Safety and Effectiveness of As-Needed Formoterol in Asthma Patients Taking Inhaled Corticosteroid (ICS)-Formoterol or ICS-Salmeterol Maintenance Therapy.

BACKGROUND: As-needed low-dose inhaled corticosteroid (ICS)-formoterol reliever is recommended in patients with asthma prescribed maintenance ICS-formoterol. Clinicians often ask whether ICS-formoterol reliever can be used with other maintenance ICS-long-acting ß2-agonists. OBJECTIVE: To evaluate the safety and effectiveness of as-needed formoterol in patients taking maintenance ICS-formoterol or ICS-salmeterol from the RELIEF study. METHODS: RELIEF (SD-037-0699) was a 6-month, open-label study that randomized 18,124 patients with asthma to as-needed formoterol 4.5 µg or salbutamol 200 µg on top of maintenance therapy. This post hoc analysis included patients on maintenance ICS-formoterol or ICS-salmeterol (n = 5436). The primary safety outcome was a composite of serious adverse events (SAEs) and/or adverse events leading to discontinuation (DAEs); the primary effectiveness outcome was time-to-first exacerbation. RESULTS: For both maintenance groups and both relievers, similar numbers of patients had ≥1 SAE and/or DAE. In patients taking maintenance ICS-salmeterol, but not ICS-formoterol, significantly more non-asthma-related and nonserious DAEs occurred with as-needed formoterol versus as-needed salbutamol (P = .0066 and P = .0034, respectively). In patients taking maintenance ICS-formoterol, there was a significantly lower risk in time-to-first exacerbation with as-needed formoterol versus as-needed salbutamol (hazard ratio [HR]: 0.82, 95% confidence interval [CI]: 0.70, 0.95; P = .007). In patients taking ICS-salmeterol maintenance, time-to-first exacerbation was not significantly different between treatment arms (HR: 0.95, 95% CI: 0.84, 1.06; P = .35). CONCLUSIONS: As-needed formoterol significantly reduced exacerbation risk compared with as-needed salbutamol when added to maintenance ICS-formoterol, but not to maintenance ICS-salmeterol. More DAEs were seen with ICS-salmeterol maintenance therapy plus as-needed formoterol. Further research is needed to assess whether this is relevant to as-needed combination ICS-formoterol.

Adherence monitoring and e-health: how clinicians and researchers can use technology to promote inhaler adherence for asthma.

In the past decade, rapid technological developments have advanced electronic monitoring devices (EMD) for asthma inhalers beyond simple recording of actuations to providing adherence promotion features and detailed information about patterns of medication use. This article describes currently available EMDs, discusses their utility and limitations in assessing adherence, and describes the potential for EMD-based adherence promotion interventions in clinical settings. To date, the main use of EMDs has been in clinical research. In selected populations, simple EMD-based adherence interventions, delivered either through clinician-to-patient feedback about medication use or by direct-to-patient reminders for missed doses, can significantly improve adherence. Further work is now needed to determine the impact of EMDs on clinical outcomes and their cost-effectiveness and feasibility for different clinical settings, including in disadvantaged populations. If this evidence can be provided, then the use of EMDs could expand into the management of asthma in populations with high health care costs, eg, severe asthma. In the future, medication monitoring could help distinguish poor treatment response from poor adherence, guide prescribing decisions, and prompt providers to discuss barriers to adherence; electronic health records may provide the gateway for integrating medication-use monitoring into digital chronic care management.