11.11.2012 Views

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

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

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

SHOW MORE
SHOW LESS

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

(Continued)<br />

Faye 2003 SEN<br />

(509 participants)<br />

Guthmann 2004 AGO<br />

(134 participants)<br />

Kobbe 2007 GHA<br />

(237 participants)<br />

Koram 2003 GHA<br />

(105 participants)<br />

FBC, WBC and liver enzymes<br />

on days 0, 7 and 28<br />

An adverse event defined as not<br />

present at enrolment but occurring<br />

during follow -up<br />

All side effects were monitored<br />

actively (days 0, 1, 2, 7, 14, 21,<br />

and 28) and passively during<br />

the study<br />

25% were randomly selected <strong>for</strong><br />

blood counts, liver and renal<br />

function tests at days 0, 14, and<br />

28<br />

Adverse event monitoring not<br />

described<br />

’<strong>The</strong> comparative tolerability<br />

was assessed by the risk of occurrence<br />

of an adverse event’<br />

For each adverse event causality<br />

was assessed as recommended<br />

by the WHO<br />

Adverse event monitoring not<br />

described<br />

<strong>Artemisinin</strong>-<strong>based</strong> <strong>combination</strong> <strong>therapy</strong> <strong>for</strong> treating uncomplicated malaria (Review)<br />

Copyright © 2009 <strong>The</strong> <strong>Cochrane</strong> Collaboration. Published by John Wiley & Sons, Ltd.<br />

GI: No significant difference in<br />

abdominal pain or vomiting<br />

CVS/RS: No significant difference<br />

in cough or palpitations<br />

Haem: A significant transient<br />

decline in neutrophil counts between<br />

days 0 and 7 with AL<br />

which recovered by day 28<br />

Biochemical: No statistically<br />

significant disturbance in blood<br />

chemistry. <strong>The</strong> study drugs did<br />

not adversely affect liver enzymes<br />

Open label SAE: No serious adverse events<br />

Overall comment: <strong>The</strong> side effects<br />

observed with each treatment<br />

<strong>combination</strong> were minor,<br />

mainly gastralgia, dizziness,<br />

pruritis, asthenia, and<br />

vomiting<br />

Biochemical: No severe alterations<br />

in renal or hepatic function<br />

were observed<br />

Unclear AE not reported<br />

(2<br />

patients excluded from AS+AQ<br />

group <strong>for</strong> vomiting and 1 from<br />

AL)<br />

Open label SAE: 2 SAE in each group, all<br />

classified as unlikely to be related<br />

to the treatment (asthma<br />

attack, febrile convulsion, enteritic<br />

bacterial infection, and<br />

severe anaemia)<br />

GI: No difference in GI symptoms<br />

including vomiting<br />

CVS/RS: No difference in respiratory<br />

symptoms<br />

Derm: No difference in dermatological<br />

symptoms<br />

Open label AE not reported<br />

(3 patients with AS+AQ and 1<br />

with AL were withdrawn <strong>for</strong> excessive<br />

vomiting)<br />

229

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!