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Neuropsychopharmacology Reports Mar 2024This systematic review and frequentist network meta-analysis used random-effects models is conducted to determine whether there are differences in the efficacy,... (Meta-Analysis)
Meta-Analysis
AIM
This systematic review and frequentist network meta-analysis used random-effects models is conducted to determine whether there are differences in the efficacy, acceptability, tolerability, and safety profiles of brexpiprazole (BRE) and aripiprazole (ARI) for Japanese with major depressive disorder (MDD) who were inadequately responsive to antidepressants.
METHODS
Outcome measures were scores on the Montgomery Åsberg Depression Rating Scale (primary), the Clinical Global Impression severity scale, and social functioning scale; the non-response rate; the non-remission rate; all-cause discontinuation; discontinuation due to adverse events (DAE); at least one adverse event (1AE); serious adverse event, akathisia; tremor; weight gain.
RESULTS
A literature search identified three double-blind, randomized, placebo-controlled trials. These comprised one BRE study (with a 1 mg/day [BRE1] and a 2 mg/day [BRE2]) and two ARI studies (with a 3 mg/day arm and a flexible-dose arm[within the dosage range approved in Japan]) (n = 1736). Both BRE and ARI demonstrated better efficacy than the placebo. BRE but not ARI had a higher DAE than the placebo. ARI but not BRE had a higher 1AE than the placebo. BRE and ARI had a higher risk of akathisia and weight gain than the placebo. There were no significant differences between BRE and ARI for any of the outcomes. Although BRE1 had good efficacy, it carried risk of weight gain. Although BRE2 also had efficacy, it carried risks of DAE, akathisia, and weight gain. However, the risk of akathisia in BRE2 was reduced by an initial dose of 0.5 mg/day rather than 1.0 mg/day.
CONCLUSIONS
Overall BRE showed similar utility to ARI and a good risk-benefit balance.
Topics: Humans; Aripiprazole; Depressive Disorder, Major; Japan; Psychomotor Agitation; Network Meta-Analysis; Weight Gain; Randomized Controlled Trials as Topic; Thiophenes; Quinolones
PubMed: 38219278
DOI: 10.1002/npr2.12414 -
Global Spine Journal Sep 2023Literature review and meta-analysis.
STUDY DESIGN
Literature review and meta-analysis.
OBJECTIVES
Single-center series may be underpowered to detect whether high-dose (HD) tranexamic acid (TXA) confers a higher risk of complications. We sought to determine the safety and efficacy of HD TXA as compared to low-dose (LD) or placebo.
METHODS
A systematic literature review was performed to find studies where spine surgery patients were given HD TXA (loading dose ≥30 mg/kg). Complication rates were pooled, and meta-analyses performed on outcomes of interest. Articles were evaluated for risk of bias and a strength of evidence assessment was given for each conclusion.
RESULTS
Twenty three studies (n = 2331) were included. The pooled medical complication rate was 3.2% in pediatric patients, 8.2% in adults. Using lower dose TXA or placebo as the reference, meta-analysis showed no difference in medical complications (n = 1,723, OR 1.22 [95% CI, .78 to 1.22]; = .388; I = 0%) or thrombotic events (n = 1158 patients, OR 1.27 [95% CI, .71 to 2.63]; = .528; I = 0%). Compared to LD, HD TXA was associated with less intraoperative blood loss (823 patients, WMD = -285 [95% CI, -564 to -5.90]; = .0454; I = 86%), fewer perioperative transfusions (n = 505, OR .28 [95% CI, .082 to .96]; = .043; I = 76%) and lower perioperative transfusion volumes (n = 434, WMD -227.7 mL [95% CI, -377.3 to -78.02]; = .0029; I = 0%).
CONCLUSION
Compared to LD TXA or placebo, there is moderate evidence that HD is not associated with an increased risk of medical complications. Compared to LD, there is moderate evidence that HD reduces transfusion requirements. High-Dose TXA can be safely utilized in healthy patients undergoing major spine surgery.
PubMed: 36592635
DOI: 10.1177/21925682221148686 -
EClinicalMedicine Jul 2023Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease with poor prognosis and a high economic burden for individuals and healthcare resources....
BACKGROUND
Idiopathic pulmonary fibrosis (IPF) is a progressive interstitial lung disease with poor prognosis and a high economic burden for individuals and healthcare resources. Studies of the costs associated with the efficiency of IPF medications are scarce. We aimed to conduct a network meta-analysis (NMA) and cost-effectiveness analysis to identify the optimum pharmacological strategy among all currently available IPF regimens.
METHODS
We first performed a systematic review and network meta-analysis. We searched eight databases for eligible randomised controlled trials (RCTs) published, in any language, between January 1, 1992 and July 31, 2022, that investigated the efficacy or tolerability (or both) of drug therapies for the treatment of IPF. The search was updated on February 1, 2023. Eligible RCTs were enrolled, with no restriction on dose, duration, or length of follow-up, if they included at least one of: all-cause mortality, acute exacerbation rate, disease progression rate, serious adverse events, and any adverse events under investigation. A subsequent Bayesian NMA within random-effects models was performed, followed by a cost-effectiveness analysis using the data obtained from our NMA, by developing a Markov model from the US payer's perspective. Assumptions were checked by deterministic and probabilistic sensitivity approaches to identify sensitive factors. We prospectively registered the protocol (CRD42022340590) in PROSPERO.
FINDINGS
51 publications comprising 12,551 participants with IPF were analysed for the NMA, and the findings indicated that pirfenidone and -acetylcysteine (NAC) + pirfenidone were the most efficacious and tolerable. The pharmacoeconomic analysis showed that NAC + pirfenidone was associated with the highest potentiality of being cost-effective at willingness-to-pay (WTP) thresholds of US$150,000 and $200,000, on the basis of quality-adjusted life years (QALYs), disability-adjusted life years (DALYs) and mortality, with the probability ranging from 53% to 92%. NAC was the minimum cost agent. Compared with placebo, NAC + pirfenidone improved effectiveness by increasing QALYs by 7.02, and reducing DALYs by 7.10 and deaths by 8.40, whilst raising overall costs by $516,894.
INTERPRETATION
This NMA and cost-effectiveness analysis suggests that NAC + pirfenidone is the most cost-effective option for treatment of IPF at WTP thresholds of $150,000 and $200,000. However, given that clinical practice guidelines have not addressed the application of this therapy, large well-designed and multicentre trials are warranted to provide a better picture of IPF management.
FUNDING
None.
PubMed: 37434745
DOI: 10.1016/j.eclinm.2023.102071 -
Advances in Therapy Jul 2023Randomized controlled trials (RCTs) of biologics in patients with severe, uncontrolled asthma have shown differential results by baseline blood eosinophil count (BEC).... (Review)
Review
INTRODUCTION
Randomized controlled trials (RCTs) of biologics in patients with severe, uncontrolled asthma have shown differential results by baseline blood eosinophil count (BEC). In the absence of head-to-head trials, we describe the effects of biologics on annualized asthma exacerbation rate (AAER) by baseline BEC in placebo-controlled RCTs. Exacerbations associated with hospitalization or an emergency room visit, pre-bronchodilator forced expiratory volume in 1 s, Asthma Control Questionnaire score, and Asthma Quality of Life Questionnaire score were also summarized.
METHODS
MEDLINE (via PubMed) was searched for RCTs of biologics in patients with severe, uncontrolled asthma and with AAER reduction as a primary or secondary endpoint. AAER ratios and change from baseline in other outcomes versus placebo were compared across baseline BEC subgroups. Analysis was limited to US Food and Drug Administration-approved biologics.
RESULTS
In patients with baseline BEC ≥ 300 cells/μL, AAER reduction was demonstrated with all biologics, and other outcomes were generally improved. In patients with BEC 0 to < 300 cells/μL, consistent AAER reduction was demonstrated only with tezepelumab; improvements in other outcomes were inconsistent across biologics. In patients with BEC 150 to < 300 cells/μL, consistent AAER reduction was demonstrated with tezepelumab and dupilumab (300 mg dose only), and in those with BEC 0 to < 150 cells/μL, AAER reduction was demonstrated only with tezepelumab.
CONCLUSION
The efficacy of all biologics in reducing AAER in patients with severe asthma increases with higher baseline BEC, with varying profiles across individual biologics likely due to differing mechanisms of action.
Topics: Humans; Eosinophils; Anti-Asthmatic Agents; Biological Products; Asthma; Leukocyte Count; Eosinophilia; Double-Blind Method
PubMed: 37233876
DOI: 10.1007/s12325-023-02514-0 -
BMC Urology Mar 2024The effectiveness of immunosuppressive and corticosteroid treatments for Immunoglobulin A (IgA) nephropathy (IgAN) remains thoroughly evaluated. We undertook a... (Meta-Analysis)
Meta-Analysis
BACKGROUND AND OBJECTIVE
The effectiveness of immunosuppressive and corticosteroid treatments for Immunoglobulin A (IgA) nephropathy (IgAN) remains thoroughly evaluated. We undertook a meta-analysis to investigate the efficacy and safety of low-dose corticosteroids plus leflunomide for progressive IgA nephropathy.
METHODS
Eligible studies were obtained from PubMed, Embase, and Cochrane Library databases. We also searched the references of the included studies. Our protocol followed the preferred reporting items for systematic reviews and meta-analyses (PRISMA) checklist. Eligibility criteria were defined using a PICOS framework.
RESULTS
Our study included three articles presenting 342 patient cases. Findings revealed that low-dose corticosteroids combined with the leflunomide group were effective in relieving urine protein excretion (UPE) [mean difference (MD) = -0.35, 95% confidence interval (CI): -0.41 to -0.30, P < 0.00001] compared with the full-dose corticosteroids group. Regarding serum creatinine (SCr), estimated glomerular filtration rate (eGFR), complete remission rate, and overall response rate, there was no difference between the groups (p > 0.05). Regarding safety, low-dose corticosteroids combined with leflunomide significantly reduced the risk of serious adverse events [odds ratio (OR): 0.11, 95% CI: 0.01 to 0.91, P = 0.04]. Besides, no significant differences were observed between the two groups in the incidence of respiratory infection, abnormal liver function, diarrhea, herpes zoster, alopecia, pruritus, insomnia, pneumonia, diabetes, and urinary tract infection (P > 0.05).
CONCLUSIONS
Low-dose corticosteroids combined with leflunomide are a safe and effective treatment for progressive IgA nephropathy.
TRIAL REGISTRATION
The PROSPERO registration number is CRD42022361883.
Topics: Humans; Leflunomide; Glomerulonephritis, IGA; Immunosuppressive Agents; Adrenal Cortex Hormones; Glomerular Filtration Rate
PubMed: 38468247
DOI: 10.1186/s12894-024-01438-3 -
Cardiovascular Therapeutics 2023Optimal antithrombotic therapy during the chronic maintenance period in patients with coronary artery disease (CAD) is unknown. We compared five kinds of mainstream... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Optimal antithrombotic therapy during the chronic maintenance period in patients with coronary artery disease (CAD) is unknown. We compared five kinds of mainstream chronic maintenance antithrombotic strategies at least one year after the acute phase: aspirin alone, clopidogrel alone, ticagrelor alone, continued dual antiplatelet therapy (DAPT) for a period of time, and maintenance with aspirin combined with a low-dose anticoagulant such as rivaroxaban.
METHODS
Ten randomized, controlled trials were selected using PubMed, Ovid MEDLINE, Embase, and Cochrane library through February 2023. The primary outcome was main adverse cardiac events (MACEs), and secondary outcomes include net adverse clinical events (NACEs), cardiac death, all-cause death, ischemic stroke, stent thrombosis, total bleeding, and major bleeding. A network meta-analysis was conducted with a random-effects model. Data extraction was performed by three independent reviewers.
RESULTS
Our search identified ten eligible randomized controlled trials enrolling a total of 82,084 patients comparing different chronic maintenance antithrombotic strategies. As for the primary endpoint, there was no statistical difference in MACE outcomes between any two of the five methods. As for the secondary endpoint, there was no statistical difference in NACE, major bleeding, all-cause death, cardiac death, and stent thrombosis between any two methods. The aspirin plus low-dose rivaroxaban group had a lower incidence of ischemic stroke compared to the aspirin group (OR = 0.49, 95% CrI 0.26-0.91). And the prolonged DAPT group had a higher total bleeding rate compared to aspirin group (OR = 2.4, 95% CrI 1.1-5.9).
CONCLUSIONS
In terms of MACE, NACE, all-cause death, cardiac death, stent thrombosis, and major bleeding, there were no significant differences between using aspirin alone, clopidogrel alone, and ticagrelor alone; extending DAPT duration; and using aspirin combined with low-dose rivaroxaban for chronic maintenance antithrombotic regimens. However, choosing aspirin combined with low-dose rivaroxaban can reduce the incidence of ischemic stroke, and prolonged DAPT may have a higher rate of total bleeding. However, it is important to note that this study is based on indirect comparisons, and there is currently a lack of direct evidence comparing various maintenance antiplatelet therapy regimens. Further high-quality studies are needed to address this gap and provide more conclusive evidence on the comparative effectiveness of different maintenance antiplatelet strategies.
Topics: Humans; Coronary Artery Disease; Network Meta-Analysis; Rivaroxaban; Clopidogrel; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Ticagrelor; Ischemic Stroke; Aspirin
PubMed: 37636560
DOI: 10.1155/2023/5446271 -
BMJ Open Jan 2024The objective of the current study is to compare the treatment effects of different vitamins on essential hypertension to provide an initial basis for developing... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
The objective of the current study is to compare the treatment effects of different vitamins on essential hypertension to provide an initial basis for developing evidence-based practices.
DESIGN
Systematic review and network meta-analysis.
DATA SOURCES
Five electronic databases (PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials and ClinicalTrials.gov) were searched from their inception to 25 September 2023.
OUTCOMES
The primary outcomes were the difference between the intervention group and the control group in changes in office systolic blood pressure (SBP) and office diastolic blood pressure (DBP) from baseline. The secondary outcomes were the difference between the intervention group and the control group in changes in 24-hour mean ambulatory systolic blood pressure (24 hours SBP), 24-hour mean ambulatory diastolic blood pressure (24 hours DBP) and heart rate (HR) from baseline.
RESULTS
A total of 23 studies comparing five vitamins (vitamin B, vitamin C, vitamin D, vitamin E, folic acid) and involving 2218 participants were included. The included trials were all vitamin versus placebo, so the network was star-shaped. Among the five vitamins, only vitamin E was significantly more effective at reducing SBP (mean difference: -14.14 mm Hg, 95% credible intervals: -27.62 to -0.88) than placebo. In addition, no evidence was found that any of the five vitamins influenced DBP, 24 hours SBP, 24 hours DBP, or HR. The dose of vitamins, geographical region and percentage of males (only SBP) might be sources of heterogeneity. Sensitivity and subgroup analysis revealed that the effect of vitamin intervention on blood pressure varies according to different doses of vitamins.
CONCLUSIONS
According to the results, vitamin E might be an effective measure to reduce SBP, but more research is needed to validate this finding.
PROSPERO REGISTRATION NUMBER
CRD42022352332.
Topics: Adult; Male; Humans; Vitamin D; Ascorbic Acid; Hypertension; Folic Acid; Riboflavin; Vitamin E; Network Meta-Analysis; Vitamins; Essential Hypertension; Blood Pressure; Vitamin A; Vitamin K
PubMed: 38296289
DOI: 10.1136/bmjopen-2023-074511 -
Heliyon Sep 2023As a nutritious food, Tart cherries ( L) benefit cardiovascular health. This study aims to clarify the effectiveness of Tart cherry in controlling blood pressure, heart... (Review)
Review
Dose-dependent effect of tart cherry on blood pressure and selected inflammation biomarkers: A GRADE-assessed systematic review and meta-analysis of randomized controlled trials.
OBJECTIVES
As a nutritious food, Tart cherries ( L) benefit cardiovascular health. This study aims to clarify the effectiveness of Tart cherry in controlling blood pressure, heart rate, and inflammatory biomarkers, the appropriate dosage for this effect, and suggest directions for future studies.
METHODS
PubMed, Scopus, and Web of Science were searched (up to May 2022), to identify eligible randomized controlled trials. It measured publication bias and was assessed for all outcomes. Evidence quality was evaluated using the Cochrane risk of bias tool and GRADE (Grades of Recommendations, Assessment, Development, and Evaluations)
RESULTS
Regarding the 21 included trials, Tart cherry didn't affect blood pressure, heart rate, high-sensitive C-reactive protein, and interleukin-6 (P > 0.05). In contrast, with moderate certainty, it can reduce serum C-reactive protein (WMD: - 0.39 mg/l; 95% CI: - 0.74, - 0.05; P = 0.024) and with very low certainty can decrease tumor necrosis factor-alpha (WMD: - 0.14 pg/ml; 95% CI: - 0.27, - 0.02; P = 0.026). In addition, dose-response analysis implies that with each 30 ml elevation in dose, CRP reduces by 0.19 mg/l (95% CI: - 0.37, - 0.01).
CONCLUSIONS
Tart cherry can control inflammation by administering the proper dose. Even though tart cherry generally doesn't affect blood pressure and heart rate, further high-quality studies are needed to determine its effect.
PubMed: 37809623
DOI: 10.1016/j.heliyon.2023.e19987 -
The Journal of Maternal-fetal &... Dec 2023There is ongoing interest in glucocorticoid treatment during oocyte stimulation to treat infertility in women who have undergone Assisted Reproductive Technology (ART). (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There is ongoing interest in glucocorticoid treatment during oocyte stimulation to treat infertility in women who have undergone Assisted Reproductive Technology (ART).
OBJECTIVE
This meta-analysis was performed to evaluate the efficiency and safety of adjuvant glucocorticoid therapy on pregnancy outcomes in infertile women undergoing ART cycles.
STUDY DESIGN
A literature search was performed in PubMed, EMBASE, Web of Science, and the Cochrane Library up to December 2022. To assess the efficacy and safety of additional glucocorticoid treatment during ovulation induction in women who underwent IVF or ICSI treatment, only randomized controlled trials were included.
RESULTS
Overall, glucocorticoid therapy during ovulation showed a nonsignificant effect of prednisolone improving the live birth rate (OR = 1.03, 95% CI [.75, 1.43], I = .0%, = .84), abortion rate (OR = 1.14, 95% CI [.62, 2.08], I = 31%, = .68), and implantation rate (OR = 1.1, 95% CI [.82, 1.5], I = 8%, = .52) of infertile women compared to the control group. The present meta-analysis revealed that the clinical pregnancy rate per cycle tended to increase after glucocorticoid treatment (OR = 1.29, 95% CI [1.02, 1.63], I = 8%, = .52).
CONCLUSIONS
The present meta-analysis suggested that ovarian stimulation prednisolone therapy does not significantly improve clinical outcomes in women undergoing IVF/ICSI. Although the results indicated that adjuvant glucocorticoid therapy during ovarian stimulation may increase the clinical pregnancy rate, subgroup analysis showed that it was affected by infertility factors, dose schedules, and length of treatment. Therefore, these results should be interpreted with caution.
Topics: Female; Pregnancy; Humans; Glucocorticoids; Infertility, Female; Ovulation Induction; Prednisolone; Adjuvants, Pharmaceutic; Dietary Supplements
PubMed: 37385781
DOI: 10.1080/14767058.2023.2227310 -
BMC Pregnancy and Childbirth Apr 2024The objective was to assess the efficacy and safety of low-dose aspirin for the prevention of preterm birth in nulliparous women. (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The objective was to assess the efficacy and safety of low-dose aspirin for the prevention of preterm birth in nulliparous women.
DATA SOURCES
We searched PubMed, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to June 2022.
STUDY ELIGIBILITY CRITERIA
Randomized controlled trials that compared aspirin to placebo in nulliparous women were eligible.
METHODS
This study was reported in accordance with the PRISMA 2020 checklist. The primary outcomes of this study were the rates of preterm birth at less than 37 weeks and less than 34 weeks of gestation. The secondary outcomes included postpartum hemorrhage, placental abruption, cesarean section, any hypertensive disorder of pregnancy and small for gestational age. Relative risks with their 95% confidence intervals were calculated for analysis. Heterogeneity was assessed by Cochran's Q test and Higgins's I. A random-effects model was used when I was > 50% to generate the RR and 95% CI; otherwise, a fixed-effects model was used. The risk of publication bias was assessed by funnel plots. We performed sensitivity analysis by sequentially omitting each included study to confirm the robustness of the analysis.
RESULTS
Seven studies with a total of 29,029 participants were included in this review. Six studies were assessed as having a low risk of bias or an unclear risk of bias, and one study was judged as having a high risk of bias. In nulliparous women, low-dose aspirin was associated with a significant reduction in the rate of preterm birth at less than 34 weeks of gestational age (RR 0.84,95% CI: 0.71-0.99; I = 0%; P = 0.04), but we did not observe a significant difference in the rate of preterm birth at less than 37 weeks of gestation (RR 0.96,95% CI: 0.90-1.02; I = 31%; P = 0.18). Low-dose aspirin was associated with a significant increase in the rates of postpartum hemorrhage (RR 1.32,95% CI: 1.14-1.54; I = 0%; P = 0.0003), placental abruption (RR 2.18,95% CI: 1.10-4.32; I = 16%; P = 0.02) and cesarean section (RR 1.053, 95% CI: 1.001-1.108; I = 0%; P = 0.05) in nulliparous women. We also did not observe a significant effect of low-dose aspirin on the rates of any hypertensive disorder of pregnancy (RR 1.05, 95% CI: 0.96-1.14; I = 9%; P = 0.28) or small for gestational age (RR 0.96, 95% CI: 0.91-1.02; I = 0%; P = 0.16) in nulliparous women. Funnel plots indicated that no significant publication bias existed in this meta-analysis. Except for preterm birth at less than 34 weeks of gestation, placental abruption and cesarean section, the sensitivity analysis showed similar results, which confirmed the robustness of this meta-analysis.
CONCLUSIONS
Low-dose aspirin might reduce the risk of preterm birth at less than 34 weeks of gestation in nulliparous women. The use of low-dose aspirin in nulliparous women increased the risk of postpartum hemorrhage and might increase the risk of placental abruption and cesarean section.
Topics: Female; Pregnancy; Infant, Newborn; Humans; Premature Birth; Abruptio Placentae; Cesarean Section; Postpartum Hemorrhage; Placenta; Aspirin; Hypertension; Randomized Controlled Trials as Topic
PubMed: 38605330
DOI: 10.1186/s12884-024-06413-2