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Spiriva Increases Risk of Heart Problems

Posted by Chrissie Cole
Wednesday, September 24, 2008 4:10 PM EST
Category: Major Medical
Tags: FDA & Prescription Drugs, COPD, Pfizer, Boehringer, Spiriva, Atrovent, Heart Attack, Combivent, Stroke, Inhaled Anticholinergics

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IMAGE SOURCE: Wikimedia Commons /Healthy lung vs. COPD/ author: Mrug

Commonly prescribed drugs used for treatment of chronic obstructive pulmonary disease (COPD) increases the risk of deadly heart problems, a new study finds.

People with COPD suffer from crippling airflow obstruction; a COPD diagnosis, which is evolving and likely is underreported, historically has included labels such as emphysema, chronic bronchitis, and asthmatic bronchitis. COPD is the fourth-leading killer in the United States.

Many experts say that smoking and its residual effects cause about 90% of COPD deaths. However, the National Institute for Occupational Safety and Health reports that nearly 30% of COPD and adult asthma is caused by occupational exposure.

The use of two widely prescribed anticholinergics, Spiriva and Atrovent, for a month or more increased the risk of heart attack, stroke, or dying of cardiovascular problems by 58%, says Sonal Singh, MD, MPH, assistant professor of internal medicine at Wake Forest University School of Medicine in Winston-Salem, N.C.

Researchers pooled data of 17 clinical trials that included more than 14,000 patients and compared Spiriva and Atrovent, with other COPD treatments.

1.2 percent of control patients suffered a non-fatal heart attack or died from cardiovascular disease during the follow-up, which lasted from six weeks up to five years, 1.8 percent of those taking anticholinergics did – accounting for the 58 percent increase.

Boehringer and Pfizer, in response to the study, released a new analysis strongly disagreeing with the study findings that suggests an increased risk of cardiovascular problems associated with Spirivia use.

Another study recently published in the Annals of Internal Medicine found a 34% increased risk of death from a heart attack or irregular heartbeat in COPD patients taking ipratropium, a medication in the same class as Spiriva, compared with those taking albuterol, another widely used drug for COPD treatment or taking nothing.

The FDA, in March, notified health care providers that a pooled analysis comparing a placebo and Spiriva found a possible increased risk of stroke in patients taking the drug. At that time the FDA had not substantiated those findings.

The study is published in the Journal of the American Medical Association. #


4 Comments

Anonymous User
Posted by Allen West
Wednesday, September 24, 2008 6:41 PM EST

Thomson Financial News
Drugmaker says new study backs Spiriva safety
09.24.08, 12:04 PM ET


NEW YORK LONDON, Sept 24 (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, Boehringer said on Wednesday.

A pooled analysis from past studies published on Tuesday in the United States had concluded that Spiriva, or tiotropium, raised the risk of heart attack, stroke and death from heart disease.

But results from a four-year clinical trial known as Uplift, involving nearly 6,000 patients, showed no such increase.

'There was no evidence of an increased risk of death during the study,' Boehringer said in a statement.

'During treatment, fatal events occurred in 381 patients (12.8 percent) in the tiotropium-treated group and 411 (13.7 percent) in the placebo group -- a 16 percent risk reduction in the tiotropium group.'

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

(Reporting by Ben Hirschler) Keywords: PFIZER BOEHRINGER/SPIRIVA

Chuck Mikolajczak

cm


COPYRIGHT

Anonymous User
Posted by Boyce George
Sunday, September 28, 2008 9:29 AM EST

As a Spriva "patient" I will be in contact with my physician on Monday, 9-29.

Anonymous User
Posted by oluleke taiwo
Monday, September 29, 2008 12:23 PM EST

I am a GP (General Practitioner) in the UK. What should I tell my patients??

Anonymous User
Posted by Donna Corley
Saturday, October 11, 2008 12:17 AM EST

I used Spriva for about 3 or 4 years and stopped because of the powder build-up on my throat had caused me to have chronic sore throat. I had to have surgery to get it scraped off. In the meantime the gross swelling in my feet and legs went away. Now my doctor talkd me into trying it again, and after only 4 days, my feet and legs are again swollen, and my breathing and activity level have dramaticlly decreased. Until now, I had not even considered the relationship between spiriva and the swelling. I almost didn't make it from my car into the house tonight.

Comments for this article are closed.

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