GSK Supports GINA's 2007 World Asthma Day - 'You Can Control Your Asthma'

Main Category: Respiratory / Asthma
Article Date: 02 May 2007 - 1:00 PDT

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Today is 2007 World Asthma Day, adopting the theme: "You can control your asthma". According to the Global Initiative for Asthma (GINA), the goal of asthma treatment is for patients to achieve and maintain control of their condition.1 Any symptoms and the need for reliever treatment are signs that asthma is not being properly controlled.1

Asthma UK states that there are more than 5 million people in the UK with asthma and the symptoms of nine out of ten of them should be controllable with the treatments currently available.2

Combination treatments are one of the cornerstones of asthma treatment, bringing together an inhaled steroid (to reduce the underlying cause of asthma, chronic inflammation) with a bronchodilator (to open up the airways). SeretideTM (salmeterol/fluticasone propionate - GlaxoSmithKline) is the most widely prescribed combination treatment in the UK.3

Regular, twice-daily dosing with GlaxoSmithKline's Seretide is a well-established treatment approach which, in line with treatment guidelines, focuses on control of asthma symptoms - the treatment approach aims to prevent asthma symptoms and control the ongoing inflammation for asthma patients. With Seretide's treatment approach, very high levels of asthma control can be achieved in the majority of patients, in line with stringent levels of control defined in asthma treatment guidelines.4

The Seretide treatment approach is supported by the findings of the landmark Gaining Optimal Asthma ControL study (GOAL) which was the first prospective clinical trial to assess whether GINA's stringent guideline-defined asthma control could be achieved in patients with different severities of asthma using regular, twice-daily dosing with Seretide (salmeterol/fluticasone).4 GOAL showed that for patients previously uncontrolled on low dose inhaled corticosteroid, 75% of patients achieved GINA's guideline-defined control with Seretide and 44% achieved the even stricter measure of total control. (Guideline-defined control and total control were defined as the requisite levels of control for 7 out of 8 weeks - see Notes section for requirements to meet these).

Simplicity for patients

According to Asthma UK, one of the key reasons why patients suffer sub-optimal control is that they may not be taking their medication as prescribed.2 Regular, twice-daily dosing with Seretide offers a simple and effective treatment approach.

Focus on inflammation

Effective control of asthma relies on effective control of underlying inflammation. Symptoms are an indication that inflammation is uncontrolled and regular dosing is the one way of gaining effective control.5

The principle of using a regular, twice daily treatment approach to proactively manage asthma, rather than short-term treatment adaptations in reaction to symptoms, is widely supported by clinical data. For the majority of patients, this regular stable maintenance approach will enable them to achieve World Asthma Day's aim of gaining control of their asthma.

About GOAL (Gaining Optimal Asthma ControL)4

The GOAL study is a multi-centre, stratified, randomised, double-blind, parallel-group, step-up comparison of the level of asthma control achieved with Seretide (salmeterol/fluticasone propionate) Accuhaler compared with fluticasone propionate alone in adults and adolescents.

The primary endpoint of the GOAL study was to determine the proportion of patients who achieved GINA's guideline-defined controlled asthma (i.e. near-perfect levels of asthma control) with salmeterol/fluticasone compared with fluticasone alone.

75% of patients who were previously uncontrolled on a low-dose inhaled steroid (stratum 2) achieved GINA's guideline-defined control of their asthma (near-perfect levels of asthma control) compared to 60% and 28% respectively of patients taking fluticasone propionate alone.

Patients who achieved GINA's guideline-defined control of their asthma experienced for at least seven out of eight weeks:

-- Minimal daytime symptoms and rescue salbutamol use
-- No exacerbations
-- No emergency visits
-- No days with AM PEF ≤80% predicted
-- No night-time awakenings
-- No treatment related side effects enforcing change in asthma therapy

Seretide is not currently licensed for steroid naïve patients in the UK.

References:

1. The Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA) 2006. Available from: www.ginasthma.com Date of access: 30.04.07
2. Everyday Asthma Out of Control? A report published by Asthma UK, 2004.
3. GlaxoSmithKline Data on File: SFL/DOF/07/30920/1
4. Bateman ED et al. Can Guideline-Defined Asthma Control be Achieved? The Gaining Optimal Asthma ControL Study. Am J Respir Crit Care Med 2004.
5. Woolcock A et al. Comparison of addition of salmeterol to inhaled steroids with doubling of the dose of inhaled steroids. Am J Respir Crit Care Med 1996; 153: 1481 - 1488.

Prescribing Information
(Please refer to full SPCs before prescribing)

Seretide Accuhaler and Evohaler (salmeterol xinafoate and fluticasone propionate)

Uses: Asthma: Regular treatment of asthma, where a long-acting bronchodilator and inhaled corticosteroid is appropriate, i.e. patients uncontrolled on inhaled corticosteroids and 'as needed' short-acting inhaled bronchodilator or patients controlled on inhaled corticosteroid and long-acting bronchodilator. Lowest strength Seretide (50 Evohaler and 100 Accuhaler) not appropriate in severe asthma. COPD: Symptomatic treatment of patients with severe COPD (FEV1 <50% predicted normal) and a history of repeated exacerbations, who have significant symptoms despite regular bronchodilator therapy.

Dosage and administration: Inhalation only. Asthma: Adults and adolescents 12 years and over: Seretide Accuhaler - one blister b.d. of: Seretide 100 (salmeterol 50 mcg/fluticasone propionate 100 mcg) or Seretide 250 (salmeterol 50 mcg/fluticasone propionate 250 mcg) or Seretide 500 (salmeterol 50 mcg/fluticasone propionate 500 mcg). Seretide Evohaler - two puffs b.d. of: Seretide 50 (salmeterol 25 mcg/fluticasone propionate 50 mcg) or Seretide 125 (salmeterol 25 mcg/fluticasone propionate 125 mcg) or Seretide 250 (salmeterol 25 mcg/fluticasone propionate 250 mcg). Children 4-11 years: Seretide 50 Evohaler (salmeterol 25 mcg/fluticasone propionate 50 mcg): two puffs b.d. Spacer recommended for co-ordination. Seretide 100 Accuhaler (salmeterol 50 mcg/fluticasone propionate 100 mcg) one blister b.d. Regularly review patients and reduce dose to lowest that maintains effective symptom control. Where the control of symptoms is maintained with the lowest strength of the combination, patients may be prescribed an inhaled corticosteroid alone, or if a long-acting β2 agonist is required, Seretide may be given once daily. COPD: one blister b.d. of Seretide 500 Accuhaler (salmeterol 50 mcg/fluticasone propionate 500 mcg. If rapid control of asthma in adults or adolescents with moderate persistent asthma (defined as patients with daily symptoms, daily rescue use and moderate to severe airflow limitation) is essential, an initial dose of two puffs b.d of Seretide 50 Evohaler (salmeterol 25 mcg/ fluticasone propionate 50 mcg) or one puff b.d of Seretide 100 Accuhaler (salmeterol 50 mcg/fluticasone propionate 100 mcg) may be considered on a short-term basis. Once control of asthma is attained treatment should be regularly reviewed and stepped down. Doubling the dose of all strengths of Seretide may be considered when adult patients require additional short-term (up to 14 days) inhaled corticosteroid therapy but this causes a small increase in beta-agonist-related adverse events.

Contra-indications: Hypersensitivity.

Precautions: Pulmonary tuberculosis, severe cardiovascular disorders, diabetes mellitus, hypokalaemia and thyrotoxicosis Severe unstable asthma: Warn patients to seek medical advice if short-acting inhaled bronchodilator use increases. Consider increased inhaled/additional corticosteroid therapy. Acute symptoms: Not for acute symptoms. Use short-acting inhaled bronchodilator. Systemic effects: Systemic effects of inhaled corticosteroids may occur, particularly at high doses for prolonged periods, but much less likely than with oral corticosteroids. May include Cushing's syndrome, Cushingoid features, adrenal suppression, adrenal crisis, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma. Monitor height of children on prolonged inhaled corticosteroid therapy. In asthma, therapy should be down titrated under physician supervision to lowest effective dose and treatment should not be abruptly stopped due to risk of exacerbation. Serious asthma-related adverse events and exacerbations may occur during treatment with Seretide. Patients should not be initiated on Seretide during an exacerbation, or if they have significantly worsening or acutely deteriorating asthma. Data from a large asthma trial suggested patients of black African or Afro-Caribbean ancestry were at increased risk of serious respiratory-related events or deaths when using salmeterol. All patients should continue treatment but seek medical advice if asthma symptoms remain uncontrolled or worsen when initiated on Seretide or using Seretide. In COPD cessation of therapy may also be associated with decompensation and should be supervised by a physician. Transfer from oral steroids: Special care needed. Consider appropriate steroid therapy in stressful situations.

Drug interactions: Avoid beta-blockers. Avoid strong inhibitors of CYP 3A4 (e.g. ritonavir, ketoconazole, itraconazole).

Pregnancy and lactation: Experience limited. Balance risks against benefits.

Side effects: Common: Oral candidiasis, hoarseness, throat irritation, headache, palpitations, tremor, muscle cramps. Uncommon Hypersensitivity, tachycardia Very Rare: Anxiety, sleep disorders and behavioural changes, including hyperactivity and irritability (predominantly in children). Also hyperglycaemia, angioedema, myalgia, arthralgia, tremor, and cardiac arrhythmias. Paradoxical bronchospasm: Substitute alternative therapy.

Legal category: POM.

Presentation and Basic NHS cost: Accuhaler 60 inhalations. Seretide 100 - £31.19. Seretide 250 - £36.65. Seretide 500 - £40.92 . Evohaler 120 inhalations. Seretide 50 - £18.14. Seretide 125 - £36.65. Seretide 250 - £62.29.

Product Licence (PL) nos: 10949/0314-0316, 10949/0337-0339.

PL holder: Allen & Hanburys, Stockley Park West, Uxbridge, UB11 1BT.

Last date of revision: 5 January 2007

In order to continually monitor and evaluate the safety of Seretide, we encourage healthcare professionals to report adverse events, pregnancy, overdose and unexpected benefits to GlaxoSmithKline on 0800 221 441. Please consult the Summary of Product Characteristics for full details on the safety profile of Seretide. Information about adverse event reporting can also be found at www.yellowcard.gov.uk