Intermittent Treatment for the Prevention of Malaria during Pregnancy in Benin: A Randomized, Open-Label Equivalence Trial Comparing Sulfadoxine-Pyrimethamine with Mefloquine
BackgroundIn the context of the increasing resistance to sulfadoxine-pyrimethamine (SP), we evaluated the efficacy of mefloquine (MQ) for intermittent preventive treatment during pregnancy (IPTp) MethodsA multicenter, open-label equivalence trial was conducted in Benin from July 2005 through April 2...
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| creator | Briand, Valérie Bottero, Julie Noël, Harold Masse, Virginie Cordel, Hugues Guerra, José Kossou, Hortense Fayomi, Benjamin Ayemonna, Paul Fievet, Nadine Massougbodji, Achille Cot, Michel |
| description | BackgroundIn the context of the increasing resistance to sulfadoxine-pyrimethamine (SP), we evaluated the efficacy of mefloquine (MQ) for intermittent preventive treatment during pregnancy (IPTp) MethodsA multicenter, open-label equivalence trial was conducted in Benin from July 2005 through April 2008. Women of all gravidities were randomized to receive SP (1500 mg of sulfadoxine and 75 mg of pyrimethamine) or 15 mg/kg MQ in a single intake twice during pregnancy. The primary end point was the proportion of low–birth-weight (LBW) infants (body weight, |
| doi_str_mv | 10.1086/605474 |
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Women of all gravidities were randomized to receive SP (1500 mg of sulfadoxine and 75 mg of pyrimethamine) or 15 mg/kg MQ in a single intake twice during pregnancy. The primary end point was the proportion of low–birth-weight (LBW) infants (body weight, <2500 g; equivalence margin, 5%) ResultsA total of 1601 women were randomized to receive MQ (n=802) or SP (n=799). In the modified intention-to-treat analysis, which assessed only live singleton births, 59 (8%) of 735 women who were given MQ and 72 (9.8%) of 730 women who were given SP gave birth to LBW infants (difference between low birth weights in treatment groups, −1.8%; 95% confidence interval [CI], −4.8% to 1.1%]), establishing equivalence between the drugs. The per-protocol analysis showed consistent results. MQ was more efficacious than SP in preventing placental malaria (prevalence, 1.7% vs 4.4% of women; P=.005), clinical malaria (incidence rate, 26 cases/10,000 person-months vs. 68 cases/10,000 person-months; P=.007), and maternal anemia at delivery (as defined by a hemoglobin level <10 g/dL) (prevalence, 16% vs 20%; marginally significant at P=.09). Adverse events (mainly vomiting, dizziness, tiredness, and nausea) were more commonly associated with the use of MQ (prevalence, 78% vs 32%; P<10-3). One woman in the MQ group had severe neuropsychiatric symptoms ConclusionsMQ proved to be highly efficacious—both clinically and parasitologically—for use as IPTp. However, its low tolerability might impair its effectiveness and requires further investigations Clinical Trials RegistrationNCT00274235</description><identifier>ISSN: 0022-1899</identifier><identifier>EISSN: 1537-6613</identifier><identifier>DOI: 10.1086/605474</identifier><identifier>PMID: 19656069</identifier><language>eng</language><publisher>United States: The University of Chicago Press</publisher><subject>Abnormalities, Drug-Induced ; Abortion, Spontaneous - chemically induced ; Adult ; Anemia ; Antimalarials ; Antimalarials - adverse effects ; Antimalarials - therapeutic use ; Birth weight ; Blood ; Dosage ; Drug Combinations ; Female ; Humans ; Infant ; Infant, Newborn ; Infants ; Malaria ; Malaria - prevention & control ; Mefloquine - adverse effects ; Mefloquine - therapeutic use ; PARASITES ; Pregnancy ; Pregnancy Complications, Parasitic - prevention & control ; Pyrimethamine - adverse effects ; Pyrimethamine - therapeutic use ; Single-Blind Method ; Stillbirth ; Sulfadoxine - adverse effects ; Sulfadoxine - therapeutic use ; Women ; Young Adult</subject><ispartof>The Journal of infectious diseases, 2009-09, Vol.200 (6), p.991-1001</ispartof><rights>2009 Infectious Diseases Society of America</rights><rights>2009 by the Infectious Diseases Society of America 2009</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c426t-265fa2421229878c1158f7c207ea0f2bd9d1131f8ea46b8c7fab14b02cdddb0f3</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.jstor.org/stable/pdf/27794166$$EPDF$$P50$$Gjstor$$H</linktopdf><linktohtml>$$Uhttps://www.jstor.org/stable/27794166$$EHTML$$P50$$Gjstor$$H</linktohtml><link.rule.ids>314,777,781,800,27905,27906,57998,58231</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/19656069$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Briand, Valérie</creatorcontrib><creatorcontrib>Bottero, Julie</creatorcontrib><creatorcontrib>Noël, Harold</creatorcontrib><creatorcontrib>Masse, Virginie</creatorcontrib><creatorcontrib>Cordel, Hugues</creatorcontrib><creatorcontrib>Guerra, José</creatorcontrib><creatorcontrib>Kossou, Hortense</creatorcontrib><creatorcontrib>Fayomi, Benjamin</creatorcontrib><creatorcontrib>Ayemonna, Paul</creatorcontrib><creatorcontrib>Fievet, Nadine</creatorcontrib><creatorcontrib>Massougbodji, Achille</creatorcontrib><creatorcontrib>Cot, Michel</creatorcontrib><title>Intermittent Treatment for the Prevention of Malaria during Pregnancy in Benin: A Randomized, Open-Label Equivalence Trial Comparing Sulfadoxine-Pyrimethamine with Mefloquine</title><title>The Journal of infectious diseases</title><addtitle>The Journal of Infectious Diseases</addtitle><addtitle>The Journal of Infectious Diseases</addtitle><description>BackgroundIn the context of the increasing resistance to sulfadoxine-pyrimethamine (SP), we evaluated the efficacy of mefloquine (MQ) for intermittent preventive treatment during pregnancy (IPTp) MethodsA multicenter, open-label equivalence trial was conducted in Benin from July 2005 through April 2008. Women of all gravidities were randomized to receive SP (1500 mg of sulfadoxine and 75 mg of pyrimethamine) or 15 mg/kg MQ in a single intake twice during pregnancy. The primary end point was the proportion of low–birth-weight (LBW) infants (body weight, <2500 g; equivalence margin, 5%) ResultsA total of 1601 women were randomized to receive MQ (n=802) or SP (n=799). In the modified intention-to-treat analysis, which assessed only live singleton births, 59 (8%) of 735 women who were given MQ and 72 (9.8%) of 730 women who were given SP gave birth to LBW infants (difference between low birth weights in treatment groups, −1.8%; 95% confidence interval [CI], −4.8% to 1.1%]), establishing equivalence between the drugs. The per-protocol analysis showed consistent results. MQ was more efficacious than SP in preventing placental malaria (prevalence, 1.7% vs 4.4% of women; P=.005), clinical malaria (incidence rate, 26 cases/10,000 person-months vs. 68 cases/10,000 person-months; P=.007), and maternal anemia at delivery (as defined by a hemoglobin level <10 g/dL) (prevalence, 16% vs 20%; marginally significant at P=.09). Adverse events (mainly vomiting, dizziness, tiredness, and nausea) were more commonly associated with the use of MQ (prevalence, 78% vs 32%; P<10-3). One woman in the MQ group had severe neuropsychiatric symptoms ConclusionsMQ proved to be highly efficacious—both clinically and parasitologically—for use as IPTp. However, its low tolerability might impair its effectiveness and requires further investigations Clinical Trials RegistrationNCT00274235</description><subject>Abnormalities, Drug-Induced</subject><subject>Abortion, Spontaneous - chemically induced</subject><subject>Adult</subject><subject>Anemia</subject><subject>Antimalarials</subject><subject>Antimalarials - adverse effects</subject><subject>Antimalarials - therapeutic use</subject><subject>Birth weight</subject><subject>Blood</subject><subject>Dosage</subject><subject>Drug Combinations</subject><subject>Female</subject><subject>Humans</subject><subject>Infant</subject><subject>Infant, Newborn</subject><subject>Infants</subject><subject>Malaria</subject><subject>Malaria - prevention & control</subject><subject>Mefloquine - adverse effects</subject><subject>Mefloquine - therapeutic use</subject><subject>PARASITES</subject><subject>Pregnancy</subject><subject>Pregnancy Complications, Parasitic - prevention & control</subject><subject>Pyrimethamine - adverse effects</subject><subject>Pyrimethamine - therapeutic use</subject><subject>Single-Blind Method</subject><subject>Stillbirth</subject><subject>Sulfadoxine - adverse effects</subject><subject>Sulfadoxine - therapeutic use</subject><subject>Women</subject><subject>Young Adult</subject><issn>0022-1899</issn><issn>1537-6613</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2009</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kcFu1DAQhi0EokuBNwCZCycCtpPYCbd2VXYrbdUCBSEulpOMuy6JHWyndHkonhEvu2pPnDyj__M_o_kRek7JW0oq_o6TshDFAzSjZS4yzmn-EM0IYSyjVV0foCchXBNCipyLx-iA1rzkhNcz9OfURvCDiRFsxJceVBy2lXYexzXgCw83qTfOYqfxmeqVNwp3kzf2aiteWWXbDTYWH4M19j0-wp-U7dxgfkP3Bp-PYLOVaqDHJz8nc6N6sC2kOUb1eO6GUf0z-jz1WnXu1ljILjbeDBDXakgd_mXiGp-B7l36buEpeqRVH-DZ_j1EXz6cXM6X2ep8cTo_WmVtwXjMGC-1YgWjjNWVqFpKy0qLlhEBimjWdHVHaU51BargTdUKrRpaNIS1Xdc1ROeH6PXOd_RpMIQoBxNa6HtlwU1BsnT0krL6Hmy9C8GDlmNaX_mNpERuk5G7ZBL4cu84NQN099g-igS82gFuGv9v8mLHXIfo_B3FhKgLynnSs51uQoTbO135H5KLXJRy-e27XBxXS_F18VHO878FBK6Z</recordid><startdate>20090915</startdate><enddate>20090915</enddate><creator>Briand, Valérie</creator><creator>Bottero, Julie</creator><creator>Noël, Harold</creator><creator>Masse, Virginie</creator><creator>Cordel, Hugues</creator><creator>Guerra, José</creator><creator>Kossou, Hortense</creator><creator>Fayomi, Benjamin</creator><creator>Ayemonna, Paul</creator><creator>Fievet, Nadine</creator><creator>Massougbodji, Achille</creator><creator>Cot, Michel</creator><general>The University of Chicago Press</general><general>University of Chicago Press</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>C1K</scope><scope>F1W</scope><scope>H95</scope><scope>H97</scope><scope>L.G</scope><scope>M7N</scope></search><sort><creationdate>20090915</creationdate><title>Intermittent Treatment for the Prevention of Malaria during Pregnancy in Benin: A Randomized, Open-Label Equivalence Trial Comparing Sulfadoxine-Pyrimethamine with Mefloquine</title><author>Briand, Valérie ; Bottero, Julie ; Noël, Harold ; Masse, Virginie ; Cordel, Hugues ; Guerra, José ; Kossou, Hortense ; Fayomi, Benjamin ; Ayemonna, Paul ; Fievet, Nadine ; Massougbodji, Achille ; Cot, Michel</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c426t-265fa2421229878c1158f7c207ea0f2bd9d1131f8ea46b8c7fab14b02cdddb0f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2009</creationdate><topic>Abnormalities, Drug-Induced</topic><topic>Abortion, Spontaneous - chemically induced</topic><topic>Adult</topic><topic>Anemia</topic><topic>Antimalarials</topic><topic>Antimalarials - adverse effects</topic><topic>Antimalarials - therapeutic use</topic><topic>Birth weight</topic><topic>Blood</topic><topic>Dosage</topic><topic>Drug Combinations</topic><topic>Female</topic><topic>Humans</topic><topic>Infant</topic><topic>Infant, Newborn</topic><topic>Infants</topic><topic>Malaria</topic><topic>Malaria - prevention & control</topic><topic>Mefloquine - adverse effects</topic><topic>Mefloquine - therapeutic use</topic><topic>PARASITES</topic><topic>Pregnancy</topic><topic>Pregnancy Complications, Parasitic - prevention & control</topic><topic>Pyrimethamine - adverse effects</topic><topic>Pyrimethamine - therapeutic use</topic><topic>Single-Blind Method</topic><topic>Stillbirth</topic><topic>Sulfadoxine - adverse effects</topic><topic>Sulfadoxine - therapeutic use</topic><topic>Women</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Briand, Valérie</creatorcontrib><creatorcontrib>Bottero, Julie</creatorcontrib><creatorcontrib>Noël, Harold</creatorcontrib><creatorcontrib>Masse, Virginie</creatorcontrib><creatorcontrib>Cordel, Hugues</creatorcontrib><creatorcontrib>Guerra, José</creatorcontrib><creatorcontrib>Kossou, Hortense</creatorcontrib><creatorcontrib>Fayomi, Benjamin</creatorcontrib><creatorcontrib>Ayemonna, Paul</creatorcontrib><creatorcontrib>Fievet, Nadine</creatorcontrib><creatorcontrib>Massougbodji, Achille</creatorcontrib><creatorcontrib>Cot, Michel</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>Environmental Sciences and Pollution Management</collection><collection>ASFA: Aquatic Sciences and Fisheries Abstracts</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 1: Biological Sciences & Living Resources</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 3: Aquatic Pollution & Environmental Quality</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) Professional</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><jtitle>The Journal of infectious diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Briand, Valérie</au><au>Bottero, Julie</au><au>Noël, Harold</au><au>Masse, Virginie</au><au>Cordel, Hugues</au><au>Guerra, José</au><au>Kossou, Hortense</au><au>Fayomi, Benjamin</au><au>Ayemonna, Paul</au><au>Fievet, Nadine</au><au>Massougbodji, Achille</au><au>Cot, Michel</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Intermittent Treatment for the Prevention of Malaria during Pregnancy in Benin: A Randomized, Open-Label Equivalence Trial Comparing Sulfadoxine-Pyrimethamine with Mefloquine</atitle><jtitle>The Journal of infectious diseases</jtitle><stitle>The Journal of Infectious Diseases</stitle><addtitle>The Journal of Infectious Diseases</addtitle><date>2009-09-15</date><risdate>2009</risdate><volume>200</volume><issue>6</issue><spage>991</spage><epage>1001</epage><pages>991-1001</pages><issn>0022-1899</issn><eissn>1537-6613</eissn><abstract>BackgroundIn the context of the increasing resistance to sulfadoxine-pyrimethamine (SP), we evaluated the efficacy of mefloquine (MQ) for intermittent preventive treatment during pregnancy (IPTp) MethodsA multicenter, open-label equivalence trial was conducted in Benin from July 2005 through April 2008. Women of all gravidities were randomized to receive SP (1500 mg of sulfadoxine and 75 mg of pyrimethamine) or 15 mg/kg MQ in a single intake twice during pregnancy. The primary end point was the proportion of low–birth-weight (LBW) infants (body weight, <2500 g; equivalence margin, 5%) ResultsA total of 1601 women were randomized to receive MQ (n=802) or SP (n=799). In the modified intention-to-treat analysis, which assessed only live singleton births, 59 (8%) of 735 women who were given MQ and 72 (9.8%) of 730 women who were given SP gave birth to LBW infants (difference between low birth weights in treatment groups, −1.8%; 95% confidence interval [CI], −4.8% to 1.1%]), establishing equivalence between the drugs. The per-protocol analysis showed consistent results. MQ was more efficacious than SP in preventing placental malaria (prevalence, 1.7% vs 4.4% of women; P=.005), clinical malaria (incidence rate, 26 cases/10,000 person-months vs. 68 cases/10,000 person-months; P=.007), and maternal anemia at delivery (as defined by a hemoglobin level <10 g/dL) (prevalence, 16% vs 20%; marginally significant at P=.09). Adverse events (mainly vomiting, dizziness, tiredness, and nausea) were more commonly associated with the use of MQ (prevalence, 78% vs 32%; P<10-3). One woman in the MQ group had severe neuropsychiatric symptoms ConclusionsMQ proved to be highly efficacious—both clinically and parasitologically—for use as IPTp. However, its low tolerability might impair its effectiveness and requires further investigations Clinical Trials RegistrationNCT00274235</abstract><cop>United States</cop><pub>The University of Chicago Press</pub><pmid>19656069</pmid><doi>10.1086/605474</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Abnormalities, Drug-Induced Abortion, Spontaneous - chemically induced Adult Anemia Antimalarials Antimalarials - adverse effects Antimalarials - therapeutic use Birth weight Blood Dosage Drug Combinations Female Humans Infant Infant, Newborn Infants Malaria Malaria - prevention & control Mefloquine - adverse effects Mefloquine - therapeutic use PARASITES Pregnancy Pregnancy Complications, Parasitic - prevention & control Pyrimethamine - adverse effects Pyrimethamine - therapeutic use Single-Blind Method Stillbirth Sulfadoxine - adverse effects Sulfadoxine - therapeutic use Women Young Adult |
| title | Intermittent Treatment for the Prevention of Malaria during Pregnancy in Benin: A Randomized, Open-Label Equivalence Trial Comparing Sulfadoxine-Pyrimethamine with Mefloquine |
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