BackgroundLateral ankle sprains are common in indoor sports. High shoe–surface friction is considered a risk factor for non-contact lateral ankle sprains. Spraino is a novel low-friction patch that can be attached to the outside of sports shoes to minimise friction at the lateral edge, which could mitigate the risk of such injury. We aimed to determine preliminary effectiveness (incidence rate and severity) and safety (harms) of Spraino to prevent lateral ankle sprains among indoor sport athletes.MethodsIn this exploratory, parallel-group, two-arm pilot randomised controlled trial, 510 subelite indoor sport athletes with a previous lateral ankle sprain were randomly allocated (1:1) to Spraino or ‘do-as-usual’. Allocation was concealed and the trial was outcome assessor blinded. Match and training exposure, number of injuries and associated time loss were captured weekly via text messages. Information on harms, fear-of-injury and ankle pain was also documented.Results480 participants completed the trial. They reported a total of 151 lateral ankle sprains, of which 96 were categorised as non-contact, and 50 as severe. All outcomes favoured Spraino with incidence rate ratios of 0.87 (95% CI 0.62 to 1.23) for all lateral ankle sprains; 0.64 (95% CI 0.42 to 0.98) for non-contact lateral ankle sprains; and 0.47 (95% CI 0.25 to 0.88) for severe lateral ankle sprains. Time loss per injury was also lower in the Spraino group (1.8 vs 2.8 weeks, p=0.014). Six participants reported minor harms because of Spraino.ConclusionCompared with usual care, athletes allocated to Spraino had a lower risk of lateral ankle sprains and less time loss, with only few reported minor harms.Trial registration numberNCT03311490.
Low-dose acetylsalicylic acid (ASA) is widely used as antithrombotic prophylaxis. Enteric-coated ASA has been developed to decrease the risk of gastrointestinal side effects. The consequences of enteric coating on pharmacokinetics and antiplatelet effect of ASA have not systematically been assessed. This MiniReview demonstrates that data from clinical trials indicate that enteric coating can reduce the antiplatelet effect of ASA compared to plain ASA. This is possibly due to decreased bioavailability of ASA caused by prolonged solvation and absorption of the enteric-coated formulations. Therefore, low-dose entericcoated ASA might not be bioequivalent to plain ASA, entailing the risk of insufficient cardiovascular prophylaxis.Low-dose acetylsalicylic acid (ASA) is effective both as primary and secondary prophylaxis of thromboembolism [1]. ASA inhibits platelet aggregation by irreversible acetylation and inactivation of the enzyme cyclooxygenase (COX). This disables platelets and endothelia to convert arachidonic acid to prostaglandins and platelet-activating thromboxane (TX) [2].ASA is known to cause gastrointestinal side effects, primarily dyspepsia or peptic ulcer [3]. Enteric-coated formulations of ASA have been designed to resist disintegration in the stomach, releasing ASA in the proximal small intestine, anticipating that this could decrease the harmful effects of ASA on gastric mucosa. It has been shown that enteric-coated ASA causes significantly fewer asymptomatic minor gastrointestinal lesions compared to plain ASA as evaluated by endoscopy after short-term treatment [4]. Nevertheless, there is questionable evidence as to whether enteric coating of low-dose ASA truly reduces gastrointestinal side effects such as incident dyspepsia [4][5][6] or gastrointestinal bleeding of clinical relevance [7]. This supports that injury severe enough to induce bleeding is thought to reflect the systemic rather than the topical harmful effects of ASA [8].However, it is unknown whether enteric coating can have negative consequences for solubility, absorption and antiplatelet effect of ASA. Therefore, we carried out a review of the literature to evaluate the effect of enteric coating on pharmacokinetics and antiplatelet effect of ASA. Materials and MethodsThe databases PubMed and EMBASE were searched in October 2014 for relevant studies with the search terms enteric coating, enterocoating, acetylsalicylic acid, aspirin, bioavailability, absorption, effect, response, resistance, antiplatelet and pharmacokinetics. The search terms were used both singularly and combined. Only papers written in English or Scandinavian languages and based on adult patients (aged 18 years or above) were included. Concurrent hand searching of relevant journals and articles was undertaken for other possible references and to pursue references of references. Each unique abstract was scrutinized by the first author to determine relevancy. Any doubts regarding eligibility of a study were resolved through consensus among the authors. Data e...
The recommended dosage of tinzaparin in the treatment of thromboembolism during pregnancy is 175 IU/kg/day, as for non-pregnant subjects. In clinical practice, we have experienced a need for a higher dosage, especially in the initial phase of the treatment of deep vein thrombosis, based on four-hour post-dose measurements of anti-Xa activity. Twenty-two pregnant patients with a confirmed deep venous thrombosis were treated with tinzaparin either in a once- or twice-daily regimen. Four-hour post-dosage plasma anti-Xa activity was measured in 357 sequential blood samples during treatment. An higher dosage than recommended, was required to maintain anti-Xa activity in the target range. We suggest that the starting dosage should be 250 IU/kg/day in a twice-daily regimen, and that the dose in the initial phase be adjusted by daily monitoring of anti-Xa.
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