Anoro - umeclidinium bromide and vilanterol

What is Anoro - umeclidinium bromide and vilanterol and what is it used for?

Anoro is a medicine that contains the active substances umeclidinium bromide and vilanterol. It is used as maintenance (regular) therapy to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). COPD is a chronic disease in which the airways and alveoli of the lungs are damaged or blocked, resulting in difficulty in breathing.

How is Anoro used - umeclidinium bromide and vilanterol?

Anoro can only be obtained with a prescription. It is available as an inhalation powder contained in a portable inhaler. The inhaler delivers 22 micrograms of vilanterol and 55 micrograms of umeclidinium (as umeclidinium bromide) for each inhalation. The recommended dose is one inhalation per day, at the same time each day. For more information on how to use the inhaler correctly, see the instructions in the package leaflet.

How does Anoro - umeclidinium bromide and vilanterol work?

The active ingredients in Anoro, umeclidinium and vilanterol, work differently to dilate the airways and improve breathing in COPD. Anoro contains two active ingredients: vilanterol is a long-acting beta-2 adrenergic agonist. It works by binding to beta-2 adrenergic receptors found in the muscle cells of many organs, including the lung airways. Once inhaled, vilanterol reaches the lungs. receptors present in the airways and activates them, thus relaxing the muscles of the airways.

Umeclidinium is a muscarinic receptor antagonist. It works by blocking other receptors called "muscarinic receptors", which are responsible for controlling muscle contraction. When inhaled, umeclidinium also exerts a relaxing effect on the muscles of the airways. The combined action of the two active ingredients helps keep the airways dilated and allows the patient to breathe more easily. Muscarinic receptor antagonists and long-acting beta-2 agonists are usually combined in the treatment of COPD.

What benefit has Anoro - umeclidinium bromide and vilanterol shown during the studies?

The combination of umeclidinium and vilanterol was investigated in five main studies involving over 5,600 patients. Two studies compared the fixed-dose combination of umeclidinium and vilanterol (one corresponding to Anoro and a combination of more) with vilanterol taken alone, umeclidinium taken alone and placebo (a dummy treatment). In one study, the dose of umeclidinium 55 micrograms / vilanterol 22 micrograms (Anoro) was used, while a higher dose was used in the second study. consisting of umeclidinium 113 micrograms / vilanterol 22 micrograms. Two other studies compared these two fixed-dose combinations of umeclidinium and vilanterol with another medicine, called tiotropium, used in the treatment of COPD, while one last study compared only the dose. lower than umeclidinium and vilanterol (55 micrograms / 22 micrograms) with tiotropium. the main measure of effectiveness was the improvement in forced expiratory volume (FEV1, the maximum volume of air a person is able to exhale in one second). Studies showed that after 24 weeks of treatment, Anoro improved lung function with an average FEV1 of 167ml more than placebo. Anoro also increased FEV1 by an average of 95 ml more than vilanterol monotherapy and 52 ml more than umeclidinium bromide monotherapy. The mean increase in FEV1 with Anoro was 60, 90 and 112 ml more than tiotropium after 24 weeks of treatment in the three studies where Anoro was compared with tiotropium. Compared with placebo, Anoro was also shown to improve breathing difficulties. The combination with higher doses of umeclidinium (113 micrograms) and vilanterol (22 micrograms), compared to the combination with lower doses (55 micrograms / 22 micrograms), did not result in improvements in lung function consistently enough to justify use.

What is the risk associated with Anoro - umeclidinium bromide and vilanterol?

The most common side effects with Anoro (which may affect 1 to 10 users in 100) are upper respiratory tract infections (colds), urinary tract infections (infections of the structures that carry urine), pharyngitis (inflammation of the throat). , sinusitis (inflammation of the sinuses), nasopharyngitis (inflammation of the nose and throat), headache, cough, oropharyngeal pain (pain in the mouth and throat), constipation and dry mouth. For the complete list of side effects and limitations, see package leaflet.

Why has Anoro - umeclidinium bromide and vilanterol been approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Anoro's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that Anoro has been shown to be effective in improve lung function and symptoms of BCPO when compared to placebo or individually with its components as well as tiotropium. The CHMP also noted that there were no major issues related to the use of Anoro and that the side effects are manageable, although only limited data on long-term safety are available so far. The CHMP recommended carrying out a study to investigate this in more detail.

What measures are being taken to ensure the safe and effective use of Anoro - umeclidinium bromide and vilanterol?

A risk management plan has been developed to ensure that Anoro is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Anoro, including the appropriate precautions to be followed by healthcare professionals and patients. As medicines belonging to the same class as Anoro can affect the heart and blood vessels in the brain, the company will continue to closely monitor the heart and brain effects of the medicine and will carry out other long-term studies in patients to identify potential risks. Further information can be found in the summary of the risk management plan.

More information about Anoro - umeclidinium bromide and vilanterol

On 8 May 2014, the European Commission issued a "marketing authorization" for Anoro, valid throughout the European Union. For more information about Anoro therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist. Last update of this summary: 05/2014

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