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Does daily treatment with formoterol result in more serious adverse events compared to placebo or daily salbutamol?

Asthma is a common condition that affects the airways – the small tubes that carry air in and out of the lungs. When a person with asthma comes into contact with an irritant (an asthma trigger), the muscles around the walls of the airways tighten, the airways become narrower, and the lining of the airways becomes inflamed and starts to swell. This leads to the symptoms of asthma ‐ wheezing, coughing and difficulty in breathing. They can lead to an asthma attack or exacerbation. People can have underlying inflammation in their lungs and sticky mucus or phlegm may build up, which can further narrow the airways. There is no cure for asthma; however there are medications that allow most people to control their asthma so they can get on with daily life.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Does daily treatment with salmeterol result in more serious adverse events compared with placebo or a salbutamol?

Asthma is a common condition that affects the airways – the small tubes that carry air in and out of the lungs. When a person with asthma comes into contact with an irritant (an asthma trigger), the muscles around the walls of the airways tighten, the airways become narrower, and the lining of the airways becomes inflamed and starts to swell. This leads to the symptoms of asthma ‐ wheezing, coughing and difficulty in breathing. They can lead to an asthma attack or exacerbation. People can have underlying inflammation in their lungs and sticky mucus or phlegm may build up, which can further narrow the airways. There is no cure for asthma; however there are medications that allow most people to control their asthma so they can get on with daily life.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

The use of salbutamol (albuterol) in the management of transient tachypnea of the newborn

Background: Transient tachypnea (abnormally rapid breathing) of the newborn is characterized by high respiratory rate (more than 60 breaths per minute) and signs of respiratory distress (difficulty in breathing); it typically appears within the first two hours of life in infants born at or after 34 weeks' gestational age. Although transient tachypnea of the newborn is usually improves without treatment, it is associated with wheezing syndromes in late childhood. The idea behind using salbutamol for transient tachypnea of the newborn is based on studies showing that medicines called β‐agonists, such as epinephrine (also known as adrenaline), can accelerate the rate of clearance of fluid from small cavities within the lungs called the alveoli. This review reported and critically analyzed the available evidence on the effectiveness of salbutamol in the management of transient tachypnea of the newborn.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2016

The evidence from published randomised controlled trials is inadequate to establish the effectiveness of any drug for treating facioscapulohumeral muscular dystrophy. More research is needed

Facioscapulohumeral muscular dystrophy is a progressive muscle disease. Muscle weakness is often relatively mild and progression slow but around one fifth of affected people eventually become wheelchair‐bound. The muscles of the face, shoulder blades and upper arms are most severely effected, but weakness occurs in other muscles. There is no agreed treatment. Only two randomised controlled trials have been published. One small trial of albuterol (also known as salbutamol)and another small trial of creatine (a dietary supplement for building muscle) were inadequate to confirm or refute a significant effect. Further trials of albuterol, creatine and other agents are needed.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2008

Bronchodilators for the prevention and treatment of chronic lung disease in preterm infants

Not enough evidence to show the effect of bronchodilators for chronic lung disease (CLD) in preterm babies.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Formoterol versus short‐acting beta‐agonists as symptom relief for adults and children with asthma

Short‐acting beta‐agonists are traditionally used to ease symptoms when people experience wheezing and breathlessness during asthma exacerbations. Formoterol is a bronchodilator that works quickly to relieve symptoms and the effect lasts longer. We are interested in whether there are any benefits or disadvantages associated with using formoterol instead of more traditional treatments to relieve symptoms.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Anticholinergic therapy for acute asthma in children

Asthma is a condition that affects the airways (tubes carrying air in and out of the lungs). During an asthma exacerbation (attack), the airways narrow and drugs can be taken to dilate, or widen, the airways. Common bronchodilators (medicines used to widen the airways) are short‐acting beta2‐ agonists (e.g. salbutamol) or anticholinergics (e.g. ipratropium bromide). In this review, we examined if the use of anticholinergic inhalers during an asthma attack in children aged over two years is effective compared to either placebo or another bronchodilator. We also looked at combinations of anticholinergic plus a beta2‐agonist compared to an anticholinergic on its own.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Epinephrine for acute viral bronchiolitis in children less than two years of age

Bronchiolitis is the most common acute infection of the airways and lungs during the first years of life. It is caused by viruses, the most common being respiratory syncytial virus. The illness starts similarly to a cold, with symptoms such as a runny nose, mild fever and cough. It later leads to fast, troubled and often noisy breathing (for example, wheezing). While the disease is often mild for most healthy babies and young children, it is a major cause of clinical illness and financial health burden worldwide. Hospitalizations have risen in high‐income countries, there is substantial healthcare use, and bronchiolitis may be linked with preschool wheezing disorders and the child later developing asthma.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2011

Short‐acting beta2‐agonists for stable chronic obstructive pulmonary disease

This review has shown that regular use for at least seven days of inhaled beta‐2 medicines that relieve airways obstruction and can also improve the symptoms associated with chronic obstructive pulmonary disease (COPD) in most patients but not all. Patients are far more likely to prefer treatment with these type of medicines than with placebo, and less likely to fail or drop‐out from treatment when treated with such medicines. Regular treatment with such inhaled medicines should be reserved for those patients who report symptomatic and clinical benefit from their use. Newer, long acting bronchodilators are currently available, and they may be more practical and/or effective in these patients. However, this review indicates that these older inexpensive drugs are effective in the treatment of COPD.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Long‐acting beta2‐agonists for poorly reversible chronic obstructive pulmonary disease

This review aims to determine the effectiveness of long‐acting beta‐agonists, salmeterol or formoterol, in the treatment of COPD (emphysema/chronic bronchitis). These drugs improve airflow in the lungs, and enable people with COPD to get on with their daily activities. Twenty‐four studies (6061 participants) reported the effects of LABAs in people with COPD. People taking salmeterol 50 mcg daily do have fewer exacerbations than those on placebo, and some improvement in lung function and certain quality of life scores. The findings were not consistent enough to support a general recommendation for the use of these drugs in the group of people with COPD with minimal variation in their lung function, although there is some evidence of improvement in important outcomes and these findings require further exploration in additional trials.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Addition of intravenous beta2‐agonists to inhaled beta2‐agonists for acute asthma

We found three trials involving 104 people (75 children and 29 adults) with acute asthma. There was no significant difference in adults receiving intravenous beta‐agonists as well as standard care in the one small trial considering this comparison. We also looked at length of stay in the emergency department. Two reported shorter recovery time or quicker discharge from the emergency department in patients also receiving intravenous beta‐agonists. One trial reported that more children experienced tremor if they had received injected beta‐agonists whereas another trial, with adults, reported no significant difference in adverse effects. As there are so few trials and so few included patients we cannot be sure about the reliability of these findings.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Long‐acting beta2‐agonists versus theophylline for maintenance treatment of asthma

This review compared three asthma medications, salmeterol, formoterol (both long acting beta‐agonists) and theophylline. These medications are used to help control symptoms of asthma, especially those which occur during the night. This review found that salmeterol showed a greater improvement in lung function, and reduced the need for extra short‐term inhalers in the day and the night. Salmeterol and formoterol are less likely to produce side‐effects (such as headaches and nausea) when compared to theophylline.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Interventions for non‐oliguric hyperkalaemia in preterm neonates

Elevated levels of potassium (an important salt for normal body functions) are common in infants born very preterm or with birth weight less than 1500 g. High potassium levels in the blood may lead to irregular or rapid heart rate that may result in bleedings in the brain and/or sudden death. The objective of this review was to determine the effectiveness and safety of interventions for this serious condition. Two studies enrolling 52 infants that assessed the use of a combination of insulin and sugar to reduce the blood levels of potassium were identified. This combination reduced the duration of high blood levels of potassium and the risk for bleeds in the brains of the infants. One study that enrolled 19 patients reported on the use of albuterol (a medication that helps to move potassium from the blood to the body cells). Albuterol lowered the blood levels of potassium both at four and at eight hours after the treatment had started. Because of the few infants enrolled in the studies to date, no firm recommendations for the treatment of too high blood levels of potassium in neonates can be made. Further research is needed.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Regular treatment with formoterol versus regular treatment with salmeterol in chronic asthma: serious adverse events

Asthma is a common condition that affects the airways – the small tubes that carry air in and out of the lungs. When a person with asthma comes into contact with an irritant (an asthma trigger), the muscles around the walls of the airways tighten, the airways become narrower, and the lining of the airways becomes inflamed and starts to swell. This leads to the symptoms of asthma ‐ wheezing, coughing and difficulty in breathing. They can lead to an asthma attack or exacerbation. People can have underlying inflammation in their lungs and sticky mucus or phlegm may build up, which can further narrow the airways. There is no cure for asthma; however there are medications that allow most people to control their asthma so they can get on with daily life.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Ipratropium bromide versus long‐acting beta‐2 agonists for stable chronic obstructive pulmonary disease

This review looks at studies that compare the regular use for at least four weeks of different types of bronchodilator medicine (long acting beta‐2 agonist medicines and ipratropium) in people with stable chronic obstructive pulmonary disease (COPD, or emphysema/chronic bronchitis).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2008

Different combinations of inhaled steroids and long‐acting beta‐agonists for chronic asthma (fluticasone/salmeterol versus budesonide/formoterol)

People with persistent asthma often require an additional treatment to regular inhaled steroids. Some preparations of long‐acting beta‐agonists are delivered in the same inhaler device as the inhaled corticosteroids. Inhaled steroids help to treat inflammation of the airway and long‐acting beta‐agonists help the airway to relax, improving symptoms and lung function. This systematic review examined randomised controlled trials comparing two commonly available combinations administered at a fixed dose through a single inhaler, fluticasone/salmeterol and budesonide/formoterol. We included five studies which recruited 5537 people. The trials were generally well designed but only recruited adults and adolescents and not children. Participants were already taking regular inhaled steroids before the studies commenced and had mild or moderate asthma based on tests of their airway. We found that the number of people who required treatment with oral steroids and admission to hospital was similar between the treatments, but due to the statistical uncertainty of this result we could not rule out important differences in favour of either drug combination. Additional trials would enable us to draw more reliable conclusions about how well these drugs work compared with each other. We also looked at serious adverse events. Again, the results did not indicate that one combination was clearly better than the other, but again these results were imprecise so we cannot be certain. However, lung function and rescue medication use were similar between the treatments. We could not assess the relative effects of these drugs on mortality because there were so few deaths which leads to statistical uncertainty; out of the five studies, one person died. Quality of life was measured in different ways in two studies and we could not determine how the treatments compared in this respect. Further studies are needed to strengthen and better explain these findings. In particular studies which assess the effects of these therapies in children and studies which measure quality of life are a priority.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2012

Regular treatment with salmeterol and inhaled steroids for chronic asthma: serious adverse events

There has been some concern raised at the possibility of increased serious adverse events following administration of salmeterol, a long‐acting beta2‐agonist, to people with asthma. We analysed data from 35 studies in adults and 5 in children that compared regular salmeterol in addition to inhaled corticosteroids, against the same dose of inhaled corticosteroids. Too few deaths occurred in the trials to gain any conclusive reassurance that regular salmeterol taken with inhaled corticosteroids either reduces the risk of mortality, or in fact does not increase it. The frequency of deaths in the studies was equivalent to around 10 per 10,000 adults or adolescents treated with inhaled corticosteroids and between 3 and 26 per 10,000 when treated with salmeterol and inhaled corticosteroids. No deaths occurred in the studies conducted in children. Serious adverse events were not significantly increased in adults or children when regular salmeterol was added to inhaled corticosteroids as randomised treatment, but the results are too imprecise to conclude that there is no increased risk. The frequency of serious adverse events was 21 per 1000 in the adults treated with inhaled corticosteroids and 24 per 1000 in those treated with salmeterol and inhaled corticosteroids. There were fewer serious adverse events in children, 5 per thousand on inhaled corticosteroids and 6 per 1000 on salmeterol and inhaled corticosteroids. Large surveillance studies are currently ongoing.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2013

Oral betamimetics for the prevention of preterm labour and birth for women with twin pregnancies

There is insufficient evidence from randomised controlled trials to support the routine use of oral betamimetics (drugs that reduce or prevent uterine contraction) to prevent preterm birth of twins.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2016

Tiotropium versus long‐acting beta2‐agonists (LABAs) in the management of COPD

Tiotropium is an inhaled medication that helps open the airways (bronchodilator) and is used to manage persistent symptoms of COPD. We found seven studies including 12,223 participants that compared tiotropium with long‐acting beta2‐agonists (LABAs), which are another type of bronchodilator. This systematic review found that currently there is insufficient evidence to suggest which of these treatments provides greater long‐term benefit in quality of life. Furthermore, both treatments had similar effects on symptoms, lung function and death rates.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2016

For people with COPD, is it better to take a combination of tiotropium and long‐acting beta2‐agonists than either inhaler alone?

Chronic obstructive pulmonary disease (COPD) is a lung disease that includes the conditions chronic bronchitis and emphysema. The symptoms include breathlessness and a chronic cough. COPD is an irreversible disease that is usually brought on by airway irritants, such as smoking or inhaled dust.

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2015

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