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

Kimutai, Robert and Musa, Ahmed M and Njoroge, Simon and Omollo, Raymond and Alves, Fabiana and Hailu, Asrat and Khalil, Eltahir A G and Diro, Ermias and Soipei, Peninah and Musa, Brima and Salman, Khalid and Ritmeijer, Koert and Chappuis, Francois and Rashid, Juma and Mohammed, Rezika and Jameneh, Asfaw and Makonnen, Eyasu and Olobo, Joseph and Okello, Lawrence and Sagaki, Patrick and Strub, Nathalie and Ellis, Sally and Alvar, Jorge and Balasegaram, Manica and Alirol, Emilie and Wasunna, Monique (2017) Safety and Effectiveness of Sodium Stibogluconate and Paromomycin Combination for the Treatment of Visceral Leishmaniasis in Eastern Africa: Results from a Pharmacovigilance Programme. Clinical drug investigation, 37 (3). pp. 259-272. ISSN 1179-1918

[img]
Preview
Text
40261_2016_Article_481.pdf - Published Version

Download (582kB) | Preview

Abstract

INTRODUCTION In 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. METHODS A 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. RESULTS Overall 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. CONCLUSIONS This 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.

Item Type: Article
Subjects: R Medicine > RM Therapeutics. Pharmacology
Depositing User: Unnamed user with email almegdadsharaf@gmail.com
Date Deposited: 11 Jan 2018 15:34
Last Modified: 11 Jan 2018 15:34
URI: http://search.srh.edu.sd/id/eprint/2601

Actions (login required)

View Item View Item