New Research Shows Few Side Effects Related to Short-Term Aspirin Use

MORRISTOWN, N.J., Sept. 1, 2011 /PRNewswire/ -- A new meta-analysis published this week in Drugs in R&D(1), reaffirms the safety profile of aspirin for short-term treatment of mild to moderate pain, and aches and fever due to colds when used as directed.  The analysis of 67 clinical trials of aspirin for pain relief/fever reduction – the largest conducted to date – encompassed more than 20 years of research and involved mostly single-dose treatment of acute pain.  Patient-reported data showed very few serious gastrointestinal (GI) side effects or other complications associated with aspirin when used in apparently healthy, non-elderly populations without known risk of GI complications.  Findings showed there was only one additional GI adverse event for every 111 patients treated with aspirin compared to placebo (9.9 vs. 9.0 percent, p<0.01).  Findings are consistent with those reported in previous published analyses.  In addition, no significant differences in GI adverse events were seen with aspirin compared to ibuprofen, or with aspirin compared to acetaminophen.

"Aspirin has been life-tested by generations, yet misperceptions regarding its safety when used short-term may be overestimated today.  The results of this new analysis in apparently healthy non-elderly people are reassuring for both healthcare providers and the millions of people who take aspirin, for the most part single-dose, for short-term relief of pain, fever and pain symptoms associated with colds," said Dr. Angel Lanas, University of Zaragoza, and lead author.  "In our extensive meta-analysis, there was a low incidence of patient-reported adverse events, including major GI complications, and a virtual absence of non-GI complications associated with doses and duration of aspirin commonly used for relieving pain, fever or the pain symptoms of colds."

Results of the individual patient-level meta-analysis showed that the overall risk of GI-related adverse events from aspirin, as reported by study participants, was low, with a small, but statistically increased risk of dyspepsia, or upset stomach, when compared to placebo.  Serious GI adverse events were very few (one with aspirin vs. three with placebo), and no differences were found for non-GI adverse events.  Additionally, no cases of cerebral hemorrhage were reported.  

"This extensive analysis reaffirmed the safety profile of single-dose aspirin when used to relieve short-term conditions, such as pain, fever and the pain symptoms of colds," said Wes E. Cetnarowski, M.D., Senior Vice President, Bayer Global Research and Development, Bayer HealthCare.  "With this new information, consumers and healthcare providers can be even more confident that the aspirin they trust is a safe, as well as effective and low-cost way to obtain relief."

About the Study

The individual patient-level meta-analysis, titled "Short-Term Aspirin Use for Pain and Cold: Gastrointestinal Adverse Events," included information from 67 clinical trials involving more than 13,000 patients, with a mean age of 32.9 years, of whom 6,181 were treated with aspirin and aspirin combinations, 3,515 with placebo and 3,526 with an active comparator, such as acetaminophen and ibuprofen.* Of those using aspirin:

• 82.5 percent received a single dose (commonly between 500 to 1,000 milligrams)
• 17.5 percent received multiple doses
• 3 percent being treated for more than five days

There was one additional GI adverse event reported for every 111 patients treated with aspirin compared to placebo (9.9 vs. 9.0 percent, p<0.01).  No significant differences in GI adverse events were reported in patients treated with aspirin compared to those treated with ibuprofen, or with aspirin compared to acetaminophen.  Only for the MedDRA (Medical Dictionary for Regulatory Activities) term dyspepsia was a slight increase observed when compared to acetaminophen.  

It is important to note that this analysis included studies of aspirin monotherapy versus placebo, as well as aspirin plus additional therapy versus placebo plus additional therapy (additional therapy was an additional active ingredient, e.g., pseudoephedrine, lidocaine or dextromethorphan).  The data presented in this analysis have several limitations, as the authors note.  These include variations in aspirin use across the studies included in the analysis.  Also, as with any clinical study that has clearly defined inclusion/exclusion criteria, the safety data reported here may not be valid for all patient populations (e.g., the elderly or those with an ulcer history).  Larger studies may be needed to confirm the findings of this analysis.

The meta-analysis was funded by Bayer HealthCare and included individual data obtained from studies conducted by Bayer HealthCare through March 31, 2008.  The academic authors had full access to all of the data in the study, interpreted the results and had full control of the final manuscript.  Bayer authors also contributed to both interpretation of data and preparation of the manuscript.

* Studies involving other comparators (n=1627) were not reported.  These studies did not have sufficient numbers of cases to carry out appropriate analyses.

About Aspirin for Pain Relief

For more than 100 years, the world has relied on aspirin for fast and potent relief of pain.  With more than a century of clinical experience, aspirin continues to be recognized today as a proven, trusted and cost-effective pain reliever and is very rarely associated with serious adverse events when taken short-term (i.e., single doses) as labeled for pain relief.  Aspirin is one of the most extensively studied drugs in history.  Numerous single-dose studies examining different indications (migraine, tension-type headache, dental pain, etc.) have shown that aspirin is well tolerated at OTC doses.

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 16.913 billion (2010), is one of the world's leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare's aim is to discover and manufacture products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2010) and is represented in more than 100 countries. Find more information at www.bayerhealthcare.com.

About Bayer Consumer Care

The Consumer Care division of Bayer HealthCare, is headquartered in Morristown, N.J. Bayer's Consumer Care division is among the largest marketers of over-the-counter medications and nutritional supplements in the world. Some of the most trusted and recognizable brands in the world today come from the Bayer portfolio of products. These include Bayer® Aspirin, ALEVE®, Alka-Seltzer Plus®, Bactine®, RID®, Phillips'® Milk of Magnesia, Midol®, Alka-Seltzer®, One A Day® vitamins, and Flintstones™ vitamins in the United States, and, globally, Flanax®/Apronax®, Talcid®, Rennie®, Canesten®, Bepanthen®, Bepanthol®, Supradyn®, Redoxon®, Berocca®, Cal-D-Vita/Elevit®, Vital 50 Plus®, and CardioAspirin®.

Forward-looking statements

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

(1) Lanas, et al. Short-Term Aspirin Use for Pain and Cold: Gastrointestinal Adverse Effects. Drugs in R&D. 2011. doi:10.2165/11593880-000000000-00000

SOURCE Bayer HealthCare