Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial
Among patients receiving hemodialysis, abnormalities in calcium regulation have been linked to an increased risk of cardiovascular events. Cinacalcet lowers serum calcium concentrations through its effect on parathyroid hormone secretion and has been hypothesized to reduce the risk of cardiovascular...
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| Veröffentlicht in: | Hemodialysis international 2016-07, Vol.20 (3), p.421-431 |
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| creator | Pun, Patrick H. Abdalla, Safa Block, Geoffrey A. Chertow, Glenn M. Correa-Rotter, Ricardo Dehmel, Bastian Drüeke, Tilman B. Floege, Jürgen Goodman, William G. Herzog, Charles A. London, Gerard M. Mahaffey, Kenneth W. Moe, Sharon M. Parfrey, Patrick S. Wheeler, David C. Middleton, John P. |
| description | Among patients receiving hemodialysis, abnormalities in calcium regulation have been linked to an increased risk of cardiovascular events. Cinacalcet lowers serum calcium concentrations through its effect on parathyroid hormone secretion and has been hypothesized to reduce the risk of cardiovascular events. In observational cohort studies, prescriptions of low dialysate calcium concentration and larger observed serum–dialysate calcium gradients have been associated with higher risks of in‐dialysis facility or peri‐dialytic sudden cardiac arrest. We performed this study to examine the risks associated with dialysate calcium and serum–dialysate gradients among participants in the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial. In EVOLVE, 3883 hemodialysis patients were randomized 1:1 to cinacalcet or placebo. Dialysate calcium was administered at the discretion of treating physicians. We examined whether baseline dialysate calcium concentration or the serum–dialysate calcium gradient modified the effect of cinacalcet on the following adjudicated endpoints: (1) primary composite endpoint (death or first non‐fatal myocardial infarction, hospitalization for unstable angina, heart failure, or peripheral vascular event); (2) cardiovascular death; and (3) sudden death. In EVOLVE, use of higher dialysate calcium concentrations was more prevalent in Europe and Latin America compared with North America. There was a significant fall in serum calcium concentration in the cinacalcet group; dialysate calcium concentrations were changed infrequently in both groups. There was no association between baseline dialysate calcium concentration or serum–dialysate calcium gradient and the endpoints examined. Neither the baseline dialysate calcium nor the serum–dialysate calcium gradient significantly modified the effects of cinacalcet on the outcomes examined. The effects of cinacalcet on cardiovascular death and major cardiovascular events are not altered by the dialysate calcium prescription and serum–dialysate calcium gradient. |
| doi_str_mv | 10.1111/hdi.12382 |
| format | Article |
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Cinacalcet lowers serum calcium concentrations through its effect on parathyroid hormone secretion and has been hypothesized to reduce the risk of cardiovascular events. In observational cohort studies, prescriptions of low dialysate calcium concentration and larger observed serum–dialysate calcium gradients have been associated with higher risks of in‐dialysis facility or peri‐dialytic sudden cardiac arrest. We performed this study to examine the risks associated with dialysate calcium and serum–dialysate gradients among participants in the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial. In EVOLVE, 3883 hemodialysis patients were randomized 1:1 to cinacalcet or placebo. Dialysate calcium was administered at the discretion of treating physicians. We examined whether baseline dialysate calcium concentration or the serum–dialysate calcium gradient modified the effect of cinacalcet on the following adjudicated endpoints: (1) primary composite endpoint (death or first non‐fatal myocardial infarction, hospitalization for unstable angina, heart failure, or peripheral vascular event); (2) cardiovascular death; and (3) sudden death. In EVOLVE, use of higher dialysate calcium concentrations was more prevalent in Europe and Latin America compared with North America. There was a significant fall in serum calcium concentration in the cinacalcet group; dialysate calcium concentrations were changed infrequently in both groups. There was no association between baseline dialysate calcium concentration or serum–dialysate calcium gradient and the endpoints examined. Neither the baseline dialysate calcium nor the serum–dialysate calcium gradient significantly modified the effects of cinacalcet on the outcomes examined. The effects of cinacalcet on cardiovascular death and major cardiovascular events are not altered by the dialysate calcium prescription and serum–dialysate calcium gradient.</description><identifier>ISSN: 1492-7535</identifier><identifier>EISSN: 1542-4758</identifier><identifier>DOI: 10.1111/hdi.12382</identifier><identifier>PMID: 26564024</identifier><language>eng</language><publisher>Canada: Blackwell Publishing Ltd</publisher><subject>Cardiovascular ; Cardiovascular Diseases - therapy ; Cinacalcet Hydrochloride - therapeutic use ; dialysate fluid compatibility and quality ; Dialysis Solutions - therapeutic use ; Female ; Humans ; international dialysis issues ; Male ; Middle Aged ; outcomes research ; Renal Dialysis - adverse effects</subject><ispartof>Hemodialysis international, 2016-07, Vol.20 (3), p.421-431</ispartof><rights>2015 International Society for Hemodialysis</rights><rights>2015 International Society for Hemodialysis.</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4532-89a87e4ab7fb31c31308eda6b32034a6f422bc570c02671a25f0d57812071d523</citedby><cites>FETCH-LOGICAL-c4532-89a87e4ab7fb31c31308eda6b32034a6f422bc570c02671a25f0d57812071d523</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fhdi.12382$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fhdi.12382$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>230,314,776,780,881,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26564024$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pun, Patrick H.</creatorcontrib><creatorcontrib>Abdalla, Safa</creatorcontrib><creatorcontrib>Block, Geoffrey A.</creatorcontrib><creatorcontrib>Chertow, Glenn M.</creatorcontrib><creatorcontrib>Correa-Rotter, Ricardo</creatorcontrib><creatorcontrib>Dehmel, Bastian</creatorcontrib><creatorcontrib>Drüeke, Tilman B.</creatorcontrib><creatorcontrib>Floege, Jürgen</creatorcontrib><creatorcontrib>Goodman, William G.</creatorcontrib><creatorcontrib>Herzog, Charles A.</creatorcontrib><creatorcontrib>London, Gerard M.</creatorcontrib><creatorcontrib>Mahaffey, Kenneth W.</creatorcontrib><creatorcontrib>Moe, Sharon M.</creatorcontrib><creatorcontrib>Parfrey, Patrick S.</creatorcontrib><creatorcontrib>Wheeler, David C.</creatorcontrib><creatorcontrib>Middleton, John P.</creatorcontrib><title>Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial</title><title>Hemodialysis international</title><addtitle>Hemodial Int</addtitle><description>Among patients receiving hemodialysis, abnormalities in calcium regulation have been linked to an increased risk of cardiovascular events. Cinacalcet lowers serum calcium concentrations through its effect on parathyroid hormone secretion and has been hypothesized to reduce the risk of cardiovascular events. In observational cohort studies, prescriptions of low dialysate calcium concentration and larger observed serum–dialysate calcium gradients have been associated with higher risks of in‐dialysis facility or peri‐dialytic sudden cardiac arrest. We performed this study to examine the risks associated with dialysate calcium and serum–dialysate gradients among participants in the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial. In EVOLVE, 3883 hemodialysis patients were randomized 1:1 to cinacalcet or placebo. Dialysate calcium was administered at the discretion of treating physicians. We examined whether baseline dialysate calcium concentration or the serum–dialysate calcium gradient modified the effect of cinacalcet on the following adjudicated endpoints: (1) primary composite endpoint (death or first non‐fatal myocardial infarction, hospitalization for unstable angina, heart failure, or peripheral vascular event); (2) cardiovascular death; and (3) sudden death. In EVOLVE, use of higher dialysate calcium concentrations was more prevalent in Europe and Latin America compared with North America. There was a significant fall in serum calcium concentration in the cinacalcet group; dialysate calcium concentrations were changed infrequently in both groups. There was no association between baseline dialysate calcium concentration or serum–dialysate calcium gradient and the endpoints examined. Neither the baseline dialysate calcium nor the serum–dialysate calcium gradient significantly modified the effects of cinacalcet on the outcomes examined. The effects of cinacalcet on cardiovascular death and major cardiovascular events are not altered by the dialysate calcium prescription and serum–dialysate calcium gradient.</description><subject>Cardiovascular</subject><subject>Cardiovascular Diseases - therapy</subject><subject>Cinacalcet Hydrochloride - therapeutic use</subject><subject>dialysate fluid compatibility and quality</subject><subject>Dialysis Solutions - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>international dialysis issues</subject><subject>Male</subject><subject>Middle Aged</subject><subject>outcomes research</subject><subject>Renal Dialysis - adverse effects</subject><issn>1492-7535</issn><issn>1542-4758</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kUtvEzEUhS1ERR-w4A8gL0HqtH7b2SChNE0qIooQBImNdcfjIYbJTGvPBPLv6zJtBAu8seVz7ucjH4ReUnJG8zpfV-GMMm7YE3REpWCF0NI8zWcxYYWWXB6i45R-EMIoIeoZOmRKKkGYOELfpqEFB43z_SmuAjS7BL3H9zdh2GDXtc63fYQ-dO0phrbKUqxCt4XkhgYi9tusJxxa3K89nq2ul6sZ7mMmPUcHNTTJv3jYT9CXy9nn6aJYXs-vpu-WhROSs8JMwGgvoNR1yanjlBPjK1AlZ4QLULVgrHRSE0eY0hSYrEkltaGMaFpJxk_Q25F7M5QbX415G3sTwwbiznYQ7L9KG9b2e7e1wig1oSIDXj8AYnc7-NTbTUjONw20vhuSpYbQHMJIla1vRquLXUrR1_tnKLH3Xdjchf3TRfa--jvX3vn4-dlwPhp-hcbv_k-yi4urR2QxToTU-9_7CYg_rdJcS_v1w9wuVmz-8dP7qdX8DsE3onQ</recordid><startdate>201607</startdate><enddate>201607</enddate><creator>Pun, Patrick H.</creator><creator>Abdalla, Safa</creator><creator>Block, Geoffrey A.</creator><creator>Chertow, Glenn M.</creator><creator>Correa-Rotter, Ricardo</creator><creator>Dehmel, Bastian</creator><creator>Drüeke, Tilman B.</creator><creator>Floege, Jürgen</creator><creator>Goodman, William G.</creator><creator>Herzog, Charles A.</creator><creator>London, Gerard M.</creator><creator>Mahaffey, Kenneth W.</creator><creator>Moe, Sharon M.</creator><creator>Parfrey, Patrick S.</creator><creator>Wheeler, David C.</creator><creator>Middleton, John P.</creator><general>Blackwell Publishing Ltd</general><scope>BSCLL</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>7X8</scope><scope>5PM</scope></search><sort><creationdate>201607</creationdate><title>Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial</title><author>Pun, Patrick H. ; Abdalla, Safa ; Block, Geoffrey A. ; Chertow, Glenn M. ; Correa-Rotter, Ricardo ; Dehmel, Bastian ; Drüeke, Tilman B. ; Floege, Jürgen ; Goodman, William G. ; Herzog, Charles A. ; London, Gerard M. ; Mahaffey, Kenneth W. ; Moe, Sharon M. ; Parfrey, Patrick S. ; Wheeler, David C. ; Middleton, John P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4532-89a87e4ab7fb31c31308eda6b32034a6f422bc570c02671a25f0d57812071d523</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Cardiovascular</topic><topic>Cardiovascular Diseases - therapy</topic><topic>Cinacalcet Hydrochloride - therapeutic use</topic><topic>dialysate fluid compatibility and quality</topic><topic>Dialysis Solutions - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>international dialysis issues</topic><topic>Male</topic><topic>Middle Aged</topic><topic>outcomes research</topic><topic>Renal Dialysis - adverse effects</topic><toplevel>online_resources</toplevel><creatorcontrib>Pun, Patrick H.</creatorcontrib><creatorcontrib>Abdalla, Safa</creatorcontrib><creatorcontrib>Block, Geoffrey A.</creatorcontrib><creatorcontrib>Chertow, Glenn M.</creatorcontrib><creatorcontrib>Correa-Rotter, Ricardo</creatorcontrib><creatorcontrib>Dehmel, Bastian</creatorcontrib><creatorcontrib>Drüeke, Tilman B.</creatorcontrib><creatorcontrib>Floege, Jürgen</creatorcontrib><creatorcontrib>Goodman, William G.</creatorcontrib><creatorcontrib>Herzog, Charles A.</creatorcontrib><creatorcontrib>London, Gerard M.</creatorcontrib><creatorcontrib>Mahaffey, Kenneth W.</creatorcontrib><creatorcontrib>Moe, Sharon M.</creatorcontrib><creatorcontrib>Parfrey, Patrick S.</creatorcontrib><creatorcontrib>Wheeler, David C.</creatorcontrib><creatorcontrib>Middleton, John P.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Hemodialysis international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pun, Patrick H.</au><au>Abdalla, Safa</au><au>Block, Geoffrey A.</au><au>Chertow, Glenn M.</au><au>Correa-Rotter, Ricardo</au><au>Dehmel, Bastian</au><au>Drüeke, Tilman B.</au><au>Floege, Jürgen</au><au>Goodman, William G.</au><au>Herzog, Charles A.</au><au>London, Gerard M.</au><au>Mahaffey, Kenneth W.</au><au>Moe, Sharon M.</au><au>Parfrey, Patrick S.</au><au>Wheeler, David C.</au><au>Middleton, John P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial</atitle><jtitle>Hemodialysis international</jtitle><addtitle>Hemodial Int</addtitle><date>2016-07</date><risdate>2016</risdate><volume>20</volume><issue>3</issue><spage>421</spage><epage>431</epage><pages>421-431</pages><issn>1492-7535</issn><eissn>1542-4758</eissn><abstract>Among patients receiving hemodialysis, abnormalities in calcium regulation have been linked to an increased risk of cardiovascular events. Cinacalcet lowers serum calcium concentrations through its effect on parathyroid hormone secretion and has been hypothesized to reduce the risk of cardiovascular events. In observational cohort studies, prescriptions of low dialysate calcium concentration and larger observed serum–dialysate calcium gradients have been associated with higher risks of in‐dialysis facility or peri‐dialytic sudden cardiac arrest. We performed this study to examine the risks associated with dialysate calcium and serum–dialysate gradients among participants in the Evaluation of Cinacalcet Hydrochloride Therapy to Lower Cardiovascular Events (EVOLVE) trial. In EVOLVE, 3883 hemodialysis patients were randomized 1:1 to cinacalcet or placebo. Dialysate calcium was administered at the discretion of treating physicians. We examined whether baseline dialysate calcium concentration or the serum–dialysate calcium gradient modified the effect of cinacalcet on the following adjudicated endpoints: (1) primary composite endpoint (death or first non‐fatal myocardial infarction, hospitalization for unstable angina, heart failure, or peripheral vascular event); (2) cardiovascular death; and (3) sudden death. In EVOLVE, use of higher dialysate calcium concentrations was more prevalent in Europe and Latin America compared with North America. There was a significant fall in serum calcium concentration in the cinacalcet group; dialysate calcium concentrations were changed infrequently in both groups. There was no association between baseline dialysate calcium concentration or serum–dialysate calcium gradient and the endpoints examined. Neither the baseline dialysate calcium nor the serum–dialysate calcium gradient significantly modified the effects of cinacalcet on the outcomes examined. The effects of cinacalcet on cardiovascular death and major cardiovascular events are not altered by the dialysate calcium prescription and serum–dialysate calcium gradient.</abstract><cop>Canada</cop><pub>Blackwell Publishing Ltd</pub><pmid>26564024</pmid><doi>10.1111/hdi.12382</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Hemodialysis international, 2016-07, Vol.20 (3), p.421-431 |
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| subjects | Cardiovascular Cardiovascular Diseases - therapy Cinacalcet Hydrochloride - therapeutic use dialysate fluid compatibility and quality Dialysis Solutions - therapeutic use Female Humans international dialysis issues Male Middle Aged outcomes research Renal Dialysis - adverse effects |
| title | Cinacalcet, dialysate calcium concentration, and cardiovascular events in the EVOLVE trial |
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