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Frontiers in Endocrinology 2023The safety results of different recommended doses of sodium-glucose cotransporter 2 inhibitors (SGLT-2i) for patients with type 2 diabetes mellitus (T2DM) remain... (Comparative Study)
Comparative Study Meta-Analysis
Comparative safety of different recommended doses of sodium-glucose cotransporter 2 inhibitors in patients with type 2 diabetes mellitus: a systematic review and network meta-analysis of randomized clinical trials.
OBJECTIVE
The safety results of different recommended doses of sodium-glucose cotransporter 2 inhibitors (SGLT-2i) for patients with type 2 diabetes mellitus (T2DM) remain uncertain. This study aims to comprehensively estimate and rank the relative safety outcomes with different doses of SGLT-2i for T2DM.
METHODS
PubMed, Embase, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, Chinese National Knowledge Infrastructure, WanFang database, and SinoMed database were searched from the inception to 31 May 2023. We included double-blind randomized controlled trials (RCTs) comparing SGLT-2i with placebo or another antihyperglycemic as oral monotherapy in the adults with a diagnosis of T2DM.
RESULTS
Twenty-five RCTs with 12,990 patients randomly assigned to 10 pharmacological interventions and placebo were included. Regarding genital infections (GI), all SGLT-2i, except for ertugliflozin and ipragliflozin, were associated with a higher risk of GI compared to placebo. Empagliflozin 10mg/d (88.2%, odds ratio [OR] 7.90, 95% credible interval [CrI] 3.39 to 22.08) may be the riskiest, followed by empagliflozin 25mg/d (83.4%, OR 7.22, 95%CrI 3.11 to 20.04)) and canagliflozin 300mg/d (70.8%, OR 5.33, 95%CrI 2.25 to 13.83) based on probability rankings. Additionally, dapagliflozin 10mg/d ranked highest for urinary tract infections (UTI, OR 2.11, 95%CrI 1.20 to 3.79, 87.2%), renal impairment (80.7%), and nasopharyngitis (81.6%) when compared to placebo and other treatments. No increased risk of harm was observed with different doses of SGLT-2i regarding hypoglycemia, acute kidney injury, diabetic ketoacidosis, or fracture. Further subgroup analysis by gender revealed no significantly increased risk of UTI. Dapagliflozin 10mg/d (91.9%) and canagliflozin 300mg/d (88.8%) ranked first in the female and male subgroups, respectively, according to the probability rankings for GI.
CONCLUSION
Current evidence indicated that SGLT-2i did not significantly increase the risk of harm when comparing different doses, except for dapagliflozin 10mg/d, which showed an increased risk of UTI and may be associated with a higher risk of renal impairment and nasopharyngitis. Additionally, compared with placebo and metformin, the risk of GI was notably elevated for empagliflozin 10mg/d, canagliflozin 300mg/d, and dapagliflozin 10mg/d. However, it is important to note that further well-designed RCTs with larger sample sizes are necessary to verify and optimize the current body of evidence.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/PROSPERO/, identifier CRD42023396023.
Topics: Female; Humans; Male; Canagliflozin; Diabetes Mellitus, Type 2; Glucose; Nasopharyngitis; Network Meta-Analysis; Randomized Controlled Trials as Topic; Sodium; Sodium-Glucose Transporter 2 Inhibitors
PubMed: 38027214
DOI: 10.3389/fendo.2023.1256548 -
Environmental Health Perspectives Aug 2023Neural tube defects (NTDs) affect pregnancies worldwide annually. Few nongenetic factors, other than folate deficiency, have been identified that may provide... (Review)
Review
BACKGROUND
Neural tube defects (NTDs) affect pregnancies worldwide annually. Few nongenetic factors, other than folate deficiency, have been identified that may provide intervenable solutions to reduce the burden of NTDs. Prenatal exposure to toxic metals [arsenic (As), cadmium (Cd), mercury (Hg), manganese (Mn) and lead (Pb)] may increase the risk of NTDs. Although a growing epidemiologic literature has examined associations, to our knowledge no systematic review has been conducted to date.
OBJECTIVE
Through adaptation of the Navigation Guide systematic review methodology, we aimed to answer the question "does exposure to As, Cd, Hg, Mn, or Pb during gestation increase the risk of NTDs?" and to assess challenges to evaluating this question given the current evidence.
METHODS
We selected available evidence on prenatal As, Cd, Hg, Mn, or Pb exposure and risk of specific NTDs (e.g., spina bifida, anencephaly) or all NTDs via a comprehensive search across MEDLINE, Embase, Web of Science, and TOXLINE databases and applied inclusion/exclusion criteria. We rated the quality and strength of the evidence for each metal. We applied a customized risk of bias protocol and evaluated the sufficiency of evidence of an effect of each metal on NTDs.
RESULTS
We identified 30 studies that met our criteria. Risk of bias for confounding and selection was high in most studies, but low for missing data. We determined that, although the evidence was limited, the literature supported an association between prenatal exposure to Hg or Mn and increased risk of NTDs. For the remaining metals, the evidence was inadequate to establish or rule out an effect.
CONCLUSION
The role of gestational As, Cd, or Pb exposure in the etiology of NTDs remains unclear and warrants further investigation in high-quality studies, with a particular focus on controlling confounding, mitigating selection bias, and improving exposure assessment. https://doi.org/10.1289/EHP11872.
Topics: Female; Pregnancy; Humans; Cadmium; Lead; Prenatal Exposure Delayed Effects; Neural Tube Defects; Mercury; Manganese; Arsenic
PubMed: 37647124
DOI: 10.1289/EHP11872 -
Occupational and Environmental Medicine Oct 2023The aetiology and pathophysiology of sarcoidosis is ill defined-current hypotheses centre on complex genetic-immune-environmental interactions in an individual,...
The aetiology and pathophysiology of sarcoidosis is ill defined-current hypotheses centre on complex genetic-immune-environmental interactions in an individual, triggering a granulomatous process. The aim of this systematic review is to define and describe which airborne occupational exposures (aOE) are associated with and precede a diagnosis of pulmonary sarcoidosis. The methodology adopted for the purpose was systematic review and meta-analyses of ORs for specified aOE associated with pulmonary sarcoidosis (DerSimonian Laird random effects model (pooled log estimate of OR)). Standard search terms and dual review at each stage occurred. A compendium of aOE associated with pulmonary sarcoidosis was assembled, including mineralogical studies of sarcoidosis granulomas. N=81 aOE were associated with pulmonary sarcoidosis across all study designs. Occupational silica, pesticide and mould or mildew exposures were associated with increased odds of pulmonary sarcoidosis. Occupational nickel and aluminium exposure were associated with a non-statistically significant increase in the odds of pulmonary sarcoidosis. Silica exposure associated with pulmonary sarcoidosis was reported most frequently in the compendium (n=33 studies) and was the most common mineral identified in granulomas. It was concluded that aOE to silica, pesticides and mould or mildew are associated with increased odds of pulmonary sarcoidosis. Equipoise remains concerning the association and relationship of metal dusts with pulmonary sarcoidosis.
PubMed: 37640537
DOI: 10.1136/oemed-2022-108632 -
Cardiology in Review Dec 2023Coronary stent infection is a rare yet serious complication of coronary artery stenting, with potentially significant morbidity and mortality. This systematic review...
Coronary stent infection is a rare yet serious complication of coronary artery stenting, with potentially significant morbidity and mortality. This systematic review aimed to comprehensively assess the available evidence on the diagnosis, management, and outcomes of coronary stent infection. A comprehensive search of electronic databases, including PubMed, Embase, Cochrane Library, and Scopus, was conducted from inception until March 2023, in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A total of 1 case series and 41 case reports, covering a cumulative sample size of 44 patients, were included in the analysis. The predominant stent types were drug-eluting stents in 22 studies, bare-metal stents in 3 studies, and a combination of drug-eluting stents and bare-metal stents in 4 studies. Staphylococcus aureus was the predominant identified organism in microbiological profiles. Primary outcomes, including mortality, morbidity, and recurrence rates, were evaluated. The aggregate mortality rate across studies was 18%, underscoring the severity of coronary stent infections. Morbidity ranged from 3% to 60%, with a spectrum of complications such as sepsis, heart failure, and embolic events. Recurrence rates varied from 3% to 33%, emphasizing the importance of effective management. Treatment strategies encompassed antibiotics alone, antibiotics with stent removal, and antibiotics with stent retention, with the duration of antibiotic therapy ranging from 2 weeks to 12 months. The optimal management strategy remains uncertain due to limited high-quality evidence. Early diagnosis and treatment were emphasized as critical factors in improving outcomes. Prophylactic antibiotics during stenting procedures and increased awareness among healthcare providers were suggested as preventive measures.
PubMed: 38038434
DOI: 10.1097/CRD.0000000000000631 -
Environmental Health : a Global Access... Nov 2023Early life exposure to lead, mercury, polychlorinated biphenyls (PCBs), polybromide diphenyl ethers (PBDEs), organophosphate pesticides (OPPs), and phthalates have been... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Early life exposure to lead, mercury, polychlorinated biphenyls (PCBs), polybromide diphenyl ethers (PBDEs), organophosphate pesticides (OPPs), and phthalates have been associated with lowered IQ in children. In some studies, these neurotoxicants impact males and females differently. We aimed to examine the sex-specific effects of exposure to developmental neurotoxicants on intelligence (IQ) in a systematic review and meta-analysis.
METHOD
We screened abstracts published in PsychINFO and PubMed before December 31st, 2021, for empirical studies of six neurotoxicants (lead, mercury, PCBs, PBDEs, OPPs, and phthalates) that (1) used an individualized biomarker; (2) measured exposure during the prenatal period or before age six; and (3) provided effect estimates on general, nonverbal, and/or verbal IQ by sex. We assessed each study for risk of bias and evaluated the certainty of the evidence using Navigation Guide. We performed separate random effect meta-analyses by sex and timing of exposure with subgroup analyses by neurotoxicant.
RESULTS
Fifty-one studies were included in the systematic review and 20 in the meta-analysis. Prenatal exposure to developmental neurotoxicants was associated with decreased general and nonverbal IQ in males, especially for lead. No significant effects were found for verbal IQ, or postnatal lead exposure and general IQ. Due to the limited number of studies, we were unable to analyze postnatal effects of any of the other neurotoxicants.
CONCLUSION
During fetal development, males may be more vulnerable than females to general and nonverbal intellectual deficits from neurotoxic exposures, especially from lead. More research is needed to examine the nuanced sex-specific effects found for postnatal exposure to toxic chemicals.
Topics: Child; Pregnancy; Humans; Male; Female; Polychlorinated Biphenyls; Lead; Sex Characteristics; Halogenated Diphenyl Ethers; Mercury; Insecticides; Organophosphorus Compounds; Prenatal Exposure Delayed Effects
PubMed: 37978510
DOI: 10.1186/s12940-023-01029-z -
Journal of Endovascular Therapy : An... Nov 2023Covered stents and bare metal stents (BMS) have been regarded as viable treatment options for aortoiliac arterial diseases. We performed this systematic review and... (Review)
Review
PURPOSE
Covered stents and bare metal stents (BMS) have been regarded as viable treatment options for aortoiliac arterial diseases. We performed this systematic review and meta-analysis to compare the efficacy of covered stents with BMS for aortoiliac arterial diseases.
MATERIALS AND METHODS
The Cochrane Library, Embase, and Medline databases were searched by 2 authors (C.Z. and Z.W.) to retrieve all studies comparing the outcomes of covered stents vs BMS for aortoiliac arterial diseases. The Cochrane tool and the Newcastle-Ottawa scale were used to assess the risk of bias in randomized controlled trials and observational studies, respectively. The outcomes at the same stage reported in at least 2 studies were pooled together. The fixed effects model combined the data when <50%, otherwise the random effects model was applied. The results for dichotomous variables were presented as odds ratio (OR) or risk difference and 95% confidence interval (CI); continuous variables were reported as mean difference and 95% CI.
RESULTS
Herein, 10 studies with a total of 1695 limbs were included. The covered stents significantly increased the freedom from target lesion revascularization (OR 2.85, 95% CI: 1.28-6.33, p=0.010) compared to the BMS during a 24-month follow-up. However, no statistically significant difference was found in the technical success, primary patency, secondary patency, major adverse events (MAEs), ankle-brachial index (ABI) improvement, limb salvage, and survival between the two groups.
CONCLUSION
Compared to BMS, covered stents appear to have similar technical success, primary patency, secondary patency, MAEs, ABI improvement, limb salvage, and survival but may have advantages in reducing target lesion revascularization. More well-designed, prospective studies are warranted to determine such findings.
CLINICAL IMPACT
Covered stents may increase freedom from target lesion revascularization (TLR) compared to bare metal stents (BMS) in the treatment of aortoiliac arterial diseases. However, technical success, primary patency, secondary patency, major adverse events (MAEs), ABI improvement, limb salvage, and survival were similar. The aforementioned results are still not sufficient to draw a solid conclusion about the selection of stents for aortoiliac arterial diseases. More well-designed, prospective studies are warranted to determine such findings.
PubMed: 38031669
DOI: 10.1177/15266028231212761 -
Neurological Sciences : Official... Oct 2023Neurological deterioration, soon after anti-copper treatment initiation, is problematic in the management of Wilson's disease (WD) and yet reports in the literature are... (Meta-Analysis)
Meta-Analysis Review
INTRODUCTION
Neurological deterioration, soon after anti-copper treatment initiation, is problematic in the management of Wilson's disease (WD) and yet reports in the literature are limited. The aim of our study was to systematically assess the data according to early neurological deteriorations in WD, its outcome and risk factors.
METHODS
Using PRISMA guidelines, a systematic review of available data on early neurological deteriorations was performed by searching the PubMed database and reference lists. Random effects meta-analytic models summarized cases of neurological deterioration by disease phenotype.
RESULTS
Across the 32 included articles, 217 cases of early neurological deterioration occurred in 1512 WD patients (frequency 14.3%), most commonly in patients with neurological WD (21.8%; 167/763), rarely in hepatic disease (1.3%; 5/377), and with no cases among asymptomatic individuals. Most neurological deterioration occurred in patients treated with d-penicillamine (70.5%; 153/217), trientine (14.2%; 31/217) or zinc salts (6.9%; 15/217); the data did not allow to determine if that reflects how often treatments were chosen as first line therapy or if the risk of deterioration differed with therapy. Symptoms completely resolved in 24.2% of patients (31/128), resolved partially in 27.3% (35/128), did not improve in 39.8% (51/128), with 11 patients lost to follow-up.
CONCLUSIONS
Given its occurrence in up to 21.8% of patients with neurological WD in this meta-analysis of small studies, there is a need for further investigations to distinguish the natural time course of WD from treatment-related early deterioration and to develop a standard definition for treatment-induced effects.
Topics: Humans; Hepatolenticular Degeneration; Penicillamine; Trientine; Copper; Nervous System Diseases
PubMed: 37311952
DOI: 10.1007/s10072-023-06895-6 -
Journal of Medicine and Life Nov 2023Dysmenorrhea, affecting approximately 80% of adolescents, significantly impairs quality of life, disrupts sleep patterns, and induces mood changes. Furthermore, its... (Review)
Review
Dysmenorrhea, affecting approximately 80% of adolescents, significantly impairs quality of life, disrupts sleep patterns, and induces mood changes. Furthermore, its economic impact is substantial, accounting for an estimated $200 billion in the United States and $4.2 million in Japan annually. This review aimed to identify the effects of vitamin D and calcium on primary dysmenorrhea. We conducted a comprehensive literature search across Web of Science, PubMed, Scopus, and Science Direct, focusing on studies published from 2010 to 2020. Keywords included 'primary dysmenorrhea', 'vitamin D', '25-OH vitamin D3', 'cholecalciferol', and 'calcium'. The quality assessment of the articles was done using the Consolidated Standards of Reporting Trials (CONSORT) and the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) checklists, and the risk bias was assessed using the Cochrane assessment tool. Abnormal low Vit. D levels increased the severity of primary dysmenorrhea through increased prostaglandins and decreased calcium absorption. Vitamin D and calcium supplements could reduce the severity of primary dysmenorrhea and the need for analgesics. This systematic review found an inverse relation between the severity of dysmenorrhea and low serum Vit. D and calcium.. Vitamin D and calcium supplements could reduce the severity of primary dysmenorrhea and the need for analgesics.
Topics: Female; Adolescent; Humans; Vitamin D; Calcium; Dysmenorrhea; Quality of Life; Vitamins; Calcifediol; Vitamin D Deficiency; Analgesics; Dietary Supplements
PubMed: 38406773
DOI: 10.25122/jml-2023-0248 -
Frontiers in Endocrinology 2023This study aimed to systematically review research on cinacalcet and secondary hyperparathyroidism (SHPT) using machine learning-based statistical analyses. (Meta-Analysis)
Meta-Analysis
INTRODUCTION
This study aimed to systematically review research on cinacalcet and secondary hyperparathyroidism (SHPT) using machine learning-based statistical analyses.
METHODS
Publications indexed in the Web of Science Core Collection database on Cinacalcet and SHPT published between 2000 and 2022 were retrieved. The R package "Bibliometrix," VOSviewer, CiteSpace, meta, and latent Dirichlet allocation (LDA) in Python were used to generate bibliometric and meta-analytical results.
RESULTS
A total of 959 articles were included in our bibliometric analysis. In total, 3753 scholars from 54 countries contributed to this field of research. The United States, Japan, and China were found to be among the three most productive countries worldwide. Three Japanese institutions (Showa University, Tokai University, and Kobe University) published the most articles on Cinacalcet and SHPT. Fukagawa, M.; Chertow, G.M.; Goodman W.G. were the three authors who published the most articles in this field. Most articles were published in , , and . Research on Cinacalcet and SHPT has mainly included three topics: 1) comparative effects of various treatments, 2) the safety and efficacy of cinacalcet, and 3) fibroblast growth factor-23 (FGF-23). Integrated treatments, cinacalcet use in pediatric chronic kidney disease, and new therapeutic targets are emerging research hotspots. Through a meta-analysis, we confirmed the effects of Cinacalcet on reducing serum PTH ( = -0.56, 95% = -0.76 to -0.37, = 0.001) and calcium ( = -0.93, 95% = -1.21to -0.64, = 0.001) and improving phosphate ( = 0.17, 95% = -0.33 to -0.01, = 0.033) and calcium-phosphate product levels ( = -0.49, 95% = -0.71 to -0.28, = 0.001); we found no difference in all-cause mortality ( = 0.97, 95% = 0.90 to 1.05, = 0.47), cardiovascular mortality ( = 0.69, 95% = 0.36 to 1.31, = 0.25), and parathyroidectomy ( = 0.36, 95% = 0.09 to 1.35, = 0.13) between the Cinacalcet and non-Cinacalcet users. Moreover, Cinacalcet was associated with an increased risk of nausea ( = 2.29, 95% = 1.73 to 3.05, = 0.001), hypocalcemia ( = 4.05, 95% = 2.33 to 7.04, = 0.001), and vomiting ( = 1.90, 95% = 1.70 to 2.11, = 0.001).
DISCUSSION
The number of publications indexed to Cinacalcet and SHPT has increased rapidly over the past 22 years. Literature distribution, research topics, and emerging trends in publications on Cinacalcet and SHPT were analyzed using a machine learning-based bibliometric review. The findings of this meta-analysis provide valuable insights into the efficacy and safety of cinacalcet for the treatment of SHPT, which will be of interest to both clinical and researchers.
Topics: Child; Humans; Calcimimetic Agents; Calcium; Cinacalcet; Hyperparathyroidism, Secondary; Phosphates; United States; Machine Learning
PubMed: 37538795
DOI: 10.3389/fendo.2023.1146955 -
Global Heart 2023Hypertension is a prevalent cardiovascular condition, with excessive sodium intake being a significant risk factor. Various studies have investigated measures to reduce... (Meta-Analysis)
Meta-Analysis Review
Effects of Behavioral Interventions for Salt Reduction on Blood Pressure and Urinary Sodium Excretion: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
Hypertension is a prevalent cardiovascular condition, with excessive sodium intake being a significant risk factor. Various studies have investigated measures to reduce salt intake, including integrated lifestyle interventions and health education. However, the effectiveness of behavioral interventions focused solely on salt reduction remains unclear. This systematic review and meta-analysis aimed to investigate the effects of a behavioral intervention based on salt reduction on blood pressure and urinary sodium excretion. A comprehensive search of the Cochrane Central Register of Controlled Trials, EMBASE, PubMed, and Web of Science was conducted to identify relevant literature. Study and intervention characteristics were extracted for descriptive synthesis, and the quality of the included studies was assessed. A total of 10 studies, comprising 4,667 participants (3,796 adults and 871 children), were included. The interventions involved the provision of salt-restriction spoons or devices, salt-reduction education, self-monitoring devices for urinary sodium, and salt-reduction cooking classes. Meta-analysis results showed that behavioral interventions focused on salt reduction significantly reduced systolic blood pressure (SBP) (-1.17 mmHg; 95% CI, -1.86 to -0.49), diastolic blood pressure (DBP) (-0.58 mmHg; 95% CI, -1.07 to -0.08) and urinary sodium excretion (-21.88 mmol/24 hours; 95% CI, -32.12 to -11.64). These findings suggest that behavioral change interventions centered on salt reduction can effectively lower salt intake levels and decrease blood pressure levels. However, to enhance effectiveness, behavioral interventions for salt reduction should be combined with other salt-reduction strategies.
Topics: Adult; Child; Humans; Blood Pressure; Sodium; Sodium Chloride, Dietary; Randomized Controlled Trials as Topic; Hypertension; Diet, Sodium-Restricted
PubMed: 38143483
DOI: 10.5334/gh.1281