Title |
Safety and Effectiveness of Sodium Stibogluconate and Paromomycin Combination for the Treatment of Visceral Leishmaniasis in Eastern Africa: Results from a Pharmacovigilance Programme
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Published in |
Clinical Drug Investigation, January 2017
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DOI | 10.1007/s40261-016-0481-0 |
Pubmed ID | |
Authors |
Robert Kimutai, Ahmed M. Musa, Simon Njoroge, Raymond Omollo, Fabiana Alves, Asrat Hailu, Eltahir A. G. Khalil, Ermias Diro, Peninah Soipei, Brima Musa, Khalid Salman, Koert Ritmeijer, Francois Chappuis, Juma Rashid, Rezika Mohammed, Asfaw Jameneh, Eyasu Makonnen, Joseph Olobo, Lawrence Okello, Patrick Sagaki, Nathalie Strub, Sally Ellis, Jorge Alvar, Manica Balasegaram, Emilie Alirol, Monique Wasunna |
Abstract |
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. 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. 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. 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. |
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Geographical breakdown
Country | Count | As % |
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United Kingdom | 4 | 67% |
United States | 1 | 17% |
Unknown | 1 | 17% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 5 | 83% |
Science communicators (journalists, bloggers, editors) | 1 | 17% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
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Switzerland | 1 | <1% |
Unknown | 185 | 99% |
Demographic breakdown
Readers by professional status | Count | As % |
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Student > Master | 29 | 16% |
Student > Ph. D. Student | 29 | 16% |
Researcher | 24 | 13% |
Student > Bachelor | 15 | 8% |
Student > Postgraduate | 11 | 6% |
Other | 23 | 12% |
Unknown | 55 | 30% |
Readers by discipline | Count | As % |
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Medicine and Dentistry | 46 | 25% |
Pharmacology, Toxicology and Pharmaceutical Science | 16 | 9% |
Nursing and Health Professions | 11 | 6% |
Biochemistry, Genetics and Molecular Biology | 9 | 5% |
Agricultural and Biological Sciences | 8 | 4% |
Other | 32 | 17% |
Unknown | 64 | 34% |