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Steroid-sparing effects of pentoxifylline in pulmonary sarcoidosis.

ABSTRACT: BACKGROUND:Agents that target pro-inflammatory cytokines may be useful in pulmonary sarcoidosis. OBJECTIVE:To determine effectiveness of a non-selective cyclic nucleotide phosphodiesterase (PDE) inhibitor, pentoxifylline (POF). DESIGN:Randomized, double-blind, placebo-controlled trial, SETTING:Clinical Research Center, National Institutes of Health. PATIENTS:27 patients with biopsy-confirmed pulmonary sarcoidosis receiving prednisone. INTERVENTION:Placebo or POF (1200-2000 mg/day) for 10 months, as prednisone was tapered. MEASUREMENTS:Primary endpoints: sustained improvement in two or more pulmonary function parameters, or a combination of one pulmonary function parameter and dyspnea. RESULTS:Except for one patient, primary endpoints were not reached in POF-treated patients. Therefore, a post hoc analysis was performed. The observed relative risk reduction for flares associated with POF treatment was 54.9% (95% CI 0.21, 0.89) and the absolute risk reduction was 50.6% (95% CI 0.22, 0.80). Compared to placebo treatment, in the POF group, the mean prednisone dose was lower at 8 and 10 months (p = 0.007 and 0.01 respectively), and there was a trend towards less prednisone usage over the entire study period (p = 0.053), as determined by cumulative change analysis. CONCLUSIONS:Although our exploratory post hoc analysis suggested that POF reduced flares and had steroid-sparing effects, given the study limitations, definitive conclusions cannot be drawn regarding the efficacy of POF in pulmonary sarcoidosis. In addition, gastrointestinal side-effects, at the doses used, would seem to limit the use of POF in treating pulmonary sarcoidosis. Overall, however, this trial may provide a basis for using more specific, better-tolerated, PDE inhibitors in future clinical trials.

SUBMITTER: Park MK

PROVIDER: S-EPMC2946799 | biostudies-literature | 2009 Jul

REPOSITORIES: biostudies-literature

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Steroid-sparing effects of pentoxifylline in pulmonary sarcoidosis.

Park M K MK Fontana Babaali H H Gilbert-McClain L I LI Stylianou M M Joo J J Moss J J Manganiello V C VC

Sarcoidosis, vasculitis, and diffuse lung diseases : official journal of WASOG 20090701 2

<h4>Background</h4>Agents that target pro-inflammatory cytokines may be useful in pulmonary sarcoidosis.<h4>Objective</h4>To determine effectiveness of a non-selective cyclic nucleotide phosphodiesterase (PDE) inhibitor, pentoxifylline (POF).<h4>Design</h4>Randomized, double-blind, placebo-controlled trial,<h4>Setting</h4>Clinical Research Center, National Institutes of Health.<h4>Patients</h4>27 patients with biopsy-confirmed pulmonary sarcoidosis receiving prednisone.<h4>Intervention</h4>Place ...[more]

PMID: 20560292

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Project description:PurposeReduced physical activity in many chronic diseases is consistently associated with increased morbidity. Little is known about physical activity in sarcoidosis. The aim of this study was to objectively assess physical activity in patients with pulmonary sarcoidosis and investigate its relationship with lung function, exercise capacity, symptom burden, and health status.MethodsPhysical activity was assessed over one week in 15 patients with pulmonary sarcoidosis and 14 age-matched healthy controls with a tri-axial accelerometer (ActivPal™) and the International Physical Activity Questionnaire (IPAQ). All participants underwent pulmonary function tests, 6-min walk test (6MWT) and completed the Fatigue Assessment Scale (FAS), Medical Research Council (MRC) Dyspnoea Scale and the King's Sarcoidosis Questionnaire (KSQ).ResultsPatients with sarcoidosis had significantly lower daily step counts than healthy controls; mean (SD) 5624 (1875) versus 10,429 (2942) steps (p?<?0.01) and a trend towards fewer sit-to-stand transitions each day (p?=?0.095). Only two patients (13%) self-reported undertaking vigorous physical activity (IPAQ) compared to half of healthy individuals (p?<?0.01). Daily step count was significantly associated with 6MWT distance in sarcoidosis (r?=?0.634, p?=?0.01), but not with forced vital capacity (r?=?0.290), fatigue (r?=?0.041), dyspnoea (r?=?-0.466) or KSQ health status (r?=?0.099-0.484). Time spent upright was associated with fatigue (r?=?-0.630, p?=?0.012) and health status (KSQ Lung scores r?=?0.524, p?=?0.045), and there was a significant correlation between the number of sit-to-stand transitions and MRC dyspnoea score (r?=?-0.527, p?=?0.044).ConclusionPhysical activity is significantly reduced in sarcoidosis and is associated with reduced functional exercise capacity (6MWD). Fatigue, exertional symptoms and health status were more closely associated with time spent upright and the number of bouts of physical activity, as compared to step counts. Further studies are warranted to identify the factors that determine different physical activity profiles in sarcoidosis.

Dataset Information

Steroid-sparing effects of pentoxifylline in pulmonary sarcoidosis.

Publications

Steroid-sparing effects of pentoxifylline in pulmonary sarcoidosis.

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