Abstract Title

Comparison of Pulmonary Impairment after Tuberculosis in patients treated with Moxifloxacin-based regimens vs standard RIPE (Rifampin-Isoniazid-Pyrazinamide-Ethambutol)

Presenter Name

James Akiddas

RAD Assignment Number

1126

Abstract

Purpose: Tuberculosis (TB) is a global health-care problem. Of the 9.6 million people affected every year, 1.6 million dies, and 70% of remaining survivors develop functional and anatomical lung damage. The lung injury after cured TB has been well characterized and is known as Pulmonary Impairment after Tuberculosis (PIAT). PIAT occurs despite completion of treatment with standard RIPE (Rifampin, Isoniazid, Pyrazinamide, and Ethambutol) regimen. Moxifloxacin regimens have shown effectiveness curing PTB besides having an immuno-modulatory effect that may limit extension and severity of tissue destruction in the lung.

Hypothesis: Patients receiving Moxifloxacin based regimen for PTB exhibit less frequent and reduced severity of PIAT in comparison with those receiving standard regimen (RIPE).

Methods: We compared results of Pulmonary Function Test (PFT) in 166 patients diagnosed with PTB. Twenty-three were treated with a Moxifloxacin-based regimen (sponsored clinical trial) and 143 with standard regimen (RIPE). Pulmonary impairment (presence and severity) was assessed following AMA criteria. FVC, FEV1, and FEV1/FVC ratio values were compared with predicted values considering gender and race standards. Lung restrictive defect was defined as FEV1/FVC ratio >70% with an FVC < 80% of predicted. Airway obstruction was defined as FEV1/FVC ratio80% of predicted. Mixed pattern was FVC of < 80% predicted and FEV1/FVC ratio 20 weeks of therapy when culture results were negative. Demographic and risk factors for lung impairment were collected.

Results: Both groups had similar risk factors for lung impairment. PIAT was present in 35% of patients receiving Moxifloxacin and 57% of patients receiving standard RIPE regimen (p =0.0510). Mean FVC, FEV1, FEV1/FVC ratios flow, and FEF 25-75 values showed no significant difference between the two groups. Patients treated with RIPE regimen showed predominately restrictive pattern of disease compared with those in Moxifloxacin. Twelve patients treated with standard RIPE regimen had 50% less of their expected vital capacity vs none in the group treated with Moxifloxacin. After adjusting for other risks associated with lung impairment and severity, we found that patients receiving standard RIPE regimen had 2.5 more risk of having abnormal PFT in comparison with patients in Moxifloxacin (95% CI (1.03-6.18).

Conclusion: These data confirm our previous findings of residual lung impairment in near half of patients cured of PTB. Patients treated with Moxifloxacin regimen had less impairment than those who received standard regimen. Restrictive pattern of disease was predominant in patients treated with standard regimen. Further research is required to assess the effect of Moxifloxacin on PIAT.

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General Public Health

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Poster

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Comparison of Pulmonary Impairment after Tuberculosis in patients treated with Moxifloxacin-based regimens vs standard RIPE (Rifampin-Isoniazid-Pyrazinamide-Ethambutol)

Purpose: Tuberculosis (TB) is a global health-care problem. Of the 9.6 million people affected every year, 1.6 million dies, and 70% of remaining survivors develop functional and anatomical lung damage. The lung injury after cured TB has been well characterized and is known as Pulmonary Impairment after Tuberculosis (PIAT). PIAT occurs despite completion of treatment with standard RIPE (Rifampin, Isoniazid, Pyrazinamide, and Ethambutol) regimen. Moxifloxacin regimens have shown effectiveness curing PTB besides having an immuno-modulatory effect that may limit extension and severity of tissue destruction in the lung.

Hypothesis: Patients receiving Moxifloxacin based regimen for PTB exhibit less frequent and reduced severity of PIAT in comparison with those receiving standard regimen (RIPE).

Methods: We compared results of Pulmonary Function Test (PFT) in 166 patients diagnosed with PTB. Twenty-three were treated with a Moxifloxacin-based regimen (sponsored clinical trial) and 143 with standard regimen (RIPE). Pulmonary impairment (presence and severity) was assessed following AMA criteria. FVC, FEV1, and FEV1/FVC ratio values were compared with predicted values considering gender and race standards. Lung restrictive defect was defined as FEV1/FVC ratio >70% with an FVC < 80% of predicted. Airway obstruction was defined as FEV1/FVC ratio80% of predicted. Mixed pattern was FVC of < 80% predicted and FEV1/FVC ratio 20 weeks of therapy when culture results were negative. Demographic and risk factors for lung impairment were collected.

Results: Both groups had similar risk factors for lung impairment. PIAT was present in 35% of patients receiving Moxifloxacin and 57% of patients receiving standard RIPE regimen (p =0.0510). Mean FVC, FEV1, FEV1/FVC ratios flow, and FEF 25-75 values showed no significant difference between the two groups. Patients treated with RIPE regimen showed predominately restrictive pattern of disease compared with those in Moxifloxacin. Twelve patients treated with standard RIPE regimen had 50% less of their expected vital capacity vs none in the group treated with Moxifloxacin. After adjusting for other risks associated with lung impairment and severity, we found that patients receiving standard RIPE regimen had 2.5 more risk of having abnormal PFT in comparison with patients in Moxifloxacin (95% CI (1.03-6.18).

Conclusion: These data confirm our previous findings of residual lung impairment in near half of patients cured of PTB. Patients treated with Moxifloxacin regimen had less impairment than those who received standard regimen. Restrictive pattern of disease was predominant in patients treated with standard regimen. Further research is required to assess the effect of Moxifloxacin on PIAT.