Artemisinin-based combination therapy for ... - The Cochrane Library

(Continued)
Zongo 2007 BFA
(371 participants)
An adverse event defined as any
unfavourable and unintended
sign associated temporally with
the use of the drug administered
Differential WBC count (and
liver function tests at 1 site only)
assessed at days 0 and 14
A standardized history and examination
on days 0, 1, 2, 3, 7,
14, 21, 28, 35, and 42
Adverse events defined as untoward
medical occurrences
Haemoglobin measured on
days 0 and 42 or day of clinical
failure
Artesunate plus mefloquine vs Artemether-lumefantrine
Study ID Adverse event monitoring Blinding Adverse events
Faye 2003 SEN
(294 participants)
Hutagalung 2002 THA
(490 participants)
Lefevre 1999 THA
(219 participants)
All side effects were monitored
actively (days 0, 1, 2, 7, 14, 21,
and 28) and passively during
the study
25% were randomly selected for
blood counts, liver and renal
function tests at days 0, 14, and
28
Routine follow up daily until
fever and parasites cleared then
weekly to day 42 or any other
day they became unwell
At each visit a questionnaire on
adverse events was completed
An adverse event defined as
symptoms or signs that were
not present on admission and
that developed after the start of
treatment
Routine follow up at days 1, 2,
3, 7, 14, 21, and 28.
Adverse events assessed at each
visit. ECG monitoring and lab-
Artemisinin-based combination therapy for treating uncomplicated malaria (Review)
Copyright © 2009 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
pain, diarrhoea, nausea
CNS: More fatigue with AQSP (P = 0.001). No difference
in seizures, headache, dizziness, drowsiness
CVS/RS: No difference in cough, angina, oedema
Biochemical: No differences in mean PCV or mean
WBC. No hepatotoxicity observed (one site only)
Other: No difference in rash
Open label SAE: No serious adverse events were observed
GI: Abdominal pain was more common with
AQ+SP (P < 0.05). No difference in vomiting, diarrhoea,
or anorexia.
CNS: No difference in headache or weakness
CVS/RS: No difference in cough
Other: Pruritis more common with AQ+SP (P <
0.05)
Open label SAE: No serious adverse events
Overall comment: The side effects observed with
each treatment combination were minor, mainly
gastralgia, dizziness, pruritis, asthenia, and vomiting
Biochemical: No severe alterations in renal or hepatic
function were observed
Open label SAE: None reported
Overall comment: Both treatment regimens were
well tolerated
Open label SAE: No comment.
GI: Abdominal pain, nausea, vomiting, diarrhoea,
anorexia, constipation 18.3% AL vs 21.8%
224