New study shows Seretide patients had on average 24 more symptom-free days over a year, and a 47% reduction in the rate of moderate/severe exacerbations, compared to Symbicort patients, according to GlaxoSmithKline.
Drug giant GlaxoSmithKline (GSK) sparred with rival AstraZeneca on Thursday on the effectiveness of their asthma medications.
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| GlaxoSmithKline (GSK) had sales of £20.3 billion ($37.2 billion) and profit before tax of £6.1 billion ($11.1 billion). Total pharmaceutical turnover was just over £17 billion ($31 billion) and consumer healthcare turnover was £3.2 billion ($5.8 billion). GSK has over 100,000 employees worldwide. Of these, over 40,000 are in sales and marketing, the largest sales force in the industry. Around 35,000 employees work at 82 manufacturing sites in 37 countries and over 16,000 are in R&D. |
Europe's largest drug manufacturer highlighted the results published in the journal Clinical Therapeutics on Thursday, to bolster its dominant position in respiratory medicine as AstraZeneca moves to launch Symbicort in the US market in 2006.
GSK's respiratory drugs's sales in 2004 accounted for one-fifth of revenues.
Asthma patients receiving stable-dose Seretide
(salmeterol/fluticasone propionate combination) averaged 24 more symptom-free days than patients receiving adjustable maintenance dose (AMD) Symbicort (formoterol /budesonide) in a 12-month study published Thursday in the journal Clinical Therapeutics. The salmeterol/fluticasone patients also experienced a 47% reduction in the annual rate of moderate/severe exacerbations when compared to the formoterol/budesonide patients.
AstraZeneca said that patients taking its drug in the latest trial were under-dosed, as they were given an average of just 1.8 puffs of the inhaled treatment each day. An earlier study, using an average 3.4 puffs a day, had favoured Symbicort.
The CONCEPT (CONtrol CEntred Patient Treatment) study was a multi-national, randomized, doubleblind, double-dummy clinical trial carried out in 688 symptomatic adult patients. The results from the primary endpoint of the study showed that patients treated with stable-dose salmeterol/fluticasone propionate (50/250 micrograms) had significantly more symptom-free days over the 12 months of the study, than patients treated with AMD formoterol/budesonide (6/200 micrograms) (median 59% versus 52%; p=0.034, weeks 1-52, average difference 24 days per year). The 12-month treatment period consisted of a 1-month stabilization phase and an 11-month period when stable and adjustable-maintenance-dosing strategies were compared*. The difference in the percentage of symptom-free days was even greater over this 11-month period: 74% for patients receiving salmeterol/fluticasone propionate versus 65% for patients receiving formoterol/budesonide (p=0.030), which equates to an average 32 more symptom-free days per year for salmeterol/fluticasone propionate patients.
AstraZeneca said that the CONCEPT results conflicted with evidence from eight previous clinical trials, involving more than 10,000 patients.
Professor Andy Greening from the Western General Hospital, Edinburgh, said: "I have been concerned for a long while that Health-Care Professionals and patients are not ambitious enough about asthma control. Too often regular symptoms are seen as acceptable, so long as severe asthma does not occur. A strategy of symptom driven use of therapy seems to view this as acceptable. Asthma patients really deserve more, and should expect to have a symptom-free life with full daily activities. Combination inhalers have the potential to deliver this to a significant number of patients. The results of the CONCEPT study indicate that getting patients to take such therapy on a regular twice daily basis is probably the most effective way of achieving this ambitious level of asthma control."
Patients receiving stable-dose salmeterol/fluticasone propionate also had a 47% reduction in the rate of exacerbations requiring either a course of oral steroids, an emergency room visit or a hospitalization, compared with patients receiving formoterol/budesonide AMD (adjusted annual rate of 0.18 compared to 0.33 exacerbations; p=0.008). The total numbers of exacerbations recorded were 50 on stable-dose salmeterol/fluticasone propionate and 96 on formoterol/budesonide AMD.
Over 95% of people with asthma lead a life that is compromised by their symptoms
2, with nearly half reporting that symptoms regularly wake them at night, or irritate or frustrate them during the day. A recent survey of asthma patients showed that only one in ten believed it possible to gain control of their asthma symptoms.
Darrell Baker, Senior Vice President, Respiratory Medicine Development Centre at GSK, said: "The results from this study confirm that to minimize symptoms and lower the risk of exacerbations, patients do better by taking regular stable doses of their controller treatment. The goal for asthma patients should be freedom from all symptoms and exacerbations. A doctor-led treatment strategy, seeking an optimal stable-dose strength of Seretide (50/100, 50/250 or 50/500 micrograms), treats both the symptoms and the underlying inflammatory component of asthma effectively."
He added: "The study also shows that short-term adjustment of dose by patients, based on their perception of symptoms, clearly is not the best way to control asthma."
Other secondary endpoints from the CONCEPT study also showed a statistically significant advantage for stable-dose salmeterol/fluticasone over AMD formoterol/budesonide (weeks1-52):
The median percentage of days when rescue medication was not used (rescue-free days) was significantly higher (91% versus 86%; p=0.008).
The median daily rescue medication usage was significantly lower (0.1 occasions per day versus 0.2 occasions per day; p=0.006).
The mean morning peak expiratory flow (PEF) was significantly higher (400 vs. 391 litres per minute, adjusted mean difference 9.5 litres per minute, p=0.006).
No differences between treatments were seen in daily symptom scores or in night -time awakening due to symptoms. The incidence of adverse events was similar in both the stable-dose salmeterol/fluticasone propionate and AMD formoterol/budesonide groups. The most common adverse event reported in both groups was nasopharyngitis. The percentage of patients receiving salmeterol/fluticasone propionate and AMD formoterol/budesonide who experienced any adverse event was 49% versus 52%, respectively; 429 events versus 537 events. Serious adverse events were reported in 3% of patients in each group. Drug-related adverse events were also reported in 6% of patients in both groups.
The earlier SUND study, using an average 3.4 puffs a day, had come out in favour of Symbicort.
GSK <GSK.L> generates around one fifth of its sales from respiratory drugs, led by Advair, which had sales of 2.5 billion pounds in 2004.
Both Symbicort and Advair combine bronchodilators for short-term asthma relief with cortosteroids to treat inflammation. AstraZeneca's medicine uses an adjustable dosing regimen, controlled by the patient, while Advair is given at fixed doses.
"The results from this study confirm that to minimise symptoms and lower the risk of exacerbations, patients do better by taking regular stable doses of their controller treatment," said Darrell Baker, senior vice president at GSK's Respiratory Medicine Development Centre.
"The study also shows that short-term adjustment of dose by patients, based on their perception of symptoms, clearly is not the best way to control asthma," he added.
