Bronchiectasis in Türkiye: Data from a Multicenter Registry (Turkish Adult Bronchiectasis Database).

Background: Bronchiectasis is a chronic lung disease characterized by permanent bronchial wall dilatation. Although it has been known as an orphan disease, it has recently gained attention because of registry-based studies and drug research. Aims: We aimed to use a multicenter database to analyze and compare data regarding the etiology, associated comorbidities, microbiological characteristics, and preventive strategies of bronchiectasis in Türkiye to those of other countries. Study Design: A multicenter prospective cohort study. Methods: The multicenter, prospective cohort study was conducted between March 2019 and January 2022 using the Turkish Adult Bronchiectasis Database, in which 25 centers in Türkiye participated. Patients aged > 18 years who presented with respiratory symptoms such as cough, sputum, and dyspnea and were diagnosed with non-cystic fibrosis bronchiectasis using computed tomography were included in the study. Demographic information, etiologies, comorbidities, pulmonary functions, and microbiological, radiological, and clinical data were collected from the patients. Results: Of the 1,035 study participants, 518 (50%) were females. The mean age of the patients was 56.1 ± 16.1 years. The underlying etiology was detected in 565 (54.6%) patients. While postinfectious origin was the most common cause of bronchiectasis (39.5%), tuberculosis was identified in 11.3% of the patients. An additional comorbidity was detected in 688 (66.5%) patients. The most common comorbidity was cardiovascular disease, and chronic obstructive pulmonary disease (COPD) and bronchiectasis was identified in 19.5% of the patients. The most commonly detected microbiological agent was Pseudomonas aeruginosa (29.4%). Inhaled corticosteroids (ICS) were used in 70.1% of the patients, and the frequency of exacerbations in the last year was significantly higher in patients using ICS than in nonusers (p < 0.0001). Age [odds ratio (OR): 1.028; 95% confidence interval (CI): 1.005-1.051], cachexia (OR: 4.774; 95% CI: 2,054-11,097), high modified medical research council dyspnea scale score (OR: 1,952; 95% CI: 1,459-2,611), presence of chronic renal failure (OR: 4,172; 95% CI: 1,249-13,938) and use of inhaled steroids (OR: 2,587; 95% CI: 1,098-6,098) were significant risk factors for mortality. Mortality rates were higher in patients with COPD than in those with no COPD (21.7-9.1%, p = 0.016). Patients with bronchiectasis and COPD exhibited more frequent exacerbations, exacerbation-related hospitalizations, and hospitalization in the intensive care unit in the previous year than patients without COPD. Conclusion: This is the first multicenter study of bronchiectasis in Türkiye. The study results will provide important data that can guide the development of health policies in Türkiye on issues such as infection control, vaccination, and the unnecessary use of antibiotics and steroids.

Real-life data in the treatment and follow-up of idiopathic pulmonary fibrosis: A single-center study.

Introduction: The aim of this study was to evaluate the real-life treatment and follow-up data of patients with idiopathic pulmonary fibrosis (IPF) in a singlecenter setting. Materials and Methods: The study included consecutive patients diagnosed with IPF who were followed up at the Akdeniz University, between January 1, 2014 and December 31, 2022. Patient information was obtained from the hospital automation system. Result: A total of 227 patients with a mean age of 72.0 ± 8.2 years were included in the study. One hundred sixty-seven patients (73.6%) received pirfenidone while 60 patients (26.4%) received nintedanib treatment. Radiological findings were used to diagnose IPF in 79.3% (n= 180) of cases. Mean duration of antifibrotic treatment was 26.3 ± 19.9 months. Of the patients, 49.8% experienced hospital admissions during the treatment course, with respiratory reasons accounting for a majority of these admissions (33.6%). Disease exacerbation was detected in 26.6% of the patients during the treatment period. At least one side effect was observed in 126 patients (55.5%), with a significant portion of these side effects being mild to moderate (n= 79, 34.8%). Disease progression was observed in 21.6% of the patients under antifibrotic treatment. Dose reduction was necessary in 22.9% of the patients, with an average duration of dose reduction of 29 months. Antifibrotic treatment was switched to another medication in 24.2% of the patients. There were no statistically significant differences in baseline forced vital capacity (FVC) levels between the two groups (p= 0.314) while the diffusing capacity of the lungs for carbon monoxide (DLCO) level was higher in the nintedanib group (p= 0.024), and the six-minute walk distance was shorter (p= 0.049). Conclusions: In this study evaluating patients with IPF under follow-up in our hospital, it was observed that the majority of patients consisted of elderly male individuals, frequent hospitalizations were due to respiratory reasons, and both antifibrotic medications were well tolerated with a similar side effect profile.

Disease progression in idiopathic pulmonary fibrosis under anti-fibrotic treatment.

Idiopathic pulmonary fibrosis (IPF) is the most common progressive interstitial disease of unknown etiology. The course of disease is not possible to predict. Frequent monitoring using multiple assessments is important to evaluate disease progression. Currently, there is no consensus on how progression should be defined. Nintedanib and pirfenidone slow the progression of IPF, but the disease can progress even under anti-fibrotic treatment. The goal of this review is to examine and summarize the current data about IPF progression in patients who were on anti-fibrotic treatment. Also, we outline the limitations of the tests used for disease progression.

Elderly idiopathic pulmonary fibrosis patients remain on therapy despite higher incidence of adverse events and dose reductions.

BACKGROUND: Idiopathic pulmonary fibrosis (IPF) predominantly affects people over the age of 60 years and its incidence increases with age. Limited data is available on the use of antifibrotics in the elderly IPF population. We aimed to examine the tolerability and safety of antifibrotics (pirfenidone, nintedanib) in elderly patients with IPF in a real-world setting. METHODS: Medical records of 284 elderly (≥75 years) and 446 non-elderly IPF patients (<75 years) were retrospectively analyzed in this multi-center study. Patient characteristics, treatments, adverse events (AEs), tolerability, hospitalizations, exacerbations, and mortality were compared between the elderly and non-elderly group. RESULTS: In the elderly group, the mean age was 79 years and the mean antifibrotic treatment duration was 26.1 months. The most commonly reported AEs were weight loss, loss of appetite and nausea. Elderly IPF patients had a significantly higher incidence of AEs (62.9% vs. 55.1%, p = 0.039) and dose reductions (27.4% vs. 18.1%, p = 0.003) than the non-elderly did, but the rate of discontinuation of antifibrotics was not different between groups (13% vs. 10.8%, p = 0.352). In addition, the severity of the disease, frequency of hospitalizations, exacerbations, and mortality rates were higher in elderly patients. CONCLUSION: The present study showed that elderly IPF patients experienced significantly increased AEs and dose reductions due to antifibrotic use, while the discontinuation rates of the drugs were similar to those of drugs used by non-elderly patients.

Characteristics and outcomes of COVID-19 patients with IPF: A multi-center retrospective study.

BACKGROUND: There are few data on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (COVID-19) infection in patients with idiopathic pulmonary fibrosis (IPF). The objective of this study is to describe the characteristics and outcomes of IPF patients confirmed COVID-19 infection. METHODS: In this retrospective, multi-center, cohort study, patients from 4 hospital medical records with known IPF and a COVID-19 diagnosis were identified. Demographic and clinical outcome data were abstracted through a review of electronic medical records. RESULTS: Records for 46 patients with IPF and COVID-19 were abstracted. The mean age was 65±10 years. The most common symptom was dyspnea, followed by fever and cough. Ground-glass opacities (n = 35, 83.3%) and consolidations (n = 11, 26.1%) were the main imaging features of the disease in thorax computed tomography (CT). Twenty-four patients (52.1%) required hospitalization. Among the hospitalized patients, 16 (66.6%) were admitted to the intensive care unit (ICU), and 10 (41.6%) underwent invasive mechanical ventilation. Thirteen patients (28.2%) died of COVID-19 complications. Mortality rate was significantly associated with lower DLCO/VA, long term oxygen therapy and consolidation finding on CT of thorax (p<0.05). On multivariable analysis, neither factor was associated with hospitalization or mortality. CONCLUSIONS: IPF patients represent a vulnerable population for COVID-19, according to the high rate of hospitalization, ICU requirement, and mortality rate. Measures to minimize the risk of COVID-19 infection remain key to protect IPF patients.

Alterations in plasma miR-21, miR-590, miR-192 and miR-215 in idiopathic pulmonary fibrosis and their clinical importance.

BACKGROUND: Many studies have revealed that microRNA (miRNA) molecules may take part in idiopathic pulmonary fibrosis (IPF). But, the role of miRNAs in the development of IPF is not yet clear. METHODS: We investigated the plasma levels of miR-21, miR-590, miR-192, and miR-215 in IPF (n = 88) and healthy control (n = 20) groups in this study. We compared the expression levels of target miRNAs in patients with IPF and healthy participants. We grouped the patients with IPF according to age, forced vital capacity, carbon monoxide diffusing capacity (DLCO), gender-Age-pulmonary physiology (GAP) score, the presence of honeycombing and compared the expression levels of target miRNAs in these clinical subgroups. RESULTS: 82 (93.18%) of the patients with IPF were male and the mean age was 66.6 ± 8.6 years. There was no significant difference between the gender and age distributions of IPF and the control group. The mean plasma miR-21 and miR-590 levels in IPF group were significantly higher than in the control group (p < 0.0001, p < 0.0001, respectively). There was no significant difference between the miR-192 and miR-215 expression levels of the IPF and control group. Both miR-21 and miR-590 correlated positively with age (p = 0.041, p = 0.007, respectively) while miR-192 and miR-215 displayed a negative correlation with age (p = 0.0002, p < 0.0001, respectively). The levels of miR-192 and miR-215 increased as the GAP score decreased. The levels of miR-192 in patients with honeycombing were significantly lower than in those without honeycombing (p = 0.003). CONCLUSIONS: Our study showed that both miR-21 and miR-590 were overexpressed in IPF. The miR-21 and miR-590 were associated with DLCO, while miR-192 and miR-215 were associated with the GAP score and honeycombing.

Acute asthma exacerbation after SARS-CoV-2 vaccine (Sinovac®): a case report.

A 76-year-old female received a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (CoronaVac, Sinovac®, Beijing, China) and subsequently experienced chest discomfort. A computed tomography performed 1 day after vaccination showed multiple infiltrations in both lungs and ground-glass shadows in both lung fields. Her fingertip oxygen saturation was 81% and there was widespread wheezing on physical examination. Based on these findings, the patient was hospitalized with a preliminary diagnosis of drug-induced pneumonitis and acute asthma exacerbation due to a SARS-CoV-2 vaccine. During her hospitalization, 40 mg/d systemic steroid, 4 times a day salbutamol nebulized, 2 L/min inhaled oxygen therapy and 400 mg/d moxifloxacin intravenous were administered for 5 days. One month later, the thorax computed tomography scan revealed that the previous findings were almost completely regressed.

Tolerability and efficacy of second-line antifibrotics in patients with idiopathic pulmonary fibrosis.

BACKGROUND: The antifibrotic drugs nintedanib and pirfenidone reduce disease progression in idiopathic pulmonary fibrosis (IPF) and have also shown to improve survival. Switching first-line antifibrotic drug may required in IPF due to disease progression or intolerable adverse effects. The aim of this study was to assess the safety and efficacy of second-line antifibrotic treatment in patients with IPF. MATERIAL AND METHODS: This retrospective, multicenter study was conducted at three referral interstitial lung disease centers who received first-line antifibrotics more than one month and switched the treatment to a second-line antifibrotic agent during January 2016-June 2021. The drug's safety was evaluated based on the type of adverse effect. Disease progression was defined as an absolute decline in FVC of >10% within 12 months with or without radiological progression. RESULTS: Among 629 consecutive patients with IPF, 66 patients switched antifibrotics. The median duration of antifibrotics was 13 (1-41) months prior to the switch, and 14 (2-42) months after the switch. The mean age was 70.6 ± 8.9 years and, median FVC (%) was 72.1 ± 18.7 at the initiation of first-line antifibrotics. The most common reason for the switch was disease progression (56%) followed by severe adverse effects (SAEs) (44%). SAEs were significantly less observed after the switch compared before the switch (43.9% vs12.1%, respectively, p < 0.001). Eighteen patients had adverse effects due to second-line antifibrotics. Among these patients, 10 had mild adverse effects and 8 had severe adverse effects. While there was no change in the FVC (%) values in 30.3% patients 12 months after the first-line antifibrotic treatment (before the switch), there was no change in the FVC (%) values in 40% patients at the end of 12 months after the switch. Fourteen patients (42.4%) who received antifibrotic treatment before the switch had more than 10% decline in FVC (%) at the end of 12 months. Eight patients (32.0%) had 10% or more decline in FVC (%) 12 months after the switch. CONCLUSION: Patients with IPF who do not tolerate first-line antifibrotic treatment or those showing disease progression despite treatment, switching antifibrotics may be a feasible management strategy.

Evaluation of efficacy and safety of pirfenidone 200 mg tablets in patients with idiopathic pulmonary fibrosis in a real-life setting

Background/aim: Phase III trials have demonstrated a significant efficacy and an acceptable safety for pirfenidone in patients having mild to moderate idiopathic pulmonary fibrosis (IPF). Real-life data on the use of pirfenidone 200 mg tablets are limited. This study aimed to investigate the efficacy and safety of pirfenidone 200 mg tablets for the treatment of IPF in a real-life setting. Materials and methods: A retrospective, multicenter study conducted in four university hospitals in Turkey between January 2017 and January 2019. Clinical records of patients diagnosed with mild to moderate IPF and receiving pirfenidone (200 mg tablets, total 2400 mg/day) were reviewed retrospectively and consecutively. Pulmonary function measurements including forced vital capacity (FVC%) and diffusing capacity of the lungs for carbon monoxide (DLCO%) were analyzed at baseline and after 6-month of pirfenidone treatment. Descriptive statistics were expressed as mean, standard error or median (minimum-maximum), number and percentage, where appropriate. Results: The study included 82 patients, of whom 87.8% were males (mean age, 66 years). After 6-month of treatment, 7 patients discontinued the treatment. Of the remaining 75 patients, 71 (94.6%) remained stable, 4 (5.4%) had progressive disease as evident by a decline in the FVC% of at least 10% while on treatment, and 45 (61.3%) had improved cough. At least one adverse event (AE) associated with the treatment was observed in 28 (37.3%) patients. Conclusion: Pirfenidone 200 mg was effective and well tolerated and associated with relatively mild and manageable AEs in IPF patien

Effects of the COVID-19 pandemic on the follow-up and treatment of patients with idiopathic pulmonary fibrosis: a cross-sectional, multicentre phone call survey.

OBJECTIVE: To learn about the attitudes and behaviours of patients with idiopathic pulmonary fibrosis (IPF) in relation to the difficulties experienced during the COVID-19 pandemic. DESIGN: A cross-sectional, multicentre phone call survey. SETTING: Four university hospitals in Turkey. PARTICIPANTS: The study included patients with IPF receiving antifibrotics for at least 3 months and with doctor appointment and/or scheduled routine blood analysis between March and May 2020 (the first 3 months after the official announcement of the COVID-19 pandemic in Turkey). INTERVENTIONS: Phone calls (a 5 min interview) were performed in June 2020. A questionnaire and the Hospital Anxiety-Depression Scale were applied. MAIN OUTCOME MEASURES: Patients' preferences for disease monitoring, patients' attitudes and behaviours towards IPF, drug continuation, COVID-19 diagnosis and anxiety/depression status. RESULTS: The study included 115 patients with IPF (82 male; mean age, 68.43±7.44 years). Of the patients, 73.9% had doctor appointment and 52.2% had scheduled routine blood testing; 54.5% of patients with doctor appointment self-cancelled their appointments and 53.3% of patients with scheduled routine blood testing did not undergo testing. Of the patients, 32.2% were on nintedanib and 67.8% were on pirfenidone; self-initiated drug discontinuation rate was 22.6%. The percentage of patients communicating with their physicians was 35.7%. The route of communication was by phone (34.8%). The frequency of depression and anxiety was 27.0% and 38.3%, respectively. The rates of drug discontinuation (35.1% vs 16.7%, p<0.05) and depression (37.8% vs 21.8%, p=0.07) were higher in nintedanib users than in pirfenidone users. Only two (1.7%) patients had COVID-19 diagnosis. CONCLUSIONS: During the COVID-19 pandemic, a significant proportion (>50%) of patients self-cancelled their appointments and nearly a quarter of patients discontinued their medications. Providing a documentation of the problems experienced by patients with IPF about management of the necessary requirements during the COVID-19 pandemic, this study may be a model for patients with chronic diseases.

Morbidity and mortality of surgical lung biopsy in the diagnosis of usual interstitial pneumonia.

BACKGROUND: Histology represents the major source of information to define a usual interstitial pneumonia (UIP) pattern. However, the procedure is associated with significant morbidity and mortality. The aim of this study was to evaluate morbidity and mortality of surgical lung biopsy (SLB) in diagnosing UIP. METHODS: Patients undergoing SLB with the ultimate diagnosis of UIP were studied. Clinical data concerning medical history, histology, pulmonary functions, radiology, length of hospital stay (LOS), morbidity and mortality status were retrospectively recruited from four hospitals. RESULTS: The study included consecutive 93 patients with a SLB diagnosis of UIP. Mean age was 61 ± 8 years, with one third of the patients were ≥65 years. In 58 cases (62.4%), the biopsy was performed by video-assisted thoracoscopic surgery, in 35 (37.7%) by limited thoracotomy. Eighty patients (86%) had possible UIP, 12 (12.9%) had inconsistent with UIP and one (1.1%) had UIP pattern on high-resolution computed tomography. The mean LOS was 5.47 ± 3.16 days. LOS was associated with smoking status (P = 0.024), type of biopsy (P = 0.00), 6-min walk test (P = 0.00) and number of biopsy (P = 0.00). There was no in-hospital and 30-day mortality in our cohort, and 90-day mortality rate was 1.1%. In seven patients (7.5%), we observed postoperative morbidities, predominantly prolonged air leakage (7.5% of all cases). Postoperative morbidity was only associated with the type of SLB. Patients with limited thoracotomy showed greater morbidity rates (17.1% versus 1.7%, P = 0.011). CONCLUSION: SLB is a relatively safe procedure in the diagnosis of UIP and can be performed in suitable patients with suspected UIP/idiopathic pulmonary fibrosis.

The Role of Pneumococcal Pneumonia among Community-Acquired Pneumonia in Adult Turkish Population: TurkCAP Study.

OBJECTIVE: To evaluate the rate of pneumococcal pneumonia (PP) among patients with community-acquired pneumonia (CAP) in Turkey and to investigate and compare features of PP and non-PP CAP patients. MATERIAL AND METHODS: This multicenter, non-interventional, prospective, observational study included adult CAP patients (age ≥ 18 years). Diagnosis of PP was based on the presence of at least 1 positive laboratory test result for Streptococcus pneumoniae (blood culture or sputum culture or urinary antigen test [UAT]) in patients with radiographic findings of pneumonia. RESULTS: Four hundred sixty-five patients were diagnosed with CAP, of whom 59 (12.7%) had PP. The most common comorbidity was chronic obstructive pulmonary disease (30.1%). The mean age, smoking history, presence of chronic neurological disease, and CURB-65 score were significantly higher in PP patients, when compared to non-PP patients. In PP patients, 84.8% were diagnosed based ony on the UAT. The overall rate of PP patients among CAP was calculated as 22.8% considering the UAT sensitivity ratio of 63% (95% confidence interval: 45-81). The rate of intensive care treatment was higher in PP patients (P = .007). While no PP patients were vaccinated for pneumococcus, 3.8% of the non-PP patients were vaccinated (P = .235). Antibiotic use in the preceding 48 hours was higher in the non-PP group than in the PP group (31.8% vs. 11.1%, P = .002). The CURB-65 score and the rate of patients requiring inpatient treatment according to this score were higher in the PP group. CONCLUSION: The facts that PP patients were older and required intensive care treatment more frequently as compared to non-PP patients underline the burden of PP.

Demographic, Clinical and Management Characteristics of Newly Diagnosed COPD Patients in Turkey: A Real-Life Study.

Purpose: In order to determine the clinical and sociodemographic characteristics of newly diagnosed treatment-naïve asthma and COPD patients in Turkey, a multicenter study in 2012 was initiated . We aimed to investigate the characteristics and therapies of COPD patients in the original study in more detail. Patients and Methods: This nation-wide, multicentric, non-interventional, prospective, real-life observational cohort study was conducted in 122 centers. The newly diagnosed patients were not receiving any treatment before the recruitment. Their general characteristics, the combined GOLD 2011 COPD categories and exacerbation histories were noted. The patients were followed up with 3 voluntary visits for 1 year. Their adherence to the inhaled treatment according to GOLD 2011 was evaluated during follow-up visits. Results: The study included 776 COPD patients. Their mean age was 59.4±9.1 years, and 11.9% of the patients were female. 35.1% of the patients were in the GOLD 2011 C and D category. 12.6% are frequent exacerbators, and 52.8% had at least one comorbid condition. 71.8% overtreatment rate was detected. Their attendance rates for three follow-up visits became 55.9%, 32.9% and 18.7%, respectively. The adherence rate to the treatment was measured as 81.9%. Conclusion: Although these patients were diagnosed for the first time, the GOLD C and D categories and frequent exacerbator phenotype were found at a high rate. They were usually prescribed an overtreatment regimen. We think that newly diagnosed COPD patients should be evaluated carefully, and best effort should be made to treat these patients in accordance with the recommendations of the major COPD guidelines.

The effect of inhaled corticosteroids in the outcomes of community-acquired pneumonia: ICCAP study (TURKCAP Database).

OBJECTIVE: We aimed to investigate the effect of inhaled corticosteroids (ICS) in the outcomes of community-acquired pneumonia (CAP), as well as to determine if ICS usage is exist among the risk factors for mortality in those patients. MATERIALS AND METHODS: In this retrospective cross-sectional multicentre study, 1069 hospitalised CAP patients were investigated using CAP Database of Turkish Thoracic Society (TURKCAP Database). The patients were divided into two groups, depending on their ICS use. The data were analysed by appropriate statistical methods. RESULTS: 172 (75.8%) of the 227 patients who were on ICS had COPD and 37 (16.3%) had asthma. There were fewer patients with fever among ICS-users compared to non-ICS users (P = 0.013), and less muscle pain (P = 0.015) and fewer GIS symptoms (P = 0.022). No statistically significant difference was found between ICS use/ type of ICS and the duration of hospitalisation (P = 0.286). The multivariate regression analysis showed that patients using ICS had lower body temperature and, less crackles/bronchial sound. In the multivariate logistic regression model lung cancer (OR: 6.75), glucose (OR: 1.01) and CURB-65 (OR: 1.72) were significantly associated with mortality in the CAP patients. ICS usage were not found to be associated with mortality. CONCLUSION: The use of ICS by the patients with CAP admitted to the hospital is not independently related with any radiological pattern, hospitalisation duration and mortality. ICS usage may diminish fever response and may suppress the findings of crackles and/or bronchial sounds. This needs further confirmation.

Factors Affecting Cost of Patients with Severe Community-Acquired Pneumonia in Intensive Care Unit.

OBJECTIVES: The aim of this study is to investigate the factors affecting cost in patients with severe community-acquired pneumonia (CAP) who were admitted to the intensive care unit (ICU). MATERIALS AND METHODS: This retrospective cohort study was conducted between January 2013 and December 2016. A total of 291 sequential patients with severe CAP were included in the study. Patients' demographic and clinical data; the need for invasive mechanical ventilation or non-invasive mechanical ventilation; intensive care severity (ICU) scores, including Acute Physiology and Chronic Health Evaluation (APACHE II), Sepsis-related Organ Failure Assessment, Quick SOFA, pneumonia severity index (PSI); and Confusion, Urea, Respiratory Rate, and Blood Pressure-65 (CURB-65) scores were obtained from medical records and recorded for all cases. RESULTS: The mean age of 291 patients was 68.4±16.8 years, and 61% were female. The median length of ICU stay was 7 days. Forty-six percent of patients had chronic obstructive pulmonary disease (COPD), and 42% had hypertension. The mean cost of each hospitalization was US$ 2722 (TL 5578). The highest cost was found in the group of patients aged 50-59 years, and the lowest cost was found in the patients aged <50 years. A statistically significant relationship was found between ICU severity scores and health cost. The cost of patients in PSI class V, APACHE II (>20 points), and CURB-65 score were higher. The presence of COPD, atrial fibrillation, congestive heart failure, hypoalbuminemia, mental state deterioration, in-hospital mortality, severe sepsis, septic shock, mechanical ventilation requirement, and haloperidol and vasopressor usage were associated with higher cost, while the use of florokinolon was associated with lower cost. CONCLUSION: The presence of certain comorbidities and high disease severity in patients with severe CAP hospitalized in ICU increase the cost of inpatient treatment. The need for mechanical ventilation during treatment and the presence of sepsis/septic shock are additional factors that increase the cost.

Efficacy and safety profile of roflumilast in a real-world experience.

BACKGROUND: Roflumilast is the only phosphodiesterase enzyme 4 inhibitor approved in the treatment of chronic obstructive pulmonary disease (COPD) patients with chronic cough and sputum and a history of exacerbations. Real-world studies about the use of roflumilast are limited. Our aim was to assess the efficacy, safety and tolerability of roflumilast in the treatment of stable COPD, in a real-world setting. METHODS: From August 2014 to August 2017, medical records of all COPD patients who were prescribed roflumilast therapy in Akdeniz University Hospital were analyzed retrospectively. COPD patients were studied in terms of efficacy, safety, and drug discontinuation rate. Efficacy was evaluated as the effect of roflumilast on exacerbation and hospitalization rates of COPD compared to the pre-treatment period. RESULTS: Eighty-three COPD patients treated with roflumilast were included (mean age 66.2±9.3 years, 88.0% male). All the patients were chronic bronchitis and frequent exacerbator clinical phenotype and were classified in the Global Initiative for Chronic Obstructive Lung Disease categories C (n=17; 20.5%) and D (n=66; 79.5%). Mean duration of roflumilast use was 18.9±10.4 months. There was a significant decrease in both COPD exacerbations (2.7 vs. 1.16; P<0.001) and hospitalizations (0.77 vs. 0.32; P<0.001) in roflumilast users compared to the pre-treatment period. Of the patients, 22 (26.5%) experienced adverse events (AE) during their treatment period. The most frequently reported AEs were weight loss (10.8%), loss of appetite (10.8%) and nausea (8.4%). Serious or life-threatening AEs were not detected. Sixteen (19.3%) patients discontinued roflumilast because of AEs. CONCLUSIONS: Roflumilast reduced exacerbations and hospitalizations in our real-world population with severe COPD. AEs are common and frequently leading to discontinuation of roflumilast therapy.

The Effectiveness, Safety, and Tolerability of Pirfenidone in Idiopathic Pulmonary Fibrosis: A Retrospective Study.

INTRODUCTION: In this study we aimed to investigate the effectiveness and safety profile of pirfenidone for the treatment of idiopathic pulmonary fibrosis (IPF) in a real-life setting. METHODS: Clinical records of patients diagnosed with mild-to-moderate IPF and receiving pirfenidone treatment across three centers in Turkey between January and September 2017 were retrospectively collected. Pulmonary function measurements, including percentage of forced vital capacity (FVC%) and percentage of diffusion capacity (DLCO%) were analyzed in patients who received pirfenidone treatment for at least 6 months. Decline in lung function, defined as an absolute decline of at least 10% in FVC from baseline, or death at 6 months was also analyzed. Safety data were included for all follow-up visits. RESULTS: In the pooled cohort (n = 60), patients were mostly men (73.4%) and current or former smokers (61.7%). Average baseline FVC% and DLCO% were 68.4% and 48.7%, respectively. Forty-seven patients (78.3%) had a high-resolution computed tomography scan with a definite interstitial pneumonia (UIP) pattern, and 18 patients (30%) had a surgically proven UIP pattern. Forty-six (76.7%) patients with IPF remained stable and 14 (23.3%) patients had progressed according to decline in FVC of at least 10% during the therapy course. After 6 months of therapy, cough decreased in 58.3% of patients. At least one side effect due to therapy was encountered in 33 (55.0%) IPF patients. Dyspepsia (36.4%), nausea (27.3%), and rash/photosensitivity (24.2%) were the most frequent side effects in our cohort. Sixteen patients (26.7%) needed dose adjustment, one patient (1.7%) discontinued therapy, and one patient (1.7%) died in the study period. CONCLUSIONS: This study shows that pirfenidone seems to be an effective treatment for IPF and also had tolerable and relatively acceptable side effects. FUNDING: Roche.

Asthma control and adherence in newly diagnosed young and elderly adult patients with asthma in Turkey.

OBJECTIVE: This study aimed to evaluate the factors that affect asthma control and adherence to treatment in newly diagnosed elderly asthmatics in Turkey compared with younger patients. METHODS: This real-life prospective observational cohort study was conducted at 136 centers. A web-based questionnaire was administered to the patients who were followed up for 12 months. RESULTS: Analysis included 1037 young adult asthma patients (age <65 years) and 79 elderly asthma patients (age ≥65 years). The percentage of patients with total control in the elderly and young groups were 33.9% and 37.1% at visit 1, 20.0% and 42.1% (p = 0.012) at visit 2, and 50.0% and 49.8% at visit 3, respectively. Adherence to treatment was similar for both groups. Visit compliance was better in the elderly group than in the young group at visit 1 (72.2% vs. 60.8%, p = 0.045), visit 2 (51.9% vs. 34.9%, p = 0.002), and visit 3 (32.9% vs. 19.4%, p = 0.004). Adherence to treatment increased with asthma control in both groups (both p < 0.001) but decreased with the presence of gastritis/ulcer, gastroesophageal reflux, and coronary artery disease in the elderly. CONCLUSIONS: Asthma control and adherence to treatment were similar for the elderly and young asthma patients, though the follow-up rate was lower in young patients. The presence of gastritis/ulcer, gastroesophageal reflux and coronary artery disease had negative impacts on the adherence to treatment in elderly adult patients.

Antibiotic treatment outcomes in community-acquired pneumonia

Background/aim: The optimal empiric antibiotic regimen for patients with community-acquired pneumonia (CAP) remains unclear. This study aimed to evaluate the clinical cure rate, mortality, and length of stay among patients hospitalized with community- acquired pneumonia in nonintensive care unit (ICU) wards and treated with a ß-lactam, ß-lactam and macrolide combination, or a fluoroquinolone. Materials and methods: This prospective cohort study was performed using standardized web-based database sheets from January 2009 to September 2013 in nine tertiary care hospitals in Turkey. Results: Six hundred and twenty-one consecutive patients were enrolled. A pathogen was identified in 78 (12.6%) patients. The most frequently isolated bacteria were S. pneumoniae (21.8%) and P. aeruginosa (19.2%). The clinical cure rate and length of stay were not different among patients treated with ß-lactam, ß-lactam and macrolide combination, and fluoroquinolone. Forty-seven patients (9.2%) died during the hospitalization period. There was no difference in survival among the three treatment groups. Conclusion: In patients admitted to non-ICU hospital wards for CAP, there was no difference in clinical outcomes between ß-lactam, ß-lactam and macrolide combination, and fluoroquinolone regimens.

Long-Term Omalizumab Treatment: A Multicenter, Real-Life, 5-Year Trial.

BACKGROUND: Omalizumab has demonstrated therapeutic benefits both in controlled clinical trials and real-life studies. However, research concerning the long-term effects and tolerability of omalizumab is needed. The main objective of this study was to evaluate the effectiveness and tolerability of treatment with omalizumab for up to 5 years. METHODS: A multicenter, retrospective, chart-based study was carried out to compare documented exacerbations, hospitalizations, systemic steroid requirement, FEV1, and asthma control test (ACT) results during 1 year prior to omalizumab treatment versus at 1, 3, and 5 years of treatment. Adverse events and reasons for discontinuation were also recorded at each time point. RESULTS: Four hundred and sixty-five patients were enrolled in the study. Outcome variables had improved after the 1st year and were sustained after the 3rd and 5th years of treatment with omalizumab. Omalizumab treatment reduced the asthma exacerbation rate by 71.3% (p < 0.001) at 1 year, 64.3% (p < 0.001) at 3 years, and 54.8% (p = 0.002) at 5 years. The hospitalization rate also decreased; by the 5th year of the treatment no patients were hospitalized. ACT results had also improved significantly: 12 (p < 0.001) at 1 year, 12 (p < 0.001) at 3 years, and 12 (p = 0.002) at 5 years. Overall, 12.7% of patients reported adverse events (most of these were mild-to-moderate) and the overall dropout rate was 9.0%. CONCLUSION: Omalizumab had a significant effect on asthma outcomes and this effect was maintained over 5 years. The drug was found to be generally safe and treatment compliance was good.