Dataset Information

A short-term effect of low-dose aspirin on major hemorrhagic risks in primary prevention: a case-crossover design.

ABSTRACT:

Background

Very few studies have examined the risk of short-term adverse hemorrhage of low-dose aspirin use in primary prevention. This case-crossover study examined the transient effect of low-dose aspirin use on major hemorrhagic risks.

Methods

A representative database of 1,000,000 patients randomly sampled from the Taiwan's National Health Insurance Research Database in 2000 was analyzed. The study cohort consisted of a total of 501,946 individuals, aged 30-95 years old, at risk of a major bleeding event in 2000. A case-crossover study was used to retrieve data on 10,905 incident patients with major hemorrhagic complications (3,781 cerebral and 7,124 gastrointestinal) and prescribed low-dose aspirin (?300 mg/day) from 2000-2008. A 56-day time window (?2 months) was used as the case period for which the odds ratio (OR) was estimated using the ratio of patients exposed during the 56-day case period only (1-56 days before the index date) compared to its corresponding 56-day control period only (57-112 days before the index date).

Results

Four hundred eighty-nine (4.5%) of the 10,905 hemorrhagic patients had used low-dose aspirin during the 56-day case only period; 294 (2.7%) of the same patients had used low-dose aspirin during control only period. Low-dose aspirin use increase the risk of developing a major hemorrhage 1.33-fold (95% CI?=?1.13-1.55, P<0.0001). Significance was found prominent in 4,453 non-hypertensive and non-diabetic subjects (Adjusted odds ratio?=?1.88, 95% CI?=?1.21-2.91).

Conclusion

Transient low-dose aspirin use increases risk for major hemorrhagic events in Han Chinese.

SUBMITTER: Wu IC

PROVIDER: S-EPMC4039487 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

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Publications

A short-term effect of low-dose aspirin on major hemorrhagic risks in primary prevention: a case-crossover design.

Wu I-Chen IC Lin Ming-Yen MY Yu Fang-Jung FJ Hsieh Hui-Min HM Chiu Kuei-Fen KF Wu Ming-Tsang MT

PloS one 20140530 5

<h4>Background</h4>Very few studies have examined the risk of short-term adverse hemorrhage of low-dose aspirin use in primary prevention. This case-crossover study examined the transient effect of low-dose aspirin use on major hemorrhagic risks.<h4>Methods</h4>A representative database of 1,000,000 patients randomly sampled from the Taiwan's National Health Insurance Research Database in 2000 was analyzed. The study cohort consisted of a total of 501,946 individuals, aged 30-95 years old, at ri ...[more]

PMID: 24879431

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Project description:ObjectiveTo calculate the short-term risk-benefit effect of occasional and regular use of low-dose aspirin (?100?mg/day) in primary prevention.Study designTwo retrospective cohort studies.SettingTaiwan.Participants63?788 and 24?910 patients of two nationwide population-based studies were examined.MethodsTwo databases of 1?000?000 patients were randomly sampled from data of Taiwan's National Health Insurance (NHI) for years 1997-2000 (NHI 2000) and 2005 (NHI 2005). In NHI 2000, 63?788 patients 30-95?years of age were found not to have previously been prescribed aspirin before 1 January 2000, but to have first been prescribed low-dose aspirin after that date. They were also found to be at risk of first hospitalisation for any major vascular diseases including haemorrhage (major gastrointestinal haemorrhage or cerebral haemorrhage) and ischaemia (acute myocardial infarction or ischaemic stroke) after their first prescription. We also applied it to NHI 2005, and the number of eligible patients was 24?910. Patients prescribed low-dose aspirin for <20% of the days of a 60-day follow-up period were considered to be occasional users, and those prescribed low-dose aspirin for ?80% of the days were considered to be regular users. Differences in rate of haemorrhage and ischaemia between these users were used to calculate their net clinical risk.Primary outcomeVascular diseases.ResultsIn NHI 2000, the overall unadjusted rates of haemorrhage and ischaemia were 0.09% and 0.21%, respectively, for occasional users and 0.32% and 2.30%, respectively, for regular users. Adjusted net clinical risk of low-dose aspirin use between the two groups was 2.24% (95% CI 2.03% to 2.48%; p<0.001). Similar results were also found in NHI 2005.ConclusionsShort-term regular use of low-dose aspirin might not be better than occasional use for preventing major vascular diseases in primary prevention. Prescribing regular low-dose aspirin for primary prevention should be done with caution. Future studies should explore the risk-benefit effect of long-term low-dose aspirin use in primary prevention.

Project description:BackgroundGlucocorticoids (GCs), such as prednisone, are the standard of care for several inflammatory and immunologically mediated diseases, but their chronic systemic administration is severely limited by serious adverse effects that are both dose and time dependent. Short-term treatment (7-14 days) with oral prednisone is used for many acute inflammatory and allergic conditions. This study was conducted to characterize the safety and pharmacodynamic (PD) dose-response of a 7-day course of oral prednisone on biomarkers of GC receptor agonism.MethodsIn this randomized, single-blind, placebo-controlled, crossover study (A9001309), 37 healthy subjects received placebo or a prednisone dose from 2.5-60 mg daily over 7 days in each of three treatment periods. White blood cell counts and plasma samples for measuring cortisol, osteocalcin and procollagen type 1 N-propeptide (P1NP) were obtained at 2, 4, 8, and 12 h post-dose on Day 1, immediately prior to dosing on Days 1, 2, and 4, and at nominal dosing time on Days 0 and 8. Urine samples for urinary N-terminal cross-linked telopeptide of type 1 collagen (uNTX) were collected on Days 0, 1, 2, 4, and 8. Serum samples for adiponectin were obtained prior to dosing on days 0, 1, 4 and 8.ResultsDaily doses of prednisone up to 60 mg resulted in dose- and time-dependent decreases in plasma osteocalcin, plasma P1NP, serum cortisol, and absolute blood eosinophil counts. Absolute blood neutrophil counts increased, while blood lymphocyte counts rebounded to an increased level following an initial rapid decrease after dosing. An increase was observed for uNTX and adiponectin. The incidence of adverse effects with prednisone was not dose related, and nervous system disorders, mainly headache, were the most frequently reported adverse effects.ConclusionsThis characterization provides important and relevant information on safety and PD responses of short-term prednisone dosing over the commonly-used clinical dose range, and also provides a reference for early clinical development of dissociated agents targeting a differentiated PD profile.Trial registration numberNCT02767089 (retrospectively registered: 21 April 2016).

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Project description:BACKGROUND:Knowledge of the effect of marine protein hydrolysate (MPH) supplementation to promote recovery after high intensity performance training is scarce. The aim of this study was to examine the effect of MPH supplementation to whey protein (WP) and carbohydrate (CHO): (CHO-WP-MPH), on short-term recovery following high intensity performance, compared to an isoenergetic and isonitrogenous supplement of WP and CHO: (CHO-WP), in male cyclists. METHODS:This was a double-blinded crossover study divided into three phases. Fourteen healthy men participated. In phase I, an incremental bicycle exercise test was performed for establishment of intensities used in phase II and III. In phase II (9-16?days after phase 1), the participants performed first one high intensity performance cycling session, followed by nutrition supplementation (CHO-WP-MPH or CHO-WP) and 4 hours of recovery, before a subsequent high intensity performance cycling session. Phase III (1 week after phase II), was similar to phase II except for the nutrition supplementation, where the participants received the opposite supplementation compared to phase II. Primary outcome was difference in time to exhaustion between the cycling sessions, after nutrition supplementations containing MPH or without MPH. Secondary outcomes were differences in heart rate (HR), respiratory exchange ratio (RER), blood lactate concentration and glucose. RESULTS:The mean age of the participants was 45.6?years (range 40-58). The maximal oxygen uptake (mean?±?SD) measured at baseline was 54.7?±?4.1?ml?min-?1?kg-?1. There were no significant differences between the two nutrition supplementations measured by time to exhaustion at the cycling sessions (meandiff?=?0.85?min, p?=?0.156, 95% confidence interval (CI), -?0.37, 2.06), HR (meandiff?=?0.8 beats pr.min, p?=?0.331, 95% CI, -?0.9, 2.5), RER (meandiff?=?-?0.05, p?=?0.361, 95% CI -0.07 - 0.17), blood lactate concentration (meandiff?=?-?0.24, p?=?0.511, 95% CI, -?1.00, 0.53) and glucose (meandiff?=?0.23, p?=?0.094, 95% CI, -?0.05, 0.51). CONCLUSIONS:A protein supplement with MPH showed no effects on short-term recovery in middle-aged healthy male cyclists compared to a protein supplement without MPH. TRIAL REGISTRATION:The study was registered 02.05.2017 at ClinicalTrials.gov (Protein Supplements to Cyclists, NCT03136133 , https://clinicaltrials.gov/ct2/show/NCT03136133?cond=marine+peptides&rank=1 .

Dataset Information

A short-term effect of low-dose aspirin on major hemorrhagic risks in primary prevention: a case-crossover design.

Background

Methods

Results

Conclusion

Publications

A short-term effect of low-dose aspirin on major hemorrhagic risks in primary prevention: a case-crossover design.

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