Risk of sudden unexplained death after use of dihydroartemisinin–piperaquine for malaria: a systematic review and Bayesian meta-analysis
Dihydroartemisinin–piperaquine is an effective and well tolerated artemisinin-based combination therapy that has been assessed extensively for the prevention and treatment of malaria. Piperaquine, similar to several structurally related antimalarials currently used, can prolong cardiac ventricular r...
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| Veröffentlicht in: | The Lancet infectious diseases 2018-08, Vol.18 (8), p.913-923 |
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| creator | Chan, Xin Hui S Win, Yan Naung Mawer, Laura J Tan, Jireh Y Brugada, Josep White, Nicholas J |
| description | Dihydroartemisinin–piperaquine is an effective and well tolerated artemisinin-based combination therapy that has been assessed extensively for the prevention and treatment of malaria. Piperaquine, similar to several structurally related antimalarials currently used, can prolong cardiac ventricular repolarisation duration and the electrocardiographic QT interval, leading to concerns about its proarrhythmic potential. We aimed to assess the risk of potentially lethal iatrogenic ventricular arrhythmias in individuals receiving dihydroartemisinin–piperaquine.
We did a systematic review and Bayesian meta-analysis. We searched clinical bibliographic databases (last on May 24, 2017) for studies of dihydroartemisinin–piperaquine in human beings. Further unpublished studies were identified with the WHO Evidence Review Group on the Cardiotoxicity of Antimalarials. We searched for articles containing “dihydroartemisinin-piperaquine” as title, abstract, or subject heading keywords, with synonyms and variant spellings as additional search terms. We excluded animal studies, but did not apply limits on language or publication date. Eligible studies were prospective, randomised, controlled trials or cohort studies in which individuals received at least one 3-day treatment course of dihydroartemisinin–piperaquine for mass drug administration, preventive therapy, or case management of uncomplicated malaria, with follow-up over at least 3 days. At least two independent reviewers screened titles, abstracts, and full texts, agreed study eligibility, and extracted information about study and participant characteristics, adverse event surveillance methodology, dihydroartemisinin–piperaquine exposures, loss-to-follow up, and any deaths after dihydroartemisinin–piperaquine treatment into a standardised database. The risk of sudden unexplained death after dihydroartemisinin–piperaquine with 95% credible intervals (CI) generated by Bayesian meta-analysis was compared with the baseline rate of sudden cardiac death.
Our search identified 94 eligible primary studies including data for 197 867 individuals who had received dihydroartemisinin–piperaquine: 154 505 in mass drug administration programmes; 15 188 in 14 studies of repeated courses in preventive therapies and case management of uncomplicated malaria; and 28 174 as single-course treatments of uncomplicated malaria in 76 case-management studies. There was one potentially drug-related sudden unexplained death: a healthy woman aged |
| doi_str_mv | 10.1016/S1473-3099(18)30297-4 |
| format | Article |
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We did a systematic review and Bayesian meta-analysis. We searched clinical bibliographic databases (last on May 24, 2017) for studies of dihydroartemisinin–piperaquine in human beings. Further unpublished studies were identified with the WHO Evidence Review Group on the Cardiotoxicity of Antimalarials. We searched for articles containing “dihydroartemisinin-piperaquine” as title, abstract, or subject heading keywords, with synonyms and variant spellings as additional search terms. We excluded animal studies, but did not apply limits on language or publication date. Eligible studies were prospective, randomised, controlled trials or cohort studies in which individuals received at least one 3-day treatment course of dihydroartemisinin–piperaquine for mass drug administration, preventive therapy, or case management of uncomplicated malaria, with follow-up over at least 3 days. At least two independent reviewers screened titles, abstracts, and full texts, agreed study eligibility, and extracted information about study and participant characteristics, adverse event surveillance methodology, dihydroartemisinin–piperaquine exposures, loss-to-follow up, and any deaths after dihydroartemisinin–piperaquine treatment into a standardised database. The risk of sudden unexplained death after dihydroartemisinin–piperaquine with 95% credible intervals (CI) generated by Bayesian meta-analysis was compared with the baseline rate of sudden cardiac death.
Our search identified 94 eligible primary studies including data for 197 867 individuals who had received dihydroartemisinin–piperaquine: 154 505 in mass drug administration programmes; 15 188 in 14 studies of repeated courses in preventive therapies and case management of uncomplicated malaria; and 28 174 as single-course treatments of uncomplicated malaria in 76 case-management studies. There was one potentially drug-related sudden unexplained death: a healthy woman aged 16 in Mozambique who developed heart palpitations several hours after the second dose of dihydroartemisinin–piperaquine and collapsed and died on the way to hospital (no autopsy or ECG was done). The median pooled risk estimate of sudden unexplained death after dihydroartemisinin–piperaquine was 1 in 757 950 (95% CI 1 in 2 854 490 to 1 in 209 114). This risk estimate was not higher than the baseline rate of sudden cardiac death (0·7–11·9 per 100 000 person-years or 1 in 1 714 280 to 1 in 100 835 over a 30-day risk period). The risk of bias was low in most studies and unclear in a few.
Dihydroartemisinin–piperaquine was associated with a low risk of sudden unexplained death that was not higher than the baseline rate of sudden cardiac death. Concerns about repolarisation-related cardiotoxicity need not limit its current use for the prevention and treatment of malaria.
Wellcome Trust, UK Medical Research Council, WHO, Bill & Melinda Gates Foundation, and University of Oxford.</description><identifier>ISSN: 1473-3099</identifier><identifier>EISSN: 1474-4457</identifier><identifier>DOI: 10.1016/S1473-3099(18)30297-4</identifier><identifier>PMID: 29887371</identifier><language>eng</language><publisher>United States: Elsevier Ltd</publisher><subject>Adolescent ; Animals ; Antimalarials ; Antimalarials - administration & dosage ; Antimalarials - adverse effects ; Artemisinin ; Artemisinins - administration & dosage ; Artemisinins - adverse effects ; Autopsies ; Autopsy ; Bayes Theorem ; Bayesian analysis ; Cardiotoxicity ; Case management ; Cause of Death ; Charities ; Clinical trials ; Cohort Studies ; Death ; Dihydroartemisinin ; Drug dosages ; Drug Therapy, Combination - mortality ; EKG ; Electrocardiogram ; Electrocardiography ; Female ; Heart ; Heart rate ; Humans ; Infections ; Infectious diseases ; Malaria ; Malaria - drug therapy ; Management ; Medical research ; Medicine, Preventive ; Meta-analysis ; Mortality ; Mozambique ; Pregnancy ; Prevention ; Preventive health services ; Prospective Studies ; Quinolines - administration & dosage ; Quinolines - adverse effects ; Reviews ; Risk assessment ; Studies ; Systematic review ; Therapy ; Vector-borne diseases ; Ventricle ; Womens health</subject><ispartof>The Lancet infectious diseases, 2018-08, Vol.18 (8), p.913-923</ispartof><rights>2018 World Health Organization</rights><rights>Copyright 2018 World Health Organization; licensee Elsevier. This is an Open Access article published under the CC BY–NC–ND 4·0 IGO license, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. In any use of this article, there should be no suggestion that WHO endorses any specific organisation, products or services. The use of the WHO logo is not permitted. This notice should be preserved along with the article's original URL.</rights><rights>Copyright Elsevier Limited Aug 2018</rights><rights>2018 World Health Organization 2018</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c526t-52303d6e04a42a94b8954758de39079f5c20fe88b37a94582450247e67ef10883</citedby><cites>FETCH-LOGICAL-c526t-52303d6e04a42a94b8954758de39079f5c20fe88b37a94582450247e67ef10883</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2076163307?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>230,314,780,784,885,3550,27924,27925,45995,64385,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/29887371$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Chan, Xin Hui S</creatorcontrib><creatorcontrib>Win, Yan Naung</creatorcontrib><creatorcontrib>Mawer, Laura J</creatorcontrib><creatorcontrib>Tan, Jireh Y</creatorcontrib><creatorcontrib>Brugada, Josep</creatorcontrib><creatorcontrib>White, Nicholas J</creatorcontrib><title>Risk of sudden unexplained death after use of dihydroartemisinin–piperaquine for malaria: a systematic review and Bayesian meta-analysis</title><title>The Lancet infectious diseases</title><addtitle>Lancet Infect Dis</addtitle><description>Dihydroartemisinin–piperaquine is an effective and well tolerated artemisinin-based combination therapy that has been assessed extensively for the prevention and treatment of malaria. Piperaquine, similar to several structurally related antimalarials currently used, can prolong cardiac ventricular repolarisation duration and the electrocardiographic QT interval, leading to concerns about its proarrhythmic potential. We aimed to assess the risk of potentially lethal iatrogenic ventricular arrhythmias in individuals receiving dihydroartemisinin–piperaquine.
We did a systematic review and Bayesian meta-analysis. We searched clinical bibliographic databases (last on May 24, 2017) for studies of dihydroartemisinin–piperaquine in human beings. Further unpublished studies were identified with the WHO Evidence Review Group on the Cardiotoxicity of Antimalarials. We searched for articles containing “dihydroartemisinin-piperaquine” as title, abstract, or subject heading keywords, with synonyms and variant spellings as additional search terms. We excluded animal studies, but did not apply limits on language or publication date. Eligible studies were prospective, randomised, controlled trials or cohort studies in which individuals received at least one 3-day treatment course of dihydroartemisinin–piperaquine for mass drug administration, preventive therapy, or case management of uncomplicated malaria, with follow-up over at least 3 days. At least two independent reviewers screened titles, abstracts, and full texts, agreed study eligibility, and extracted information about study and participant characteristics, adverse event surveillance methodology, dihydroartemisinin–piperaquine exposures, loss-to-follow up, and any deaths after dihydroartemisinin–piperaquine treatment into a standardised database. The risk of sudden unexplained death after dihydroartemisinin–piperaquine with 95% credible intervals (CI) generated by Bayesian meta-analysis was compared with the baseline rate of sudden cardiac death.
Our search identified 94 eligible primary studies including data for 197 867 individuals who had received dihydroartemisinin–piperaquine: 154 505 in mass drug administration programmes; 15 188 in 14 studies of repeated courses in preventive therapies and case management of uncomplicated malaria; and 28 174 as single-course treatments of uncomplicated malaria in 76 case-management studies. There was one potentially drug-related sudden unexplained death: a healthy woman aged 16 in Mozambique who developed heart palpitations several hours after the second dose of dihydroartemisinin–piperaquine and collapsed and died on the way to hospital (no autopsy or ECG was done). The median pooled risk estimate of sudden unexplained death after dihydroartemisinin–piperaquine was 1 in 757 950 (95% CI 1 in 2 854 490 to 1 in 209 114). This risk estimate was not higher than the baseline rate of sudden cardiac death (0·7–11·9 per 100 000 person-years or 1 in 1 714 280 to 1 in 100 835 over a 30-day risk period). The risk of bias was low in most studies and unclear in a few.
Dihydroartemisinin–piperaquine was associated with a low risk of sudden unexplained death that was not higher than the baseline rate of sudden cardiac death. Concerns about repolarisation-related cardiotoxicity need not limit its current use for the prevention and treatment of malaria.
Wellcome Trust, UK Medical Research Council, WHO, Bill & Melinda Gates Foundation, and University of Oxford.</description><subject>Adolescent</subject><subject>Animals</subject><subject>Antimalarials</subject><subject>Antimalarials - administration & dosage</subject><subject>Antimalarials - adverse effects</subject><subject>Artemisinin</subject><subject>Artemisinins - administration & dosage</subject><subject>Artemisinins - adverse effects</subject><subject>Autopsies</subject><subject>Autopsy</subject><subject>Bayes Theorem</subject><subject>Bayesian analysis</subject><subject>Cardiotoxicity</subject><subject>Case management</subject><subject>Cause of Death</subject><subject>Charities</subject><subject>Clinical trials</subject><subject>Cohort Studies</subject><subject>Death</subject><subject>Dihydroartemisinin</subject><subject>Drug dosages</subject><subject>Drug Therapy, Combination - mortality</subject><subject>EKG</subject><subject>Electrocardiogram</subject><subject>Electrocardiography</subject><subject>Female</subject><subject>Heart</subject><subject>Heart rate</subject><subject>Humans</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Malaria</subject><subject>Malaria - drug therapy</subject><subject>Management</subject><subject>Medical research</subject><subject>Medicine, Preventive</subject><subject>Meta-analysis</subject><subject>Mortality</subject><subject>Mozambique</subject><subject>Pregnancy</subject><subject>Prevention</subject><subject>Preventive health services</subject><subject>Prospective Studies</subject><subject>Quinolines - administration & dosage</subject><subject>Quinolines - adverse effects</subject><subject>Reviews</subject><subject>Risk assessment</subject><subject>Studies</subject><subject>Systematic review</subject><subject>Therapy</subject><subject>Vector-borne diseases</subject><subject>Ventricle</subject><subject>Womens health</subject><issn>1473-3099</issn><issn>1474-4457</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2018</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><recordid>eNqFkc1u1TAQhSMEoqXwCCBLSAgWATt2YocFqFT8SZWQ-Flbc-PJvS65dmo7pdmxZssb8iT43pQKVqxseb4zPjOnKO4z-pRR1jz7xITkJadt-5ipJ5xWrSzFjeIwP4tSiFre3N8X5KC4E-MZpUwyKm4XB1WrlOSSHRY_Ptr4lfiexMkYdGRyeDkOYB0aYhDShkCfMJAp4o4ydjOb4CEk3NponXW_vv8c7YgBzqcsIr0PZAsDBAvPCZA4x0xCsh0JeGHxGwFnyCuYMVpwZIsJSnAwzNHGu8WtHoaI967Oo-LLm9efT96Vpx_evj85Pi27umpSWVecctMgFSAqaMVKtbWQtTLIWyrbvu4q2qNSKy5ztVaVqGklJDYSe0aV4kfFi6XvOK22aDp0KcCgx2C3EGbtwep_K85u9Npf6IY2lKo6N3h41SD48wlj0md-CnmKqCsqG9ZwTmWmHi3UGgbU1nXeJbxMa5hi1Po4e1a85c3OT72AXfAxBuyvrTCqd1nrfdZ6F6RmSu-z1iLrHvw9x7XqT7gZeLkAmLeZlx907Cy6Do0N2CVtvP3PF78Bpq28EQ</recordid><startdate>201808</startdate><enddate>201808</enddate><creator>Chan, Xin Hui S</creator><creator>Win, Yan Naung</creator><creator>Mawer, Laura J</creator><creator>Tan, Jireh Y</creator><creator>Brugada, Josep</creator><creator>White, Nicholas J</creator><general>Elsevier Ltd</general><general>Elsevier B.V</general><general>Elsevier Limited</general><general>Elsevier Science ;, The Lancet Pub. 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administration & dosage</topic><topic>Antimalarials - adverse effects</topic><topic>Artemisinin</topic><topic>Artemisinins - administration & dosage</topic><topic>Artemisinins - adverse effects</topic><topic>Autopsies</topic><topic>Autopsy</topic><topic>Bayes Theorem</topic><topic>Bayesian analysis</topic><topic>Cardiotoxicity</topic><topic>Case management</topic><topic>Cause of Death</topic><topic>Charities</topic><topic>Clinical trials</topic><topic>Cohort Studies</topic><topic>Death</topic><topic>Dihydroartemisinin</topic><topic>Drug dosages</topic><topic>Drug Therapy, Combination - mortality</topic><topic>EKG</topic><topic>Electrocardiogram</topic><topic>Electrocardiography</topic><topic>Female</topic><topic>Heart</topic><topic>Heart rate</topic><topic>Humans</topic><topic>Infections</topic><topic>Infectious diseases</topic><topic>Malaria</topic><topic>Malaria - drug therapy</topic><topic>Management</topic><topic>Medical research</topic><topic>Medicine, Preventive</topic><topic>Meta-analysis</topic><topic>Mortality</topic><topic>Mozambique</topic><topic>Pregnancy</topic><topic>Prevention</topic><topic>Preventive health services</topic><topic>Prospective Studies</topic><topic>Quinolines - 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Piperaquine, similar to several structurally related antimalarials currently used, can prolong cardiac ventricular repolarisation duration and the electrocardiographic QT interval, leading to concerns about its proarrhythmic potential. We aimed to assess the risk of potentially lethal iatrogenic ventricular arrhythmias in individuals receiving dihydroartemisinin–piperaquine.
We did a systematic review and Bayesian meta-analysis. We searched clinical bibliographic databases (last on May 24, 2017) for studies of dihydroartemisinin–piperaquine in human beings. Further unpublished studies were identified with the WHO Evidence Review Group on the Cardiotoxicity of Antimalarials. We searched for articles containing “dihydroartemisinin-piperaquine” as title, abstract, or subject heading keywords, with synonyms and variant spellings as additional search terms. We excluded animal studies, but did not apply limits on language or publication date. Eligible studies were prospective, randomised, controlled trials or cohort studies in which individuals received at least one 3-day treatment course of dihydroartemisinin–piperaquine for mass drug administration, preventive therapy, or case management of uncomplicated malaria, with follow-up over at least 3 days. At least two independent reviewers screened titles, abstracts, and full texts, agreed study eligibility, and extracted information about study and participant characteristics, adverse event surveillance methodology, dihydroartemisinin–piperaquine exposures, loss-to-follow up, and any deaths after dihydroartemisinin–piperaquine treatment into a standardised database. The risk of sudden unexplained death after dihydroartemisinin–piperaquine with 95% credible intervals (CI) generated by Bayesian meta-analysis was compared with the baseline rate of sudden cardiac death.
Our search identified 94 eligible primary studies including data for 197 867 individuals who had received dihydroartemisinin–piperaquine: 154 505 in mass drug administration programmes; 15 188 in 14 studies of repeated courses in preventive therapies and case management of uncomplicated malaria; and 28 174 as single-course treatments of uncomplicated malaria in 76 case-management studies. There was one potentially drug-related sudden unexplained death: a healthy woman aged 16 in Mozambique who developed heart palpitations several hours after the second dose of dihydroartemisinin–piperaquine and collapsed and died on the way to hospital (no autopsy or ECG was done). The median pooled risk estimate of sudden unexplained death after dihydroartemisinin–piperaquine was 1 in 757 950 (95% CI 1 in 2 854 490 to 1 in 209 114). This risk estimate was not higher than the baseline rate of sudden cardiac death (0·7–11·9 per 100 000 person-years or 1 in 1 714 280 to 1 in 100 835 over a 30-day risk period). The risk of bias was low in most studies and unclear in a few.
Dihydroartemisinin–piperaquine was associated with a low risk of sudden unexplained death that was not higher than the baseline rate of sudden cardiac death. Concerns about repolarisation-related cardiotoxicity need not limit its current use for the prevention and treatment of malaria.
Wellcome Trust, UK Medical Research Council, WHO, Bill & Melinda Gates Foundation, and University of Oxford.</abstract><cop>United States</cop><pub>Elsevier Ltd</pub><pmid>29887371</pmid><doi>10.1016/S1473-3099(18)30297-4</doi><tpages>11</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | The Lancet infectious diseases, 2018-08, Vol.18 (8), p.913-923 |
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| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_6060085 |
| source | MEDLINE; Access via ScienceDirect (Elsevier); ProQuest Central UK/Ireland |
| subjects | Adolescent Animals Antimalarials Antimalarials - administration & dosage Antimalarials - adverse effects Artemisinin Artemisinins - administration & dosage Artemisinins - adverse effects Autopsies Autopsy Bayes Theorem Bayesian analysis Cardiotoxicity Case management Cause of Death Charities Clinical trials Cohort Studies Death Dihydroartemisinin Drug dosages Drug Therapy, Combination - mortality EKG Electrocardiogram Electrocardiography Female Heart Heart rate Humans Infections Infectious diseases Malaria Malaria - drug therapy Management Medical research Medicine, Preventive Meta-analysis Mortality Mozambique Pregnancy Prevention Preventive health services Prospective Studies Quinolines - administration & dosage Quinolines - adverse effects Reviews Risk assessment Studies Systematic review Therapy Vector-borne diseases Ventricle Womens health |
| title | Risk of sudden unexplained death after use of dihydroartemisinin–piperaquine for malaria: a systematic review and Bayesian meta-analysis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-23T00%3A11%3A36IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_pubme&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Risk%20of%20sudden%20unexplained%20death%20after%20use%20of%20dihydroartemisinin%E2%80%93piperaquine%20for%20malaria:%20a%20systematic%20review%20and%20Bayesian%20meta-analysis&rft.jtitle=The%20Lancet%20infectious%20diseases&rft.au=Chan,%20Xin%20Hui%20S&rft.date=2018-08&rft.volume=18&rft.issue=8&rft.spage=913&rft.epage=923&rft.pages=913-923&rft.issn=1473-3099&rft.eissn=1474-4457&rft_id=info:doi/10.1016/S1473-3099(18)30297-4&rft_dat=%3Cgale_pubme%3EA547839368%3C/gale_pubme%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2076163307&rft_id=info:pmid/29887371&rft_galeid=A547839368&rft_els_id=S1473309918302974&rfr_iscdi=true |