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Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis (2020)

Chapter: Appendix C: Epidemiologic Studies That Met the Committee's Inclusion Criteria

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Suggested Citation:"Appendix C: Epidemiologic Studies That Met the Committee's Inclusion Criteria." National Academies of Sciences, Engineering, and Medicine. 2020. Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis. Washington, DC: The National Academies Press. doi: 10.17226/25688.
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Page 393
Suggested Citation:"Appendix C: Epidemiologic Studies That Met the Committee's Inclusion Criteria." National Academies of Sciences, Engineering, and Medicine. 2020. Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis. Washington, DC: The National Academies Press. doi: 10.17226/25688.
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Page 394
Suggested Citation:"Appendix C: Epidemiologic Studies That Met the Committee's Inclusion Criteria." National Academies of Sciences, Engineering, and Medicine. 2020. Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis. Washington, DC: The National Academies Press. doi: 10.17226/25688.
×
Page 395
Suggested Citation:"Appendix C: Epidemiologic Studies That Met the Committee's Inclusion Criteria." National Academies of Sciences, Engineering, and Medicine. 2020. Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis. Washington, DC: The National Academies Press. doi: 10.17226/25688.
×
Page 396
Suggested Citation:"Appendix C: Epidemiologic Studies That Met the Committee's Inclusion Criteria." National Academies of Sciences, Engineering, and Medicine. 2020. Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis. Washington, DC: The National Academies Press. doi: 10.17226/25688.
×
Page 397
Suggested Citation:"Appendix C: Epidemiologic Studies That Met the Committee's Inclusion Criteria." National Academies of Sciences, Engineering, and Medicine. 2020. Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis. Washington, DC: The National Academies Press. doi: 10.17226/25688.
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Page 398

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Appendix C Epidemiologic Studies That Met the Committee’s Inclusion Criteria 393

Body Systems 394 Reference Design Population Study Groups‡ Examined Ackert et al., Randomized Healthy male and female adult Tafenoquine (n = 306) Eye 2019* controlled trial volunteers (ages 18–45) in the Placebo (n = 161) United States Andersen et al., Randomized Semi-immune male and female Doxycycline (n = 55) Other 1998 controlled trial adult volunteers (ages 18–55) in Azithromycin (n = 117) Kenya 250 mg daily (n = 59) 1,000 mg weekly (n = 58) Placebo (n = 60) DeSouza, 1983 Clinical trial Healthy male adult volunteers (age Mefloquine Gastrointestinal range not reported) in Brazil 1,000 mg (n = 10) Cardiovascular Sulfadoxine (1,000 mg) and pyrimethamine (500 mg) (n = 10) Eick-Cost et al., Retrospective Male and female active-duty U.S. Deployed (n = 275,097) Neurologic 2017* observational study service members (ages ≥17) Mefloquine (n = 25,691) Psychiatric A/P (n = 2,620) Doxycycline (n = 246,786) Nondeployed (n = 92,743) Mefloquine (n = 10,847) A/P (n = 10,261) Doxycycline (n = 71,635) Green et al., 2014* Randomized Healthy male and female adult Tafenoquine (n = 156) Cardiovascular controlled trial volunteers (ages 18–65) in the Supratherapeutic dose of 1,200 mg (n = 52) United States Therapeutic dose of 300 mg (n = 52) Therapeutic dose of 600 mg (n = 52) Moxifloxacin (400 mg) (n = 52) Placebo (n = 52)

Laothavorn et al., Prospective Male patients with malaria and Mefloquine (750 mg) (n = 18) Cardiovascular 1992 observational healthy male adult volunteers (ages Patients with malaria (n = 102) study 26–46) in Thailand Leary et al., 2009* Randomized Healthy male and female adult Tafenoquine (n = 81) Eye controlled trial volunteers (ages 18–55) recruited Placebo (n = 39) Other from the United States and the United Kingdom Lee et al., 2013 Cross-sectional survey Current and former male and Doxycycline (n = 189) Gastrointestinal female adult members of the Deployed (n = 171) Australian Federal Police Nondeployed (n = 18) Association (ages 35–45) Lege-Oguntoye et Randomized Semi-immune male and female Chloroquine (n = 20) Other al., 1990 controlled trial adult volunteers (ages 25–34) in Ascorbic acid (200 mg) (n = 10) Nigeria Meier et al., 2004* Retrospective Male and female adult travelers Mefloquine (n = 16,491) Neurologic observational (ages 17–79) in the United Doxycycline (n = 4,574) Psychiatric study Kingdom Proguanil and/or chloroquine (n = 16,129) Eye Miller et al., 2013 Randomized Healthy male and female adult Chloroquine (600 mg) and placebo for Eye controlled trial volunteers (ages 18–55) in the tafenoquine (n = 20) Other United States Placebo for chloroquine and tafenoquine (450 mg) (n = 20) Chloroquine (600 mg) and tafenoquine (450 mg) (n = 20) Nasveld et al., Randomized Healthy male and female Mefloquine followed by primaquine (30 mg) Psychiatric 2010* controlled trial Australian soldiers (ages 18–55) (n = 162) Gastrointestinal Tafenoquine followed by placebo (n = 492) Eye Cardiovascular Other continued 395

Body Systems 396 Reference Design Population Study Groups‡ Examined Rueangweerayut et Prospective Healthy female adult volunteers Tafenoquine (n = 51) Other al., 2017 observational study (ages 18–45) in Thailand 100 mg (n = 12) 200 mg (n = 19) 300 mg (n = 9) Primaquine (n = 11) Schlagenhauf et Prospective Healthy male and female adult Mefloquine (n = 394) Neurologic al., 1996† observational Swiss travelers (ages 18–65) Psychiatric study Schneider et al., Retrospective Male and female travelers (ages Mefloquine (n = 10,169) Neurologic 2013* observational study ≥1) from the United Kingdom A/P (n = 28,502) Psychiatric Chloroquine and/or proguanil (n = 2,904) Unexposed (n = 41,573) Schneider et al., Retrospective Male and female travelers (ages Mefloquine (n = 10,169) Eye 2014* observational ≥1) from the United Kingdom A/P (n = 28,502) study Chloroquine and/or proguanil (n = 2,904) Unexposed (n = 41,573) Schneiderman et Cross-sectional survey Post 9/11 male and female U.S. Deployed (n = 12,456) Psychiatric al., 2018* military veterans (ages ≥24) No antimalarial use (n = 5,806) Mefloquine (n = 307) Doxycycline (n = 1,315) Primaquine (n = 98) Chloroquine (n = 274) Mefloquine + other antimalarial (n = 425) Other antimalarial (n = 525) Type not specified (n = 3,706) Nondeployed (n = 7,031) No antimalarial use (n = 5,294) Mefloquine (n = 39)

Chloroquine (n = 110) Doxycycline (n = 141) Primaquine (n = 35) Mefloquine + other antimalarial (n = 52) Other antimalarial (n = 114) Type not specified (n = 1,246) Schwartz and Prospective Non-immune adult Israeli travelers Mefloquine (n = 25) Unknown Regev-Yochay, observational (ages 22–65) (sex distribution not Doxycycline (n = 19) 1999 study reported) Primaquine (n = 106) 15 mg daily for individuals with a body weight of <70 kg 30 mg daily for individuals with a body weight of >70 kg Hydroxychloroquine (200 mg) (n = 8) Tan et al., 2017 Cross-sectional survey Male and female returned U.S. Mefloquine (n = 2,981) Neurologic Peace Corps volunteers (age range A/P (n = 183) Psychiatric not reported) Doxycycline (n = 831) Gastrointestinal Chloroquine (n = 674) Eye Other prophylactic medication (n = 386) Cardiovascular No antimalarial use (n = 3,876) Other Walsh et al., 2004 Randomized Thai soldiers (ages 18–55) (sex Tafenoquine (n = 104) Other controlled trial distribution not reported) 400 mg for 3 consecutive days, followed by 400 mg once monthly Placebo (n = 101) continued 397

Body Systems 398 Reference Design Population Study Groups‡ Examined Wells et al., 2006* Retrospective Male and female U.S. active-duty Mefloquine (n = 8,858) Neurologic observational service members (ages ≥17) U.S. active-duty service members Psychiatric study prescribed at least seven tablets of Gastrointestinal mefloquine and deployed to operational Cardiovascular theater or combat zone Other No antimalarial drug use U.S. active-duty service members assigned to Europe or Japan (n = 156,203) U.S. active-duty service members deployed for at least one month (n = 232,381) * Denotes epidemiologic studies considered to provide the most contributory evidence to address the committee’s charge. † Although study investigators did not make a traditional comparison between exposed and unexposed groups, they did compare individuals who experienced adverse events with those who did not experience adverse events in the data analysis; thus, the committee included this study in their evaluation of the available scientific evidence. ‡ For the six antimalarial drugs of interest the dosing regimen used follows standard FDA guidance unless otherwise noted.

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Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors

At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.

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