Adherence to raloxifene therapy: assessment methods and relationship with efficacy
Summary Response to therapy depends on patient compliance but accurate assessment is difficult and adequate levels of adherence are uncertain. Adherence to raloxifene treatment may be assessed more accurately by electronic monitoring than by counting returned tablets. The level of adherence is posit...
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| Veröffentlicht in: | Osteoporosis international 2013-11, Vol.24 (11), p.2879-2886 |
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| creator | Finigan, J. Naylor, K. Paggiosi, M. A. Peel, N. F. Eastell, R. |
| description | Summary
Response to therapy depends on patient compliance but accurate assessment is difficult and adequate levels of adherence are uncertain. Adherence to raloxifene treatment may be assessed more accurately by electronic monitoring than by counting returned tablets. The level of adherence is positively associated with the degree of bone response.
Introduction
Adherence to study medication is usually estimated by counting returned tablets. This method relies on subjects’ honesty and may be inaccurate. We aimed to assess adherence more accurately, and examine its effect on measures of bone response, by using electronic monitoring.
Methods
Osteopenic women, ages 50 to 80, were prescribed daily raloxifene for 2 years. Electronic bottle caps (Medication Event Monitoring System (MEMS), Aardex) recorded the date and time on opening. Returned tablets were also counted. We measured bone mineral density (BMD) in duplicate at the spine and hip at baseline and 2 years. We also measured urinary N-terminal cross-linked telopeptide of type I collagen (NTX) at baseline, 1 and 2 years. We calculated the percentage changes in BMD and NTX from mean baseline to mean follow up measurements. Percentage adherence was assessed by both methods for 71 subjects that completed the study.
Results
The two methods correlated significantly (
p |
| doi_str_mv | 10.1007/s00198-013-2386-6 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1462371941</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1462371941</sourcerecordid><originalsourceid>FETCH-LOGICAL-c372t-a0dfa3c8c5eaa69692f193e9b9f812d86921fddf9267f74d8c2769bd55b50eb43</originalsourceid><addsrcrecordid>eNp1kFtLAzEQhYMotlZ_gC-y4Isvq7nsJhvfSvEGBUEUfAvZZGK37KUmu2j_vSmtIoJPw0y-cyZzEDol-JJgLK4CxkQWKSYspazgKd9DY5Kx2Eme76MxlkykMiOvI3QUwhJHjZTiEI0o4zLPKB6jp6ldgIfWQNJ3idd191k5aGMXx3q1vk50CBBCA22fNNAvOhsS3drEQ637qmvDololH1W_SMC5ymizPkYHTtcBTnZ1gl5ub55n9-n88e5hNp2nhgnapxpbp5kpTA5ac8kldUQykKV0BaG2iAPirHWScuFEZgtDBZelzfMyx1BmbIIutr4r370PEHrVVMFAXesWuiEoknHKBIn3R_T8D7rsBt_G320oUmRUUBkpsqWM70Lw4NTKV432a0Ww2gSutoGrGLjaBK541JztnIeyAfuj-E44AnQLhPjUvoH_tfpf1y-u1Yu0</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1461842729</pqid></control><display><type>article</type><title>Adherence to raloxifene therapy: assessment methods and relationship with efficacy</title><source>MEDLINE</source><source>Springer Nature - Complete Springer Journals</source><creator>Finigan, J. ; Naylor, K. ; Paggiosi, M. A. ; Peel, N. F. ; Eastell, R.</creator><creatorcontrib>Finigan, J. ; Naylor, K. ; Paggiosi, M. A. ; Peel, N. F. ; Eastell, R.</creatorcontrib><description>Summary
Response to therapy depends on patient compliance but accurate assessment is difficult and adequate levels of adherence are uncertain. Adherence to raloxifene treatment may be assessed more accurately by electronic monitoring than by counting returned tablets. The level of adherence is positively associated with the degree of bone response.
Introduction
Adherence to study medication is usually estimated by counting returned tablets. This method relies on subjects’ honesty and may be inaccurate. We aimed to assess adherence more accurately, and examine its effect on measures of bone response, by using electronic monitoring.
Methods
Osteopenic women, ages 50 to 80, were prescribed daily raloxifene for 2 years. Electronic bottle caps (Medication Event Monitoring System (MEMS), Aardex) recorded the date and time on opening. Returned tablets were also counted. We measured bone mineral density (BMD) in duplicate at the spine and hip at baseline and 2 years. We also measured urinary N-terminal cross-linked telopeptide of type I collagen (NTX) at baseline, 1 and 2 years. We calculated the percentage changes in BMD and NTX from mean baseline to mean follow up measurements. Percentage adherence was assessed by both methods for 71 subjects that completed the study.
Results
The two methods correlated significantly (
p
<0.001, Spearman’s rho = 0.73) but the tablet count showed a higher median adherence than the MEMS caps (95.7 vs. 85.0 %,
p
<0.001), with greater divergence at lower adherence levels. MEMS adherence in 65 subjects with complete data correlated with NTX response (
p
<0.01, rho = −0.33) but with BMD response only at the femoral neck. However, adherence in the lowest quartile was associated with poorer BMD response at all sites (
p
<0.05).
Conclusion
Tablet counts may give similar results overall but conceal substantial individual non-adherence. Monitoring caps may assess adherence more accurately than tablet counts and would be the preferred method in clinical trials. The degree of adherence is associated with both bone turnover and BMD responses to anti-resorptive therapy.</description><identifier>ISSN: 0937-941X</identifier><identifier>EISSN: 1433-2965</identifier><identifier>DOI: 10.1007/s00198-013-2386-6</identifier><identifier>PMID: 23695420</identifier><language>eng</language><publisher>London: Springer London</publisher><subject>Absorptiometry, Photon - methods ; Aged ; Aged, 80 and over ; Biomarkers - urine ; Bone Density - drug effects ; Bone Density Conservation Agents - administration & dosage ; Bone Density Conservation Agents - therapeutic use ; Bone Resorption - physiopathology ; Bone Resorption - prevention & control ; Bone Resorption - urine ; Bones ; Collagen Type I - urine ; Compliance ; Drug Administration Schedule ; Drug Monitoring - instrumentation ; Drug Monitoring - methods ; Drug Packaging ; Drug therapy ; Electrical Equipment and Supplies ; Electronic monitoring ; Endocrinology ; England ; Female ; Humans ; Medication Adherence - statistics & numerical data ; Medicine ; Medicine & Public Health ; Middle Aged ; Original Article ; Orthopedics ; Osteoporosis, Postmenopausal - drug therapy ; Osteoporosis, Postmenopausal - physiopathology ; Osteoporosis, Postmenopausal - urine ; Peptides - urine ; Raloxifene Hydrochloride - administration & dosage ; Raloxifene Hydrochloride - therapeutic use ; Rheumatology ; Tablets ; Womens health</subject><ispartof>Osteoporosis international, 2013-11, Vol.24 (11), p.2879-2886</ispartof><rights>International Osteoporosis Foundation and National Osteoporosis Foundation 2013</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c372t-a0dfa3c8c5eaa69692f193e9b9f812d86921fddf9267f74d8c2769bd55b50eb43</citedby><cites>FETCH-LOGICAL-c372t-a0dfa3c8c5eaa69692f193e9b9f812d86921fddf9267f74d8c2769bd55b50eb43</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/s00198-013-2386-6$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s00198-013-2386-6$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23695420$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Finigan, J.</creatorcontrib><creatorcontrib>Naylor, K.</creatorcontrib><creatorcontrib>Paggiosi, M. A.</creatorcontrib><creatorcontrib>Peel, N. F.</creatorcontrib><creatorcontrib>Eastell, R.</creatorcontrib><title>Adherence to raloxifene therapy: assessment methods and relationship with efficacy</title><title>Osteoporosis international</title><addtitle>Osteoporos Int</addtitle><addtitle>Osteoporos Int</addtitle><description>Summary
Response to therapy depends on patient compliance but accurate assessment is difficult and adequate levels of adherence are uncertain. Adherence to raloxifene treatment may be assessed more accurately by electronic monitoring than by counting returned tablets. The level of adherence is positively associated with the degree of bone response.
Introduction
Adherence to study medication is usually estimated by counting returned tablets. This method relies on subjects’ honesty and may be inaccurate. We aimed to assess adherence more accurately, and examine its effect on measures of bone response, by using electronic monitoring.
Methods
Osteopenic women, ages 50 to 80, were prescribed daily raloxifene for 2 years. Electronic bottle caps (Medication Event Monitoring System (MEMS), Aardex) recorded the date and time on opening. Returned tablets were also counted. We measured bone mineral density (BMD) in duplicate at the spine and hip at baseline and 2 years. We also measured urinary N-terminal cross-linked telopeptide of type I collagen (NTX) at baseline, 1 and 2 years. We calculated the percentage changes in BMD and NTX from mean baseline to mean follow up measurements. Percentage adherence was assessed by both methods for 71 subjects that completed the study.
Results
The two methods correlated significantly (
p
<0.001, Spearman’s rho = 0.73) but the tablet count showed a higher median adherence than the MEMS caps (95.7 vs. 85.0 %,
p
<0.001), with greater divergence at lower adherence levels. MEMS adherence in 65 subjects with complete data correlated with NTX response (
p
<0.01, rho = −0.33) but with BMD response only at the femoral neck. However, adherence in the lowest quartile was associated with poorer BMD response at all sites (
p
<0.05).
Conclusion
Tablet counts may give similar results overall but conceal substantial individual non-adherence. Monitoring caps may assess adherence more accurately than tablet counts and would be the preferred method in clinical trials. The degree of adherence is associated with both bone turnover and BMD responses to anti-resorptive therapy.</description><subject>Absorptiometry, Photon - methods</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Biomarkers - urine</subject><subject>Bone Density - drug effects</subject><subject>Bone Density Conservation Agents - administration & dosage</subject><subject>Bone Density Conservation Agents - therapeutic use</subject><subject>Bone Resorption - physiopathology</subject><subject>Bone Resorption - prevention & control</subject><subject>Bone Resorption - urine</subject><subject>Bones</subject><subject>Collagen Type I - urine</subject><subject>Compliance</subject><subject>Drug Administration Schedule</subject><subject>Drug Monitoring - instrumentation</subject><subject>Drug Monitoring - methods</subject><subject>Drug Packaging</subject><subject>Drug therapy</subject><subject>Electrical Equipment and Supplies</subject><subject>Electronic monitoring</subject><subject>Endocrinology</subject><subject>England</subject><subject>Female</subject><subject>Humans</subject><subject>Medication Adherence - statistics & numerical data</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Original Article</subject><subject>Orthopedics</subject><subject>Osteoporosis, Postmenopausal - drug therapy</subject><subject>Osteoporosis, Postmenopausal - physiopathology</subject><subject>Osteoporosis, Postmenopausal - urine</subject><subject>Peptides - urine</subject><subject>Raloxifene Hydrochloride - administration & dosage</subject><subject>Raloxifene Hydrochloride - therapeutic use</subject><subject>Rheumatology</subject><subject>Tablets</subject><subject>Womens health</subject><issn>0937-941X</issn><issn>1433-2965</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kFtLAzEQhYMotlZ_gC-y4Isvq7nsJhvfSvEGBUEUfAvZZGK37KUmu2j_vSmtIoJPw0y-cyZzEDol-JJgLK4CxkQWKSYspazgKd9DY5Kx2Eme76MxlkykMiOvI3QUwhJHjZTiEI0o4zLPKB6jp6ldgIfWQNJ3idd191k5aGMXx3q1vk50CBBCA22fNNAvOhsS3drEQ637qmvDololH1W_SMC5ymizPkYHTtcBTnZ1gl5ub55n9-n88e5hNp2nhgnapxpbp5kpTA5ac8kldUQykKV0BaG2iAPirHWScuFEZgtDBZelzfMyx1BmbIIutr4r370PEHrVVMFAXesWuiEoknHKBIn3R_T8D7rsBt_G320oUmRUUBkpsqWM70Lw4NTKV432a0Ww2gSutoGrGLjaBK541JztnIeyAfuj-E44AnQLhPjUvoH_tfpf1y-u1Yu0</recordid><startdate>20131101</startdate><enddate>20131101</enddate><creator>Finigan, J.</creator><creator>Naylor, K.</creator><creator>Paggiosi, M. A.</creator><creator>Peel, N. F.</creator><creator>Eastell, R.</creator><general>Springer London</general><general>Springer Nature B.V</general><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>7QP</scope><scope>7RV</scope><scope>7TS</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>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PHGZM</scope><scope>PHGZT</scope><scope>PJZUB</scope><scope>PKEHL</scope><scope>PPXIY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20131101</creationdate><title>Adherence to raloxifene therapy: assessment methods and relationship with efficacy</title><author>Finigan, J. ; Naylor, K. ; Paggiosi, M. A. ; Peel, N. F. ; Eastell, R.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c372t-a0dfa3c8c5eaa69692f193e9b9f812d86921fddf9267f74d8c2769bd55b50eb43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Absorptiometry, Photon - methods</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Biomarkers - urine</topic><topic>Bone Density - drug effects</topic><topic>Bone Density Conservation Agents - administration & dosage</topic><topic>Bone Density Conservation Agents - therapeutic use</topic><topic>Bone Resorption - physiopathology</topic><topic>Bone Resorption - prevention & control</topic><topic>Bone Resorption - urine</topic><topic>Bones</topic><topic>Collagen Type I - urine</topic><topic>Compliance</topic><topic>Drug Administration Schedule</topic><topic>Drug Monitoring - instrumentation</topic><topic>Drug Monitoring - methods</topic><topic>Drug Packaging</topic><topic>Drug therapy</topic><topic>Electrical Equipment and Supplies</topic><topic>Electronic monitoring</topic><topic>Endocrinology</topic><topic>England</topic><topic>Female</topic><topic>Humans</topic><topic>Medication Adherence - statistics & numerical data</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Original Article</topic><topic>Orthopedics</topic><topic>Osteoporosis, Postmenopausal - drug therapy</topic><topic>Osteoporosis, Postmenopausal - physiopathology</topic><topic>Osteoporosis, Postmenopausal - urine</topic><topic>Peptides - urine</topic><topic>Raloxifene Hydrochloride - administration & dosage</topic><topic>Raloxifene Hydrochloride - therapeutic use</topic><topic>Rheumatology</topic><topic>Tablets</topic><topic>Womens health</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Finigan, J.</creatorcontrib><creatorcontrib>Naylor, K.</creatorcontrib><creatorcontrib>Paggiosi, M. A.</creatorcontrib><creatorcontrib>Peel, N. F.</creatorcontrib><creatorcontrib>Eastell, R.</creatorcontrib><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>Calcium & Calcified Tissue Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Physical Education Index</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>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest Central (New)</collection><collection>ProQuest One Academic (New)</collection><collection>ProQuest Health & Medical Research Collection</collection><collection>ProQuest One Academic Middle East (New)</collection><collection>ProQuest One Health & Nursing</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>MEDLINE - Academic</collection><jtitle>Osteoporosis international</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Finigan, J.</au><au>Naylor, K.</au><au>Paggiosi, M. A.</au><au>Peel, N. F.</au><au>Eastell, R.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Adherence to raloxifene therapy: assessment methods and relationship with efficacy</atitle><jtitle>Osteoporosis international</jtitle><stitle>Osteoporos Int</stitle><addtitle>Osteoporos Int</addtitle><date>2013-11-01</date><risdate>2013</risdate><volume>24</volume><issue>11</issue><spage>2879</spage><epage>2886</epage><pages>2879-2886</pages><issn>0937-941X</issn><eissn>1433-2965</eissn><abstract>Summary
Response to therapy depends on patient compliance but accurate assessment is difficult and adequate levels of adherence are uncertain. Adherence to raloxifene treatment may be assessed more accurately by electronic monitoring than by counting returned tablets. The level of adherence is positively associated with the degree of bone response.
Introduction
Adherence to study medication is usually estimated by counting returned tablets. This method relies on subjects’ honesty and may be inaccurate. We aimed to assess adherence more accurately, and examine its effect on measures of bone response, by using electronic monitoring.
Methods
Osteopenic women, ages 50 to 80, were prescribed daily raloxifene for 2 years. Electronic bottle caps (Medication Event Monitoring System (MEMS), Aardex) recorded the date and time on opening. Returned tablets were also counted. We measured bone mineral density (BMD) in duplicate at the spine and hip at baseline and 2 years. We also measured urinary N-terminal cross-linked telopeptide of type I collagen (NTX) at baseline, 1 and 2 years. We calculated the percentage changes in BMD and NTX from mean baseline to mean follow up measurements. Percentage adherence was assessed by both methods for 71 subjects that completed the study.
Results
The two methods correlated significantly (
p
<0.001, Spearman’s rho = 0.73) but the tablet count showed a higher median adherence than the MEMS caps (95.7 vs. 85.0 %,
p
<0.001), with greater divergence at lower adherence levels. MEMS adherence in 65 subjects with complete data correlated with NTX response (
p
<0.01, rho = −0.33) but with BMD response only at the femoral neck. However, adherence in the lowest quartile was associated with poorer BMD response at all sites (
p
<0.05).
Conclusion
Tablet counts may give similar results overall but conceal substantial individual non-adherence. Monitoring caps may assess adherence more accurately than tablet counts and would be the preferred method in clinical trials. The degree of adherence is associated with both bone turnover and BMD responses to anti-resorptive therapy.</abstract><cop>London</cop><pub>Springer London</pub><pmid>23695420</pmid><doi>10.1007/s00198-013-2386-6</doi><tpages>8</tpages></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 0937-941X |
| ispartof | Osteoporosis international, 2013-11, Vol.24 (11), p.2879-2886 |
| issn | 0937-941X 1433-2965 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_1462371941 |
| source | MEDLINE; Springer Nature - Complete Springer Journals |
| subjects | Absorptiometry, Photon - methods Aged Aged, 80 and over Biomarkers - urine Bone Density - drug effects Bone Density Conservation Agents - administration & dosage Bone Density Conservation Agents - therapeutic use Bone Resorption - physiopathology Bone Resorption - prevention & control Bone Resorption - urine Bones Collagen Type I - urine Compliance Drug Administration Schedule Drug Monitoring - instrumentation Drug Monitoring - methods Drug Packaging Drug therapy Electrical Equipment and Supplies Electronic monitoring Endocrinology England Female Humans Medication Adherence - statistics & numerical data Medicine Medicine & Public Health Middle Aged Original Article Orthopedics Osteoporosis, Postmenopausal - drug therapy Osteoporosis, Postmenopausal - physiopathology Osteoporosis, Postmenopausal - urine Peptides - urine Raloxifene Hydrochloride - administration & dosage Raloxifene Hydrochloride - therapeutic use Rheumatology Tablets Womens health |
| title | Adherence to raloxifene therapy: assessment methods and relationship with efficacy |
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