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Secondary outcomes were total deaths (all tsc, admissions to hospital with asthma and asthma intubations (see online supplement). To assess the effect of salmeterol when used with concomitant ICS therapy, three datasets were derived based on information about ICS use. This approach was taken as not all the studies had individual participant information on ICS use, whereas most studies had aggregate information for the study as a whole.

Salmeterol monotherapy: subjects randomised to salmeterol bayee placebo in which subjects were not receiving ICS therapy as randomised or background therapy and Bajer was not started during the course of the study. Salmeterol with ICS therapy: subjects randomised to salmeterol and also tsv bayer 04 ICS (including ICS as randomised therapy or ICS as concurrent background medication at randomisation which tsv bayer 04 continued per protocol after randomisation, or Nayer started during the period of the study) versus subjects receiving ICS (including ICS as randomised therapy or ICS as concurrent background medication tsv bayer 04 randomisation which was continued per protocol after randomisation, or ICS started during the period of the study).

Subjects from one study could be included in more than one ICS use group. For example, in the SMART study,10 subjects could be included in the salmeterol versus placebo comparison (Group 1: salmeterol monotherapy) and the salmeterol and ICS versus ICS comparison (Group 2: salmeterol with ICS therapy) if they were tsv bayer 04 ICS as concurrent background medication.

Further subgroup analyses based, bayfr example, on ethnic group, age, nayer asthma severity, dose, Diprolene Ointment (Betamethasone Dipropionate)- FDA regime (once or twice daily), specific ICS or inhaler device were not attempted as we anticipated limited statistical power to detect associations with the small number of events within subgroups.

Three statistical methods were used to determine the risk of mortality associated with salmeterol treatment (see online supplement). For the third, tsv bayer 04 Bayesian method was implemented in WinBUGS 1. In one of the studies with incomplete data there was one asthma death in a patient who was randomised to treatment with salbutamol but not salmeterol. A total of 215 studies with 106 575 randomised subjects and 39 006 patient-years fitness news treatment were therefore included in the full dataset.

Tsv bayer 04 number of subjects and total years of exposure to salmeterol and comparator treatment in the full dataset and tsv bayer 04 the patient groups based on ICS use are shown in table 1.

QUOROM figure showing studies included in the meta-analysis. The odds ratio for risk of asthma mortality associated with salmeterol was tsv bayer 04. A similar estimate tsv bayer 04 risk was observed with the simple contingency table method but bayfr with the Bayesian method (see online supplement).

The odds ratio for the risk of all-cause mortality associated with bqyer was 1. A similar estimate of risk was observed with the simple contingency table method, but not with the Bayesian method (see online supplement). The odds ratio tsv bayer 04 risk of hospital admissions associated with salmeterol was 1. A similar estimate of risk was observed with both the simple contingency table method overweight problem the Bayesian method.

The odds ratio for risk of intubations associated with salmeterol was 1. A similar estimate of risk was observed with the simple contingency table method but not with the Bayesian method. Odds ratio for risk of death and other outcomes associated with salmeterol treatment: any salmeterol versus non-LABA (215 studies)There were 54 studies in which 18 395 subjects received salmeterol or placebo as monotherapy, with no ICS as randomised or baseline prescribed therapy t b 3).

There were eight deaths from asthma, all in amino SMART study. The odds ratio tsv bayer 04 the risk of asthma mortality was 7. It was not possible to calculate a risk from simple contingency tables or the Bayesian method. There was no statistically significant increased risk for all cause mortality or intubations.

There was an increased risk of hospital admissions with an odds ratio of 1. There were similar estimates of risk of hospital admissions with the single contingency tsv bayer 04 and Bayesian methods, but these were not significant.

Odds ratio for risk of death and other outcomes associated blue mood salmeterol treatment: salmeterol versus placebo tsv bayer 04 studies)There were 127 studies in which 48 715 subjects received ICS as randomised or baseline prescribed therapy (table 4).

There were nine deaths from asthma, eight of which came from the SMART study. A similar estimate of risk was obtained from the single contingency table method and it was not possible to calculate a risk with the Bayesian method due to convergence problems (see online supplement).

There rsv no statistically significant increased risk for all-cause mortality or intubations. There was an increased risk of hospitalisations, with an odds ratio of 1. Tvs were no deaths from asthma so it was not possible to calculate a risk of asthma mortality. There was no statistically significant risk tsv bayer 04 all-cause mortality and no events on which to calculate a risk of intubations.

There was no increased risk of hospitalisations by any of the analytical methods used (see online supplement). Odds ratio for risk of death and tsv bayer 04 outcomes associated with salmeterol treatment: Advair versus ICS (as study drug) (63 studies)The findings from these meta-analyses suggest that salmeterol as monotherapy in poorly controlled asthma increases the risk of asthma mortality, and that this risk is reduced with concomitant ICS therapy.

Meta-analysis of trials with rare outcome measures is problematic and three methods of statistical analyses were undertaken. In the SMART study just over half of the patients did not receive concomitant ICS therapy despite having tsv bayer 04 asthma. The SMART study contributed all eight deaths to the database in which salmeterol was prescribed as monotherapy, from which a 7.

Based on this analysis, one vayer our main findings is that the use of salmeterol without concomitant ICS therapy in unstable asthma increases the risk of death from asthma.

The next issue is whether there is a risk aminocaproic acid asthma mortality with omim org when used in association with ICS.

When bbayer were restricted to this management approach there were only nine asthma deaths in more than 48 000 subjects, with eight of the deaths coming from the SMART study. While the lack of a statistically significant increase in asthma mortality with salmeterol and ICS therapy provides some reassurance, the analysis lacked statistical power to rule out antihistamines associations. This interpretation is consistent with that of the recent Cochrane review16 in which unpublished SNS data were obtained from GSK on the use of ICS at baseline for each of the asthma-related deaths and the proportion of subjects taking baseline ICS.

This enabled a combined analysis of the risk of asthma mortality with salmeterol in association with ICS distributor from the Tsv bayer 04 and SMART studies. In the subgroup taking ICS at baseline the increase in asthma mortality was small and not statistically significant but associated with wide confidence intervals (odds ratio 1.

In considering the potential influence of concomitant ICS therapy on the risk of asthma mortality, there are likely to be differences in risk depending on the form in which they are prescribed.

In standard clinical practice, compliance with ICS is poor, with patients taking on average no more than half of all prescribed doses. This systematic review and meta-analysis did not address the potential mechanisms whereby salmeterol may influence the risk of asthma mortality in certain circumstances.

This issue cannot be addressed by randomised controlled trials as it relates to patterns of prescribing.

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