Table 1.
Summary of selected pharmacoepidemiological studies relating to mefloquine prophylaxis safety and tolerability.
| Year | Reference | Country | Population | Study design | Nonsevere adverse event (AE) report | Standardised testing1 | Participants | Severe AE (%)2 | Nonsevere AE (%)2 |
|---|---|---|---|---|---|---|---|---|---|
| 1993 | [85] | Australia | Military | Nonrandom field trial | Unknown | Nil | 40 | n.d. | n.d. |
|
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| 1993 | [78] | US | Military | RCT | Questionnaire, interview | POMS, sleep monitoring, and ESQ | 203 | 0% | 43% |
|
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| 1996 | [75] | Australia | Civilian | Retrospective | Questionnaire (mail) | Nil | 285 | 0% | 6.3% |
|
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| 1996 | [80] | Netherlands | Military | Nonrandom field trial | Questionnaire (mail) | Nil | 2,289 | 0% | 22.8% |
|
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| 1996 | [83] | Switzerland | Civilian | Longitudinal | Investigator nonleading question | POMS, NES, and ESQ | 420 | 0% | 7.9% |
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| 1997 | [81] | UK | Military | Nonrandom field trial | Questionnaire | Nil | 317 | 0% | 29.0% |
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| 1999 | [82] | Italy | Military | Retrospective | Questionnaire | Nil | 1,386 | 0% | 17.0% |
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| 2001 | [76] | Neth., Ger., UK, Can., and SA | Civilian | RCT | Questionnaire, interview | Nil | 483 | 0% | 3.9% |
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| 2002 | [77] | Netherlands | Civilian | RCT | Screening, interview | POMS, NES | 58 | n.d. | n.d. |
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| 2005 | [88] | Australia | Military | Nonrandom field trial | Questionnaire | Nil | 1,157 | n.d. | n.d. |
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| 2005 | [91] | Canada | Military | Retrospective | Data-mining medical records | Nil | 1,413 | n.d. | n.d. |
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| 2007 | [79] | Japan | Military | Nonrandom field trial | Questionnaire | Nil | 1,876 | 0% | 18.2% |
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| 2008 | [84] | Sweden | Military | Retrospective | Questionnaire | Nil | 488 | 0% | 57% |
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| 2010 | [87] | Australia | Military | Nonrandom field trial | Investigator nonleading question | Nil | 162 | 0% | 11.7% |
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| 2014 | [90] | Denmark | Civilian | Retrospective | AE report to drug regulator | SCL-90-R, PSE, and SF-36 (long-term) | 673 | n/a4 | n/a4 |
|
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| Total | 10,664 | ||||||||
Notes.
1POMS: Profile of Mood States. ESQ: Environmental Symptoms Questionnaire. NES: Neurobehavioral Evaluation System. SCL-90-R: Symptom Checklist-90-Revised. PSE: Present State Examination. SF-36: Short Form Health Survey-36.
2The adverse event (AE) figures listed here are neuropsychiatric AE, where it is possible to elicit that data from the report. n.d.: not determinable.
3There were 73 subjects; however 6 of these had used mefloquine at treatment doses. The remaining 67 had used the drug for chemoprophylaxis.
4This was a follow-up study that only considered subjects who had submitted adverse event reports to the national drug regulator.