Data released early to show lung drug Spiriva safe

By Ben Hirschler

LONDON (Reuters) - Results of a clinical study to be presented next month show the blockbuster inhaled lung drug Spiriva, marketed by Pfizer and Boehringer Ingelheim, actually cuts heart risk, researchers said on Wednesday.

The finding contradicts the conclusion of a pooled analysis from past studies published on Tuesday which found Spiriva raised the risk of heart attack, stroke and death from heart disease.

The results from the new four-year clinical trial, known as Uplift and involving nearly 6,000 patients, showed no such increase.

"There was no evidence of an increased risk of death during the study," lead investigator Marc De Cramer of the University Hospitals Leuven, Belgium, said in a statement.

His comments were issued by Boehringer which, together with Pfizer, sponsored the Uplift study.

The decision to bring forward release of clinical trial marks a step-up in the fight to defend a drug which had sales of 1.8 billion euros ($2.6 billion) in 2007.

Germany's privately held Boehringer and Pfizer had already said they strongly disagreed with the conclusions of the pooled analysis published in the Journal of the American Medical Association (JAMA).

Full safety and efficacy data on the Uplift study will be presented at the annual meeting of the European Respiratory Society in Berlin on October 5.

The highlights issued in the statement showed that 381, or 12.8 percent, of patients died in the Spiriva-treated arm of the trial against 411, or 13.7 percent, in the placebo group -- a 16 percent risk reduction in favor of Spiriva.

There was also a similar risk reduction for serious cardiac adverse events.

Industry analysts had been looking to the Uplift data to clarify the safety profile of Spiriva, which is used to treat chronic bronchitis and emphysema -- serious disorders typically caused by smoking.

If the safety worries over Spiriva drag on, rival drugmakers could benefit and one potential gainer could be Glaxo's top-selling medicine Advair, according to analysts at Deutsche Bank.

The safety controversy over Spiriva, sparked by the JAMA article, has some similarities to last year's row over GlaxoSmithKline's diabetes pill Avandia, which was also linked to increased heart risk in a pooled analysis.