Aspirin™ - Surprisingly Versatile
With its more than 120 years of age, Aspirin™ can look back at a rich, long-standing history and exciting future. Thanks to its active ingredient acetylsalicylic acid, Aspirin™ is surprisingly versatile: not only does it stop pain, it is also effective in preventing cardiovascular events in appropriate at-risk patients.
Aspirin™ has been an important medicine for more than 120 years because of its remarkable pain relief, as well as cardiovascular (CV) event prevention, properties. It has withstood the test of time, and is an excellent case study in both science and branding. As a brand, Aspirin™ has been trusted over time by more consumers worldwide longer than any other over –the-counter (OTC) pain reliever.
As has been the case since the introduction of Aspirin™, acetylsalicylic acid (ASA), its active ingredient, continues to be used as the benchmark in pain relief and CV event prevention. At over-the-counter (OTC) doses, Aspirin™ offers the same pain-relieving properties as many molecules discovered decades later. It has been the most utilized pain reliever in history. As such, its efficacy and safety profile is well documented, which has certainly contributed to its remarkable longevity. Its anti-platelet and blood thinning properties separate it from all other category ingredients, and it is the only one to offer both pain relief and remarkable CV benefits. In fact, Aspirin™ is included in the World Health Organization’s list of essential medications based on its pain relief and anti-platelet effects.1
For more than 120 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 well tolerated at OTC doses. Recent meta-analyses2,3 included individual patient data or study-level population data from 145 clinical trials representing more than 32,000 patients and 20 years of research on such use.
Collectively, results reaffirmed the overall GI safety profile of Aspirin™ in short-term treatment of mild to moderate pain, aches and fever due to cold or flu when used as directed, demonstrating a low incidence of minor GI side effects and no drug-related serious adverse events.
For CV event prevention, low-dose (81 mg–325 mg) Aspirin™ Cardio products are recognized for use – as directed by a physician – during suspected heart attack to help reduce damage to the heart, and as cornerstone therapy for reducing risk of recurrent CV events, specifically, heart attack and ischemic stroke. Furthermore, the drug is approved in more than 50 countries for the prevention of a first heart attack or stroke (primary prevention) in appropriate patients. In terms of safety, when used as directed for its approved cardiovascular indications, Aspirin™ is well-tolerated and effective, and, for the vast majority of patients, is infrequently associated with clinically relevant side effects. For prevention of CV events, more than 200,000 patients have been studied in more than 200 randomized clinical trials evaluating the safety and efficacy of Aspirin™. Serious bleeding rarely occurs.
GI bleeding has been shown to occur in less than 1% (41 of 6,300 patients) of those taking Aspirin™ to prevent a recurrent CVD event, such as a heart attack.4 A landmark meta-analysis showed that for patients taking low-dose Aspirin™ to prevent a first CV event, there was a positive benefit/risk ratio for Aspirin™ greater than 2:1.5 As with all drugs, the potentially life-saving benefits of longer-term, low-dose Aspirin™ therapy to prevent CV events such as heart attack and ischemic stroke must be weighed against its risks. Patients should work with their doctors to best determine if they are appropriate candidates for Aspirin™ therapy.
Bayer supports the use of Aspirin™ for primary prevention of CV events in patients at appropriate risk only where there are approved indications. The cornerstone role of low-dose acetylsalicylic acid in CV event reduction is based upon clinical studies and extensive, real-world experience; most importantly, it continues to be supported and reinforced by the global scientific community through multiple international and national medical guidelines recommending its use in appropriate at-risk patients for prevention of CV events in both the primary and secondary settings. Aspirin™ is universally available and offers excellent value for its cost.
The proven role of Aspirin™ in OTC pain management and low-dose Aspirin™ Cardio for cardiovascular disease prevention continues to make it a truly globally versatile, trusted brand, now more than ever. The ever-increasing global focus on cost-effective treatments further underlines the relevance of Aspirin™ across the globe, both in developed as well as emerging or under-served markets.
The Road to Success
The following events are only some important milestones in the history of Aspirin™.
In a Bayer laboratory in Wuppertal, Germany, young scientist Dr. Felix Hoffmann is the first to succeed in synthesizing a chemically pure and stable form of acetylsalicylic acid (ASA), which becomes the active ingredient in Aspirin™.
Aspirin™ is registered as a trademark. It is launched on the market in powder form. Bayer delivers the medicine to pharmacies in small 250-gram glass vials. 500 mg of the powder is then weighed out and dispensed to customers in small paper bags. Just one year later, Bayer launches the analgesic in its classic tablet form – one of the first medicines to be marketed in this dosage form.
Aspirin™ becomes available without a prescription and becomes a best-seller in the USA.
Aspirin™ turns 50, and the following year, is for the first time featured in the Guinness Book of Records as the most frequently sold pain reliever in the world.
A box of Aspirin™ flies to the moon aboard Apollo 11.
A study reports that Aspirin™ can prevent ischemic stroke in appropriate patients.6
In the same year, the World Health Organization (WHO) introduces its “Essential Drug List”. Aspirin™ is included right from the start as an essential analgesic.
British pharmacologist Professor John Vane receives the Noble Prize for Medicine for his discovery that the anti-inflammatory properties of Aspirin™ result from its ability to inhibit the body’s production of certain chemical mediators (prostaglandins) that promote inflammation.
Publication of the Veterans Administration Cooperative Study (VACS) trial, one of the five key trials demonstrating that Aspirin™ reduces the risk of events in patients with angina.7
Bayer introduces, in Germany and other various countries, Aspirin™ Protect, a low-dose Aspirin™ formulation for use by appropriate at-risk patients in the prevention of cardiovascular events.
Acetylsalicylic acid, the active ingredient in Aspirin™, celebrates its centenary.
Results of the International Stroke Trial, with nearly 20,000 patients in 36 countries, are published. They support use of Aspirin™ within 48 hours after ischemic stroke.8
On March 6, exactly 100 years after Aspirin™ was entered into the trademark register of the Imperial Patent Office in Berlin, Bayer set a Guinness world record by transforming its 122 meter tall headquarters building in Leverkusen into the largest Aspirin™ box. The building is wrapped with more than 22,500 square meters of fabric to celebrate the 100th birthday of Aspirin™.
Aspirin™ takes its place among such medical advances as the stethoscope and artificial heart when it is inducted into the Smithsonian Institution’s National Museum of American History, USA.
British researcher Professor Derek W. Gilroy elucidates the anti-inflammatory properties of Aspirin™,9
adding to previous research on its mechanism of action by Sir John Vane and others.
Publication in the journal Headache by Lampl et al, which reaffirms the effectiveness of Aspirin™ as a first-line treatment of migraine or episodic tension type headache and finds that pre-treatment headache intensity does not predict potential success or failure of Aspirin™.10
Beginning with the launch in Germany (the birthplace of Aspirin™) New Aspirin™ is being introduced to consumers in countries throughout Europe and Latin America. The active ingredient of New Aspirin™, acetylsalicylic acid, is used in the form of microparticles that are on average 10 percent of the size of particles found in previous Aspirin™ tablets. Microparticles are combined with sodium carbonate, which acts as a disintegrant and local buffer, helping New Aspirin™ dissolve more quickly, enter the bloodstream faster, and relieve pain twice as fast as previous Aspirin™ tablets11,12.
Who List of Essential Medications: 17th List, March, 2011. http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf (accessed March 22, 2013).
Lanas, et al. Short-term Aspirin™ use for pain and cold: gastrointestinal adverse effects. Drugs in R&D. 2011;11: 277–288.
Baron JA, Senn S, Voelker M et al. gastrointestinal adverse effects of short term Aspirin™ use: a meta-analysis of published randomized controlled trials. Drugs in R&D 2013;13(1):9–16.
Weisman S, Graham D. Evaluation of the benefits and risks of low-dose Aspirin™ in the secondary prevention of cardiovascular and cerebrovascular events. Arch Intern Med 2002;162(19):2197–2202.
Antithrombotic Trialists’ (ATT) Collaboration. Aspirin™ in the primary and secondary prevention of vascular disease: collaborative metaanalysis of individual participant data from randomized clinical trials. Lancet 2009; 373:1849–1860.
Genton E, Barnett HJ, Fields WS et al. XIV. Cerebral ischemia: the role of thrombosis and of antithrombotic therapy. Study group on antithrombotic therapy. Stroke 1977;8(1):150–175.
Lewis HD Jr, Davis JW, Archibald DG et al. Protective effects of Aspirin™ against acute myocardial infarction and death in men with unstable angina. Results of a Veterans Administration Cooperative Study. N Engl J Med 1983;309(7):396–403.
International Stroke Trial Collaborative Group. The International Stroke Trial (IST): a randomized trial of Aspirin™, subcutaneous heparin, both, or neither among 19435 patients with acute ischaemic stroke. Lancet 1997;349(9065):1569–1581.
Paul-Clark MJ, Van Cao T, Moradi-Bidhendi N et al. 15-epi-lipoxin A4-mediated induction of nitric oxide explains how Aspirin™ inhibits acute inflammation. J Exp Med 2004;200(1):69–78.
Lampl C, Voelker M, Steiner TJ. Aspirin™ is First-Line Treatment for Migraine and Episodic Tension-Type Headache Regardless of Headache Intensity. Headache 2012;52(1):48–56.
Voelker M.,Hammer M., Inflammopharmacology 2012;20:225-231
Cooper SA., Voelker M., Inflammopharmacology 2012;20:225-242