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Introduction: SABINA III assessed short-acting β2-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. Methods: 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. [ABSTRACT FROM AUTHOR]

Introduction: Little is known about the correlation between chronic obstructive pulmonary disease (COPD) and heroin smoking. Heroin smoking is a recent underinvestigated problem. The goal of this study is to study the impact of heroin smoking among COPD patients. Methods: This is a descriptive clinical study. A combination of self-reporting questionnaires and data extraction tools were used to collect information during baseline tests, interviews, and follow-ups. Patients' medical, clinical, and socioeconomic history were recorded. Participants were recruited using random sampling from multiple centers. Results: Out of 1034 COPD patients, heroin smokers represented the vast majority of addiction cases (n = 133). Heroin smokers were leaner than non-addicts (19.78 ± 4.07 and 24.01 ± 5.6, respectively). The most common type of comorbidities among heroin smokers was emphysema (27%). Both the forced expiratory volume (FEV1)/forced vital capacity ratio and FEV1% predicted were lower among heroin smokers than non-addicts (52.79 ± 12.71 and 48.54 ± 14.38, respectively). The majority of heroin smokers (55%) had advanced COPD, and at least 15% of heroin smokers suffered from frequent respiratory failure. The mean ± SD for COPD onset age among heroin smokers was 44.23 ± 5.72, and it showed a statistically significant correlation (P < 0.001). Conclusion: Heroin smoking might be linked to the onset of COPD. Heroin smokers showed a significantrespiratory impairment compared to tobacco smokers of the same age group. [ABSTRACT FROM AUTHOR]

The link between chronic obstructive pulmonary disease (COPD) and osteoporosis is unclear and yet to be understood. The study goals were to detect the prevalence of osteoporosis and investigate its predictors among COPD patients. This is a longitudinal study conducted in a tertiary care setting. During the study, patients' bone mineral density was checked, pulmonary parameters were recorded, and a risk assessment tool was validated. Based on T-score, more than 50% of subjects were osteoporotic. Spirometric parameters were significantly lower among osteoporotic patients. For the risk assessment tool, a cutoff point of 34 made the optimum balance between sensitivity and specificity (0.867 and 0.087, respectively) with a generated area under the curve of 0.934. Severe COPD patients were four times at higher risk of getting osteoporosis, forced expiratory volume (FEV) % predicted, and FEV/forced vital capacity was inversely related to the risk of osteoporosis. Patients with severe dyspnea had twice the risk of getting osteoporosis. Osteoporosis was prevalent among COPD patients, and severe COPD patients were at higher risk of getting osteoporosis. [ABSTRACT FROM AUTHOR]

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. 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. 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%. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Chronic obstructive pulmonary disease (COPD) can be associated with systemic inflammatory trademarks and can coexist with other chronic debilitating diseases such as osteoporosis, which is considered among the most serious comorbidities of COPD. In this review, we aimed at finding answers for the following questions and tried to encapsulate the available literature: (1) how prevalent is osteoporosis among patients with COPD? (2) What are severity patterns of osteoporosis in case of COPD? (3) What are the therapeutic outcomes for patients with osteoporotic COPD? The total number of patients with COPD from all studies was 3815, majority of which were male (2658) representing 69.67% of patients. The mean ± standard deviation for percentage of forced expiratory volume in 1s (FEV1%) was 55.43 ± 14.62%, body mass index for almost 91.29% of patients was 24.4 ± 4.45 kg/m2, whereas fat-free mass index (FFMI) was 17 ± 0.93 kg/m2 for 17.66%. The percentage of patients with COPD having osteoporosis varied in the analyzed studies from 14% up to 66.6%. The mean prevalence of reported osteopenia from 14 studies (n = 2107) was 39.91%, whereas for osteoporosis, the mean prevalence was 37.62% for all included studies. Osteoporosis was highly prevalent among patients with COPD. It is reasonable to call for osteoporosis screening in patients with COPD who are above 65 years, in advanced stages, with BMI lower than 21 kg/m2 or with FFMI lower than 16 kg/m2 for males and 15 kg/m2 for females. There is a lack of research investigating severity and treatments of osteoporosis in patients with COPD. [ABSTRACT FROM AUTHOR]

Background/aim: Multiple asthma guidelines have been developed to reduce asthma mortality, morbidity, and cost associated with asthma worldwide. In Malaysia, within this context, it is relatively unknown to what extent doctors adhere to the asthma guidelines. This study aimed to assess guideline adherence and calculate the cost of adhered and nonadhered prescriptions by medical doctors in a public tertiary health care facility. Materials and methods: A cross-sectional study was carried out at Hospital Pulau Pinang, Malaysia. One hundred and eighty patients, a total of 30 patients per doctor, were enrolled to assess guideline adherence. The patients were followed for a second visit to assess their lung function. The costs of adhered and nonadhered prescriptions were calculated. Results: One hundred and forty-three patients (79%) received guideline (Global Initiative for Asthma 2011)-adhering pharmacotherapy. In the majority of patients (n = 133, 73.9%) asthma control was classified as partially controlled. There was no significant association observed between patient asthma control and patient demographics; however, there was a significant difference (P < 0.001) between lung function values from the first and second visits. The cost of adhered prescription was higher (70.1 Malaysian ringgit) than that of nonadhered prescription (13.74 Malaysian ringgit). Conclusion: Fair levels of guideline adherence were observed. Emphasis should be placed on identifying appropriate cost-effective medication regimens based on patient asthma control and constant feedback from patients. [ABSTRACT FROM AUTHOR]

Background: Tuberculous meningitis is a major public health issue, despite showing low incidence, tuberculous meningitis causes substantial mortality. For better clinical management, identification of prognostic factors is crucial to reduce health risk of Malaysian society. Therefore, the aim of this study was to determine the prognostic factors of adult tuberculous meningitis in peninsular Malaysia. Materials & methods: Initially, a retrospective cohort study and one-year of follow-up period was carried out. In addition, a total of 217 adult tuberculous meningitis patients treated or had follow-up in four tertiary hospitals in peninsular Malaysia were recruited. Cox proportional hazards regression was employed to perform multivariable analysis. Results: The overall survival probability of adult tuberculous meningitis was 36.8% with median survival time 244 days. Significant prognostic factors were Glasgow coma scale score (aHR=0.71, 95% CI=0.65, 0.76; p<0.001), HIV status (aHR=1.94, 95% confidence interval [CI]=1.19, 3.15; p=0.008), headache (aHR=0.48, 95% CI=0.31, 0.76; p=0.002) and meningeal enhancement (aHR=0.47, 95% CI=0.30, 0.74; p=0.001), nausea (aHR=2.21, 95% CI=1.33, 3.66; p=0.002), and vomit (aHR=0.58, 95% CI=0.36, 0.93; p=0.023). Conclusions: Evidently, the survival of among adults with tuberculous meningitis was low. Since HIV positive has a significant influence in mortality; early screening, diagnosis, and prompt treatment in this subgroup of patients play a key role in survival. [ABSTRACT FROM AUTHOR]