Short-acting ß2-agonist prescription patterns and clinical outcomes in Malaysia: A nationwide cohort of the SABINA III study.

Introduction: SABINA III assessed short-acting ß2-agonist (SABA) prescription patterns and their association with asthma-related outcomes globally. Herein, we examined SABA prescription and clinical outcomes in the Malaysian cohort of SABINA III. Method: In this observational, cross-sectional study, patients (≥12 years) were recruited between July and December 2019 from 15 primary and specialty care centres in Malaysia. Prescribed asthma treatments and severe exacerbation history within 12 months prior and asthma symptom control during the study visit were evaluated. Associations of SABA prescription with asthma control and severe exacerbation were analysed using multivariable regression models. Results: Seven hundred thirty-one patients (primary care, n=265 [36.3%]; specialty care, n=466 [63.7%]) were evaluated. The prevalence of SABA over-prescription (≥3 SABA prescriptions/year) was 47.4% (primary care, 47.1%; specialty care, 47.6%), 51.8% and 44.5% among all patients and patients with mild and moderate-to-severe asthma, respectively. Altogether 9.0% (n=66) purchased SABA without a prescription; among them, 43.9% (n=29) purchased ≥3 inhalers. The mean (standard deviation) number of severe asthma exacerbations was 1.38 (2.76), and 19.7% (n=144) and 25.7% (n=188) had uncontrolled and partly controlled symptoms, respectively. Prescriptions of ≥3 SABA inhalers (vs 1-2) were associated with lower odds of at least partly controlled asthma (odds ratio=0.42; 95% confidence interval [CI]=0.27-0.67) and higher odds of having severe exacerbation(s) (odds ratio=2.04; 95% CI=1.44-2.89). Conclusion: The prevalence of SABA over-prescription in Malaysia is high, regardless of the prescriber type, emphasising the need for healthcare providers and policymakers to adopt latest evidence-based recommendations to address this public health concern.

Survival Trend of Tuberculosis Patients and Risk Factors Associated with Mortality and Developing Drug-Resistant Tuberculosis in Hospital Pulau Pinang, Malaysia: A Retrospective Study.

BACKGROUND: Multidrug resistance TB (MDR-TB) has emerged as a public health issue worldwide, and the mortality rate is worrying. Therefore, this study was conducted to investigate the factors related to MDR-TB occurrence and the survival experience of TB patients. METHODS: A retrospective cohort study was conducted at Hospital Pulau Pinang in Malaysia. Medical records of active TB patients from 2014-2018 were reviewed. Cox regression was used to identify the factors associated with MDR-TB development and mortality among TB patients. RESULTS: The patients had a mean age of 48.84 ± 16.713 years, and a majority of the Chinese race (46.4%). Out of 351 TB patients, 325 (92.6%) were drug-susceptible TB, and 26 (7.4%) were diagnosed with MDR-TB. Among drug-susceptible TB patients, 245 (75.4%) achieved successful outcomes, and 73 (22.5%) passed away. In multivariable Cox regression, drug addiction, levels of white blood cells, urea, platelets, and albumin were significantly associated with death. Relapsed TB, alcohol consumption, and being single were significant risk factors for MDR-TB development. CONCLUSION: Patients achieved a success rate of 75.4%, which is encouraging but still far below the WHO target (at least an 85% success rate) and has room for further improvement.

Tracheobronchopathia osteochondroplastica-stalactite of airways.

A case of tracheobronchopathia osteochondroplastica (TO) was diagnosed in a 53-year-old man, who presented with prolonged cough and recurrent respiratory tract infection. Bronchoscopy revealed exostosis over the anterolateral wall of trachea and main bronchi sparing the posterior membranous wall. The endobronchial biopsy subsequently revealed ossification of the cartilage. To date, the aetiology of this condition remains unknown, and treatment is mainly symptomatic, emphasizing on timely management of recurrent respiratory infections. Bronchoscopy or surgical intervention is usually reserved for symptomatic patients with severe airway narrowing and airflow obstruction.

Efficacy, Safety and Immunogenicity of MB02 (Bevacizumab Biosimilar) versus Reference Bevacizumab in Advanced Non-Small Cell Lung Cancer: A Randomized, Double-Blind, Phase III Study (STELLA).

BACKGROUND: MB02 (bevacizumab biosimilar) showed similar structural, functional, and pharmacokinetic properties to reference bevacizumab (Avastin®; EU-bevacizumab). OBJECTIVES: To confirm clinical similarity between MB02 and EU-bevacizumab, a comparability study was undertaken in the first-line treatment of stage IIIB/IV non-squamous non-small cell lung cancer (NSCLC). PATIENTS AND METHODS: This multinational, double-blind, randomized, phase III study (STELLA) compared MB02 or EU-bevacizumab (15 mg/kg) administered with chemotherapy (paclitaxel 200 mg/m2 and carboplatin AUC6) on Day 1 of every 3-week cycle for 6 cycles (Week 18), followed by MB02/EU-bevacizumab in blinded monotherapy until disease progression, unacceptable toxicity, death, withdrawal of consent or end of study (Week 52). The primary efficacy endpoint was objective response rate (ORR) evaluated by an independent radiological review committee (IRC) at Week 18 (intent-to-treat population). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety and immunogenicity. RESULTS: A total of 627 subjects were randomized 1:1 to MB02 (n = 315) or EU-bevacizumab (n = 312). ORR, assessed by the IRC at Week 18, was comparable in MB02 (40.3%) and EU-bevacizumab (44.6%) groups. ORR risk ratio of 0.910 (90% CI 0.780 to 1.060; 95% CI 0.758 to 1.092) and ORR risk difference of -4.02 (90% CI -10.51 to 2.47; 95% CI -11.76 to 3.71) were within the similarity predefined margins. There were no significant differences between MB02 and EU-bevacizumab groups in median PFS (36.0 vs 37.3 weeks, respectively; HR 1.187; 95% CI 0.98 to 1.44) and median OS (not achieved; HR 1.108; 95% CI: 0.83 to 1.49) at the end of study. The safety profile of MB02 and EU-bevacizumab regarding nature, frequency and severity of the adverse events (AE) was comparable. The most frequent grade ≥3 investigational-product-related AEs were hypertension and anemia, with a difference between treatment groups of <5%. Anti-drug antibodies (ADA) and neutralizing ADA (NAb) incidence were similar in both treatment groups. CONCLUSION: MB02 demonstrated similar efficacy to EU-bevacizumab, in combination with carboplatin and paclitaxel, in subjects with advanced non-squamous NSCLC, with comparable safety and immunogenicity profiles. CLINICAL TRIAL REGISTRATION: EudraCT No. 2017-001769-26; ClinicalTrials.gov: NCT03296163.

Translation and validation of the Test of Adherence to Inhalers (TAI) questionnaire among adult patients with asthma in Malaysia.

OBJECTIVE: The Test of Adherence to Inhalers (TAI) is a validated self-reported questionnaire that can reliably assess adherence to inhalers through patient self-report. However, it was not available in Bahasa Melayu (BM) language, nor has it been validated for use in the Malaysian population. The study aimed, therefore, to translate the 10-item TAI questionnaire into BM and evaluate its psychometric properties. METHODS: The translation of the English version of the valid 10-item TAI questionnaire into BM was followed by subjecting it to a series of tests establishing factorial, concurrent and known group validities. Concurrent validity was assessed through Spearman's rank correlation coefficient against pharmacy refill-based adherence scores. Known group validity was assessed by cross-tabulation against asthma symptom control and using chi-square test. The internal consistency of the test scale was determined by a test-retest method using Cronbach's alpha (α) value and intraclass correlation coefficients. RESULTS: A total of 120 adult asthma patients participated in the study. A 2-factor structure was obtained and confirmed with acceptable fit indices; CFI, NFI, IFI, TLI >0.9 and, RMSEA was 0.08. The reliability of the scale was 0.871. The test-retest reliability coefficient for the total sum score was 0.832 (p < 0.01), which indicated good reliability. The 10-item TAI-BM established concurrent and known group validities. The sensitivity and specificity of the tool were >85%. CONCLUSIONS: The scale successfully translated into BM and validated. The 10-item TAI-BM appears fit for use in testing inhaler adherence of Malaysian patients with asthma.

Effectiveness of Home Visits in Adult Patients with Asthma: A Systematic Review of Randomized Controlled Trials.

BACKGROUND: The effectiveness of home visits is well discussed for children with asthma, but limited in adults. OBJECTIVE: The present systematic review aimed to investigate the potential role of home visits in improving outcomes among adult patients with asthma. METHODS: The systematic review was performed in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. An extensive literature search was conducted using databases such as PubMed, ProQuest, CINAHL, The Cochrane Library, PsycINFO, and Google Scholar from inception to June 2019. The studies included were randomized controlled trials, which reported asthma outcomes in adult patients. RESULTS: The literature search yielded 8331 publications, of which 63 studies were selected for full-text review, and of these studies, 9 studies with a total of 2011 patients were included in the final analysis. The included randomized controlled trials reported quality of life, asthma symptoms, exacerbations, health care utilization, and pulmonary function. Improvements in asthma outcomes were observed predominantly in quality of life. The effects on asthma symptom control were inconsistent. The evidence on the impact of home visits in asthma exacerbations and health care utilization was rather limited. There were no significant differences observed between intervention versus control arms in terms of pulmonary function; however, 1 study reported significant improvements in peak expiratory flow rate. CONCLUSIONS: Home visits may serve as an adjuvant activity that complements the existing health care system-based initiatives. It may be concluded that home visits have the potential to improve outcomes in adult patients with asthma; however, the randomized controlled trials reviewed in the present systematic review reported several limitations that warrant further investigation.

The economic burden of chronic obstructive pulmonary disease (COPD) in the USA, Europe, and Asia: results from a systematic review of the literature.

Background: Lack of information about economic burden of COPD is a major cause of lack of attention to this chronic condition from governments and policymakers. Objective: To find the economic burden of COPD in Asia, USA and Europe, and to identify the key cost driving factors in management of COPD patients. Methodology: Relevant studies assessing the cost of COPD from patient perspective or societal perspective were retrieved by thoroughly searching PUBMED, SCIENCE DIRECT, GOOGLE SCHOLAR, SCOPUS, and SAGE Premier Databases. Results: In the USA annual per patient direct medical cost and hospitalization cost were reported as $10,367 and $6852, respectively. In Asia annual per patient direct medical cost in Iran, Korea and Singapore was reported as $1544, $3077, and $2335, respectively. However, annual per patient hospitalization cost in Iran, Korea, Singapore, India, China, and Turkey was reported as $865, $1371, $1868, $296, $1477 and $1031, respectively. In Europe annual per patient direct medical cost was reported as $11,787, $10,552, $8644, $8203, $7760, $3190, $1889, $2162, and $2254 in Norway, Denmark, Germany, Italy, Sweden, Greece, Spain, Belgium, and Serbia, respectively. Conclusion: Limiting the disease to early stage and preventing exacerbations may reduce the cost of management of COPD.

Hospitalisation of multiethnic older patients with AECOPD: exploration of the occurrence of anxiety, depression and factors associated with short-term hospital readmission.

INTRODUCTION: The elderly, with chronic obstructive pulmonary disease (COPD), are at a higher risk of hospitalisation due to acute exacerbation of COPD (AECOPD). They also often encounter multiple co-morbidities. OBJECTIVES: This study was aimed to explore the occurrence of anxiety, depression and to identify the factors associated with hospital readmission among older patients after AECOPD discharge. METHODS: A multicentre prospective study was conducted in Malaysia (from 1st September 2012 till 31st September 2013) among older patients (≥60 years) hospitalised for AECOPD. Anxiety and depression were assessed on discharge using previously validated questionnaires, Generalized Anxiety Disorder-7 (GAD-7 and Geriatric Depression Scale (GDS-15), respectively. Patients were followed up for a period of 3 months after discharge. RESULTS: A total of 81 patients with a median age of 72 years (IQR 66.40-78.00) were recruited. Anxiety was observed in 34.57% while 38.27% had depression. Both anxiety and depression were detected in 25.93% of the patients. A history of frequent AECOPD admissions was found to be associated with developing depressive symptoms, while anxiety scores were associated with severe dyspnoea. Severe depression was more commonly identified among patients aged 60-75 and in those with a history of tuberculosis. A high readmission rate (40.74%) during the 3-month period was noticed. History of frequent AECOPD admissions (OR = 2.87; 95% CI 1.05-7.85, P = 0.040) and ischemic heart disease (IHD) (OR = 4.04; 95% CI 1.1-14.6, P = 0.032) were identified as the factors associated with the risk of hospital readmission. CONCLUSIONS: Anxiety and depression were found to be relatively common among older patients with AECOPD. IHD and history of frequent COPD hospitalisation were associated with short-term readmission among the elderly.