The Efficacy and Safety of the Novel Long-Acting β 2 Agonist Vilanterol in Patients With COPD

Cardiovascular safety of new inhaled medications for asthma and chronic obstructive pulmonary disease: a critical review from pharmacist perspective

“…In general, the use of vilanterol was not found associated with an increased risk of cardiac events, including arrhythmias, cardiac ischemia, hypertension, cardiac failure, QTc prolongation and ECG changes. 42,58,59 Incidences of cardiovascular AE were very low across treatment groups (<1-2%) and the placebo group (2%). The most commonly experienced cardiovascular AE were ventricular extrasystoles, ventricular tachycardia and AF.…”

“…39 However, a study by Hanania NA et al found that vilanterol monotherapy was not associated with significant changes in QTc interval or vital signs among COPD patients, even with increased doses. 59 However, limitations of these studies make it not possible to distinguish between the effect of vilanterol and SABA use (allowed as when required dosing) and its association with disease severity. In addition, the limited number of clinical trials currently available, strict selection criteria, short duration of follow up and other conflict of interests prevents us from making meaningful conclusions on the long-term safety of vilanterol, which is intended to be used in a wide range of patients with multiple comorbidities.…”

“…38 In addition, one study has found that serum potassium and glucose levels were slightly increased without reaching significance, and incidences of other AEs were lower in the treatment group. 59 Although these agents were administered via an inhaler device, small amounts of the drug were absorbed systematically, and it is believed that high plasma levels can contribute to greater extra-pulmonary effects. 9,18 In addition, the systemic bioavailability of drugs largely depends on the pharmacokinetic properties, inhaler device used, as well as technique.…”

New bronchodilators in treatment of chronic obstructive pulmonary disease

“…Patients were randomized (double-blind) to vilanterol 3, 6.25, 12.5, 25, or 50 μg or placebo once daily for 28 days. At the end of the 4th week, improvement in the pulmonary functions is dose dependent and vilanterol 25, or 50μg leads to statistically significant improvement in FEV1 values [8].…”

Efficacy and safety of long-acting beta-2-agonists

“…По сравнению с плацебо наблюдалось клинически значимое изменение средневзвешен ного ОФВ 1 в 0 и 24 ч и ОФВ 1 в конце интервала до зирования ≥ 130 мл при применении 25 и 50 мкг вилантерола. Прием всех исследованных дозировок вилантерола сопровождался низкой частотой побоч ных эффектов [39]. Кармотерол -чистый R,R изомер -некатехолами новый агонист β 2 АР с р метоксифенильной груп пой на аминовой боковой цепи и 8 гидроксильной группой на карбостириловом ароматическом коль це [40].…”