Safety, tolerability, efficacy and plasma concentrations of diethylcarbamazine and albendazole co-administration in a field study in an area endemic for lymphatic filariasis in India.
Identifieur interne : 003A40 ( PubMed/Checkpoint ); précédent : 003A39; suivant : 003A41Safety, tolerability, efficacy and plasma concentrations of diethylcarbamazine and albendazole co-administration in a field study in an area endemic for lymphatic filariasis in India.
Auteurs : N A Kshirsagar [Inde] ; N J Gogtay ; B S Garg ; P R Deshmukh ; D D Rajgor ; V S Kadam ; B G Kirodian ; N S Ingole ; A M Mehendale ; L. Fleckenstein ; J. Karbwang ; J K Lazdins-HeldsSource :
- Transactions of the Royal Society of Tropical Medicine and Hygiene [ 0035-9203 ] ; 2004.
Descripteurs français
- KwdFr :
- Adolescent, Adulte, Adulte d'âge moyen, Albendazole (administration et posologie), Albendazole (effets indésirables), Albendazole (sang), Association de médicaments, Diéthylcarbamazine (administration et posologie), Diéthylcarbamazine (effets indésirables), Diéthylcarbamazine (sang), Enfant, Enfant d'âge préscolaire, Femelle, Filaricides (administration et posologie), Filaricides (effets indésirables), Filaricides (sang), Filariose lymphatique (sang), Filariose lymphatique (traitement médicamenteux), Filariose lymphatique (épidémiologie), Humains, Inde (épidémiologie), Maladies endémiques, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus.
- MESH :
- administration et posologie : Albendazole, Diéthylcarbamazine, Filaricides.
- effets indésirables : Albendazole, Diéthylcarbamazine, Filaricides.
- sang : Albendazole, Diéthylcarbamazine, Filaricides, Filariose lymphatique.
- traitement médicamenteux : Filariose lymphatique.
- épidémiologie : Filariose lymphatique, Inde.
- Adolescent, Adulte, Adulte d'âge moyen, Association de médicaments, Enfant, Enfant d'âge préscolaire, Femelle, Humains, Maladies endémiques, Mâle, Méthode en double aveugle, Résultat thérapeutique, Sujet âgé, Sujet âgé de 80 ans ou plus.
- Wicri :
- geographic : Inde.
English descriptors
- KwdEn :
- Adolescent, Adult, Aged, Aged, 80 and over, Albendazole (administration & dosage), Albendazole (adverse effects), Albendazole (blood), Child, Child, Preschool, Diethylcarbamazine (administration & dosage), Diethylcarbamazine (adverse effects), Diethylcarbamazine (blood), Double-Blind Method, Drug Therapy, Combination, Elephantiasis, Filarial (blood), Elephantiasis, Filarial (drug therapy), Elephantiasis, Filarial (epidemiology), Endemic Diseases, Female, Filaricides (administration & dosage), Filaricides (adverse effects), Filaricides (blood), Humans, India (epidemiology), Male, Middle Aged, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Albendazole, Diethylcarbamazine, Filaricides.
- chemical , adverse effects : Albendazole, Diethylcarbamazine, Filaricides.
- chemical , blood : Albendazole, Diethylcarbamazine, Filaricides.
- geographic , epidemiology : India.
- blood : Elephantiasis, Filarial.
- drug therapy : Elephantiasis, Filarial.
- epidemiology : Elephantiasis, Filarial.
- Adolescent, Adult, Aged, Aged, 80 and over, Child, Child, Preschool, Double-Blind Method, Drug Therapy, Combination, Endemic Diseases, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
Filariasis control programmes are moving towards a strategy of repeated single-dose mass treatment of endemic populations. Using a combination, such as albendazole (ALB) to diethylcarbamazine (DEC) gives both macrofilaricidal and anti-helmintic activity. However, the safety of the combination versus DEC alone should be established in field studies in large populations prior to incorporation into national programmes. The present study compared the safety, tolerability, and efficacy of single doses of DEC 6 mg/kg + ALB placebo with DEC 6 mg/kg + ALB 400 mg in populations living in two filariasis endemic villages in the district of Wardha in western India. The study was double blind, parallel group, and randomized. Safety and tolerability study were studied in males and females older than 5 years. Safety was assessed by monitoring if adverse events (AEs) over 5 days affected daily acivities. Subjects in the 2 treatment groups experienced insignificantly different effects on daily activities and the combination was shown to be safe. Efficacy was evaluated by microfilaraemia (Mf), immunochromatographic test (ICT) and ultrasonography (USG) at 0, 3, 6, and 12 months of follow up. The efficacy study enrolled 103 male patients (aged 18-50 years) in microfilariae positive, clinical disease and asymptomatic, amicrofilaremic groups. There was no significant difference in efficacy between groups at 12 months. Within the Mf positive group, significant differences were seen in microfilaraemia (P < 0.001) with both treatments, and in USG (P < 0.001 and P < 0.004 respectively), at 12 months. The present field study has shown the combination of DEC + ALB to be as safe as the single drug DEC and thus the combination can be put in use in the national filariasis control programmes. Both drugs were adequately absorbed. The study at present does not provide evidence for the greater efficacy of the combination at 12 months follow up. While the safety of the combination has been ascertained, the incorporation or otherwise of ALB into national programmes for greater efficacy must await results of studies with longer follow up.
PubMed: 15049459
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Filarial (blood)</term><term>Elephantiasis, Filarial (drug therapy)</term><term>Elephantiasis, Filarial (epidemiology)</term><term>Endemic Diseases</term><term>Female</term><term>Filaricides (administration & dosage)</term><term>Filaricides (adverse effects)</term><term>Filaricides (blood)</term><term>Humans</term><term>India (epidemiology)</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adolescent</term><term>Adulte</term><term>Adulte d'âge moyen</term><term>Albendazole (administration et posologie)</term><term>Albendazole (effets indésirables)</term><term>Albendazole (sang)</term><term>Association de médicaments</term><term>Diéthylcarbamazine (administration et posologie)</term><term>Diéthylcarbamazine (effets indésirables)</term><term>Diéthylcarbamazine (sang)</term><term>Enfant</term><term>Enfant d'âge préscolaire</term><term>Femelle</term><term>Filaricides (administration et 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préscolaire</term><term>Femelle</term><term>Humains</term><term>Maladies endémiques</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Sujet âgé</term><term>Sujet âgé de 80 ans ou plus</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Inde</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Filariasis control programmes are moving towards a strategy of repeated single-dose mass treatment of endemic populations. Using a combination, such as albendazole (ALB) to diethylcarbamazine (DEC) gives both macrofilaricidal and anti-helmintic activity. However, the safety of the combination versus DEC alone should be established in field studies in large populations prior to incorporation into national programmes. The present study compared the safety, tolerability, and efficacy of single doses of DEC 6 mg/kg + ALB placebo with DEC 6 mg/kg + ALB 400 mg in populations living in two filariasis endemic villages in the district of Wardha in western India. The study was double blind, parallel group, and randomized. Safety and tolerability study were studied in males and females older than 5 years. Safety was assessed by monitoring if adverse events (AEs) over 5 days affected daily acivities. Subjects in the 2 treatment groups experienced insignificantly different effects on daily activities and the combination was shown to be safe. Efficacy was evaluated by microfilaraemia (Mf), immunochromatographic test (ICT) and ultrasonography (USG) at 0, 3, 6, and 12 months of follow up. The efficacy study enrolled 103 male patients (aged 18-50 years) in microfilariae positive, clinical disease and asymptomatic, amicrofilaremic groups. There was no significant difference in efficacy between groups at 12 months. Within the Mf positive group, significant differences were seen in microfilaraemia (P < 0.001) with both treatments, and in USG (P < 0.001 and P < 0.004 respectively), at 12 months. The present field study has shown the combination of DEC + ALB to be as safe as the single drug DEC and thus the combination can be put in use in the national filariasis control programmes. Both drugs were adequately absorbed. The study at present does not provide evidence for the greater efficacy of the combination at 12 months follow up. While the safety of the combination has been ascertained, the incorporation or otherwise of ALB into national programmes for greater efficacy must await results of studies with longer follow up.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">15049459</PMID><DateCreated><Year>2004</Year><Month>03</Month><Day>30</Day></DateCreated><DateCompleted><Year>2004</Year><Month>05</Month><Day>24</Day></DateCompleted><DateRevised><Year>2013</Year><Month>11</Month><Day>21</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Print">0035-9203</ISSN><JournalIssue CitedMedium="Print"><Volume>98</Volume><Issue>4</Issue><PubDate><Year>2004</Year><Month>Apr</Month></PubDate></JournalIssue><Title>Transactions of the Royal Society of Tropical Medicine and Hygiene</Title><ISOAbbreviation>Trans. R. Soc. Trop. Med. Hyg.</ISOAbbreviation></Journal><ArticleTitle>Safety, tolerability, efficacy and plasma concentrations of diethylcarbamazine and albendazole co-administration in a field study in an area endemic for lymphatic filariasis in India.</ArticleTitle><Pagination><MedlinePgn>205-17</MedlinePgn></Pagination><Abstract><AbstractText>Filariasis control programmes are moving towards a strategy of repeated single-dose mass treatment of endemic populations. Using a combination, such as albendazole (ALB) to diethylcarbamazine (DEC) gives both macrofilaricidal and anti-helmintic activity. However, the safety of the combination versus DEC alone should be established in field studies in large populations prior to incorporation into national programmes. The present study compared the safety, tolerability, and efficacy of single doses of DEC 6 mg/kg + ALB placebo with DEC 6 mg/kg + ALB 400 mg in populations living in two filariasis endemic villages in the district of Wardha in western India. The study was double blind, parallel group, and randomized. Safety and tolerability study were studied in males and females older than 5 years. Safety was assessed by monitoring if adverse events (AEs) over 5 days affected daily acivities. Subjects in the 2 treatment groups experienced insignificantly different effects on daily activities and the combination was shown to be safe. Efficacy was evaluated by microfilaraemia (Mf), immunochromatographic test (ICT) and ultrasonography (USG) at 0, 3, 6, and 12 months of follow up. The efficacy study enrolled 103 male patients (aged 18-50 years) in microfilariae positive, clinical disease and asymptomatic, amicrofilaremic groups. There was no significant difference in efficacy between groups at 12 months. Within the Mf positive group, significant differences were seen in microfilaraemia (P < 0.001) with both treatments, and in USG (P < 0.001 and P < 0.004 respectively), at 12 months. The present field study has shown the combination of DEC + ALB to be as safe as the single drug DEC and thus the combination can be put in use in the national filariasis control programmes. Both drugs were adequately absorbed. The study at present does not provide evidence for the greater efficacy of the combination at 12 months follow up. While the safety of the combination has been ascertained, the incorporation or otherwise of ALB into national programmes for greater efficacy must await results of studies with longer follow up.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Kshirsagar</LastName><ForeName>N A</ForeName><Initials>NA</Initials><AffiliationInfo><Affiliation>Department of Clinical Pharmacology, New MS Building, 1st Floor, Seth GS Medical College & KEM Hospital, Parel, Mumbai 400 012, India. dcpkem@vsnl.com</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gogtay</LastName><ForeName>N J</ForeName><Initials>NJ</Initials></Author><Author ValidYN="Y"><LastName>Garg</LastName><ForeName>B S</ForeName><Initials>BS</Initials></Author><Author ValidYN="Y"><LastName>Deshmukh</LastName><ForeName>P R</ForeName><Initials>PR</Initials></Author><Author ValidYN="Y"><LastName>Rajgor</LastName><ForeName>D D</ForeName><Initials>DD</Initials></Author><Author ValidYN="Y"><LastName>Kadam</LastName><ForeName>V S</ForeName><Initials>VS</Initials></Author><Author ValidYN="Y"><LastName>Kirodian</LastName><ForeName>B G</ForeName><Initials>BG</Initials></Author><Author ValidYN="Y"><LastName>Ingole</LastName><ForeName>N S</ForeName><Initials>NS</Initials></Author><Author ValidYN="Y"><LastName>Mehendale</LastName><ForeName>A M</ForeName><Initials>AM</Initials></Author><Author ValidYN="Y"><LastName>Fleckenstein</LastName><ForeName>L</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Karbwang</LastName><ForeName>J</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Lazdins-Helds</LastName><ForeName>J K</ForeName><Initials>JK</Initials></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016430">Clinical Trial</PublicationType><PublicationType UI="D003160">Comparative Study</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trans R Soc Trop Med Hyg</MedlineTA><NlmUniqueID>7506129</NlmUniqueID><ISSNLinking>0035-9203</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D005369">Filaricides</NameOfSubstance></Chemical><Chemical><RegistryNumber>F4216019LN</RegistryNumber><NameOfSubstance UI="D015766">Albendazole</NameOfSubstance></Chemical><Chemical><RegistryNumber>V867Q8X3ZD</RegistryNumber><NameOfSubstance UI="D004049">Diethylcarbamazine</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="ErratumIn"><RefSource>Trans R Soc Trop Med Hyg. 2004 May;98(5):329</RefSource></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015766" MajorTopicYN="N">Albendazole</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D002648" MajorTopicYN="N">Child</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D002675" MajorTopicYN="N">Child, Preschool</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004049" MajorTopicYN="N">Diethylcarbamazine</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004359" MajorTopicYN="N">Drug Therapy, Combination</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004605" MajorTopicYN="N">Elephantiasis, Filarial</DescriptorName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D019353" MajorTopicYN="Y">Endemic Diseases</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005369" MajorTopicYN="N">Filaricides</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName><QualifierName UI="Q000097" MajorTopicYN="N">blood</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007194" MajorTopicYN="N" Type="Geographic">India</DescriptorName><QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="pubmed"><Year>2004</Year><Month>3</Month><Day>31</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2004</Year><Month>5</Month><Day>25</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2004</Year><Month>3</Month><Day>31</Day><Hour>5</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">15049459</ArticleId><ArticleId IdType="pii">S0035920303000440</ArticleId></ArticleIdList></PubmedData></pubmed><affiliations><list><country><li>Inde</li></country></list><tree><noCountry><name sortKey="Deshmukh, P R" sort="Deshmukh, P R" uniqKey="Deshmukh P" first="P R" last="Deshmukh">P R Deshmukh</name><name sortKey="Fleckenstein, L" sort="Fleckenstein, L" uniqKey="Fleckenstein L" first="L" last="Fleckenstein">L. Fleckenstein</name><name sortKey="Garg, B S" sort="Garg, B S" uniqKey="Garg B" first="B S" last="Garg">B S Garg</name><name sortKey="Gogtay, N J" sort="Gogtay, N J" uniqKey="Gogtay N" first="N J" last="Gogtay">N J Gogtay</name><name sortKey="Ingole, N S" sort="Ingole, N S" uniqKey="Ingole N" first="N S" last="Ingole">N S Ingole</name><name sortKey="Kadam, V S" sort="Kadam, V S" uniqKey="Kadam V" first="V S" last="Kadam">V S Kadam</name><name sortKey="Karbwang, J" sort="Karbwang, J" uniqKey="Karbwang J" first="J" last="Karbwang">J. Karbwang</name><name sortKey="Kirodian, B G" sort="Kirodian, B G" uniqKey="Kirodian B" first="B G" last="Kirodian">B G Kirodian</name><name sortKey="Lazdins Helds, J K" sort="Lazdins Helds, J K" uniqKey="Lazdins Helds J" first="J K" last="Lazdins-Helds">J K Lazdins-Helds</name><name sortKey="Mehendale, A M" sort="Mehendale, A M" uniqKey="Mehendale A" first="A M" last="Mehendale">A M Mehendale</name><name sortKey="Rajgor, D D" sort="Rajgor, D D" uniqKey="Rajgor D" first="D D" last="Rajgor">D D Rajgor</name></noCountry><country name="Inde"><noRegion><name sortKey="Kshirsagar, N A" sort="Kshirsagar, N A" uniqKey="Kshirsagar N" first="N A" last="Kshirsagar">N A Kshirsagar</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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