PMID- 27724891
OWN - NLM
STAT- MEDLINE
DCOM- 20170531
LR  - 20220410
IS  - 1471-2334 (Electronic)
IS  - 1471-2334 (Linking)
VI  - 16
IP  - 1
DP  - 2016 Oct 10
TI  - Safety and efficacy of liposomal amphotericin B for treatment of complicated 
      visceral leishmaniasis in patients without HIV, North-West Ethiopia.
PG  - 548
LID - 548
AB  - BACKGROUND: Visceral leishmaniasis (VL) is a protozoan disease that is invariably 
      fatal if left untreated. The disease is found in 70 countries with incidence of 
      0.2 - 0.4 million cases. The mainstay of treatment in resource limited countries 
      like Ethiopia is antimonials, while use of liposomal amphotericin B is reserved 
      for treatment of complicated VL cases. The aim of this study was to assess the 
      safety and efficacy of liposomal amphotericin B in HIV negative VL patients 
      diagnosed with complications. METHODS: A retrospective chart review was conducted 
      involving records of patients admitted between January 2009 and December 2014. 
      Baseline sociodemographic, clinical, and treatment outcome data were collected. 
      The doses of liposomal amphotericin B and adverse events related to treatment 
      were retrieved. Categorical and continuous variables respectively were analyzed 
      by Chi-square and Mann-Whitney U tests. A p-value of less than 0.05 was 
      considered statistically significant. RESULTS: A total of 147 patients with 
      severe VL were treated with liposomal amphotericin B in total dose ranges of 
      20 mg/kg to 35 mg/kg. In the overall treatment outcome analysis, initial cure 
      (30 days after start of treatment) was observed in 128 (87.1 %), treatment 
      failures in 10 (6.8 %), interruptions in 2(1.4 %) and deaths in 7 (4.8 %) 
      patients. Initial cure rate at high dose (24-35 mg/kg total dose) was 96.7 % 
      (59/61) versus 80.2 % (69/86) at lower doses (<24 mg/kg); which was significantly 
      higher (P < 0.01), OR = 4.56: 95 %, Confidence Interval (CI) = 1.17 - 20.78). Ten 
      cases (11.8 %) of treatment failure occurred in the low dose treatment group. The 
      most common adverse events (AEs) were hypokalemia in 39 cases (26.5 %) and 
      infusion related reactions in 16 (10.9 %). The frequency of hypokalemia and 
      infusion related reactions were not significantly different between the low and 
      high dose liposomal amphotericin B. CONCLUSION: In HIV negative complicated VL 
      patients, high dose of liposomal amphotericin B was found to have high cure rate 
      at the end of treatment. The appropriate dose for better efficacy needs to be 
      determined. Monitoring serum potassium level during treatment with liposomal 
      amphotericin B should be an essential component of the clinical management of VL.
FAU - Tamiru, Aschalew
AU  - Tamiru A
AD  - Leishmaniasis Research and Treatment Center, University of Gondar, College of 
      Medicine and Health Science, Gondar, Ethiopia. aschex2006@yahoo.com.
FAU - Tigabu, Bethlehem
AU  - Tigabu B
AD  - Tuberculosis Clinic, University of Gondar, College of Medicine and Health 
      Science, Gondar, Ethiopia.
FAU - Yifru, Sisay
AU  - Yifru S
AD  - Department of Pediatrics, University of Gondar, College of Medicine and Health 
      Science, Gondar, Ethiopia.
FAU - Diro, Ermias
AU  - Diro E
AD  - Department of Internal Medicine, University of Gondar, College of Medicine and 
      Health Science, Gondar, Ethiopia.
FAU - Hailu, Asrat
AU  - Hailu A
AD  - Department of Microbiology, Immunology and Parasitology, College of Health 
      Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
LA  - eng
PT  - Journal Article
DEP - 20161010
PL  - England
TA  - BMC Infect Dis
JT  - BMC infectious diseases
JID - 100968551
RN  - 0 (Antiprotozoal Agents)
RN  - 0 (liposomal amphotericin B)
RN  - 7XU7A7DROE (Amphotericin B)
SB  - IM
MH  - Adult
MH  - Amphotericin B/*therapeutic use
MH  - Antiprotozoal Agents/*therapeutic use
MH  - Drug Administration Schedule
MH  - Ethiopia
MH  - Female
MH  - Follow-Up Studies
MH  - HIV Infections
MH  - Humans
MH  - Leishmaniasis, Visceral/*drug therapy
MH  - Male
MH  - Retrospective Studies
MH  - Treatment Outcome
PMC - PMC5057416
OTO - NOTNLM
OT  - Efficacy
OT  - Liposomal amphotericin B
OT  - Safety
OT  - Visceral leishmaniasis
EDAT- 2016/10/12 06:00
MHDA- 2017/06/01 06:00
PMCR- 2016/10/10
CRDT- 2016/10/12 06:00
PHST- 2015/12/31 00:00 [received]
PHST- 2016/08/03 00:00 [accepted]
PHST- 2016/10/12 06:00 [entrez]
PHST- 2016/10/12 06:00 [pubmed]
PHST- 2017/06/01 06:00 [medline]
PHST- 2016/10/10 00:00 [pmc-release]
AID - 10.1186/s12879-016-1746-1 [pii]
AID - 1746 [pii]
AID - 10.1186/s12879-016-1746-1 [doi]
PST - epublish
SO  - BMC Infect Dis. 2016 Oct 10;16(1):548. doi: 10.1186/s12879-016-1746-1.