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Author: Anoma Ranaweera B.V.Sc; PhD, Clinical Biochemistry, University of Liverpool, UK. Chief Editor: Dr Amanda Oakley, Dermatologist, Hamilton, New Zealand, April 2015. Copy edited by Gus Mitchell. Updated June 2018.
Posaconazole is also indicated for:
|Proportion (%) of patients with proven/probable IFIs – no./total no. patients (%)|
|On treatment period*|
|Study 1||7/291 (2)||22/288 (8)||0.0038|
|Study 2||7/304 (2)||25/298 (8)||0.0009|
|Fixed time period**|
|Study 1||7/301 (2)||21/299 (7)||< 0.0059|
|Study 2||4/304 (1)||26/298 (9)||< 0.0001|
* In study 2, this was the period from randomization to last dose of study medication plus 7 days; in study 1, it was the period from first dose to last dose of study medication plus 7 days.
**In study 2, this was the period from randomization to 100 days post-randomization; in study 1, it was the period from the Baseline day to 111 days post-baseline. a) fluconazole (study 1); fluconazole/itraconazole (study 2).
|Clinical success rate at Day 14||91.7% (155/169)||92.5% (148/160)|
|Clinical success rate(a) 4 weeks after end of treatment||68.5% (98/143)||61.8% (84/136)|
|Mycological response rate(b) 4 weeks after end of treatment**||40.6% (41/101)||26.4% (24/91)|
(a) Clinical success rate was defined as the number of cases assessed as having a clinical response (cure or improvement) divided by the total number of cases eligible for analysis.
(b) Mycological response rate was defined as mycological success (≤ 20 CFU/ml) divided by the total number of cases eligible for analysis.
** p = 0.04
|End point||Posaconazole||External control group|
|Overall response||45/107 (42%)||22/86 (26%)|
|Survival at day 365||38%||22% [P= 0.006]|
|Success by species|
|Aspergillus fumigatus||12/29 (41%)||12/34 (35%)|
|Aspergillus flavus||10/19 (53%)||3/16 (19%)|
|Aspergillus tereus||4/14 (29%)||2/13 (15%)|
|Aspergillus niger||3/5 (60%)||2/7 (29%)|
If you are not based in New Zealand, we suggest you refer to your national drug approval agency for further information about medicines (eg, the Australian Therapeutic Goods Administration and the US Food and Drug Administration) or a national or state-approved formulary (eg, the New Zealand Formulary and New Zealand Formulary for Children and the British National Formulary and British National Formulary for Children).
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