Adverse Drug Effects, Risk Assessment & Treatment Outcomes of Beta Agonist in Asthma Patients in DG Hospital

Asthma is a chronic inflammatory disorder of the airways characterized by reversible airflow obstruction, bronchial hyperresponsiveness, and recurring episodes of wheezing, breathlessness, chest tightness, and coughing.^1,2 It represents a significant global health burden, affecting individuals of all age groups and contributing to reduced quality of life and increased healthcare utilization. Effective management of asthma requires both control of chronic inflammation and prompt relief of acute bronchospasm.^3,4

Among the cornerstone therapies in asthma management are β-agonists, which act by stimulating β₂-adrenergic receptors in the bronchial smooth muscles, leading to rapid bronchodilation. Short-acting β-agonists (SABAs) are commonly used as rescue medications for immediate symptom relief, while long-acting β-agonists (LABAs) are used in combination with inhaled corticosteroids for maintenance therapy.^5,10 Despite their clinical efficacy, β-agonists are associated with a range of adverse drug effects, including tremors, tachycardia, hypokalemia, and, in some cases, paradoxical bronchospasm. Prolonged or inappropriate use may also lead to tolerance, reduced responsiveness, and increased risk of asthma exacerbations.⁹

Assessment of adverse drug effects and associated risk factors is essential to optimize therapeutic outcomes and ensure patient safety. Factors such as age, comorbid conditions, dosing patterns, inhalation technique, and concomitant medications may influence both the efficacy and safety profile of β-agonists. Therefore, systematic evaluation of these parameters is crucial in clinical practice, particularly in hospital settings where diverse patient populations are treated.

Drug utilization studies and pharmacovigilance play a vital role in identifying patterns of adverse drug reactions and evaluating treatment outcomes. Monitoring these aspects in a tertiary care hospital setting, such as District Government Hospital (DGH) Amaravati, provides valuable real-world evidence that can guide clinicians in improving prescribing practices and patient management strategies.

This study aims to assess the adverse drug effects, evaluate associated risk factors, and analyse treatment outcomes of β-agonist therapy in asthma patients at DGH Amaravati. The findings of this study are expected to contribute to safer and more effective use of β-agonists, ultimately enhancing the quality of care and clinical outcomes in asthma management.

Aim & Objectives

To comprehensively evaluate the adverse drug effects, risk factors, and treatment outcomes associated with β-agonist therapy in patients with asthma at District Government Hospital (DGH), Amravati.

• To identify and analyse the adverse drug effects associated with β-agonist use in asthma patients.
• To assess the risk factors and potential complications related to β-agonist therapy.
• To evaluate the treatment outcomes and clinical effectiveness of β-agonists in the management of asthma.

To monitor and analyse changes in key clinical and biochemical parameters, including serum potassium levels, electrocardiographic (ECG) findings, blood glucose levels, and leukocyte count during β-agonist therapy.

• To determine the causality and severity of adverse drug reactions using standardized assessment tools (e.g., Naranjo’s scale and CTCAE).

MATERIALS AND METHODS

Study Design and Setting

A hospital-based prospective observational study was conducted at the District Government Hospital (DGH), Amaravati. The study was carried out in the Departments of General Medicine, Paediatrics, and Intensive Care Unit (ICU).

Study Duration

The study was conducted over a period of six months, from October 2024 to March 2025.

Study Population

A total of 130 patients diagnosed with asthma and receiving β-agonist therapy were included in the study. Patients were selected from inpatient departments of General Medicine, Paediatrics, and ICU.

Inclusion Criteria

Patients of all age groups diagnosed with asthma

Patients receiving β-agonist therapy (current or past use)

Patients with a history of asthma or related respiratory diseases

Patients willing to participate and provide informed consent

Exclusion Criteria

Patients       attending outpatient        departments (OPD).

Patients unwilling to participate in the study Pregnant and breastfeeding women

Data Collection

Data were collected using a pre-designed and validated patient data collection form. Information was obtained through:

• Patient interviews.
• Review of case records and medical charts.

The collected data included:

• Demographic details (age, gender, occupation)
• Clinical characteristics and type of respiratory disease
• Details of β-agonist therapy (type, duration, and frequency)
• Concomitant medications
• Adverse drug effects (ADEs) experienced during treatment
• Laboratory and monitoring parameters such as serum potassium levels, blood glucose levels, ECG findings, and leukocyte count
• Assessment of Adverse Drug Effects

Adverse drug effects were evaluated and classified using:

• Naranjo’s Adverse Drug Reaction Probability Scale for causality assessment
• Common Terminology Criteria for Adverse Events (CTCAE) for severity grading and risk classification.

Outcome Measures

The primary outcomes assessed included:

• Incidence and type of adverse drug effects associated with β-agonists
• Risk factors and complications related to therapy

Treatment outcomes, including symptom improvement, exacerbations, and overall patient well-being.

Study Approval & Ethical Considerations Informed consent was obtained from all participants (with verbal consent and a witness for illiterate patients), and confidentiality was maintained. Institutional Ethics Committee approval was secured prior to conducting the study at District General Hospital, Amravati.

Statistical Analysis

Data were analysed using appropriate descriptive statistical methods. Results were expressed in terms of percentages and frequency distributions.

RESULTS

A total of 130 asthma patients receiving β-agonist therapy were included in the study conducted at District Government Hospital (DGH), Amaravati.

Table 1: Demographic and Clinical Profile of Participants (n = 130)

Table 3: Monitoring Parameters and Treatment Outcome

 

 

Fig.no.1. Utilization of Beta-agonist drugs

Fig.no.2. Adverse Drug effects

 

Fig.no.3. Treatment outcomes

CONCLUSION

The present study highlights that β-agonists are highly effective bronchodilators in the management of asthma, with the majority of patients showing significant improvement in symptoms and overall well-being. However, their use is associated with a considerable incidence of adverse drug effects, particularly tachycardia, headache, muscle cramps, hypokalaemia, and hyperglycaemia.

Most adverse drug reactions were found to be mild to moderate in severity and showed a probable association with β-agonist therapy, indicating that these effects are generally manageable with proper monitoring. The study also identified key risk factors such as high dosage, frequent use, comorbid conditions, and advanced age, which may increase the likelihood of adverse outcomes.

The high prevalence of electrolyte imbalance and ECG abnormalities observed  in  this  study underscores the importance of regular clinical and laboratory monitoring, especially in patients with underlying cardiovascular conditions. Additionally, the low level of patient awareness regarding potential risks emphasizes the need for patient education and counselling to improve safe medication use.

Overall, β-agonists remain an essential component of asthma therapy; however, their rational use, careful dose optimization, and continuous pharmacovigilance are crucial to minimize adverse effects and enhance treatment outcomes. Implementation of these strategies can significantly improve patient safety and the quality of asthma care in clinical practice.

ACKNOWLEDGEMENTS

The authors express their sincere gratitude to the management and staff of District Government Hospital (DGH), Amaravati, for granting permission and providing the necessary facilities to carry out this study. We are especially thankful to the physicians, nursing staff, and supporting healthcare professionals of the Departments of General Medicine, Paediatrics, and Intensive Care Unit for their valuable cooperation and assistance during data collection.

We extend our heartfelt appreciation to our academic mentors and faculty members for their continuous guidance, encouragement, and support throughout the study. Their expertise and constructive suggestions played a crucial role in the successful completion of this work.

We are also grateful to all the patients who willingly participated in this study and contributed valuable information, without whom this research would not have been possible.

Finally, we acknowledge the support of our colleagues and friends who directly or indirectly contributed to the completion of this study.

CONFLICT OF INTEREST

The authors declare that there are no conflicts of interest regarding the publication of this study. The research was conducted independently, and no financial or commercial relationships that could be construed as a potential conflict of interest were involved.

SUMMARY

Asthma is a chronic respiratory disorder requiring effective bronchodilator therapy for symptom control and prevention of exacerbations. β-agonists are widely used due to their rapid bronchodilatory effect; however, their use is associated with various adverse drug effects that may influence patient safety and treatment outcomes.

This prospective observational study was conducted at District Government Hospital (DGH), Amaravati, including 130 patients receiving β-agonist therapy. The study assessed the incidence of adverse drug effects, associated risk factors, and overall treatment outcomes. The majority of patients were elderly males, and short-acting β-agonists, particularly salbutamol, were the most commonly prescribed drugs.

Commonly observed adverse drug effects included headache, muscle cramps, and tachycardia. Significant metabolic and cardiac effects such as hypokalaemia, hyperglycaemia, and ECG abnormalities were also noted. Most adverse drug reactions were categorized as probable and were mild to moderate in severity. Identified risk factors included high dosage, frequent drug use, comorbid conditions, and advanced age.

Despite the occurrence of adverse effects, the majority of patients showed significant clinical improvement and better overall well-being, indicating the effectiveness of β-agonists when used appropriately.

In conclusion, β-agonists remain a key component in asthma management; however, careful monitoring, dose optimization, and pharmacovigilance are essential to minimize adverse effects and improve therapeutic outcomes

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