BACKGROUND: Chronic spontaneous urticaria (CSU) is a dermatologic condition defined by recurrent wheals, angioedema, or both for ≥6 weeks. Although current treatments such as second-generation H1-antihistamines and omali...BACKGROUND: Chronic spontaneous urticaria (CSU) is a dermatologic condition defined by recurrent wheals, angioedema, or both for ≥6 weeks. Although current treatments such as second-generation H1-antihistamines and omalizumab improve symptoms, many patients remain uncontrolled. Remibrutinib, a highly selective oral Bruton tyrosine kinase inhibitor, is a promising novel therapy. This meta-analysis evaluated its efficacy and safety in antihistamine-refractory CSU. DATA SOURCES: A systematic search of PubMed, Embase, Cochrane Library, Scopus, Web of Science, and clinicaltrials.gov was conducted through March 2025. Only randomized controlled trials reporting UAS7, ISS7, HSS7, and safety data were included. Risk of bias was assessed using Cochrane RoB 2.0, and statistical analyses were performed using RevMan 5.4.1. MAIN FINDINGS AND LIMITATIONS: Three randomized controlled trials (n = 997) were included. Remibrutinib significantly improved disease control versus placebo, with higher odds of achieving UAS7 ≤ 6 (odds ratios 4.38; P < 0.0001) and greater reductions in UAS7 scores (MD -9.45; P < 0.00001). Complete response (UAS7 ≤ 0) was not statistically significant (odds ratios 2.14; P = 0.16). Mild infections, nasopharyngitis, petechiae, and URTIs were more frequent with remibrutinib, while overall adverse events, serious events, and discontinuations were similar. CONCLUSIONS: Remibrutinib demonstrates significant efficacy and an overall favorable short-term safety profile for refractory CSU, though increased mild infections warrant monitoring. Larger, long-term studies and direct comparisons with omalizumab are needed.
BACKGROUND: Therapeutic Strategies for Patient Safety represents, regardless of the medical field in which it is developed, a way of approaching that can lead to reducing the risks of applying therapies, developing patie...BACKGROUND: Therapeutic Strategies for Patient Safety represents, regardless of the medical field in which it is developed, a way of approaching that can lead to reducing the risks of applying therapies, developing patient-oriented therapeutic plans, based on the promotion of positive results, but also on the development of personalized medicine, applicable and adaptable to each patient. The literature is typically focused on therapeutic strategies or patient safety, but fewer approaches focus on promoting patient safety and implementing a plan to prevent harm. AREAS OF UNCERTAINTY: The development of therapeutic strategies that prioritize patient safety requires the advancement of specific research and the creation of reliable therapeutic tools and measures, which are essential for the strategy to be effective, grounded in moral principles, and in accordance with established ethical standards. DATA SOURCES: The understanding of the phenomenon of the development of Therapeutic Strategies for Patient Safety was achieved both based on 5 literature searches in PubMed, MEDLINE, Plus, Scopus, and Web of Science (2015-2023) and through the development of articles (review or original), from different medical fields, by doctoral students (first author) and their teams, and which are part of a special issue of the American Journal of Therapeutics, entitled "Therapeutic strategies for patient safety." THERAPEUTIC ADVANCES: Patient safety and therapeutic strategies are regulated by laws and regulations at the EU level and are a concern for those developing research in the field of clinical medicine. The articles that are part of the special issue of the AJT each represent a model for the development of research in the field of patient safety, regardless of the field of medical (polypharmacy, vancomycin therapy) or surgical (urolithiasis, rectal cancer) therapy, of the use of conventional or nonconventional instruments (remote monitoring devices, telemedicine, transcranial direct current stimulation), through care organized within medical institutions or through self-care (effective self-care among newly diagnosed patients), regardless of the stage or severity of the condition (end-of-life care, management of organophosphate poisoning). CONCLUSIONS: The development of a health system based on moral and ethical values and oriented toward increasing the quality of life through therapeutic strategies and measures to ensure patient safety, a holistic approach to the patient and the disease, and the development of personalized therapies contribute to increasing the efficiency of medical activity and improving clinical outcomes in conditions of reduced risks and errors in health systems.
BACKGROUND: Transcranial direct current stimulation (tDCS) has expanded its use for the treatment of chronic pain. Trials have proven the efficacy of tDCS, but there are still uncertainties over adverse effects (AEs). AR...BACKGROUND: Transcranial direct current stimulation (tDCS) has expanded its use for the treatment of chronic pain. Trials have proven the efficacy of tDCS, but there are still uncertainties over adverse effects (AEs). AREAS OF UNCERTAINTY: There are no systematic data assessing tDCS safety profile in chronic pain conditions. DATA SOURCES: A comprehensive systematic review was performed using PubMed and Web of Science databases. It included randomized sham-controlled clinical trials conducted in patients with different chronic pain conditions treated with tDCS. Based on the level of AEs reported, studies were classified as follows: type I, studies that provided numerical data on AEs; type II, studies that mentioned the occurrence of AEs; type III, studies that reported the absence of AEs; and type IV, studies that made no mention of AEs. THERAPEUTIC ADVANCES: The review included 141 studies: 60 type I, 21 type II, 34 type III, and 26 type IV. There were no significant differences in study design between studies that reported AEs quantitatively and those that reported the absence of AEs. Considering the number of studies that reported AEs quantitatively, the most documented for active versus sham groups were headache (18.86% vs. 19.23%) and tingling (15.43% vs. 19.23%). However, when considering frequency, the most common AEs observed for active versus sham groups were tingling (26.3% vs. 23.65%) and skin redness (17.6% vs. 9.56%). In comparing headache and tingling, no statistically significant difference between active and sham groups could be identified. CONCLUSIONS: In the present form of reporting AEs of tDCS in clinical studies involving patients with chronic pain, this procedure seems to be safe. Nevertheless, we identified diverse modalities of reporting and assessing AEs, which should raise the need for a standardized procedure in this domain.
BACKGROUND: The growing prevalence of pesticide poisonings, particularly those derived from organophosphate exposure, represents a significant challenge to global public health, because of their high toxicity and widespr...BACKGROUND: The growing prevalence of pesticide poisonings, particularly those derived from organophosphate exposure, represents a significant challenge to global public health, because of their high toxicity and widespread agricultural use.Effective and rapid emergency department management of organophosphate (OP) poisonings is essential to mitigate complications associated with acute exposure and ensure patient survival. AREAS OF UNCERTAINTY: We aim to review the literature and present the most up-to-date treatment strategies, and the use of various technological tools, in the detection of organophosphorus pesticides to improve the management of organophosphate poisoning in emergency medical services. DATA SOURCES: This review will be based on scientific articles published in recognized databases and reports from international organizations such as the World Health Organization, the Environmental Protection Agency, and the European Food Safety Authority, considering the challenges in management and barriers to effective treatment. THERAPEUTICS ADVANCES: Treatment of OP poisoning focuses on life support, the use of antidotes, and the administration of anticonvulsants to mitigate neurotoxicity. Treatment's efficacy depends on the type of compound involved and the time elapsed since exposure, which has prompted the development of new therapeutic strategies, including more effective reactivators and combination therapies. Emerging advances include recombinant bioscavengers, reactivators, along with neuroprotective compounds that could attenuate neurological damage. In parallel, the design of portable biosensors for the rapid detection of OPs represents a promising tool to optimize the medical response in acute or mass exposure contexts. CONCLUSIONS: Challenges in management and barriers (rural/agricultural area, delay in seeking medical help, limited availability of diagnostic tests) could lead to delay diagnosis and recognition of affective treatment, which affects patient safety. Preventive strategies and public health initiatives, including personalized approaches and digital health technologies, must be considered and updated.
BACKGROUND: Therapeutic drug monitoring represents an improvement in treatment efficacy and helps reduce side effects. For vancomycin therapy, plasma analysis helps prevent subtherapeutic dosages, which can lead to treat...BACKGROUND: Therapeutic drug monitoring represents an improvement in treatment efficacy and helps reduce side effects. For vancomycin therapy, plasma analysis helps prevent subtherapeutic dosages, which can lead to treatment failure and the potential emergence of antibiotic resistance, while also limiting side effects caused by toxicity. AREAS OF UNCERTAINTY: Although vancomycin dosing based on area under the curve (AUC) has been supported by scientific grade IIIA evidence as improving patient outcomes, it is still not widely adopted, and many questions remain unanswered. There is significant heterogeneity in therapeutic range values presented in guidelines for both point-to-point and AUC measurements, and uncertainty about when to apply these protocols in vancomycin administration. This narrative review aims to evaluate the indications and target values presented in current vancomycin monitoring guidelines, comparing them with studies where vancomycin dosing is not recommended. DATA SOURCES: Articles related to vancomycin dosing were searched on medical databases such as Scopus, PubMed, and Google Scholar. THERAPEUTIC ADVANCES: All review articles and guidelines issued by scientific societies support vancomycin dosing, particularly for dialysis patients, pediatric patients, and those in intensive care units. Although target values may vary across guidelines, trough values between 10 and 20 mg/L are widely accepted. Although AUC-based dosing is more complex, it is recommended, with a therapeutic range between 400 and 700 mg/L/24 h. Although some authors challenge this approach, they reflect the opinions of a relatively small group of experts. CONCLUSIONS: Further pharmacokinetic studies are required to furnish robust evidence and facilitate the establishment of a uniform recommendation for vancomycin drug monitoring by guidelines. In addition, it is essential to assess vancomycin dosing across all patient categories to examine the viability of theories that do not support the need for vancomycin dosing.
BACKGROUND: Polypharmacy is widespread among older adults and presents significant clinical challenges. Although necessary for managing multimorbidity, inappropriate polypharmacy is linked to adverse drug reactions, drug...BACKGROUND: Polypharmacy is widespread among older adults and presents significant clinical challenges. Although necessary for managing multimorbidity, inappropriate polypharmacy is linked to adverse drug reactions, drug-drug interactions, cognitive decline, and increased health care utilization. Interventions such as deprescribing and medication reviews aim to mitigate these risks, but their effectiveness in improving clinical outcomes remains uncertain. AREAS OF UNCERTAINTY: Despite reductions in potentially inappropriate medications, polypharmacy interventions show a limited impact on mortality, hospitalization rates, and quality of life. Variability in intervention intensity, poor implementation strategies, and a lack of integration between pharmacists and prescribers contribute to inconsistent findings. In addition, current deprescribing approaches often fail to account for patient priorities, multimorbidity, and real-world feasibility in primary care settings. DATA SOURCES: This review synthesizes findings from systematic reviews, randomized controlled trials, and meta-analyses evaluating polypharmacy interventions and their clinical impact. THERAPEUTIC ADVANCES: Medication reviews using STOPP/START, Beers Criteria, and Medication Appropriateness Index improve prescribing quality but require a shift toward comprehensive clinical medication reviews. High-intensity interventions involving multidisciplinary teams, including clinical pharmacologists, show promise in reducing hospitalizations and adverse drug reactions. Emerging strategies such as shared decision making, digital deprescribing tools, and artificial intelligence-driven clinical decision support systems may enhance polypharmacy management. CONCLUSIONS: To improve clinical outcomes, future polypharmacy interventions must emphasize structured implementation, real-world adaptability, and patient-centered approaches. Integrating clinical pharmacologists, strengthening pharmacist-prescriber collaboration, and leveraging technology will be essential for optimizing medication use in older adults.
BACKGROUND: Inferior rectal cancer, a malignancy occurring in the lower portion of the rectum, represents a significant clinical challenge due to its complex anatomical location and the diverse treatment approaches requi...BACKGROUND: Inferior rectal cancer, a malignancy occurring in the lower portion of the rectum, represents a significant clinical challenge due to its complex anatomical location and the diverse treatment approaches required for optimal patient outcomes. Over the past few decades, advancements in surgical techniques, radiotherapy, and systemic treatments have contributed to improving survival rates and minimizing morbidity associated with this disease. AREAS OF UNCERTAINTY: Neoadjuvant therapy combined with tumor resection surgery has demonstrated significant improvements in survival in patients with rectal cancer. However, uncertainty persists due to variability in therapeutic responses among different groups of patients and the limited availability of long-term data on the efficacy of pathologic responses. These limitations affirm the need for further studies to optimize and personalize the therapeutic approach to rectal cancer. DATA SOURCES: A search for information was conducted using recognized databases, including Cochrane, PubMed, Scielo, ScienceDirect, and Scopus. The search strategy was designed using specific terms such as: "rectal neoplasms" OR ("rectal AND neoplasms") OR "rectal cancer" AND ("therapeutics" OR "treatments"), to identify relevant publications. THERAPEUTIC ADVANCES: Minimally invasive techniques offer oncologic outcomes equivalent to open surgery with faster recovery and lower morbidity, supported by total neoadjuvant therapy, which has become the standard of care for locally advanced rectal cancer, achieving higher pathologic complete response rates (OR 2.44, 95% CI, 1.99-2.98) and longer disease-free survival (OR 2.07, 95% CI, 1.20-3.56) than conventional chemoradiotherapy. In addition, emerging targeted agents (VEGF and EGFR inhibitors) in molecularly selected patients and PD-1 blockade in dMMR tumors further improve response rates and support organ preservation strategies. CONCLUSIONS: Despite notable advances in treatment strategies for rectal cancer, challenges remain in identifying a therapeutic modality that can improve both overall survival and disease-free survival without exposing the patient to overly aggressive interventions.
BACKGROUND: The patterns of care for patients with advanced cancer in the last week of life are critical for ensuring quality and dignity during a vulnerable time. As patients approach end of life, the focus typically sh...BACKGROUND: The patterns of care for patients with advanced cancer in the last week of life are critical for ensuring quality and dignity during a vulnerable time. As patients approach end of life, the focus typically shifts from aggressive treatment to palliative care, emphasizing comfort and symptom management. The term "non-comfortoriented care" describes a set of medical interventions and treatments that prioritize prolonging life. This can lead to increased physical discomfort, emotional burden, or reduced quality of life. AREAS OF UNCERTAINTY: For those who die in a medical setting, end-of-life care practices vary greatly and the care can be either comfort-oriented or noncomfort-oriented. There is a need for a clear overview of patterns for end-of-life care for patients with advanced cancer. DATA SOURCES: Based on Whittemore's integrative review method, comprehensive searches were conducted in PubMed, Science Direct, Scopus, and Google Scholar databases. Population/Patient, Exposure, and Outcome format was used to formulate a research review question. THERAPEUTICS ADVANCES: Twenty-four articles were included. The key components of the patterns of care implemented during the last week of life are settings, palliative care involvement, intensity of therapeutics interventions, duration, and planning in advance. The only setting where solely comfort-oriented care was delivered was the community. In hospital settings, both comfort and noncomfort-oriented care were offered. Palliative care involvement was associated with comfort-oriented care, early recognition of dying (median 6 days), medication rationalizing, and implementation of care pathways. Noncomfort-oriented care patterns occurred in emergency departments, oncology, and general wards in acute hospitals with late recognition of dying (median 2 days) and use of inappropriate therapeutics interventions. CONCLUSION: To deliver the best care in the last week of life, new strategies are necessary to guide the clinical practices and to ensure patient-centered care.
BACKGROUND: Heart failure (HF) is a growing global health challenge with high morbidity and mortality. Remote monitoring has emerged as a potential tool to improve outcomes, particularly in reducing hospitalizations and...BACKGROUND: Heart failure (HF) is a growing global health challenge with high morbidity and mortality. Remote monitoring has emerged as a potential tool to improve outcomes, particularly in reducing hospitalizations and mortality. However, the comparative effectiveness of noninvasive versus invasive strategies remains unclear. AREAS OF UNCERTAINTY: Despite the increasing use of telemedicine in HF management, uncertainties remain regarding its long-term impact, the role of patient adherence, and the effectiveness of specific technologies across different patient populations. DATA SOURCES: We conducted a systematic search of PubMed and the Cochrane Library for studies published between January 1, 1994, and February 1, 2025. Eligible studies included randomized controlled trials and observational studies assessing the impact of remote monitoring interventions on mortality, hospitalizations, adherence, and quality of life in patients with HF. RESULTS: A total of 105 studies (85 randomized controlled trials and 19 observational) with 45,072 patients were included. Noninvasive remote monitoring, particularly structured telephone support, was associated with significant reductions in both all-cause mortality (P = 0.005) and HF hospitalizations (P < 0.0001). Telemonitoring also reduced hospitalizations but had limited mortality benefits. Invasive hemodynamic monitoring showed a significant reduction in hospitalizations (P < 0.00001), whereas cardiac implantable electronic devices demonstrated a nonsignificant trend toward reduced mortality (P = 0.14). Quality-of-life improvements were reported more frequently in noninvasive studies. Studies varied widely in methodology, monitoring protocols, and patient populations, contributing to moderate-to-high heterogeneity. CONCLUSIONS: Remote monitoring, particularly noninvasive strategies, is associated with improved outcomes in HF care. Structured telephone support showed the most consistent benefits. Invasive techniques may be valuable in selected patients, although further studies are needed, particularly in populations receiving contemporary guideline-directed medical therapy. Integration of artificial intelligence and improved adherence strategies may enhance future telemonitoring effectiveness.
BACKGROUND: Urolithiasis, a common renal complication, presents unique challenges when occurring in patients with congenital kidney abnormalities. Anatomical anomalies such as horseshoe kidney, ureteropelvic junction obs...BACKGROUND: Urolithiasis, a common renal complication, presents unique challenges when occurring in patients with congenital kidney abnormalities. Anatomical anomalies such as horseshoe kidney, ureteropelvic junction obstruction (UPJO), and kidney duplication complicate stone management because of altered urinary dynamics and access challenges. STUDY QUESTION: How do congenital anatomical kidney anomalies affect stone burden and surgical outcomes, and what treatment approaches yield optimal results in these patients? STUDY DESIGN: A retrospective analysis was conducted on 27 patients with urolithiasis in anomalous kidneys treated between 2019 and 2024. MEASURES AND OUTCOMES: Patients were evaluated using laboratory tests and imaging modalities, including CT and ultrasonography, to plan appropriate surgical interventions. Data included demographics, stone characteristics (size, density, and location), anatomical abnormalities, and surgical parameters. Surgical outcomes, including stone-free rates, complications, and hemoglobin drop, were analyzed. RESULTS: The cohort had a mean age of 47.3 years, with men comprising 62.9% of cases. Anatomical abnormalities included ureteropelvic junction obstruction (55.5%), duplication (25.9%), and horseshoe kidney (18.5%). The mean stone burden was 30.9 ± 17.0 mm, and staghorn stones were observed in 40.7% of cases. Open surgical interventions accounted for 59.2% of treatments, achieving a stone clearance rate of 85.8%. Percutaneous nephrolithotomy demonstrated a favourable minimally invasive profile with comparable success with open surgery, particularly for large or high-density stones. CONCLUSIONS: Effective management of urolithiasis in congenital kidney anomalies requires individualized treatment strategies. Percutaneous nephrolithotomy offers a minimally invasive option with high success rates, although complex cases may necessitate open surgery. Comprehensive preoperative planning is essential to optimize outcomes and minimize complications, emphasizing the need for specialized multidisciplinary care.
BACKGROUND: Type 2 diabetes mellitus (T2DM) is becoming an urgent public health concern in European developing country, where research on newly diagnosed patients is limited. Effective diabetes management depends on adhe...BACKGROUND: Type 2 diabetes mellitus (T2DM) is becoming an urgent public health concern in European developing country, where research on newly diagnosed patients is limited. Effective diabetes management depends on adherence to prescribed therapy and patients' ability to engage in self-care behaviors, daily practices such as healthy eating, regular activity, blood glucose monitoring, taking medications as directed, and foot care. These behaviors are influenced by personal, social, and economic factors and play a central role in preventing complications and maintaining quality of life. STUDY QUESTION: What are the experiences and challenges that influence the adherence of patients newly diagnosed with T2DM? STUDY DESIGN: We used a qualitative, semi-structured interview design to collect data from 30 newly diagnosed patients with T2DM through in-depth, face-to-face interviews at public primary health care centers in urban areas of a European developing country. MEASURES AND OUTCOMES: We selected participants using purposive sampling to ensure a diverse representation of age, gender, and level of education. Data were analyzed using thematic analysis after Braun and Clarke's 6-phase method to identify patterns and key themes across the interviews. RESULTS: Participants noted several significant obstacles to self-care. Among those 60 and above, physical limitations such as joint pain and fatigue were common, affecting slightly more than half of this group (62.5%). The high cost of medications and healthy food also continued to be a significant barrier to managing their condition, as about half of the study participants reported. The patients diagnosed recently during 3-6 months experienced a significant psychological impact (33%), with anxiety and fear of complications being dominant concerns. Family support was key: fewer than one-third of participants (26.7%) received strong encouragement, whereas more than two-thirds (73.3%) lacked family members with prior experience managing diabetes. The self-care motivation was fear of complications reported by over one-third of participants (36.7%), whereas nearly one-third were motivated by desire for a better quality of life (30%). Social stigma was also a concern, with nearly one-quarter of participants (23.3%) reporting that they avoided social gatherings due to dietary restrictions and perceived judgment from others. CONCLUSIONS: Increasing treatment adherence depends on how self-care is managed among newly diagnosed patients with type 2 diabetes. Improving self-care requires addressing physical and socio-economic challenges, managing time constraints, and leveraging family support. These findings suggest the need for family-centered interventions and tailored education within primary care to better support self-care efforts in this population.
Paulino-Gonzalez D, Pardiño-Vega MA, Andrade-Arbaiza E
… +5 more, Xiloj-López SA, Juárez-Aldana KV, Cruz-Hernandez SE, Amezcua-Guerra LM, Navarro-Martinez DA
Sodium-glucose cotransporter-2 (SGLT-2) inhibitors have proven to be highly effective in the treatment of heart failure (HF), but their role in preventing stroke, cardiac death, or worsening heart failure events in patie...Sodium-glucose cotransporter-2 (SGLT-2) inhibitors have proven to be highly effective in the treatment of heart failure (HF), but their role in preventing stroke, cardiac death, or worsening heart failure events in patient's postacute coronary syndrome remains unclear. This meta-analysis evaluates whether SGLT-2 inhibitors improve cardiovascular outcomes in this setting. A comprehensive search of PubMed, Embase, and the Cochrane database was conducted for studies published up to December 2024, identifying 10 studies, 7 randomized controlled trials (RCTs), and 3 cohort studies, which compared the use of SGLT-2 inhibitors initiated after ACS versus placebo in patients hospitalized for acute coronary syndrome with at least 1 additional risk factor for heart failure hospitalization or adverse cardiovascular outcomes. Following PRISMA guidelines, the meta-analysis (PROSPERO registration: CRD42024543392) included data from 15,114 patients (6826 receiving SGLT-2 inhibitors and 8288 receiving placebo). SGLT-2 inhibitors significantly reduced the risk of first HF hospitalization (RR = 0.78, 95% CI, 0.66-0.92, P = 0.003) and stroke (RR = 0.56, 95% CI, 0.35-0.90, P = 0.02), with low heterogeneity (I 2 = 0%). A significant reduction in cardiac death was also observed (RR = 0.84, 95% CI, 0.74-0.96, P = 0.0009), though this was driven mainly by observational studies. No significant effect was found for all-cause mortality. Subgroup analyses showed that empagliflozin significantly reduced HF hospitalization risk, while dapagliflozin did not. These findings suggest that the use of SGLT-2 inhibitors as part of postacute coronary syndrome management lowers the risk of heart failure hospitalization, cardiac death, and stroke.