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DRUG TRIALS SNAPSHOT OF XOFLUZA

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发表于 2018-11-8 15:46:45 | 显示全部楼层 |阅读模式
DRUG TRIALS SNAPSHOT SUMMARY:What is the drug for?
XOFLUZA is a drug to treat the flu (influenza) in people 12 years of age and older who have had flu symptoms for no more than 48 hours.
How is this drug used?
XOFLUZA is a tablet taken as a single dose by mouth within 48 hours of flu symptoms.
The dose depends on the patient’s weight.
What are the benefits of this drug?
Patients treated with XOFLUZA had a shorter time to relieve symptoms compared with patients treated with placebo.


What are the benefits of this drug (results of trials used to assess efficacy)?
The figures below summarize efficacy results for the evaluated patients in Trials 1 and 2. The primary outcome was time to alleviation of symptoms.
Table 2. Time to Alleviation of Symptoms after Single Dose in Adult Subjects with Acute Uncomplicated Influenza in Trial 1 (Median Hours)

XOFLUZA 40 mg
(95% CI1)
N = 100
Placebo
(95% CI1)
N = 100
Adults (20 to 64 Years of Age)
50 hours2
(45, 64)
78 hours
(68, 89)

1CI: Confidence interval
2XOFLUZA treatment resulted in a statistically significant shorter time to alleviation of symptoms compared to placebo using the Gehan-Breslow’s generalized Wilcoxon test (p-value: 0.014, adjusted for multiplicity). The primary analysis using the Cox Proportional Hazards Model did not reach statistical significance (p-value: 0.165).
Table 3. Time to Alleviation of Symptoms after Single Dose in Subjects 12 Years of Age and Older with Acute Uncomplicated Influenza in Trial 2 (Median Hours)

XOFLUZA 40 mg or 80 mg1
(95% CI2)
N = 455
Placebo
(95% CI2)
N = 230
Subjects (≥ 12 Years of Age)
54 hours3
(50, 59)
80 hours
(73, 87)

1Dosing was based on weight. Subjects weighing < 80 kg received a single 40 mg dose and subjects ≥ 80 kg received a single 80 mg dose.
2CI: Confidence interval
3XOFLUZA treatment resulted in a statistically significant shorter time to alleviation of symptoms compared to placebo using the Peto-Prentice’s generalized Wilcoxon test (p-value: <0.001).


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发表于 2018-11-8 16:11:22 | 显示全部楼层
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