (6), p.e0129477 |
issn | 1932-6203 1932-6203 |
language | eng |
recordid | cdi_plos_journals_1687821797 |
source | Publicly Available Content Database; PubMed Central(OpenAccess) |
subjects | Adult Aged Alcohol use Annan klinisk medicin Antidiabetics Body mass Care and treatment Clinical Medicine Combination therapy Diabetes Diabetes mellitus Diabetes mellitus (non-insulin dependent) Diabetes Mellitus, Type 2 - drug therapy Drug Therapy, Combination Durability Endocrinology and Diabetes Endokrinologi och diabetes FDA approval Female Glucose Hemoglobin Hemoglobin A - metabolism Homeostasis Humans Hypoglycemic Agents - administration & dosage Hypoglycemic Agents - adverse effects Hypoglycemic Agents - therapeutic use Insulin Insulin resistance Internal medicine Klinisk medicin Male Medical and Health Sciences Medical research Medicin och hälsovetenskap Medicine Metformin Metformin - administration & dosage Metformin - adverse effects Metformin - therapeutic use Middle Aged Other Clinical Medicine Patients Reduction Review boards Sitagliptin Phosphate - administration & dosage Sitagliptin Phosphate - adverse effects Sitagliptin Phosphate - therapeutic use Studies Systematic review Therapy Type 2 diabetes |
title | Four-Year Durability of Initial Combination Therapy with Sitagliptin and Metformin in Patients with Type 2 Diabetes in Clinical Practice; COSMIC Study |
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