Lege Artis Medicinae

[Treatment of chronic Pseudomonas aeruginosa lung infections in cystic fibrosis with inhaled tobramycin]

NAGY Béla, HOLICS Klára

JULY 20, 2015

Lege Artis Medicinae - 2015;25(06-07)

[BACKGROUND - Intermittent or chronic pulmonary infections caused by Pseudo­monas aeruginosa (Pa) deteriorate clinical status and worsen lung function in patients with cystic fibrosis (CF). The prognosis of the disease and life expectancy of patients are substantially dependent on lung infections and inflammation; therefore the primary goal of the treatment is the early termination of the infection. PATIENTS AND METHODS - Efficacy of tobramycin (TOBI® 300 mg/5 mL solution for inhalation, henceforth TOBI®) inhalation in Pa pulmonary infections was studied in a non-interventional, observational, open-label, single-arm trial in subjects with CF. Fifty-three patients aged six to 31 years (averaged 15.8 years) were enrolled into the study. Three treatment cycles of TOBI® inhalation (28 days on drug, 28 days off drug) plus 6 months observational period were evaluated. Primary endpoint was changing in the predictive values of forced expiratory volume in 1 sec (FEV1) compared to the initial values after three cycles of the treatment. Secondary endpoints were changing in the FEV1 predictive values at the end of the complete study compared to the initial values; ratios of patients with decreased density of originally Pa-positive result of sputum culture; as well as safety and tolerability of the TOBI® treatment. RESULTS - FEV1 and FEV1% results were unchanged comparing to the initial values at the end of the treatment and after the observational period in the whole study population. However, sputum cultures became negative in 47.2% of all subjects as a result of the treatment, and the FEV1 values were gradually increased in these patients: after the third treatment cycle plus 160 mL, and at the end of the study plus 110 mL comparing to the initial values. Similar considerable increase was detected in the predictive FEV1% in this sub-group: after the first cycle plus 5.2%, at the end of third cycle plus 7%, after the observational period above 3.8% considering the starting results. CONCLUSIONS - TOBI® inhalation proved to be effective in improvement of lung function results and eradication of infection in our patients with Pa positive CF. The treatment was well tolerated and safe.]

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[Effect of mycophenolate sodium therapy on quality of life of renal transplant patients]

LÁZÁR György, SZENOHRADSZKY Pál, SZEDERKÉNYI Edit, SURMANN Ágnes, TORONYI Éva, TÖRÖK Szilárd, FÖLDES Katalin, KALMÁR-NAGY Károly, SZAKÁLY Péter

[Enteric-coated mycophenolate sodium (EC-MPS; Myfortic®, Novartis Pharma AG, Basel, Switzerland) is an enteric-coated formulation delivering MPA. Enteric-coated MPS has been developed with the aim of improving the upper GI tolerability of MPA while providing a therapeutical equivalence. The primary objective of the study was to measure the quality of life of kidney transplant patients, with special attention to gastrointestinal symptoms during mycophenolate sodium therapy. The secondary objective was to measure the mean daily mycophenolate sodium dose during routine therapy. These two parameters can significantly influence long-term graft survival of the patients. The study was a multicentric, non-interventional, 12 weeks, single arm, cohort, observational study, in which 251 adult, kidney transplant patients were enrolled in 4 study centers. As part of the study, the patient completed a questionnaire to assess the gastrointestinal status: the Gastrointestinal Symp­tom Rating Scale (GSRS). The patient’s average age was 51.03 years by the time of the inclusion. 61% of the patients were male and 39% female. Kidney transplant was performed averagely 6.3 years (SD: 4.3 years) prior to the screening visit. At the first visit the average intensity of gastrointestinal side effects was 0.87, at the final visit was 0.28. The change of the average number of gastrointestinal side effects between the first and last visit was examined by Wilcoxon test, and it was significant (p<0.0001). Patients had to complete the GSRS questionnaire aiming at five gastrointestinal symptom groups. In all five symp­tom-groups significant (p<0.0001) improvement was observed between the visits. Our results support that, in renal transplant patients with gastrointestinal undesirable effects due to MMF, using enteric-coated mycophenolate sodium may increase the maximum tolerated dose of MPA and reduce GI disorders.]

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