title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Statistical analysis | REGRESSION | Statistical analyses were performed using R software (version 4.0.3)A multivariable logistic regression model was used to estimate the OR and the 95 per cent c.i. associated with the use of patches and CR-POPF. POPF survival rates were plotted for treatment groups using Kaplan–Meier analysis and were compared using a l... | PMC10077024 | |
Results | fistula | SECONDARY, LEAKAGE | Among the total 72 patients who were randomized (36 in each group), five subjects in the patch group and three in the control group underwent a total pancreatectomy and were excluded from the analyses. The final analyses included 64 patients (31 in the patch group and 33 in the control group) (CONSORT diagramBaseline c... | PMC10077024 |
Discussion | PD, POPF | ADVERSE EVENTS, SECONDARY, COMPLICATIONS, POSTOPERATIVE COMPLICATIONS | The results of this study suggested that in patients who underwent PD with a PJ, the use of the PEG-coated collagen patch reduces the incidence of CR-POPF. Moreover, the capacity of the PEG-coated patch to prevent the onset of POPF was dependent on the FRS: the higher the FRS, the higher the protection. The incidences ... | PMC10077024 |
Supplementary Material | Click here for additional data file. | PMC10077024 | ||
Acknowledgements | This study was done by an independent, interdisciplinary academic non-profit research organization in Spain. We received an Investigator Initiated Research Grant from Baxter Healthcare SA, Switzerland, to augment study funding. Medical writing and editorial assistant services were provided by Antonio Martinez (MD) of C... | PMC10077024 | ||
Funding | This study received an Investigator Initiated Research Grant from Baxter Healthcare Corporation SA, Switzerland. | PMC10077024 | ||
Author contributions | Mario Serradilla-Martín (Conceptualization, Formal analysis, Funding acquisition, Investigation, Methodology, Supervision, Writing—original draft, Writing—review & editing), Sandra Paterna-López (Data curation, Investigation, Writing—review & editing), Ana Palomares-Cano (Data curation, Writing—review & editing), Migue... | PMC10077024 | ||
Disclosure | Mario Serradilla-Martín receives fees from Baxter International Inc. (Deerfield, IL, USA) as a consultant. Mario Serradilla-Martín declares no other conflict of interest. The rest of the authors declare no conflict of interest. | PMC10077024 | ||
Supplementary material | PMC10077024 | |||
Data availability | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10077024 | ||
References | PMC10077024 | |||
Background | T2D, type 2 diabetes, cardiovascular disease | TYPE 2 DIABETES, CARDIOVASCULAR DISEASE | In clinical practice, anthropometric measures other than BMI are rarely assessed yet may be more predictive of cardiovascular (CV) risk. We analyzed the placebo group of the REWIND CV Outcomes Trial to compare several anthropometric measures as baseline risk factors for cardiovascular disease (CVD)-related outcomes in ... | PMC9999507 |
Methods | T2D | EVENT | Data from the REWIND trial placebo group (N = 4952) were analyzed. All participants had T2D, age ≥ 50 years, had either a previous CV event or CV risk factors, and a BMI of ≥ 23 kg/m | PMC9999507 |
Results | deaths, HC | EVENTS | Participants in the placebo group experienced 663 MACE-3 events, 346 CVD-related deaths, 592 all-cause deaths, and 226 events of HF requiring hospitalization during the median follow-up of 5.4 years. WHR and WC, but not BMI, were identified as independent risk factors of MACE-3 (hazard ratio [HR] for WHR: 1.11 [95% CI ... | PMC9999507 |
Conclusions | In this post hoc analysis of the REWIND placebo group, WHR, WC and/or WC adjusted for HC were risk factors for MACE-3, CVD-related mortality, and all-cause mortality; while BMI was only a risk factor for HF requiring hospitalization. These findings indicate the need for anthropometric measures that consider body fat di... | PMC9999507 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12933-023-01757-z. | PMC9999507 | ||
Keywords | PMC9999507 | |||
Background | Obesity, obesity, adiposity | OBESITY, OBESITY, CVD, ADIPOSITY, EVENTS, TYPE 2 DIABETES | Obesity, defined as excess adiposity that is detrimental to health, is a major risk factor for type 2 diabetes and other comorbidities [Obesity can be assessed using different measures. In the absence of imaging modalities, which are typically not used in routine clinical practice, BMI, waist-to-hip ratio (WHR), and wa... | PMC9999507 |
Methods | PMC9999507 | |||
Study design and patients | obesity, death, HC, stroke, deaths | OBESITY, STROKE, MYOCARDIAL INFARCTION, CREST | Data from the placebo group of the REWIND trial were used for this analysis. Details of the REWIND trial are published elsewhere [Weight measurements were taken at baseline and throughout the trial annually as well as at the final study visit. Height, waist circumference, and hip circumference were measured at baseline... | PMC9999507 |
Results | PMC9999507 | |||
Baseline characteristics and demographics | There were 4952 participants in the REWIND placebo group. The average age was 66.2 years, 46.1% were female, and 75.6% were White (Table | PMC9999507 | ||
Incidence of health outcomes | deaths | EVENTS | During follow-up in the placebo group, there were 663 MACE-3 events, 346 CVD-related deaths, 592 all-cause deaths, and 226 events of HF requiring hospitalization or urgent care. | PMC9999507 |
Association of obesity measures with health outcomes | obesity | OBESITY | The list of variables included in the Stepwise Variable Selection can be found in Table Additional file Association of BMI, WHR, WC, and WC adjusted for HC with (For MACE-3, WHR was found to be a significant independent risk factor (HR = 1.11; 95% CI 1.03 to 1.21; p = 0.009), as was WC (HR = 1.12; 95% CI 1.02 to 1.22; ... | PMC9999507 |
Discussion | obesity, HC | CVD, OBESITY, TYPE 2 DIABETES | This post hoc analysis of the placebo group of the REWIND CV Outcomes Trial showed that the anthropometric measures WHR and/or WC, but not BMI, were risk factors for MACE-3, CVD-related mortality, and all-cause mortality in patients with type 2 diabetes and CV risk factors or established CVD. BMI was a significant risk... | PMC9999507 |
General adiposity poorly reflects the risk of CV outcomes | obesity, overweight, overweight or obesity | OBESITY, MODERATE OBESITY | While used routinely in clinical practice, increasing BMI is not a reliable universal risk factor for CV-related outcomes in patients with overweight or obesity. Data from the ORIGIN trial showed that obesity, categorized using BMI, had a U-shaped association with mortality and CV outcomes, and patients with overweight... | PMC9999507 |
Central adiposity measures as recommended risk factors for CV outcomes | obesity | OBESITY, PATHOLOGY, CVD, ADIPOSITY, EVENTS, TYPE 2 DIABETES | Our results showed that either WHR or WC were risk factors for MACE-3, CVD-related mortality, and all-cause mortality. Given that different measures of obesity indicate general adiposity versus specific areas of fat depots, such as central fat, this may translate to different physiological effects and therefore varied ... | PMC9999507 |
Strengths and limitations | type 2 diabetes | CVD, EVENTS, TYPE 2 DIABETES, ADIPOSITY | This study had several strengths. The REWIND placebo group was a large cohort of patients with type 2 diabetes and CV risk factors or established CVD. The follow-up period was long (median 5.4 years). The REWIND study protocol did not prescribe interventions on body weight or weight change advice. The REWIND trial data... | PMC9999507 |
Conclusions | obesity | CVD, OBESITY, EVENTS, TYPE 2 DIABETES | In a cohort of patients with type 2 diabetes with high risk for CVD, different general and central measures of obesity better reflected patients’ risk of CV events. There was no single obesity measure that was a risk factor for all outcomes (MACE-3, CVD-related or all-cause mortality, or HF requiring hospitalization), ... | PMC9999507 |
Author contributions | NNA, MK, and HK designed the study. EF, PP, and HCG were involved in the collection of the data. EF, PP, JB, CN, SR, AH, NNA, MK, HK, and HCG were involved in the analysis of the data and/or interpretation of the results. All authors were involved in the drafting or critical revising of the manuscript. All authors read... | PMC9999507 | ||
Funding | This study was sponsored by Eli Lilly and Company. | PMC9999507 | ||
Availability of data and materials | Eli Lilly and Company provides access to all individual participant data collected during the trial, after anonymization, with the exception of pharmacokinetic or genetic data. Data are available to request 6 months after the indication studied has been approved in the US and EU and after primary publication acceptance... | PMC9999507 | ||
Declarations | PMC9999507 | |||
Ethics approval and consent to participate | The REWIND protocol was approved by research ethics boards for all sites. All participants provided written informed consent. The trial was carefully monitored by members of an independent data monitoring committee who reviewed accruing and unblinded data every 6 months. | PMC9999507 | ||
Consent for publication | Not applicable. | PMC9999507 | ||
Competing interests | Diabetes | DIABETES | EF has acted as an advisor to AstraZeneca, Boehringer Ingelheim, Novo Nordisk, and Polfa Tarchomin, and reports honoraria for speaking from AstraZeneca, Bioton, Boehringer Ingelheim, Eli Lilly and Company, Novo Nordisk, Polfa Tarchomin, Sanofi, and Servier. PP discloses no conflicts of interest. JB declares research gr... | PMC9999507 |
References | PMC9999507 | |||
Background | pain | The aim of this study was to compare pain-scores in three targeted treatment-strategies in JIA-patients and to identify characteristics predicting persistent pain. | PMC10464062 | |
Methods | pain | In the BeSt-for-Kids-study 92 DMARD-naïve JIA-patients were randomized in 3 treatment-strategies: 1) initial sequential DMARD-monotherapy 2) initial methotrexate (MTX)/prednisolone-bridging or 3) initial MTX/etanercept. Potential differences in VAS pain scores (0-100 mm) over time between treatment-strategies were comp... | PMC10464062 | |
Results | pain | Pain-scores over time reduced from mean 55.3 (SD 21.7) to 19.5 (SD 25.3) mm after 24 months. On average, pain-scores decreased significantly with β -1.37 mm (95% CI -1.726; -1.022) per month. No significant difference was found between treatment-strategies (interaction term treatment arm*time (months) β (95% CI) arm 1:... | PMC10464062 | |
Conclusions | pain | CHRONIC PAIN | Treatment-to-target seems effective in pain-reduction in non-systemic JIA-patients irrespective of initial treatment-strategy. Several baseline-predictors for pain over time were found, which could help to identify patients with a high risk for development of chronic pain. | PMC10464062 |
Trial registration | Dutch Trial Registry number 1574. | PMC10464062 | ||
Keywords | PMC10464062 | |||
Background | JIA, pain, auto-immune disease | DISEASE, REMISSION, JUVENILE IDIOPATHIC ARTHRITIS | Juvenile Idiopathic Arthritis (JIA) is the most common auto-immune disease in children, with an estimated prevalence of 33 per 100.000 children [In JIA, treatment to target (T2T) with clinical remission as a treatment goal has been widely recommended [The aim of this subanalysis is to compare pain scores over two years... | PMC10464062 |
Methods | PMC10464062 | |||
Patients | juvenile psoriatic arthritis, JIA, uveitis, polyarticular JIA | DISEASE, UVEITIS, JUVENILE PSORIATIC ARTHRITIS | The BeSt for Kids study (NTR 1574) is a Dutch multicenter randomized single-blinded trial. It was designed to investigate the effectiveness of three different treat to target strategies for non-systemic JIA patients. Newly diagnosed patients between 2 and 16 years old with JIA (oligoarticular JIA, RF negative polyartic... | PMC10464062 |
Outcome measures | [Inactive disease, pain | The primary outcome measure was pain intensity. This was assessed using a 100 mm visual analogue scale (VAS), where 0 mm is ‘no pain’ and 100 mm is ‘unbearable pain’. Patients were asked to rate their pain over the last 7 days. Under the age of 12, pain was estimated by the parents. A VAS pain of ≤ 35mm is considered ‘... | PMC10464062 | |
Statistical methods | Juvenile Arthritis, active joints, JIA, pain | JUVENILE ARTHRITIS, DISEASE, DISEASE, PGA | Descriptive statistics were used with mean and standard deviations (SDs) for continuous variables and absolute frequency percentage for categorical variables. Potential differences in VAS pain scores over time between treatment arms were compared using linear mixed models with random intercept and random slope for visi... | PMC10464062 |
Results | PMC10464062 | |||
VAS pain | active disease, Pain, pain | DISEASE | Mean (SD) pain at 24 months was 17.3 (25.5) mm in arm 1, 25.6 (28.5) mm in arm 2 and 15.8 (21.0) mm in arm 3 (overall 19.5(25.3)). When comparing pain scores over time per treatment arm, pain decreased significantly in every arm with β -1.37 mm (95% CI -1.73;-1.02) per month. No significant difference was found in pain... | PMC10464062 |
Baseline predictors | active joints, pain | Several baseline characteristics were selected beforehand and tested for predictive value for pain over time, first in a univariable and subsequently in a multivariable prediction model. In the multivariable model, higher VAS pain and number of active joints at baseline were significantly predictive of higher pain over... | PMC10464062 | |
Discussion | JIA, active joints, pain | DISEASE, PGA | The BeSt for Kids is one of the first treat-to-target studies in newly diagnosed, DMARD naïve, non-systemic JIA patients investigating pain as outcome measure. In the current subanalysis, three frequently used initial treatment strategies were compared for effectiveness in treating pain [Although few studies have addre... | PMC10464062 |
Acknowledgements | DER | We would like to thank Bastiaan van Dijk and Joy van der Pol for their support in formatting the graphs. | PMC10464062 | |
Authors’ contributions | All authors were involved in drafting the article or revising it critically for important intellectual content. All authors approved the final version to be published. Ms Spekking and dr Hissink Muller had full access to all data in the study and takes responsibility for the integrity of the data and the accuracy of th... | PMC10464062 | ||
Funding | The BeSt for Kids study is an investigator-initiated study which received financial support from Pfizer, who had no role in study design, data collection, data analysis, data interpretation, writing of an abstract, or decision to submit a manuscript for submission. | PMC10464062 | ||
Availability of data and materials | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10464062 | ||
Declarations | PMC10464062 | |||
Ethics approval and consent to participate | Approval of the Medical Ethical Committee of the Leiden University Medical Center and local Ethical Committees was obtained prior to start at each study site. Written Informed consent was obtained from patients above 12 years of age and parents of all participating patients. | PMC10464062 | ||
Consent for publication | Not applicable. | PMC10464062 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10464062 | ||
References | PMC10464062 | |||
Research Design and Methods: | T1D, Diabetes | DIABETES | This multicenter 12-week 1:1 randomized, controlled, parallel-arm trial included 100 participants with established T1D aged 4–13 years (mean 10.9 ± 2.3 years) naive to isCGM and with elevated HbA1c 7.5%–12.2% [58–110 mmol/mol] [mean HbA1c was 9.05 (1.3)%] [75.4 (13.9) mmol/mol]. Participants were allocated to 12-week i... | PMC10698781 |
Results: | −0.21 | There was no evidence of a difference between groups for change in HbA1c at 12 weeks (0.23 [95% confidence interval; CI: −0.21 to 0.67], | PMC10698781 | |
Conclusions: | For children aged 4–13 years with elevated Hba1c isCGM led to improvements in glucose testing frequency and reduced time below range. However, isCGM did not translate into reducing Hba1c or psychosocial outcomes compared to usual care over 12-weeks. The trial is registered within the Australian New Zealand Trial Regist... | PMC10698781 | ||
Introduction | TYPE 1 DIABETES | Self-monitoring of glucose levels, whether by self-monitored capillary blood glucose (SMBG), real-time continuous glucose monitoring (rtCGM), or intermittently scanned continuous glucose monitoring [isCGM]), is strongly recommended for children with type 1 diabetes (T1D).When compared with first-generation isCGM, rtCGM... | PMC10698781 | |
Methods | comorbidity, Diabetes, ketoacidosis, hypoglycemia, Diabetes Self-Management (SEDM).Data, diabetes | KETOACIDOSIS, ADVERSE EVENTS, EVENT, RECRUITMENT, HYPOGLYCEMIA, DIABETES, DIABETES, HYPOGLYCEMIA | This 12-week multisite 1: 1 randomized, 2-arm, parallel, controlled open-label study was conducted across five diabetes centers in New Zealand: Northland (NDHB), Auckland (ADHB), Bay of Plenty (BOPDHB), Capital and Coast (CCDHB), and Southern (SDHB) from October 2020 to August 2022. For full details, see the published ... | PMC10698781 |
Ethics | RECRUITMENT | The protocol underwent Māori (indigenous New Zealanders) consultation, which fostered input into this study. The study protocol was approved by the Northern A Health and Disability Ethics Committee (ethics reference: 20/NTA/12). All district health boards approved recruitment and conduct of the study at their site. The... | PMC10698781 | |
Statistical analysis and data management | DKA | HYPOGLYCEMIA, RECRUITMENT, DIABETIC KETOACIDOSIS | As described in our published methodology, a sample size of 88 (44 participants in each group) was estimated to provide 80% power to detect a difference in changes in HbA1c of 7 mmol/mol (0.75%) between the intervention and control groups using standard deviation (SD) of 15 mmol/mol and correlation of 0.7 between repea... | PMC10698781 |
Results | capillary blood glucose | Baseline characteristics are presented in Demographic and Clinical Characteristics of the Participants at BaselineThe participants (or parents/guardians) could select more than one ethnic group. However, they were assigned to a single ethnic group for statistical evaluation with the list prioritized in the standardized... | PMC10698781 | |
Glucose monitoring | In the isCGM group, there was an increase in mean (SD) glucose checks performed per day from 4.7 (2.7) SMBG at baseline to 10.7 (4.6) combined interstitial and SMBG per day at 12 weeks. In the SMBG group, the baseline glucose checks decreased from 3.9 (2.2)/day to 3.2 (1.6)/day at 12 weeks. This translated to the isCGM... | PMC10698781 | ||
Other glucose metrics | 3.9–10, −2.7 | % Time in target 70–180 mg/dL (3.9–10 mmol/L) showed an absolute increase in the isCGM group (28.7% [16.6] at baseline to 36.4% [13.2]) at 12 weeks, and remained similar in the SMBG group (27.3% [16] and 25.1% [13]), however, this did not translate to a statistically significant difference between groups, +4.7% (CI: −2... | PMC10698781 | |
Psychosocial assessments | diabetes symptoms, HFS, hypoglycemia, diabetes, Diabetes, Hypoglycemia | HYPOGLYCEMIA, DIABETES, HYPOGLYCEMIA, DIABETES | At 12 weeks there was no difference in PedsQL Diabetes Module Total score (or 5 subscales), Fear of Hypoglycemia (2 subscales), nor in Self-efficacy for Diabetes Self-Management score (see Comparison of Psychological Outcomes Between Groups at Baseline and at 12 Weeks: Children's and Parent's ScoresData are mean ± SD u... | PMC10698781 |
Adverse events | hypoglycemia, hyperthyroidism, DKA | HYPOGLYCEMIA, DRUG-INDUCED HEPATITIS, HYPERTHYROIDISM | There was one episode of DKA in the control group and none in the intervention group. There were no episodes of severe hypoglycemia in either group, or any reported hospitalizations for other reasons. There was one case in the intervention group of acquired hyperthyroidism and subsequent drug-induced hepatitis requirin... | PMC10698781 |
Cutaneous reactions | cutaneous reaction, erythema, dryness | ERYTHEMA | There was one local reaction (erythema, dryness, and irritation) to a baseline blinded Libre pro, data not repeated due to subject choice. There was one reported episode of cutaneous reaction to a skin tape fixation in the intervention group, not repeated once the tape fixation was removed, and no reaction to subsequen... | PMC10698781 |
Discussion | hypoglycemia, T1D, diabetes | HYPOGLYCEMIA, RECRUITMENT, DIABETES | This study investigated second-generation isCGM in children with elevated glycemic control who were naive to any form of CGM. This is the first RCT to be conducted in children aged <13 years worldwide and importantly was carried out independently (i.e., was not industry funded). The main findings are that despite a cle... | PMC10698781 |
Strengths and limitations | T1D, fits, diabetes | DIABETES | To our knowledge, this is the only trial to date of isCGM 2.0 in children, and it is important to validate diabetes technology although it is an ever-changing and emerging field.The study deliberately targeted those with elevated HbA1c levels who (for whatever reason: cost, social support, or other) have not been on is... | PMC10698781 |
Conclusion | T1D, diabetes | HYPOGLYCEMIA, DIABETES | This RCT highlights that isCGM 2.0 is appealing and engages families and children with T1D and elevated HbA1c, as shown by the increased glucose monitoring behavior, and reduced time in hypoglycemia. However, in this study, the use of isCGM (Libre 2.0) did not translate into reducing HbA1c compared with usual care SMBG... | PMC10698781 |
Supplementary Material | PMC10698781 | |||
Supplemental data | PMC10698781 | |||
Supplemental data | PMC10698781 | |||
Authors' Contributions | C.A.J.: Conceptualization (colead), methodology (colead), supervision, visualization, and writing—original and editing. A.B. and S.E.S.: Investigation, project administration, resources, software, supervision, and writing—review and editing. B.C.: Investigation, visualization, software, and validation. V.R.M.: Visualiz... | PMC10698781 | ||
Consent to Participate | Written informed consent was obtained from parents, written informed assent was obtained from participants aged 7 to 13 years, and verbal assent was obtained from participants aged 4 to 6 years. | PMC10698781 | ||
Author Disclosure Statement | No competing financial interests exist. | PMC10698781 | ||
Funding Information | The study funder is The Starship Foundation A +8211 (Auckland, New Zealand). The funder and the isCGM manufacturer had no roles or responsibilities in the study design, conduct, data analysis and interpretation, or article writing. Intervention supplies and blinded glucose sensors were purchased commercially from the i... | PMC10698781 | ||
Supplementary Material | PMC10698781 | |||
References | PMC10698781 | |||
Key Points | PMC10551818 | |||
Question | CARDIOVASCULAR DISEASE | Does enteric coating on aspirin reduce effectiveness or increase safety in patients with cardiovascular disease? | PMC10551818 | |
Findings | atherosclerotic cardiovascular disease, death, stroke | BLEEDING, MYOCARDIAL INFARCTION, STROKE, SECONDARY, ATHEROSCLEROTIC CARDIOVASCULAR DISEASE | In this post hoc secondary analysis of 10 678 participants with atherosclerotic cardiovascular disease from the ADAPTABLE randomized clinical trial, there were no significant differences in the primary effectiveness (death, hospitalization for myocardial infarction, or hospitalization for stroke) or safety (major bleed... | PMC10551818 |
Meaning | EVENTS, SECONDARY | These findings suggested that enteric coating on aspirin is not associated with changes in the effectiveness or safety of aspirin for secondary prevention of cardiovascular events, allowing patients to determine the aspirin formulation. | PMC10551818 | |
Importance | gastrointestinal bleeding, coronary artery disease | GASTROINTESTINAL BLEEDING, CORONARY ARTERY DISEASE, SECONDARY | Clinicians recommend enteric-coated aspirin to decrease gastrointestinal bleeding in secondary prevention of coronary artery disease even though studies suggest platelet inhibition is decreased with enteric-coated vs uncoated aspirin formulations. | PMC10551818 |
Objective | To assess whether receipt of enteric-coated vs uncoated aspirin is associated with effectiveness or safety outcomes. | PMC10551818 | ||
Design, Setting, and Participants | atherosclerotic cardiovascular disease | ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, SECONDARY | This is a post hoc secondary analysis of ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness), a pragmatic study of 15 076 patients with atherosclerotic cardiovascular disease having data in the National Patient-Centered Clinical Research Network. Patients were enrolled fro... | PMC10551818 |
Intervention | ADAPTABLE participants were regrouped according to aspirin formulation self-reported at baseline, with a median (IQR) follow-up of 26.2 (19.8-35.4) months. | PMC10551818 | ||
Main Outcomes and Measures | death, bleeding | BLEEDING, MYOCARDIAL INFARCTION, STROKE, INTRACRANIAL HEMORRHAGE, EVENT, EVENTS | The primary effectiveness end point was the cumulative incidence of the composite of myocardial infarction, stroke, or death from any cause, and the primary safety end point was major bleeding events (hospitalization for a bleeding event with use of a blood product or intracranial hemorrhage). Cumulative incidence at m... | PMC10551818 |
Results | Baseline aspirin formulation used in ADAPTABLE was self-reported for 10 678 participants (median [IQR] age, 68.0 [61.3-73.7] years; 7285 men [68.2%]), of whom 7366 (69.0%) took enteric-coated aspirin and 3312 (31.0%) took uncoated aspirin. No significant difference in effectiveness (adjusted hazard ratio [AHR], 0.94; 9... | PMC10551818 | ||
Conclusions and Relevance | death, bleeding | SECONDARY, MYOCARDIAL INFARCTION, STROKE, BLEEDING | In this post hoc secondary analysis of the ADAPTABLE randomized clinical trial, enteric-coated aspirin was not associated with significantly higher risk of myocardial infarction, stroke, or death or with lower bleeding risk compared with uncoated aspirin, regardless of dose, although a reduction in bleeding with enteri... | PMC10551818 |
Trial Registration | ATHEROSCLEROTIC CARDIOVASCULAR DISEASE, SECONDARY | ClinicalTrials.gov Identifier: This post hoc secondary analysis of a randomized clinical trial compares the effectiveness and safety of enteric-coated aspirin vs uncoated aspirin among patients with atherosclerotic cardiovascular disease. | PMC10551818 | |
Introduction | cardiovascular disease | SECONDARY, CARDIOVASCULAR DISEASE | Aspirin has been one of the most widely used medications since its introduction in the 1890s.The association of enteric-coated aspirin with secondary prevention of cardiovascular disease is controversial. Several studies have proposed that the enteric coating reduces the bioavailability of aspirin due to reduced dissol... | PMC10551818 |
Methods | death, bleeding, Gastrointestinal tract bleeding, GI bleed, stroke, ASCVD, coronary artery disease | PERIPHERAL ARTERIAL DISEASE, BLEEDING, TRANSIENT ISCHEMIC ATTACK, GI BLEED, EVENT, STROKE, SECONDARY, DIABETES TYPE 1, ASCVD, CEREBROVASCULAR DISEASE, CORONARY ARTERY DISEASE | The ADAPTABLE study design has been previously described in detail.Overall, 15 076 participants 18 years or older with known ASCVD and at least 1 enrichment factor (age >65 years, serum creatinine >1.5 mg/dL [to convert milligrams per deciliter to micromoles per liter, multiply by 88.4], diabetes type 1 or type 2, 3-ve... | PMC10551818 |
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