Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study
Aims/hypothesis The renal and cardiovascular protective effects of angiotensin receptor blocker (ARB) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI). Methods We examined the effects of olmesartan, an AR...
Gespeichert in:
| Veröffentlicht in: | Diabetologia 2011-12, Vol.54 (12), p.2978-2986 |
|---|---|
| Hauptverfasser: | , , , , , , |
| Format: | Artikel |
| Sprache: | eng |
| Schlagworte: | |
| Online-Zugang: | Volltext |
| Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
| container_end_page | 2986 |
|---|---|
| container_issue | 12 |
| container_start_page | 2978 |
| container_title | Diabetologia |
| container_volume | 54 |
| creator | Imai, E. Chan, J. C. N. Ito, S. Yamasaki, T. Kobayashi, F. Haneda, M. Makino, H. |
| description | Aims/hypothesis
The renal and cardiovascular protective effects of angiotensin receptor blocker (ARB) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI).
Methods
We examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with overt nephropathy. Secondary outcome included composite cardiovascular outcomes, changes in renal function and proteinuria. Randomisation and allocation to trial group were carried out by a central computer system. Participants, caregivers, the people carrying out examinations and people assessing the outcomes were blinded to group assignment.
Results
Five hundred and seventy-seven (377 Japanese, 200 Chinese) patients treated with antihypertensive therapy (73.5% [
n
= 424] received concomitant ACEI), were given either once-daily olmesartan (10–40 mg) (
n
= 288) or placebo (
n
= 289) over 3.2 ± 0.6 years (mean±SD). In the olmesartan group, 116 developed the primary outcome (41.1%) compared with 129 (45.4%) in the placebo group (HR 0.97, 95% CI 0.75, 1.24;
p
= 0.791). Olmesartan significantly decreased blood pressure, proteinuria and rate of change of reciprocal serum creatinine. Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases). Hyperkalaemia was more frequent in the olmesartan group than the placebo group (9.2% vs 5.3%).
Conclusions/interpretation
Olmesartan was well tolerated but did not improve renal outcome on top of ACEI.
Trial registration:
ClinicalTrials.gov NCT00141453
Funding:
The ORIENT study was supported by a research grant from Daiichi Sankyo. |
| doi_str_mv | 10.1007/s00125-011-2325-z |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3210358</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2505481141</sourcerecordid><originalsourceid>FETCH-LOGICAL-c498t-edf56fe2339c125f5963b1ea6508c43e27554c406adabf0960431c9e9dab11ad3</originalsourceid><addsrcrecordid>eNp1kcluFDEURS0EIk3gA9ggC4ldCjzUyCISisIgRWIDEjvrlf2cduQuF7arUedP-FvcdJPAgpWHe96gewl5ztlrzlj3JjHGRVMxzishy-X2AVnxWoqK1aJ_SFZ7ueJ9--2EPEnphjEmm7p9TE4EHwbZcbYiPy-tRZ0TDZYGv8EEMcNEw0QjTuApTIZqiMaFLSS9eIg0LFmHQlI30bybkQpqHIyYy9cPl9c0bDFmOuG8jmGGvN69pUA3i89O45QjntFY2oaNS2jO6OxB4xgqHYoWvEdDU17M7il5ZMEnfHY8T8nX95dfLj5WV58_fLp4d1XpeuhzhcY2rUUh5aCLGbYZWjlyhLZhva4liq5pal2zFgyMlg0tqyXXAw7lyTkYeUrOD33nZdyg-b0ieDVHt4G4UwGc-leZ3Fpdh62Sghc_-9Lg5bFBDN8XTFndhCUW85IamGh6zsUe4gdIx5BSRHs3gDO1D1MdwlQlTLUPU92Wmhd_b3ZX8Se9Arw6AiUb8LbYql265-quYaLrCicOXCrSdI3xfsP_T_8FuKS8Ng</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>902581128</pqid></control><display><type>article</type><title>Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Imai, E. ; Chan, J. C. N. ; Ito, S. ; Yamasaki, T. ; Kobayashi, F. ; Haneda, M. ; Makino, H.</creator><creatorcontrib>Imai, E. ; Chan, J. C. N. ; Ito, S. ; Yamasaki, T. ; Kobayashi, F. ; Haneda, M. ; Makino, H. ; ORIENT study investigators ; for the ORIENT study investigators</creatorcontrib><description>Aims/hypothesis
The renal and cardiovascular protective effects of angiotensin receptor blocker (ARB) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI).
Methods
We examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with overt nephropathy. Secondary outcome included composite cardiovascular outcomes, changes in renal function and proteinuria. Randomisation and allocation to trial group were carried out by a central computer system. Participants, caregivers, the people carrying out examinations and people assessing the outcomes were blinded to group assignment.
Results
Five hundred and seventy-seven (377 Japanese, 200 Chinese) patients treated with antihypertensive therapy (73.5% [
n
= 424] received concomitant ACEI), were given either once-daily olmesartan (10–40 mg) (
n
= 288) or placebo (
n
= 289) over 3.2 ± 0.6 years (mean±SD). In the olmesartan group, 116 developed the primary outcome (41.1%) compared with 129 (45.4%) in the placebo group (HR 0.97, 95% CI 0.75, 1.24;
p
= 0.791). Olmesartan significantly decreased blood pressure, proteinuria and rate of change of reciprocal serum creatinine. Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases). Hyperkalaemia was more frequent in the olmesartan group than the placebo group (9.2% vs 5.3%).
Conclusions/interpretation
Olmesartan was well tolerated but did not improve renal outcome on top of ACEI.
Trial registration:
ClinicalTrials.gov NCT00141453
Funding:
The ORIENT study was supported by a research grant from Daiichi Sankyo.</description><identifier>ISSN: 0012-186X</identifier><identifier>EISSN: 1432-0428</identifier><identifier>DOI: 10.1007/s00125-011-2325-z</identifier><identifier>PMID: 21993710</identifier><language>eng</language><publisher>Berlin/Heidelberg: Springer-Verlag</publisher><subject>Angina pectoris ; Angiotensin II Type 1 Receptor Blockers - therapeutic use ; Antihypertensive Agents - therapeutic use ; Asian Continental Ancestry Group - statistics & numerical data ; Associated diseases and complications ; Biological and medical sciences ; Cardiovascular Diseases - drug therapy ; Cardiovascular Diseases - mortality ; Consent ; Creatinine ; Creatinine - blood ; Diabetes ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - mortality ; Diabetes. Impaired glucose tolerance ; Diabetic Nephropathies - drug therapy ; Diabetic Nephropathies - mortality ; Diabetic nephropathy ; Drug Therapy, Combination - adverse effects ; Drug Therapy, Combination - statistics & numerical data ; Endocrine pancreas. Apud cells (diseases) ; Endocrinology ; Endocrinopathies ; Enzymes ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Female ; Heart attacks ; Human Physiology ; Humans ; Hyperkalemia - chemically induced ; Hypertension - drug therapy ; Imidazoles - therapeutic use ; Internal Medicine ; Ischemia ; Kidney diseases ; Kidney Failure, Chronic - drug therapy ; Kidney Failure, Chronic - mortality ; Kidneys ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Metabolic Diseases ; Middle Aged ; Nephrology ; Nephrology. Urinary tract diseases ; Proteinuria - drug therapy ; Stroke - epidemiology ; Tetrazoles - therapeutic use ; Treatment Outcome ; University graduates ; Urinary system involvement in other diseases. Miscellaneous ; Veins & arteries</subject><ispartof>Diabetologia, 2011-12, Vol.54 (12), p.2978-2986</ispartof><rights>The Author(s) 2011</rights><rights>2015 INIST-CNRS</rights><rights>Springer-Verlag 2011</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c498t-edf56fe2339c125f5963b1ea6508c43e27554c406adabf0960431c9e9dab11ad3</citedby><cites>FETCH-LOGICAL-c498t-edf56fe2339c125f5963b1ea6508c43e27554c406adabf0960431c9e9dab11ad3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s00125-011-2325-z$$EPDF$$P50$$Gspringer$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00125-011-2325-z$$EHTML$$P50$$Gspringer$$Hfree_for_read</linktohtml><link.rule.ids>230,314,776,780,881,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=24750277$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/21993710$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Imai, E.</creatorcontrib><creatorcontrib>Chan, J. C. N.</creatorcontrib><creatorcontrib>Ito, S.</creatorcontrib><creatorcontrib>Yamasaki, T.</creatorcontrib><creatorcontrib>Kobayashi, F.</creatorcontrib><creatorcontrib>Haneda, M.</creatorcontrib><creatorcontrib>Makino, H.</creatorcontrib><creatorcontrib>ORIENT study investigators</creatorcontrib><creatorcontrib>for the ORIENT study investigators</creatorcontrib><title>Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study</title><title>Diabetologia</title><addtitle>Diabetologia</addtitle><addtitle>Diabetologia</addtitle><description>Aims/hypothesis
The renal and cardiovascular protective effects of angiotensin receptor blocker (ARB) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI).
Methods
We examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with overt nephropathy. Secondary outcome included composite cardiovascular outcomes, changes in renal function and proteinuria. Randomisation and allocation to trial group were carried out by a central computer system. Participants, caregivers, the people carrying out examinations and people assessing the outcomes were blinded to group assignment.
Results
Five hundred and seventy-seven (377 Japanese, 200 Chinese) patients treated with antihypertensive therapy (73.5% [
n
= 424] received concomitant ACEI), were given either once-daily olmesartan (10–40 mg) (
n
= 288) or placebo (
n
= 289) over 3.2 ± 0.6 years (mean±SD). In the olmesartan group, 116 developed the primary outcome (41.1%) compared with 129 (45.4%) in the placebo group (HR 0.97, 95% CI 0.75, 1.24;
p
= 0.791). Olmesartan significantly decreased blood pressure, proteinuria and rate of change of reciprocal serum creatinine. Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases). Hyperkalaemia was more frequent in the olmesartan group than the placebo group (9.2% vs 5.3%).
Conclusions/interpretation
Olmesartan was well tolerated but did not improve renal outcome on top of ACEI.
Trial registration:
ClinicalTrials.gov NCT00141453
Funding:
The ORIENT study was supported by a research grant from Daiichi Sankyo.</description><subject>Angina pectoris</subject><subject>Angiotensin II Type 1 Receptor Blockers - therapeutic use</subject><subject>Antihypertensive Agents - therapeutic use</subject><subject>Asian Continental Ancestry Group - statistics & numerical data</subject><subject>Associated diseases and complications</subject><subject>Biological and medical sciences</subject><subject>Cardiovascular Diseases - drug therapy</subject><subject>Cardiovascular Diseases - mortality</subject><subject>Consent</subject><subject>Creatinine</subject><subject>Creatinine - blood</subject><subject>Diabetes</subject><subject>Diabetes Mellitus, Type 2 - drug therapy</subject><subject>Diabetes Mellitus, Type 2 - mortality</subject><subject>Diabetes. Impaired glucose tolerance</subject><subject>Diabetic Nephropathies - drug therapy</subject><subject>Diabetic Nephropathies - mortality</subject><subject>Diabetic nephropathy</subject><subject>Drug Therapy, Combination - adverse effects</subject><subject>Drug Therapy, Combination - statistics & numerical data</subject><subject>Endocrine pancreas. Apud cells (diseases)</subject><subject>Endocrinology</subject><subject>Endocrinopathies</subject><subject>Enzymes</subject><subject>Etiopathogenesis. Screening. Investigations. Target tissue resistance</subject><subject>Female</subject><subject>Heart attacks</subject><subject>Human Physiology</subject><subject>Humans</subject><subject>Hyperkalemia - chemically induced</subject><subject>Hypertension - drug therapy</subject><subject>Imidazoles - therapeutic use</subject><subject>Internal Medicine</subject><subject>Ischemia</subject><subject>Kidney diseases</subject><subject>Kidney Failure, Chronic - drug therapy</subject><subject>Kidney Failure, Chronic - mortality</subject><subject>Kidneys</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Metabolic Diseases</subject><subject>Middle Aged</subject><subject>Nephrology</subject><subject>Nephrology. Urinary tract diseases</subject><subject>Proteinuria - drug therapy</subject><subject>Stroke - epidemiology</subject><subject>Tetrazoles - therapeutic use</subject><subject>Treatment Outcome</subject><subject>University graduates</subject><subject>Urinary system involvement in other diseases. Miscellaneous</subject><subject>Veins & arteries</subject><issn>0012-186X</issn><issn>1432-0428</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2011</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kcluFDEURS0EIk3gA9ggC4ldCjzUyCISisIgRWIDEjvrlf2cduQuF7arUedP-FvcdJPAgpWHe96gewl5ztlrzlj3JjHGRVMxzishy-X2AVnxWoqK1aJ_SFZ7ueJ9--2EPEnphjEmm7p9TE4EHwbZcbYiPy-tRZ0TDZYGv8EEMcNEw0QjTuApTIZqiMaFLSS9eIg0LFmHQlI30bybkQpqHIyYy9cPl9c0bDFmOuG8jmGGvN69pUA3i89O45QjntFY2oaNS2jO6OxB4xgqHYoWvEdDU17M7il5ZMEnfHY8T8nX95dfLj5WV58_fLp4d1XpeuhzhcY2rUUh5aCLGbYZWjlyhLZhva4liq5pal2zFgyMlg0tqyXXAw7lyTkYeUrOD33nZdyg-b0ieDVHt4G4UwGc-leZ3Fpdh62Sghc_-9Lg5bFBDN8XTFndhCUW85IamGh6zsUe4gdIx5BSRHs3gDO1D1MdwlQlTLUPU92Wmhd_b3ZX8Se9Arw6AiUb8LbYql265-quYaLrCicOXCrSdI3xfsP_T_8FuKS8Ng</recordid><startdate>20111201</startdate><enddate>20111201</enddate><creator>Imai, E.</creator><creator>Chan, J. C. N.</creator><creator>Ito, S.</creator><creator>Yamasaki, T.</creator><creator>Kobayashi, F.</creator><creator>Haneda, M.</creator><creator>Makino, H.</creator><general>Springer-Verlag</general><general>Springer</general><general>Springer Nature B.V</general><scope>C6C</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>5PM</scope></search><sort><creationdate>20111201</creationdate><title>Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study</title><author>Imai, E. ; Chan, J. C. N. ; Ito, S. ; Yamasaki, T. ; Kobayashi, F. ; Haneda, M. ; Makino, H.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c498t-edf56fe2339c125f5963b1ea6508c43e27554c406adabf0960431c9e9dab11ad3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2011</creationdate><topic>Angina pectoris</topic><topic>Angiotensin II Type 1 Receptor Blockers - therapeutic use</topic><topic>Antihypertensive Agents - therapeutic use</topic><topic>Asian Continental Ancestry Group - statistics & numerical data</topic><topic>Associated diseases and complications</topic><topic>Biological and medical sciences</topic><topic>Cardiovascular Diseases - drug therapy</topic><topic>Cardiovascular Diseases - mortality</topic><topic>Consent</topic><topic>Creatinine</topic><topic>Creatinine - blood</topic><topic>Diabetes</topic><topic>Diabetes Mellitus, Type 2 - drug therapy</topic><topic>Diabetes Mellitus, Type 2 - mortality</topic><topic>Diabetes. Impaired glucose tolerance</topic><topic>Diabetic Nephropathies - drug therapy</topic><topic>Diabetic Nephropathies - mortality</topic><topic>Diabetic nephropathy</topic><topic>Drug Therapy, Combination - adverse effects</topic><topic>Drug Therapy, Combination - statistics & numerical data</topic><topic>Endocrine pancreas. Apud cells (diseases)</topic><topic>Endocrinology</topic><topic>Endocrinopathies</topic><topic>Enzymes</topic><topic>Etiopathogenesis. Screening. Investigations. Target tissue resistance</topic><topic>Female</topic><topic>Heart attacks</topic><topic>Human Physiology</topic><topic>Humans</topic><topic>Hyperkalemia - chemically induced</topic><topic>Hypertension - drug therapy</topic><topic>Imidazoles - therapeutic use</topic><topic>Internal Medicine</topic><topic>Ischemia</topic><topic>Kidney diseases</topic><topic>Kidney Failure, Chronic - drug therapy</topic><topic>Kidney Failure, Chronic - mortality</topic><topic>Kidneys</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Metabolic Diseases</topic><topic>Middle Aged</topic><topic>Nephrology</topic><topic>Nephrology. Urinary tract diseases</topic><topic>Proteinuria - drug therapy</topic><topic>Stroke - epidemiology</topic><topic>Tetrazoles - therapeutic use</topic><topic>Treatment Outcome</topic><topic>University graduates</topic><topic>Urinary system involvement in other diseases. Miscellaneous</topic><topic>Veins & arteries</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Imai, E.</creatorcontrib><creatorcontrib>Chan, J. C. N.</creatorcontrib><creatorcontrib>Ito, S.</creatorcontrib><creatorcontrib>Yamasaki, T.</creatorcontrib><creatorcontrib>Kobayashi, F.</creatorcontrib><creatorcontrib>Haneda, M.</creatorcontrib><creatorcontrib>Makino, H.</creatorcontrib><creatorcontrib>ORIENT study investigators</creatorcontrib><creatorcontrib>for the ORIENT study investigators</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical 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>PubMed Central (Full Participant titles)</collection><jtitle>Diabetologia</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Imai, E.</au><au>Chan, J. C. N.</au><au>Ito, S.</au><au>Yamasaki, T.</au><au>Kobayashi, F.</au><au>Haneda, M.</au><au>Makino, H.</au><aucorp>ORIENT study investigators</aucorp><aucorp>for the ORIENT study investigators</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study</atitle><jtitle>Diabetologia</jtitle><stitle>Diabetologia</stitle><addtitle>Diabetologia</addtitle><date>2011-12-01</date><risdate>2011</risdate><volume>54</volume><issue>12</issue><spage>2978</spage><epage>2986</epage><pages>2978-2986</pages><issn>0012-186X</issn><eissn>1432-0428</eissn><abstract>Aims/hypothesis
The renal and cardiovascular protective effects of angiotensin receptor blocker (ARB) remain controversial in type 2 diabetic patients treated with a contemporary regimen including an angiotensin converting enzyme inhibitor (ACEI).
Methods
We examined the effects of olmesartan, an ARB, on primary composite outcome of doubling of serum creatinine, endstage renal disease and death in type 2 diabetic patients with overt nephropathy. Secondary outcome included composite cardiovascular outcomes, changes in renal function and proteinuria. Randomisation and allocation to trial group were carried out by a central computer system. Participants, caregivers, the people carrying out examinations and people assessing the outcomes were blinded to group assignment.
Results
Five hundred and seventy-seven (377 Japanese, 200 Chinese) patients treated with antihypertensive therapy (73.5% [
n
= 424] received concomitant ACEI), were given either once-daily olmesartan (10–40 mg) (
n
= 288) or placebo (
n
= 289) over 3.2 ± 0.6 years (mean±SD). In the olmesartan group, 116 developed the primary outcome (41.1%) compared with 129 (45.4%) in the placebo group (HR 0.97, 95% CI 0.75, 1.24;
p
= 0.791). Olmesartan significantly decreased blood pressure, proteinuria and rate of change of reciprocal serum creatinine. Cardiovascular death was higher in the olmesartan group than the placebo group (ten vs three cases), whereas major adverse cardiovascular events (cardiovascular death plus non-fatal stroke and myocardial infarction) and all-cause death were similar between the two groups (major adverse cardiovascular events 18 vs 21 cases, all-cause deaths; 19 vs 20 cases). Hyperkalaemia was more frequent in the olmesartan group than the placebo group (9.2% vs 5.3%).
Conclusions/interpretation
Olmesartan was well tolerated but did not improve renal outcome on top of ACEI.
Trial registration:
ClinicalTrials.gov NCT00141453
Funding:
The ORIENT study was supported by a research grant from Daiichi Sankyo.</abstract><cop>Berlin/Heidelberg</cop><pub>Springer-Verlag</pub><pmid>21993710</pmid><doi>10.1007/s00125-011-2325-z</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0012-186X |
| ispartof | Diabetologia, 2011-12, Vol.54 (12), p.2978-2986 |
| issn | 0012-186X 1432-0428 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_3210358 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Angina pectoris Angiotensin II Type 1 Receptor Blockers - therapeutic use Antihypertensive Agents - therapeutic use Asian Continental Ancestry Group - statistics & numerical data Associated diseases and complications Biological and medical sciences Cardiovascular Diseases - drug therapy Cardiovascular Diseases - mortality Consent Creatinine Creatinine - blood Diabetes Diabetes Mellitus, Type 2 - drug therapy Diabetes Mellitus, Type 2 - mortality Diabetes. Impaired glucose tolerance Diabetic Nephropathies - drug therapy Diabetic Nephropathies - mortality Diabetic nephropathy Drug Therapy, Combination - adverse effects Drug Therapy, Combination - statistics & numerical data Endocrine pancreas. Apud cells (diseases) Endocrinology Endocrinopathies Enzymes Etiopathogenesis. Screening. Investigations. Target tissue resistance Female Heart attacks Human Physiology Humans Hyperkalemia - chemically induced Hypertension - drug therapy Imidazoles - therapeutic use Internal Medicine Ischemia Kidney diseases Kidney Failure, Chronic - drug therapy Kidney Failure, Chronic - mortality Kidneys Male Medical sciences Medicine Medicine & Public Health Metabolic Diseases Middle Aged Nephrology Nephrology. Urinary tract diseases Proteinuria - drug therapy Stroke - epidemiology Tetrazoles - therapeutic use Treatment Outcome University graduates Urinary system involvement in other diseases. Miscellaneous Veins & arteries |
| title | Effects of olmesartan on renal and cardiovascular outcomes in type 2 diabetes with overt nephropathy: a multicentre, randomised, placebo-controlled study |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-10T02%3A41%3A09IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Effects%20of%20olmesartan%20on%20renal%20and%20cardiovascular%20outcomes%20in%20type%202%20diabetes%20with%20overt%20nephropathy:%20a%20multicentre,%20randomised,%20placebo-controlled%20study&rft.jtitle=Diabetologia&rft.au=Imai,%20E.&rft.aucorp=ORIENT%20study%20investigators&rft.date=2011-12-01&rft.volume=54&rft.issue=12&rft.spage=2978&rft.epage=2986&rft.pages=2978-2986&rft.issn=0012-186X&rft.eissn=1432-0428&rft_id=info:doi/10.1007/s00125-011-2325-z&rft_dat=%3Cproquest_pubme%3E2505481141%3C/proquest_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=902581128&rft_id=info:pmid/21993710&rfr_iscdi=true |