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Clinical and Applied... 2024Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is a standard therapy in patients with ischemic vascular diseases (IVD) including coronary artery,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor is a standard therapy in patients with ischemic vascular diseases (IVD) including coronary artery, cerebrovascular and peripheral arterial diseases, although the optimal duration of this treatment is still debated. Previous meta-analyses reported conflicting results about the effects of long-term and short-term as well as non-DAPT use in various clinical settings. Herein, we conducted a comprehensive meta-analysis to assess the efficacy and safety of different durations of DAPT.
METHODS
We reviewed relevant articles and references from database, which were published prior to April 2023. Data from prospective studies were processed using RevMan5.0 software, provided by Cochrane Collaboration and transformed using relevant formulas. The inclusion criteria involved randomization to long-term versus short-term or no DAPT; the endpoints included at least one of total or cardiovascular (CV) mortalities, IVD recurrence, and bleeding.
RESULTS
A total of 34 randomized studies involving 141 455 patients were finally included. In comparison with no or short-term DAPT, long-term DAPT reduced MI and stroke, but did not reduce the total and CV mortalities. Meanwhile, bleeding events were increased, even though intracranial and fatal bleedings were not affected. Besides, the reduction of MI and stroke recurrence showed no statistical significance between long-term and short-term DAPT groups.
CONCLUSION
Long-term DAPT may not reduce the mortality of IVD besides increasing bleeding events, although reduced the incidences of MI and stroke early recurrence to a certain extent and did not increase the risk of fatal intracranial bleeding.
Topics: Humans; Aspirin; Drug Therapy, Combination; Hemorrhage; Myocardial Infarction; Percutaneous Coronary Intervention; Platelet Aggregation Inhibitors; Prospective Studies; Randomized Controlled Trials as Topic; Stroke; Treatment Outcome
PubMed: 38571479
DOI: 10.1177/10760296241244772 -
Journal of Gastrointestinal Cancer Jun 2024Hepatocellular carcinoma (HCC) is a disease demonstrating increasing morbidity and mortality, especially in patients with chronic viral hepatitis. Studies have shown... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hepatocellular carcinoma (HCC) is a disease demonstrating increasing morbidity and mortality, especially in patients with chronic viral hepatitis. Studies have shown that aspirin can reduce the incidence of liver cancer; however, the degree of benefit in patients with viral hepatitis is unclear. This study focused on the association between aspirin use and HCC risk in patients with chronic viral hepatitis.
METHODS
A systematic search of the PubMed, Embase, Web of Science, and Cochrane Library databases was performed from the earliest available date to December 16, 2023. The primary outcome was HCC incidence, and the secondary outcome was gastrointestinal bleeding. The results were expressed as hazard ratios (HRs) and 95% confidence intervals (CIs). Meta-analyses were performed by using random or fixed-effects models based on the heterogeneity assessed via the I statistic.
RESULTS
A total of 13 articles (303,414 participants and 14,423 HCC patients) were included in the analysis. The incidence of HCC in aspirin users was lower than that in non-aspirin users (HR 0.75; 95% CI, 0.68-0.83; P < 0.001; I = 90.0%). Subgroup analysis further showed that this effect may be more obvious in HCV patients, non-cirrhotic patients, patients with statins, and long-term aspirin users, but it may have the risk of gastrointestinal bleeding (HR 1.13; 95% CI, 1.07-1.20; P = 0.906; I = 0.0%).
CONCLUSIONS
Our meta-analysis shows that in patients with chronic viral hepatitis, aspirin use is associated with a significantly reduced risk of liver cancer, but attention should be paid to the possible risk of gastrointestinal bleeding, and this conclusion needs further validation in the future.
Topics: Humans; Aspirin; Liver Neoplasms; Carcinoma, Hepatocellular; Observational Studies as Topic; Gastrointestinal Hemorrhage; Incidence; Hepatitis, Viral, Human; Hepatitis C, Chronic
PubMed: 38557825
DOI: 10.1007/s12029-024-01027-5 -
The American Journal of Cardiology Jun 2024The 2019 American College of Cardiology and American Heart Association guidelines regarding low-dose aspirin in the primary prevention of atherosclerotic cardiovascular... (Review)
Review
The 2019 American College of Cardiology and American Heart Association guidelines regarding low-dose aspirin in the primary prevention of atherosclerotic cardiovascular disease (ASCVD) indicate an increased risk of bleeding without a net benefit. The coronary artery calcium (CAC) score could be used to guide aspirin therapy in high-risk patients without an increased risk of bleeding. With this systematic review, we aimed to analyze studies that have investigated the role of CAC in primary prevention with aspirin. A total of 4 relevant studies were identified and the primary outcomes of interest were bleeding events and major adverse cardiac events. The outcomes of interest were stratified into 3 groups based on CAC scoring: 0, 1 to 99, and ≥100. A study concluded from 2,191 patients that with a low bleeding risk, CAC ≥100, and ASCVD risk ≥5% aspirin confers a net benefit, whereas patients with a high bleeding risk would experience a net harm, irrespective of ASCVD risk or CAC. All other studies demonstrated net benefit in patients with CAC ≥100 with a clear benefit. CAC scores correspond to calcified plaque in coronary vessels and are associated with graded increase in adverse cardiovascular events. Our review has found that in the absence of a significant bleeding risk, increased ASCVD risk and CAC score corelate with increased benefit from aspirin. A study demonstrated a decrease in the odds of myocardial infarction from 3 to 0.56 in patients on aspirin. The major drawback of aspirin for primary prevention is the bleeding complication. At present, there is no widely validated tool to predict the bleeding risk with aspirin, which creates difficulties in accurately delineating risk. Barring some discrepancy between studies, evidence shows a net harm for the use of aspirin in low ASCVD risk (<5%), irrespective of CAC score.
Topics: Humans; Aspirin; Primary Prevention; Coronary Artery Disease; Vascular Calcification; Coronary Vessels; Platelet Aggregation Inhibitors; Risk Assessment; Hemorrhage
PubMed: 38548012
DOI: 10.1016/j.amjcard.2024.03.021 -
JBRA Assisted Reproduction Jun 2024To verify, based on a systematic literature review, the effects of the main analgesics on male fertility. (Review)
Review
OBJECTIVE
To verify, based on a systematic literature review, the effects of the main analgesics on male fertility.
DATA SOURCES
The studies were analyzed from the PubMed, SciELO and LILACS databases.
STUDY SELECTION
The articles selected for the present review included: cohort studies; cross-sectional studies, clinical trials; complete studies; studies with animal models that addressed the proposed theme and that were published within the stipulated period from March 1, 2013, to March 31, 2023, in English, Portuguese and Spanish. These would later have to go through inclusion stages such as framing the type of study and exclusion criteria.
DATA COLLECTION
Author's name, year of publication, study population, number of patients, analgesic, administration time, dose, and effect.
CONCLUSIONS
There are in vitro and in vivo studies that link paracetamol and ibuprofen to endocrine and seminal changes that are harmful to male fertility. However, more clinical research is needed to determine the doses and timing of administration that affect fertility. The effects of aspirin on male fertility are still unclear due to the lack of studies and consistent methodologies. There is not enough research on dipyrone and its relationship with male fertility, requiring more studies in this area.
Topics: Humans; Male; Analgesics; Fertility; Infertility, Male; Ibuprofen; Acetaminophen; Animals; Dipyrone; Aspirin
PubMed: 38546117
DOI: 10.5935/1518-0557.20240020 -
European Radiology Mar 2024This systematic review and meta-analysis aimed to determine the true risk of bleeding and nondiagnostic (ND) specimens associated with fine-needle aspiration cytology...
OBJECTIVES
This systematic review and meta-analysis aimed to determine the true risk of bleeding and nondiagnostic (ND) specimens associated with fine-needle aspiration cytology (FNAC) for neck lesions in patients taking antithrombotic/anticoagulation (AT/AC) medications.
METHODS
Using the Population Intervention Comparison and Outcome modeling, we searched PubMed and Google Scholar databases to identify studies published between January 2000 and March 2023 reporting the safety and sample adequacy of FNAC for neck lesions in patients taking AT/AC medications. The pooled incidences of bleeding and ND specimens and pooled risk ratio (RR) with 95% confidence intervals (CIs) obtained using a fixed-effects model were compared for patients continuing AT/AC (AT/AC group) and patients not receiving AT/AC therapy (no-AT/AC group).
RESULTS
We included six original articles involving a total of 3014 patients. The pooled incidence of bleeding was 0.9% (95% CI, 0.344-2.026) and 0.7% (95% CI, 0.390-1.146) in the AT/AC and no-AT/AC groups, respectively. The pooled RR under the fixed-effects model was 1.39 (95% CI, 0.56-3.44) with no evidence of between-study heterogeneity (I = 0.0%; p = 0.92). The pooled incidence of ND specimens was 7.6% (95% CI, 5.617-10.073) and 7.6% (95% CI, 6.511-8.752) in the AT/AC and no-AT/AC groups, respectively. The pooled RR under the fixed-effects model was 1.33 (95% CI, 0.98-1.81) with moderate between-study heterogeneity (I = 60.0%; p = 0.06).
CONCLUSIONS
The AT/AC medication is not associated with increased risk of bleeding or ND specimens in FNAC for neck lesions. Therefore, interruption of the AT/AC medication is not recommended before FNAC even in patients taking AT/AC medications.
CLINICAL RELEVANCE STATEMENT
This study is the first meta-analysis evaluating risk of bleeding and nondiagnostic specimens associated with fine-needle cytology for neck lesions in patients taking antithrombotic/anticoagulation (AT/AC) medications. This suggests withholding AT/AC medications is not mandatory for safe and diagnostic FNACs.
KEY POINTS
• True risk of fine-needle aspiration cytology (FNAC) for neck lesions in patients taking antithrombotic/anticoagulation (AT/AC) medications is still controversial. • This meta-analysis demonstrated that maintaining AT/AC medication was not associated with increased risk in terms of both bleeding and nondiagnostic samples. • Interruption of the AT/AC medication is not needed for safe and diagnostic FNAC for neck lesions even in patients taking AT/AC medications.
PubMed: 38536462
DOI: 10.1007/s00330-024-10709-4 -
The Cochrane Database of Systematic... Mar 2024Cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for almost 18 million deaths annually. People with CVDs have a five times greater... (Review)
Review
BACKGROUND
Cardiovascular diseases (CVDs) are the leading cause of death globally, accounting for almost 18 million deaths annually. People with CVDs have a five times greater chance of suffering a recurrent cardiovascular event than people without known CVDs. Although drug interventions have been shown to be cost-effective in reducing the risk of recurrent cardiovascular events, adherence to medication remains suboptimal. As a scalable and cost-effective approach, mobile phone text messaging presents an opportunity to convey health information, deliver electronic reminders, and encourage behaviour change. However, it is uncertain whether text messaging can improve medication adherence and clinical outcomes. This is an update of a Cochrane review published in 2017.
OBJECTIVES
To evaluate the benefits and harms of mobile phone text messaging for improving medication adherence in people with CVDs compared to usual care.
SEARCH METHODS
We searched CENTRAL, MEDLINE, Embase, four other databases, and two trial registers. We also checked the reference lists of all primary included studies and relevant systematic reviews and meta-analyses. The date of the latest search was 30 August 2023.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) with participants with established arterial occlusive events. We included trials investigating interventions using short message service (SMS) or multimedia messaging service (MMS) with the aim of improving adherence to medication for the secondary prevention of cardiovascular events. The comparator was usual care. We excluded cluster-RCTs and quasi-RCTs.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were medication adherence, fatal cardiovascular events, non-fatal cardiovascular events, and combined CVD event. Secondary outcomes were low-density lipoprotein cholesterol for the effect of statins, blood pressure for antihypertensive drugs, heart rate for the effect of beta-blockers, urinary 11-dehydrothromboxane B2 for the antiplatelet effects of aspirin, adverse effects, and patient-reported experience. We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
We included 18 RCTs involving a total of 8136 participants with CVDs. We identified 11 new studies in the review update and seven studies in the previous version of the review. Participants had various CVDs including acute coronary syndrome, coronary heart disease, stroke, myocardial infarction, and angina. All studies were conducted in middle- and high-income countries, with no studies conducted in low-income countries. The mean age of participants was 53 to 64 years. Participants were recruited from hospitals or cardiac rehabilitation facilities. Follow-up ranged from one to 12 months. There was variation in the characteristics of text messages amongst studies (e.g. delivery method, frequency, theoretical grounding, content used, personalisation, and directionality). The content of text messages varied across studies, but generally included medication reminders and healthy lifestyle information such as diet, physical activity, and weight loss. Text messages offered advice, motivation, social support, and health education to promote behaviour changes and regular medication-taking. We assessed risk of bias for all studies as high, as all studies had at least one domain at unclear or high risk of bias. Medication adherence Due to different evaluation score systems and inconsistent definitions applied for the measurement of medication adherence, we did not conduct meta-analysis for medication adherence. Ten out of 18 studies showed a beneficial effect of mobile phone text messaging for medication adherence compared to usual care, whereas the other eight studies showed either a reduction or no difference in medication adherence with text messaging compared to usual care. Overall, the evidence is very uncertain about the effects of mobile phone text messaging for medication adherence when compared to usual care. Fatal cardiovascular events Text messaging may have little to no effect on fatal cardiovascular events compared to usual care (odds ratio 0.83, 95% confidence interval (CI) 0.47 to 1.45; 4 studies, 1654 participants; low-certainty evidence). Non-fatal cardiovascular events We found very low-certainty evidence that text messaging may have little to no effect on non-fatal cardiovascular events. Two studies reported non-fatal cardiovascular events, neither of which found evidence of a difference between groups. Combined CVD events We found very low-certainty evidence that text messaging may have little to no effect on combined CVD events. Only one study reported combined CVD events, and did not find evidence of a difference between groups. Low-density lipoprotein cholesterol Text messaging may have little to no effect on low-density lipoprotein cholesterol compared to usual care (mean difference (MD) -1.79 mg/dL, 95% CI -4.71 to 1.12; 8 studies, 4983 participants; very low-certainty evidence). Blood pressure Text messaging may have little to no effect on systolic blood pressure (MD -0.93 mmHg, 95% CI -3.55 to 1.69; 8 studies, 5173 participants; very low-certainty evidence) and diastolic blood pressure (MD -1.00 mmHg, 95% CI -2.49 to 0.50; 5 studies, 3137 participants; very low-certainty evidence) when compared to usual care. Heart rate Text messaging may have little to no effect on heart rate compared to usual care (MD -0.46 beats per minute, 95% CI -1.74 to 0.82; 4 studies, 2946 participants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
Due to limited evidence, we are uncertain if text messaging reduces medication adherence, fatal and non-fatal cardiovascular events, and combined cardiovascular events in people with cardiovascular diseases when compared to usual care. Furthermore, text messaging may result in little or no effect on low-density lipoprotein cholesterol, blood pressure, and heart rate compared to usual care. The included studies were of low methodological quality, and no studies assessed the effects of text messaging in low-income countries or beyond the 12-month follow-up. Long-term and high-quality randomised trials are needed, particularly in low-income countries.
Topics: Humans; Middle Aged; Text Messaging; Cardiovascular Diseases; Secondary Prevention; Cell Phone; Cholesterol, LDL; Medication Adherence
PubMed: 38533994
DOI: 10.1002/14651858.CD011851.pub3 -
Cancer Medicine Mar 2024Due to encouraging pre-clinical data and supportive observational studies, there has been growing interest in applying cardiovascular drugs (including aspirin,... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Due to encouraging pre-clinical data and supportive observational studies, there has been growing interest in applying cardiovascular drugs (including aspirin, angiotensin-converting enzyme [ACE] inhibitors, statins, and metformin) approved to treat diseases such as hypertension, hyperlipidemia, and diabetes mellitus to the field of oncology. Moreover, given growing costs with cancer care, these medications have offered a potentially more affordable avenue to treat or prevent recurrence of cancer. We sought to investigate the anti-cancer effects of drugs repurposed from cardiology or anti-inflammatories to treat cancer. We specifically evaluated the following drug classes: HMG-CoA reductase inhibitors (statins), cyclo-oxygenase inhibitors, aspirin, metformin, and both angiotensin receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors. We also included non-steroidal anti-inflammatory drugs (NSAIDs) because they exert a similar mechanism to aspirin by blocking prostaglandins and reducing inflammation that is thought to promote the development of cancer.
METHODS
We performed a systematic literature review using PubMed and Web of Science with search terms including "aspirin," "NSAID," "statin" (including specific statin drug names), "metformin," "ACE inhibitors," and "ARBs" (including specific anti-hypertensive drug names) in combination with "cancer." Searches were limited to human studies published between 2000 and 2023.
MAIN OUTCOMES AND MEASURES
The number and percentage of studies reported positive results and pooled estimates of overall survival, progression-free survival, response, and disease-free survival.
RESULTS
We reviewed 3094 titles and included 67 randomized clinical trials. The most common drugs that were tested were metformin (n = 21; 30.9%), celecoxib (n = 20; 29.4%), and simvastatin (n = 8; 11.8%). There was only one study that tested cardiac glycosides and none that studied ACE inhibitors. The most common tumor types were non-small-cell lung cancer (n = 19; 27.9%); breast (n = 8; 20.6%), colorectal (n = 7; 10.3%), and hepatocellular (n = 6; 8.8%). Most studies were conducted in a phase II trial (n = 38; 55.9%). Most studies were tested in metastatic cancers (n = 49; 72.1%) and in the first-line setting (n = 36; 521.9%). Four studies (5.9%) were stopped early because of difficulty with accrual. The majority of studies did not demonstrate an improvement in either progression-free survival (86.1% of studies testing progression-free survival) or in overall survival (94.3% of studies testing overall survival). Progression-free survival was improved in five studies (7.4%), and overall survival was improved in three studies (4.4%). Overall survival was significantly worse in two studies (3.8% of studies testing overall survival), and progression-free survival was worse in one study (2.8% of studies testing progression-free survival).
CONCLUSIONS AND RELEVANCE
Despite promising pre-clinical and population-based data, cardiovascular drugs and anti-inflammatory medications have overall not demonstrated benefit in the treatment or preventing recurrence of cancer. These findings may help guide future potential clinical trials involving these medications when applied in oncology.
Topics: Humans; Angiotensin-Converting Enzyme Inhibitors; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Carcinoma, Non-Small-Cell Lung; Angiotensin Receptor Antagonists; Lung Neoplasms; Randomized Controlled Trials as Topic; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Aspirin; Antihypertensive Agents; Metformin
PubMed: 38491813
DOI: 10.1002/cam4.7049 -
Otolaryngology--head and Neck Surgery :... Jul 2024Provide clinicians with current evidence for biologic therapy in children with chronic rhinosinusitis with nasal polyposis (CRSwNP). (Review)
Review
OBJECTIVE
Provide clinicians with current evidence for biologic therapy in children with chronic rhinosinusitis with nasal polyposis (CRSwNP).
DATA SOURCES
PubMed, MEDLINE, Cochrane, and clinical trial registries.
REVIEW METHODS
Key search terms related to biologic therapy in pediatric CRSwNP were identified via a structured query of current medical literature and clinical trial databases.
CONCLUSIONS
There is a dearth of active clinical trials and research studies for biologics targeting pediatric CRSwNP. There is an ongoing compassionate-use clinical trial involving Dupilumab for children with nasal polyps as well as only 1 published work specifically focused on Dupilumab for pediatric CRSwNP in the setting of aspirin-exacerbated respiratory disease.
IMPLICATIONS FOR PRACTICE
For children with atopic dermatitis, asthma, and chronic idiopathic urticaria, biologic therapies such as Omalizumab, Dupilumab, and Mepolizumab have gained Food and Drug Administration approval. The role of biologic therapy in pediatric CRSwNP demonstrates significant promise in the comprehensive management of the unified airway. Additional Phase III trials are necessary to broaden clinical indications for children with comorbid conditions and complex sinonasal disease.
Topics: Humans; Sinusitis; Chronic Disease; Rhinitis; Child; Biological Therapy; Nasal Polyps; Omalizumab; Rhinosinusitis; Antibodies, Monoclonal, Humanized
PubMed: 38488239
DOI: 10.1002/ohn.717 -
PloS One 2024Colorectal adenomas have the potential of malignant transformation if left untreated. Multiple randomized controlled trials have been performed to evaluate the efficacy... (Meta-Analysis)
Meta-Analysis
Colorectal adenomas have the potential of malignant transformation if left untreated. Multiple randomized controlled trials have been performed to evaluate the efficacy of aspirin in preventing colorectal adenoma recurrence in a population with a history of colorectal adenoma but not colorectal cancer, however, the relationship between aspirin dose and colorectal adenoma recurrence remains unclear. We conducted pairwise meta-analysis, meta-regression, trial sequential analysis, and network meta-analysis of all eligible studies. The ROB 2.0 tool was used to assess the risk of bias in the studies. The confidence in network meta-analysis (CINeMA) approach was used to evaluate the confidence of the network meta-analysis results. The network meta-analysis included eight RCTs (nine reports), comprising four on aspirin (low or high dose) alone and four on aspirin combined with another medication, all compared with placebo. In the network meta-analysis, low-dose aspirin (LDA <300 mg per day) was more effective than high-dose aspirin (HDA ≥300 mg per day) and placebo, with risk ratios of 0.76 (95% CI: 0.58 to 0.99) and 0.7 (95% CI: 0.54 to 0.91), respectively. LDA was the optimal treatment relative to HDA and placebo (P-score = 0.99). In the trial sequential analysis, LDA was only more effective than placebo when the number of included participants exceeded the optimal information size; this was not the case for HDA. LDA has statistically significant efficacy for colorectal adenoma prevention, but compared with HDA, its efficacy remains uncertain. Further trials are therefore required.
Topics: Humans; Aspirin; Network Meta-Analysis; Randomized Controlled Trials as Topic; Colorectal Neoplasms; Adenoma
PubMed: 38483854
DOI: 10.1371/journal.pone.0279784 -
PLOS Global Public Health 2024The quality of medicines for the prevention and management of hypertensive disorders of pregnancy globally is a critical challenge in the reduction of maternal mortality...
The quality of medicines for the prevention and management of hypertensive disorders of pregnancy globally is a critical challenge in the reduction of maternal mortality rate. We aimed to conduct a systematic review of available studies on the quality of the eight medicines recommended globally for the prevention and management of hypertensive disorders of pregnancy. We searched five electronic databases- Ovid MEDLINE, EMBASE, CINAHL, ProQuest and Cochrane Library, and also grey literature, without year or language limitations. Any study assessing the quality parameters (Active Pharmaceutical Ingredients, pH, sterility, solubility, impurities) of medicines by using any valid laboratory methods was eligible. Two reviewers independently screened the studies, extracted data and applied Medicine Quality Assessment Reporting Guidelines tool for quality assessment. Results were narratively reported and stratified by the drug types. Of 5669 citations screened, 33 studies from 27 countries were included. Five studies reported on the quality of magnesium sulphate-two (Nigeria and USA) found substandard medicine due to failing API specification and contaminants, respectively. Another study from Nigeria and a multi-country study (10 lower-middle- and low-income countries) found poor-quality due to failing the pH criteria. Seven of eight studies evaluating aspirin found quality issues, including degraded medicines in five studies (Brazil, USA, Yugoslavia and Pakistan). Five studies of calcium supplements found quality issues, particularly heavy metal contamination. Of 15 antihypertensives quality studies, 12 found substandard medicines and one study identified counterfeit medicines. This systematic review identified pervasive issues of poor-quality medicines across all recommended medicines used to prevent or treat hypertensive disorders of pregnancy, raising concerns regarding their safety and effectiveness.
PubMed: 38412179
DOI: 10.1371/journal.pgph.0002962