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Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.

Noble PW, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, Lancaster L, Lederer DJ, Leff JA, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, King TE - Eur. Respir. J. (2015)

Bottom Line: Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis.At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%).A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea.

View Article: PubMed Central - PubMed

Affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.

No MeSH data available.


Related in: MedlinePlus

Summary of clinical efficacy outcomes at 1 year across studies. FVC: forced vital capacity; 6MWD: 6-min walk distance; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire; TE: treatment-emergent; IPF: idiopathic pulmonary fibrosis; STE: standardised treatment effect. p>0.05 for all tests for interaction between treatment and study. #: decline in FVC % predicted ≥10% or death; ¶: decline in 6MWD ≥50 m or death; +: increase in UCSD SOBQ score ≥20 points or death; §: estimated as the difference in the rank mean change from baseline between groups divided by the estimate of the common standard deviation from each study.
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Figure 5: Summary of clinical efficacy outcomes at 1 year across studies. FVC: forced vital capacity; 6MWD: 6-min walk distance; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire; TE: treatment-emergent; IPF: idiopathic pulmonary fibrosis; STE: standardised treatment effect. p>0.05 for all tests for interaction between treatment and study. #: decline in FVC % predicted ≥10% or death; ¶: decline in 6MWD ≥50 m or death; +: increase in UCSD SOBQ score ≥20 points or death; §: estimated as the difference in the rank mean change from baseline between groups divided by the estimate of the common standard deviation from each study.

Mentions: Figure 4 summarises the overall efficacy results in the pooled population. The point estimate and 95% confidence interval for the relative risk/hazard ratio favoured pirfenidone and excluded “no effect” for each clinical efficacy outcome. Additionally, analysis of outcomes by study revealed generally similar treatment effects across all three independent studies, with no statistical evidence of an interaction between treatment and study (figure 5).FIGURE 4


Pirfenidone for idiopathic pulmonary fibrosis: analysis of pooled data from three multinational phase 3 trials.

Noble PW, Albera C, Bradford WZ, Costabel U, du Bois RM, Fagan EA, Fishman RS, Glaspole I, Glassberg MK, Lancaster L, Lederer DJ, Leff JA, Nathan SD, Pereira CA, Swigris JJ, Valeyre D, King TE - Eur. Respir. J. (2015)

Summary of clinical efficacy outcomes at 1 year across studies. FVC: forced vital capacity; 6MWD: 6-min walk distance; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire; TE: treatment-emergent; IPF: idiopathic pulmonary fibrosis; STE: standardised treatment effect. p>0.05 for all tests for interaction between treatment and study. #: decline in FVC % predicted ≥10% or death; ¶: decline in 6MWD ≥50 m or death; +: increase in UCSD SOBQ score ≥20 points or death; §: estimated as the difference in the rank mean change from baseline between groups divided by the estimate of the common standard deviation from each study.
© Copyright Policy - open-access
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC4697914&req=5

Figure 5: Summary of clinical efficacy outcomes at 1 year across studies. FVC: forced vital capacity; 6MWD: 6-min walk distance; UCSD SOBQ: University of California San Diego Shortness of Breath Questionnaire; TE: treatment-emergent; IPF: idiopathic pulmonary fibrosis; STE: standardised treatment effect. p>0.05 for all tests for interaction between treatment and study. #: decline in FVC % predicted ≥10% or death; ¶: decline in 6MWD ≥50 m or death; +: increase in UCSD SOBQ score ≥20 points or death; §: estimated as the difference in the rank mean change from baseline between groups divided by the estimate of the common standard deviation from each study.
Mentions: Figure 4 summarises the overall efficacy results in the pooled population. The point estimate and 95% confidence interval for the relative risk/hazard ratio favoured pirfenidone and excluded “no effect” for each clinical efficacy outcome. Additionally, analysis of outcomes by study revealed generally similar treatment effects across all three independent studies, with no statistical evidence of an interaction between treatment and study (figure 5).FIGURE 4

Bottom Line: Pooled analyses of outcomes at 1 year were based on the pre-specified end-points and analytic methods described in the ASCEND study protocol.A total of 1247 patients were included in the analysis.At 1 year, pirfenidone reduced the proportion of patients with a ≥10% decline in per cent predicted forced vital capacity or death by 43.8% (95% CI 29.3-55.4%) and increased the proportion of patients with no decline by 59.3% (95% CI 29.0-96.8%).A treatment benefit was also observed for progression-free survival, 6-min walk distance and dyspnoea.

View Article: PubMed Central - PubMed

Affiliation: Cedars-Sinai Medical Center, Los Angeles, CA, USA Paul.Noble@cshs.org.

No MeSH data available.


Related in: MedlinePlus