Salmeterol

Additional information

Pharmacokinetics and dosing

In a population pharmacokinetic analysis in healthy individuals (n=57) were given single dose of fluticasone/salmeterol 500/50 µg. Men had higher clearance than women [5]. The clinical relevance of this difference is unclear.

Effects

Difference between men and women in effects in the efficacy of salmeterol has been investigated in a post-hoc analysis of a large 1-year double-blind trial, TRISTAN, where Chronic Obstructive Pulmonary Disease (COPD) patients (539 men, 180 women) were randomized to the salmeterol/fluticasone or placebo [6, 7]. No differences between men and women was found for any study outcome; FEV improvement, a reduction in COPD exacerbation rate, a reduction in COPD exacerbation requiring treatment with oral corticosteroids and improvement in health status.

A post hoc-analysis to the TORCH study, a trial investigated the effect of fluticasone and/or salmeterol therapy (4631 men, 1481 women) over 3 years showed that women were 16% less likely to die over the period of the study compared to men [8]. However, correcting for important covariates, such as degree of airflow obstruction, body mass index, region of the world, and previous myocardial infarction, this difference was not statistically significant (HR 1.16). The causes of death were similar in men and women [9] .

Adverse effects

The frequency of adverse events from salmeterol/fluticasone combination treatment for COPD was similar in men and women [6].

Reproductive health issues

Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).

Other information

In a study on inhalation technique using metered dose inhalers (33 men, 26 women), 75% of the participants had an incorrect inhalation technique, especially women, regardless of age. Only 4% of women and 43% of men had an acceptable inhalation technique. The authors speculate that this may add to the worse asthma prognosis in women, shown in a meta-analysis of six trials of randomly assigned asthma treatment [1].

Several studies have shown worse prognosis for women with asthma. In an observational registry study (416 men, 498 women), women were found to have more asthmatic symptoms, worse quality of life and require more health care due to their asthma [2]. In a Danish prospective study on hospitalization due to asthma (6104 men of whom 2.5% had asthma, 7436 women of whom 2.2% had asthma), women had a 1.7 higher relative risk to be hospitalized [3]. An observational study from Singapore found hospitalization due to asthma to be more common in boys than girls aged 0-4 years (boys/girls ratio 1.69). In adults aged 35-64 years, women were more hospitalized (men/women ratio 0.81) [4].