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1.
Int J Cardiol ; 416: 132510, 2024 Dec 01.
Article in English | MEDLINE | ID: mdl-39222885

ABSTRACT

BACKGROUND: Despite a large body of evidence supporting the use of intravascular imaging (IVI) to guide percutaneous coronary intervention (PCI), concerns exist about its universal recommendation. The selective use of IVI to guide PCI of complex lesions and patients is perceived as a rational approach. METHODS: We performed a systematic review and meta-analysis of randomized controlled trials (RCTs). Embase, PubMed, and Cochrane were systematically searched for RCTs that compared IVI-guided PCI with angiography-guided PCI in high-risk patients and complex coronary anatomies. The primary outcome was major adverse cardiac events (MACE). A random-effects model was used to calculate the risk ratios (RRs) with 95 % confidence intervals (CIs). RESULTS: A total of 15 RCTs with 14,109 patients were included and followed for a weighted mean duration of 15.8 months. IVI-guided PCI was associated with a decrease in the risk of MACE (RR: 0.65; 95 % CI: 0.56-0.77; p < 0.01), target vessel failure (TVF) (RR: 0.66; 95 % CI: 0.52-0.84; p < 0.01), all-cause mortality (RR: 0.71; 95 % CI: 0.55-0.91; p < 0.01), cardiovascular mortality (RR: 0.47; 95 % CI: 0.34-0.65; p < 0.01), stent thrombosis (RR: 0.55; 95 % CI: 0.38-0.79; p < 0.01), myocardial infarction (RR: 0.81; 95 % CI: 0.67-0.98; p = 0.03), and repeated revascularizations (RR: 0.70; 95 % CI: 0.58-0.85; p < 0.01) compared with angiography. There was no significant difference in procedure-related complications (RR: 1.03; 95 % CI: 0.75-1.42; p = 0.84) between groups. CONCLUSIONS: Compared with angiographic guidance alone, IVI-guided PCI of complex lesions and high-risk patients significantly reduced all-cause and cardiovascular mortality, MACE, TVF, stent thrombosis, myocardial infarction, and repeat revascularization.


Subject(s)
Coronary Angiography , Percutaneous Coronary Intervention , Surgery, Computer-Assisted , Ultrasonography, Interventional , Humans , Coronary Angiography/adverse effects , Coronary Angiography/methods , Coronary Artery Disease/complications , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/mortality , Coronary Artery Disease/surgery , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Randomized Controlled Trials as Topic/methods , Ultrasonography, Interventional/adverse effects , Ultrasonography, Interventional/methods , Surgery, Computer-Assisted/adverse effects , Surgery, Computer-Assisted/methods
2.
Metabol Open ; 24: 100321, 2024 Dec.
Article in English | MEDLINE | ID: mdl-39318607

ABSTRACT

Aim: To assess the effects of once-weekly subcutaneous retatrutide on weight and metabolic markers and the occurrence of side effects in patients with overweight, obesity and/or type 2 diabetes (T2D). Methods: PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were systematically searched for placebo-controlled, randomized clinical trials (RCTs) published up until February 23, 2024. Weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) for binary endpoints were computed, with 95 % confidence intervals (CIs). Results: A total of three studies were included, comprising 640 patients, of whom 510 were prescribed retatrutide. Compared with placebo, retatrutide significantly reduced body weight (WMD -10.66 kg; 95 % CI -17.63, -3.69), body mass index (WMD -4.53 kg/m2; 95 % CI -7.51, -1.55), and waist circumference (WMD -6.61 cm; 95 % CI -13.17, -0.05). In addition, retatrutide significantly increased the proportion of patients who achieved a weight reduction of ≥5 % (RR 2.92; 95 % CI 2.17-3.93), ≥10 % (RR 9.32; 95 % CI 4.56-19.06), ≥15 % (RR 18.40; 95 % CI 6.00-56.42), and ≥20 % (RR 16.61; 95 % CI 4.17-66.12). Conclusions: In this meta-analysis, the use of once-weekly subcutaneous retatrutide was associated with a significant reduction in body weight and improvement of metabolic markers in patients with overweight, obesity and/or T2D, compared with placebo, with an increase in non-severe gastrointestinal and hypersensitivity adverse events. Phase 3 RCTs are expected to shed further light on the efficacy and safety of once-weekly subcutaneous retatrutide over the long term.

3.
Arq Bras Cardiol ; 121(7): e20230738, 2024 Jun.
Article in Portuguese, English | MEDLINE | ID: mdl-39082575

ABSTRACT

BACKGROUND: Vitamin K antagonists (VKAs) are the recommended first-line treatment for left ventricular thrombus (LVT); however, direct oral anticoagulants (DOACs) have been considered an alternative therapy. OBJECTIVES: To evaluate the efficacy and safety of DOACs compared with VKAs therapy in patients with LVT. METHODS: PubMed, Embase, and Cochrane were systematically searched for randomized clinical trials or cohort studies that compared DOACs versus VKAs for LVT. Risk ratios (RRs) were computed for binary endpoints, with 95% confidence intervals (95% CIs). Statistical significance was defined as p value < 0.05. RESULTS: A total of 4 randomized clinical trials and 29 cohort studies were included, with 4,450 patients assigned to either DOACs or VKAs. There was no significant difference between groups for stroke or systemic embolic (SSE) events (RR 0.84; 95% CI 0.65 to 1.07; p = 0.157), stroke (RR 0.73; 95% CI 0.48 to 1.11; p = 0.140), systemic embolic (SE) events (RR 0.69; 95% CI 0.40 to 1.17; p = 0.166), thrombus resolution (RR 1.05; 95% CI 0.99 to 1.11; p = 0.077), any bleeding (RR 0.78; 95% CI 0.60 to 1.00; p = 0.054), clinically relevant bleeding (RR 0.69; 95% CI 0.46 to 1.03; p = 0.066), minor bleeding (RR 0.73; 95% CI 0.43 to 1.23; p = 0.234), major bleeding (RR 0.87; 95% CI 0.42 to 1.80; p = 0.705), and all-cause mortality (RR 1.05; 95% CI 0.79 to 1.39; p = 0.752). Compared with VKAs, rivaroxaban significantly reduced SSE events (RR 0.35; 95% CI 0.16 to 0.91; p = 0.029) and SE events (RR 0.39; 95% CI 0.16 to 0.95; p = 0.037). CONCLUSIONS: DOACs had a similar rate of thromboembolic and hemorrhagic events, as well as thrombus resolution, compared to VKAs in the treatment of LVTs. Rivaroxaban therapy had a significant reduction in thromboembolic events, compared to VKAs.


Subject(s)
Anticoagulants , Heart Ventricles , Thrombosis , Vitamin K , Humans , Vitamin K/antagonists & inhibitors , Anticoagulants/therapeutic use , Thrombosis/drug therapy , Heart Ventricles/drug effects , Administration, Oral , Hemorrhage/chemically induced , Heart Diseases/drug therapy , Treatment Outcome , Stroke/drug therapy , Randomized Controlled Trials as Topic
4.
J Glaucoma ; 2024 Jul 17.
Article in English | MEDLINE | ID: mdl-39018052

ABSTRACT

PRCIS: Selective laser trabeculoplasty (SLT) and medical therapy groups displayed comparable intraocular pressure (IOP) at most follow-ups. SLT was associated with significantly decreased rates of glaucoma surgeries, antiglaucomatous medications, and ocular adverse effects. PURPOSE: To evaluate the efficacy and safety of selective laser trabeculoplasty (SLT) compared to medical therapy in the treatment of open-angle glaucoma (OAG) or ocular hypertension (OHT). METHODS: A systematic search was performed in PubMed, Embase, Cochrane Library and Web of Science databases. Randomized controlled trials (RCTs) comparing SLT with medical therapy were included. We computed mean differences (MDs) or standardized mean differences (STDs) for continuous endpoints and risk ratios (RRs) for binary endpoints, with 95% confidence intervals (CIs). Heterogeneity was assessed with I2 statistics. Software R, version 4.2.1, was used for statistical analyses. Subgroup analyses were performed on treatment-naive patients and on the class of drugs in the medical therapy group. RESULTS: Fourteen RCTs comprising 1,706 patients were included, of whom 936 were submitted to SLT. Medical therapy was associated with a significantly improved IOP at 1 month and a higher proportion of patients achieving ≥20% IOP reduction. There were no significant differences between groups in IOP at 2, 3, 6, and 12 months, IOP fluctuation, rate of eyes at target IOP, visual field, and quality of life. The SLT group exhibited significantly decreased rates of glaucoma surgeries, antiglaucoma medications, and ocular adverse effects. CONCLUSION: SLT demonstrated comparable efficacy to medical therapy in IOP control at most follow-ups, along with favorable impacts on critical treatment-related factors. Our findings support SLT as a safe and effective treatment for OAG or OHT.

6.
Arq. bras. cardiol ; Arq. bras. cardiol;121(7): e20230738, jun.2024. tab, graf
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1563932

ABSTRACT

Resumo Fundamento Os antagonistas da vitamina K (AVKs) são o tratamento de primeira linha recomendado para trombo ventricular esquerdo (TVE); entretanto, os anticoagulantes orais diretos (AODs) têm sido considerados uma terapia alternativa. Objetivos Avaliar a eficácia e a segurança dos AODs em comparação com a terapia com AVKs em pacientes com TVE. Métodos PubMed, Embase e Cochrane foram sistematicamente pesquisados em busca de ensaios clínicos randomizados ou estudos de coorte que comparassem AODs versus AVKs para TVE. As razões de risco (RR) foram calculadas para desfechos binários, com intervalos de confiança (IC) de 95%. A significância estatística foi definida como valor de p < 0,05. Resultados Foram incluídos um total de 4 ensaios clínicos randomizados e 29 estudos de coorte, com 4.450 pacientes designados para AODs ou AVKs. Não houve diferença significativa entre os grupos para acidente vascular cerebral ou eventos embólicos sistêmicos (AVC/EES) (RR 0,84; IC 95% 0,65 a 1,07; p = 0,157), acidente vascular cerebral (RR 0,73; IC 95% 0,48 a 1,11; p = 0,140), eventos embólicos sistêmicos (EES) (RR 0,69; IC 95% 0,40 a 1,17; p = 0,166), resolução do trombo (RR 1,05; IC 95% 0,99 a 1,11; p = 0,077), qualquer sangramento (RR 0,78; IC 95% 0,60 a 1,00; p = 0,054), sangramento clinicamente relevante (RR 0,69; IC 95% 0,46 a 1,03; p = 0,066), sangramento menor (RR 0,73; IC 95% 0,43 a 1,23; p = 0,234), sangramento maior (RR 0,87; IC 95% 0,42 a 1,80; p = 0,705) e mortalidade por todas as causas (RR 1,05; IC 95% 0,79 a 1,39; p = 0,752). Em comparação com AVKs, a rivaroxabana reduziu significativamente AVC/EES (RR 0,35; IC 95% 0,16 a 0,91; p = 0,029) e EES (RR 0,39; IC 95% 0,16 a 0,95; p = 0,037). Conclusões Os AODs tiveram uma taxa semelhante de eventos tromboembólicos e hemorrágicos, bem como de resolução do trombo, em comparação com os AVKs no tratamento de TVE. A terapia com rivaroxabana teve uma redução significativa nos eventos tromboembólicos, em comparação com os AVKs.


Abstract Background Vitamin K antagonists (VKAs) are the recommended first-line treatment for left ventricular thrombus (LVT); however, direct oral anticoagulants (DOACs) have been considered an alternative therapy. Objectives To evaluate the efficacy and safety of DOACs compared with VKAs therapy in patients with LVT. Methods PubMed, Embase, and Cochrane were systematically searched for randomized clinical trials or cohort studies that compared DOACs versus VKAs for LVT. Risk ratios (RRs) were computed for binary endpoints, with 95% confidence intervals (95% CIs). Statistical significance was defined as p value < 0.05. Results A total of 4 randomized clinical trials and 29 cohort studies were included, with 4,450 patients assigned to either DOACs or VKAs. There was no significant difference between groups for stroke or systemic embolic (SSE) events (RR 0.84; 95% CI 0.65 to 1.07; p = 0.157), stroke (RR 0.73; 95% CI 0.48 to 1.11; p = 0.140), systemic embolic (SE) events (RR 0.69; 95% CI 0.40 to 1.17; p = 0.166), thrombus resolution (RR 1.05; 95% CI 0.99 to 1.11; p = 0.077), any bleeding (RR 0.78; 95% CI 0.60 to 1.00; p = 0.054), clinically relevant bleeding (RR 0.69; 95% CI 0.46 to 1.03; p = 0.066), minor bleeding (RR 0.73; 95% CI 0.43 to 1.23; p = 0.234), major bleeding (RR 0.87; 95% CI 0.42 to 1.80; p = 0.705), and all-cause mortality (RR 1.05; 95% CI 0.79 to 1.39; p = 0.752). Compared with VKAs, rivaroxaban significantly reduced SSE events (RR 0.35; 95% CI 0.16 to 0.91; p = 0.029) and SE events (RR 0.39; 95% CI 0.16 to 0.95; p = 0.037). Conclusions DOACs had a similar rate of thromboembolic and hemorrhagic events, as well as thrombus resolution, compared to VKAs in the treatment of LVTs. Rivaroxaban therapy had a significant reduction in thromboembolic events, compared to VKAs.

7.
Heart Rhythm ; 21(9): 1604-1612, 2024 09.
Article in English | MEDLINE | ID: mdl-38705438

ABSTRACT

BACKGROUND: The optimal treatment of atrial fibrillation (AF) in patients with heart failure with reduced ejection fraction (HFrEF) remains unsettled. OBJECTIVE: The purpose of this study was to assess the efficacy of catheter ablation (CA) and medical therapy compared to medical therapy alone in patients with AF and HFrEF. METHODS: We performed a systematic review of randomized controlled trials (RCTs) comparing CA with guideline-directed medical therapy for AF in patients with HFrEF (left ventricular ejection fraction [LVEF] ≤ 40%). We systematically searched PubMed, Embase, and Cochrane for eligible trials. A random effects model was used to calculate the risk ratios (RRs) and mean differences (MDs), with 95% confidence intervals (CIs). RESULTS: Six RCTs comprising 1055 patients were included, of whom 530 (50.2%) were randomized to CA. Compared with medical therapy, CA was associated with a significant reduction in heart failure (HF) hospitalization (RR 0.57; 95% CI 0.45-0.72; P < .01), cardiovascular mortality (RR 0.46; 95% CI 0.31-0.70; P < .01), all-cause mortality (RR 0.53; 95% CI 0.36-0.78; P < .01), and AF burden (MD -29.8%; 95% CI -43.73% to -15.90%; P < .01). Also, there was a significant improvement in LVEF (MD 3.8%; 95% CI 1.6%-6.0%; P < .01) and quality of life (Minnesota Living with Heart Failure Questionnaire; MD -4.92 points; 95% CI -8.61 to -1.22 points; P < .01) in the ablation group. CONCLUSION: In this meta-analysis of RCTs of patients with AF and HFrEF, CA was associated with a reduction in HF hospitalization, cardiovascular mortality, and all-cause mortality as well as a significant improvement in LVEF and quality of life.


Subject(s)
Atrial Fibrillation , Catheter Ablation , Heart Failure , Stroke Volume , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/physiopathology , Atrial Fibrillation/surgery , Catheter Ablation/methods , Heart Failure/complications , Heart Failure/physiopathology , Heart Failure/surgery , Quality of Life , Randomized Controlled Trials as Topic , Stroke Volume/physiology , Treatment Outcome , Ventricular Function, Left/physiology
8.
J Stroke Cerebrovasc Dis ; 33(8): 107730, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38679214

ABSTRACT

OBJECTIVES: To provide an update on the effect of sodium-glucose cotransporter 2 (SGLT2) inhibitors on stroke in patients with type 2 diabetes (T2D). METHODS: PubMed, Embase, and Cochrane Library were systematically searched for randomized controlled trials (RCTs) comparing SGLT2 inhibitors versus placebo or other therapies in patients with T2D and reporting stroke endpoint. We computed the risk ratios (RRs) to binary endpoints, with 95 % confidence intervals (CIs). RESULTS: A total of 71 RCTs and 105,914 patients were included, of whom 62,488 (59 %) were randomized to the SGLT2 inhibitors group. The follow-up ranged from 12 weeks to 4.2 years. There were no significant differences between groups in all types of stroke (RR 0.96; 95 % CI 0.89-1.04), ischemic stroke (RR 0.89; 95 % CI 0.76-1.04), and transient ischemic attack (RR 0.96; 95 % CI 0.79-1.16). Patients on SGLT2 inhibitors experienced lower rates of hemorrhagic stroke (RR 0.62; 95 % CI 0.39-0.98). In the subgroup analysis of the type of drug, sotagliflozin significantly reduced all types of stroke (RR 0.74; 95 % CI 0.56-0.97). CONCLUSION: In this meta-analysis of 71 RCTs comprising 105,914 patients with T2D, SGLT2 inhibitors were not associated with a reduced risk of stroke and transient ischemic attack compared to placebo or other therapies; however, there was a trend toward reduced risk of hemorrhagic stroke. Among all SGLT2 inhibitors, sotagliflozin significantly reduced the risk of stroke.


Subject(s)
Diabetes Mellitus, Type 2 , Randomized Controlled Trials as Topic , Sodium-Glucose Transporter 2 Inhibitors , Stroke , Humans , Diabetes Mellitus, Type 2/drug therapy , Diabetes Mellitus, Type 2/complications , Diabetes Mellitus, Type 2/diagnosis , Sodium-Glucose Transporter 2 Inhibitors/therapeutic use , Sodium-Glucose Transporter 2 Inhibitors/adverse effects , Stroke/diagnosis , Stroke/drug therapy , Treatment Outcome , Risk Factors , Risk Assessment , Male , Female , Middle Aged , Aged , Hemorrhagic Stroke/diagnosis , Time Factors , Ischemic Stroke/diagnosis , Ischemic Stroke/drug therapy , Sodium-Glucose Transporter 2
9.
Climacteric ; 27(3): 245-254, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38619017

ABSTRACT

This systematic review and meta-analysis investigated the efficacy and safety of fezolinetant for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause. PubMed, Cochrane Library, Embase and Web of Science were searched for randomized controlled trials (RCTs) published from inception to June 2023, comparing fezolinetant to placebo in postmenopausal women suffering from moderate-to-severe VMS. The mean difference and risk ratio were calculated for continuous and binary outcomes, respectively. R software was used for the statistical analysis, and RoB-2 (Cochrane) to assess the risk of bias. We performed subgroup analysis based on different dosing regimens. Five RCTs comprising 3302 patients were included. Compared with placebo, at 12-week follow-up, fezolinetant significantly reduced the daily frequency of moderate-to-severe VMS (weighted mean difference [WMD] - 2.36; 95% confidence interval [CI] - 2.92, -1.81) and daily severity of moderate-to-severe VMS (WMD -0.22; 95% CI -0.31, -0.13). Also, fezolinetant significantly improved the quality of life (WMD -0.42; 95% CI -0.58, -0.26) and sleep disturbance (WMD -1.10; 95% CI -1.96, -0.24). There were no significant differences between groups in adverse events. These findings support the efficacy and safety of fezolinetant for the treatment of VMS related to menopause.


Subject(s)
Hot Flashes , Menopause , Humans , Female , Hot Flashes/drug therapy , Randomized Controlled Trials as Topic , Middle Aged , Treatment Outcome , Vasomotor System/drug effects , Quality of Life
10.
BMC Cancer ; 24(1): 240, 2024 Feb 21.
Article in English | MEDLINE | ID: mdl-38383390

ABSTRACT

BACKGROUND: The benefit of adding Zolbetuximab to the treatment in patients with Claudin-18 isoform 2 (CLDN18.2)-positive, human epidermal growth factor receptor 2-negative, locally advanced unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma (GC/GEJ) is not yet fully elucidated. METHODS: We searched PubMed, Embase and Cochrane databases for randomized controlled trials (RCTs) that investigated Zolbetuximab plus chemotherapy versus chemotherapy alone for GC or GEJ adenocarcinoma. We computed hazard-ratios (HRs) or odds-ratios (ORs) for binary endpoints, with 95% confidence intervals (CIs). RESULTS: Three studies and 1,233 patients were included. Comparing with Zolbetuximab plus chemotherapy versus chemotherapy alone, progression-free survival (PFS) rate (HR 0.64; 95% CI 0.49-0.84; p < 0.01) and overall survival (OS) rate (HR 0.72; 95% CI 0.62-0.83; p < 0.01) were significant in favor of the Zolbetuximab group. Regarding effectiveness, the Objective Response Rate (ORR) was (OR 1.15; 95% CI 0.87-1.53; p = 0.34). CONCLUSIONS: In this comprehensive systematic review and meta-analysis of RCTs, the incorporation of Zolbetuximab alongside chemotherapy offers a promising prospect for reshaping the established treatment paradigms for patients diagnosed with advanced CLDN18.2-positive GC/GEJ cancer.


Subject(s)
Adenocarcinoma , Esophageal Neoplasms , Stomach Neoplasms , Humans , Randomized Controlled Trials as Topic , Stomach Neoplasms/pathology , Antibodies, Monoclonal/adverse effects , Adenocarcinoma/pathology , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Esophagogastric Junction/pathology , Claudins
11.
Diabetes Technol Ther ; 26(4): 252-262, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38090767

ABSTRACT

Introduction: Continuous glucose monitoring (CGM) has shown favorable outcomes in patients with type 2 diabetes (T2D) who are on insulin therapy. However, the efficacy of CGM in managing glucose levels in noninsulin-treated people with T2D remains controversial. Methods: PubMed, Cochrane, and Embase were searched for randomized controlled trials (RCTs) comparing CGM to self-monitoring of blood glucose (SMBG) in people with T2D not using insulin. We computed weighted mean differences (WMDs) and standard mean differences (SMD) for continuous outcomes, with 95% confidence intervals (CIs). Heterogeneity was assessed using I2 statistics. Statistical analyses were performed using R version 4.2.3. Results: We included six RCTs comprising 407 noninsulin-treated people with T2D of whom 228 were randomized to CGM. Diabetes duration ranged from 5.4 to 13.9 years. The mean age was 57.9 years and the mean body mass index was 30.8 kg/m2. Four trials used real-time CGM (rt-CGM) and two intermittent scanning CGM (is-CGM). Compared with SMBG, CGM significantly reduced the glycated hemoglobin level (WMD -0.31%; 95% CI -0.42 to -0.21; I2 = 0%), glucose level (WMD -11.16 mg/dL; 95% CI -19.94 to -2.39; I2 = 0%), time in hypoglycemia level 2 (WMD -0.28%; 95% CI -0.52 to -0.03; I2 = 91%), glucose time >180 mg/dL (WMD -7.75%; 95% CI -12.04 to -3.45; I2 = 0%), and the standard deviation of glucose variation (WMD -4.00 mg/dL; 95% CI -6.86 to -1.14; I2 = 0%). CGM also increased time in range (WMD 8.63%; 95% CI 4.54-12.71; I2 = 0%) and treatment satisfaction (SMD 0.79; 95% CI 0.54-1.05; I2 = 0%). Conclusion: In this meta-analysis, rt-CGM and is-CGM were associated with improvement in glycemic control in people with T2D not using insulin when compared to SMBG.


Subject(s)
Diabetes Mellitus, Type 1 , Diabetes Mellitus, Type 2 , Humans , Middle Aged , Blood Glucose/analysis , Continuous Glucose Monitoring , Randomized Controlled Trials as Topic , Diabetes Mellitus, Type 2/drug therapy , Insulin/therapeutic use , Blood Glucose Self-Monitoring , Insulin, Regular, Human
12.
Arch. endocrinol. metab. (Online) ; 68: e230280, 2024. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1556938

ABSTRACT

ABSTRACT The aim of this study was to assess the efficacy and safety of hybrid closed-loop (HCL) systems for insulin delivery in children and adolescents with type 1 diabetes (T1D). We searched Embase, PubMed, and Cochrane Library for randomized controlled trials (RCTs) published until March 2023 comparing the HCL therapy with control therapies for children and adolescents with T1D. We computed weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) with 95% confidence intervals (CIs) for binary endpoints. Four RCTs and 501 patients were included, of whom 323 were randomized to HCL therapy. Compared with control therapies, HCL significantly improved the period during which glucose level was 70-180 mg/dL (WMD 10.89%, 95% CI 8.22-13.56%) and the number of participants with glycated hemoglobin (HbA1c) level < 7% (RR 2.61, 95% CI 1.29-5.28). Also, HCL significantly reduced the time during which glucose level was > 180 mg/dL (WMD -10.46%, 95% CI -13.99 to -6.93%) and the mean levels of glucose (WMD -16.67 mg/dL, 95% CI -22.25 to -11.09 mg/dL) and HbA1c (WMD -0.50%, 95% CI -0.68 to -0.31). There were no significant differences between therapies regarding time during which glucose level was < 70 mg/dL or <54 mg/dL or number of episodes of ketoacidosis, hyperglycemia, and hypoglycemia. In this meta-analysis, HCL compared with control therapies was associated with improved time in range and HbA1c control in children and adolescents with T1D and a similar profile of side effects. These findings support the efficacy of HCL in the treatment of T1D in this population.

13.
Int Urol Nephrol ; 56(6): 2001-2010, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38153665

ABSTRACT

PURPOSE: Patients with atrial fibrillation (AF) and end-stage renal disease on chronic hemodialysis are at risk for thromboembolic and bleeding events. We aimed to perform a meta-analysis to evaluate the safety and efficacy of direct oral anticoagulants (DOACs) compared with vitamin K antagonists (VKAs) in this population. METHODS: We systematically searched PubMed, Excerpta Medica Database (EMBASE) and Cochrane Library for randomized controlled trials (RCTs) comparing DOACs with VKAs in patients with AF on chronic hemodialysis from inception to February 2023 in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Outcomes were reported using risk ratios (RRs) with 95% confidence intervals (CIs). Statistical analyses were performed using R version 4.2.2. RESULTS: We selected three RCTs including 341 patients, of whom 176 (51.6%) were randomized to DOACs. Follow-up ranged from 174 days to 3.38 years. There was no significant difference between groups in terms of cardiovascular mortality (RR 1.34; 95% CI 0.69-2.60; p = 0.39), all-cause mortality (RR 0.96; 95% CI 0.72-1.27; p = 0.77), ischemic/uncertain type of stroke or transient ischemic attack (RR 0.50; 95% CI 0.19-1.35; p = 0.17), or major or life-threatening bleeding (RR 0.70; 95% CI 0.39-1.25; p = 0.22). CONCLUSION: In this meta-analysis of three RCTs, no significant difference was observed between DOACs and VKAs in cardiovascular mortality, all-cause mortality, ischemic/uncertain type of stroke or transient ischemic attack, or major or life-threatening bleeding in patients with AF on chronic hemodialysis.


Subject(s)
Anticoagulants , Atrial Fibrillation , Randomized Controlled Trials as Topic , Renal Dialysis , Vitamin K , Humans , Atrial Fibrillation/complications , Atrial Fibrillation/drug therapy , Vitamin K/antagonists & inhibitors , Administration, Oral , Anticoagulants/therapeutic use , Kidney Failure, Chronic/therapy , Kidney Failure, Chronic/complications
14.
Asian J Neurosurg ; 18(3): 468-475, 2023 Sep.
Article in English | MEDLINE | ID: mdl-38152541

ABSTRACT

Endoscopic third ventriculostomy (ETV) and ventriculoperitoneal shunt (VPS) are surgical methods for treating obstructive hydrocephalus. However, there is still disagreement regarding the most effective technique, in terms of both operative success and postoperative complications. Therefore, we performed a systematic review and meta-analysis to compare the efficacy and safety of these two methods in patients with obstructive hydrocephalus. We performed a systematic search of the PubMed, Scopus, and Cochrane Library databases. Randomized clinical trials (RCTs) comparing ETV and VPS in pediatric or adult patients with obstructive hydrocephalus were included. The outcomes included were operative success, postoperative cerebrospinal fluid leak, postoperative infection, postoperative or intraoperative bleeding, blockage rate, and mortality. The risk ratio (RR) was calculated with a 95% confidence interval (CI). Heterogeneity was evaluated with I 2 statistics. We used a fixed-effects model for outcomes with I 2 < 25% and DerSimonian and Laird random-effects model for other conditions. The Cochrane collaboration tool for assessing the risk of bias in randomized trials was used for risk-of-bias assessment. R, version 4.2.1, was used for statistical analyses. Of the 2,353 identified studies, 5 RCTs were included, involving 310 patients with obstructive hydrocephalus, of which 163 underwent ETV. There was a significant difference in favor of ETV for postoperative infection (risk ratio [RR]: 0.11; 95% confidence interval [CI]: 0.04-0.33; p < 0.0001; I 2 = 0%) and blockage rate (RR: 0.15; 95% CI: 0.03-0.75; p = 0.02; I 2 = 53%). Meanwhile, there was no significant difference between groups for the postoperative or intraoperative bleeding (RR: 0.44; 95% CI: 0.17-1.15; p = 0.09; I 2 = 0%), postoperative cerebrospinal fluid leak (RR: 0.65; 95% CI: 0.22-1.92; p = 0.44; I 2 = 18%), operative success (RR: 1.18; 95% CI: 0.77-1.82; p = 0.44; I 2 = 84%), and mortality (RR: 0.19; 95% CI: 0.03-1.09; p = 0.06; I 2 = 0%). Three RCTs had some concerns about the risk of bias and one RCT had a high risk of bias due to the process of randomization and selection of reported results. Thus, this meta-analysis of RCTs evaluating ETV compared with VPS demonstrated that although there is no superiority of ETV in terms of operative success, the incidence of complications was significantly higher in patients who underwent VPS. Our results suggest that the use of ETV provides greater benefits for the treatment of obstructive hydrocephalus. However, more RCTs are needed to corroborate the superiority of ETV.

15.
Cancers (Basel) ; 15(21)2023 Oct 26.
Article in English | MEDLINE | ID: mdl-37958317

ABSTRACT

Background: The benefit of adding programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors to the treatment of early-stage non-small cell lung cancer (NSCLC), both neoadjuvant therapy (NAT) and adjuvant therapy (AT), is not yet fully elucidated. Methods: We searched PubMed, Embase, and Cochrane databases for randomized controlled trials (RCT) that investigated PD-1/PD-L1 inhibitors plus chemotherapy for resectable stage NSCLC. We computed hazard ratios (HRs) or odds ratios (ORs) for binary endpoints, with 95% confidence intervals (CIs). Results: A total of seven RCTs comprising 3915 patients with resectable stage NSCLC were randomized to chemotherapy with or without PD-1/PD-L1 inhibitors as NAT or AT. As NAT, the PD-1/PD-L1 inhibitors plus chemotherapy group demonstrated significantly improved overall survival (HR 0.66; 95% CI 0.51-0.86) and event-free survival (HR 0.53; 95% CI 0.43-0.67) compared with the chemotherapy alone group. There was a significant increase in favor of the PD-1/PD-L1 inhibitors plus chemotherapy group for major pathological response (OR 6.40; 95% CI 3.86-10.61) and pathological complete response (OR 8.82; 95% CI 4.51-17.26). Meanwhile, as AT, disease-free survival was significant in favor of the PD-1/PD-L1 inhibitors plus chemotherapy group (HR 0.78; 95% CI 0.69-0.90). Conclusions: In this comprehensive systematic review and meta-analysis of RCTs, the incorporation of PD-1/PD-L1 inhibitors alongside chemotherapy offers a promising prospect for reshaping the established treatment paradigms for patients diagnosed with resectable stages of NSCLC. Moreover, our analyses support that neoadjuvant administration with these agents should be encouraged, in light of the fact that it was associated with an increased survival and pathological response, at the expense of a manageable safety profile.

16.
Eur J Trauma Emerg Surg ; 49(6): 2531-2541, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37526708

ABSTRACT

PURPOSE: Conflicting evidence exists on the choice of surgical or non-surgical treatment of flail chest injuries. We aimed to perform a meta-analysis comparing outcomes in patients presenting flail chest undergoing surgical or non-surgical treatment. METHODS: Embase, PubMed, and Cochrane databases were searched for randomized controlled trials (RCTs) comparing surgery to no surgery in patients with acute unstable chest wall injuries. We computed weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) for binary endpoints, with 95% confidence intervals (CIs). Random effects meta-analyses were performed. Heterogeneity was assessed using I2 statistics. RESULTS: Six RCTs (544 patients) were included, and surgical treatment was used in 269 (49.4%). Compared to no surgery, surgery reduced mechanical ventilation days (WMD - 4.34, 95% CI - 6.98, - 1.69; p < 0.01; I2 = 87%; GRADE: very low; PI - 13.51, 4.84); length of intensive care unit stay (WMD - 4.62, 95% CI - 7.19, - 2.05; p < 0.01; I2 = 78%; GRADE: low; PI - 12.86, 3.61) and the incidence of pneumonia (RR 0.50, 95% CI 0.31, 0.81; p = 0.005; I2 = 54%; GRADE: moderate; PI 0.13, 1.91). No difference in mortality (RR 0.56, 95% CI 0.19, 1.65; p = 0.27; I2 = 23%; GRADE: moderate; PI 0.04, 7.25), length of hospital stay (WMD - 5.39, 95% CI - 11.38, - 0.60; p = 0.08; I2 = 89%; GRADE: very low; PI - 11.38, 0.60), or need for tracheostomy (RR 0.59, 95% CI 0.34, 1.03; p = 0.06; I2 = 54%; GRADE: moderate; PI 0.11, 3.24) was found. CONCLUSIONS: Our results suggest that surgical treatment is advantageous compared to non-surgical treatment for patients with flail chest secondary to rib fractures.


Subject(s)
Flail Chest , Rib Fractures , Thoracic Injuries , Humans , Flail Chest/surgery , Randomized Controlled Trials as Topic , Rib Fractures/surgery , Rib Fractures/complications , Thoracic Injuries/complications , Respiration, Artificial , Length of Stay
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