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Frontiers in Endocrinology 2022Diabetes mellitus (DM) is a global health problem, and it has become a shocking threat in the contemporary era. The objective of this study was to analyze the safety of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Diabetes mellitus (DM) is a global health problem, and it has become a shocking threat in the contemporary era. The objective of this study was to analyze the safety of sotagliflozin in patients with DM systematically and intuitively.
METHODS
On November 15, 2021, literature retrieval was performed on PubMed, Web of Science, EBSCO, and Cochrane libraries. The meta-analysis results included genital mycotic infection, related-to-acidosis events, and other related adverse events, including diarrhea, severe nocturnal hypoglycemia event, and volume depletion. In addition, a subgroup analysis was also conducted based on different doses of sotagliflozin. Moreover, the patient-treated years analyzed in the study were 12 weeks, 24 weeks, and 52 weeks, respectively, for type 1 diabetes, and were 12 weeks, 22 weeks, and 52 weeks, respectively, for type 2 diabetes.
RESULTS
The results of this meta-analysis illustrated that sotagliflozin could increase the risk of genital mycotic infection for patients with T1D and T2D (RR: 3.49, 95% Cl: 2.54-4.79, < 0.001; RR: 2.83, 95% Cl: 2.04-3.93, < 0.001; respectively). In addition, the subgroup analysis showed that the drug doses that could increase the risk of genital mycotic infection were 400 mg and 200 mg (RR: 3.63, 95% Cl: 2.46-5.36, < 0.001; RR: 3.21, 95% Cl: 1.84-5.62, < 0.001; respectively) in T1D. Moreover, sotagliflozin could increase the risk of events related to acidosis in the patients of T1D, including acidosis-related adverse events, positively adjudicated diabetic ketoacidosis, acidosis-related event, and diabetic ketoacidosis (RR: 7.49, 95% Cl: 3.20-17.52, < 0.001; RR: 6.05, 95% Cl: 2.56-14.30, < 0.001; RR: 4.83, 95% Cl: 3.13-7.45, < 0.001; RR: 8.12, 95% Cl: 3.06-21.52, p < 0.001; respectively). In the patients of T2D, sotagliflozin could not increase the risk of DKA (RR: 1.30, 95% Cl: 0.34-4.99, p = 0.70). About serious of acidosis-related adverse events, positively adjudicated diabetic ketoacidosis (DKA) and acidosis-related event, the included studies were not reported for T2D patients. As for the other related adverse events, sotagliflozin was found to be a risk factor for diarrhea and volume depletion in T1D patients (RR: 1.44, 95% Cl: 1.09-1.90, p = 0.01; RR: 2.50, 95% Cl: 1.33-4.69, p < 0.01; respectively) and T2D patients (RR: 1.44, 95% Cl: 1.26-1.64, p < 0.001; RR: 1.25, 95% Cl: 1.07-1.45, p < 0.01; respectively).
CONCLUSIONS
This meta-analysis showed that the adverse events of sotagliflozin were tolerable to patients with DM, in terms of the incidence of genital mycotic infection, related-to-acidosis events, diarrhea, volume depletion, and severe nocturnal hypoglycemia events. In addition, the subgroup analysis of sotagliflozin dosage is considered to have great clinical significance for future guidance of sotagliflozin application in patients with DM.
Topics: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Ketoacidosis; Diarrhea; Humans; Hypoglycemia; Randomized Controlled Trials as Topic
PubMed: 36225203
DOI: 10.3389/fendo.2022.968478 -
Cardiology 2022There have been few studies published on the use of contrast media (CM) in metformin-treated patients. In this study, we conducted a systematic review and meta-analysis... (Meta-Analysis)
Meta-Analysis
BACKGROUND
There have been few studies published on the use of contrast media (CM) in metformin-treated patients. In this study, we conducted a systematic review and meta-analysis to investigate the relationship between metformin and contrast-induced acute kidney injury (CI-AKI).
METHODS
A comprehensive search of the Medline, PubMed, Embase, and Web of Science databases for literature on associations between metformin use and CI-AKI incidence was conducted. The pooled odds ratio (OR), or relative risk, as well as the corresponding 95% confidence intervals (CIs), was calculated to assess the relationship between metformin and CI-AKI risk as well as the incidence of lactic acidosis (LA).
RESULTS
In total, seven studies met our eligibility criteria on associations between metformin use and CI-AKI incidence, comprising 2,325 individuals, with 279 new cases of CI-AKI exposed to CM. The pooled analysis revealed no statistically significant increase in the risk of CI-AKI development in patients who used metformin continuously (random-effects OR: 1.15, 95% CI: 0.70-1.90, p = 0.57). No cases of LA that occurred during CM exposure were reported.
CONCLUSION
Metformin can be safely used in patients with moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m2) during CM exposure.
Topics: Humans; Metformin; Contrast Media; Acute Kidney Injury; Incidence; Odds Ratio
PubMed: 36202076
DOI: 10.1159/000527384 -
Pediatric Research Apr 2023Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of type 1 diabetes mellitus (T1DM) that has increased during the COVID-19 pandemic. This study... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of type 1 diabetes mellitus (T1DM) that has increased during the COVID-19 pandemic. This study will not only shed light on such life-threatening complications but also be a step to increase the awareness of healthcare providers about such complications in the upcoming pandemic waves and increased dependence on telemedicine. Thus, we aimed to further investigate the increase of DKA in pediatrics.
METHODS
PubMed, Web of Science, and Scopus were broadly searched for studies assessing the incidence of DKA in pediatrics during the COVID-19 pandemic.
RESULTS
Our study included 24 papers with a total of 124,597 children with diabetes. A statistically significant increase occurred in the risk of DKA among newly diagnosed T1DM patients during the pandemic (RR 1.41; 95% CI 1.19, 1.67; p < 0.01; I = 86%), especially in the severe form of DKA (RR 1.66: 95% CI 1.3, 2.11) when compared to before.
CONCLUSION
DKA in newly diagnosed children with T1DM has increased during the pandemic and presented with a severe form. This may reflect that COVID-19 may have contributed not only to the development but also the severity of DKA.
IMPACT
Diabetic ketoacidosis (DKA) is a life-threatening complication of type 1 diabetes mellitus (T1DM) that has increased during the COVID-19 pandemic. Our study included 25 papers with a total of 124,597 children with diabetes. A statistically significant increase occurred in the risk of DKA among newly diagnosed T1DM patients during the pandemic. Our findings reflect that COVID-19 may have an altered presentation in T1DM and can be related to DKA severity.
Topics: Humans; Child; Diabetic Ketoacidosis; Diabetes Mellitus, Type 1; Pandemics; Incidence; Retrospective Studies; COVID-19; Severity of Illness Index
PubMed: 35953513
DOI: 10.1038/s41390-022-02241-2 -
Frontiers in Endocrinology 2022Most patients with type 1 diabetes (T1DM) do not reach the blood glucose goal with treatment of insulin. In our research, we intended to estimate the therapeutic effect... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Most patients with type 1 diabetes (T1DM) do not reach the blood glucose goal with treatment of insulin. In our research, we intended to estimate the therapeutic effect and safety of additional different doses of dapagliflozin on insulin treatment in T1DM.
METHODS
We performed direct and indirect network meta-analysis using Bayesian models and graded different dosages of dapagliflozin by mixed therapy contrasts. We retrieved information from the PubMed, Embase, The Cochrane Library, Web of Science, China Biology Medicine (CBM) disc, China National Knowledge Infrastructure (CNKI), Wanfang Data, and WEIPU Data. Our research included randomized controlled trials (RCTs) including T1DM treated with insulin and additional dapagliflozin 5 mg or dapagliflozin 10 mg from January 2012 to June 2021. Thirteen RCTs with 10,701 participants were divided into three groups as below: insulin alone, dapagliflozin 5 mg + insulin, and dapagliflozin 10 mg + insulin.
RESULTS
Dapagliflozin dose-dependently exhibited reductions in glycated hemoglobin (HbA1c), total insulin daily dose (TDD), and body weight. Neither dapagliflozin 5 mg nor 10 mg could induce hypoglycemia or severe hypoglycemia. However, both doses of dapagliflozin increased the incidence of diabetic ketoacidosis (DKA) and genital infection.
CONCLUSIONS
Dapagliflozin 10 mg could achieve a better outcome in efficacy and could not increase the risk of hypoglycemia. Although it may induce a higher risk of DKA and genital infection, there was no significant difference between dapagliflozin 10 mg and 5 mg. Our outcomes indicate that dapagliflozin 10mg has a high reliability of being graded prior as a supplementary treatment to insulin in T1DM.
Topics: Adult; Benzhydryl Compounds; Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Glucosides; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin; Network Meta-Analysis
PubMed: 35872994
DOI: 10.3389/fendo.2022.923376 -
Journal of Medical Virology Nov 2022Viral infections may increase the risk of developing type 1 diabetes (T1D), and recent reports suggest that Coronavirus Disease 2019 (COVID-19) might have increased the... (Meta-Analysis)
Meta-Analysis Review
Viral infections may increase the risk of developing type 1 diabetes (T1D), and recent reports suggest that Coronavirus Disease 2019 (COVID-19) might have increased the incidence of pediatric T1D and/or diabetic ketoacidosis (DKA). Therefore, this meta-analysis aims to estimate the risk of global pediatric new-onset T1D, DKA, and severe DKA before and after the COVID-19 pandemic. A systematic search of MEDLINE/PubMed, CINAHL, Scopus, and EMBASE was conducted for articles published up to March 2022. A random-effects meta-analysis was performed to compare the relative risk of T1D and DKA among pediatric patients with T1D between the COVID-19 pre-pandemic and pandemic periods. We also compared glucose and HbA1c values in children who were newly diagnosed with T1D before and after the COVID-19 pandemic. The global incidence rate of T1D in the 2019 period was 19.73 per 100 000 children and 32.39 per 100 000 in the 2020 period. Compared with pre-COVID-19 pandemic, the number of worldwide pediatric new-onset T1D, DKA, and severe DKA during the first year of the COVID-19 pandemic increased by 9.5%, 25%, and 19.5%, respectively. Compared with pre-COVID-19 pandemic levels, the median glucose, and HbA1c values in newly diagnosed T1D children after the COVID-19 pandemic increased by 6.43% and 6.42%, respectively. The COVID-19 pandemic has significantly increased the risk of global pediatric new-onset T1D, DKA, and severe DKA. Moreover, higher glucose and HbA1c values in newly diagnosed T1D children after the COVID-19 pandemic mandates targeted measures to raise public and physician awareness.
Topics: COVID-19; Child; Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Glucose; Glycated Hemoglobin; Humans; Incidence; Pandemics
PubMed: 35831242
DOI: 10.1002/jmv.27996 -
Ultrasound in Obstetrics & Gynecology :... Sep 2022To investigate the performance of severe smallness in the prediction of adverse perinatal outcome among fetuses with suspected late-onset small-for-gestational age (SGA). (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To investigate the performance of severe smallness in the prediction of adverse perinatal outcome among fetuses with suspected late-onset small-for-gestational age (SGA).
METHODS
A systematic search was performed to identify relevant studies in PubMed, Web of Science and Scopus. Late-onset SGA was defined as estimated fetal weight (EFW) or abdominal circumference (AC) < 10 percentile diagnosed at or after 32 weeks' gestation, while severe SGA was defined as EFW or AC < 3 percentile or < 2 SD. Random-effects modeling was used to generate hierarchical summary receiver-operating-characteristics (HSROC) curves. The performance of severe SGA (as a presumptive diagnosis) in predicting adverse perinatal outcome among singleton pregnancies with suspected late-onset SGA was expressed as area under the HSROC curve (AUC), sensitivity, specificity and positive/negative likelihood ratios. The association between suspected severe SGA and adverse perinatal outcome was also assessed by random-effects modeling using the Mantel-Haenszel method and presented as odds ratio (OR). The non-exposed group was defined as non-severe SGA (EFW ≥ 3 centile).
RESULTS
Twelve cohort studies were included in this systematic review and meta-analysis. The studies included a total of 3639 fetuses with suspected late-onset SGA, of which 1246 had suspected severe SGA. Significant associations were found between suspected severe SGA and composite adverse perinatal outcome (OR, 1.97 (95% CI, 1.33-2.92)), neonatal intensive care unit admission (OR, 2.87 (95% CI, 1.84-4.47)) and perinatal death (OR, 4.26 (95% CI, 1.07-16.93)). However, summary ROC curves showed limited performance of suspected severe SGA in predicting perinatal outcomes, with AUCs of 60.9%, 66.9%, 53.6%, 57.2%, 54.6% and 64.9% for composite adverse perinatal outcome, neonatal intensive care unit admission, neonatal acidosis, Cesarean section for intrapartum fetal compromise, low Apgar score and perinatal death, respectively.
CONCLUSION
Although suspected severe SGA was associated with a higher risk of perinatal complications, it performed poorly as a standalone parameter in predicting adverse perinatal outcome. © 2022 International Society of Ultrasound in Obstetrics and Gynecology.
Topics: Cesarean Section; Female; Fetal Growth Retardation; Fetal Weight; Fetus; Gestational Age; Humans; Infant, Newborn; Infant, Small for Gestational Age; Perinatal Death; Predictive Value of Tests; Pregnancy; Ultrasonography, Prenatal
PubMed: 35748873
DOI: 10.1002/uog.24977 -
Journal of Dairy Science Jul 2022A systematic review was conducted to assess the cost of ketosis in dairy cattle, and to elucidate how ketosis cost is estimated in each of the studies. Scientific papers...
A systematic review was conducted to assess the cost of ketosis in dairy cattle, and to elucidate how ketosis cost is estimated in each of the studies. Scientific papers addressing the economic impact of ketosis in dairy cows were identified through a search in 4 databases (Medline, ISI Web of Science, CAB Abstracts, and Agricola). The literature search was conducted with no restrictions on the date of study publication, publication type, or language. The methodological quality of the studies was assessed regarding study design, data collection, and analysis and interpretation of the study results. Of 531 identified records, 10 were selected, of which 9 were published from 2015 onward. Of the 10 studies reviewed, 9 report cost of a case of ketosis, and the estimates vary widely, with values ranging from €19 to €812. Two studies report ketosis cost at a farm level (€3.6-€29/cow per year). Among the studies, we observed great variation not only in the estimation models and inputs used (costs and losses associated with the disease) but also in the definition of ketosis and its prevalence or incidence figures. Moreover, the cost of ketosis was estimated for dairy farms in the United States, Canada, the Netherlands, Denmark, France, Germany, Spain, Sweden, Norway, and India. Consequently, there was great heterogeneity regarding herd characteristics, milk production, milk prices, culled cows' value, feed prices, and costs of veterinary services. Ketosis cost estimates vary as a consequence of all these aspects. Therefore, although most of the studies were well-designed and used high-quality data, the systematic approach review does not allow combination of the cost estimates of into a single figure. In conclusion, our review highlights an overall considerable economic impact of ketosis in dairy cattle. Economic prevention and mitigation strategies should be taken according to herd- and country-specific conditions. Ketosis cost figures reported in economic studies should always be considered carefully and interpreted with appropriate consideration of the inputs of the estimation, country context, and herd parameters.
Topics: Animals; Cattle; Cattle Diseases; Dairying; Farms; Female; Ketosis; Lactation; Milk; Prevalence
PubMed: 35534272
DOI: 10.3168/jds.2021-21539 -
Nephrology, Dialysis, Transplantation :... Feb 2023Vascular calcification (VC) is a common comorbidity among patients with chronic kidney disease (CKD), indicating major cardiovascular events. This study aimed to... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vascular calcification (VC) is a common comorbidity among patients with chronic kidney disease (CKD), indicating major cardiovascular events. This study aimed to evaluate the effects and safety of intravenous sodium thiosulphate (STS) for VC in CKD patients.
METHODS
Electronic databases were searched for clinical trials that provided data comparing outcomes among patients treated with and without STS. The PRISMA guidelines were followed. Efficacy was assessed using calcification scores and arterial stiffness. Safety was examined by analyzing adverse symptoms, electrolytes and bone mineral density (BMD). Random-effects models were performed. Meta-regression and sensitivity analysis were done. The risk of bias was assessed using the Cochrane tools.
RESULTS
Among the 5601 publications, 6 studies involving 305 participants (mean age: 56 years, male: 56.6%) with all participants on maintenance hemodialysis met eligibility criteria. For efficacy, the progression in Agatston scores in the coronary arteries [107 patients, mean difference (MD): -241.27, 95% confidence interval (95% CI): -421.50 to -61.03] and iliac arteries (55 patients, MD: -382.00, 95% CI: -751.07 to -12.93) was lower in the STS treated group compared with controls. The increase in pulse wave velocity was lower in the STS group (104 patients, MD: -1.29 m/s, 95% CI: -2.24 to -0.34 m/s). No association was found between the change in calcification scores and STS regimen. For safety, gastrointestinal symptoms (e.g. nausea) and increased anion gap acidosis were noted. No reduction in BMD by STS was observed.
CONCLUSIONS
Intravenous STS may attenuate the progression of VC and arterial stiffness in hemodialysis patients. Large and well-designed randomized controlled trials are warranted.
Topics: Humans; Male; Middle Aged; Pulse Wave Analysis; Vascular Calcification; Renal Dialysis; Vascular Stiffness; Renal Insufficiency, Chronic
PubMed: 35521751
DOI: 10.1093/ndt/gfac171 -
Neurology Jun 2022Stroke management in the context of primary mitochondrial disease is clinically challenging, and the best treatment options for patients with stroke-like episodes remain...
BACKGROUND AND OBJECTIVES
Stroke management in the context of primary mitochondrial disease is clinically challenging, and the best treatment options for patients with stroke-like episodes remain uncertain. We sought to perform a systematic review of the safety and efficacy of l-arginine use in the acute and prophylactic management of stroke-like episodes in patients with mitochondrial disease.
METHODS
The systematic review was registered in PROSPERO (CRD42020181230). We searched 6 databases from inception to January 15, 2021: MEDLINE, Embase, Scopus, Web of Science, CINAHL, and ClinicalTrials.gov. Original articles and registered trials available, in English, reporting l-arginine use in the acute or prophylactic management of stroke-like episodes in patients with genetically confirmed mitochondrial disease were eligible for inclusion. Data on safety and treatment response were extracted and summarized by multiple observers. Risk of bias was assessed by the methodologic quality of case reports, case series, and a risk-of-bias checklist for nonrandomized studies. Quality of evidence was synthesized with the Oxford Centre for Evidence-Based Medicine Levels of Evidence and Grade of Recommendations. The predetermined main outcome measures were clinical response to l-arginine treatment, adverse events, withdrawals, and deaths (on treatment and/or during follow-up), as defined by the author.
RESULTS
Thirty-seven articles met inclusion criteria (0 randomized controlled trials; 3 open-label; 1 retrospective cohort; 33 case reports/case series) (N = 91 patients; 86% m.3243A>G). In the case reports, 54% of patients reported a positive clinical response to acute l-arginine, of which 40% were concomitantly treated with antiepileptic drugs. Improved headache at 24 hours was the greatest reported benefit in response to IV l-arginine in the open-label trials (31 of 39, 79%). In 15 of 48 patients (31%) who positively responded to prophylactic l-arginine, antiepileptic drugs were either used (7 of 15) or unreported (8 of 15). Moderate adverse events were reported in the follow-up of both IV and oral l-arginine treatment, and 11 patients (12%) died during follow-up or while on prophylactic treatment.
DISCUSSION
The available evidence is of poor methodologic quality and classified as Level 5. IV and oral l-arginine confers no demonstrable clinical benefit in either the acute or prophylactic treatment of mitochondrial encephalopathy, lactic acidosis, and stroke-like episodes, with more robust controlled trials required to assess its efficacy and safety profile.
Topics: Acidosis, Lactic; Anticonvulsants; Arginine; Humans; Mitochondrial Diseases; Mitochondrial Encephalomyopathies; Retrospective Studies; Stroke
PubMed: 35428733
DOI: 10.1212/WNL.0000000000200299 -
Frontiers in Endocrinology 2022Previous reports suggest that the Coronavirus Disease-2019 (COVID-19) pandemic might have affected incidences of diabetic ketoacidosis (DKA) and new diagnoses of type 1... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Previous reports suggest that the Coronavirus Disease-2019 (COVID-19) pandemic might have affected incidences of diabetic ketoacidosis (DKA) and new diagnoses of type 1 diabetes. This systematic review and meta-analysis aimed to estimate the risk of DKA, including severe DKA, during the COVID-19 pandemic versus the prior-to-COVID-19 period among pediatric patients with type 1 diabetes.
METHODS
PubMed and EMBASE were searched for observational studies investigating the risk of DKA among pediatric patients with type 1 diabetes during the COVID-19 pandemic and the prior-to-COVID-19 period. A random meta-analysis model was performed to estimate the relative risk of DKA during the COVID-19 pandemic compared to before the pandemic. Subgroup analyses were conducted based on the type 1 diabetes status, established or newly diagnosed. In addition, sensitivity analysis was conducted for studies that reported results from adjusted analysis for potential confounders using fixed effect model.
RESULTS
A total of 20 observational studies reported the risk of DKA, of which 18 reported the risk of severe DKA. The risks of DKA and severe DKA were 35% (RR 1.35, 95%CI 1.2-1.53, = 71%) and 76% (RR 1.76, 95%CI 1.33-2.33, 44%) higher in the during-COVID-19 group compared to the prior-to-COVID-19 group, respectively. Among patients with newly diagnosed type 1 diabetes, the risk of DKA was 44% higher for the during-COVID-19 group compared to the prior-to-COVID-19 group (RR 1.44, 95%CI 1.26-1.65; = 64%). Only two studies reported the risk of DKA among patients with established type 1 diabetes and the cumulative risk was not statistically significant. In the sensitivity analysis, four studies reported an adjusted odds ratio (aOR) of the risk of DKA during COVID-19 compared to the prior-to-COVID-19 period. The fixed estimate from the meta-analysis found an increase in the risk of DKA in the during-COVID-19 group compared to the prior-to-COVID-19 group (aOR 2.04, 95%CI 1.66-2.50).
CONCLUSIONS
This study showed that DKA risk, especially the risk of severe DKA, has increased significantly during the pandemic. Healthcare systems must be aware and prepared for such an increase in DKA cases and take all necessary measures to prevent future spikes during the pandemic.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=272775, identifier PROSPERO [CRD42021272775].
Topics: COVID-19; Child; Diabetes Mellitus, Type 1; Diabetic Ketoacidosis; Humans; Incidence; Pandemics; Pediatrics
PubMed: 35355556
DOI: 10.3389/fendo.2022.856958