-
Brain Sciences Nov 2023SPN-812 has been approved for attention-deficit/hyperactivity disorder (ADHD) treatment in children and adolescents. (Review)
Review
Efficacy and Safety of SPN-812 (Extended-Release Viloxazine) in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-Analysis.
BACKGROUND
SPN-812 has been approved for attention-deficit/hyperactivity disorder (ADHD) treatment in children and adolescents.
OBJECTIVE
We aimed to analyze the efficacy and safety of different doses of SPN-812 for ADHD pediatric patients of different ages, verify its clinical efficacy, and evaluate its safety.
METHODS
Up until 30 August 2023, randomized controlled trials (RCTs) were searched in EMBASE, MEDLINE, the Cochrane Library, and clinicaltrials.gov to evaluate different doses of SPN-812 and a placebo.
RESULTS
We pooled 1619 patients from five RCTs with a duration of 6-8 weeks. Patients (6-17 years old) in SPN-812 (100, 200, and 400 mg/d) groups were superior to the control group in all efficacy outcomes with lower attention-deficit/hyperactivity disorder rating scale-5 (ADHD-RS-5), Conners 3-parent short form composite T score (Conners 3-PS), Weiss functional impairment rating scale-parent (WFIRS-P), and increased clinical global impression-improvement (CGI-I) score (both < 0.05). At the same time, only SPN-812 300 mg/d did not show a significantly high risk of the adverse events (AEs) such as somnolence and decreased appetite ( = 0.09). There was no significant difference between placebo and SPN-812 groups (100, 200, and 400 mg/d) in serious adverse events (SAEs) such as syncope. The subgroup analyses showed that, both in children and adolescents subgroups, SPN-812 showed better efficacy than the placebo. The two age subgroups showed a significantly higher risk of AEs and an insignificant risk of SAEs than the placebo.
CONCLUSION
At present, SPN-812 (100, 200, and 400 mg/d) is superior to the corresponding control in efficacy measures. However, the safety problem cannot be ignored.
PubMed: 38137075
DOI: 10.3390/brainsci13121627 -
World Journal of Clinical Cases Dec 2023Heart failure (HF), an end-stage manifestation of various cardiac diseases, poses an enormous economic and health burden on society. Vericiguat may be an effective drug...
BACKGROUND
Heart failure (HF), an end-stage manifestation of various cardiac diseases, poses an enormous economic and health burden on society. Vericiguat may be an effective drug in the treatment of HF.
AIM
To explore by meta-analysis the efficacy and safety of Vericiguat in treating chronic heart failure.
METHODS
Databases, including PubMed, EMBASE, Web of Science, and Cochrane Library, were searched to collect all published randomized controlled trials (RCTs) on Vericiguat treatment of chronic heart failure from the earliest electronic records to those published in March 2023. Two investigators independently screened the literature according to inclusion and exclusion criteria, evaluated the quality of the studies, and extracted valid data before conducting a meta-analysis using RevMan5.4.
RESULTS
Four RCTs with 5919 patients were included, and the meta-analysis showed that treatment with 10 mg Vericiguat reduced the incidence of the primary endpoint (a composite of cardiovascular mortality and first heart-failure-related hospitalization) in patients with chronic heart failure compared to placebo [relative risk (RR) = 0.91, 95% confidence interval (CI): 0.85-0.98, = 0.01], and reduced the incidence of heart-failure-related hospitalization (RR = 0.92, 95%CI: 0.84-1.00, = 0.05). However, for the incidence of cardiovascular and all-cause death, there were no significant differences between the Vericiguat and placebo groups. In addition, the two groups did not show significant differences in blood pressure, heart rate, and Kansas Cardiomyopathy Questionnaire physical limitation score. In terms of safety, 10 mg Vericiguat did not increase the risk of adverse effects in patients with chronic heart failure. Vericiguat may increase the risk of symptomatic hypotension (RR = 1.17, 95%CI: 0.98-1.39, = 0.08) and syncope (RR = 1.18, 95%CI: 0.90-1.55, = 0.24), but not significantly.
CONCLUSION
Vericiguat (10 mg) was more effective than placebo in treating patients with chronic heart failure and had a better safety profile.
PubMed: 38130613
DOI: 10.12998/wjcc.v11.i35.8330 -
Diagnostics (Basel, Switzerland) Oct 2023Double-outlet left ventricle (DOLV) is an abnormal ventriculo-arterial connection characterized by the origin of both great arteries from the morphological left... (Review)
Review
Double-outlet left ventricle (DOLV) is an abnormal ventriculo-arterial connection characterized by the origin of both great arteries from the morphological left ventricle. The aim of our paper is to describe the morphological and imaging features of DOLV and to assess the prevalence of the associated malformations and their surgical outcomes. METHODS From 2011 to 2022, we retrospectively reviewed the electronic case records of patients diagnosed with DOLV at the Bambino Gesu Children's Hospital. A systematic search was developed in MEDLINE, Web of Science, and EMBASE databases to identify reports assessing the morphology and outcomes of DOLV between 1975 and 2023. RESULTS: Over a median follow-up of 9.9 years (IQR 7.8-11.7 y), four cases of DOLV were identified at our institution. Two patients were diagnosed with (S,D,D) DOLV subaortic VSD and pulmonary stenosis (PS): one patient had (S,D,D) DOLV with doubly committed VSD and hypoplastic right ventricle, and another patient had (S,D,L) DOLV with subaortic VSD and PS (malposition type). Pulmonary stenosis was the most commonly associated lesion (75%). LITERATURE REVIEW: After systematic evaluation, a total of 12 reports fulfilled the eligibility criteria and were included in our analysis. PS or right ventricular outflow tract obstruction was the most commonly associated lesion (69%, 95% CI 62-76%). The most common locations of VSD were subaortic (pooled prevalence: 75%, 95% CI 68-81), subpulmonary (15%, 95% CI 10-21), and doubly committed (7%, 95% CI 4-12). The position of the great arteries showed that d-transposition of the aorta was present in 128 cases (59% 95% CI 42-74), and l-transposition was present in 77 cases (35%, 95% CI 29-43).
PubMed: 37891996
DOI: 10.3390/diagnostics13203175 -
Cureus Sep 2023Paroxysmal supraventricular arrhythmias are a group of common rhythm disturbances that are often prevalent, frequently recurrent, sporadic, and life-threatening. These... (Review)
Review
Paroxysmal supraventricular arrhythmias are a group of common rhythm disturbances that are often prevalent, frequently recurrent, sporadic, and life-threatening. These arrhythmias are precipitated by factors such as age, sex, and associated comorbidities. Typically, patients with paroxysmal arrhythmias are asymptomatic during evaluation, and the condition is often detected incidentally. Symptoms associated with these arrhythmias include palpitations, fatigue, light-headedness, chest discomfort, dyspnea, presyncope, and, less commonly, polyuria and serious psychological distress. In terms of treatment, common modalities include antiarrhythmic drug therapy and catheter ablation. When selecting drug therapy, factors such as comorbidities, patient-specific modifiers, preferences, follow-up frequency, and cost-effectiveness are taken into account. For long-term treatment, calcium channel blockers are often used instead of adenosine, while adenosine is preferred for acute attacks due to its higher efficacy. Comparatively, adenosine and verapamil are commonly used drugs in the emergency setting to treat paroxysmal supraventricular tachycardia (PSVT). Adenosine exhibits a faster onset of action, but adverse effects occur more commonly, whereas verapamil has a slower onset of action and a lower incidence of adverse effects. We searched for articles from PubMed, PubMed Central (PMC), and Science Direct, and these articles were reviewed systematically. After applying the search strategy to these databases, 195 articles were identified. Fourteen of these were finalized for review. The efficacy of adenosine versus verapamil in terminating acute attacks of PSVT is reviewed in our article.
PubMed: 37885520
DOI: 10.7759/cureus.45946 -
The Journals of Gerontology. Series A,... Feb 2024Falls are a common cause of injury, hospitalization, functional decline, and residential care admission among older adults. Cardiovascular disorders are recognized risk... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Falls are a common cause of injury, hospitalization, functional decline, and residential care admission among older adults. Cardiovascular disorders are recognized risk factors for falls. This systematic review assesses the association between cardiovascular disorders and falls in older adults.
METHODS
Systematic searches were conducted on MEDLINE and Embase, encompassing all literature published prior to December 31, 2022. Included studies addressed persons aged 50 years and older, and assessed the association between cardiovascular disorders and falls or the efficacy of cardiovascular-based interventions to reduce falls. Two reviewers independently extracted data and assessed study quality utilizing a modified Newcastle-Ottawa scale for observational studies, and the Cochrane Risk of Bias 2 tool for interventional studies. A systematic narrative analysis of all cardiovascular outcomes, and meta-analyses of unadjusted odds ratios (ORs) were performed.
RESULTS
One hundred and eighty-four studies were included: 181 observational and 3 interventional. Several cardiovascular disorders, including stroke, coronary artery disease, valvular heart disease, arterial stiffness, arrhythmia, orthostatic hypotension, and carotid sinus hypersensitivity, were consistently associated with falls. In meta-analysis of unadjusted ORs, the largest positive pooled associations with falls during a 12-month reporting interval were for stroke (OR: 1.90, 95% confidence interval [CI]: 1.70-2.11), peripheral arterial disease (OR: 1.82, 95% CI: 1.12-2.95), atrial fibrillation (OR: 1.52, 95% CI: 1.27-1.82), and orthostatic hypotension (OR: 1.39, 95% CI: 1.18-1.64).
CONCLUSIONS
Several cardiovascular disorders are associated with falls. These results suggest the need to incorporate cardiovascular assessments for patients with falls. This review informed the cardiovascular recommendations in the new World Guidelines for falls in older adults.Clinical Trials Registration Number: CRD42021272245.
Topics: Humans; Middle Aged; Aged; Hypotension, Orthostatic; Accidental Falls; Cardiovascular Diseases; Risk Factors; Stroke
PubMed: 37738307
DOI: 10.1093/gerona/glad221 -
Cureus Aug 2023Sudden cardiac death (SCD) is a condition that accounts for a high percentage of cardiovascular fatalities, with ventricular tachyarrhythmias being the most common... (Review)
Review
Sudden cardiac death (SCD) is a condition that accounts for a high percentage of cardiovascular fatalities, with ventricular tachyarrhythmias being the most common cause. There are signs and symptoms of SCD that occur spontaneously without any warning and are deadly. Despite preventative efforts focusing on the use of subcutaneous implanted cardioverter defibrillators (S-ICD) in the highest-risk population categories, a high number of SCDs occur in the normal population and in people who do not have a documented cardiac condition. Therefore, primary prevention for SCD should be a more viable strategy for the general population, considering measures in the form of preventive medicine such as knowing more about any genetic predisposition, family history of any fatal arrhythmia, continuous surveillance after any syncope with unknown causes, etc. However, little data about SCD risk factors are known in comparison with other well-known diseases like ischemic heart disease and stroke. In search of medical databases for relevant medical literature, we looked at PubMed/Medline, the Cochrane Library, and Google Scholar. Thirteen publications were discovered after the papers were located, assessed, and qualifying criteria were applied. The finished articles were done to give an overview of SCD. Some others have shown that the major predisposition for SCD is related to the male gender, which increases the incidence if they have a family history of SCD. We described the importance of obstructive sleep apnea (OSA) as a comorbid condition. Patients with S-ICD and young athletes with a history of ventricular arrhythmia showed us that the predisposition for SCD can be higher than in the normal population. Based on the above, we concluded that more study is required to establish the most important approach for each of the risk factors mentioned in this systematic review in order to apply them in daily practice and have more knowledge about how to apply preventive and therapeutic medicine to the population at risk and the ones that already develop the disease.
PubMed: 37664320
DOI: 10.7759/cureus.42859 -
Texas Heart Institute Journal Aug 2023The study aimed to review differences in the presentation and outcomes of acute pulmonary embolism (PE) between men and women. (Meta-Analysis)
Meta-Analysis
BACKGROUND
The study aimed to review differences in the presentation and outcomes of acute pulmonary embolism (PE) between men and women.
METHODS
PubMed, CENTRAL, Web of Science, and Embase were searched for studies comparing clinical features or outcomes of PE between men and women. Baseline comorbidities, risk factors, clinical features, and mortality rates were also compared between men and women.
RESULTS
Fourteen studies were included. It was noted that men presented with PE at a statistically significantly younger age than women (P < .001). Smoking history (P < .001), lung disease (P = .004), malignancy (P = .02), and unprovoked PE (P = .004) were significantly more frequent among men than among women. There was no difference between the sexes for hypertension, diabetes, and a history of recent immobilization. A significantly higher proportion of men presented with chest pain (P = .02) and hemoptysis (P < .001), whereas syncope (P = .005) was more frequent in women. Compared with men, women had a higher proportion of high-risk PE (P = .003). There was no difference in the use of thrombolytic therapy or inferior vena cava filter. Neither crude nor adjusted mortality rates were significantly different between men and women.
CONCLUSION
This review found that the age at presentation, comorbidities, and symptoms of PE differed between men and women. Limited data also suggest that women more frequently had high-risk PE compared with men, but the use of thrombolytic therapy did not differ between the 2 sexes. Importantly, both crude and adjusted data show that the mortality rate did not differ between men and women.
Topics: Male; Humans; Female; Pulmonary Embolism; Risk Factors; Comorbidity; Neoplasms; Acute Disease
PubMed: 37577766
DOI: 10.14503/THIJ-23-8113 -
International Journal of Molecular... Jul 2023Despite recent advances in heart failure (HF) therapy, the risk of cardiovascular (CV) mortality, morbidity, and HF hospitalization (HFH) are major challenges in HF... (Review)
Review
Despite recent advances in heart failure (HF) therapy, the risk of cardiovascular (CV) mortality, morbidity, and HF hospitalization (HFH) are major challenges in HF treatment. We aimed to review the potential of vericiguat as a treatment option for HF. A systematic literature review was performed using the PubMed database and ClinicalTrials.gov. Four randomized controlled trials were identified, which study the safety and efficacy of vericiguat in HF patients. Vericiguat activates soluble guanylate cyclase (sGC) by binding to the beta-subunit, bypassing the requirement for NO-induced activation. The nitric oxide (NO)-sGC-cyclic guanosine monophosphate (cGMP) pathway plays an essential role in cardiovascular (CV) regulation and the protection of healthy cardiac function but is impaired in HF. Vericiguat reduced the risk of CV death and HFH in HF patients with reduced ejection fraction (HFrEF) but showed no therapeutic effect on HF with preserved ejection fraction (HFpEF). The trials demonstrated a favorable safety profile with most common adverse events such as hypotension, syncope, and anemia. Therefore, vericiguat is recommended for patients with HFrEF and a minimum systolic blood pressure of 100 mmHg. Treatment with vericiguat is considered when the individual patient experiences decompensation despite being on guideline-recommended medication, e.g., angiotensin-converting inhibitor/AT1 receptor antagonist, beta-adrenoceptor antagonist, spironolactone, and sodium-glucose transporter 2 inhibitors. Furthermore, larger studies are required to investigate any potential effect of vericiguat in HFpEF patients. Despite the limitations, vericiguat can be recommended for patients with HFrEF, where standard-of-care is insufficient, and the disease worsens.
Topics: Humans; Heart Failure; Treatment Outcome; Stroke Volume; Soluble Guanylyl Cyclase; Cardiotonic Agents; Diuretics
PubMed: 37511587
DOI: 10.3390/ijms241411826 -
Tomography (Ann Arbor, Mich.) Jul 2023Traditionally, mechanical thrombectomy performed for pulmonary embolism (PE) necessitates the utilization of iodinated contrast. Intravascular ultrasound (IVUS) has been... (Review)
Review
BACKGROUND
Traditionally, mechanical thrombectomy performed for pulmonary embolism (PE) necessitates the utilization of iodinated contrast. Intravascular ultrasound (IVUS) has been used as a diagnostic and therapeutic modality in the management of acute high and intermediate-risk PE. Recently, with the shortage of contrast supplies and the considerable incidence of contrast-induced acute kidney injury (CI-AKI), other safer and more feasible IVUS methods have become desirable. The purpose of this systematic review was to evaluate the importance of IVUS in patients with PE undergoing thrombectomy.
METHODS
Medline/PubMed, Embase, Scopus, and Google Scholar were searched for review studies, case reports, and case series. Clinical characteristics, outcomes and the usage of IVUS-guided mechanical thrombectomy during the treatment of acute high and intermediate-risk PE were examined in a descriptive analysis.
RESULTS
In this systematic review, we included one prospective study, two case series, and two case reports from July 2019 to May 2023. A total of 39 patients were evaluated; most were female (53.8%). The main presenting symptoms were dyspnea and chest pain (79.5%); three patients (7.9%) presented with syncope, one with shock and one with cardiac arrest. Biomarkers (troponin and BNP) were elevated in 94.6% of patients. Most patients (87.2%) had intermediate-risk PE, and 12.8% had high-risk PE. All patients presented with right-heart strain (RV/LV ratio ≥ 0.9, = 39). Most patients (56.4%) had bilateral PE. Mechanical thrombectomy was performed using IVUS without contrast utilization in 39.4% of the patients. After the initial learning curve, contrast usage decreased gradually over time. There was a significant decrease in the composite mean arterial pressure immediately following IVUS-guided thrombectomy from 35.1 ± 7.2 to 25.2 ± 8.3 mmHg ( < 0.001). Post-procedure, there was no reported (0%) CI-AKI, no all-cause mortality, no major bleeding, or other adverse events. There was a significant improvement in symptoms and RV function at the mean follow-up.
CONCLUSIONS
New evidence suggests that IVUS-guided mechanical thrombectomy is safe, with visualization of the thrombus for optimal intervention, and reduces contrast exposure.
Topics: Humans; Female; Male; Thrombolytic Therapy; Prospective Studies; Treatment Outcome; Pulmonary Embolism; Thrombectomy; Ultrasonography, Interventional
PubMed: 37489479
DOI: 10.3390/tomography9040111 -
Clinical Cardiology Jul 2023Vasovagal syncope (VVS) is the most prevalent type of syncope and its management includes pharmacologic and non-pharmacologic interventions. Recently, studies have... (Meta-Analysis)
Meta-Analysis Review
Vasovagal syncope (VVS) is the most prevalent type of syncope and its management includes pharmacologic and non-pharmacologic interventions. Recently, studies have investigated vitamin D levels in VVS patients. In this systematic review and meta-analysis, we aim to review these studies to find possible associations between vitamin D deficiency and vitamin D levels with VVS. International databases including Scopus, Web of Science, PubMed, and Embase were searched with keywords related to "vasovagal syncope" and "vitamin D." Studies were screened and the data were extracted from them. Random-effect meta-analysis was conducted to calculate the standardized mean difference (SMD) and 95% confidence interval (CI) for vitamin D levels in comparison to VVS patients and controls. Also, VVS occurrence was measured and the odds ratio (OR) and 95% CI were calculated for comparison of vitamin D deficient cases and nondeficient individuals. Six studies were included with 954 cases investigated. Meta-analysis showed that patients with VVS had significantly lower vitamin D serum levels in comparison to non-VVS cases (SMD -1.05, 95% CI -1.54 to -0.57, p-value < .01). Moreover, VVS occurrence was higher in vitamin D-deficient individuals (OR 5.43, 95% CI 2.40 to 12.27, p-value < .01). Our findings which show lower vitamin D levels in VVS patients can have clinical implications in order for clinicians to pay attention to this when approaching VVS. Further randomized controlled trials are certainly warranted to assess the role of vitamin D supplementation in individuals with VVS.
Topics: Humans; Tilt-Table Test; Syncope, Vasovagal; Syncope; Vitamin D Deficiency; Vitamin D
PubMed: 37226313
DOI: 10.1002/clc.24035