Dataset Information

Combined pirfenidone, azithromycin and prednisolone in post-H1N1 ARDS pulmonary fibrosis.

ABSTRACT: There are no specific data on the management of pulmonary fibrosis post-H1N1 ARDS. We present the cases of three patients who responded positively to treatment with pirfenidone, azithromycin and prednisolone. Three males, aged 40, 45 and 59 years, had H1N1 ARDS requiring mechanical ventilation for two weeks or longer. After weaning off ventilation, they had persistent symptoms and hypoxemia at rest despite receiving prednisolone and home oxygen for at least three weeks following discharge. Computed tomography (CT) of the chest showed fibrosis and traction bronchiectasis. At presentation, they could not perform spirometry. Investigations ruled out infection. Pirfenidone (600 mg daily escalated to maximum tolerable dose of 2.4 gm daily) and azithromycin (500 mg thrice weekly) were added off-label to prednisolone. In one patient pirfenidone was discontinued after three months due to an adverse reaction and azithromycin was continued for nine months. At one year follow-up, all patients had symptomatic improvement, better effort tolerance, regression of opacities and no progression of fibrosis on CT, and improvement in spirometry and six minute walk tests. Pirfenidone and azithromycin added to prednisolone may have led to clinical and radiological improvement. The current experience suggests that this treatment approach to pulmonary fibrosis post-H1N1 ARDS be studied further. (Sarcoidosis Vasc Diffuse Lung Dis 2018; 35: 85-90).

SUBMITTER: Saha A

PROVIDER: S-EPMC7170064 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Combined pirfenidone, azithromycin and prednisolone in post-H1N1 ARDS pulmonary fibrosis.

Saha Avinandan A Vaidya Preyas J PJ Chavhan Vinod B VB Achlerkar Amolkumar A Leuppi Jörg D JD Chhajed Prashant N PN

Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG 20180428 1

There are no specific data on the management of pulmonary fibrosis post-H1N1 ARDS. We present the cases of three patients who responded positively to treatment with pirfenidone, azithromycin and prednisolone. Three males, aged 40, 45 and 59 years, had H1N1 ARDS requiring mechanical ventilation for two weeks or longer. After weaning off ventilation, they had persistent symptoms and hypoxemia at rest despite receiving prednisolone and home oxygen for at least three weeks following discharge. Compu ...[more]

PMID: 32476885

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Project description:AimThe efficacy and safety of pirfenidone have been previously demonstrated in patients with mild-to-moderate idiopathic pulmonary fibrosis (IPF). However, the effect of pirfenidone in patients with advanced IPF remains unclear. Here, we investigated the effects of pirfenidone against advanced IPF in a real-world setting.MethodsA prospective nationwide post-marketing study was conducted on 258 patients from 10 Korean institutions. Patients with a predicted forced vital capacity (FVC) less than 50% or a diffusing capacity of the lung for carbon monoxide (DLco) less than 35% at baseline were classified as the advanced IPF group.ResultsOf 219 patients included in the analysis, the majority were male (76.3%); the mean age was 67.3 years, and the advanced group accounted for 17.8% of the patients. The median treatment duration was 298 days. Among the subjects, 86.3% experienced adverse events (AEs), of which a decreased appetite (32.4%) and a photosensitivity reaction (13.7%) were the most frequent. The incidence of AEs was similar between the advanced and non-advanced groups (92.3% vs. 85.0%, respectively; p = 0.229). Although the overall discontinuation rate was higher in the advanced group than in the non-advanced group (74.4% vs. 50.0%, respectively; p = 0.006), the percentages of the patients who discontinued treatment as a result of AEs were similar in both groups (20.5% vs. 23.3%, respectively; p = 0.704). In all patients, the rates of decline in the predicted FVC and DLco over 48 weeks were - 4.3 ± 1.3% and - 4.4 ± 1.7%, respectively. There was no between-group difference in the rate of lung function decline.ConclusionsPirfenidone used for the treatment of patients with IPF in a real-world setting was well tolerated, with an acceptable safety profile and a consistent therapeutic effect, regardless of the disease severity.Trial registrationClinicalTrials.gov NCT03761082; the trial was retrospectively registered on December 3, 2018.

Project description:IntroductionIn the European Union (EU), the indication for the antifibrotic pirfenidone prior to April 2023 did not include patients with advanced idiopathic pulmonary fibrosis (IPF). This analysis compared the efficacy and safety of pirfenidone in advanced IPF versus non-advanced IPF.MethodsData were included from the following studies of pirfenidone: ASCEND (NCT01366209); CAPACITY (004 [NCT00287716] and 006 [NCT00287729]); RECAP (NCT00662038; advanced IPF defined as percent predicted forced vital capacity [%FVC] < 50% and/or percent predicted carbon monoxide diffusing capacity [%DLco] < 35% at baseline); PASSPORT (NCT02699879; advanced IPF defined as baseline %FVC < 50%); and SP-IPF (NCT02951429; patients with advanced IPF [defined as %DLco ≤ 40% at screening] at risk of group 3 pulmonary hypertension).ResultsIn the pooled ASCEND/CAPACITY studies, the annual mean rate of FVC decline from baseline to Week 52 was significantly lower for pirfenidone versus placebo in advanced (p = 0.0035) and non-advanced IPF (p = 0.0001). Rate of all-cause mortality over 52 weeks was numerically lower for pirfenidone versus placebo in advanced and non-advanced IPF. In RECAP, the mean annual rate of FVC decline from baseline to Week 180 of pirfenidone treatment was similar in patients with advanced (- 141.5 mL) and non-advanced IPF (- 153.5 mL). In SP-IPF, the mean annual rate of FVC decline and rate of all-cause mortality from baseline to Week 52 in patients treated with placebo + pirfenidone were - 93.0 mL and 20.2%, respectively. No new safety signals were identified, and the safety profile of pirfenidone in patients with advanced IPF was generally consistent with that of non-advanced IPF.ConclusionsThese results highlight the benefit of pirfenidone treatment in patients with advanced and non-advanced IPF. As such, the indication for pirfenidone in the EU has now been updated to include the treatment of adult patients with advanced IPF.Trial registrationsASCEND (NCT01366209), CAPACITY 004 (NCT00287716), CAPACITY 006 (NCT00287729), RECAP (NCT00662038), PASSPORT (NCT02699879), and SP-IPF (NCT02951429).

Dataset Information

Combined pirfenidone, azithromycin and prednisolone in post-H1N1 ARDS pulmonary fibrosis.

Publications

Combined pirfenidone, azithromycin and prednisolone in post-H1N1 ARDS pulmonary fibrosis.

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