PMID- 15049459
OWN - NLM
STAT- MEDLINE
DCOM- 20040524
LR  - 20190513
IS  - 0035-9203 (Print)
IS  - 0035-9203 (Linking)
VI  - 98
IP  - 4
DP  - 2004 Apr
TI  - 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.
PG  - 205-17
AB  - 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.
FAU - Kshirsagar, N A
AU  - Kshirsagar NA
AD  - Department of Clinical Pharmacology, New MS Building, 1st Floor, Seth GS Medical 
      College & KEM Hospital, Parel, Mumbai 400 012, India. dcpkem@vsnl.com
FAU - Gogtay, N J
AU  - Gogtay NJ
FAU - Garg, B S
AU  - Garg BS
FAU - Deshmukh, P R
AU  - Deshmukh PR
FAU - Rajgor, D D
AU  - Rajgor DD
FAU - Kadam, V S
AU  - Kadam VS
FAU - Kirodian, B G
AU  - Kirodian BG
FAU - Ingole, N S
AU  - Ingole NS
FAU - Mehendale, A M
AU  - Mehendale AM
FAU - Fleckenstein, L
AU  - Fleckenstein L
FAU - Karbwang, J
AU  - Karbwang J
FAU - Lazdins-Helds, J K
AU  - Lazdins-Helds JK
LA  - eng
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Trans R Soc Trop Med Hyg
JT  - Transactions of the Royal Society of Tropical Medicine and Hygiene
JID - 7506129
RN  - 0 (Filaricides)
RN  - F4216019LN (Albendazole)
RN  - V867Q8X3ZD (Diethylcarbamazine)
SB  - IM
EIN - Trans R Soc Trop Med Hyg. 2004 May;98(5):329
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Albendazole/*administration & dosage/adverse effects/blood
MH  - Child
MH  - Child, Preschool
MH  - Diethylcarbamazine/*administration & dosage/adverse effects/blood
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Elephantiasis, Filarial/blood/*drug therapy/epidemiology
MH  - *Endemic Diseases
MH  - Female
MH  - Filaricides/*administration & dosage/adverse effects/blood
MH  - Humans
MH  - India/epidemiology
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
EDAT- 2004/03/31 05:00
MHDA- 2004/05/25 05:00
CRDT- 2004/03/31 05:00
PHST- 2004/03/31 05:00 [pubmed]
PHST- 2004/05/25 05:00 [medline]
PHST- 2004/03/31 05:00 [entrez]
AID - S0035920303000440 [pii]
AID - 10.1016/s0035-9203(03)00044-0 [doi]
PST - ppublish
SO  - Trans R Soc Trop Med Hyg. 2004 Apr;98(4):205-17. doi: 
      10.1016/s0035-9203(03)00044-0.