Evidence map›Paper›PMID 28066878›Full record

ArticleClinical drug investigation2017

Safety and Effectiveness of Sodium Stibogluconate and Paromomycin Combination for the Treatment of Visceral Leishmaniasis in Eastern Africa: Results from a Pharmacovigilance Programme.

Robert Kimutai, Ahmed M Musa, Simon Njoroge, Raymond Omollo, Fabiana Alves, Asrat Hailu, Eltahir A G Khalil, Ermias Diro, Peninah Soipei, Brima Musa and 16 more

Open access · hybridAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Clinical drug investigation, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 5 pooled it
6.4field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 5 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
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  6. Review
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  10. Article
  11. Article
  12. Exploration of Antileishmanial Compounds Derived from Natural Sources.Anti-inflammatory & anti-allergy agents in medicinal chemistry · 2024
    Review
  13. Article
  14. Article
  15. Article
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  19. Epidemiological features of cutaneous leishmaniasis endemic in hilly areas of district Karak, Khyber-Pakhtunkhwa province of Pakistan.Journal of parasitic diseases : official organ of the Indian Society for Parasitology · 2020
    Article
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 10 institutions in 5 countries.

Robert KimutaiCentre for Clinical Research, Kenya Medical Research Institute, PO Box 20778-00202, Off Mbagathi Rd, Nairobi, Kenya. rkimutai@dndi.org.ORCID http://orcid.org/0000-0002-1039-378X
Ahmed M MusaInstitute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Simon NjorogeCentre for Clinical Research, Kenya Medical Research Institute, PO Box 20778-00202, Off Mbagathi Rd, Nairobi, Kenya.
Raymond OmolloDrugs for Neglected Diseases Initiative (DNDi), Nairobi, Kenya.
Fabiana AlvesDrugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland.
Asrat HailuSchool of Medicine, Addis Ababa University, Addis Ababa, Ethiopia.
Eltahir A G KhalilInstitute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Ermias DiroUniversity of Gondar, Gondar, Ethiopia.
Peninah SoipeiDrugs for Neglected Diseases Initiative (DNDi), Nairobi, Kenya.
Brima MusaInstitute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Khalid SalmanInstitute of Endemic Diseases, University of Khartoum, Khartoum, Sudan.
Koert RitmeijerMédecins Sans Frontières, Geneva, Switzerland.
Francois ChappuisMédecins Sans Frontières, Geneva, Switzerland.
Juma RashidCentre for Clinical Research, Kenya Medical Research Institute, PO Box 20778-00202, Off Mbagathi Rd, Nairobi, Kenya.
Rezika MohammedUniversity of Gondar, Gondar, Ethiopia.
Asfaw JamenehArba Minch Hospital, Regional Health Bureau of SNNPR State, Arba Minch, Ethiopia.
Eyasu MakonnenSchool of Medicine, Addis Ababa University, Addis Ababa, Ethiopia.
Joseph OloboMakerere University, Kampala, Uganda.
Lawrence OkelloAmudat Hospital, Amudat, Uganda.
Patrick SagakiAmudat Hospital, Amudat, Uganda.
Nathalie StrubDrugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland.
Sally EllisDrugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland.
Jorge AlvarDrugs for Neglected Diseases Initiative (DNDi), Geneva, Switzerland.
Manica BalasegaramMSF Access Campaign, Geneva, Switzerland.
Emilie AlirolMédecins Sans Frontières, Geneva, Switzerland.
Monique WasunnaCentre for Clinical Research, Kenya Medical Research Institute, PO Box 20778-00202, Off Mbagathi Rd, Nairobi, Kenya.
Drugs for Neglected Diseases Initiative · CHUniversity of Khartoum · SDKenya Medical Research Institute · KEAddis Ababa University · ETKenya AIDS Vaccine Initiative · KEUniversity Hospital of Geneva · CHUniversity of Gondar · ETMakerere University · UGMédecins Sans Frontières · CHSouthern Nations, Nationalities, and Peoples' Region · ET

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn 2010, WHO recommended a new first-line treatment for visceral leishmaniasis (VL) in Eastern Africa. The new treatment, a combination of intravenous (IV) or intramuscular (IM) sodium stibogluconate (SSG) and IM paromomycin (PM) was an improvement over SSG monotherapy, the previous first-line VL treatment in the region. To monitor the new treatment's safety and effectiveness in routine clinical practice a pharmacovigilance (PV) programme was developed.

methodsA prospective PV cohort was developed. Regulatory approval was obtained in Sudan, Kenya, Uganda and Ethiopia. Twelve sentinel sites sponsored by the Ministries of Health, Médecins Sans Frontières (MSF) and Drugs for Neglected Diseases initiative (DNDi) participated. VL patients treated using the new treatment were consented and included in a common registry that collected demographics, baseline clinical characteristics, adverse events, serious adverse events and treatment outcomes. Six-monthly periodic safety update reports (PSUR) were prepared and reviewed by a PV steering committee.

resultsOverall 3126 patients were enrolled: 1962 (62.7%) from Sudan, 652 (20.9%) from Kenya, 322 (10.3%) from Ethiopia and 190 (6.1%) from Uganda. Patients were mostly male children (68.1%, median age 11 years) with primary VL (97.8%). SSG-PM initial cure rate was 95.1%; no geographical differences were noted. HIV/VL co-infected patients and patients older than 50 years had initial cure rates of 56 and 81.4%, respectively, while 1063 (34%) patients had at least one adverse event (AE) during treatment and 1.92% (n = 60) had a serious adverse event (SAE) with a mortality of 1.0% (n = 32). There were no serious unexpected adverse drug reactions.

conclusionsThis first regional PV programme in VL supports SSG-PM combination as first-line treatment for primary VL in Eastern Africa. SSG-PM was effective and safe except in HIV/VL co-infected or older patients. Active PV surveillance of targeted safety, effectiveness and key VL outcomes such us VL relapse, PKDL and HIV/VL co-infection should continue and PV data integrated to national and WHO PV databases.

Indexed as

Administration, IntravenousAdolescentAdultAfrica, EasternAntimony Sodium GluconateAntiprotozoal AgentsChildChild, PreschoolCoinfectionDrug Therapy, CombinationFemaleHIV InfectionsHumansLeishmaniasis, VisceralMaleMiddle AgedAntimony Sodium GluconateAntiprotozoal AgentsParomomycin

Identifiers

PMID28066878
PMCPMC5315726
OpenAlexW2568800115

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.