4CPS-024 Efficacy, safety and acceptance of treatment with alirocumab or evolocumab in patients with dyslipidaemia
BackgroundAlirocumab and evolocumab are two monoclonal antibodies proproteinconvertasesubtilisin/kexin type 9 inhibitors (iPCSK9) approved for the treatment of hypercholesterolaemia.PurposeEvaluation of the efficacy, safety and patient acceptance of treatment with iPCSK9 in a cohort of patients with...
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| Veröffentlicht in: | European journal of hospital pharmacy. Science and practice 2019-03, Vol.26 (Suppl 1), p.A78-A79 |
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| description | BackgroundAlirocumab and evolocumab are two monoclonal antibodies proproteinconvertasesubtilisin/kexin type 9 inhibitors (iPCSK9) approved for the treatment of hypercholesterolaemia.PurposeEvaluation of the efficacy, safety and patient acceptance of treatment with iPCSK9 in a cohort of patients with dyslipidaemia.Material and methodsRetrospective observational study performed in a university hospital. Included patients started with iPCSK9 therapy from September 2016 to June 2018.Data collected: demographic; iPCSK9 dose; prevention; indication; cardiovascular risk factors (CVRF) (excluding dyslipidaemia), cardiovascular risk (CVR) (by ESC 2016 guidelines); and statin intolerance.At baseline (pre) and 6–12 weeks after starting treatment (post), LDL value and concomitant lipid lowering agents (LLA) were collected.Additionally, reported adverse events and patient treatment were evaluated through a validated survey1 during the pharmaceutical visit.Statistics: Categorical variables: n (%), Fisher’s exact test.Quantitative variables: mean ±SD/median(rank), Mann–Whitney U test.ResultsAbstract 4CPS-024 Table 1 Baseline Alirocumab (n= 48) Evolocumab (n= 10) P-value Male29 (60.4%)9 (90.0%)Age62.6±8.655.8±8.8Initial dose:75 mg/2 weeks40 (83.3%)-Secondary prevention38 (79.2%)10 (100.0%)IndicationPolygenic-hypercholesterolaemia31 (64.6%)8 (80.0%)Familial-hypercholesterolaemia14 (29.2%)1 (10.0%)Other3 (6.3%)1 (10.0%)CVRFNone13 (27.1%)1 (10.0%)117 (35.4%)2 (20.0%)≥218 (37.5%)7 (70.0%)High-risk CVR38 (79.2%)10 (100.0%)Statin intolerance25 (52.1%)4 (40.0%)Pre LLA45 (93.7%)9 (90.0%) LDLLDL (mg/dL)Pre138.5 (92–308)111.5 (92–216)0.067Post59 (17–223)28.5 (4–59)0.002% LDL reduction57.7 (13.2–87.5)75.2 (47.3–97.3)0.015LDL post |
| doi_str_mv | 10.1136/ejhpharm-2019-eahpconf.173 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_bmj_p</sourceid><recordid>TN_cdi_proquest_journals_2190000251</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2190000251</sourcerecordid><originalsourceid>FETCH-LOGICAL-b1263-bee395965e9b92f1cd6320b48844b5970dc277bd0d01eb9255cfb5376f7d70bf3</originalsourceid><addsrcrecordid>eNo9kMtKAzEUhoMoWGrfIejWqblOmqWUeoGCgroOuTIpnYuZVJmdG1_UJ3FKrWdzzoGP_4cPgEuM5hjT8sZvqq7SqS4IwrLwuups24Q5FvQETAhiopCyZKf_Ny_Pwazvo0Gc0oVkVE5AZsvnlwIR9vP1vQohWm2Ha9jr4PMAdeOgttZ3WTfWwzbAnLzOtW8y_Iy5gnobU2t3tTawTdB_tNu_Lzaw0zmOYH8g3dBvYxed9nXUF-As6G3vZ397Ct7uVq_Lh2L9dP-4vF0XBpOSFsZ7KrksuZdGkoCtKylBhi0WjBkuBXKWCGEccgj7keDcBsOpKINwAplAp-DqkNul9n3n-6w27S41Y6UiWKJxCMcjxQ-UqTeqS7HWaVAYqb1jdXSs9o7V0bEaHdNfXYN2jQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2190000251</pqid></control><display><type>article</type><title>4CPS-024 Efficacy, safety and acceptance of treatment with alirocumab or evolocumab in patients with dyslipidaemia</title><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><creator>Monge, I ; Acin, P ; Navarrete-Rouco, E ; Recasens, L ; Pedro-Botet, J ; Oliveras, A ; González-Colominas, E ; Luque, S ; Grau, S</creator><creatorcontrib>Monge, I ; Acin, P ; Navarrete-Rouco, E ; Recasens, L ; Pedro-Botet, J ; Oliveras, A ; González-Colominas, E ; Luque, S ; Grau, S</creatorcontrib><description>BackgroundAlirocumab and evolocumab are two monoclonal antibodies proproteinconvertasesubtilisin/kexin type 9 inhibitors (iPCSK9) approved for the treatment of hypercholesterolaemia.PurposeEvaluation of the efficacy, safety and patient acceptance of treatment with iPCSK9 in a cohort of patients with dyslipidaemia.Material and methodsRetrospective observational study performed in a university hospital. Included patients started with iPCSK9 therapy from September 2016 to June 2018.Data collected: demographic; iPCSK9 dose; prevention; indication; cardiovascular risk factors (CVRF) (excluding dyslipidaemia), cardiovascular risk (CVR) (by ESC 2016 guidelines); and statin intolerance.At baseline (pre) and 6–12 weeks after starting treatment (post), LDL value and concomitant lipid lowering agents (LLA) were collected.Additionally, reported adverse events and patient treatment were evaluated through a validated survey1 during the pharmaceutical visit.Statistics: Categorical variables: n (%), Fisher’s exact test.Quantitative variables: mean ±SD/median(rank), Mann–Whitney U test.ResultsAbstract 4CPS-024 Table 1 Baseline Alirocumab (n= 48) Evolocumab (n= 10) P-value Male29 (60.4%)9 (90.0%)Age62.6±8.655.8±8.8Initial dose:75 mg/2 weeks40 (83.3%)-Secondary prevention38 (79.2%)10 (100.0%)IndicationPolygenic-hypercholesterolaemia31 (64.6%)8 (80.0%)Familial-hypercholesterolaemia14 (29.2%)1 (10.0%)Other3 (6.3%)1 (10.0%)CVRFNone13 (27.1%)1 (10.0%)117 (35.4%)2 (20.0%)≥218 (37.5%)7 (70.0%)High-risk CVR38 (79.2%)10 (100.0%)Statin intolerance25 (52.1%)4 (40.0%)Pre LLA45 (93.7%)9 (90.0%) LDLLDL (mg/dL)Pre138.5 (92–308)111.5 (92–216)0.067Post59 (17–223)28.5 (4–59)0.002% LDL reduction57.7 (13.2–87.5)75.2 (47.3–97.3)0.015LDL post<70 mg/dL29 (60.4%)10 (100%)0.022Adverse events4 (8.3%)*0 (0%)1.000 Treatment acceptanceVery acceptable40 (83.3%)9 (90.0%)Quite acceptable6 (12.5%)0 (0%)Acceptable2 (4.2%)1 (10.0%)*Pseudogrippal syndrome (3) and constipation (1).All patients decreased LDL except 1 patient on alirocumab who was non-adherent.Post: 15 treatment changes in 13 (27.1%) patients with alirocumab (five (33.3%) alirocumab dose increase, seven (46.7%) other LLA introduction/dose increase, three (20.0%) other LLA suspension/dose decrease). With evolocumab patients, only 1 stopped ezetimibe.After the survey, all patients desired to continue with iPCSK9.ConclusionAfter 6–12 weeks of iPCSK9 treatment, all patients reduced LDL level except 1 who was non-adherent. The LDL reduction ranged between 54%–71% and all patients on evolocumab achieved a LDL <70 mg/dL.The tolerability was excellent and only mild adverse events in about 8% of patients were experienced.A high acceptance of both alirocumab and evolocumab was reported by all patients who would continue with iPCSK9 treatment.References and/or acknowledgementsNo conflict of interest.</description><identifier>ISSN: 2047-9956</identifier><identifier>EISSN: 2047-9964</identifier><identifier>DOI: 10.1136/ejhpharm-2019-eahpconf.173</identifier><language>eng</language><publisher>London: BMJ Publishing Group LTD</publisher><subject>Metabolic disorders ; Monoclonal antibodies ; Patients</subject><ispartof>European journal of hospital pharmacy. Science and practice, 2019-03, Vol.26 (Suppl 1), p.A78-A79</ispartof><rights>2019, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>2019 2019, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,27901,27902</link.rule.ids></links><search><creatorcontrib>Monge, I</creatorcontrib><creatorcontrib>Acin, P</creatorcontrib><creatorcontrib>Navarrete-Rouco, E</creatorcontrib><creatorcontrib>Recasens, L</creatorcontrib><creatorcontrib>Pedro-Botet, J</creatorcontrib><creatorcontrib>Oliveras, A</creatorcontrib><creatorcontrib>González-Colominas, E</creatorcontrib><creatorcontrib>Luque, S</creatorcontrib><creatorcontrib>Grau, S</creatorcontrib><title>4CPS-024 Efficacy, safety and acceptance of treatment with alirocumab or evolocumab in patients with dyslipidaemia</title><title>European journal of hospital pharmacy. Science and practice</title><description>BackgroundAlirocumab and evolocumab are two monoclonal antibodies proproteinconvertasesubtilisin/kexin type 9 inhibitors (iPCSK9) approved for the treatment of hypercholesterolaemia.PurposeEvaluation of the efficacy, safety and patient acceptance of treatment with iPCSK9 in a cohort of patients with dyslipidaemia.Material and methodsRetrospective observational study performed in a university hospital. Included patients started with iPCSK9 therapy from September 2016 to June 2018.Data collected: demographic; iPCSK9 dose; prevention; indication; cardiovascular risk factors (CVRF) (excluding dyslipidaemia), cardiovascular risk (CVR) (by ESC 2016 guidelines); and statin intolerance.At baseline (pre) and 6–12 weeks after starting treatment (post), LDL value and concomitant lipid lowering agents (LLA) were collected.Additionally, reported adverse events and patient treatment were evaluated through a validated survey1 during the pharmaceutical visit.Statistics: Categorical variables: n (%), Fisher’s exact test.Quantitative variables: mean ±SD/median(rank), Mann–Whitney U test.ResultsAbstract 4CPS-024 Table 1 Baseline Alirocumab (n= 48) Evolocumab (n= 10) P-value Male29 (60.4%)9 (90.0%)Age62.6±8.655.8±8.8Initial dose:75 mg/2 weeks40 (83.3%)-Secondary prevention38 (79.2%)10 (100.0%)IndicationPolygenic-hypercholesterolaemia31 (64.6%)8 (80.0%)Familial-hypercholesterolaemia14 (29.2%)1 (10.0%)Other3 (6.3%)1 (10.0%)CVRFNone13 (27.1%)1 (10.0%)117 (35.4%)2 (20.0%)≥218 (37.5%)7 (70.0%)High-risk CVR38 (79.2%)10 (100.0%)Statin intolerance25 (52.1%)4 (40.0%)Pre LLA45 (93.7%)9 (90.0%) LDLLDL (mg/dL)Pre138.5 (92–308)111.5 (92–216)0.067Post59 (17–223)28.5 (4–59)0.002% LDL reduction57.7 (13.2–87.5)75.2 (47.3–97.3)0.015LDL post<70 mg/dL29 (60.4%)10 (100%)0.022Adverse events4 (8.3%)*0 (0%)1.000 Treatment acceptanceVery acceptable40 (83.3%)9 (90.0%)Quite acceptable6 (12.5%)0 (0%)Acceptable2 (4.2%)1 (10.0%)*Pseudogrippal syndrome (3) and constipation (1).All patients decreased LDL except 1 patient on alirocumab who was non-adherent.Post: 15 treatment changes in 13 (27.1%) patients with alirocumab (five (33.3%) alirocumab dose increase, seven (46.7%) other LLA introduction/dose increase, three (20.0%) other LLA suspension/dose decrease). With evolocumab patients, only 1 stopped ezetimibe.After the survey, all patients desired to continue with iPCSK9.ConclusionAfter 6–12 weeks of iPCSK9 treatment, all patients reduced LDL level except 1 who was non-adherent. The LDL reduction ranged between 54%–71% and all patients on evolocumab achieved a LDL <70 mg/dL.The tolerability was excellent and only mild adverse events in about 8% of patients were experienced.A high acceptance of both alirocumab and evolocumab was reported by all patients who would continue with iPCSK9 treatment.References and/or acknowledgementsNo conflict of interest.</description><subject>Metabolic disorders</subject><subject>Monoclonal antibodies</subject><subject>Patients</subject><issn>2047-9956</issn><issn>2047-9964</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>BENPR</sourceid><recordid>eNo9kMtKAzEUhoMoWGrfIejWqblOmqWUeoGCgroOuTIpnYuZVJmdG1_UJ3FKrWdzzoGP_4cPgEuM5hjT8sZvqq7SqS4IwrLwuups24Q5FvQETAhiopCyZKf_Ny_Pwazvo0Gc0oVkVE5AZsvnlwIR9vP1vQohWm2Ha9jr4PMAdeOgttZ3WTfWwzbAnLzOtW8y_Iy5gnobU2t3tTawTdB_tNu_Lzaw0zmOYH8g3dBvYxed9nXUF-As6G3vZ397Ct7uVq_Lh2L9dP-4vF0XBpOSFsZ7KrksuZdGkoCtKylBhi0WjBkuBXKWCGEccgj7keDcBsOpKINwAplAp-DqkNul9n3n-6w27S41Y6UiWKJxCMcjxQ-UqTeqS7HWaVAYqb1jdXSs9o7V0bEaHdNfXYN2jQ</recordid><startdate>201903</startdate><enddate>201903</enddate><creator>Monge, I</creator><creator>Acin, P</creator><creator>Navarrete-Rouco, E</creator><creator>Recasens, L</creator><creator>Pedro-Botet, J</creator><creator>Oliveras, A</creator><creator>González-Colominas, E</creator><creator>Luque, S</creator><creator>Grau, S</creator><general>BMJ Publishing Group LTD</general><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>201903</creationdate><title>4CPS-024 Efficacy, safety and acceptance of treatment with alirocumab or evolocumab in patients with dyslipidaemia</title><author>Monge, I ; Acin, P ; Navarrete-Rouco, E ; Recasens, L ; Pedro-Botet, J ; Oliveras, A ; González-Colominas, E ; Luque, S ; Grau, S</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b1263-bee395965e9b92f1cd6320b48844b5970dc277bd0d01eb9255cfb5376f7d70bf3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Metabolic disorders</topic><topic>Monoclonal antibodies</topic><topic>Patients</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Monge, I</creatorcontrib><creatorcontrib>Acin, P</creatorcontrib><creatorcontrib>Navarrete-Rouco, E</creatorcontrib><creatorcontrib>Recasens, L</creatorcontrib><creatorcontrib>Pedro-Botet, J</creatorcontrib><creatorcontrib>Oliveras, A</creatorcontrib><creatorcontrib>González-Colominas, E</creatorcontrib><creatorcontrib>Luque, S</creatorcontrib><creatorcontrib>Grau, S</creatorcontrib><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</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>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</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><jtitle>European journal of hospital pharmacy. Science and practice</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Monge, I</au><au>Acin, P</au><au>Navarrete-Rouco, E</au><au>Recasens, L</au><au>Pedro-Botet, J</au><au>Oliveras, A</au><au>González-Colominas, E</au><au>Luque, S</au><au>Grau, S</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>4CPS-024 Efficacy, safety and acceptance of treatment with alirocumab or evolocumab in patients with dyslipidaemia</atitle><jtitle>European journal of hospital pharmacy. Science and practice</jtitle><date>2019-03</date><risdate>2019</risdate><volume>26</volume><issue>Suppl 1</issue><spage>A78</spage><epage>A79</epage><pages>A78-A79</pages><issn>2047-9956</issn><eissn>2047-9964</eissn><abstract>BackgroundAlirocumab and evolocumab are two monoclonal antibodies proproteinconvertasesubtilisin/kexin type 9 inhibitors (iPCSK9) approved for the treatment of hypercholesterolaemia.PurposeEvaluation of the efficacy, safety and patient acceptance of treatment with iPCSK9 in a cohort of patients with dyslipidaemia.Material and methodsRetrospective observational study performed in a university hospital. Included patients started with iPCSK9 therapy from September 2016 to June 2018.Data collected: demographic; iPCSK9 dose; prevention; indication; cardiovascular risk factors (CVRF) (excluding dyslipidaemia), cardiovascular risk (CVR) (by ESC 2016 guidelines); and statin intolerance.At baseline (pre) and 6–12 weeks after starting treatment (post), LDL value and concomitant lipid lowering agents (LLA) were collected.Additionally, reported adverse events and patient treatment were evaluated through a validated survey1 during the pharmaceutical visit.Statistics: Categorical variables: n (%), Fisher’s exact test.Quantitative variables: mean ±SD/median(rank), Mann–Whitney U test.ResultsAbstract 4CPS-024 Table 1 Baseline Alirocumab (n= 48) Evolocumab (n= 10) P-value Male29 (60.4%)9 (90.0%)Age62.6±8.655.8±8.8Initial dose:75 mg/2 weeks40 (83.3%)-Secondary prevention38 (79.2%)10 (100.0%)IndicationPolygenic-hypercholesterolaemia31 (64.6%)8 (80.0%)Familial-hypercholesterolaemia14 (29.2%)1 (10.0%)Other3 (6.3%)1 (10.0%)CVRFNone13 (27.1%)1 (10.0%)117 (35.4%)2 (20.0%)≥218 (37.5%)7 (70.0%)High-risk CVR38 (79.2%)10 (100.0%)Statin intolerance25 (52.1%)4 (40.0%)Pre LLA45 (93.7%)9 (90.0%) LDLLDL (mg/dL)Pre138.5 (92–308)111.5 (92–216)0.067Post59 (17–223)28.5 (4–59)0.002% LDL reduction57.7 (13.2–87.5)75.2 (47.3–97.3)0.015LDL post<70 mg/dL29 (60.4%)10 (100%)0.022Adverse events4 (8.3%)*0 (0%)1.000 Treatment acceptanceVery acceptable40 (83.3%)9 (90.0%)Quite acceptable6 (12.5%)0 (0%)Acceptable2 (4.2%)1 (10.0%)*Pseudogrippal syndrome (3) and constipation (1).All patients decreased LDL except 1 patient on alirocumab who was non-adherent.Post: 15 treatment changes in 13 (27.1%) patients with alirocumab (five (33.3%) alirocumab dose increase, seven (46.7%) other LLA introduction/dose increase, three (20.0%) other LLA suspension/dose decrease). With evolocumab patients, only 1 stopped ezetimibe.After the survey, all patients desired to continue with iPCSK9.ConclusionAfter 6–12 weeks of iPCSK9 treatment, all patients reduced LDL level except 1 who was non-adherent. The LDL reduction ranged between 54%–71% and all patients on evolocumab achieved a LDL <70 mg/dL.The tolerability was excellent and only mild adverse events in about 8% of patients were experienced.A high acceptance of both alirocumab and evolocumab was reported by all patients who would continue with iPCSK9 treatment.References and/or acknowledgementsNo conflict of interest.</abstract><cop>London</cop><pub>BMJ Publishing Group LTD</pub><doi>10.1136/ejhpharm-2019-eahpconf.173</doi><oa>free_for_read</oa></addata></record> |
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| subjects | Metabolic disorders Monoclonal antibodies Patients |
| title | 4CPS-024 Efficacy, safety and acceptance of treatment with alirocumab or evolocumab in patients with dyslipidaemia |
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