Low-dose Aspirin Therapy Research Articles

Accuracy of Second Trimester Prediction of Preterm Preeclampsia by 3 Different Screening Algorithms

(Aust N Z J Obstet Gynaecol. 2018;58:192–196) Preeclampsia (PE) is a major risk factor for maternal and perinatal morbidity and mortality. Thus, early screening in the first trimester to identify patients at high risk for PE allows the initiation of early preventive measures, such as low-dose aspirin therapy begun before 16 weeks gestation. Many women, though, do not have their first prenatal visit until after 16 weeks, and identifying high-risk patients in the second trimester can still be beneficial, especially for identifying early signs of PE and providing timely treatment. Currently, the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom has guidelines for identifying at risk women using maternal demographics and medical history. Likewise in the United States, the American College of Obstetricians and Gynecologists (ACOG) have recommendations for screening that uses demographics and medical history to define those women considered at high risk for PE. In contrast, the Fetal Medicine Foundation (FMF) has published an algorithm for identifying women at risk for early PE that includes measurement of mean arterial pressure and uterine artery Doppler pulsatility index in addition to medical history. This prospective nonintervention study aimed to compare the efficacy of these three screening methods used during the second trimester to predict the occurrence of PE.

Role of aspirin dose in reducing uterine artery resistance in 16-24 weeks pregnant women with abnormal uterine artery resistance

Objectives: To compare the decrease of resistance index (RI) from uterine artery in pregnant woman receiving low dose aspirin therapy between 80 mg/day and 125 mg/day who had abnormal doppler velocimetry (DV) ultrasound examination at 16-24 weeks.Materials and Methods: An experimental study using double blind randomized clinical trial design. Subjects were from Mulyorejo and Kalijudan public health service in Surabaya, that included pregnant women with 16-24 weeks of pregnancy with abnormal uterine artery velocimetry ultrasound. The results of ultrasound Doppler examination were divided into four levels; normal (RI<0.58; (-) diastolic notching), level I (RI> 0.58; (-) diastolic notching), level II (RI<0.58; (+) disatolic notching) and level III (RI> 0.58; (+) diastolic notching). Uterine doppler ultrasound examination was performed at Fetomaternal Division, Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Airlangga, Dr. Soetomo Hospital, Surabaya, Indonesia, by fetomaternal consultants before and after the admin-istration of low-dose aspirin of 125 mg/day and 80 mg/day for four weeks.Results: Ninety subjects were obtained and randomized into 2 groups, with 45 subject in each group. Before treatment, in 125 mg/day group those with level I were 34 subjects and level III 11 subjects. In 80 mg/day group, level I 41 subjects, level II 2 subjects and level III 2 subjects. After 4 weeks of treatment, a second DV USG was performed in Aspirin 125 mg/day group. Normal were 40 subjects, level I 4 subjects, and level III 1 subject. In aspirin group 80 mg/day, normal 22 subjects, level I 19 subjects and level III 4 subjects. The analysis was performed with Wilcoxon test before and after treatment in both aspirin treatment group 125 mg/day and 80 mg/day with p value respectively, p=0.001 and p=0.005.Conclusion: Compared with aspirin of 80 mg/day, aspirin of 125 mg/day is more superior to decrease uterine arterial resistance in pregnant women with ultrasound uterine arterial doppler velocimetry at 16-24 weeks gestational age.

Helicobacter pylori and low-dose aspirin ulcer risk: A meta-analysis.

Owing to wide-spread use, low-dose aspirin (LDA) produces a substantial amount of peptic ulcer disease. Current guidelines are ambivalent about the need for Helicobacter pylori eradication to protect against LDA ulcers. This study aimed to determine, through meta-analysis, if (and by how much) infection alters the baseline risk of peptic ulcers during LDA therapy. Literature screening was performed in MEDLINE and EMBASE from inception to May 2018. Original studies reporting prevalence or incidence of uncomplicated ulcers in LDA users were included. Ulcer endpoints needed to be specified separately, according to H.pylori infection status. Meta-analysis was performed in MIX 2.0 Pro. Ten cross-sectional studies and seven randomized controlled trials were included (n=5964). The pooled odds ratios with 95% confidence intervals (CI) for the risk of LDA ulcers in H.pylori-positive versus H.pylori-negative individuals were 1.68 (95%CI 1.40-2.02) and 1.65 (95%CI 1.29-2.08) under fixed-effects and random-effects models, respectively. Heterogeneity among studies was minimal (I2 =26.9%). After adjusting for the protective effects of antisecretory drugs, the odds ratios increased to 1.94 (95%CI 1.54-2.46). This analysis suggests that H.pylori increases the risk of LDA ulcers by almost 70% in a population where some were taking proton pump inhibitors and/or other acid suppressants. Without antisecretory drugs, the risk almost doubles. Clinically, these findings may support the use of a test-and-treat approach to H.pylori in LDA users, particularly those already at higher risk of developing peptic ulcers.

Budget Impact of Appropriate Low-Dose Aspirin Use for Primary and Secondary Cardiovascular Event Prevention in the Managed Care Setting.

Cardiovascular disease remains the leading cause of death in adults in the United States and constitutes a substantial portion of overall national health expenditures. Aspirin is generally recommended for primary cardiovascular event prevention based on a given patient's underlying cardiovascular event risk profile, particularly for those aged 50-69 years with a 10-year risk of coronary heart disease of ≥ 10%. Evidence-based clinical guidelines are in agreement for secondary prevention consisting of lifelong, low-dose aspirin therapy following a cardiovascular event. Despite these recommendations, research suggests suboptimal concordance between guidelines and clinical practice. To evaluate the budget impact of appropriate low-dose aspirin use for primary and secondary cardiovascular event prevention compared with current rates of low-dose aspirin use. An economic model measuring budget spend for cardiovascular events, aspirin, and aspirin-related adverse events was developed from the perspective of a U.S. payer. The model compared current rates of aspirin use to appropriate rates of aspirin use according to guideline recommendations for both primary and secondary cardiovascular event prevention. For a hypothetical plan with 1 million members, an estimated 18,026 patients were on aspirin therapy for primary cardiovascular event prevention, while guidelines recommend that 55,788 patients should have been on aspirin therapy for this indication. Optimal aspirin use in the primary cardiovascular event prevention population reduced the number of nonfatal myocardial infarctions (MIs; -367), ischemic strokes (-232), and deaths (-60), with an increase in the number of gastrointestinal bleeds (169) and hemorrhagic strokes (98). Evidence-based guideline-compliant use of aspirin for primary cardiovascular event prevention resulted in total cost savings of approximately $4.2 million over a 5-year time horizon. For secondary cardiovascular event prevention, an estimated 48,663 patients were on aspirin, while clinical guidelines recommend that 71,316 patients should have been on aspirin therapy for this indication. Optimal aspirin use in secondary cardiovascular event prevention reduced the number of nonfatal MIs (-515), ischemic strokes (-375), and deaths (-217), with an increase in the number of gastrointestinal bleeds (98) and hemorrhagic strokes (58). Evidence-based guideline-compliant use of aspirin for secondary cardiovascular event prevention resulted in total cost savings of approximately $11 million over a 5-year time horizon. Appropriate low-dose aspirin use for primary and secondary cardiovascular event prevention can result in improved patient outcomes with significant cost savings for U.S. payers. As a simple and inexpensive prophylactic measure for cardiovascular event prevention, aspirin use should be carefully considered in all appropriate at-risk adult patients. Development of this manuscript and the corresponding budget impact analysis was funded by Bayer. Coppolecchia, Williamson, and Cameron are employees of Bayer. Carlton, Lennert, and Moradi are employees of Xcenda, a consulting firm that received funding from Bayer to assist in the completion of this study. Khalaf-Gillard was an employee of Xcenda at the time of the study. The corresponding poster was presented at the Academy of Managed Care Pharmacy Nexus 2017; October 16-19, 2017; Dallas, TX.

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Progress of aspirin in endometrial neoplasms

Obesity and exogenous hormone exposure are the well-established endometrial cancer risk factors, which are associated with chronic inflammation. Some evidences have shown that inflammation is potentially related to the increased risk of endometrial neoplasms. Aspirin is one of the most studied non-steroidal anti-inflammatory drugs, which can benefit the endometrial cancer patients with obesity. Although aspirin-related bleeding has to be considered prior to therapy, in most cases, the benefits of low-dose aspirin therapy substantially will exceed the risk. Aspirin and other non-steroidal anti-inflammatory drugs are expected to become effective new methods for the treatment of the tumors. This paper reviews the progress of aspirin in endometrial neoplasms. Key words: Endometrial neoplasms; Aspirin; Non-steroidal anti-inflammatory drugs

Effect of Aspirin on Disability-free Survival in the Healthy Elderly

BackgroundInformation on the use of aspirin to increase healthy independent life span in older persons is limited. Whether 5 years of daily low-dose aspirin therapy would extend disability-free life in healthy seniors is unclear.MethodsFrom 2010 through 2014, we enrolled community-dwelling persons in Australia and the United States who were 70 years of age or older (or ≥65 years of age among blacks and Hispanics in the United States) and did not have cardiovascular disease, dementia, or physical disability. Participants were randomly assigned to receive 100 mg per day of enteric-coated aspirin or placebo orally. The primary end point was a composite of death, dementia, or persistent physical disability. Secondary end points reported in this article included the individual components of the primary end point and major hemorrhage.ResultsA total of 19,114 persons with a median age of 74 years were enrolled, of whom 9525 were randomly assigned to receive aspirin and 9589 to receive placebo. A total of 56.4% of the participants were women, 8.7% were nonwhite, and 11.0% reported previous regular aspirin use. The trial was terminated at a median of 4.7 years of follow-up after a determination was made that there would be no benefit with continued aspirin use with regard to the primary end point. The rate of the composite of death, dementia, or persistent physical disability was 21.5 events per 1000 person-years in the aspirin group and 21.2 per 1000 person-years in the placebo group (hazard ratio, 1.01; 95% confidence interval [CI], 0.92 to 1.11; P=0.79). The rate of adherence to the assigned intervention was 62.1% in the aspirin group and 64.1% in the placebo group in the final year of trial participation. Differences between the aspirin group and the placebo group were not substantial with regard to the secondary individual end points of death from any cause (12.7 events per 1000 person-years in the aspirin group and 11.1 events per 1000 person-years in the placebo group), dementia, or persistent physical disability. The rate of major hemorrhage was higher in the aspirin group than in the placebo group (3.8% vs. 2.8%; hazard ratio, 1.38; 95% CI, 1.18 to 1.62; P<0.001).ConclusionsAspirin use in healthy elderly persons did not prolong disability-free survival over a period of 5 years but led to a higher rate of major hemorrhage than placebo. (Funded by the National Institute on Aging and others; ASPREE ClinicalTrials.gov number, NCT01038583.)

Risk factors for linezolid-induced thrombocytopenia in patients without haemato-oncologic diseases.

This study aimed to describe the occurrence and to evaluate the predictive factors of thrombocytopenia caused by parenteral linezolid in hospitalised patients without haemato-oncologic diseases. Using electronic medical records, a retrospective safety evaluation was performed among all hospitalised adult patients who received parenteral linezolid therapy between January 2005 and June 2016. Of all identified 264 patients with an average age of 63.4 (SD 15.8) years, thrombocytopenia occurred at a rate of 29.2% after an average of 11.2 (SD 7.4) days of the initiation of linezolid therapy. Significant predictive factors for thrombocytopenia included the duration of linezolid therapy longer than or equal to 7days (adjusted odds ratios [ORs] 7.25, 19.51 and 28.80; 95% confidence intervals [CIs] 1.92-27.38, 4.76-79.95 and 6.48-127.92 for 7-13days, 14-20days and ≥21days, respectively; P<0.01 for all values), baseline platelet count <150×103 /mm3 (adjusted OR, 5.08; 95% CI, 2.06-12.55; P<0.001), creatinine clearance <30mL/min (adjusted OR, 4.19; 95% CI, 1.59-11.06; P=0.004) and concurrent low-dose aspirin therapy (adjusted OR, 2.99; 95% CI, 1.26-7.08; P=0.013). Baseline platelet count less than 150×103 /mm3 was an independent predictor of early-onset (≤6days) thrombocytopenia (adjusted OR, 5.07; 95% CI, 1.46-17.58; P=0.011). Closer monitoring of platelet count is required in patients who receive parenteral linezolid therapy for 7days or more, and have low baseline platelet counts or impaired renal function.

PCV3 - IMPROVING ASPIRIN TOXICITY THROUGH PRECISION MEDICINE

Low Dose Aspirin (LDA) is the cornerstone of secondary prevention in Coronary Artery Disease (CAD). Despite its established efficacy, it has a prime limitation arising from its gastric toxicity. The reason why some patients develop clinically significant toxicities while others develop no or minor toxicities is yet to be demystified. This study aims at identifying biomarkers for Low Dose Aspirin (LDA)-induced gastric toxicity and efficacy in CAD patients, which may enable personalization of LDA therapy. CAD patients attending the cardiac clinic of Hospital Pulau Pinang that satisfy the study inclusion criteria were recruited after informed consent. Blood samples of recruited patients were obtained at baseline(Pre) and after one month(Post) of initiating LDA therapy. For each patient, Complete blood count was ordered and the Pre- and Post-LDA serum were analyzed using Proton nuclear magnetic resonance (1H NMR) spectroscopy to identify the biomarkers that may distinguish between those with and without gastric toxicity. Thirty-eight percent (38%) of the 74 patients that meet up with the inclusion criteria had a history of gastric toxicity. Chi-square test indicated a significant difference between the means of those with and without gastric toxicity (P-value: 0.001). Multinomial logistic regression indicated Platelet count between 150-180x103/μL as a significant predictor of gastric toxicity to LDA (rs: 0.021, p-value: 0.004). Preliminary results of the 1H NMR pharmacometabolomic analysis show some metabolites that are potential biomarkers for LDA-induced gastric toxicity in CAD patients. This study clearly demonstrates the gastric toxicity of LDA. Multivariate statistical analysis and validation to ascertain these discriminating metabolites that may be linked to the gastric toxicity is ongoing.

A One-Dose-Fits-All Approach to Aspirin Therapy is Suboptimal

According to this study: The clinical effectiveness of low-dose aspirin therapy for the prevention of cardiovascular events depends on body size, diminishing as body size increases.A tailored dosing strategy is called for.

Study of Incidence of Gastric Cancer After H. pylori Eradication in Patients With Long-Term Administration of Low-Dose Aspirin

Introduction: We investigated incidence of gastric cancer after H.pylori eradication in patients with long-term administration of low-dose aspirin (LDA). Methods: The subjects were 101 consecutive outpatients attending the Cardiovascular Department and who had been on LDA therapy for at least 3 months from February 2007 to December 2008. Average age was 67.2 ± 8.3, male/ female ratio was 3.8:1. Firstly all patients were conducted esophagogastroduodenoscopy (EGD) and 13C- Urea breath test. H.pyloripositive patients were received eradication treatment. After eradication all patients were received periodic EGD. Results:H.pylori positive was 55cases and negative 46 cases. We detected 4 cases early gastric cancer, detection rate was very high (3.96%). All gastric cancer patients were H.pyloripositive and advanced endoscopic atrophy. We performed H.pylori eradication 41 cases. Afterword we detected 3 cases early gastric cancer, detection rate was also high (6.52%). Interestingly the periods from eradication of H.pylori to detection of gastric cancer was longer (average: 80 month) than that of previous reports in non-LDA users (within 60 month). Total taking LDA period was also very long (average: 184 month). Conclusion: LDA does not prevent from incidence of gastric cancer after H.pylorieradication. But it is possible that taking LDA delay the growth of gastric cancer after H.pylori eradication.

Does low-dose aspirin improve pregnancy rate in women undergoing frozen-thawed embryo transfer cycle? A pilot double-blind, randomized placebo-controlled trial.

To evaluate the effect of adjuvant low-dose aspirin therapy on clinical pregnancy rate and uterine perfusion in women undergoing frozen-thawed embryo transfer (FET) cycles. This study was performed as a pilot randomized, double-blind placebo-controlled trial, from May 2012 to February 2015. Overall, 60 available eligible women who were candidates for FET were randomly assigned to two groups receiving either 100 mg oral aspirin (n =30) or placebo (n =30). The primary outcome measure was clinical pregnancy rate. Secondary outcome measures were pulsatility index (PI), resistance index (RI), implantation rate, live birth rate and miscarriage rate. There was no significant difference in endometrial thickness, PI and RI. However, the study group had higher rates of clinical pregnancy, implantation, live birth (P = 0.042, P = 0.031 and P = 0.007, respectively) and lower rate of miscarriage (P = 0.020) as compared to the control group. Twin birth rate was comparable between the two groups. Our pilot study demonstrated that administration of low-dose aspirin in FET cycles results in better pregnancy, implantation and live birth rates without changing the uterine hemodynamics or endometrial thickness. However, further randomized clinical studies in larger populations are needed to confirm these findings.

Annals for Educators - 21 August 2018.

Annals for Educators - 21 August 2018.

P609A systematic review of adherence to preventative low-dose aspirin therapy and its effects on ischaemic vascular outcomes

P609A systematic review of adherence to preventative low-dose aspirin therapy and its effects on ischaemic vascular outcomes

Effect of systemic long-term, low-dose aspirin on periodontal status and soluble CD14 in gingival crevicular fluid: a case-control study.

In the present study, we evaluated the effect of systemic long-term, low-dose aspirin on the periodontal status and gingival crevicular fluid (GCF) concentrations of aspirin-triggered lipoxins (ATL) and soluble CD14 (sCD14). The study group consisted of 45 patients who were on long-term, low-dose aspirin therapy, and the control group included patients not on aspirin therapy. Mean bleeding index, plaque index (PI), probing depth (PD), and clinical attachment loss (CAL) were recorded. GCF samples were analyzed for concentrations of ATL, and sCD14 using enzyme-linked immunosorbent assay method. The means of PI, PD, and CAL were higher for the control group compared to the study group. The mean concentration of ATL was significantly higher for the study group (49.13±37.39ng/mL). The mean concentration of sCD14 was higher in the control group (5.75±3.91μg/mL). There was a negative correlation in the study group between concentrations of ATL with PD (r=-0.54) and CAL (r=-0.123). There was a positive correlation between sCD14 and CAL (r=0.047) in the study group. A negative correlation was also observed between concentrations of sCD14 and ATL (r=-0.134) in the study group. The results indicate better periodontal status among long-term aspirin users compared to non-aspirin users.

One quarter of total myocardial infarctions are silent manifestation in patients with type 2 diabetes mellitus

BackgroundSilent events with newly developed Q waves in electrocardiogram (ECG) [silent myocardial infarction (MI)] in diabetic patients is reported to be independently associated with an increased risk of fatal MI. However, the incidence rate of silent MI in diabetic patients has yet to be clarified. We sought to determine the incidence rate of first symptomatic MI and silent MI in diabetic patients. MethodsWe conducted a prospective cohort study on patients enrolled in the Japanese primary prevention of atherosclerosis with aspirin for diabetes (JPAD) trial which was started in 2002. It is a randomized controlled trial to examine the efficacy of low-dose aspirin therapy for the primary prevention of atherosclerotic events in type 2 diabetic patients. No patients had Q waves in their ECG before entry to the JPAD trial. We followed-up 1825 patients until July 2015 after completion of the JPAD trial in 2008. The median follow-up period was 10.3 years. We collected 1648 patients’ ECGs to identify patients with silent MI. ResultsSymptomatic MI occurred in 65 patients and silent MI occurred in 22 patients. The incidence rate of symptomatic MI was 4.26 per 1000 patient-years and 1.44 for silent MI in diabetic patients. Thus, 25% of total MIs were silent. Cause-specific Cox proportional hazard model indicated that age (hazard ratio 1.06, 95% confidence interval; 1.03–1.10, p=0.0004) and long history of diabetes (1.00, 1.01–1.07, p=0.01) were independently associated with symptomatic MI, but these were not associated with silent MI. ConclusionsWe demonstrated that incidence rate of first silent MI and that proportion of silent MI to all MIs was 25% in diabetic patients without a history of atherosclerotic events. Diabetic patients frequently need ECG screening for detection of silent MI.

A prospective study to examine the bleeding tendency of patients receiving regular low-dose aspirin therapy

The fear of uncontrolled bleeding often prompts medical practitioners to stopaspirin intake for seven to 10 days before any surgical procedure. This study wasinitiated to evaluate the effect of aspirin on bleeding in patients undergoing oralsurgery.The study group consisted of 39 patients who were subjected to undergo dentalextraction. All patients were receiving 100 milligrams of aspirin daily on a regularbasis. Patients were randomly divided into two groups: those who stopped the aspirintherapy before the procedure and those who continued the aspirin therapy. One hourbefore the procedures, all patients underwent a bleeding time test. In addition, theamount of bleeding during the procedure was measured.The mean (± standard deviation) bleeding time was 1.8 ± 0.47 minutes for patientswho stopped aspirin therapy one week before the procedure. For patients whocontinued aspirin therapy, the bleeding time was 3.1 ± 0.65 minutes. The differencewas statistically significant (P = .004). However, both groups were within the normalbleeding time range, and in both groups, a local hemostatic method was sufficient tocontrol bleeding. No episodes of uncontrolled intraoperative or postoperative bleedingwere noted.Stopping of low-dose aspirin therapy is not a must before oral surgery. Localhemostasis is sufficient to control bleeding.

Effect of early use of low-dose aspirin therapy on late-onset preeclampsia

Objective: Low-dose aspirin (LDA) therapy has been found to be effective in preventing the development of early-onset preeclampsia. However, its effect on late-onset preeclampsia has not been described. Our study was aimed at determining if LDA therapy prescribed from early in pregnancy modified the severity of late-onset preeclampsia. Materials and methods: A retrospective analysis of all women who were screened for early-onset preeclampsia at 11–13+6 weeks’ gestation between April 2012 and October 2014 at our institution, and who subsequently developed late-onset preeclampsia. The treatment group consisted of women who were prescribed LDA therapy from early in pregnancy as a result of the screening. The control group consisted of women who did not receive LDA therapy. Results: The aspirin group was associated with earlier delivery at 38.0 (37.5–38.5) weeks’ gestation versus 39.0 (38.7–39.4) weeks’ gestation for the nonaspirin group (p < .01). The aspirin group was also associated with lower absolute birth weight 2851 (2646–3055) versus 3215 (3068–3362) grams in the nonaspirin group (p < .01). However, when normalised for gestational age at delivery, the proportion of foetuses that were small for gestation age (< 10th centile) were not significantly different between the two groups [28% in aspirin group versus 23% in nonaspirin group; p = .62]. No other significant difference was noted. Conclusions: There was no difference in the clinical severity of late-onset preeclampsia between women screened as high risk for early-onset preeclampsia and subsequently prescribed LDA during their pregnancy, compared to women found to be at low risk and not prescribed LDA.

Aspirin or heparin or both in the treatment of recurrent spontaneous abortion in women with antiphospholipid antibody syndrome: a meta-analysis of randomized controlled trials

Objective: This study was designed to evaluate the efficacy of aspirin or heparin or both in the treatment for recurrent spontaneous abortion (RSA) in women with antiphospholipid antibody syndrome (APS).Methods: Systematic searches for randomized clinical trials (RCTs) evaluating on live birth and preterm delivery, preeclampsia, intrauterine growth restriction, gestational diabetes, bleeding of RSA with APS patients receiving aspirin, and heparin therapy were carried out, from PubMed, EMBASE, ScienceDirect, and CNKI. Related data were extracted from eligible studies and then subjected to Reviewer Manage 5.3 for analysis. Relative risk (RR) and its 95% confidence interval were calculated.Results: Nineteen publications with randomized controlled trials were selected for this study, which included a total of 1251 pregnant patients with diagnosis of RSA with APS. With respect to live birth, it was remarkably improved in aspirin plus heparin or heparin alone group [RR =1.23, 95% CI (1.12–1.36), p < .0001; RR = 1.18, 95% CI (1.03–1.35), p = .02]; aspirin alone group, however, there was no statistically significant difference compare to placebo [RR = 0.97, 95% CI (0.80–1.16), p = .71]. Meanwhile, aspirin plus heparin therapy did not significantly reduce the risk of recurrent placenta-mediated pregnancy complications including preterm birth, intrauterine growth retardation (IUGR), gestational diabetes, and minor bleeding. A beneficial therapeutic effect of heparin alone therapy was found on preventing preterm birth and low-dose aspirin plus heparin therapy was significant reduce the risk of preeclampsia.Conclusion: An improvement of pregnancy outcomes in women with RSA and APS can be achieved by treatment strategies combining low-dose aspirin plus heparin or heparin alone. Aspirin alone, by contrast, seemed inferior to other treatments in achieving more live birth.

Yosprala: A Fixed Dose Combination of Aspirin and Omeprazole.

Cardiovascular disease is the leading cause of morbidity and mortality in the United States. Patients who survive a primary cerebrovascular or cardiovascular event are at increased risk of a subsequent occurrence. Antiplatelet therapy plays an essential role for secondary prevention in individuals with stroke, transient ischemic attack, acute or chronic artery disease, or peripheral arterial disease. Maintaining high-risk patients on low-dose aspirin therapy is a fundamental component of management. However, poor adherence, secondary to the drug's gastrointestinal side effects, has been associated with negative cardiovascular outcomes. Numerous studies have indicated that proton-pump inhibitors significantly reduce the risk of upper gastrointestinal adverse events in aspirin-treated patients. The US Food and Drug Administration approved Yosprala (Aralez Pharmaceuticals), a fixed-dose combination of delayed-release aspirin and immediate-release omeprazole, on September 15, 2016. It is the first product to become available in the United States that combines these 2 pharmacologic drug classes, and represents a new therapeutic option for patients and healthcare providers who strive to improve adherence to daily aspirin therapy.