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European Journal of Heart Failure Jun 2024Haemodynamic monitoring using implantable pressure sensors reduces the risk of heart failure (HF) hospitalizations. Patient self-management (PSM) of haemodynamics in HF...
AIMS
Haemodynamic monitoring using implantable pressure sensors reduces the risk of heart failure (HF) hospitalizations. Patient self-management (PSM) of haemodynamics in HF has the potential to personalize treatment, increase adherence, and reduce the risk of worsening HF, while lowering clinicians' burden.
METHODS AND RESULTS
The VECTOR-HF I and IIa studies are prospective, single-arm, open-label clinical trials assessing safety, usability and performance of left atrial pressure (LAP)-guided HF management using PSM in New York Heart Association class II and III HF patients. Physician-prescribed LAP thresholds trigger patient self-adjustment of diuretics. Primary endpoints include the ability to perform LAP measurements and transmit data to the healthcare provider (HCP) interface and the patient guidance application, and safety outcomes. This is an interim analysis of 13 patients using the PSM approach. Over 12 months, no procedure- or device-related major adverse cardiovascular or neurological events were observed, and there were no failures to obtain measurements from the sensor and transmit the data to the HCP interface and the patient guidance application. Patient adherence was 91.4%. Using PSM, annualized HF hospitalization rate significantly decreased compared to a similar period prior to PSM utilization (0 admissions vs. 0.69 admissions over 11.84 months, p = 0.004). At 6 months, 6-min walk test distance and the Kansas City Cardiomyopathy Questionnaire overall summary score demonstrated significant improvement.
CONCLUSIONS
Interim findings suggest that PSM using a LAP monitoring system is feasible and safe. PSM is associated with high patient adherence, potentially improving HF patients' functional status, quality of life, and limiting HF hospitalizations.
PubMed: 38899626
DOI: 10.1002/ejhf.3338 -
Diabetes, Obesity & Metabolism Jun 2024Diabetic nephropathy, also known as diabetic kidney disease (DKD), remains a challenge in clinical practice as this is the major cause of kidney failure worldwide.... (Review)
Review
A review of the latest real-world evidence studies in diabetic kidney disease: What have we learned about clinical practice and the clinical effectiveness of interventions?
Diabetic nephropathy, also known as diabetic kidney disease (DKD), remains a challenge in clinical practice as this is the major cause of kidney failure worldwide. Clinical trials do not answer all the questions raised in clinical practice and real-world evidence provides complementary insights from randomized controlled trials. Real-life longitudinal data highlight the need for improved screening and management of diabetic nephropathy in primary care. Adherence to the recommended guidelines for comprehensive care appears to be suboptimal in clinical practice in patients with DKD. Barriers to the initiation of sodium-glucose cotransporter-2 (SGLT2) inhibitors for patients with DKD persist in clinical practice, in particular for the elderly. Attainment of blood pressure targets often remains an issue. Initiation of glucagon-like peptide-1 receptor agonists (GLP-1RAs) in routine clinical practice is associated with a reduced risk of albuminuria progression and a possible beneficial effect on kidney function. Real-world evidence confirms a beneficial effect of SGLT2 inhibitors on the decline of glomerular filtration, even in the absence of albuminuria, with a lower risk of acute kidney injury events compared to GLP-1RA use. In addition, SGLT2 inhibitors confer a lower risk of hyperkalaemia after initiation compared with dipeptidyl peptidase-4 inhibitors in patients with DKD. Data from a large population indicate that diuretic treatment increases the risk of a significant decline in glomerular filtration rate in the first few weeks of treatment after SGLT2 inhibitor initiation. The perspective for a global approach targeting multifaceted criteria for diabetic individuals with DKD is emerging based on real-world evidence but there is still a long way to go to achieve this goal.
PubMed: 38899425
DOI: 10.1111/dom.15710 -
BMC Pediatrics Jun 2024With a wide therapeutic index, efficacy, ease of use, and other neuroprotective and respiratory benefits, caffeine citrate(CC) is currently the drug of choice for...
BACKGROUND
With a wide therapeutic index, efficacy, ease of use, and other neuroprotective and respiratory benefits, caffeine citrate(CC) is currently the drug of choice for preterm neonates (PTNs). Caffeine-induced excessive energy expenditure, diuresis, natriuresis, and other CC-associated potential side-effects (CC-APSEs) result in lower daily-weight gain (WG) in premature neonates. This study aimed to evaluate the risk factors for daily-WG in neonates exposed to different dose regimens of caffeine in ICU.
METHOD
This retrospective cohort study included neonates of ≤ 36weeks gestational age (GA) and received CC-therapy. The same participants were followed for data analysis in two postnatal phases: 15-28 and 29-42 days of life (DOL). Based on daily CC-dose, formed group-I (received; standard-doses = 5 mg/kg/day), group-II (received;>5-7 mg/kg/day), and group-III (received;>7 mg/kg/day). Prenatal and postnatal clinical characteristics, CC-regimen, daily-WG, CC-APSEs, and concomitant risk-factors, including daily-caloric intake, Parenteral-Nutrition duration, steroids, diuretics, and ibuprofen exposure, were analyzed separately for group-II and group-III using group-I as standard. Regression analysis was performed to evaluate the risk factors for daily-WG.
RESULTS
Included 314 PTNs. During 15-28 DOL, the mean-daily-WG(MD-WG) was significantly higher in group-I than group-II [19.9 ± 0.70 g/kg/d vs. 17.7 ± 0.52 p = 0.036] and group-III [19.9 ± 0.70 g/kg/d vs. 16.8 ± 0.73 p < 0.001]. During 29-42 DOL the MD-WG of group-I was only significantly higher than group-III [21.7 ± 0.44 g/kg/d vs. 18.3 ± 0.41 g/kg/d p = 0.003] and comparable with group-II. During 15-28 DOL, observed CC-APSEs was significantly higher in group-II and III but during 29-42 DOL it was only significant in group-III. In the adjusted regression analysis for daily-WG during 15-28DOL, with respect to standard-dose, 5-7 mg/kg/day (β=-1.04; 95%CI:-1.62,-0.93) and > 7-10 mg/kg/day (β=-1.36; 95%CI:-1.56,-1.02) were associated with a lower daily-WG. However, during 29-42DOL, this association was present only for > 7-10 mg/kg/day (β=-1.54; 95%CI:-1.66,-1.42). The GA ≤ 27weeks (β=-1.03 95%CI:-1.24, -0.88) was associated with lower daily-WG only during 15-28DOL. During both periods of therapy, higher cumulative-caffeine dose and presence of culture proven sepsis, tachypnea, hyponatremia, and feeding intolerance were significantly associated with lower daily-WG. Conversely, daily kcal intake was found to be linked with an increase in daily-WG in both periods.
CONCLUSION
In this study cohort exposure to higher caffeine daily and cumulative doses is associated with lower postnatal daily-WG in PTNs than standard-daily doses, which may be due to its catabolic effects and CC-APSEs.
Topics: Humans; Caffeine; Retrospective Studies; Infant, Newborn; Female; Male; Infant, Premature; Weight Gain; Dose-Response Relationship, Drug; Risk Factors; Intensive Care Units, Neonatal; Citrates; Central Nervous System Stimulants
PubMed: 38898410
DOI: 10.1186/s12887-024-04850-8 -
Scientific Reports Jun 2024We compared the efficacy of 4 mg drospirenone (DRSP) progestin-only pills (POPs) versus combined oral contraceptive pills (COCs) containing 0.02 mg of ethinyl... (Randomized Controlled Trial)
Randomized Controlled Trial
We compared the efficacy of 4 mg drospirenone (DRSP) progestin-only pills (POPs) versus combined oral contraceptive pills (COCs) containing 0.02 mg of ethinyl estradiol (EE) and 0.075 mg of gestodene (GS) in ovulation inhibition and inducing unfavorable cervical mucus changes using a delayed-starting approach. This randomized controlled trial involved 36 participants aged 18-45 years. The major outcomes included ovulation inhibition assessed using the Hoogland and Skouby score, and cervical mucus permeability, assessed using the modified World Health Organization score. The results demonstrated ovulation inhibition rates of 77.8% for the EE/GS group and 88.9% for the DRSP group. The risk ratio and absolute risk reduction were 0.50 (95% confidence interval [CI]: 0.10, 2.40) and - 0.11 (95% CI: - 0.35, 0.13), respectively, satisfying the 20% non-inferiority margin threshold. The median time to achieve unfavorable cervical mucus changes was comparable between the DRSP (3 days, interquartile range [IQR]: 6 days) and EE/GS (3.5 days, IQR: 4 days) groups. However, the DRSP group had a higher incidence of unscheduled vaginal bleeding (55.56% vs. 11.11%; p = 0.005). DRSP-only pills, initiated on days 7-9 of the menstrual cycle, were non-inferior to EE/GS pills in ovulation inhibition. However, they exhibited delayed unfavorable cervical mucus changes compared to the standard two-day backup recommendation.Clinical trial registration: Thai Clinical Trials Registry (TCTR20220819001) https://www.thaiclinicaltrials.org/show/TCTR20220819001 .
Topics: Humans; Female; Adult; Ethinyl Estradiol; Androstenes; Young Adult; Adolescent; Contraceptives, Oral, Combined; Ovulation Inhibition; Single-Blind Method; Middle Aged; Norpregnenes; Ovulation; Cervix Mucus
PubMed: 38898193
DOI: 10.1038/s41598-024-64753-7 -
BMJ (Clinical Research Ed.) Jun 2024Resistant hypertension is defined as blood pressure that remains above the therapeutic goal despite concurrent use of at least three antihypertensive agents of different... (Review)
Review
Resistant hypertension is defined as blood pressure that remains above the therapeutic goal despite concurrent use of at least three antihypertensive agents of different classes, including a diuretic, with all agents administered at maximum or maximally tolerated doses. Resistant hypertension is also diagnosed if blood pressure control requires four or more antihypertensive drugs. Assessment requires the exclusion of apparent treatment resistant hypertension, which is most often the result of non-adherence to treatment. Resistant hypertension is associated with major cardiovascular events in the short and long term, including heart failure, ischemic heart disease, stroke, and renal failure. Guidelines from several professional organizations recommend lifestyle modification and antihypertensive drugs. Medications typically include an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, a calcium channel blocker, and a long acting thiazide-type/like diuretic; if a fourth drug is needed, evidence supports addition of a mineralocorticoid receptor antagonist. After a long pause since 2007 when the last antihypertensive class was approved, several novel agents are now under active development. Some of these may provide potent blood pressure lowering in broad groups of patients, such as aldosterone synthase inhibitors and dual endothelin receptor antagonists, whereas others may provide benefit by allowing treatment of resistant hypertension in special populations, such as non-steroidal mineralocorticoid receptor antagonists in patients with chronic kidney disease. Several device based approaches have been tested, with renal denervation being the best supported and only approved interventional device treatment for resistant hypertension.
Topics: Humans; Hypertension; Antihypertensive Agents; Drug Resistance; Drug Therapy, Combination; Calcium Channel Blockers; Blood Pressure
PubMed: 38897628
DOI: 10.1136/bmj-2023-079108 -
FP Essentials Jun 2024Acne is a chronic, recurrent inflammatory condition of the pilosebaceous unit. It affects approximately 85% of adolescents and creates significant psychosocial and... (Review)
Review
Acne is a chronic, recurrent inflammatory condition of the pilosebaceous unit. It affects approximately 85% of adolescents and creates significant psychosocial and financial burdens. The pathogenesis involves altered follicular growth and differentiation, microbial colonization with , increased sebum production influenced by androgen levels, and inflammation. Evidence-based risk factors include family history and body mass index. Diagnosis of acne is clinical, according to patient age and acne morphology and severity. Setting treatment expectations is an important aspect of management. For mild acne, benzoyl peroxide is an effective first-line drug as monotherapy or in combination with a topical retinoid and/or topical antibiotic. Oral tetracyclines are first-line drugs as part of a multipart treatment regimen for moderate to severe acne for patients older than 8 years. Oral isotretinoin is the first-line drug for moderate to severe inflammatory acne. Because of its teratogenic effects, its prescribing is monitored through the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program. Prescribing oral or topical antibiotics as monotherapy for acne is not recommended, as this may increase microbial resistance. Combined oral contraceptives and spironolactone are used as adjunctive therapies in female adolescents. Patients with skin of color, pregnant patients, and transgender or gender diverse patients warrant special considerations in acne management.
Topics: Humans; Acne Vulgaris; Adolescent; Child; Dermatologic Agents; Anti-Bacterial Agents; Isotretinoin; Female; Benzoyl Peroxide; Risk Factors; Male; Spironolactone; Retinoids
PubMed: 38896825
DOI: No ID Found -
Arquivos Brasileiros de Cardiologia 2024Residual venous congestion is a major contributor to readmission of patients with heart failure, and the venous excess ultrasound (VExUS) score is a potentially useful...
BACKGROUND
Residual venous congestion is a major contributor to readmission of patients with heart failure, and the venous excess ultrasound (VExUS) score is a potentially useful tool to evaluate systemic congestion.
OBJECTIVES
To investigate the association between VExUS score before hospital discharge among patients with heart failure and the risk of readmission due to acute decompensated heart failure (ADHF) within 90 days after discharge.
METHODS
This prospective cohort study enrolled adults with signs and symptoms of ADHF, left ventricular ejection fraction of 40% or below (heart failure with reduced ejection fraction), New York Heart Association functional class II to IV symptoms, and clinical evidence of venous congestion necessitating intravenous diuretics. Just prior to discharge, we conducted VExUS score evaluation. The primary outcome was a composite endpoint of readmission or emergency visits due to ADHF within 90 days following hospital discharge. Statistical significance was set at p < 0.05.
RESULTS
The cohort comprised 49 individuals, 11 (22.4%) of whom experienced the primary outcome. At discharge, 34.7% of participants had VExUS score 2 or 3. Patients with VExUS 2 and 3 had a higher proportion of the primary outcome when compared with patients with VExUS of 0 (35.3% versus 9%, p = 0.044).
CONCLUSIONS
A significant proportion of patients with heart failure with reduced ejection fraction admitted for ADHF presented clinical and ultrasound signs of residual congestion at discharge. Patients with VExUS score of 2 or 3 at the time of hospital discharge were found to be at higher risk of readmissions or emergency visits due to ADHF after 90 days.
Topics: Humans; Heart Failure; Patient Readmission; Female; Male; Aged; Patient Discharge; Middle Aged; Prospective Studies; Acute Disease; Stroke Volume; Time Factors; Risk Factors; Risk Assessment; Predictive Value of Tests; Severity of Illness Index; Reference Values; Aged, 80 and over
PubMed: 38896589
DOI: 10.36660/abc.20230745 -
Rheumatology (Oxford, England) Jun 2024To develop a machine learning-based prediction model for identifying hyperuricemic participants at risk of developing gout.
OBJECTIVE
To develop a machine learning-based prediction model for identifying hyperuricemic participants at risk of developing gout.
METHODS
A retrospective nationwide Israeli cohort study used the Clalit Health Insurance database of 473 124 individuals to identify adults 18 years or older with at least two serum urate measurements exceeding 6.8 mg/dl between January 2007 and December 2022. Patients with a prior gout diagnosis or on gout medications were excluded. Patients' demographic characteristics, community and hospital diagnoses, routine medication prescriptions and laboratory results were used to train a risk prediction model. A machine learning model, XGBoost, was developed to predict the risk of gout. Feature selection methods were used to identify relevant variables. The model's performance was evaluated using the receiver operating characteristic area under the curve (ROC AUC) and precision-recall AUC. The primary outcome was the diagnosis of gout among hyperuricemic patients.
RESULTS
Among the 301 385 participants with hyperuricemia included in the analysis, 15 055 (5%) were diagnosed with gout. The XGBoost model had a ROC-AUC of 0.781 (95% CI 0.78-0.784) and precision-recall AUC of 0.208 (95% CI 0.195-0.22). The most significant variables associated with gout diagnosis were serum uric acid levels, age, hyperlipidemia, non-steroidal anti-inflammatory drugs and diuretic purchases. A compact model using only these five variables yielded a ROC-AUC of 0.714 (95% CI 0.706-0.723) and a negative predictive value (NPV) of 95%.
CONCLUSIONS
The findings of this cohort study suggest that a machine learning-based prediction model had relatively good performance and high NPV for identifying hyperuricemic participants at risk of developing gout.
PubMed: 38895877
DOI: 10.1093/rheumatology/keae273 -
Sensors (Basel, Switzerland) Jun 2024Heart failure (HF) admissions are burdensome, and the mainstay of prevention is the timely detection of impending fluid retention, creating a window for medical... (Observational Study)
Observational Study
Heart failure (HF) admissions are burdensome, and the mainstay of prevention is the timely detection of impending fluid retention, creating a window for medical treatment intensification. This study evaluated the accuracy and performance of a Triage-HF-guided carepath in real-world ambulatory HF patients in daily clinical practice. In this prospective, observational study, 92 adult HF patients (71 males (78%), with a median age of 69 [IQR 59-75] years) with the Triage-HF algorithm activated in their cardiac implantable electronic devices (CIEDs), were monitored. Following high-risk alerts, an HF nurse contacted patients to identify signs and symptoms of fluid retention. The sensitivity and specificity were 83% and 97%, respectively. The positive predictive value was 89%, and negative predictive value was 94%. The unexplained alert rate was 0.05 alerts/patient year, and the false negative rate was 0.11 alerts/patient year. Ambulatory diuretics were initiated or escalated in 77% of high-risk alert episodes. In 23% (n = 6), admission was ultimately required. The median alert handling time was 2 days. Fifty-eight percent (n = 18) of high-risk alerts were classified as true positives in the first week, followed by 29% in the second-third weeks (n = 9), and 13% (n = 4) in the fourth-sixth weeks. Common sensory triggers included an elevated night ventricular rate (84%), OptiVol (71%), and reduced patient activity (71%). The CIED-based Triage-HF algorithm-driven carepath enables the timely detection of impending fluid retention in a contemporary ambulatory setting, providing an opportunity for clinical action.
Topics: Humans; Algorithms; Male; Heart Failure; Female; Aged; Middle Aged; Triage; Prospective Studies; Defibrillators, Implantable
PubMed: 38894453
DOI: 10.3390/s24113664 -
Diagnostics (Basel, Switzerland) Jun 2024We previously reported that sodium-glucose cotransporter 2 (SGLT2) inhibitors exert sustained fluid homeostatic actions through compensatory increases in osmotic...
We previously reported that sodium-glucose cotransporter 2 (SGLT2) inhibitors exert sustained fluid homeostatic actions through compensatory increases in osmotic diuresis-induced vasopressin secretion and fluid intake. However, SGLT2 inhibitors alone do not produce durable amelioration of fluid retention. In this study, we examined the comparative effects of the SGLT2 inhibitor dapagliflozin (SGLT2i group, = 53) and the combined use of dapagliflozin and conventional diuretics, including loop diuretics and/or thiazides (SGLT2i + diuretic group, = 23), on serum copeptin, a stable, sensitive, and simple surrogate marker of vasopressin release and body fluid status. After six months of treatment, the change in copeptin was significantly lower in the SGLT2i + diuretic group than in the SGLT2i group (-1.4 ± 31.5% vs. 31.5 ± 56.3%, = 0.0153). The change in the estimated plasma volume calculated using the Strauss formula was not significantly different between the two groups. Contrastingly, changes in interstitial fluid, extracellular water, intracellular water, and total body water were significantly lower in the SGLT2i + diuretic group than in the SGLT2i group. Changes in renin, aldosterone, and absolute epinephrine levels were not significantly different between the two groups. In conclusion, the combined use of the SGLT2 inhibitor dapagliflozin and conventional diuretics inhibited the increase in copeptin levels and remarkably ameliorated fluid retention without excessively reducing plasma volume and activating the renin-angiotensin-aldosterone and sympathetic nervous systems.
PubMed: 38893720
DOI: 10.3390/diagnostics14111194