Pharmacological treatment of asthma in Sweden from 2005 to 2015.

OBJECTIVE: Despite access to effective therapies many asthma patients still do not have well-controlled disease. This is possibly related to underuse of inhaled corticosteroids (ICS) and overuse of short-acting ß2-agonists (SABA). Our aim was to investigate longitudinal trends and associated factors in asthma treatment. METHODS: Two separate cohorts of adults with physician-diagnosed asthma were randomly selected from 14 hospitals and 56 primary health centers in Sweden in 2005 (n = 1182) and 2015 (n = 1225). Information about symptoms, maintenance treatment, and use of rescue medication was collected by questionnaires. Associations between treatment and sex, age, smoking, education, body mass index (BMI), physical activity, allergic asthma, and symptom control were analyzed using Pearson's chi2-test. Odds ratios (ORs) were calculated using logistic regression. RESULTS: Maintenance treatment with ICS together with long-acting ß2-agonists (LABA) and/or montelukast increased from 39.2% to 44.2% (p = 0.012). The use of ICS + LABA as-needed increased (11.1-18.9%, p < 0.001), while SABA use decreased (46.4- 41.8%, p = 0.023). Regular treatment with ICS did not change notably (54.2-57.2%, p = 0.14). Older age, former smoking, and poor symptom control were related to treatment with ICS + LABA/montelukast. In 2015, 22.7% reported daily use of SABA. A higher step of maintenance treatment, older age, obesity, shorter education, current smoking, allergic asthma, low or very high physical activity, and a history of exacerbations were associated with daily SABA use. CONCLUSIONS: The use of ICS + LABA both for maintenance treatment and symptom relief has increased over time. Despite this, the problem of low use of ICS and high use of SABA remains.

Short-acting ß2-agonist prescription patterns in patients with asthma treated by specialists in Thailand: results from SABINA III.

OBJECTIVE: Short-acting ß2-agonist (SABA) overuse is associated with poor asthma outcomes; however, the extent of SABA use in Thailand is largely unknown. As part of the SABA use IN Asthma (SABINA) III study, we describe asthma treatment patterns, including SABA prescriptions, in patients treated by specialists in Thailand. METHODS: In this observational, cross-sectional study, patients (aged ≥12 years) with an asthma diagnosis were recruited by specialists from three Thai tertiary care centers using purposive sampling. Patients were classified by investigator-defined asthma severity (per 2017 Global Initiative for Asthma [GINA] recommendations). Data on sociodemographics, disease characteristics, and asthma treatment prescriptions were collected from existing medical records by healthcare providers and transcribed onto electronic case report forms. Analyses were descriptive. RESULTS: All 385 analyzed patients (mean age: 57.6 years; 69.6% female) were treated by specialists. Almost all (91.2%) patients were classified with moderate-to-severe asthma (GINA treatment steps 3-5), 69.1% were overweight/obese, and 99.7% reported partially/fully reimbursed healthcare. Asthma was partly controlled/uncontrolled in 24.2% of patients; 23.1% experienced ≥1 severe asthma exacerbation in the preceding 12 months. Overall, SABAs were over-prescribed (≥3 canisters/year) in 28.3% of patients. Inhaled corticosteroids (ICS), ICS/long-acting ß2-agonists, oral corticosteroid (OCS) burst treatment, and long-term OCS were prescribed to 7.0, 93.2, 19.2, and 6.2% of patients, respectively. Additionally, 4.2% of patients reported purchasing SABA over the counter. CONCLUSIONS: Despite receiving specialist treatment, 28.3% of patients were over-prescribed to SABA in the previous 12 months, highlighting a public health concern and the need to align clinical practices with current evidence-based recommendations.

Short-acting ß2-agonists over-prescription in patients with asthma: an Indian subset analysis of international SABINA III study.

OBJECTIVE: The SABINA (SABA use IN Asthma) program was initiated to describe short-acting ß2-agonists (SABA) prescription patterns and assess the impact of its over-prescription on exacerbation risk and asthma control. We evaluated SABA prescription patterns in patients with asthma in the Indian cohort of SABINA III. METHODS: This multi-centre, observational, cross-sectional study included retrospective and real-time electronic data collection. Data were extracted from medical records of patients with asthma (aged >12 years) having >3 consultations with the same healthcare practitioners between March 2019 and January 2020. The data included prescriptions of SABA and other asthma treatments and over-the-counter (OTC) purchases of SABA. SABA prescriptions were categorized by the number of SABA canisters prescribed in the 12 months preceding the study visit. RESULTS: A total of 510 patients with asthma were included from specialist care (mean age 49.1 years; 57.65 females), with 8.2% classified with mild asthma and 91.8% with moderate-to-severe asthma. SABA as monotherapy and add-on to maintenance therapy was prescribed to 4.5% (n = 23) and 44.9% (n = 229) of patients, respectively. While ICS monotherapy and ICS/LABA were prescribed to 5.1% (n = 26) and 93.3% (n = 476) of patients, respectively. SABA was found to be over-prescribed (≥3 SABA canisters/year) among 23.9% of patients (n = 122). Additionally, 8% of patients (n = 41) purchased SABA OTC without prescription. CONCLUSIONS: Nearly one-fourth of patients with asthma in India were over-prescribed SABA. Educational programmes targeted at national and regional levels should be expanded to raise greater asthma awareness and encourage the adoption of guideline-directed asthma treatment plans among healthcare practitioners.

Predictors of excessive short-acting ß2-agonist use and asthma exacerbations: a retrospective analysis of a Polish prescription database.

Introduction: Despite being linked to unfavourable outcomes, short-acting ß2-agonists (SABAs) are still overused by a substantial proportion of patients with asthma. Aim: To analyse the prevalence and predictors of SABA overuse and exacerbations in patients with asthma in a nationwide database of prescription purchase records. Material and methods: The prevalence of excessive SABA use (≥ 12 canisters) and overuse (≥ 3 canisters) was analysed among patients aged 18-64 years who purchased asthma medications in 2018. Predictors of excessive SABA use and SABA overuse were examined by quasi-Poisson regression. Negative binomial regression was used to study the association of excessive SABA use or overuse to the risk of asthma exacerbation defined as a prescription for oral corticosteroids. Results: Of 91,763 patients with asthma, 42,189 (46%) were SABA users (mean age, 47 years; 58% female). Among them, 34% purchased ≥ 3 SABA canisters, and 6% purchased ≥ 12 canisters. The risk (risk ratio, 95% CI) of excessive SABA use was lower in patients with concomitant prescriptions for inhaled corticosteroids (0.41, 0.34-0.48) or inhaled corticosteroids and long-acting ß2-agonists (0.52, 0.47-0.56), women (0.63, 0.58-0.68), and those in secondary care (0.60, 0.44-0.66); older age was associated with a higher risk of excessive SABA use (1.06, 1.03-1.10). Excessive SABA use was the strongest predictor of asthma exacerbations among all patients (3.24, 2.84-3.70) and in those with ≥ 1 exacerbation (1.60, 1.50-1.71). Conclusions: Excessive SABA use is highly prevalent in asthma management, is associated with lack of prescriptions for inhaled corticosteroids, and substantially increases the exacerbation risk.

Short-acting ß2 -agonist use and asthma exacerbations in Swedish children: A SABINA Junior study.

BACKGROUND: In adults and adolescents with asthma, use of ≥3 short-acting ß2 -agonist (SABA) canisters/year is associated with increased exacerbation risk. Whether this association is present in younger children remains unknown. In this SABA use IN Asthma (SABINA) Junior study, we assessed the association of SABA collection with exacerbation risk in the general Swedish pediatric asthma population. METHODS: This population-based cohort study utilized linked data from the Swedish national healthcare registries involving patients with asthma (<18 years) treated in secondary care between 2006-2015. Exacerbation risk, by baseline SABA collection (0-2 vs. ≥3 canisters, further examined as ordinal/continuous variable) and stratified on comorbid atopic disease (allergic rhinitis, dermatitis and eczema, and food/other allergies), was assessed for 1-year follow-up using negative binomial regression. RESULTS: Of 219,561 patients assessed, 45.4%, 31.7%, and 26.5% of patients aged 0-5, 6-11, and 12-17 years, respectively, collected ≥3 SABA canisters during the baseline year (high use). Collection of ≥3 SABA canisters (vs. 0-2) was associated with increased exacerbation risk during follow-up (incidence rate ratios [95% confidence interval]: 1.35 [1.29-1.42], 1.22 [1.15-1.29], and 1.26 [1.19-1.34] for 0-5-, 6-11-, and 12-17-year-olds, respectively); the association persisted with SABA as a continuous variable and was stronger among patients without atopic diseases (32%-44% increased risk versus. 14%-21% for those with atopic disease across groups). CONCLUSIONS: High SABA use was associated with increased asthma exacerbation risk in children, particularly in those without comorbid atopic diseases, emphasizing the need for asthma medication reviews and reformative initiatives by caregivers and healthcare providers on SABA use.

Short-acting ß2-agonist prescription patterns in patients with asthma in Turkey: results from SABINA III.

BACKGROUND: Over-reliance on short-acting ß2-agonists (SABAs) is associated with poor asthma outcomes. However, the extent of SABA use in Turkey is unclear owing to a lack of comprehensive healthcare databases. Here, we describe the demographics, disease characteristics and treatment patterns from the Turkish cohort of the SABA use IN Asthma (SABINA) III study. METHODS: This observational, cross-sectional study included patients aged ≥ 12 years with asthma from 24 centres across Turkey. Data on sociodemographics, disease characteristics and asthma treatments were collected using electronic case report forms. Patients were classified by investigator-defined asthma severity (guided by the 2017 Global Initiative for Asthma [GINA]) and practice type (primary/specialist care). The primary objective was to describe SABA prescription patterns in the 12 months prior to the study visit. RESULTS: Overall, 579 patients were included (mean age [standard deviation; SD]: 47.4 [16.1] years; 74.3% female), all of whom were treated by specialists. Most patients had moderate-to-severe asthma (82.7%, GINA steps 3-5), were overweight or obese (70.5%), had high school or university/post-graduate education (51.8%) and reported fully reimbursed healthcare (97.1%). The mean (SD) asthma duration was 12.0 (9.9) years. Asthma was partly controlled/uncontrolled in 56.3% of patients, and 46.5% experienced ≥ 1 severe exacerbation in the preceding 12 months. Overall, 23.9% of patients were prescribed ≥ 3 SABA canisters in the previous 12 months (considered over-prescription); 42.9% received no SABA prescriptions. As few patients had mild asthma, only 5.7% were prescribed SABA monotherapy. Therefore, most patients (61.5%) were prescribed SABA in addition to maintenance therapy, with 42.8% receiving ≥ 3 SABA canisters in the previous 12 months. Inhaled corticosteroids (ICS), ICS + a long-acting ß-agonist fixed-dose combination and oral corticosteroids were prescribed to 14.5%, 88.3% and 28.5% of all patients, respectively. Additionally, 10.2% of patients purchased SABA over the counter, of whom 27.1% purchased ≥ 3 canisters in the preceding 12 months. CONCLUSIONS: Despite all patients being treated by specialists and most receiving fully reimbursed healthcare, nearly a quarter of patients received prescriptions for ≥ 3 SABA canisters in the previous 12 months. This highlights a public health concern and emphasizes the need to align clinical practices with the latest evidence-based recommendations.

Salbutamol in the Management of Asthma: A Review.

Asthma is a common inflammatory disease of the lungs. The prevalence of asthma is increasing worldwide, and the tendency indicates that the number of asthma sufferers will soar in the coming years for several reasons, in particular, the lifestyles we have adopted that expose us to risk factors. Salbutamol is the first selective short-acting ß2-agonist (SABA) used as an alternative reliever in the treatment of asthma. Its therapeutic effect is based on its potent smooth muscle relaxant properties, which allow the inhibition of bronchial smooth muscle contraction and subsequent bronchodilation. Salbutamol can be administered orally, intravenously (IV), intramuscularly (IM), subcutaneously, or by inhalation. For this reason, the pharmacokinetic (PK) parameters-absorption, distribution, metabolism, and elimination-are highly diverse and, consequently, the efficacy and adverse effects also differ between each formulation. Here, we review the pharmacological profile of different salbutamol formulations, focusing on their efficacy and adverse effects for its original application, asthma.

The Association Between Short-Acting ß2-Agonist Over-Prescription, and Patient-Reported Acquisition and Use on Asthma Control and Exacerbations: Data from Australia.

INTRODUCTION: In Australia, short-acting ß2-agonists (SABA) are available both over the counter (OTC) and on prescription. This ease of access may impact SABA use in the Australian population. Our aim was to assess patterns and outcome associations of prescribed, acquired OTC and reported use of SABA by Australians with asthma. METHODS: This was a cross-sectional study, using data derived from primary care electronic medical records (EMRs) and patient completed questionnaires within Optimum Patient Care Research Database Australia (OPCRDA). A total of 720 individuals aged ≥ 12 years with an asthma diagnosis in their EMRs and receiving asthma therapy were included. The annual number of SABA inhalers authorised on prescription, acquired OTC and reported, and the association with self-reported exacerbations and asthma control were investigated. RESULTS: 92.9% (n = 380/409) of individuals issued with SABA prescription were authorised ≥ 3 inhalers annually, although this differed from self-reported usage. Of individuals reporting SABA use (n = 546) in the last 12 months, 37.0% reported using ≥ 3 inhalers. These patients who reported SABA overuse experienced 2.52 (95% confidence interval [CI] 1.73-3.70) times more severe exacerbations and were 4.51 times (95% CI 3.13-6.55) more likely to have poor asthma control than those who reported using 1-2 SABA inhalers. Patients who did not receive SABA on prescription (43.2%; n = 311/720) also experienced 2.71 (95% CI 1.07-7.26) times more severe exacerbations than those prescribed 1-2 inhalers. Of these patients, 38.9% reported using OTC SABA and other prescription medications, 26.4% reported using SABA OTC as their only asthma medication, 13.2% were prescribed other therapies but not SABA OTC and 14.5% were not using any medication. CONCLUSION: Both self-reported SABA overuse and zero SABA prescriptions were associated with poor asthma outcomes. The disconnect between prescribing authorisation, OTC availability and actual use, make it difficult for clinicians to quantify SABA use.

SABAs as Reliever Medications in Asthma Management: Evidence-Based Science.

The role of as-needed inhaled short-acting ß2-agonists (SABAs) in the management of asthma has become a subject of debate due to differing opinions in the professional community relating to the use of SABAs. In this article, we summarize the current position of SABAs when used as reliever medications and examine the challenges to appropriate use including a critique of the data that have led to the condemnation of SABA used as a reliever. We consider the evidence for the appropriate use of SABA as a reliever together with practical solutions to ensure such use, including identifying patients at risk of misusing their SABA relievers and managing issues of inhaler technique and treatment adherence. We conclude that inhaled corticosteroid (ICS)-based maintenance treatment with SABA used as-needed as a reliever is an effective and safe treatment for patients with asthma, with no scientific evidence of a causal link between SABA use as a reliever and mortality or serious adverse events (including exacerbations). Increased SABA use warns of a deterioration in asthma control, and patients at risk of misusing their ICS and SABA medication should be rapidly identified to ensure they are receiving adequate ICS-based controller therapy. Appropriate use of ICS-based controller therapy and as-needed SABA should be encouraged and promoted with educational activities.

SABA Overuse in Russia - Burden and Possible Causes: An Analysis of the Russian Population in the SABINA III (SABA use IN Asthma) Study.

Background: Short-acting ß2-agonists (SABA) overuse is associated with asthma morbidity and mortality. The SABA use IN Asthma (SABINA) program aimed to describe the global use of SABA in patients with asthma. SABINA III study was a cross-sectional study covering 24 countries. Methods: We performed statistical analysis of the Russian population (618 patients recruited in 12 centers) from the SABINA III study. In this study in patients aged ≥12 years, data on disease characteristics and asthma treatments were collected using real-time electronic case report forms. Patients were classified by asthma severity and control according to the 2017 GINA. All variables (asthma severity and control, number of severe exacerbations, SABA and other medications use) were analyzed descriptively only, no hypothesis was tested. Results: Majority of the study population consisted of patients with moderate/severe asthma (78.5%), while mild asthma was seen in 21.5%. Asthma was uncontrolled in 36.1% of patients and partly controlled in 33.5%. More than 80% of patients were treated with ICS/LABA fixed-dose combination. Almost half of all patients (47.0%) had at least 1 severe exacerbation in the previous 12 months. SABA over-prescription (≥3 canisters per year) was seen in 37% of patients. The frequency of SABA over-prescription was similar in patients with mild (35%) and moderate/severe (38%) asthma. SABA was purchased over-the-counter (OTC) in the past 12 months by 30.1% of all patients, and 14% purchased ≥3 canisters of SABA per year. About 91% of patients who purchased SABA OTC already received prescriptions for SABA, of whom 59% were prescribed ≥3 canisters per year. Conclusion: Russia is seeing very high level of SABA over-prescription. This is potentially associated with poor asthma control and frequent severe exacerbations. Over-prescription may serve as the main cause for SABA overuse in Russia. To reduce SABA overuse and improve overall asthma control in Russia, it is necessary to educate not just the patients but also the doctors, while actively implementing up-to-date asthma treatments.

Over-prescription of short-acting ß2-agonists and asthma management in the Gulf region: a multicountry observational study.

BACKGROUND: The overuse of short-acting ß2-agonists (SABA) is associated with poor asthma control. However, data on SABA use in the Gulf region are limited. Herein, we describe SABA prescription practices and clinical outcomes in patients with asthma from the Gulf cohort of the SABA use IN Asthma (SABINA) III study. METHODS: In this cross-sectional study conducted at 16 sites across Kuwait, Oman, and the United Arab Emirates, eligible patients (aged ≥ 12 years) with asthma were classified based on investigator-defined disease severity guided by the 2017 Global Initiative for Asthma report and by practice type, i.e., respiratory specialist or primary care physician. Data on demographics, disease characteristics, and prescribed asthma treatments, including SABA, in the 12 months prior to a single, prospective, study visit were transcribed onto electronic case report forms (eCRFs). All analyses were descriptive in nature. Continuous variables were summarized by the number of non-missing values, given as mean (standard deviation [SD]) and median (range). Categorical variables were summarized by frequency counts and percentages. RESULTS: This study analyzed data from 301 patients with asthma, 54.5% of whom were treated by respiratory specialists. Most patients were female (61.8%), with a mean age of 43.9 years, and 84.4% were classified with moderate-to-severe disease, with a mean (SD) asthma duration of 14.8 (10.8) years. Asthma was partly controlled or uncontrolled in 51.2% of patients, with 41.9% experiencing ≥ 1 severe exacerbation in the 12 months preceding their study visit. Overall, 58.5% of patients were prescribed ≥ 3 SABA canisters, 19.3% were prescribed ≥ 10 canisters, and 13.3% purchased SABA over-the-counter (OTC) in the 12 months before the study visit. Most patients who purchased OTC SABA (92.5%) also received SABA prescriptions. Inhaled corticosteroid/long-acting ß2-agonist combinations and oral corticosteroid bursts were prescribed to 87.7% and 22.6% of patients, respectively. CONCLUSIONS: SABA over-prescription was highly prevalent in the Gulf region, compounded by purchases of nonprescription SABA and suboptimal asthma-related outcomes. Increased awareness among policymakers and healthcare practitioners is needed to ensure implementation of current, evidence-based, treatment recommendations to optimize asthma management in this region. TRIAL REGISTRATION: NCT03857178 (ClinicalTrials.gov).

Development of a community pharmacy-based intervention for patients with uncontrolled asthma.

Background: Achieving asthma control is often difficult, despite the availability of effective medications. Because of their expertise, regular contact with patients, and accessibility, community pharmacists can play an important role in helping patients manage uncontrolled asthma. Objective: To develop a community pharmacy-based intervention for improving asthma control in patients with uncontrolled moderate to severe asthma. Methods: A qualitative study involving two focus groups with six and five community pharmacists, respectively, five individual interviews with community pharmacists, and three individual interviews with asthma patients was conducted using semi-structured interview guides. Focus groups aimed to develop the first prototype of the intervention and the topics included criteria to identify patients with uncontrolled asthma, content of the intervention to manage uncontrolled asthma, and potential logistical issues. Interviews were subsequently conducted with individual pharmacists and asthma patients to evaluate the prototype and finalize the intervention. The interviews and focus group transcripts were analyzed thematically, using an iterative process. Results: In focus groups and interviews, the pharmacists discussed how they screen patients with uncontrolled asthma using prescriptions refills, their needs for a convenient tool to assess asthma control, the necessity to identify causes of uncontrolled asthma to guide asthma management strategies, and the importance of patient follow-up. During interviews, patients shared their interest for the commitment of pharmacists to managing asthma. The final intervention consists of structured face-to-face counselling sessions at community pharmacies, with six steps: screening of patients with potential uncontrolled moderate to severe asthma, assessment of asthma control, identification of the causes of uncontrolled asthma, strategies for controlling asthma, an optional follow-up at the next prescription refill, and a follow-up 3 months after the initial intervention. Conclusions: The patients and community pharmacists reached consensus on the intervention's key elements and provided support for implementing the intervention in community pharmacies.

Budesonide + formoterol fumarate dihydrate for the treatment of asthma.

INTRODUCTION: One of the most widely used fixed combinations in asthma management is dry powder budesonide+formoterol fumarate dihydrate which is commercially available as Symbicort Turbuhaler(®) (and generic products), Easyhaler Bufomix(®) and DuoRespSpiromax(®) inhaler. The aim of this paper was to review the fixed dry powder combination of inhaled budesonide+formoterol fumarate dihydrate for asthma treatment in adolescents and adults. AREAS COVERED: A literature search using relevant search terms, reference lists for reviews and meta-analyses was performed. EXPERT OPINION: In symptomatic adolescent and adult patients with asthma maintenance and reliever therapy with a single-inhaler fixed combination of dry powder budesonide+formoterol fumarate dihydrate is an evidenced option. The combination treatment is convenient to patients. It reduces the number of exacerbations requiring treatment with oral corticosteroids. In some patients the strategy may also reduce the total intake of inhaled corticosteroids over time. Whether important outcome measures of asthma treatment, such as hospital admission and emergency room visit rates, may be reduced is less well documented since the published studies may have been influenced by publication bias. Non-pharmaceutical company-sponsored research evaluating such measures is needed. There is no evidence for the use of single inhaler fixed combinations of inhaled corticosteroids+long-acting ß(2)-agonists in children (<12 years of age), and budesonide+formoterol fumarate dihydrate should not be prescribed to the age group.