Long-term safety of symbicort use
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Long-Term Safety of Symbicort: Clinical Trial and Real-World Evidence
Symbicort Long-Term Safety in Asthma: Clinical Trial Data
Multiple studies have evaluated the long-term safety of Symbicort (budesonide/formoterol) in patients with asthma. A 52-week randomized, double-blind study compared different doses of Symbicort and budesonide alone, monitoring asthma exacerbations, ECGs, lung function, adverse events, and laboratory parameters. The study found no single safety concern, indicating a favorable long-term safety profile for Symbicort over one year of use . Another 52-week tolerability study in patients aged 12 and older showed that even at double the maximum recommended dose, Symbicort’s safety profile was similar to that of budesonide alone, with no unexpected safety issues .
A six-month extension study compared Symbicort in a single inhaler to separate inhalers for budesonide and formoterol. The incidence and severity of adverse events were low and similar between groups, with no clinically important differences in laboratory or ECG findings. Both regimens maintained improvements in lung function and asthma control, supporting the long-term safety of Symbicort . In children aged 6 to 11, a 26-week study also focused on long-term safety, though specific results are not detailed here .
Symbicort in COPD: Long-Term Safety Findings
A one-year observational study in patients with chronic obstructive pulmonary disease (COPD) using Symbicort Turbuhaler found that adverse drug reactions (ADRs) occurred in 5.8% of patients, with the most common being dysphonia, oropharyngeal discomfort, palpitations, bronchitis, oral candidiasis, pneumonia, and cough. Serious adverse events were rare and mostly unrelated to the drug. The study concluded that no new safety concerns were identified during long-term use, and Symbicort was effective in improving symptoms and lung function .
Safety in Special Populations and Real-World Use
Symbicort has also been studied in special populations, such as pregnant women with asthma, where long-term use was found to be effective, safe, and convenient . Real-world studies comparing Symbicort Maintenance and Reliever Therapy (SMART) to conventional best practice regimens in asthma management found that Symbicort was at least as effective, with similar or fewer adverse events, and often at a lower inhaled corticosteroid dose 6910.
Regulatory and Prescribing Considerations
While Symbicort is generally well tolerated, it contains a long-acting beta2-agonist (LABA), which carries a class warning for increased risk of asthma-related death. This risk is considered a class effect of LABAs, and current guidelines recommend using Symbicort only in patients not adequately controlled on inhaled corticosteroids alone. Regular assessment and step-down therapy are advised once asthma control is achieved .
Conclusion
Long-term use of Symbicort in both asthma and COPD patients is generally safe, with adverse events being infrequent and similar to those seen with other inhaled therapies. No new or unexpected safety concerns have emerged in studies lasting up to one year or longer. However, as with all LABA-containing medications, careful patient selection and regular monitoring are recommended to minimize risks 12468910.
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