Comparative evaluation of efficacy and safety of artesunate–lumefantrine vs. artemether–lumefantrine fixed‐dose combination in the treatment of uncomplicated Plasmodium falciparum malaria
Objective To establish efficacy and safety of artesunate/lumefantrine fixed‐dose combination (FDC) in comparison with artemether/lumefantrine FDC in treatment of uncomplicated Plasmodium falciparum malaria. Methods Confirmed cases of uncomplicated P. falciparum malaria were randomly assigned to rece...
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| Veröffentlicht in: | Tropical medicine & international health 2013-05, Vol.18 (5), p.578-587 |
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| creator | Pareek, Anil Chandurkar, Nitin Srivastav, Vipul Lakhani, Jitendra Karmakar, Partha S. Basu, Subrata Ray, Arnab Pednekar, Sangeeta Gupta, P. B. Suthar, Nilay Lakhani, Sucheta |
| description | Objective
To establish efficacy and safety of artesunate/lumefantrine fixed‐dose combination (FDC) in comparison with artemether/lumefantrine FDC in treatment of uncomplicated Plasmodium falciparum malaria.
Methods
Confirmed cases of uncomplicated P. falciparum malaria were randomly assigned to receive artesunate (100 mg)/lumefantrine (480 mg) (ASLF FDC) or artemether (80 mg)/lumefantrine (480 mg) (AMLF FDC) tablets for 3 days. Patients were followed up on Day 7, 14, 21 and 28.
Results
Of the 158 enrolled patients, 144 completed the study. Seventy‐three patients (94.8%) from the ASLF group and 71 patients (94.7%) from the AMLF group showed parasite clearance within 48 h. The mean parasite clearance time was 25.40 ± 14.82 h in the ASLF group and 24 ± 13.32 h in the AMLF group (P = 0.542). All patients showed gametocyte clearance by Day 7 and remained gametocyte free till Day 28. Sixty‐five patients (84.4%) from the ASLF group and 56 patients (74.7%) from the AMLF group were afebrile within 24 h. The mean fever clearance time was 17.38 ± 12.33 h in the ASLF group and 17.2 ± 12.01 h in the AMLF group (P = 0.929). There was one early treatment failure in the AMLF group as per WHO criteria. Improvement in haemoglobin and haematocrit was comparable in both the treatment groups. In the ASLF group, of the 25 (32.47%) patients anaemic at baseline, only seven (9.09%) reported anaemia on Day 28, while in the AMLF group, of the 14 (18.67%) patients anaemic at baseline, only four (5.33%) reported anaemia on Day 28. Both study medications were well tolerated.
Conclusion
Artesunate (100 mg)/lumefantrine (480 mg) fixed‐dose combination could add one more option to currently available artemisinin combinations in treatment of uncomplicated P. falciparum malaria.
Objectif
Mesurer l'efficacité et la sécurité de combinaisons à dose fixe (CDF) d'artésunate/luméfantrine comparées à celles de la CDF d'artéméther/luméfantrine dans le traitement du paludisme non compliqué à
P
lasmodium falciparum.
Méthodes
Les cas confirmés de paludisme non compliqué à
P
. falciparum ont été randomisés pour recevoir soit des comprimés d'artésunate (100 mg)/luméfantrine (480 mg) (ASLF‐CDF) ou d'artéméther (80 mg)/luméfantrine (480 mg) (AMLF‐CDF) pendant 3 jours. Les patients ont été suivis jusqu'aux jours 7, 14, 21 et 28.
Résultats
Sur les 158 patients inscrits, 144 ont terminé l’étude. L’élimination des parasites a été observée dans les 48 heures chez 73 patients (94,8%) du groupe ASLF et 71 (94,7% |
| doi_str_mv | 10.1111/tmi.12088 |
| format | Article |
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To establish efficacy and safety of artesunate/lumefantrine fixed‐dose combination (FDC) in comparison with artemether/lumefantrine FDC in treatment of uncomplicated Plasmodium falciparum malaria.
Methods
Confirmed cases of uncomplicated P. falciparum malaria were randomly assigned to receive artesunate (100 mg)/lumefantrine (480 mg) (ASLF FDC) or artemether (80 mg)/lumefantrine (480 mg) (AMLF FDC) tablets for 3 days. Patients were followed up on Day 7, 14, 21 and 28.
Results
Of the 158 enrolled patients, 144 completed the study. Seventy‐three patients (94.8%) from the ASLF group and 71 patients (94.7%) from the AMLF group showed parasite clearance within 48 h. The mean parasite clearance time was 25.40 ± 14.82 h in the ASLF group and 24 ± 13.32 h in the AMLF group (P = 0.542). All patients showed gametocyte clearance by Day 7 and remained gametocyte free till Day 28. Sixty‐five patients (84.4%) from the ASLF group and 56 patients (74.7%) from the AMLF group were afebrile within 24 h. The mean fever clearance time was 17.38 ± 12.33 h in the ASLF group and 17.2 ± 12.01 h in the AMLF group (P = 0.929). There was one early treatment failure in the AMLF group as per WHO criteria. Improvement in haemoglobin and haematocrit was comparable in both the treatment groups. In the ASLF group, of the 25 (32.47%) patients anaemic at baseline, only seven (9.09%) reported anaemia on Day 28, while in the AMLF group, of the 14 (18.67%) patients anaemic at baseline, only four (5.33%) reported anaemia on Day 28. Both study medications were well tolerated.
Conclusion
Artesunate (100 mg)/lumefantrine (480 mg) fixed‐dose combination could add one more option to currently available artemisinin combinations in treatment of uncomplicated P. falciparum malaria.
Objectif
Mesurer l'efficacité et la sécurité de combinaisons à dose fixe (CDF) d'artésunate/luméfantrine comparées à celles de la CDF d'artéméther/luméfantrine dans le traitement du paludisme non compliqué à
P
lasmodium falciparum.
Méthodes
Les cas confirmés de paludisme non compliqué à
P
. falciparum ont été randomisés pour recevoir soit des comprimés d'artésunate (100 mg)/luméfantrine (480 mg) (ASLF‐CDF) ou d'artéméther (80 mg)/luméfantrine (480 mg) (AMLF‐CDF) pendant 3 jours. Les patients ont été suivis jusqu'aux jours 7, 14, 21 et 28.
Résultats
Sur les 158 patients inscrits, 144 ont terminé l’étude. L’élimination des parasites a été observée dans les 48 heures chez 73 patients (94,8%) du groupe ASLF et 71 (94,7%) du groupe AMLF. Le temps moyen de clairance parasitaire était de 25,40 ± 14,82 h dans le groupe ASLF et 24 ± 13,32 h dans le groupe AMLF (P = 0,542). Tous les patients ont montré une clairance des gamétocytes au jour 7 et en sont restés exempts jusqu'au jour 28. 65 patients (84,4%) du groupe ASLF et 56 patients (74,7%) du groupe AMLF étaient non fébriles endéans les 24 heures. La durée moyenne pour la clairance de la fièvre était de 17,38 ± 12,33 h dans le groupe ASLF et 17,2 ± 12,01 h dans le groupe AMLF (P = 0,929). Il y a eu 1 cas d’échec thérapeutique précoce dans le groupe AMLF selon les critères de l’OMS. L'amélioration dans le taux d'hémoglobine et dans l'hématocrite était comparable dans les deux groupes de traitement. Dans le groupe ASLF, sur 25 (32,47%) patients anémiques au départ, seuls 7 (9,09%) ont rapporté de l'anémie au jour 28, alors que dans le groupe AMLF, sur 14 (18,67%) patients anémiques au départ, seuls 4 (5,33%) ont rapporté de l'anémie au jour 28. Les deux types de médicaments de l’étude ont été bien tolérés.
Conclusion
La CDF d’ASLF pourrait être une option additionnelle dans les combinaisons à base d'artémisinine actuellement disponibles dans le traitement du paludisme non compliqué à
P
. falciparum.
Objetivo
Establecer la eficacia y la seguridad de las combinaciones de dosis fija (CDF) de artesunato + lumefantrina, comparada con la CDF artemeter+lumefantrina en el tratamiento de la malaria no complicada por
P
lasmodium falciparum.
Métodos
Los casos confirmados de malaria no complicada por
P
. falciparum fueron asignados de forma aleatoria para recibir pastillas de artesunato (100 mg)/lumefantrina (480 mg) (CDF‐ASLF) o artemeter (80 mg)/lumefantrina (480 mg) (CDF‐AMLF) durante 3 días. Se realizó un seguimiento a los pacientes en los días 7, 14, 21 y 28.
Resultado
De los 158 pacientes incluidos en el estudio, 144 lo completaron. 73 pacientes (94.8%) del grupo ASLF y 71 pacientes (94.7%) del grupo AMLF estaban limpios de parásitos a las 48 h. El tiempo medio para la ausencia de parásitos era de 25.40 ± 14.82 h en el grupo ASLF y de 24 ± 13.32 h en el grupo AMLF (P = 0.542). Todos los pacientes estaban libres de gametocitos en el Día 7 y continuaban así hasta el Día 28. 65 pacientes (84.4) del grupo ASLF y 56 pacientes (74.7%) del grupo AMLF estuvieron afebriles dentro de las primeras 24 h. El tiempo medio para no tener fiebre era de 17.38 ± 12.33 h en el grupo ASLF y 17.2 ± 12.01 h en el grupo AMLF (P = 0.929). Hubo 1 fallo temprano en el tratamiento dentro del grupo AMLF según criterios de la OMS. La mejoría en la hemoglobina y el hematocrito era comparable en ambos grupos de tratamiento. En el grupo ASLF, de los 25 (32.47%) pacientes anémicos antes del tratamiento, solo 7 (9.09%) reportaron anemia a Día 28, mientras que en el grupo AMLF de los 14 (18.67%) pacientes anémicos antes de recibir tratamiento, solo 4 (5.33%) reportaron anemia a Día 28. Ambas medicaciones utilizadas en el estudio fueron bien toleradas.
Conclusión
La CDF ASLF podría ser una opción más a las combinaciones de artemisinina actualmente disponibles para el tratamiento de la malaria no complicada por
P
. falciparum.</description><identifier>ISSN: 1360-2276</identifier><identifier>EISSN: 1365-3156</identifier><identifier>DOI: 10.1111/tmi.12088</identifier><identifier>PMID: 23489465</identifier><language>eng</language><publisher>Oxford: Blackwell</publisher><subject>Adolescent ; Adult ; Aged ; Antibiotics. Antiinfectious agents. Antiparasitic agents ; Antimalarials - administration & dosage ; Antimalarials - adverse effects ; Antiparasitic agents ; artemether ; artemisinin combination therapies ; Artemisinins - administration & dosage ; Artemisinins - adverse effects ; artesunate ; Biological and medical sciences ; Comparative studies ; Double-Blind Method ; Drug Combinations ; Drug therapy ; Ethanolamines - administration & dosage ; Ethanolamines - adverse effects ; Female ; Fever ; Fluorenes - administration & dosage ; Fluorenes - adverse effects ; General aspects ; Human protozoal diseases ; Humans ; India ; Infectious diseases ; lumefantrine ; Malaria ; Malaria, Falciparum - blood ; Malaria, Falciparum - drug therapy ; Malaria, Falciparum - parasitology ; Male ; Medical sciences ; Middle Aged ; Parasite Load ; Parasitic diseases ; Pharmacology. Drug treatments ; Plasmodium falciparum ; Plasmodium falciparum - isolation & purification ; Protozoal diseases ; Time Factors ; Treatment Outcome ; uncomplicated Plasmodium falciparum malaria ; Young Adult</subject><ispartof>Tropical medicine & international health, 2013-05, Vol.18 (5), p.578-587</ispartof><rights>2013 Blackwell Publishing Ltd</rights><rights>2014 INIST-CNRS</rights><rights>2013 Blackwell Publishing Ltd.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Ftmi.12088$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Ftmi.12088$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,1433,27924,27925,45574,45575,46409,46833</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=27216538$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23489465$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Pareek, Anil</creatorcontrib><creatorcontrib>Chandurkar, Nitin</creatorcontrib><creatorcontrib>Srivastav, Vipul</creatorcontrib><creatorcontrib>Lakhani, Jitendra</creatorcontrib><creatorcontrib>Karmakar, Partha S.</creatorcontrib><creatorcontrib>Basu, Subrata</creatorcontrib><creatorcontrib>Ray, Arnab</creatorcontrib><creatorcontrib>Pednekar, Sangeeta</creatorcontrib><creatorcontrib>Gupta, P. B.</creatorcontrib><creatorcontrib>Suthar, Nilay</creatorcontrib><creatorcontrib>Lakhani, Sucheta</creatorcontrib><title>Comparative evaluation of efficacy and safety of artesunate–lumefantrine vs. artemether–lumefantrine fixed‐dose combination in the treatment of uncomplicated Plasmodium falciparum malaria</title><title>Tropical medicine & international health</title><addtitle>Trop Med Int Health</addtitle><description>Objective
To establish efficacy and safety of artesunate/lumefantrine fixed‐dose combination (FDC) in comparison with artemether/lumefantrine FDC in treatment of uncomplicated Plasmodium falciparum malaria.
Methods
Confirmed cases of uncomplicated P. falciparum malaria were randomly assigned to receive artesunate (100 mg)/lumefantrine (480 mg) (ASLF FDC) or artemether (80 mg)/lumefantrine (480 mg) (AMLF FDC) tablets for 3 days. Patients were followed up on Day 7, 14, 21 and 28.
Results
Of the 158 enrolled patients, 144 completed the study. Seventy‐three patients (94.8%) from the ASLF group and 71 patients (94.7%) from the AMLF group showed parasite clearance within 48 h. The mean parasite clearance time was 25.40 ± 14.82 h in the ASLF group and 24 ± 13.32 h in the AMLF group (P = 0.542). All patients showed gametocyte clearance by Day 7 and remained gametocyte free till Day 28. Sixty‐five patients (84.4%) from the ASLF group and 56 patients (74.7%) from the AMLF group were afebrile within 24 h. The mean fever clearance time was 17.38 ± 12.33 h in the ASLF group and 17.2 ± 12.01 h in the AMLF group (P = 0.929). There was one early treatment failure in the AMLF group as per WHO criteria. Improvement in haemoglobin and haematocrit was comparable in both the treatment groups. In the ASLF group, of the 25 (32.47%) patients anaemic at baseline, only seven (9.09%) reported anaemia on Day 28, while in the AMLF group, of the 14 (18.67%) patients anaemic at baseline, only four (5.33%) reported anaemia on Day 28. Both study medications were well tolerated.
Conclusion
Artesunate (100 mg)/lumefantrine (480 mg) fixed‐dose combination could add one more option to currently available artemisinin combinations in treatment of uncomplicated P. falciparum malaria.
Objectif
Mesurer l'efficacité et la sécurité de combinaisons à dose fixe (CDF) d'artésunate/luméfantrine comparées à celles de la CDF d'artéméther/luméfantrine dans le traitement du paludisme non compliqué à
P
lasmodium falciparum.
Méthodes
Les cas confirmés de paludisme non compliqué à
P
. falciparum ont été randomisés pour recevoir soit des comprimés d'artésunate (100 mg)/luméfantrine (480 mg) (ASLF‐CDF) ou d'artéméther (80 mg)/luméfantrine (480 mg) (AMLF‐CDF) pendant 3 jours. Les patients ont été suivis jusqu'aux jours 7, 14, 21 et 28.
Résultats
Sur les 158 patients inscrits, 144 ont terminé l’étude. L’élimination des parasites a été observée dans les 48 heures chez 73 patients (94,8%) du groupe ASLF et 71 (94,7%) du groupe AMLF. Le temps moyen de clairance parasitaire était de 25,40 ± 14,82 h dans le groupe ASLF et 24 ± 13,32 h dans le groupe AMLF (P = 0,542). Tous les patients ont montré une clairance des gamétocytes au jour 7 et en sont restés exempts jusqu'au jour 28. 65 patients (84,4%) du groupe ASLF et 56 patients (74,7%) du groupe AMLF étaient non fébriles endéans les 24 heures. La durée moyenne pour la clairance de la fièvre était de 17,38 ± 12,33 h dans le groupe ASLF et 17,2 ± 12,01 h dans le groupe AMLF (P = 0,929). Il y a eu 1 cas d’échec thérapeutique précoce dans le groupe AMLF selon les critères de l’OMS. L'amélioration dans le taux d'hémoglobine et dans l'hématocrite était comparable dans les deux groupes de traitement. Dans le groupe ASLF, sur 25 (32,47%) patients anémiques au départ, seuls 7 (9,09%) ont rapporté de l'anémie au jour 28, alors que dans le groupe AMLF, sur 14 (18,67%) patients anémiques au départ, seuls 4 (5,33%) ont rapporté de l'anémie au jour 28. Les deux types de médicaments de l’étude ont été bien tolérés.
Conclusion
La CDF d’ASLF pourrait être une option additionnelle dans les combinaisons à base d'artémisinine actuellement disponibles dans le traitement du paludisme non compliqué à
P
. falciparum.
Objetivo
Establecer la eficacia y la seguridad de las combinaciones de dosis fija (CDF) de artesunato + lumefantrina, comparada con la CDF artemeter+lumefantrina en el tratamiento de la malaria no complicada por
P
lasmodium falciparum.
Métodos
Los casos confirmados de malaria no complicada por
P
. falciparum fueron asignados de forma aleatoria para recibir pastillas de artesunato (100 mg)/lumefantrina (480 mg) (CDF‐ASLF) o artemeter (80 mg)/lumefantrina (480 mg) (CDF‐AMLF) durante 3 días. Se realizó un seguimiento a los pacientes en los días 7, 14, 21 y 28.
Resultado
De los 158 pacientes incluidos en el estudio, 144 lo completaron. 73 pacientes (94.8%) del grupo ASLF y 71 pacientes (94.7%) del grupo AMLF estaban limpios de parásitos a las 48 h. El tiempo medio para la ausencia de parásitos era de 25.40 ± 14.82 h en el grupo ASLF y de 24 ± 13.32 h en el grupo AMLF (P = 0.542). Todos los pacientes estaban libres de gametocitos en el Día 7 y continuaban así hasta el Día 28. 65 pacientes (84.4) del grupo ASLF y 56 pacientes (74.7%) del grupo AMLF estuvieron afebriles dentro de las primeras 24 h. El tiempo medio para no tener fiebre era de 17.38 ± 12.33 h en el grupo ASLF y 17.2 ± 12.01 h en el grupo AMLF (P = 0.929). Hubo 1 fallo temprano en el tratamiento dentro del grupo AMLF según criterios de la OMS. La mejoría en la hemoglobina y el hematocrito era comparable en ambos grupos de tratamiento. En el grupo ASLF, de los 25 (32.47%) pacientes anémicos antes del tratamiento, solo 7 (9.09%) reportaron anemia a Día 28, mientras que en el grupo AMLF de los 14 (18.67%) pacientes anémicos antes de recibir tratamiento, solo 4 (5.33%) reportaron anemia a Día 28. Ambas medicaciones utilizadas en el estudio fueron bien toleradas.
Conclusión
La CDF ASLF podría ser una opción más a las combinaciones de artemisinina actualmente disponibles para el tratamiento de la malaria no complicada por
P
. falciparum.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antibiotics. Antiinfectious agents. Antiparasitic agents</subject><subject>Antimalarials - administration & dosage</subject><subject>Antimalarials - adverse effects</subject><subject>Antiparasitic agents</subject><subject>artemether</subject><subject>artemisinin combination therapies</subject><subject>Artemisinins - administration & dosage</subject><subject>Artemisinins - adverse effects</subject><subject>artesunate</subject><subject>Biological and medical sciences</subject><subject>Comparative studies</subject><subject>Double-Blind Method</subject><subject>Drug Combinations</subject><subject>Drug therapy</subject><subject>Ethanolamines - administration & dosage</subject><subject>Ethanolamines - adverse effects</subject><subject>Female</subject><subject>Fever</subject><subject>Fluorenes - administration & dosage</subject><subject>Fluorenes - adverse effects</subject><subject>General aspects</subject><subject>Human protozoal diseases</subject><subject>Humans</subject><subject>India</subject><subject>Infectious diseases</subject><subject>lumefantrine</subject><subject>Malaria</subject><subject>Malaria, Falciparum - blood</subject><subject>Malaria, Falciparum - drug therapy</subject><subject>Malaria, Falciparum - parasitology</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Parasite Load</subject><subject>Parasitic diseases</subject><subject>Pharmacology. Drug treatments</subject><subject>Plasmodium falciparum</subject><subject>Plasmodium falciparum - isolation & purification</subject><subject>Protozoal diseases</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>uncomplicated Plasmodium falciparum malaria</subject><subject>Young Adult</subject><issn>1360-2276</issn><issn>1365-3156</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2013</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNksuKFDEUhgtRnHF04QtIQAQ31ZOkKpdeSuNlYEQX47o4lTqFGZJUm6R67N08guAT-SrzJKYvKszKbPJz_o_8ycmpqueMLlhZ59nbBeNU6wfVKWukqBsm5MO9pjXnSp5UT1K6ppS2rZCPqxPetHrZSnFa_VpNfg0Rst0gwQ24ucgpkGkkOI7WgNkSCANJMGLe7soQM6Y5QMa7259u9jhCyNEGJJu02Lse81eM993Rfsfh7vbHMCUkZvK9DYcoG0jhSY4I2WPIu5A5FGLtSn7GgXx2kPw02NmTEZyx5cJFenAQLTytHpViwmfH_az68u7t1epDffnp_cXqzWW9bpTSNe-Z0kiZZlorOYjB9AjMKCHoaLRpVQOy10vBlaHGtEz0lMHISpuMFAba5qx6fTh3HadvM6bceZsMOgcBpzl1rPS0XTIm1H-gXCouWbss6Mt76PU0x1AesqMEF5IqXqgXR2ruPQ7dOloPcdv9-ccCvDoCkAy4MUIwNv3jFGeF0oU7P3A31uH2r89otxukrgxStx-k7urjxV40vwExfsGH</recordid><startdate>201305</startdate><enddate>201305</enddate><creator>Pareek, Anil</creator><creator>Chandurkar, Nitin</creator><creator>Srivastav, Vipul</creator><creator>Lakhani, Jitendra</creator><creator>Karmakar, Partha S.</creator><creator>Basu, Subrata</creator><creator>Ray, Arnab</creator><creator>Pednekar, Sangeeta</creator><creator>Gupta, P. B.</creator><creator>Suthar, Nilay</creator><creator>Lakhani, Sucheta</creator><general>Blackwell</general><general>Blackwell Publishing Ltd</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>7T2</scope><scope>7U9</scope><scope>C1K</scope><scope>H94</scope><scope>K9.</scope><scope>M7N</scope><scope>7X8</scope><scope>7U2</scope><scope>F1W</scope><scope>H95</scope><scope>H97</scope><scope>L.G</scope></search><sort><creationdate>201305</creationdate><title>Comparative evaluation of efficacy and safety of artesunate–lumefantrine vs. artemether–lumefantrine fixed‐dose combination in the treatment of uncomplicated Plasmodium falciparum malaria</title><author>Pareek, Anil ; Chandurkar, Nitin ; Srivastav, Vipul ; Lakhani, Jitendra ; Karmakar, Partha S. ; Basu, Subrata ; Ray, Arnab ; Pednekar, Sangeeta ; Gupta, P. B. ; Suthar, Nilay ; Lakhani, Sucheta</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-p3778-2b178e01818876d5dcbea1c7550fc8c473a6b89527c0cc415b01af1894c65ca43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2013</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antibiotics. Antiinfectious agents. Antiparasitic agents</topic><topic>Antimalarials - administration & dosage</topic><topic>Antimalarials - adverse effects</topic><topic>Antiparasitic agents</topic><topic>artemether</topic><topic>artemisinin combination therapies</topic><topic>Artemisinins - administration & dosage</topic><topic>Artemisinins - adverse effects</topic><topic>artesunate</topic><topic>Biological and medical sciences</topic><topic>Comparative studies</topic><topic>Double-Blind Method</topic><topic>Drug Combinations</topic><topic>Drug therapy</topic><topic>Ethanolamines - administration & dosage</topic><topic>Ethanolamines - adverse effects</topic><topic>Female</topic><topic>Fever</topic><topic>Fluorenes - administration & dosage</topic><topic>Fluorenes - adverse effects</topic><topic>General aspects</topic><topic>Human protozoal diseases</topic><topic>Humans</topic><topic>India</topic><topic>Infectious diseases</topic><topic>lumefantrine</topic><topic>Malaria</topic><topic>Malaria, Falciparum - blood</topic><topic>Malaria, Falciparum - drug therapy</topic><topic>Malaria, Falciparum - parasitology</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Parasite Load</topic><topic>Parasitic diseases</topic><topic>Pharmacology. Drug treatments</topic><topic>Plasmodium falciparum</topic><topic>Plasmodium falciparum - isolation & purification</topic><topic>Protozoal diseases</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>uncomplicated Plasmodium falciparum malaria</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Pareek, Anil</creatorcontrib><creatorcontrib>Chandurkar, Nitin</creatorcontrib><creatorcontrib>Srivastav, Vipul</creatorcontrib><creatorcontrib>Lakhani, Jitendra</creatorcontrib><creatorcontrib>Karmakar, Partha S.</creatorcontrib><creatorcontrib>Basu, Subrata</creatorcontrib><creatorcontrib>Ray, Arnab</creatorcontrib><creatorcontrib>Pednekar, Sangeeta</creatorcontrib><creatorcontrib>Gupta, P. B.</creatorcontrib><creatorcontrib>Suthar, Nilay</creatorcontrib><creatorcontrib>Lakhani, Sucheta</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>Health and Safety Science Abstracts (Full archive)</collection><collection>Virology and AIDS Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>MEDLINE - Academic</collection><collection>Safety Science and Risk</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><jtitle>Tropical medicine & international health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Pareek, Anil</au><au>Chandurkar, Nitin</au><au>Srivastav, Vipul</au><au>Lakhani, Jitendra</au><au>Karmakar, Partha S.</au><au>Basu, Subrata</au><au>Ray, Arnab</au><au>Pednekar, Sangeeta</au><au>Gupta, P. B.</au><au>Suthar, Nilay</au><au>Lakhani, Sucheta</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparative evaluation of efficacy and safety of artesunate–lumefantrine vs. artemether–lumefantrine fixed‐dose combination in the treatment of uncomplicated Plasmodium falciparum malaria</atitle><jtitle>Tropical medicine & international health</jtitle><addtitle>Trop Med Int Health</addtitle><date>2013-05</date><risdate>2013</risdate><volume>18</volume><issue>5</issue><spage>578</spage><epage>587</epage><pages>578-587</pages><issn>1360-2276</issn><eissn>1365-3156</eissn><abstract>Objective
To establish efficacy and safety of artesunate/lumefantrine fixed‐dose combination (FDC) in comparison with artemether/lumefantrine FDC in treatment of uncomplicated Plasmodium falciparum malaria.
Methods
Confirmed cases of uncomplicated P. falciparum malaria were randomly assigned to receive artesunate (100 mg)/lumefantrine (480 mg) (ASLF FDC) or artemether (80 mg)/lumefantrine (480 mg) (AMLF FDC) tablets for 3 days. Patients were followed up on Day 7, 14, 21 and 28.
Results
Of the 158 enrolled patients, 144 completed the study. Seventy‐three patients (94.8%) from the ASLF group and 71 patients (94.7%) from the AMLF group showed parasite clearance within 48 h. The mean parasite clearance time was 25.40 ± 14.82 h in the ASLF group and 24 ± 13.32 h in the AMLF group (P = 0.542). All patients showed gametocyte clearance by Day 7 and remained gametocyte free till Day 28. Sixty‐five patients (84.4%) from the ASLF group and 56 patients (74.7%) from the AMLF group were afebrile within 24 h. The mean fever clearance time was 17.38 ± 12.33 h in the ASLF group and 17.2 ± 12.01 h in the AMLF group (P = 0.929). There was one early treatment failure in the AMLF group as per WHO criteria. Improvement in haemoglobin and haematocrit was comparable in both the treatment groups. In the ASLF group, of the 25 (32.47%) patients anaemic at baseline, only seven (9.09%) reported anaemia on Day 28, while in the AMLF group, of the 14 (18.67%) patients anaemic at baseline, only four (5.33%) reported anaemia on Day 28. Both study medications were well tolerated.
Conclusion
Artesunate (100 mg)/lumefantrine (480 mg) fixed‐dose combination could add one more option to currently available artemisinin combinations in treatment of uncomplicated P. falciparum malaria.
Objectif
Mesurer l'efficacité et la sécurité de combinaisons à dose fixe (CDF) d'artésunate/luméfantrine comparées à celles de la CDF d'artéméther/luméfantrine dans le traitement du paludisme non compliqué à
P
lasmodium falciparum.
Méthodes
Les cas confirmés de paludisme non compliqué à
P
. falciparum ont été randomisés pour recevoir soit des comprimés d'artésunate (100 mg)/luméfantrine (480 mg) (ASLF‐CDF) ou d'artéméther (80 mg)/luméfantrine (480 mg) (AMLF‐CDF) pendant 3 jours. Les patients ont été suivis jusqu'aux jours 7, 14, 21 et 28.
Résultats
Sur les 158 patients inscrits, 144 ont terminé l’étude. L’élimination des parasites a été observée dans les 48 heures chez 73 patients (94,8%) du groupe ASLF et 71 (94,7%) du groupe AMLF. Le temps moyen de clairance parasitaire était de 25,40 ± 14,82 h dans le groupe ASLF et 24 ± 13,32 h dans le groupe AMLF (P = 0,542). Tous les patients ont montré une clairance des gamétocytes au jour 7 et en sont restés exempts jusqu'au jour 28. 65 patients (84,4%) du groupe ASLF et 56 patients (74,7%) du groupe AMLF étaient non fébriles endéans les 24 heures. La durée moyenne pour la clairance de la fièvre était de 17,38 ± 12,33 h dans le groupe ASLF et 17,2 ± 12,01 h dans le groupe AMLF (P = 0,929). Il y a eu 1 cas d’échec thérapeutique précoce dans le groupe AMLF selon les critères de l’OMS. L'amélioration dans le taux d'hémoglobine et dans l'hématocrite était comparable dans les deux groupes de traitement. Dans le groupe ASLF, sur 25 (32,47%) patients anémiques au départ, seuls 7 (9,09%) ont rapporté de l'anémie au jour 28, alors que dans le groupe AMLF, sur 14 (18,67%) patients anémiques au départ, seuls 4 (5,33%) ont rapporté de l'anémie au jour 28. Les deux types de médicaments de l’étude ont été bien tolérés.
Conclusion
La CDF d’ASLF pourrait être une option additionnelle dans les combinaisons à base d'artémisinine actuellement disponibles dans le traitement du paludisme non compliqué à
P
. falciparum.
Objetivo
Establecer la eficacia y la seguridad de las combinaciones de dosis fija (CDF) de artesunato + lumefantrina, comparada con la CDF artemeter+lumefantrina en el tratamiento de la malaria no complicada por
P
lasmodium falciparum.
Métodos
Los casos confirmados de malaria no complicada por
P
. falciparum fueron asignados de forma aleatoria para recibir pastillas de artesunato (100 mg)/lumefantrina (480 mg) (CDF‐ASLF) o artemeter (80 mg)/lumefantrina (480 mg) (CDF‐AMLF) durante 3 días. Se realizó un seguimiento a los pacientes en los días 7, 14, 21 y 28.
Resultado
De los 158 pacientes incluidos en el estudio, 144 lo completaron. 73 pacientes (94.8%) del grupo ASLF y 71 pacientes (94.7%) del grupo AMLF estaban limpios de parásitos a las 48 h. El tiempo medio para la ausencia de parásitos era de 25.40 ± 14.82 h en el grupo ASLF y de 24 ± 13.32 h en el grupo AMLF (P = 0.542). Todos los pacientes estaban libres de gametocitos en el Día 7 y continuaban así hasta el Día 28. 65 pacientes (84.4) del grupo ASLF y 56 pacientes (74.7%) del grupo AMLF estuvieron afebriles dentro de las primeras 24 h. El tiempo medio para no tener fiebre era de 17.38 ± 12.33 h en el grupo ASLF y 17.2 ± 12.01 h en el grupo AMLF (P = 0.929). Hubo 1 fallo temprano en el tratamiento dentro del grupo AMLF según criterios de la OMS. La mejoría en la hemoglobina y el hematocrito era comparable en ambos grupos de tratamiento. En el grupo ASLF, de los 25 (32.47%) pacientes anémicos antes del tratamiento, solo 7 (9.09%) reportaron anemia a Día 28, mientras que en el grupo AMLF de los 14 (18.67%) pacientes anémicos antes de recibir tratamiento, solo 4 (5.33%) reportaron anemia a Día 28. Ambas medicaciones utilizadas en el estudio fueron bien toleradas.
Conclusión
La CDF ASLF podría ser una opción más a las combinaciones de artemisinina actualmente disponibles para el tratamiento de la malaria no complicada por
P
. falciparum.</abstract><cop>Oxford</cop><pub>Blackwell</pub><pmid>23489465</pmid><doi>10.1111/tmi.12088</doi><tpages>10</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1360-2276 |
| ispartof | Tropical medicine & international health, 2013-05, Vol.18 (5), p.578-587 |
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| language | eng |
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| source | MEDLINE; Access via Wiley Online Library; IngentaConnect Free/Open Access Journals; EZB-FREE-00999 freely available EZB journals; Wiley Online Library (Open Access Collection) |
| subjects | Adolescent Adult Aged Antibiotics. Antiinfectious agents. Antiparasitic agents Antimalarials - administration & dosage Antimalarials - adverse effects Antiparasitic agents artemether artemisinin combination therapies Artemisinins - administration & dosage Artemisinins - adverse effects artesunate Biological and medical sciences Comparative studies Double-Blind Method Drug Combinations Drug therapy Ethanolamines - administration & dosage Ethanolamines - adverse effects Female Fever Fluorenes - administration & dosage Fluorenes - adverse effects General aspects Human protozoal diseases Humans India Infectious diseases lumefantrine Malaria Malaria, Falciparum - blood Malaria, Falciparum - drug therapy Malaria, Falciparum - parasitology Male Medical sciences Middle Aged Parasite Load Parasitic diseases Pharmacology. Drug treatments Plasmodium falciparum Plasmodium falciparum - isolation & purification Protozoal diseases Time Factors Treatment Outcome uncomplicated Plasmodium falciparum malaria Young Adult |
| title | Comparative evaluation of efficacy and safety of artesunate–lumefantrine vs. artemether–lumefantrine fixed‐dose combination in the treatment of uncomplicated Plasmodium falciparum malaria |
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