Respiratory mist inhaler linked to higher deaths: BMJ

A mist inhaler that delivers a widely-prescribed respiratory drug increases the risk of dying by half, according to a paper published on Tuesday by the British Medical Journal (BMJ).

Researchers in Britain and the United States looked at five trials involving Respimat, an inhaler that delivers in a low-dosage mist a medication which can be alternatively taken in powdered form.

The study's findings have been contested by the German maker and an outside commentator noted that, in absolute terms, the number of deaths was very low.

The drug, tiotropium bromide, which is commercialised as Spiriva, relaxes muscles in the airways. It is designed to ease symptoms of chronic obstructive respiratory disease (COPD), the world's fourth leading cause of death.

The study was an overview of five trials in which patients, chosen at random, used Respimat, breathing in either Spiriva or a placebo.

A total of 6,522 patients were enrolled, 3,686 of whom used the drug and 2,836 used the lookalike. Two trials lasted 12 weeks while the others were long term, lasting one year.

The risk of death among patients using Respimat with Spiriva was 52 percent higher than in a placebo group, according to the paper, basing this estimate on data from long-term use.

The risk, it suggests, could be cardiovascular.

Tiotropium belongs to a class of drugs called anticholinergics, which increase the risk of heart rhythm disturbance, especially in those with a history of cardiac problems.

"What we think is going on is that the mist inhaler is delivering a higher concentration of tiotropium than it should be and that may be increasing the risk of death," said Sonal Singh, an assistant professor of internal medicine at Johns Hopkins University School of Medicine and lead author of the study.

The study did not look at the powdered form of Spiriva, which is administered in a daily dose of 18 microgrammes through a device called a HandiHaler.

Respimat delivers Spiriva as a mist in either five or 10 microgramme doses. In the review, 847 participants, in four of the trials, received the 10 microgramme dose; their risk of death was twice that of the placebo group.

Previous studies have indicated that blood-level concentrations of Spiriva, at five or 10 microgrammes, can be between 35 percent and 300 percent higher when compared with the 18-microgramme dose from the HandiHaler, according to the BMJ review.

Asked by AFP to respond, the German pharmaceutical firm Boehringer Ingelheim said it disagreed with the study's conclusions.

Clinical tests, it said, showed mortality rates "were within the range of other COPD trials" and data about the product's risks and benefits were well established.

It also pointed at what it called the limitations of the analysis, noting that the authors themselves said their estimates could be "imprecise owing to the fairly low incidence rates."

This argument was also put forward in a BMJ editorial written by specialist Christopher Cates of St. George's University of London medical school.

In absolute terms, "death was a rare event" in the five trials, he noted. Statistically, for every 1,000 patients treated for a year, 18 would die in the placebo group and 26 in the Spiriva group.

More than 55 countries have licenced the Spiriva Respimat, although the device has yet to gain regulatory approval in the US.

A 17,000-patient study is underway in several countries comparing the HandiHaler and the Respimat.

Pending its outcome, "the indirect evidence" is that Handihaler is safer than the Respimat, and if patients have a strong preference for the mist inhaler, "the possible increased risk" should be explained to them, Cates said.

COPD, a term including chronic bronchitis and emphysema, kills more than three million people each year, many as a result of smoking.

ri/ach

 

Life and Style
ebookNow available in paperback
ebooks
ebookPart of The Independent’s new eBook series The Great Composers
  • Get to the point
Latest stories from i100
Have you tried new the Independent Digital Edition apps?

ES Rentals

    Independent Dating
    and  

    By clicking 'Search' you
    are agreeing to our
    Terms of Use.

    iJobs Job Widget
    iJobs General

    Recruitment Genius: Senior Digital Marketing Consultant

    £28000 - £45000 per annum: Recruitment Genius: A Senior Digital Marketing Cons...

    Recruitment Genius: Assistant Stores Keeper

    £16640 - £18500 per annum: Recruitment Genius: An Assistant Stores Keeper is r...

    Recruitment Genius: Claims Administrator

    £16000 - £18500 per annum: Recruitment Genius: This is an excellent opportunit...

    Recruitment Genius: Software Developer - C# / ASP.NET / SQL

    £17000 - £30000 per annum: Recruitment Genius: Developer required to join a bu...

    Day In a Page

    Fishing for votes with Nigel Farage: The Ukip leader shows how he can work an audience as he casts his line to the disaffected of Grimsby

    Fishing is on Nigel Farage's mind

    Ukip leader casts a line to the disaffected
    Who is bombing whom in the Middle East? It's amazing they don't all hit each other

    Who is bombing whom in the Middle East?

    Robert Fisk untangles the countries and factions
    China's influence on fashion: At the top of the game both creatively and commercially

    China's influence on fashion

    At the top of the game both creatively and commercially
    Lord O’Donnell: Former cabinet secretary on the election and life away from the levers of power

    The man known as GOD has a reputation for getting the job done

    Lord O'Donnell's three principles of rule
    Rainbow shades: It's all bright on the night

    Rainbow shades

    It's all bright on the night
    'It was first time I had ever tasted chocolate. I kept a piece, and when Amsterdam was liberated, I gave it to the first Allied soldier I saw'

    Bread from heaven

    Dutch survivors thank RAF for World War II drop that saved millions
    Britain will be 'run for the wealthy and powerful' if Tories retain power - Labour

    How 'the Axe' helped Labour

    UK will be 'run for the wealthy and powerful' if Tories retain power
    Rare and exclusive video shows the horrific price paid by activists for challenging the rule of jihadist extremists in Syria

    The price to be paid for challenging the rule of extremists

    A revolution now 'consuming its own children'
    Welcome to the world of Megagames

    Welcome to the world of Megagames

    300 players take part in Watch the Skies! board game in London
    'Nymphomaniac' actress reveals what it was really like to star in one of the most explicit films ever

    Charlotte Gainsbourg on 'Nymphomaniac'

    Starring in one of the most explicit films ever
    Robert Fisk in Abu Dhabi: The Emirates' out-of-sight migrant workers helping to build the dream projects of its rulers

    Robert Fisk in Abu Dhabi

    The Emirates' out-of-sight migrant workers helping to build the dream projects of its rulers
    Vince Cable interview: Charging fees for employment tribunals was 'a very bad move'

    Vince Cable exclusive interview

    Charging fees for employment tribunals was 'a very bad move'
    Iwan Rheon interview: Game of Thrones star returns to his Welsh roots to record debut album

    Iwan Rheon is returning to his Welsh roots

    Rheon is best known for his role as the Bastard of Bolton. It's gruelling playing a sadistic torturer, he tells Craig McLean, but it hasn't stopped him recording an album of Welsh psychedelia
    Morne Hardenberg interview: Cameraman for BBC's upcoming show Shark on filming the ocean's most dangerous predator

    It's time for my close-up

    Meet the man who films great whites for a living
    Increasing numbers of homeless people in America keep their mobile phones on the streets

    Homeless people keep mobile phones

    A homeless person with a smartphone is a common sight in the US. And that's creating a network where the 'hobo' community can share information - and fight stigma - like never before