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Diabetes, Obesity & Metabolism Jul 2023To assess the efficacy of bexagliflozin in reducing glycated haemoglobin (HbA1c) and the occurrence of side effects in patients with type 2 diabetes (T2DM). (Meta-Analysis)
Meta-Analysis Review
AIM
To assess the efficacy of bexagliflozin in reducing glycated haemoglobin (HbA1c) and the occurrence of side effects in patients with type 2 diabetes (T2DM).
METHODS
We searched the PubMed, Embase, Cochrane and ClinicalTrials.gov databases for placebo-controlled, randomized clinical trials published up until 15 February 2023. The primary outcome was change in HbA1c. We computed weighted mean differences (WMDs) for continuous outcomes and odds ratios (ORs) for binary endpoints, with 95% confidence intervals (CIs).
RESULTS
A total of six studies and 3111 patients were included, of whom 1951 were prescribed bexagliflozin. Compared with placebo, bexagliflozin significantly reduced HbA1c levels (WMD -0.53%; 95% CI -0.75, -0.31), fasting plasma glucose levels (WMD -1.45 mmol/L; 95% CI -2.32, -0.57), systolic blood pressure (WMD -4.66 mmHg; 95% CI -6.41, -2.92), diastolic blood pressure (WMD -2.12 mmHg; 95% CI -3.94, -0.30), body weight overall (WMD -1.61 kg; 95% CI -2.14, -1.07), and body weight in patients with a body mass index >25 kg/m (WMD -2.05 kg; 95% CI -2.78, -1.31). The proportion of patients who achieved HbA1c < 7% was higher in patients who received bexagliflozin as compared with placebo (OR 1.94; 95% CI 1.36-2.78). There were no significant differences between groups regarding side effects such as hypoglycaemia, genital mycotic infection, urinary tract infection, diarrhoea, headache, nausea, polyuria, diabetic ketoacidosis, or all-cause mortality.
CONCLUSIONS
In this meta-analysis, the use of bexagliflozin was associated with improved clinical and laboratory measures in patients with T2DM compared with placebo, with a similar profile of side effects. These findings support the efficacy of bexagliflozin in the treatment of T2DM.
Topics: Humans; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Glycated Hemoglobin; Sodium-Glucose Transporter 2 Inhibitors; Body Weight; Blood Glucose
PubMed: 36929659
DOI: 10.1111/dom.15051 -
The Journal of Urology Apr 2014We determined the relationship between nocturia and nocturnal polyuria. (Meta-Analysis)
Meta-Analysis Review
PURPOSE
We determined the relationship between nocturia and nocturnal polyuria.
MATERIALS AND METHODS
The PubMed® and Embase® databases were searched for studies written in English, German, French or Dutch with original data on adult participants in an investigation of the relationship between nocturia and nocturnal polyuria. A meta-analysis of the difference in mean nocturnal voiding frequencies between patients with and without nocturnal polyuria was conducted. Nocturnal polyuria risk was compared between participants with and without nocturia, and the resulting odds ratio was subsequently converted to relative risk with 95% CIs.
RESULTS
From 511 references identified we selected 78 publications of 66 studies, 15 of which met the inclusion criteria for this study. Quality scores of studies were generally high for internal validity but low for external validity. In 7 studies (1,416 participants) we estimated a standardized mean difference of 0.59 (95% CI 0.29-0.89) for nocturnal voids between nocturnal polyuria and nonnocturnal polyuria cases. In 8 other studies (with 2,320 participants) we calculated a pooled OR of 4.99 (3.92-6.37) for nocturnal polyuria in individuals with nocturia. The corresponding RR, based on a nocturnal polyuria risk in the pooled population of 63.8%, was 1.41 (1.37-1.44).
CONCLUSIONS
The association between nocturia and nocturnal polyuria is apparent and robust. However, the clinical importance of the association appears to be less obvious than previously suggested based on single studies. The observed high prevalence of nocturnal polyuria, as a result of the applied International Continence Society definition, may be responsible for this discrepancy.
Topics: Epidemiologic Studies; Humans; Nocturia; Polyuria
PubMed: 24184367
DOI: 10.1016/j.juro.2013.10.100 -
Scientific Reports Nov 2021Different studies have suggested that fluoride is related to neurological disorders in children and adolescents, but clinical evidences of which neurological parameters... (Meta-Analysis)
Meta-Analysis
Different studies have suggested that fluoride is related to neurological disorders in children and adolescents, but clinical evidences of which neurological parameters associated to fluoride exposure are, in fact, still controversial. In this way, this systematic review and meta-analysis aimed to show if there is an association between fluoride exposure from different sources, doses and neurological disorders. Terms related to "Humans"; "Central nervous system"; "Fluorides"; and "Neurologic manifestations" were searched in a systematic way on PubMed, Scopus, Web of Science, Lilacs, Cochrane and Google Scholar. All studies performed on humans exposed to fluoride were included on the final assessment. A meta-analysis was then performed and the quality level of evidence was performed using the GRADE approach. Our search retrieved 4,024 studies, among which 27 fulfilled the eligibility criteria. The main source of fluoride was naturally fluoridated water. Twenty-six studies showed alterations related to Intelligence Quotient (IQ) while only one has evaluated headache, insomnia, lethargy, polydipsia and polyuria. Ten studies were included on the meta-analysis, which showed IQ impairment only for individuals under high fluoride exposure considering the World Health Organization criteria, without evidences of association between low levels and any neurological disorder. However, the high heterogeneity observed compromise the final conclusions obtained by the quantitative analyses regarding such high levels. Furthermore, this association was classified as very low-level evidence. At this time, the current evidence does not allow us to state that fluoride is associated with neurological damage, indicating the need for new epidemiological studies that could provide further evidences regarding this possible association.
Topics: Adolescent; Child; Environment; Environmental Exposure; Fluoridation; Fluorides; Fluorine Compounds; Humans; Intelligence Tests; Nervous System Diseases
PubMed: 34811523
DOI: 10.1038/s41598-021-99688-w -
Medicina (Kaunas, Lithuania) Sep 2023: Bartter syndrome (BS) is a rare group of autosomal-recessive disorders that usually presents with hypokalemic metabolic alkalosis, occasionally with hyponatremia and... (Review)
Review
: Bartter syndrome (BS) is a rare group of autosomal-recessive disorders that usually presents with hypokalemic metabolic alkalosis, occasionally with hyponatremia and hypochloremia. The clinical presentation of BS is heterogeneous, with a wide variety of genetic variants. The aim of this systematic review was to examine the available literature and provide an overview of the case reports and case series on BS. : Case reports/series published from April 2012 to April 2022 were searched through Pubmed, JSTOR, Cochrane, ScienceDirect, and DOAJ. Subsequently, the information was extracted in order to characterize the clinical presentation, laboratory results, treatment options, and follow-up of the patients with BS. : Overall, 118 patients, 48 case reports, and 9 case series ( = 70) were identified. Out of these, the majority of patients were male ( = 68). A total of 21 patients were born from consanguineous marriages. Most cases were reported from Asia (73.72%) and Europe (15.25%). In total, 100 BS patients displayed the genetic variants, with most of these being reported as Type III ( = 59), followed by Type II ( = 19), Type I ( = 14), Type IV ( = 7), and only 1 as Type V. The most common symptoms included polyuria, polydipsia, vomiting, and dehydration. Some of the commonly used treatments were indomethacin, potassium chloride supplements, and spironolactone. The length of the follow-up time varied from 1 month to 14 years. : Our systematic review was able to summarize the clinical characteristics, presentation, and treatment plans of BS patients. The findings from this review can be effectively applied in the diagnosis and patient management of individuals with BS, rendering it a valuable resource for nephrologists in their routine clinical practice.
Topics: Humans; Male; Female; Bartter Syndrome; Potassium; Hyponatremia; Spironolactone; Europe
PubMed: 37763757
DOI: 10.3390/medicina59091638 -
European Urology Focus Jan 2022Reduced renal function impairs salt and water homeostasis, which can drive nocturnal or 24-h polyuria. Nocturia can arise early in chronic kidney disease (CKD).... (Review)
Review
CONTEXT
Reduced renal function impairs salt and water homeostasis, which can drive nocturnal or 24-h polyuria. Nocturia can arise early in chronic kidney disease (CKD). Evidence-based recommendations can facilitate management outside nephrology clinics.
OBJECTIVE
To conduct a systematic review (SR) of nocturia in CKD and achieve expert consensus for management in primary care and in specialist clinics outside nephrology.
EVIDENCE ACQUISITION
Four databases were searched from January 2000 to April 2020. A total of 4011 titles and abstracts were screened, and 108 studies underwent full-text screening. Seven studies met the inclusion criteria and two were identified through other sources. Consensus was achieved among an expert panel with public involvement using the nominal group technique (NGT).
EVIDENCE SYNTHESIS
Several plausible mechanisms contribute to nocturnal or 24-h polyuria in CKD, but there is little evidence on interventions to improve nocturia. NGT assessment recommendations for nocturia (at least two voids per night) in patients with CKD or at risk of CKD being assessed in a non-nephrology setting are: history (thirst, fluid intake), medication review (diuretics, lithium, calcium channel antagonists, nonsteroidal anti-inflammatory medications), examination (oedematous state, blood pressure), urinalysis (haematuria and albumin/creatinine ratio), blood tests (blood urea, serum creatinine and electrolytes, estimated glomerular filtration rate), and a bladder diary. Renal ultrasound should follow local CKD guidelines. Treatment options include optimising blood pressure control, dietary adjustment to reduce salt intake, fluid advice, and a medication review. Referral to specialist nephrology services should follow local guidelines.
CONCLUSIONS
CKD should be considered when evaluating patients with nocturia. The aim of assessment is to identify mechanisms and instigate therapy, but the latter may be more applicable to reducing wider morbidity associated with CKD than nocturia itself.
PATIENT SUMMARY
People with kidney disease can suffer severe sleep disturbance because of a need to pass urine overnight. We looked at published research and found some useful information about the underlying mechanisms. A group of experts was able to develop practical approaches for assessing and treating this condition.
Topics: Consensus; Humans; Nocturia; Polyuria; Primary Health Care; Renal Insufficiency, Chronic
PubMed: 35031353
DOI: 10.1016/j.euf.2021.12.010 -
BJU International Apr 2015To systematically review and evaluate the impact of the International Continence Society (ICS)-2002 report on standardisation of terminology in nocturia, on publications... (Review)
Review
Impact of the International Continence Society (ICS) report on the standardisation of terminology in nocturia on the quality of reports on nocturia and nocturnal polyuria: a systematic review.
OBJECTIVE
To systematically review and evaluate the impact of the International Continence Society (ICS)-2002 report on standardisation of terminology in nocturia, on publications reporting on nocturia and nocturnal polyuria (NP). In 2002, the ICS defined NP as a Nocturnal Polyuria Index (nocturnal urine volume/total 24-h urine volume) of >0.2-0.33, depending on age.
MATERIALS AND METHODS
In April 2013 the PubMed and Embase databases were searched for studies (in English, German, French or Dutch) based on original data and adult participants, investigating the relationship between nocturia and NP. A methodological quality assessment was performed, including scores on external validity, internal validity and informativeness. Quality scores of items were compared between studies published before and after the ICS-2002 report.
RESULTS
The search yielded 78 publications based on 66 studies. Quality scores of studies were generally high for internal validity (median 5, interquartile range [IQR] 4-6) but low for external validity. After publication of the ICS-2002 report, external validity showed a significant change from 1 (IQR 1-2) to 2 (IQR 1-2.5; P = 0.019). Nocturia remained undefined in 12 studies. In all, 19 different definitions were used for NP, most often being the ICS (or similar) definition: this covered 52% (n = 11) of studies before and 66% (n = 27) after the ICS-2002 report. Clear definitions of both nocturia and NP were identified in 67% and 76% before, and in 88% and 88% of the studies after the ICS-2002 report, respectively.
CONCLUSION
The ICS-2002 report on standardisation of terminology in nocturia appears to have had a beneficial impact on reporting definitions of nocturia and NP, enabling better interpretation of results and comparisons between research projects. Because the external validity of most of the 66 studies is considered a problem, the results of these studies may not be validly extrapolated to other populations. The ICS definition of NP is used most often. However, its discriminative value seems limited due to the estimated difference of 0.6 nocturnal voids between individuals with and without NP. Refinement of current definitions based on robust research is required. Based on pathophysiological reasoning, we argue that it may be more appropriate to define NP based on nocturnal urine production or nocturnal voided volumes, rather than on a diurnal urine production pattern.
Topics: Biomedical Research; Humans; Internationality; Nocturia; Publications; Societies, Medical; Terminology as Topic
PubMed: 24684483
DOI: 10.1111/bju.12753 -
Endocrine Practice : Official Journal... Aug 2023Accurate diagnosis of diabetes insipidus (DI) is of significant importance for correct management. We aimed to evaluate the diagnostic accuracy of copeptin level... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Accurate diagnosis of diabetes insipidus (DI) is of significant importance for correct management. We aimed to evaluate the diagnostic accuracy of copeptin level measurements in the differential diagnosis between DI and primary polydipsia (PP).
METHODS
A literature search of electronic databases from January 1, 2005, to July 13, 2022, was performed. Primary studies that evaluated the diagnostic accuracy of copeptin concentration in patients with DI and PP were considered eligible. Two reviewers independently screened relevant articles and extracted data. The Quality Assessment of Diagnostic Accuracy Studies 2 tool was used to assess the quality of the included studies. The hierarchical summary receiver operating characteristic model and bivariate method were used.
RESULTS
Seven studies including 422 patients with polydipsia-polyuria syndrome were included; of the 422 patients, 189 (44.79%) presented with arginine vasopressin deficiency (AVP-D, cranial DI) and 212 (50.24%) with PP. The summary estimates of the diagnostic performance of stimulated copeptin to differentiate between PP and AVP-D were 0.93 (95% CI, 0.89-0.97) for sensitivity and 0.96 (95% CI, 0.88-1.00) for specificity. Baseline copeptin level showed high performance in identifying AVP resistance (nephrogenic DI), with a pooled sensitivity of 1.00 (95% CI, 0.82-1.00) and specificity of 1.00 (95% CI, 0.98-1.00); however, it showed little value in the differentiation between PP and AVP-D.
CONCLUSION
Copeptin level measurement is a useful tool for the differential diagnosis of patients with DI and PP. Stimulation before copeptin measurement is necessary in the diagnosis of AVP-D.
Topics: Humans; Diagnosis, Differential; Diabetes Insipidus; Glycopeptides; Diabetes Insipidus, Neurogenic; Diabetes Mellitus
PubMed: 37225043
DOI: 10.1016/j.eprac.2023.05.006 -
European Urology Focus Sep 2020Nocturia is among the most common and bothersome lower urinary tract symptoms (LUTS), but there is no clear consensus on how to identify and manage this symptom in the...
CONTEXT
Nocturia is among the most common and bothersome lower urinary tract symptoms (LUTS), but there is no clear consensus on how to identify and manage this symptom in the neurological population.
OBJECTIVE
To systematically review the literature about nocturia in neurological patients.
EVIDENCE ACQUISITION
Studies were identified by electronic search of Cochrane and Medline databases. The studies were included if their participants had acquired neurological pathology among multiple sclerosis (MS), Parkinson's disease (PD), stroke, spinal cord injury (SCI), and reported data on the epidemiology, aetiology, diagnosis, or treatment of nocturia. An independent extraction of the articles was performed by two authors using predetermined datasets, including quality-of-study indicators.
EVIDENCE SYNTHESIS
A total of 132 studies were included; 46 evaluated the epidemiology of nocturia, 28 the possible aetiologies, 10 the diagnostic tools, and 60 the treatments. Nocturia prevalence ranged from 15% to 96% depending on the pathology and definition used. It was one of the most frequently reported LUTS in PD and stroke patients. Several validated questionnaires were found to screen for nocturia in this population. Causalities were numerous: LUT, renal, sleep, cardiovascular dysfunctions, etc. Treatments targeted these mechanisms, with an overall risk of bias assessed as high or serious. The highest level of evidence was seen in MS patients: pelvic floor muscle training, cannabinoids, and desmopressin were effective, but not melatonin. In stroke patients, transcutaneous sacral and transcutaneous tibial nerve stimulation (TTNS) improved nocturia; in PD patients, TTNS, solifenacin, and rotigotine did not.
CONCLUSIONS
Nocturia is highly prevalent in patients with neurological disorders. Causalities and treatments are not different from the general population, but are poorly studied in neurological patients.
PATIENT SUMMARY
In this report, we looked at the published studies about nocturia-the fact of waking to void during the hours of sleep-in patients with neurological diseases. We found that nocturia is very frequent in this population, that the causes are the same as in the general population but may be combined, and that treatments are also the same but have an overall weak level of evidence. We conclude that more research is needed on this topic.
Topics: Humans; Nervous System Diseases; Nocturia; Polyuria
PubMed: 32192920
DOI: 10.1016/j.euf.2020.02.007 -
Acta Clinica Belgica Aug 2018Background Evidence of diagnostic accuracy for proposed definitions of nocturnal polyuria is currently unclear. Purpose Systematic review to determine population-based...
Background Evidence of diagnostic accuracy for proposed definitions of nocturnal polyuria is currently unclear. Purpose Systematic review to determine population-based evidence of the diagnostic accuracy of proposed definitions of nocturnal polyuria based on data from frequency-volume charts. Methods Seventeen pre-specified search terms identified 351 unique investigations published from 1990 to 2016 in BIOSIS, Embase, Embase Alerts, International Pharmaceutical Abstract, Medline, and Cochrane. Thirteen original communications were included in this review based on pre-specified exclusion criteria. Data were extracted from each paper regarding subject age, sex, ethnicity, health status, sample size, data collection methods, and diagnostic discrimination of proposed definitions including sensitivity, specificity, positive and negative predictive value. Results The sample size of study cohorts, participant age, sex, ethnicity, and health status varied considerably in 13 studies reporting on the diagnostic performance of seven different definitions of nocturnal polyuria using frequency-volume chart data from 4968 participants. Most study cohorts were small, mono-ethnic, including only Caucasian males aged 50 or higher with primary or secondary polyuria that were compared to a control group of healthy men without nocturia in prospective or retrospective settings. Proposed definitions had poor discriminatory accuracy in evaluations based on data from subjects independent from the original study cohorts with findings being similar regarding the most widely evaluated definition endorsed by ICS. Conclusions Diagnostic performance characteristics for proposed definitions of nocturnal polyuria show poor to modest discrimination and are not based on sufficient level of evidence from representative, multi-ethnic population-based data from both females and males of all adult ages.
Topics: Diagnostic Techniques, Urological; Female; Humans; Male; Middle Aged; Nocturia; Polyuria; Predictive Value of Tests
PubMed: 29405090
DOI: 10.1080/17843286.2018.1427821 -
European Urology Focus Jan 2022Salt and water homeostasis is regulated hormonally, so polyuria can result from endocrine disease directly or via secondary effects. These mechanisms are not... (Review)
Review
CONTEXT
Salt and water homeostasis is regulated hormonally, so polyuria can result from endocrine disease directly or via secondary effects. These mechanisms are not consistently considered in primary care management of nocturia.
OBJECTIVE
To conduct a systematic review (SR) of nocturia in endocrine disease and reach expert consensus for primary care management.
EVIDENCE ACQUISITION
Four databases were searched from January 2000 to April 2020. A total of 4382 titles and abstracts were screened, 36 studies underwent full-text screening, and 14 studies were included in the analysis. Expert and public consensus was achieved using the nominal group technique (NGT).
EVIDENCE SYNTHESIS
Twelve studies focused on mechanisms of nocturia, while two evaluated treatment options; none of the studies took place in a primary care setting. NGT consensus identified key clinical evaluation themes, including the presence of thirst, a medical background of diabetes mellitus or insipidus, thyroid disease, oestrogen status, medications (fluid loss or xerostomia), and general examination including body mass index. Proposed investigations include a bladder diary, renal and thyroid function, calcium, and glycated haemoglobin. Morning urine osmolarity should be examined in the context of polyuria of >2.5 l/24 h persisting despite fluid advice, with urine concentration >600 mOsm/l after fluid restriction excluding diabetes insipidus. Treatment should involve education, including adjustment of lifestyle and medication where possible. Any underlying endocrine disorder should be managed according to local guidance. Referral to endocrinology is needed if there is hyperthyroidism, hyperparathyroidism, or morning urine osmolarity <600 mOsm/l after overnight fluid avoidance.
CONCLUSIONS
Endocrine disease can result in nocturia via varied salt and water regulation pathways. The aim of management is to identify and treat causative factors, but secondary effects can restrict improvements in nocturia.
PATIENT SUMMARY
People with altered hormone function can suffer from severe sleep disturbance because of a need to pass urine caused by problems in controlling water and salt levels. An expert panel recommended the best ways to assess and treat these problems on the basis of the rather small amount of up-to-date published research available.
Topics: Consensus; Endocrine System Diseases; Humans; Nocturia; Polyuria; Primary Health Care; Water
PubMed: 34996740
DOI: 10.1016/j.euf.2021.12.008