Transition From Estrogen–Progestin to Raloxifene in Postmenopausal Women: Effect on Vasomotor Symptoms
OBJECTIVE:To compare vasomotor symptoms after transition from estrogen–progestin therapy to raloxifene 60 mg/d with and without a placebo washout. METHODS:Postmenopausal women currently taking continuous combined estrogen–progestin therapy (conjugated equine estrogen, 0.625 mg/medroxyprogesterone ac...
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| Veröffentlicht in: | Obstetrics and gynecology (New York. 1953) 2004-02, Vol.103 (2), p.267-273 |
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| creator | Gordon, Stephen Walsh, Brian W Ciaccia, Angelina V Siddhanti, Suresh Rosen, Amy S Plouffe, Leo |
| description | OBJECTIVE:To compare vasomotor symptoms after transition from estrogen–progestin therapy to raloxifene 60 mg/d with and without a placebo washout.
METHODS:Postmenopausal women currently taking continuous combined estrogen–progestin therapy (conjugated equine estrogen, 0.625 mg/medroxyprogesterone acetate, 2.5 or 5 mg) daily for 5 or more months were enrolled. Women were randomized to 1 of 4 blinded regimens1) 12 weeks estrogen–progestin; 2) 12 weeks placebo; 3) 4 weeks placebo, then 8 weeks raloxifene; or 4) 12 weeks raloxifene. For the final 36 weeks, all subjects received raloxifene. Vasomotor symptoms were assessed by patient diaries.
RESULTS:A total of 266 women (mean age 57.5) were enrolled. Mean hot flush frequency at baseline was approximately 1 per week in the entire population, with 16% of women reporting hot flushes. Mean frequency and severity of hot flushes during the first 12 weeks of the study were statistically greater in the 3 groups transitioned off estrogen–progestin (range of hot flushes per week4 weeks, 11–12; 8 weeks, 18–24; 12 weeks, 13–16), as compared with those continuing estrogen–progestin, with no difference between these 3 groups (P ≥ .1). Approximately 50–70% of these women reported hot flushes, generally rated as mild to moderate by participants, after estrogen–progestin discontinuation.
CONCLUSION:A large proportion of women discontinuing estrogen–progestin experience hot flushes. Raloxifene does not appear to increase the frequency or severity of vasomotor symptoms in women discontinuing estrogen–progestin more than that observed with placebo treatment after estrogen–progestin discontinuation. Transition from estrogen–progestin to raloxifene with no washout period therefore may be acceptable.
LEVEL OF EVIDENCE:I |
| doi_str_mv | 10.1097/01.AOG.0000110247.98588.ff |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_80136844</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>80136844</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3339-10db08141b1d90066788a243af0a8cacbd5e6eeae14191adcee0f5c9a11f1d9a3</originalsourceid><addsrcrecordid>eNpFkNtu1DAQhi0EokvhFZCFBHcJ49hJ7N5V1bZUqtQKyuHOmnVsNpDEW9tR6R3vwBv2SfB2V1pf-DD6_hnrI-Qdg5KBaj8CK0-vL0rIizGoRFsqWUtZOveMLJhseVFx_uM5WQBUqmilEEfkVYy_tnyj-EtyxERbi0aJBVnfBpxin3o_0fPgR7qMKfifdnr8--9me4mpn2jy9DMO_k_v7GRpLtz4mEY7-Q3OEQf63efHCV06Z02iudU3jH70yQf65WHcJD_G1-SFwyHaN_vzmHw9X96efSquri8uz06vCsM5VwWDbgWSCbZinQJomlZKrARHBygNmlVX28ZatBlRDDtjLbjaKGTM5QTyY_Jh13cT_N2cv6_HPho7DDhZP0ctgfEmK8ngyQ40wccYrNOb0I8YHjQDvfWsgensWR886yfP2rkcfrufMq9G2x2ie7EZeL8HMBocXLZs-njgasHahsnMiR1374dkQ_w9zPc26LXFIa2fRjdVDUUFICBvUGxLiv8HYKqZ2w</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>80136844</pqid></control><display><type>article</type><title>Transition From Estrogen–Progestin to Raloxifene in Postmenopausal Women: Effect on Vasomotor Symptoms</title><source>MEDLINE</source><source>Journals@Ovid Complete</source><creator>Gordon, Stephen ; Walsh, Brian W ; Ciaccia, Angelina V ; Siddhanti, Suresh ; Rosen, Amy S ; Plouffe, Leo</creator><creatorcontrib>Gordon, Stephen ; Walsh, Brian W ; Ciaccia, Angelina V ; Siddhanti, Suresh ; Rosen, Amy S ; Plouffe, Leo</creatorcontrib><description>OBJECTIVE:To compare vasomotor symptoms after transition from estrogen–progestin therapy to raloxifene 60 mg/d with and without a placebo washout.
METHODS:Postmenopausal women currently taking continuous combined estrogen–progestin therapy (conjugated equine estrogen, 0.625 mg/medroxyprogesterone acetate, 2.5 or 5 mg) daily for 5 or more months were enrolled. Women were randomized to 1 of 4 blinded regimens1) 12 weeks estrogen–progestin; 2) 12 weeks placebo; 3) 4 weeks placebo, then 8 weeks raloxifene; or 4) 12 weeks raloxifene. For the final 36 weeks, all subjects received raloxifene. Vasomotor symptoms were assessed by patient diaries.
RESULTS:A total of 266 women (mean age 57.5) were enrolled. Mean hot flush frequency at baseline was approximately 1 per week in the entire population, with 16% of women reporting hot flushes. Mean frequency and severity of hot flushes during the first 12 weeks of the study were statistically greater in the 3 groups transitioned off estrogen–progestin (range of hot flushes per week4 weeks, 11–12; 8 weeks, 18–24; 12 weeks, 13–16), as compared with those continuing estrogen–progestin, with no difference between these 3 groups (P ≥ .1). Approximately 50–70% of these women reported hot flushes, generally rated as mild to moderate by participants, after estrogen–progestin discontinuation.
CONCLUSION:A large proportion of women discontinuing estrogen–progestin experience hot flushes. Raloxifene does not appear to increase the frequency or severity of vasomotor symptoms in women discontinuing estrogen–progestin more than that observed with placebo treatment after estrogen–progestin discontinuation. Transition from estrogen–progestin to raloxifene with no washout period therefore may be acceptable.
LEVEL OF EVIDENCE:I</description><identifier>ISSN: 0029-7844</identifier><identifier>EISSN: 1873-233X</identifier><identifier>DOI: 10.1097/01.AOG.0000110247.98588.ff</identifier><identifier>PMID: 14754694</identifier><identifier>CODEN: OBGNAS</identifier><language>eng</language><publisher>New York, NY: The American College of Obstetricians and Gynecologists</publisher><subject>Administration, Oral ; Aged ; Analysis of Variance ; Biological and medical sciences ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Administration Schedule ; Drug Combinations ; Estrogens, Conjugated (USP) - administration & dosage ; Female ; Follow-Up Studies ; Gynecology. Andrology. Obstetrics ; Hot Flashes - diagnosis ; Hot Flashes - drug therapy ; Humans ; Medical sciences ; Middle Aged ; Postmenopause - drug effects ; Postmenopause - physiology ; Probability ; Progestins - administration & dosage ; Raloxifene Hydrochloride - administration & dosage ; Reference Values ; Risk Assessment ; Severity of Illness Index ; Single-Blind Method ; Treatment Outcome ; Vasomotor System - drug effects</subject><ispartof>Obstetrics and gynecology (New York. 1953), 2004-02, Vol.103 (2), p.267-273</ispartof><rights>2004 The American College of Obstetricians and Gynecologists</rights><rights>2004 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c3339-10db08141b1d90066788a243af0a8cacbd5e6eeae14191adcee0f5c9a11f1d9a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27922,27923</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15417618$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/14754694$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Gordon, Stephen</creatorcontrib><creatorcontrib>Walsh, Brian W</creatorcontrib><creatorcontrib>Ciaccia, Angelina V</creatorcontrib><creatorcontrib>Siddhanti, Suresh</creatorcontrib><creatorcontrib>Rosen, Amy S</creatorcontrib><creatorcontrib>Plouffe, Leo</creatorcontrib><title>Transition From Estrogen–Progestin to Raloxifene in Postmenopausal Women: Effect on Vasomotor Symptoms</title><title>Obstetrics and gynecology (New York. 1953)</title><addtitle>Obstet Gynecol</addtitle><description>OBJECTIVE:To compare vasomotor symptoms after transition from estrogen–progestin therapy to raloxifene 60 mg/d with and without a placebo washout.
METHODS:Postmenopausal women currently taking continuous combined estrogen–progestin therapy (conjugated equine estrogen, 0.625 mg/medroxyprogesterone acetate, 2.5 or 5 mg) daily for 5 or more months were enrolled. Women were randomized to 1 of 4 blinded regimens1) 12 weeks estrogen–progestin; 2) 12 weeks placebo; 3) 4 weeks placebo, then 8 weeks raloxifene; or 4) 12 weeks raloxifene. For the final 36 weeks, all subjects received raloxifene. Vasomotor symptoms were assessed by patient diaries.
RESULTS:A total of 266 women (mean age 57.5) were enrolled. Mean hot flush frequency at baseline was approximately 1 per week in the entire population, with 16% of women reporting hot flushes. Mean frequency and severity of hot flushes during the first 12 weeks of the study were statistically greater in the 3 groups transitioned off estrogen–progestin (range of hot flushes per week4 weeks, 11–12; 8 weeks, 18–24; 12 weeks, 13–16), as compared with those continuing estrogen–progestin, with no difference between these 3 groups (P ≥ .1). Approximately 50–70% of these women reported hot flushes, generally rated as mild to moderate by participants, after estrogen–progestin discontinuation.
CONCLUSION:A large proportion of women discontinuing estrogen–progestin experience hot flushes. Raloxifene does not appear to increase the frequency or severity of vasomotor symptoms in women discontinuing estrogen–progestin more than that observed with placebo treatment after estrogen–progestin discontinuation. Transition from estrogen–progestin to raloxifene with no washout period therefore may be acceptable.
LEVEL OF EVIDENCE:I</description><subject>Administration, Oral</subject><subject>Aged</subject><subject>Analysis of Variance</subject><subject>Biological and medical sciences</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Administration Schedule</subject><subject>Drug Combinations</subject><subject>Estrogens, Conjugated (USP) - administration & dosage</subject><subject>Female</subject><subject>Follow-Up Studies</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Hot Flashes - diagnosis</subject><subject>Hot Flashes - drug therapy</subject><subject>Humans</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Postmenopause - drug effects</subject><subject>Postmenopause - physiology</subject><subject>Probability</subject><subject>Progestins - administration & dosage</subject><subject>Raloxifene Hydrochloride - administration & dosage</subject><subject>Reference Values</subject><subject>Risk Assessment</subject><subject>Severity of Illness Index</subject><subject>Single-Blind Method</subject><subject>Treatment Outcome</subject><subject>Vasomotor System - drug effects</subject><issn>0029-7844</issn><issn>1873-233X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkNtu1DAQhi0EokvhFZCFBHcJ49hJ7N5V1bZUqtQKyuHOmnVsNpDEW9tR6R3vwBv2SfB2V1pf-DD6_hnrI-Qdg5KBaj8CK0-vL0rIizGoRFsqWUtZOveMLJhseVFx_uM5WQBUqmilEEfkVYy_tnyj-EtyxERbi0aJBVnfBpxin3o_0fPgR7qMKfifdnr8--9me4mpn2jy9DMO_k_v7GRpLtz4mEY7-Q3OEQf63efHCV06Z02iudU3jH70yQf65WHcJD_G1-SFwyHaN_vzmHw9X96efSquri8uz06vCsM5VwWDbgWSCbZinQJomlZKrARHBygNmlVX28ZatBlRDDtjLbjaKGTM5QTyY_Jh13cT_N2cv6_HPho7DDhZP0ctgfEmK8ngyQ40wccYrNOb0I8YHjQDvfWsgensWR886yfP2rkcfrufMq9G2x2ie7EZeL8HMBocXLZs-njgasHahsnMiR1374dkQ_w9zPc26LXFIa2fRjdVDUUFICBvUGxLiv8HYKqZ2w</recordid><startdate>200402</startdate><enddate>200402</enddate><creator>Gordon, Stephen</creator><creator>Walsh, Brian W</creator><creator>Ciaccia, Angelina V</creator><creator>Siddhanti, Suresh</creator><creator>Rosen, Amy S</creator><creator>Plouffe, Leo</creator><general>The American College of Obstetricians and Gynecologists</general><general>Elsevier Science</general><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>7X8</scope></search><sort><creationdate>200402</creationdate><title>Transition From Estrogen–Progestin to Raloxifene in Postmenopausal Women: Effect on Vasomotor Symptoms</title><author>Gordon, Stephen ; Walsh, Brian W ; Ciaccia, Angelina V ; Siddhanti, Suresh ; Rosen, Amy S ; Plouffe, Leo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3339-10db08141b1d90066788a243af0a8cacbd5e6eeae14191adcee0f5c9a11f1d9a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Administration, Oral</topic><topic>Aged</topic><topic>Analysis of Variance</topic><topic>Biological and medical sciences</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Administration Schedule</topic><topic>Drug Combinations</topic><topic>Estrogens, Conjugated (USP) - administration & dosage</topic><topic>Female</topic><topic>Follow-Up Studies</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Hot Flashes - diagnosis</topic><topic>Hot Flashes - drug therapy</topic><topic>Humans</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Postmenopause - drug effects</topic><topic>Postmenopause - physiology</topic><topic>Probability</topic><topic>Progestins - administration & dosage</topic><topic>Raloxifene Hydrochloride - administration & dosage</topic><topic>Reference Values</topic><topic>Risk Assessment</topic><topic>Severity of Illness Index</topic><topic>Single-Blind Method</topic><topic>Treatment Outcome</topic><topic>Vasomotor System - drug effects</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Gordon, Stephen</creatorcontrib><creatorcontrib>Walsh, Brian W</creatorcontrib><creatorcontrib>Ciaccia, Angelina V</creatorcontrib><creatorcontrib>Siddhanti, Suresh</creatorcontrib><creatorcontrib>Rosen, Amy S</creatorcontrib><creatorcontrib>Plouffe, Leo</creatorcontrib><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>MEDLINE - Academic</collection><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Gordon, Stephen</au><au>Walsh, Brian W</au><au>Ciaccia, Angelina V</au><au>Siddhanti, Suresh</au><au>Rosen, Amy S</au><au>Plouffe, Leo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Transition From Estrogen–Progestin to Raloxifene in Postmenopausal Women: Effect on Vasomotor Symptoms</atitle><jtitle>Obstetrics and gynecology (New York. 1953)</jtitle><addtitle>Obstet Gynecol</addtitle><date>2004-02</date><risdate>2004</risdate><volume>103</volume><issue>2</issue><spage>267</spage><epage>273</epage><pages>267-273</pages><issn>0029-7844</issn><eissn>1873-233X</eissn><coden>OBGNAS</coden><abstract>OBJECTIVE:To compare vasomotor symptoms after transition from estrogen–progestin therapy to raloxifene 60 mg/d with and without a placebo washout.
METHODS:Postmenopausal women currently taking continuous combined estrogen–progestin therapy (conjugated equine estrogen, 0.625 mg/medroxyprogesterone acetate, 2.5 or 5 mg) daily for 5 or more months were enrolled. Women were randomized to 1 of 4 blinded regimens1) 12 weeks estrogen–progestin; 2) 12 weeks placebo; 3) 4 weeks placebo, then 8 weeks raloxifene; or 4) 12 weeks raloxifene. For the final 36 weeks, all subjects received raloxifene. Vasomotor symptoms were assessed by patient diaries.
RESULTS:A total of 266 women (mean age 57.5) were enrolled. Mean hot flush frequency at baseline was approximately 1 per week in the entire population, with 16% of women reporting hot flushes. Mean frequency and severity of hot flushes during the first 12 weeks of the study were statistically greater in the 3 groups transitioned off estrogen–progestin (range of hot flushes per week4 weeks, 11–12; 8 weeks, 18–24; 12 weeks, 13–16), as compared with those continuing estrogen–progestin, with no difference between these 3 groups (P ≥ .1). Approximately 50–70% of these women reported hot flushes, generally rated as mild to moderate by participants, after estrogen–progestin discontinuation.
CONCLUSION:A large proportion of women discontinuing estrogen–progestin experience hot flushes. Raloxifene does not appear to increase the frequency or severity of vasomotor symptoms in women discontinuing estrogen–progestin more than that observed with placebo treatment after estrogen–progestin discontinuation. Transition from estrogen–progestin to raloxifene with no washout period therefore may be acceptable.
LEVEL OF EVIDENCE:I</abstract><cop>New York, NY</cop><pub>The American College of Obstetricians and Gynecologists</pub><pmid>14754694</pmid><doi>10.1097/01.AOG.0000110247.98588.ff</doi><tpages>7</tpages></addata></record> |
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| ispartof | Obstetrics and gynecology (New York. 1953), 2004-02, Vol.103 (2), p.267-273 |
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| source | MEDLINE; Journals@Ovid Complete |
| subjects | Administration, Oral Aged Analysis of Variance Biological and medical sciences Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Drug Combinations Estrogens, Conjugated (USP) - administration & dosage Female Follow-Up Studies Gynecology. Andrology. Obstetrics Hot Flashes - diagnosis Hot Flashes - drug therapy Humans Medical sciences Middle Aged Postmenopause - drug effects Postmenopause - physiology Probability Progestins - administration & dosage Raloxifene Hydrochloride - administration & dosage Reference Values Risk Assessment Severity of Illness Index Single-Blind Method Treatment Outcome Vasomotor System - drug effects |
| title | Transition From Estrogen–Progestin to Raloxifene in Postmenopausal Women: Effect on Vasomotor Symptoms |
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