Gastrointestinal tolerability of aspirin and the choice of over-the-counter analgesia for short-lasting acute pain

Steiner, TJ; Voelker, Michael

doi:10.1111/j.1365-2710.2008.00989.x

Cited by 24 publications

(17 citation statements)

References 23 publications

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“…[24] The former study was not a pooled analysis of individual patient data and was just focused on the efficacy of single-dose ASA for the relief of postoperative pain. Nevertheless, they found risks of AEs with ASA use (13%) and placebo (11%) similar to those reported here.…”

Section: Discussionmentioning

confidence: 99%

“…They also found a significantly higher incidence of drowsiness and what they describe as ‘gastric irritation,’ with ASA 600–650 mg than with placebo. The latter study[24] used pooled individual patient data from 1581 patients treated with ASA and 1271 patients treated with placebo in nine randomized, double-blind, placebo-controlled clinical trials, and these were included in our study. They were chosen because all patients used single doses of ASA 1000 mg for the treatment of acute migraine attacks, episodic tension-type headache, and dental pain.…”

Section: Discussionmentioning

confidence: 99%

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Short-Term Acetylsalicylic Acid (Aspirin) Use for Pain, Fever, or Colds —Gastrointestinal Adverse Effects

et al. 2011

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Background and Aim: Acetylsalicylic acid (ASA [aspirin]) is a commonly used over-the-counter drug for the treatment of pain, fever, or colds, but data on the safety of this use are very limited. The aim of this study was to provide data on the safety of this treatment pattern, which is of interest to clinicians, regulators, and the public.Methods: A meta-analysis of individual patient data from 67 studies sponsored by Bayer HealthCare was completed. The primary endpoints were patient-reported gastrointestinal (GI) adverse events (AEs); the secondary endpoints were the incidence of patient-reported non-GI AEs. Event incidence and odds ratios (ORs) based on Cochran-Mantel-Haenszel estimates are reported. In total, 6181 patients were treated with ASA, 3515 with placebo, 1145 with acetaminophen (paracetamol), and 754 with ibuprofen. Exposure to ASA was short term (82.5% of patients had a single dose).Results: GI AEs were more frequent with ASA (9.9%) than with placebo (9.0%) [OR 1.3; 95% CI 1.1, 1.5]. Dyspeptic symptoms were infrequent (4.6% in placebo subjects). The ORs for ASA were 1.3 (95% CI 1.1, 1.6) versus placebo; 1.55 (95% CI 0.7, 3.3) versus ibuprofen; and 1.04 (95% CI 0.8, 1.4) versus acetaminophen. There were very few serious GI AEs (one ASA case; three placebo cases). No differences were found for non-GI AEs and no cases of cerebral hemorrhage were reported.Conclusion: Short-term, mostly single-dose exposure to ASA for the treatment of pain, fever, or colds was associated with a small but significant increase in the risk of dyspepsia relative to placebo.No serious GI complications were reported.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Short-Term Acetylsalicylic Acid (Aspirin) Use for Pain, Fever, or Colds —Gastrointestinal Adverse Effects

et al. 2011

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“…Oral administration of heparin degrades it to inactive oligomer fragments whereas systemic administration is complicated by the need for continuous infusion and the potential for uncontrolled hemorrhage. Yet another is aspirin whose gastrointestinal delivery presents an added risk of gastrointestinal bleeding [17][18][19][20] Hence is the need to explore avenues of alternative delivery routes for such drugs. Other antihypertensive cardiovascular drugs studied iontophoretically include calcium channel blockers [21][22][23][24][25], adrenoreceptor blockers and metoprolol [26].…”

Section: Introductionmentioning

confidence: 99%

Iontophoretic study on Salicylic acid and Disprin loaded polymer hydrogels

Kanjilal

Dasgupta

Banthia

2011

Int J Plast Technol

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The study describes iontophoretic release of Salicylic acid and Potassium Salt of Acetyl Salicylic acid which is commonly known as the analgesic and thromboxane prostaglandins inhibitor, Disprin, from hydrogel patches based on Poly (vinyl alcohol), Poly (vinyl acetate-co-crotonic acid) & Poly (vinyl pyrrolidone). The experiment utilized a modified Franz cell for iontophoresis with a brine filled receptor chamber and employed Visible Colorimetry as the technique for estimation. It can be concluded that the composition of the hydrogel matrix has a direct bearing on the diffusion of the drugs. The hydrogel composition determines the extent of crosslinking, crystallinity, availability of hydrophilic groups, polymer-water interaction and hence the water take up. The ability of a drug delivery hydrogel system to control solute transport and release depends highly on the water content and water movement within the polymeric structure. The study was carried out keeping in view the eventual development of an alternative electrically controlled delivery mechanism of drugs without adverse gastrointestinal systemic ramifications.

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“…In this issue of JCPT, Steiner and Voelker (1) look at the gastrointestinal tolerability of short‐term aspirin use for acute pain and conclude that on safety grounds, there is no good reason to prefer paracetamol over aspirin. In other words, aspirin offers an acceptable adverse effects profile, and we should not be averse to use aspirin for acute pain, especially as there is ample evidence for its analgesic efficacy.…”

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confidence: 99%

Aspirin or paracetamol - what’s good for you?

Loke¹

2009

Journal of Clinical Pharmacy and Therapeutics

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Paracetamol is widely used as an over the counter analgesic because it is perceived to be safer than aspirin. In carefully selected trial populations, aspirin therapy carries a relatively low (but statistically significant) absolute risk increase in gastrointestinal adverse events. The risk from aspirin may potentially be higher in individuals who have risk factors for peptic ulcer or gastrointestinal haemorrhage. As such, paracetamol may well be the preferred choice in many instances.Keywords: acetylsalicylic acid, adverse drug reaction, analgesia, gastrointestinal, pain reliefIn this issue of JCPT, Steiner and Voelker (1) look at the gastrointestinal tolerability of short-term aspirin use for acute pain and conclude that on safety grounds, there is no good reason to prefer paracetamol over aspirin. In other words, aspirin offers an acceptable adverse effects profile, and we should not be averse to use aspirin for acute pain, especially as there is ample evidence for its analgesic efficacy. Of course, preparations of paracetamol and aspirin are widely available on the shelves of convenience stores, and for the patient with a headache, it would be nice to have some evidence to guide the choice of treatment. Does Steiner and Voelker's meta-analysis help us reach a definitive conclusion?Let's take a closer look at the data in this metaanalysis. There were nine randomized doubleblind trials of single-dose aspirin (1000 mg) vs. placebo in patients with headache or pain following dental extraction. The authors combined the results in an individual patient data meta-analysis to calculate pooled relative risks (RR) and numberneeded-to-harm (NNH). We need to pay particular attention to the exclusion criteria which meant that patients with intolerance to NSAIDs, or a history of peptic ulceration ⁄ gastric bleeding were excluded. Patients with any disorder of kidney, liver, lung or heart were also excluded, and by any measure, one would consider the trial participants to have had a very low baseline risk of gastrointestinal (GI) adverse events.Nevertheless, meta-analysis of the trials found a significantly increased risk of GI adverse events with aspirin compared to placebo, RR of 1AE7 [95% Confidence Intervals (CI) 1AE7-2AE4], and an NNH of 42 (95% CI 25-111). Steiner and Voelker then conducted an analysis on a subset under the heading of 'adverse drug reactions' (ADRs), defined as adverse events that were judged by the investigator to have some likelihood of a causal relationship with the treatment. This sub-analysis does not show a statistically significant increase in risk of GI ADRs, and the authors 'argue that ADRs are more meaningful, and more relevant to patients' choices.' However, in an adequately blinded, placebocontrolled randomized trial, the subjective act of classifying an event as an ADR merely adds a layer of bias. It simply isn't necessary to introduce the preconceptions and expectations of trial investigators here. Indeed, one wonders how many myocardial infarctions in the rofecoxib trials would have es...

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Gastrointestinal tolerability of aspirin and the choice of over-the-counter analgesia for short-lasting acute pain

Abstract: The GI ADR differences between aspirin and placebo are not great enough to support decision choices for short-lasting acute pain based on tolerability: these are better based on efficacy.

Cited by 24 publications

References 23 publications

Short-Term Acetylsalicylic Acid (Aspirin) Use for Pain, Fever, or Colds —Gastrointestinal Adverse Effects

Short-Term Acetylsalicylic Acid (Aspirin) Use for Pain, Fever, or Colds —Gastrointestinal Adverse Effects

Iontophoretic study on Salicylic acid and Disprin loaded polymer hydrogels

Aspirin or paracetamol - what’s good for you?

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