PMID- 26055735
OWN - NLM
STAT- MEDLINE
DCOM- 20151027
LR  - 20181113
IS  - 1476-1645 (Electronic)
IS  - 0002-9637 (Print)
IS  - 0002-9637 (Linking)
VI  - 93
IP  - 2
DP  - 2015 Aug
TI  - Mefloquine Versus Sulfadoxine-Pyrimethamine for Intermittent Preventive Treatment 
      in Pregnancy: A Joint Analysis on Efficacy and Tolerability.
PG  - 300-4
LID - 10.4269/ajtmh.14-0783 [doi]
AB  - Since there is no ideal candidate to replace sulfadoxine-pyrimethamine (SP) for 
      intermittent preventive treatment (IPTp), alternatives need to be evaluated on 
      basis of their benefit-risk ratio. We reanalyzed the first Beninese trial on 
      mefloquine (MQ) versus SP for IPTp using a multiple outcome approach, which 
      allowed the joint assessment of efficacy and tolerability. Overall superiority of 
      MQ to SP was defined as superiority on at least one efficacy outcome (low birth 
      weight [LBW], placental malaria, or maternal anemia), non-inferiority on all of 
      them as well as on tolerability defined as cutaneous or neuropsychiatric adverse 
      events (AEs) or low compliance with the treatment. The analysis included 1,601 
      women. MQ was found to be overall superior to SP (P = 0.004). Performing several 
      sensitivity analyses to handle both missing data and stillbirths provided similar 
      results. Using MQ for IPTp as an example, we show that a multiple outcome 
      analysis is a pragmatic way to assess the benefits/disadvantages of one drug 
      compared with another. In the current context of a lack of antimalarials that 
      could be used for IPTp, such a statistical approach could be widely used by 
      institutional policy makers for future recommendations regarding the prevention 
      of malaria in pregnancy (MiP).
CI  - (c) The American Society of Tropical Medicine and Hygiene.
FAU - Briand, Valerie
AU  - Briand V
AD  - Mere et Enfant Face aux Infections Tropicales (UMR216-MERIT), Institut de 
      Recherche pour le Developpement (IRD), Paris, France; Universite Paris Descartes, 
      Sorbonne Paris Cite, Paris, France; Inserm, UMR1181, Biostatistics, 
      Biomathematics, Pharmacoepidemiology and Infectious Diseases (B2PHI), Villejuif, 
      France; UMR1181, B2PHI, Institut Pasteur, Paris, France; UMR1181, B2PHI, 
      Universite Versailles Saint Quentin, Villejuif, France; Centre INSERM 
      U897-Epidemiologie-Biostatistique, Bordeaux, France; Laboratoire de 
      Parasitologie, Faculte des Sciences de la Sante (FSS), Cotonou, Benin; Centre 
      d'Etude et de Recherche sur le Paludisme Associe a la Grossesse et l'Enfance 
      (CERPAGE), Cotonou, Benin valerie.briand@ird.fr.
FAU - Escolano, Sylvie
AU  - Escolano S
AD  - Mere et Enfant Face aux Infections Tropicales (UMR216-MERIT), Institut de 
      Recherche pour le Developpement (IRD), Paris, France; Universite Paris Descartes, 
      Sorbonne Paris Cite, Paris, France; Inserm, UMR1181, Biostatistics, 
      Biomathematics, Pharmacoepidemiology and Infectious Diseases (B2PHI), Villejuif, 
      France; UMR1181, B2PHI, Institut Pasteur, Paris, France; UMR1181, B2PHI, 
      Universite Versailles Saint Quentin, Villejuif, France; Centre INSERM 
      U897-Epidemiologie-Biostatistique, Bordeaux, France; Laboratoire de 
      Parasitologie, Faculte des Sciences de la Sante (FSS), Cotonou, Benin; Centre 
      d'Etude et de Recherche sur le Paludisme Associe a la Grossesse et l'Enfance 
      (CERPAGE), Cotonou, Benin.
FAU - Journot, Valerie
AU  - Journot V
AD  - Mere et Enfant Face aux Infections Tropicales (UMR216-MERIT), Institut de 
      Recherche pour le Developpement (IRD), Paris, France; Universite Paris Descartes, 
      Sorbonne Paris Cite, Paris, France; Inserm, UMR1181, Biostatistics, 
      Biomathematics, Pharmacoepidemiology and Infectious Diseases (B2PHI), Villejuif, 
      France; UMR1181, B2PHI, Institut Pasteur, Paris, France; UMR1181, B2PHI, 
      Universite Versailles Saint Quentin, Villejuif, France; Centre INSERM 
      U897-Epidemiologie-Biostatistique, Bordeaux, France; Laboratoire de 
      Parasitologie, Faculte des Sciences de la Sante (FSS), Cotonou, Benin; Centre 
      d'Etude et de Recherche sur le Paludisme Associe a la Grossesse et l'Enfance 
      (CERPAGE), Cotonou, Benin.
FAU - Massougbodji, Achille
AU  - Massougbodji A
AD  - Mere et Enfant Face aux Infections Tropicales (UMR216-MERIT), Institut de 
      Recherche pour le Developpement (IRD), Paris, France; Universite Paris Descartes, 
      Sorbonne Paris Cite, Paris, France; Inserm, UMR1181, Biostatistics, 
      Biomathematics, Pharmacoepidemiology and Infectious Diseases (B2PHI), Villejuif, 
      France; UMR1181, B2PHI, Institut Pasteur, Paris, France; UMR1181, B2PHI, 
      Universite Versailles Saint Quentin, Villejuif, France; Centre INSERM 
      U897-Epidemiologie-Biostatistique, Bordeaux, France; Laboratoire de 
      Parasitologie, Faculte des Sciences de la Sante (FSS), Cotonou, Benin; Centre 
      d'Etude et de Recherche sur le Paludisme Associe a la Grossesse et l'Enfance 
      (CERPAGE), Cotonou, Benin.
FAU - Cot, Michel
AU  - Cot M
AD  - Mere et Enfant Face aux Infections Tropicales (UMR216-MERIT), Institut de 
      Recherche pour le Developpement (IRD), Paris, France; Universite Paris Descartes, 
      Sorbonne Paris Cite, Paris, France; Inserm, UMR1181, Biostatistics, 
      Biomathematics, Pharmacoepidemiology and Infectious Diseases (B2PHI), Villejuif, 
      France; UMR1181, B2PHI, Institut Pasteur, Paris, France; UMR1181, B2PHI, 
      Universite Versailles Saint Quentin, Villejuif, France; Centre INSERM 
      U897-Epidemiologie-Biostatistique, Bordeaux, France; Laboratoire de 
      Parasitologie, Faculte des Sciences de la Sante (FSS), Cotonou, Benin; Centre 
      d'Etude et de Recherche sur le Paludisme Associe a la Grossesse et l'Enfance 
      (CERPAGE), Cotonou, Benin.
FAU - Tubert-Bitter, Pascale
AU  - Tubert-Bitter P
AD  - Mere et Enfant Face aux Infections Tropicales (UMR216-MERIT), Institut de 
      Recherche pour le Developpement (IRD), Paris, France; Universite Paris Descartes, 
      Sorbonne Paris Cite, Paris, France; Inserm, UMR1181, Biostatistics, 
      Biomathematics, Pharmacoepidemiology and Infectious Diseases (B2PHI), Villejuif, 
      France; UMR1181, B2PHI, Institut Pasteur, Paris, France; UMR1181, B2PHI, 
      Universite Versailles Saint Quentin, Villejuif, France; Centre INSERM 
      U897-Epidemiologie-Biostatistique, Bordeaux, France; Laboratoire de 
      Parasitologie, Faculte des Sciences de la Sante (FSS), Cotonou, Benin; Centre 
      d'Etude et de Recherche sur le Paludisme Associe a la Grossesse et l'Enfance 
      (CERPAGE), Cotonou, Benin.
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150608
PL  - United States
TA  - Am J Trop Med Hyg
JT  - The American journal of tropical medicine and hygiene
JID - 0370507
RN  - 0 (Antimalarials)
RN  - 0 (Drug Combinations)
RN  - 37338-39-9 (fanasil, pyrimethamine drug combination)
RN  - 88463U4SM5 (Sulfadoxine)
RN  - TML814419R (Mefloquine)
RN  - Z3614QOX8W (Pyrimethamine)
SB  - IM
MH  - Anemia/blood/parasitology
MH  - Antimalarials/*therapeutic use
MH  - Benin
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Infant, Low Birth Weight/blood
MH  - Malaria/*prevention & control
MH  - Mefloquine/*therapeutic use
MH  - Placenta/parasitology
MH  - Pregnancy
MH  - Pregnancy Complications, Parasitic/*prevention & control
MH  - Pyrimethamine/*therapeutic use
MH  - Stillbirth
MH  - Sulfadoxine/*therapeutic use
MH  - Treatment Outcome
PMC - PMC4530751
EDAT- 2015/06/10 06:00
MHDA- 2015/10/28 06:00
PMCR- 2016/08/05
CRDT- 2015/06/10 06:00
PHST- 2014/12/05 00:00 [received]
PHST- 2015/04/22 00:00 [accepted]
PHST- 2015/06/10 06:00 [entrez]
PHST- 2015/06/10 06:00 [pubmed]
PHST- 2015/10/28 06:00 [medline]
PHST- 2016/08/05 00:00 [pmc-release]
AID - ajtmh.14-0783 [pii]
AID - 10.4269/ajtmh.14-0783 [doi]
PST - ppublish
SO  - Am J Trop Med Hyg. 2015 Aug;93(2):300-4. doi: 10.4269/ajtmh.14-0783. Epub 2015 
      Jun 8.