Safety and Effectiveness of Sodium Stibogluconate and Paromomycin Combination for the Treatment of Visceral Leishmaniasis in Eastern Africa: Results from a Pharmacovigilance Programme
| العنوان: | 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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| المؤلفون: | Fabiana Alves, Joseph Olobo, Khalid Salman, Eltahir A G Khalil, Jorge Alvar, Manica Balasegaram, Nathalie Strub, Brima Musa, Simon Njoroge, Peninah Soipei, Patrick Sagaki, Lawrence Okello, François Chappuis, Ermias Diro, Robert Kimutai, Monique Wasunna, Emilie Alirol, Rezika Mohammed, Raymond Omollo, Asrat Hailu, J. R. Rashid, Asfaw Jameneh, Sally Ellis, Eyasu Makonnen, Koert Ritmeijer, Ahmed Eleojo Musa |
| المصدر: | Clinical Drug Investigation |
| بيانات النشر: | Springer Science and Business Media LLC, 2017. |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Adult, Male, medicine.medical_specialty, Adolescent, Paromomycin, Sodium stibogluconate, 030231 tropical medicine, Pharmacology toxicology, Antiprotozoal Agents, HIV Infections, Pharmacology, Pharmacovigilance, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Pharmacotherapy, Recurrence, Internal medicine, parasitic diseases, medicine, Humans, Pharmacology (medical), Routine clinical practice, Original Research Article, Prospective Studies, 030212 general & internal medicine, Child, Coinfection, business.industry, General Medicine, Africa, Eastern, Middle Aged, medicine.disease, Treatment Outcome, Visceral leishmaniasis, Antimony Sodium Gluconate, Child, Preschool, Leishmaniasis, Visceral, Administration, Intravenous, Drug Therapy, Combination, Female, business, medicine.drug |
| الوصف: | 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. |
| تدمد: | 1179-1918 1173-2563 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b725ac4954e6224f92ed329886b3897dTest https://doi.org/10.1007/s40261-016-0481-0Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....b725ac4954e6224f92ed329886b3897d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 11791918 11732563 |
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