دورية أكاديمية
أعرض في EDS

Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials.

التفاصيل البيبلوغرافية
العنوان: Safety of single low-dose primaquine in glucose-6-phosphate dehydrogenase deficient falciparum-infected African males: Two open-label, randomized, safety trials.
المؤلفون: Bastiaens GJH; Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands., Tiono AB; Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso., Okebe J; Disease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia., Pett HE; Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.; Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Coulibaly SA; Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso., Gonçalves BP; Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London, United Kingdom., Affara M; Disease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia., Ouédraogo A; Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso., Bougouma EC; Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso., Sanou GS; Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso., Nébié I; Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso., Bradley J; MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom., Lanke KHW; Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands., Niemi M; Department of Clinical Pharmacology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Sirima SB; Department of Biomedical Sciences, Centre National de Recherche et de Formation sur le Paludisme, Ouagadougou, Burkina Faso., d'Alessandro U; Disease Control & Elimination Theme, Medical Research Council Unit, Fajara, The Gambia.; Department of Disease Control, Faculty of infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, United Kingdom., Bousema T; Department of Medical Microbiology, Radboud University Medical Center, Nijmegen, the Netherlands.; Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London, United Kingdom., Drakeley C; Department of Immunology and Infection, London School of Hygiene and Tropical Medicine, London, United Kingdom.
المصدر: PloS one [PLoS One] 2018 Jan 11; Vol. 13 (1), pp. e0190272. Date of Electronic Publication: 2018 Jan 11 (Print Publication: 2018).
نوع المنشور: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
أسماء مطبوعة: Original Publication: San Francisco, CA : Public Library of Science
مواضيع طبية MeSH: Antimalarials/*administration & dosage , Glucosephosphate Dehydrogenase/*genetics , Malaria, Falciparum/*drug therapy , Primaquine/*administration & dosage, Adult ; Antimalarials/adverse effects ; Burkina Faso ; Humans ; Male ; Primaquine/adverse effects ; Young Adult
مستخلص: Background: Primaquine (PQ) actively clears mature Plasmodium falciparum gametocytes but in glucose-6-phosphate dehydrogenase deficient (G6PDd) individuals can cause hemolysis. We assessed the safety of low-dose PQ in combination with artemether-lumefantrine (AL) or dihydroartemisinin-piperaquine (DP) in G6PDd African males with asymptomatic P. falciparum malaria.
Methods and Findings: In Burkina Faso, G6PDd adult males were randomized to treatment with AL alone (n = 10) or with PQ at 0.25 (n = 20) or 0.40 mg/kg (n = 20) dosage; G6PD-normal males received AL plus 0.25 (n = 10) or 0.40 mg/kg (n = 10) PQ. In The Gambia, G6PDd adult males and boys received DP alone (n = 10) or with 0.25 mg/kg PQ (n = 20); G6PD-normal males received DP plus 0.25 (n = 10) or 0.40 mg/kg (n = 10) PQ. The primary study endpoint was change in hemoglobin concentration during the 28-day follow-up. Cytochrome P-450 isoenzyme 2D6 (CYP2D6) metabolizer status, gametocyte carriage, haptoglobin, lactate dehydrogenase levels and reticulocyte counts were also determined. In Burkina Faso, the mean maximum absolute change in hemoglobin was -2.13 g/dL (95% confidence interval [CI], -2.78, -1.49) in G6PDd individuals randomized to 0.25 PQ mg/kg and -2.29 g/dL (95% CI, -2.79, -1.79) in those receiving 0.40 PQ mg/kg. In The Gambia, the mean maximum absolute change in hemoglobin concentration was -1.83 g/dL (95% CI, -2.19, -1.47) in G6PDd individuals receiving 0.25 PQ mg/kg. After adjustment for baseline concentrations, hemoglobin reductions in G6PDd individuals in Burkina Faso were more pronounced compared to those in G6PD-normal individuals receiving the same PQ doses (P = 0.062 and P = 0.022, respectively). Hemoglobin levels normalized during follow-up. Abnormal haptoglobin and lactate dehydrogenase levels provided additional evidence of mild transient hemolysis post-PQ.
Conclusions: Single low-dose PQ in combination with AL and DP was associated with mild and transient reductions in hemoglobin. None of the study participants developed moderate or severe anemia; there were no severe adverse events. This indicates that single low-dose PQ is safe in G6PDd African males when used with artemisinin-based combination therapy.
Trial Registration: Clinicaltrials.gov NCT02174900 Clinicaltrials.gov NCT02654730.
References: JAMA. 1980 May 16;243(19):1909-11. (PMID: 7365971)
N Engl J Med. 2013 Oct 3;369(14):1381-2. (PMID: 24088113)
BMC Med. 2016 Mar 08;14:40. (PMID: 26952094)
J Lab Clin Med. 1954 Sep;44(3):439-42. (PMID: 13201853)
Eur J Hum Genet. 2009 Aug;17(8):1080-5. (PMID: 19223928)
Malar J. 2012 Oct 30;11:360. (PMID: 23130957)
Clin Lab Med. 1982 Dec;2(4):685-99. (PMID: 7160151)
Antimicrob Agents Chemother. 2015 Apr;59(4):2380-7. (PMID: 25645856)
Am J Trop Med Hyg. 2001 Nov;65(5):614-22. (PMID: 11716124)
Am J Trop Med Hyg. 2013 Jun;88(6):1138-45. (PMID: 23530079)
Antimicrob Agents Chemother. 2010 May;54(5):1762-8. (PMID: 20194698)
Malar J. 2008 Jul 09;7:125. (PMID: 18613962)
Blood. 1994 Dec 1;84(11):3613-36. (PMID: 7949118)
Lancet Infect Dis. 2013 Feb;13(2):175-81. (PMID: 23182932)
Malar J. 2016 Feb 18;15:97. (PMID: 26888075)
Am J Trop Med Hyg. 2007 Oct;77(4):779-89. (PMID: 17978087)
J Infect Dis. 2013 Jun 1;207(11):1637-45. (PMID: 23468056)
Cochrane Database Syst Rev. 2009 Jul 08;(3):CD007483. (PMID: 19588433)
PLoS One. 2016 Mar 24;11(3):e0151898. (PMID: 27010542)
Trials. 2015 Mar 01;16:70. (PMID: 25887344)
Lancet Infect Dis. 2014 Feb;14(2):130-9. (PMID: 24239324)
Br J Haematol. 1979 Nov;43(3):465-7. (PMID: 497122)
Lancet. 2008 Jan 5;371(9606):64-74. (PMID: 18177777)
Malar J. 2016 Jun 10;15:316. (PMID: 27287612)
Curr Drug Metab. 2014 Feb;15(2):218-32. (PMID: 24524666)
PLoS Comput Biol. 2014 Jan;10(1):e1003434. (PMID: 24465196)
Clin Infect Dis. 2004 Nov 1;39(9):1336-45. (PMID: 15494911)
Proc Natl Acad Sci U S A. 2011 Nov 22;108(47):E1214-23. (PMID: 22042867)
J Infect Dis. 2001 Apr 15;183(8):1254-9. (PMID: 11262208)
Trends Parasitol. 2017 Mar;33(3):175-184. (PMID: 27727128)
J Lab Clin Med. 1955 Jan;45(1):30-9. (PMID: 13233625)
Pharmacogenet Genomics. 2012 Sep;22(9):692-4. (PMID: 22868903)
Clin Pharmacol Ther. 2008 Feb;83(2):234-42. (PMID: 17971818)
Bull World Health Organ. 1960;22:621-31. (PMID: 13793053)
Antimicrob Agents Chemother. 2012 Apr;56(4):2146-9. (PMID: 22252800)
PLoS One. 2007 Oct 10;2(10):e1023. (PMID: 17925871)
Lancet Infect Dis. 2016 Jun;16(6):674-684. (PMID: 26906747)
PLoS One. 2015 Apr 20;10(4):e0123549. (PMID: 25893500)
Malar J. 2016 Nov 8;15(1):539. (PMID: 27821171)
Malar J. 2013 Jun 20;12:212. (PMID: 23782898)
BMC Med. 2015 Dec 11;13:294. (PMID: 26654101)
Antimicrob Agents Chemother. 2013 Mar;57(3):1128-35. (PMID: 23254437)
Malar J. 2013 Nov 04;12:391. (PMID: 24188096)
Antimicrob Agents Chemother. 2014 Aug;58(8):4971-3. (PMID: 24913169)
PLoS Med. 2011 Jan 25;8(1):e1000396. (PMID: 21311583)
Clin Microbiol Rev. 2011 Apr;24(2):377-410. (PMID: 21482730)
Malar J. 2014 Nov 03;13:418. (PMID: 25363455)
J Trop Med Hyg. 1992 Oct;95(5):349-51. (PMID: 1404560)
Clin Infect Dis. 2017 Aug 15;65(4):535-543. (PMID: 28605472)
معلومات مُعتمدة: United Kingdom Wellcome Trust; MC_EX_MR/K007203/1 United Kingdom MRC_ Medical Research Council; MR/K012126/1 United Kingdom MRC_ Medical Research Council
سلسلة جزيئية: Dryad 10.5061/dryad.230ps
ClinicalTrials.gov NCT02174900; NCT02654730
المشرفين على المادة: 0 (Antimalarials)
EC 1.1.1.49 (Glucosephosphate Dehydrogenase)
MVR3634GX1 (Primaquine)
تواريخ الأحداث: Date Created: 20180112 Date Completed: 20180206 Latest Revision: 20220129
رمز التحديث: 20231215
مُعرف محوري في PubMed: PMC5764271
DOI: 10.1371/journal.pone.0190272
PMID: 29324864
قاعدة البيانات: MEDLINE
الوصف
تدمد:1932-6203
DOI:10.1371/journal.pone.0190272