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.

Adherence to GOLD guideline treatment recommendations among pulmonologists in Turkey.

BACKGROUND: Low adherence to Global initiative for chronic Obstructive Lung Disease (GOLD) guideline recommendations has been reported worldwide. There has been no study on the adherence to GOLD guidelines for COPD treatment in Turkey. OBJECTIVES: To investigate the rates of adherence to GOLD 2010 guidelines for COPD treatment among pulmonologists. DESIGN: A multi-center, cross-sectional, observational study was carried out in eleven pulmonary outpatient clinics across Turkey. Adherence to GOLD was evaluated through hospital records. Demographic and clinical data were recorded. RESULTS: Study included 719 patients (mean age: 62.9±9.7 years; males 85.4%) of whom 16 was classified as GOLD Stage I, 238 as II, 346 as III, and 119 as IV, and only 59.5% received appropriate treatment. Rates of guideline adherence varied across GOLD stages (I, 6.3%; II, 14.7%; III, 84.4%; and IV, 84%). Causes of inappropriate therapies were overtreatment (Stage I, 100% and Stage II, 91.1%), undertreatment (Stage III, 3.3% and Stage IV, 10.9%) and lack of treatment (Stage II, 3.8%; Stage III, 2.3%; and Stage IV, 5.9%). The most preferred regimen (43.4%) was long-acting ß2-agonist-inhaled corticosteroid-long-acting muscarinic antagonist. Overall, 614 patients (89%) received treatment containing inhaled corticosteroid. CONCLUSION: Pulmonologists in Turkey have low rates of adherence to GOLD guidelines in COPD treatment. Inappropriateness of therapies was due to overtreatment in early stages and excessive use of inhaled corticosteroid (ICS) in all disease stages.

Categorization of COPD patients in Turkey via GOLD 2013 strategy document: ALPHABET study.

OBJECTIVE: To determine distribution of COPD assessment categories and physicians' adherence to Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2013 strategy in Turkish COPD patients. METHODS: A total of 1,610 COPD patients (mean [standard deviation] age: 62.6 [9.9] years, 85.7% were males) were included in this multicenter, non-interventional, cross-sectional study. Patients were categorized via GOLD 2013 strategy document. Consistency between reported and re-classified GOLD categories, and measures used for symptom evaluation and exacerbation was analyzed. RESULTS: Overall, 41.1% of patients were assigned to GOLD A, while 13.2% were assigned to GOLD C categories. Long-acting beta-2 agonist + long-acting muscarinic antagonist + inhaled corticosteroid regimen was the most common treatment (62.0%). Over-treatment was noted in >70% of GOLD A, B, and C patients. A high consistency between measures of symptom evaluation (Kappa coefficient =0.993, P<0.0001) and a low-moderate consistency between exacerbation risk measures (Kappa coefficient =0.237, P<0.0001) were noted. CONCLUSION: Our findings revealed GOLD A as the most prevalent category in Turkish cohort of COPD patients. Group assignment was altered depending on the chosen measure for symptom and risk assessment. Physician non-adherence to treatment recommendations in GOLD 2013 document leading to over-treatment in patients assigned to GOLD A, B, and C categories was also detected.

Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey--GALATA study.

OBJECTIVE: To evaluate tolerability/safety and the efficacy of the combination of vildagliptin plus metformin in a real-life population of patients with type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS: This multicenter, single-arm, 6 month, observational, prospective cohort study was conducted at 39 centers across Turkey. T2DM patients on vildagliptin and metformin for ≤4 weeks were enrolled regardless of their previous antidiabetic therapy. MAIN OUTCOME MEASURES: Efficacy was evaluated by measuring hemoglobin A1c (HbA1c) levels. Tolerability/safety parameters evaluated included hypoglycemic events, gastrointestinal events, peripheral edema and weight gain. RESULTS: This study enrolled 665 patients with a mean ± standard deviation (SD) age of 55.1 ± 10.2 years and female predominance (n = 394, 59.2%). Safety was assessed in all enrolled patients. Hypoglycemia was reported in 10 (1.5%) patients (95% confidence interval = 0.8-2.7%). Efficacy was assessed in 289 (43.5%) patients treated for 6 ± 1 months; these patients showed a mean decrease in HbA1c of 0.8% from baseline value of 7.8% (p < 0.001). The percentages of patients who achieved HbA1c targets of ≤6.5% and ≤7.0% were significantly increased, from 10.7% to 33.6% and from 22.1% to 52.6%, respectively (p < 0.001 each). The decrease in HbA1c was independent of baseline HbA1c (≤8% vs. 8-10% vs. ≥10%), age (≤65 vs. >65 years) and body mass index (<30 vs. ≥30 kg/m(2)) (p < 0.001 each). In total, 136 adverse events (AEs) were observed in 71 (10.7%) patients; 10 (1.5%) patients experienced hypoglycemia and gastrointestinal AEs were most commonly reported (n = 29, 4.4%). CONCLUSIONS: In a 'real-life' setting, the vildagliptin and metformin combination was associated with significant improvements in reaching target HbA1c levels, even in elderly and obese patients with T2DM. Moreover, vildagliptin and metformin demonstrated a good overall tolerability/safety profile.

Efficacy and safety of valsartan/amlodipine single-pill combination in patients with essential hypertension (PEAK LOW).

OBJECTIVES: This study evaluated the efficacy as well as the safety and tolerability profile of low-dose valsartan/amlodipine (Val/Amlo) single-pill combination (SPC) (160/5 mg) in patients with essential hypertension in Turkey. STUDY DESIGN: Adult patients with essential hypertension [systolic blood pressure (SBP)>140 mmHg and/or diastolic blood pressure (DBP)>90 mmHg], who were on low dose Val/Amlo (160/5 mg) SPC before enrollment and gave informed consent, were accepted for this multi-centric observational study performed at 30 sites. The absolute changes in SBP and DBP from baseline were the primary efficacy outcomes. Safety assessments consisted of recording all adverse events. RESULTS: Of 381 patients enrolled, 327 completed the study; 39% were females. The mean age was 57.3±11.8 years. Median duration of hypertension was 38 months. Both SBP and DBP values showed reductions from 162.6±16.6 mmHg and 94.0±13.2 mmHg to 137.6±14.2 mmHg and 81.9±9.0 mmHg at 4th week and to 131.6±11.5 mmHg and 79.7±7.6 mmHg at 12th week, respectively. The control and response rates at the end of the study were 82.0% and 92.6%, respectively. Twelve patients (3.2%) experienced a total of 12 adverse events; there were no serious adverse events. The most common adverse event was edema (1.3%). Patient compliance was approximately 99%. CONCLUSION: Low-dose (160/5 mg) Val/Amlo SPC is efficacous and has a good tolerability and safety profile for the management of essential hypertension in Turkey.