Atorvastatin before percutaneous coronary intervention: A systematic review and meta-analysis.

Atorvastatin is widely recommended for long-term secondary prevention in STEMI patients with no contraindication. Although high-dose atorvastatin has been shown to reduce important patient outcomes such as MACE, there is still doubt that high-dose atorvastatin could have the same protective effect in patients undergoing PCI in the short and long term. We searched the following electronic databases: Scopus, Web of Science, MEDLINE, EMBASE, and Cochrane Central considering studies that enrolled adult patients with a confirmed diagnosis of STEMI or NSTEMI undergoing PCI. The intervention must have been atorvastatin alone compared to a placebo, standard care, or a different atorvastatin dose. A total of (n = 11) studies were included in the quantitative analysis. Information on (N = 5,399) patients was available; 2,654 were assigned to receive high-dose atorvastatin therapy, and 2,745 comprised the control group. High-dose atorvastatin pre-loading significantly reduced MACE at one month of follow-up (RR: 0.78; 95% CI: 0.67-0.91; p = 0.014) in both STEMI and NSTEMI. All-cause mortality was reduced in patients with STEMI (RR: 0.28; 95% CI: 0.10-0.81; p = 0.029). The quality of the body of evidence was rated overall as moderate. Patients presenting with STEMI or NSTEMI benefit from high-dose atorvastatin pre-loading before PCI by reducing MACE at 30 days. The use of high-dose atorvastatin in STEMI patients reduced all-cause mortality. The beneficial effects of atorvastatin pre-loading are limited to 30 days post-PCI.

Benefits of metabolic surgery on macrovascular outcomes in adult patients with type 2 diabetes: a systematic review and meta-analysis.

Type 2 diabetes (T2D) is a chronic metabolic disorder that affects millions of individuals associated with an increased risk of mortality and macrovascular complications. We aimed to synthesize the benefit of metabolic surgery (MS) on macrovascular outcomes in adult patients with T2D.We included both cohort studies and randomized controlled trials (RCTs) that evaluated MS added to medical therapy compared with medical therapy alone in the treatment of adult patients with T2D. Studies must have evaluated the incidence of any macrovascular complication of the disease for a period of at least 6 months. We performed our search using PubMed, Scopus, EMBASE, Web of Science, and COCHRANE Central database which was performed from inception date until March 2022. The trial protocol was previously registered at PROSPERO (CRD42021243739). A total of 6338 references were screened throughout the selection process from which 16 studies involving 179,246 participants fulfilled inclusion criteria. MS reduced the risk of any cardiovascular event by 44% (relative risk .56 [95% CI, .42-.75]; P = < .001), myocardial infarction by 54% (.46 [95% CI, .26-.83]; P = .009), coronary artery disease by 40% (.60 [95% CI, .42-.85]; P = .004) and heart failure by 71% (.29 [95% CI, .14-.61]; P = .001). It also provided a risk reduction of stroke by 29% (.71 [95% CI, .51-.99]; P = .04) and 38% (.62 [95% CI, .46-.85]; P = .001) for cerebrovascular events. On mortality, MS yields a risk reduction of 55% (.45 [95% CI, .36-.57]; P <.001) in overall mortality and 69% in cardiovascular mortality (relative risk .31 [95% CI, .22-.42]; P < .001). Peripheral vascular disease risk was also reduced. MS in adult patients with T2D can reduce the risk of mortality and of any macrovascular outcomes. However, there is a need for the planning of randomized clinical trials to further analyze and confirm the results.

The safety of BCG revaccination in the context of COVID-19.

The bacille Calmette-Guérin (BCG) vaccine is administered in many countries as part of their vaccination schedules. Epidemiologic studies have suggested a possible benefit of this vaccine in the context of the COVID-19 pandemic and other respiratory infections. We aimed to assess the safety of this intervention in BCG-primed adults. Adult health care workers (n = 451) received a single intradermal application of the BCG vaccine (Tokyo 172 strain) in the deltoid region of the right arm. Follow-up (30 days) calls and clinical inspections were guided using a standardized data sheet to assess local and systemic reactions. Early local reactions were common at 24 h and 7 days, such as erythema (74.9%, 69.2%), induration (55.7%, 59%), a papule (53.4%, 47.7%), and edema (48.3%, 38.1). Local symptoms (pruritus 44.8%, heat 16.2%, and pain 34.8%) were less frequent at day 7. Late expected reactions (14 and 30 days) included the formation of crusts (39.6% and 63.9%), a pustule (36.6% and 17%), or ulcers (28.8% and 17.7%). Severe reactions were limited to subcutaneous abscesses (2%) and lymphadenitis (<1%).

Retinal Microvascular Density and Perfusion during an Insulin-Induced Hypoglycemia Episode: A Warning Call.

Aim: To evaluate retinal vascular perfusion and density by optical coherence tomography angiography (OCTA) before, during, and after hypoglycemia in individuals with diabetes mellitus with or without diabetic retinopathy (DR). Methods: A focused clinical history was performed, followed by an ophthalmological examination to document retinopathy status. OCTA was performed at baseline, at hypoglycemia, and at glucose normalization. Eye tracking and eye alignment devices on the platform were used to obtain a macular thickness cube (512 × 128) and vascular perfusion and density protocols of 3 × 3 mm. Retinal vascular reactivity was analyzed with superficial plexus vascular perfusion and density protocols on OCTA. Results: Fifty-two participants encompassing 97 eyes fulfilled the eligibility criteria. Their mean age was 42.9 ± 15.1 years (range, 22 to 65), and 20 (38.2%) were men. We found a statistically significant difference in vascular perfusion and density when comparing all groups at baseline. The controls had higher vascular perfusion and density values than the cases. Vascular perfusion and density were significantly reduced in all groups during the hypoglycemia episode, except for vascular density in DR cases. Conclusion: Acute hypoglycemia significantly alters the retinal vascularity in DM patients with and without DR, suggesting that repeated episodes of acute hypoglycemia could exacerbate retinopathy in the long term.

Application of machine learning and artificial intelligence in the diagnosis and classification of polycystic ovarian syndrome: a systematic review.

Introduction: Polycystic Ovarian Syndrome (PCOS) is the most common endocrinopathy in women of reproductive age and remains widely underdiagnosed leading to significant morbidity. Artificial intelligence (AI) and machine learning (ML) hold promise in improving diagnostics. Thus, we performed a systematic review of literature to identify the utility of AI/ML in the diagnosis or classification of PCOS. Methods: We applied a search strategy using the following databases MEDLINE, Embase, the Cochrane Central Register of Controlled Trials, the Web of Science, and the IEEE Xplore Digital Library using relevant keywords. Eligible studies were identified, and results were extracted for their synthesis from inception until January 1, 2022. Results: 135 studies were screened and ultimately, 31 studies were included in this study. Data sources used by the AI/ML interventions included clinical data, electronic health records, and genetic and proteomic data. Ten studies (32%) employed standardized criteria (NIH, Rotterdam, or Revised International PCOS classification), while 17 (55%) used clinical information with/without imaging. The most common AI techniques employed were support vector machine (42% studies), K-nearest neighbor (26%), and regression models (23%) were the commonest AI/ML. Receiver operating curves (ROC) were employed to compare AI/ML with clinical diagnosis. Area under the ROC ranged from 73% to 100% (n=7 studies), diagnostic accuracy from 89% to 100% (n=4 studies), sensitivity from 41% to 100% (n=10 studies), specificity from 75% to 100% (n=10 studies), positive predictive value (PPV) from 68% to 95% (n=4 studies), and negative predictive value (NPV) from 94% to 99% (n=2 studies). Conclusion: Artificial intelligence and machine learning provide a high diagnostic and classification performance in detecting PCOS, thereby providing an avenue for early diagnosis of this disorder. However, AI-based studies should use standardized PCOS diagnostic criteria to enhance the clinical applicability of AI/ML in PCOS and improve adherence to methodological and reporting guidelines for maximum diagnostic utility. Systematic review registration: https://www.crd.york.ac.uk/prospero/, identifier CRD42022295287.

Harms of third- and fourth-generation combined oral contraceptives in premenopausal women: A systematic review and meta-analysis.

We assessed the available evidence regarding adverse effects on surrogate and patient-important health outcomes of third- and fourth-generation combined oral contraceptives among premenopausal women. We performed a systematic review and meta-analysis including randomized controlled trials and observational studies comparing third- and fourth-generation combined oral contraceptives with other generation contraceptives or placebo. Studies that enrolled women aged 15 to 50 years, with at least three cycles of intervention and 6 months of follow-up were included. A total of 33 studies comprising 629,783 women were included. Low-density lipoprotein cholesterol levels were significantly lower in fourth-generation oral contraceptives (mean differences (MD): -0.24 mmol/L; [95% CI -0.39 to -0.08]), while total cholesterol was significantly increased in levonorgestrel users when compared to third-generation oral contraceptives (MD: 0.27 mmol/L; [95% CI 0.04 to 0.50]). A decreased arterial thrombosis incidence was shown in fourth-generation oral contraceptive users, as compared to levonorgestrel (incidence rate ratio (IRR): 0.41; [95% CI 0.19 to 0.86]). No difference was found in the occurrence of deep venous thrombosis between fourth-generation oral contraceptives and levonorgestrel users (IRR: 0.91; [95% CI 0.66 to 1.27]; p = 0.60; I2 = 0%). Regarding the remaining outcomes, data were heterogeneous and showed no clear difference. In premenopausal women, the use of third- and fourth-generation oral contraceptives is associated with an improved lipid profile and lower risk of arterial thrombosis. Data were inconclusive regarding the rest of outcomes assessed. This review was registered in PROSPERO with CRD42020211133.

Determinants for Thyroid Hormone Replacement Therapy in Subclinical Hypothyroidism: A Multicenter Electronic Health Records-Based Study.

Background: The frequency and factors associated with thyroid hormone replacement therapy among patients with subclinical hypothyroidism (SCH) remain uncertain. Methods: In this electronic health records-based observational cohort study, we included adults diagnosed with SCH from four academic centers (the United States and Mexico) from January 1, 2016, to December 31, 2018. We aimed to identify the determinants of thyroid hormone replacement therapy for SCH and the frequency of treated SCH. Results: A total of 796 patients (65.2% women) had SCH, and 165 (20.7%) were treated with thyroid hormone replacement therapy. The treated group was younger [51.0 (standard deviation {SD} 18.3) vs. 55.3 (SD 18.2) years, p = 0.008] and had a higher proportion of women (72.7% vs. 63.2%, p = 0.03) compared with the untreated group. Only 46.7% of patients in the treated group and 65.6% in the untreated group had confirmatory thyroid function tests (TFTs) before the decision to start thyroid hormone replacement therapy was made. There was no difference in the frequency of thyroid autoimmunity evaluation, but a positive thyroid autoimmunity test was more frequent in the treated group compared with the untreated group (48.2% vs. 20.3%, p < 0.001). In a multivariable logistic regression model, female sex (odds ratio [OR] = 1.71 [CI 1.13-2.59], p = 0.01) and index thyrotropin (TSH) level (OR = 1.97 [CI 1.56-2.49], p < 0.001 for every SD [2.75 mIU/L] change) were associated with higher odds of treatment. Conclusions: Among patients with SCH, female sex and index TSH level were associated with higher odds of treatment. Moreover, in our population, the decision to treat or not to treat SCH was often based on only one set of abnormal TFTs, and thyroid autoimmunity assessment was underused.

Benefits and harms of fibrate therapy in patients with type 2 diabetes: a systematic review and meta-analysis.

PURPOSE: This systematic review aimed to evaluate the benefits and harms of fibrate therapy, alone or in combination with statins, in adult patients with type 2 diabetes (T2D). METHODS: A comprehensive search was conducted in six databases, from inception to January 27, 2022. Clinical trials that compared fibrate therapy with other lipid-lowering interventions or placebo were included. Outcomes of interest comprised cardiovascular (CV) events, complications of T2D, metabolic profile, and adverse events. Random-effects meta-analyses were performed to estimate mean differences (MD) and risk ratios (RR), alongside 95% confidence intervals (CI). RESULTS: A total of 25 studies were included, six comparing fibrates against statins, 11 against placebo, and eight evaluating the combination of fibrates with statins. Overall risk of bias was rated as moderate, and most outcomes rendered low confidence per GRADE approach. Fibrates showed reduction of serum triglycerides (TGs) (MD -17.81, CI -33.92 to -1.69) and a marginal increase of high-density lipoprotein cholesterol (HDL-c) (MD: 1.60, CI 0.29 to 2.90) in adults with T2D, but no differences were found in CV events when compared to statin therapy (RR 0.99, CI 0.76 to 1.09). When used in combination with statins, no major differences were exhibited regarding lipid profile and CV outcomes. Adverse events were comparable between fibrate and statin monotherapies (e.g., RR of 1.03 for rhabdomyolysis, and 0.90 for gastrointestinal events). CONCLUSIONS: Fibrate therapy in patients with T2D results in a marginal improvement of TGs and HDL-c but without reducing the risk of CV events and mortality. Their use should be reserved for very specific scenarios after a deliberative dialogue between patients and clinicians regarding their benefits and harms.

Patient-important outcomes in clinical trials of atopic diseases and asthma in the last decade: A systematic review.

Background: Randomized Clinical Trials (RCTs) are important tools to establish the effects of a given intervention. Investigators should focus on outcomes that patients perceive: patient-important outcomes (PIOs), clinical endpoints that patients value directly and reflect how they feel, function, or survive. However, it is easier to consider surrogated outcomes to reduce costs and achieve better-looking results. The problem with these outcomes is that they indirectly measure PIOs, which might not correlate linearly or translate reliably into a positive PIO. Methods: We systematically searched MEDLINE for atopic disease RCTs rated among the top 10 allergic diseases and general internal medicine journals from the last 10 years. Two independent reviewers worked in duplicate and independently to collect data from all eligible articles. We gathered information regarding the type of study, title, author information, journal, intervention type, atopic disease, and primary and secondary outcomes. We assessed the outcomes investigators used in RCTs of atopic diseases and asthma. Results: This quantitative analysis included n = 135 randomized clinical trials. The most studied atopic disease during the period selected was asthma (n = 69), followed by allergic rhinitis (n = 51). When divided by atopic disease, primary outcomes in RCTs valuing allergic rhinitis had the most significant proportion of PIOs (76.7), asthma surrogated outcomes (38), and asthma/allergic rhinitis laboratory outcomes (42.9). PIOs in allergic rhinitis trials had the most significant proportion of PIOs favoring the intervention (81.4), asthma had the greatest proportion of surrogated outcomes (33.3), and asthma/allergic rhinitis laboratory outcomes (40). When divided by atopic disease, trials studying atopic dermatitis and urticaria had the same proportion of PIOs (64.7) as their secondary outcomes. Asthma had the highest (37.5) surrogate outcomes. Journals of general/internal medicine had a greater proportion of PIOs, and a post hoc analysis showed a significant difference in the proportion and secondary outcomes that favored the intervention between PIOs and laboratory outcomes. Conclusion: Approximately 7.5 out of 10 primary outcomes in RCTs published in general/internal medicine are PIOs compared to 5 out of 10 primary outcomes in atopic disease journals. Investigators should focus on selecting patient-important outcomes in their clinical trials to establish clinical guidelines with better-quality recommendations that impact patients' life and values. Registration: International Prospective Register of Systematic Reviews (PROSPERO, NIHR) ID: CRD42021259256.

Benefits of bariatric surgery on microvascular outcomes in adult patients with type 2 diabetes: a systematic review and meta-analysis.

BACKGROUND: Microvascular diabetes complications impair patients' health-related quality of life. Bariatric surgery (BS) emerged as a compelling treatment that demonstrated to have beneficial effects on patients with diabetes and obesity. OBJECTIVE: We aimed to synthesize the benefit of bariatric surgery on microvascular outcomes in adult patients with type 2 diabetes. SETTING: 2011-2021. METHODS: We included both cohort studies and randomized trials that evaluated bariatric surgery added to medical therapy compared with medical therapy alone in the treatment of adult patients with type 2 diabetes. Studies must have evaluated the incidence of any microvascular complication of the disease for a period of at least 6 months. We performed our search using PubMed, Scopus, EMBASE, Web of Science, and COCHRANE Central database which was performed from inception date until March 2021. PROSPERO (CRD42021243739). RESULTS: A total of 25 studies (160,072 participants) were included. Pooled analysis revealed bariatric surgery to reduce the incidence of any stage of retinopathy by 71% (odds ratio [OR] .29; 95% confidence interval [CI] .10-.91), nephropathy incidence by 59% (OR .41; 95% CI 17-96), and hemodialysis/end-stage renal disease by 69% (OR .31 95% CI .20-.48). Neuropathy incidence revealed no difference between groups (OR .11; 95% CI .01-1.37). Bariatric surgery increased the odds of albuminuria regression by 15.15 (95% CI 5.96-38.52); higher odds of retinopathy regression were not observed (OR 3.73; 95% CI .29-47.71). There were no statistically significant differences between groups regarding the change in surrogate outcomes. CONCLUSIONS: Bariatric surgery in adult patients with diabetes reduced the odds of any stage of retinopathy, hemodialysis/end-stage renal disease, and nephropathy composite outcome. However, its effect on many individual outcomes, both surrogates, and clinically significant, remains uncertain.

Renal functional and cardiovascular outcomes of partial nephrectomy versus radical nephrectomy for renal tumors: a systematic review and meta-analysis.

This systematic review and meta-analysis aimed to evaluate the postoperative renal and cardiovascular outcomes of partial nephrectomy (PN) versus radical nephrectomy (RN) for the treatment of renal carcinoma. A systematic literature search was performed on scientific databases including Scopus, Web of Science, MEDLINE, and EMBASE from their inception to September 2021. Studies comparing renal and cardiovascular outcomes between PN and RN in patients with renal cancer were included. The generic inverse variance method with random-effects models was used to determine the pooled hazard ratios and odds ratio for each outcome. Quality Assessment for observational studies was guided by the New-Castle Ottawa Scale. Overall, a total of 31 studies (n=51,866) reported renal outcomes, while 11 studies (n= 101,678) reported cardiovascular outcomes. When compared to PN, RN had a higher rate of new-onset postoperative EGFR <60 mL/min/1.73 m2 (HR 3.39; CI 2.45 - 4.70; I2=93%; P=<0.00001) and EGFR <45 mL/min/1.73 m2 (HR 4.70; CI 2.26 - 9.79; I2=98%; P=<0.0001). No difference was observed in new-onset advanced kidney disease and end-stage renal disease. A 19% reduction in cardiovascular events was observed in the PN group (HR 0.81; CI 0.70 - 0.93, P=0.002). No protective effect of PN was observed in new-onset or worsening hypertension (HR 0.85; CI 0.64 - 1.14, P=0.28) nor myocardial infarction (HR 0.86; CI 0.71 - 1.04, P=0.13). PN was associated with a decreased risk of postoperative early-stage CKD and cardiovascular events compared with RN. However, no benefit of PN over RN was observed in advanced CKD, new-onset or worsening hypertension, myocardial infarction, and cardiovascular mortality.

Late-Onset 22q11.2 Deletion Syndrome With Mild Cardiac Phenotype: A Unique Adult Presentation Diagnosed at 45 Years of Age.

This case report presents a detailed exploration of an adult-onset 22q11 deletion syndrome, a rare genetic disorder typically diagnosed in children. The report highlights the diagnostic challenges posed by this atypical presentation, emphasizing the need for clinicians to consider such conditions in differential diagnoses, especially in adults. This case is remarkable for its late onset and mild symptoms, which significantly deviated from the common pediatric presentation, including hypocalcemia due to hypoparathyroidism and a fenestrated atrial septal defect without significant hemodynamic implications. The importance of recognizing the broad phenotypic variability of the syndrome and the implications for clinical practice are discussed, providing insights into the genetic and phenotypic diversity of the condition. In conclusion, this case illuminates the diverse clinical spectrum of adult-onset 22q11 deletion syndrome, emphasizing its relevance to clinical practice.

Low-Dose ACTH Stimulation Test in Obesity: A Randomized Dose Assessment.

Background: The short cosyntropin test is widely used for adrenal insufficiency screening and diagnosis. Lower cosyntropin doses may have greater sensitivity vs. the standard dose in detecting adrenal dysfunction. Obesity and overweight are increasing, impacting the clinical presentation of some diseases. Currently more than 50% of the subjects diagnosed with autoimmune adrenal insufficiency have a BMI greater than 25, and hence individuals living with overweight and obesity are more frequently requiring evaluation of the adrenal cortical function. Fixed-dose cosyntropin stimulation may not be appropriate for individuals with obesity. Objective: The primary objective was to compare cortisol response to a weight-adapted cosyntropin dose vs. a fixed low dose (1 µg) and a more physiologically fixed dose (10 µg). Methods: Twenty individuals with obesity and 20 age-matched healthy controls underwent in a randomized sequence at least one-week apart, to the The short cosyntropin test with three different doses, 0.2 µg/kg of body weight, 1 or 10 µg fixed dose stimuli. The assessment and data analysis were blinded to the individual and the investigator. Results: Cortisol response was reduced in the group with obesity with the 1 µg fixed dose stimuli at 30 minutes (median, IQR) 649.6 µg, 567.3-738.4 µg for the control group vs. 568.6 µg, 528.4-623.13 µg, p=0.04; there was a lower cortisol peak at 60' in all the three evaluated doses, with a dose-dependent trend. A weight-adapted cosyntropin dose of 0.2 µg in obesity produces a similar response to the one observed in individuals without obesity. The 1 µg ACTH test falls short on stimulating the cortisol adrenal response in individuals with obesity.

HOMA-IR as a predictor of Health Outcomes in Patients with Metabolic Risk Factors: A Systematic Review and Meta-analysis.

INTRODUCTION: There exists clinical interest in the following question: Is there an association between HOMA-IR and the risk of developing metabolic diseases? AIMS: Assessing the association between high values of HOMA-IR with the incidence of T2DM, MACE, essential hypertension, dyslipidemia, NASH, and cancer in healthy participants and participants with a component of metabolic syndrome. METHODS: Databases were searched by an experienced librarian to find eligible studies. Observational cohort studies enrolling healthy adults and adults with metabolic syndrome components that evaluated HOMA as a marker of IR were considered for inclusion. Eligibility assessment, data extraction and risk of bias assessment were performed independently and in duplicate. Baseline characteristics of patients, cutoff values of HOMA-IR to predict metabolic events were extracted independently and in duplicate. RESULTS: 38 studies (215,878 participants) proved eligible. A higher HOMA-IR value had a significant effect on the risk of developing T2DM (HR 1.87; CI 1.40-2.49), presenting non-fatal MACE (HR 1.46; CI 1.08-1.97) and hypertension (HR 1.35; CI 1.15-1.59). No association was found regarding cancer mortality and fatal MACE with higher HOMA-IR values, there was not enough information to carry out a meta-analysis to establish an association between higher values of HOMA with cancer incidence, dyslipidemia, and NASH. CONCLUSIONS: High values of HOMA were associated with an increased risk of diabetes, hypertension, and non-fatal MACE; yet, not for cardiovascular or cancer mortality. More research is needed to determine the value of the HOMA index in metabolic and cardiovascular outcomes. PROSPERO REGISTRATION NUMBER: CRD42020187645.

Serological follow up of positive SARS-CoV-2 cases.

OBJECTIVE: To describe the humoral response in a cohort with mild and asymptomatic SARS-CoV-2 infection previ-ously identified in a community-based serological survey. MATERIALS AND METHODS: This study was an observational follow up of 193 subjects previously identified with positive anti-SARS-CoV-2 antibodies invited for a second test 112 days after the first sampling. All completed a standardized electronic questionnaire. IgM/IgG antibodies were determined using a qualitative IgM/IgG chemiluminescent immunoassay. RESULTS: Among the 193 eligible subjects, a total of 174 (90%) attended the follow-up visit, and their serum samples were tested. Of the samples, 171 (98.3%) were still positive, and 3 (1.7%) were negative. Also, the cut-off index (COI) value of the immunoassay significantly increased from the first to the second test (P <0.001). CONCLUSIONS: Our findings support a sustained humoral response in individuals with mild and asymptomatic SARS-CoV-2 infection up to 112 days after a positive serologic baseline test, accompanied by increasing antibody titers.

Intensive vs. conventional blood pressure goals in older patients with type 2 diabetes: a systematic review and meta-analysis.

PURPOSE: Assess the effect of intensive vs conventional blood pressure goals on patient-important outcomes in older adults with type 2 diabetes. METHODS: A comprehensive search was performed using electronic databases. Randomized controlled trials comparing intensive vs conventional blood pressure goals in adults over 60 years of age with type 2 diabetes were included. Events were evaluated using a modified Mantel-Haenszel meta-analysis with Peto's method. Study selection and data extraction were performed independently and in duplicate. RESULTS: Seven trials were included. A 19% risk reduction (OR 0.81; 95% CI 0.69-0.95; I2 = 8%; p = 0.35) in the occurrence of major adverse cardiovascular events (MACE) and 37% risk reduction (OR 0.63; 95% CI 0.51-0.79; I2 = 0%; p = 0.56) in the occurrence of fatal or non-fatal stroke was documented in the intensive treatment group. There were no differences in the occurrence of all-cause mortality, cardiovascular mortality, non-fatal myocardial infarction, and peripheral vascular disease. Data regarding treatment adverse effects and microvascular outcomes was scarce. CONCLUSIONS: Intensive blood pressure goals in older patients with diabetes were associated with a lower risk of stroke and MACE, but not with all-cause mortality, cardiovascular mortality, non-fatal myocardial infarction, and peripheral vascular disease.

Serological follow up of positive SARS-CoV-2 cases / Seguimiento serológico de casos positivos a SARS-CoV-2

Abstract: Objective: To describe the humoral response in a cohort with mild and asymptomatic SARS-CoV-2 infection previously identified in a community-based serological survey. Materials and methods: This study was an observational follow up of 193 subjects previously identified with positive anti-SARS-CoV-2 antibodies invited for a second test 112 days after the first sampling. All completed a standardized electronic questionnaire. IgM/IgG antibodies were determined using a qualitative IgM/IgG chemiluminescent immunoassay. Results: Among the 193 eligible subjects, a total of 174 (90%) attended the follow-up visit, and their serum samples were tested. Of the samples, 171 (98.3%) were still positive, and 3 (1.7%) were negative. Also, the cut-off index (COI) value of the immunoassay significantly increased from the first to the second test (P <0.001). Conclusions: Our findings support a sustained humoral response in individuals with mild and asymptomatic SARS-CoV-2 infection up to 112 days after a positive serologic baseline test, accompanied by increasing antibody titers.

Resumen: Objetivo: Describir la respuesta humoral en una cohorte con una infección leve o asintomática por SARS-CoV-2, previamente identificada en una encuesta serológica comunitaria. Material y métodos: Se realizó un seguimiento observacional de 193 individuos previamente identificados con anticuerpos IgM/IgG anti-SARS-CoV-2 invitados 112 días después de una determinación serológica inicial. Todos los participantes completaron un cuestionario electrónico estandarizado. Se determinaron los anticuerpos IgM/IgG mediante un inmunoensayo quimioluminiscente cualitativo. Resultados: De entre los 193 sujetos elegibles, 174 (90%) acudieron al seguimiento. De las muestras, 171 (98.3%) eran positivas y 3 (1.7%) negativas. Además, el valor de COI del inmunoenasayo se incrementó al comparar la primera y segunda determinación (P <0.001). Conclusiones: Los presentes resultados apoyan una respuesta humoral sostenida en individuos con infección por SARS-CoV-2 con síntomas leves o asintomática hasta 112 días después de una prueba serológica positiva, acompañada de incremento en los títulos de anticuerpos.

Saroglitazar is noninferior to fenofibrate in reducing triglyceride levels in hypertriglyceridemic patients in a randomized clinical trial.

Saroglitazar, being a dual PPAR-α/γ agonist, has shown beneficial effect in diabetic dyslipidemia and hypertriglyceridemia. Fibrates are commonly used to treat severe hypertriglyceridemia. However, the effect of saroglitazar in patients with moderate to severe hypertriglyceridemia was not evaluated. We conducted a study to compare the efficacy and safety of saroglitazar (4 mg) with fenofibrate (160 mg) in patients with moderate to severe hypertriglyceridemia. This was a multicenter, randomized, double-blinded, double-dummy, active-control, and noninferiority trial in adult patients with fasting triglyceride (TG) levels of 500-1,500 mg/dl. The patients were randomized in a 1:1 ratio to receive daily dose of saroglitazar or fenofibrate for 12 weeks. The primary efficacy end point was the percent change in TG levels at week 12 relative to baseline. The study comprised of 41 patients in the saroglitazar group and 41 patients in the fenofibrate group. We found that the percent reduction from baseline in TG levels at week 12 was significantly higher in the saroglitazar group (least square mean = -55.3%; SE = 4.9) compared with the fenofibrate group (least square mean = -41.1%; SE = 4.9; P = 0.048). Overall, 37 treatment-emergent adverse events (AEs) were reported in 24 patients (saroglitazar: 13; fenofibrate: 11). No serious AEs were reported, and no patient discontinued the study because of AEs. We conclude that saroglitazar (4 mg) is noninferior to fenofibrate (160 mg) in reducing TG levels after 12 weeks of treatment, was safe, and well tolerated.

Treatment burden and perceptions of glucose-lowering therapy among people living with diabetes.

AIMS: Address treatment burden and general perceptions of pharmacological treatment in patients with diabetes. METHODS: We surveyed adult patients with diabetes cared for in a tertiary academic medical center about: i) knowledge about the impact of glucose-lowering medication use on diabetes control and complications, ii) common beliefs about natural medicine and insulin use, iii) attitudes towards glucose-lowering medications, iv) burden of treatment, v) general knowledge of diabetes pharmacological treatment, and vi) perceptions of shared decision-making. RESULTS: Two hundred-four participants completed the survey. While most (90%) agreed that adherence to medication would control diabetes and improve quality of life, 30-40% were not certain that it would translate to fewer disease complications. About one of three thought medications could be harmful (29.4%). Over 50% agreed or was unsure that natural remedies were as good/better than prescribed medications. About 30% acknowledged difficulties taking their diabetes medications and monitoring blood glucose, and over 50% were concerned about treatment costs. Nearly 30% denied receiving a detailed explanation from their clinician regarding their disease and is treatment. CONCLUSIONS: Our results highlight the importance of patient education regarding pharmacological treatment for diabetes, and eliciting sources of distress and treatment burden among patients with diabetes.