The Pharmaceutical Journal
Vol 270 No 7238 p295
1 March 2003

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DTB calls for more research on tiotropium in COPD

The Drug & Therapeutics Bulletin has called for more research on tiotropium (Spiriva) to assess its place next to cheaper and older antimuscarinic agents in chronic obstructive pulmonary disease (COPD).

Tiotropium was launched in September 2002 as the first once daily anticholinergic bronchodilator for use in COPD.

In a review of the efficacy and safety of tiotropium published last week, the bulletin outlines trials of the agent versus placebo, ipratropium and salmeterol in the maintenance treatment of COPD (2003;41:15).

It concludes that tiotropium appears to be more effective than the four times daily anticholinergic ipratropium in reducing exacerbations. But the bulletin adds that it is unclear from trials whether tiotropium is more effective than ipratropium in improving bronchodilation as measured by trough FEV1.

The DTB highlights a lack of trials comparing tiotropium with the twice daily antimuscarinic agent oxitropium. And it asks whether the new inhaler for tiotropium, the HandiHaler, is suitable for patients with poor dexterity or cognitive problems.

In addition, the review calls for confirmation of data suggesting that tiotropium may be more effective than the long-acting beta2-agonist salmeterol.

"At £37 for 30 days treatment, tiotropium bromide is more costly for the NHS than alternatives such as ipratropium, oxitropium and salmeterol," the DTB says in an accompanying press release. Its 30-day cost compares to about £2–£7 for ipratropium, £4–£6 for oxitropium, and £29 for salmeterol.

Professor Joe Collier, editor of the DTB, adds: "Tiotropium's once daily dosage could represent an advantage. However, its place with respect to the cheaper, twice daily oxitropium bromide is not clear. To determine tiotropium's place in practice, trials using clinically relevant endpoints are needed to compare it with ipratropium and with oxitropium."

Boehringer Ingelheim and Pfizer, co-developers of Spiriva, say that the DTB, despite containing many positive conclusions about tiotropium, has made significant omissions that have generated misunderstandings about the drug.

They point out that oxitropium is not widely used either in the UK or globally and hence was not included in the study programme. They explain that trough FEV1 was agreed with licensing authorities to be the most appropriate parameter in comparisons of tiotropium with other bronchodilators as a measure of persistent bronchodilation over 24 hours.

Commenting on price, Boehringer Ingelheim and Pfizer say that reductions in exacerbations and admissions to hospital with tiotropium could reduce overall therapy costs to the local NHS economy. This would more than offset the drug acquisition cost of tiotropium and would help release capacity within the system.

The companies emphasise that many improvements in breathlessness and health related quality of life were not included in the review.