Implementing Standard Diagnosis and Treatment for Locally Advanced Breast Cancer Through Global Research in Latin America: Results From a Multicountry Pragmatic Trial.

PURPOSE: Breast cancer mortality rates in Latin America (LA) are higher than those in the United States, possibly because of advanced disease presentation, health care disparities, or unfavorable molecular subtypes. The Latin American Cancer Research Network was established to address these challenges and to promote collaborative clinical research. The Molecular Profiling of Breast Cancer Study (MPBCS) aimed to evaluate the clinical characteristics and treatment outcomes of LA participants with locally advanced breast cancer (LABC). PATIENTS AND METHODS: The MPBCS enrolled 1,449 participants from Argentina, Brazil, Chile, Mexico, and Uruguay. Through harmonized procedures and quality assurance measures, this study evaluated clinicopathologic characteristics, neoadjuvant chemotherapy response, and survival outcomes according to residual cancer burden (RCB) and the type of surgery. RESULTS: Overall, 711 and 480 participants in the primary surgery and neoadjuvant arms, respectively, completed the 5-year follow-up period. Overall survival was independently associated with RCB (worse survival for RCBIII-adjusted hazard ratio, 8.19, P < .001, and RCBII [adjusted hazard ratio, 3.69, P < .008] compared with RCB0 [pathologic complete response or pCR]) and type of surgery (worse survival in mastectomy than in breast-conserving surgery [BCS], adjusted hazard ratio, 2.97, P = .001). The hormone receptor-negative-human epidermal growth factor receptor 2-positive group had the highest proportion of pCR (48.9%). The analysis of the ASCO Quality Oncology Practice Initiative breast module revealed high compliance with pathologic standards but lower adherence to treatment administration standards. Notably, compliance with trastuzumab administration varied widely among countries (33.3%-88.7%). CONCLUSION: In LABC, we demonstrated the survival benefit of BCS and the prognostic effect of the response to available neoadjuvant treatments despite an important variability in access to key treatments. The MPBCS represents a significant step forward in understanding the real-world implementation of oncologic procedures in LA.

Prescription patterns of ambrisentan in some cities of Colombia.

INTRODUCTION: Ambrisentan is a selective type A endothelin receptor antagonist that has shown significant effectiveness and safety in the management of patients with pulmonary hypertension. Its use pattern with real-world evidence in Colombia is unknown. OBJECTIVE: The objective of this study is to determine the prescription patterns of ambrisentan in some cities of Colombia. METHODS: A longitudinal descriptive study on the prescription patterns of ambrisentan in patients with pulmonary hypertension (all the groups) was conducted between January 2021 and December 2022 based on a population database of members of the Colombian Health System. Adherence at 1 year was determined using the Medication Possession Ratio (days the drug was dispensed/days from first dispensing to the end of the follow-up period × 100). Descriptive analysis was carried out. RESULTS: Sixty-seven patients taking ambrisentan were identified in 10 cities of the country. The individuals had a median age of 51.5 years (interquartile range-IQR: 39.8-64.0 years), and 82.1% were women. The drug possession rate was 82.2% (IQR: 65.0-96.8%), and persistence at 1 year was present in 49.3% (n = 33) of the cases. The average dose was 8.8 ± 5.0 mg/day, and 76.1% (n = 51) received it in combination therapy, mainly with phosphodiesterase type 5 inhibitors (61.2%, n = 41). CONCLUSIONS: Adherence to ambrisentan was good, but its persistence at 1 year was low. The dosages of the drug used were in accordance with the recommendations of the clinical practice guidelines, and it was used in combination therapy, especially with phosphodiesterase 5 inhibitors.

Human Coronary Artery Endothelial Cell Response to Porphyromonas gingivalis W83 in a Collagen Three-Dimensional Culture Model.

P. gingivalis has been reported to be an endothelial cell inflammatory response inducer that can lead to endothelial dysfunction processes related to atherosclerosis; however, these studies have been carried out in vitro in cell culture models on two-dimensional (2D) plastic surfaces that do not simulate the natural environment where pathology develops. This work aimed to evaluate the pro-inflammatory response of human coronary artery endothelial cells (HCAECs) to P. gingivalis in a 3D cell culture model compared with a 2D cell culture. HCAECs were cultured for 7 days on type I collagen matrices in both cultures and were stimulated at an MOI of 1 or 100 with live P. gingivalis W83 for 24 h. The expression of the genes COX-2, eNOS, and vWF and the levels of the pro-inflammatory cytokines thromboxane A2 (TXA-2) and prostaglandin I2 (PGI2) were evaluated. P. gingivalis W83 in the 2D cell culture increased IL-8 levels at MOI 100 and decreased MCP-1 levels at both MOI 100 and MOI 1. In contrast, the 3D cell culture induced an increased gene expression of COX-2 at both MOIs and reduced MCP-1 levels at MOI 100, whereas the gene expression of eNOS, vWF, and IL-8 and the levels of TXA2 and PGI2 showed no significant changes. These data suggest that in the collagen 3D culture model, P. gingivalis W83 induces a weak endothelial inflammatory response.

Down-regulation of human papillomavirus E6 oncogene and antiproliferative effect of Schisandra chinensis and Pueraria lobata natural extracts on Hela cell line.

ETHNOPHARMACOLOGICAL RELEVANCE: Cervical cancer is one of the most common malignancies in women that continues to be a public health problem worldwide. Human papillomavirus (HPV) infection is closely related as the causative agent of almost all cases of cervical cancer. Currently, there is no effective treatment for the persistence of HPV. Although vaccines have shown promising results in recent years, they are still a costly strategy for developing countries and have no therapeutic effect on existing infections, which is why the need arises to search for new strategies that can be used in treatment, suppressing oncogenic HPV and disease progression. Extracts of Schisandra Chinensis and Pueraria lobata have been used in traditional medicine, and it has been shown in recent years that some of their bioactive compounds have pharmacological, antioxidant, antitumor, apoptotic, and proliferation effects in HPV-positive cells. However, its mechanism of action has yet to be fully explored. AIM OF THE STUDY: The following study aimed to determine the chemical composition, antioxidant activity, and potential antiproliferative and viral oncogene effects of natural extracts of S. chinensis and P. lobata on HPV-18 positive cervical cancer cells. MATERIALS AND METHODS: The HPV-18-positive HeLa cells were treated for 24 and 48 h with the ethanolic extracts of S chinensis and P. lobata. Subsequently, cell viability was evaluated using the resazurin method, the effect on the cell cycle of the extracts (1.0, 10, and 100 µg/mL) was measured by flow cytometry, the gene of expression of the E6/E7, P53, BCL-2, and E2F-1 were determined by RT-PCR and the protein expression of p53, Ki-67, x|and Bcl-2 by immunohistochemistry. Additionally, the chemical characterization of the two extracts was carried out using LC-MS, and the total phenolics content (TPC), Total flavonoid content (TFC), and DPPH radical scavenging capacity were determined. Data were analyzed using the Mann-Whitney and Kruskal Wallis U test with GraphPad Prism 6 software. RESULTS: The natural extracts of Schisandra chinensis and Pueraria lobata induced down-regulation of E6 HPV oncogene (p<0.05) and a strong up-regulation of P53 (p<0.05), E2F-1 (p<0.05), and Bcl-2 (p<0.05) gene expression. Simultaneously, the natural extracts tend to increase the p53 protein levels and arrest the cell cycle of HeLa in the G1/S phase (p<0.05). Investigated extracts were characterized by the occurrence of bioactive lignans and isoflavones in S. chinensis and P. lobata, respectively. CONCLUSION: The extracts of S. chinensis and P. lobata within their chemical characterization mainly present lignan and isoflavone-type compounds, which are probably responsible for inhibiting the expression of the HPV E6 oncogene and inducing an increase in the expression of p53, Bcl -2 and E2F-1 producing cell cycle detection in S phase in HeLa cells. Therefore, these extracts are good candidates to continue studying their antiviral and antiproliferative potential in cells transformed by HPV.

Use of sacubitril/valsartan in patients with heart failure: evidence from the real world.

BACKGROUND: To characterize the use of sacubitril/valsartan in a group of patients with heart failure in Colombia. RESEARCH DESIGN AND METHODS: Follow-up study of patients with heart failure who started sacubitril/valsartan and were affiliated with the Colombian health system between 2019 and 2021. Sociodemographic, clinical, and pharmacological variables and adherence and persistence of use were identified. RESULTS: A total of 514 patients were identified, with a mean age of 65.7 years, 73.7% of whom started sacubitril/valsartan at low doses, and only 12.5% reached the maximum dose. Adherence was 78.2% and persistence was 56.8% at 1 year of follow-up. The increase in systolic blood pressure (odds ratio (OR): 1.01; 95% CI: 1.00-1.03) and the use of ß-blockers (OR: 2.63; 95% CI: 1.42-4.85) were correlated with a greater persistence, while receiving furosemide (OR: 0.59; 95% CI: 0.39-0.89) and not having received renin - angiotensin - aldosterone system inhibitors in the 3 months before starting sacubitril/valsartan (OR: 0.48; 95% CI: 0.31-0.76) were associated with lower persistence. CONCLUSIONS: The persistence of treatment 1 year after starting sacubitril/valsartan was not high, and a small proportion of patients reached the target dose of the drug. Nontitration of the drug dose was common.

PRESCRIBING PATTERNS AND THE USE OF ANTHELMINTIC DRUGS IN COLOMBIAN PATIENTS: A CROSS-SECTIONAL STUDY.

Intestinal parasites continue to be a public health problem in low- and middle-income countries. Broad use of anthelmintics during deworming programs is still necessary in many regions. However, description of the usage of these medications in general medical practice has been limited. The objective of this study was to determine the use of anthelmintic drugs and their indications in a group of Colombian patients. This was a descriptive study from a drug-dispensing database, identifying patients with prescriptions for anthelmintic drugs. A total of 381 cases were randomly selected, and their medical records were reviewed, analyzing sociodemographic, clinical, and pharmacological variables (indication of use). The lack of diagnosis registration or clinical manifestations of parasites was determined as a prescription without indication. In total, 50.9% (n = 194) of patients were female, and 67.4% of all patients were under 18 yr of age. The diagnosis of helminthiases was clearly stated in 114 (29.9%) patients, and only 4.2% (n = 16) of these had microbiological confirmation. The most commonly used anthelmintic drug was albendazole (70.4% of all prescriptions). The use of anthelmintics was not indicated in 266 cases (69.8%). Nutritional supplements or vitamin prescriptions were associated with using anthelmintics without indication (odds ratio: 2.25; 95% confidence interval: 1.26-4.03). A high proportion of patients lacked symptoms or diagnoses in their clinical records that supported the use of anthelmintic drugs.

The frequency of complications in a cohort of patients diagnosed with hemophilia A and hemophilia B receiving prophylactic treatment in Colombia: A retrospective noninterventional study.

INTRODUCTION: Hemophilia A and B are disorders associated with the deficit of coagulation factors VIII and IX. OBJECTIVE: Was to determine the incidence of complications in a cohort of patients diagnosed with moderate and severe hemophilia A or B under treatment in a specialized institution. METHODS: A retrospective study of a cohort of patients with replacement therapy for hemophilia A or B, evaluating treatment and complications between January/2012 and July/2019. Sociodemographic, clinical and disease management-related variables were extracted from the medical records. Time to inhibitor development and rate associated with bleeding and hospitalizations were evaluated. RESULTS: A total of 159 male patients were identified with hemophilia A (n = 140; 88.1%) and B (n = 19; 11.9%) with a mean follow-up of 5.9±2.3 years. The mean age was 23.6±16.1 years, hemophilia was reported as severe in 125 patients in hemophilia A (89.3%) and 13 patients in hemophilia B (68.4%). Primary prophylaxis was registered in 17.0% of patients, 44.7% secondary, and 38.3% tertiary, with recombinant factors (n = 84; 52.8%) followed by plasma derived factors (n = 75; 47.2%). The incidence of inhibitor development was 0.3 per 100 patients/year, with mean time to event of 509 days. The incidence of bleeding was 192 per 100 patients/year, especially at the joint (n = 99; 62.3%) and muscle (n = 25; 15.7%) level. The incidence of hospitalization was 3.7 per 100 patients/year. CONCLUSIONS: The most common complication was joint bleeding which was expected in this type of patients. Low proportion of patients developed factor inhibitors during the follow up.

Clinical Characteristics and Treatment of Irritable Bowel Syndrome in a Colombian Population: A Cross-Sectional Study.

BACKGROUND: Irritable bowel syndrome (IBS) is a functional disorder that leads to abdominal pain; its diagnosis is based on Rome IV criteria (recurrent abdominal pain at least 1 day per week in the last 3 months with more than two of the following: related to defecation, associated with a change in stool frequency and/or with a change in stool appearance). OBJECTIVE: To characterize an outpatient population diagnosed with IBS in Colombia during 2017-2018. METHODS: A cross-sectional study based on a review of clinical records of patients with a primary diagnosis of IBS. A representative sample of 380 individuals was recruited from a population of 38,182 people with a new diagnosis of IBS from a drug-claim database. Sociodemographic, clinical (symptoms, type of IBS, alarm features, etc.), treatment (pharmacological or not), and follow-up variables (for those with additional medical care at 3-12 months) were analyzed. The diagnosis and treatment used in the consultation were compared with clinical guidelines. RESULTS: Most of the 380 patients were women (n = 238; 62.6%), and the mean age was 40.1 ± 15.0 years. None of the physicians recorded the Rome IV criteria in the medical records. Unclassified IBS was the most prevalent subtype (n = 311; 81.8%), and the main symptom was abdominal pain (n = 327; 86.1%). Only 73 patients (19.2%) had follow-up data. The most frequently used drugs were aluminum hydroxide (n = 203; 53.4%) and hyoscine N-butyl bromide (n = 200; 52.6%). Regarding drugs included in the clinical practice guidelines, 19 people received loperamide (5.0%), 3 received trimebutine (0.8%), and 1 received sertraline (0.3%). CONCLUSIONS: The patients were diagnosed without clearly established criteria, and they were treated symptomatically with little follow-up.

Characterization and effectiveness of a Fracture Liaison Services program in Colombia.

PURPOSE: Fracture Liaison Services programs reduce mortality and the risk of refracture and increase treatment and adherence rates. Greater coverage is an important priority for the future. The aim was to determine the characteristics of patients over 50 years old who suffered fractures and the effectiveness of a Fracture Liaison Services program in a health care institution in Colombia. METHODS: This was a retrospective follow-up study of a cohort of patients with vertebral and nonvertebral fractures managed in a Fracture Liaison Services program. Sociodemographic, clinical and pharmacological variables were identified. Key performance indicators were used to evaluate the effectiveness of the program. Descriptive and bivariate analysis was performed. RESULTS: A total of 438 patients were analyzed. The average age was 77.5 years, and 78.5% were women. Hip and vertebral fractures were the most common (25.3% and 24.9%, respectively). Vertebral fractures prevailed in men (33.0% vs 22.7%; p = 0.041) and those of the radius/ulna in women (20.3% vs 10.6%; p = 0.031). A total of 29.7% had experienced a previous fracture, and 16.7% had received antiosteoporosis drugs. A total of 63.5% of the cases were managed surgically. At discharge, 58.8% received prescriptions for calcium/vitamin D, and 50.7% with prescriptions of antiosteoporotic therapy, especially teriparatide (21.2%) and denosumab (16.4%), without significant differences by sex. However, in women with hip fractures, anti-osteoporotic management prevailed (83.7% vs 64.0; p = 0.032). The effectiveness of the overall program per year was 74.6%. On follow-up, only 9.1% of patients had experienced a new fall, and of those 3.7% presented a new fracture. A total of 4.3% died during follow-up. CONCLUSIONS: Good adherence to the recommendations of the country's clinical practice guidelines was found, and overall, the effectiveness of the program was very satisfactory, with a low incidence of new fractures during follow-up. Fracture Liaison Services programs reduce mortality and the risk of refracture. A retrospective follow-up study of a cohort of patients with vertebral and nonvertebral fractures managed in a Fracture Liaison Services, showed that the effectiveness was 73.6%. On follow-up, 9.1% of patients had experienced a new fall, and of those 3.7% presented a new fracture.

Potentially Inappropriate Use of Opioids in the Management of Migraine in Colombia.

RESEARCH OBJECTIVE: To identify the frequency of opioid use in a group of patients diagnosed with migraine in Colombia. METHODS: Study of a retrospective cohort of patients with a diagnosis of migraine and a first prescription of antimigraine drugs from emergency services and a priority outpatient clinic. Sociodemographic, clinical, and pharmacological variables were identified; a 12-month follow-up was carried out to identify the use of a new opioid. RESULTS: A total of 6309 patients with a diagnosis of migraine were identified, with a mean age of 35.5 ± 12.3 years, of which 81.3% were women. Nonsteroidal anti-inflammatory drugs (51.1%) were the most frequently prescribed medications, followed by ergotamine + caffeine (31.3%), acetaminophen (15.05%), and acetaminophen + codeine (14.4%). At the time of the index, 1300 (20.6%) patients received some opioid. During the follow-up, a total of 1437 (22.8%) patients received a new opioid, of which 31.8% belonged to the group that received an initial opioid and 20.4% to the group that did not receive one, which was statistically significant (OR:1.81; 95%CI:1.58-2.07; p < 0.001). CONCLUSIONS: The frequent use of opioids in the management of migraines is potentially inappropriate and can lead to problems of tolerance, abuse and dependence. This combined with the low prescription of triptans, offers an opportunity for improvements in medical practice.

HLA-G 14 bp Ins/Del (rs66554220) Variant Is Not Associated with Breast Cancer in Women from Western Mexico.

HLA-G is a physiology and pathologic immunomodulator detrimentally related to cancer. Its gene is heavily transcriptionally and post-transcriptionally regulated by variants located in regulator regions like 3'UTR, being the most studied Ins/Del of 14-bp (rs66554220), which is known to influence the effects of endogen cell factors; nevertheless, the reports are discrepant and controversial. Herein, the relationship of the 14-bp Ins/Del variant (rs66554220) with breast cancer (BC) and its clinical characteristics were analyzed in 182 women with non-familial BC and 221 disease-free women as a reference group. Both groups from western Mexico and sex-age-matched (sm-RG). The rs66554220 variant was amplified by SSP-PCR and the fragments were visualized in polyacrylamide gel electrophoresis. The variant rs66554220 was not associated with BC in our population. However, we suggest the Ins allele as a possible risk factor for developing BC at clinical stage IV (OR = 3.05, 95% CI = 1.16-7.96, p = 0.01); nevertheless, given the small stratified sample size (n = 11, statistical power = 41%), this is inconclusive. In conclusion, the 14-bp Ins/Del (rs66554220) variant of HLA-G is not associated with BC in the Mexican population, but might be related to advanced breast tumors. Further studies are required.

Patterns and Trends in the Use of Medications for COPD Control in a Cohort of 9476 Colombian Patients, 2017-2019.

Purpose: Chronic obstructive pulmonary disease (COPD) affects approximately 174 million people worldwide. The objective was to determine the trends of COPD medication use in a group of Colombian patients. Patients and Methods: This was a retrospective study on prescription patterns of bronchodilators and other medications used in COPD from a population database with follow-up at 12 and 24 months. Patients older than 18 years of age of any sex with a COPD diagnostic code between 2017 and 2019 were included. Sociodemographic variables, medications, treatment schedules for COPD, comorbidities, comedications, and the specialty of the prescriber were considered. Results: Data from 9476 people with COPD was evaluated. The mean age was 75.9 ± 10.7 years, 50.1% were male, and 86.8% were prescribed by a general practitioner. A total of 57.9% had comorbidities, most often hypertension (44.4%). At the baseline measurement, on average, they received 1.6 medications/patient, mainly short-acting antimuscarinics (3784; 39.9%), followed by short-acting ß-agonists (2997, 31.6%) and inhaled corticosteroids (ICS) (2239, 23.6%); more than half (5083, 53.6%) received a long-acting bronchodilator. Prescription of triple therapy (antimuscarinic, ß-agonist, and ICS) went from 645 (6.8%) at baseline to 1388 (20.6%) at the 12-month mark. Conclusion: This group of patients with COPD treated in Colombia frequently received short-acting bronchodilators and ICS, but a growing proportion are undergoing controlled therapy with long-acting bronchodilators, a situation that can improve the indicators of morbidity, exacerbations, and hospitalization.

Treatment patterns of antidiabetic and kidney protective therapies among patients with type 2 diabetes mellitus and chronic kidney disease in Colombia. The KDICO descriptive study.

BACKGROUND: Type 2 diabetes mellitus is one of the most common causes of chronic kidney disease (CKD) worldwide and prevalence of 1.75 per 100 inhabitants in Colombia. The aim of this study was to describe the treatment patterns of a group of patients with type 2 diabetes mellitus and CKD in an outpatient setting from Colombia. METHODS: A cross-sectional study in adult patients with type 2 diabetes mellitus and CKD identified in the Audifarma S.A. administrative healthcare database between April 2019 and March 2020 was performed. Sociodemographic, clinical and pharmacological variables were considered and analyzed. RESULTS: A total of 14,722 patients with type 2 diabetes mellitus and CKD were identified, predominantly male (51%), with a mean age of 74.7 years. The most common treatment patterns of type 2 diabetes mellitus included the use of metformin monotherapy (20.5%), followed by the combination of metformin + dipeptidyl peptidase-4 inhibitor (13.4%). Regarding the use of drugs with nephroprotective properties, the most prescribed treatments were angiotensin receptor blockers (67.2%), angiotensin converting enzyme inhibitors (15.8%), sodium glucose cotransporter 2 inhibitors (SGLT2i) (17.0%) and glucagon-like peptide-1 analogs (GLP1a) (5.2%). CONCLUSION: In Colombia, the majority of patients with type 2 diabetes mellitus and CKD identified in this study were treated with antidiabetic and protective medications to ensure adequate metabolic, cardiovascular, and renal control. The management of type 2 diabetes mellitus and CKD may be improved if the beneficial properties of new groups of antidiabetics (SGLT2i, GLP1a), as well as novel mineralocorticoid receptor antagonists, are considered.

Antibiotic Management of Uncomplicated Skin and Soft Tissue Infections in the Real World.

Background: Skin and soft tissue infections are one of the main causes of consultations worldwide. The objective was to determine the treatment of a group of patients with uncomplicated skin and soft tissue infections in Colombia. Methods: Follow-up study of a cohort of patients with skin infections who were treated in the Colombian Health System. Sociodemographic, clinical and pharmacological variables were identified. Treatments were evaluated using clinical practice guidelines for skin infections. Results: A total of 400 patients were analyzed. They had a median age of 38.0 years and 52.3% were men. The most commonly used antibiotics were cephalexin (39.0%), dicloxacillin (28.0%) and clindamycin (18.0%). A total of 49.8% of the subjects received inappropriate antibiotics, especially those with purulent infections (82.0%). Being cared for in an outpatient clinic (OR: 2.09; 95% CI: 1.06-4.12), presenting pain (OR: 3.72; 95% CI: 1.41-9.78) and having a purulent infection (OR: 25.71; 95% CI: 14.52-45.52) were associated with a higher probability of receiving inappropriate antibiotics. Conclusions: Half of patients with uncomplicated skin and soft tissue infections were treated with antibiotics that were not recommended by clinical practice guidelines. This inappropriate use of antibiotics occurred in the vast majority of patients with purulent infections because the antimicrobials used had no effect on methicillin-resistant Staphylococcus aureus.

Clinical characterization of a cohort of patients treated for systemic lupus erythematosus in Colombia: A retrospective study.

INTRODUCTION: Systemic lupus erythematosus is an autoimmune disease associated with serious complications and high costs. The aim was to describe the clinical characteristics and health care resource utilization of a Colombian systemic lupus erythematosus outpatient cohort. METHODS: This was a retrospective descriptive study. Clinical records and claims data for systemic lupus erythematosus patients from ten specialized care centers in Colombia were reviewed for up to 12 months. Baseline clinical variables, Systemic Lupus Erythematosus Disease Activity Index, drug use, and direct costs were measured. Descriptive statistics were analyzed using SPSS. RESULTS: A total of 413 patients were included; 361 (87.4%) were female, and the mean age was 42 ± 14 years. The mean disease evolution was 8.9 ± 6.0 years; 174 patients (42.1%) had a systemic manifestation at baseline, mostly lupus nephritis (105; 25.4%). A total of 334 patients (80.9%) had at least one comorbidity, mainly antiphospholipid syndrome (90; 21.8%) and hypertension (76; 18.4%). The baseline Systemic Lupus Erythematosus Disease Activity Index score was 0 in 215 patients (52.0%), 1-5 in 154 (37.3%), 6-10 in 41 (9.9%) and 11+ in 3 (0.7%). All patients received pharmacological therapy, and the most common treatment was corticosteroids (293; 70.9%), followed by antimalarials (chloroquine 52.5%, hydroxychloroquine 31.0%), immunosuppressants (azathioprine 45.3%, methotrexate 21.5%, mycophenolate mofetil 20.1%, cyclosporine 8.0%, cyclophosphamide 6.8%, leflunomide 4.8%) and biologicals (10.9%). The mean annual costs were USD1954 per patient/year, USD1555 for antirheumatic drugs (USD10,487 for those with biologicals), USD86 for medical visits, USD235 for drug infusions and USD199 for laboratory tests. CONCLUSIONS: Systemic lupus erythematosus generates an important economic and morbidity burden for the Colombian health system. Systemic lupus erythematosus outpatient attention costs in the observation year were mainly determined by drug therapy (especially biologics), medical visits and laboratory tests. New studies addressing the rate of exacerbations, long-term follow-up or costs related to hospital care are recommended.

Improved Wisdom Tooth Diagnosis Can Reduce Dental Disease and Nonbattle Injuries.

INTRODUCTION: Wisdom teeth are a frequent cause for dental disease and nonbattle injuries (D-DNBIs) during expeditionary deployments. Improved diagnosis and timely treatment before deployment can reduce the need to evacuate a D-DNBI while in a theater. This study proposed key identifiers to diagnose wisdom teeth as Dental Readiness Classification (DRC) 3. MATERIALS AND METHODS: This study was a retrospective chart review conducted to measure concurrence among Army dentists when assigning DRC for wisdom teeth. This study also recorded demographic data and physical findings among the observed patients. Concurrence, or inter-rater reliability, was measured using Cohen's kappa (κ). RESULTS: A Cohen's κ of 0.04 suggested that there was no concurrence among Army dental providers in the diagnosis of wisdom teeth. The study concluded that caries and pericoronitis accounted for 37% and 13% of class 3 nondeployable troops, respectively. Forty-one percent of tobacco users had caries. Fifty-eight percent of the population was diagnosed as DRC 3. CONCLUSIONS: This study proposed DRC 3 criteria for wisdom teeth and measured concurrence among dental providers' diagnoses. Dental Readiness Classification 3 criteria include caries, pericoronitis, infection, and pathology. A Cohen's κ of 0.04 indicated there was a lack of concurrence in examining dentists compared to the DRC 3 criteria. Caries and pericoronitis were the most frequent diagnoses for third molars. Early diagnosis and treatment of these key identifiers can help reduce a significant source of D-DNBIs in the deployed environment.

Clinical Characteristics, Patterns of Use, and incidence of Adverse Events in Patients With Nonvalvular Atrial Fibrillation Treated With Oral Anticoagulants in Colombia.

Purpose: The aim was to analyze the characteristics, treatment patterns, and clinical outcomes of Colombian patients with non-valvular atrial fibrillation (NVAF) under treatment with oral anticoagulants (OAs). Patients and Methods: Retrospective cohort in patients with NVAF identified from a drug dispensing database, aged ≥18 years, with first prescription of an OA (index) between January/2013 and June/2018, and a follow-up until June/2019. Data from the clinical history, pharmacological variables, and outcomes were searched. International Classification of Diseases-10 codes were used to identify the patient sample and outcomes. Patients were followed until a general composite outcome of effectiveness (thrombotic events), bleeding/safety or persistence (switch/discontinuation of anticoagulant) events. Descriptive and multivariate analyzes (Cox regressions comparing warfarin and direct oral anticoagulants-DOACs) were carried out. Results: A total of 2076 patients with NVAF were included. The 57.0% of patients were women and the mean age was 73.3±10.4 years. Patients were followed for a mean of 2.3±1.6 years. 8.7% received warfarin before the index date. The most frequent OA was rivaroxaban (n=950; 45.8%), followed by warfarin (n=459; 22.1%) and apixaban (n=405; 19.5%). Hypertension was present in 87.5% and diabetes mellitus in 22.6%. The mean CHA2DS2-VASc Score was 3.6±1.5. The 71.0% (n=326/459) of the warfarin patients presented the general composite outcome, and 24.6% of those with DOACs (n=397/1617). The main effectiveness and safety outcomes were stroke (3.1%) and gastrointestinal bleeding (2.0%) respectively. There were no significant differences between patients with warfarin and DOACs regarding thrombotic events (HR: 1.28; 95% CI: 0.68-2.42), but warfarin was associated with higher bleeding/safety events (HR: 4.29; 95% CI: 2.82-6.52) and persistence events (HR: 4.51; 95% CI: 3.81 -5.33). Conclusion: The patients with NVAF in this study were mainly older adults with multiple comorbidities. Compared to warfarin, DOACs were found to be equally effective, but safer and had a lower probability of discontinuation or switch.

Adaptación y evaluación de la eficacia de un programa psicoeducativo de navegación para disminuir síntomas de ansiedad y depresión en mu-jeres mexicanas con cáncer de mama / Design and evaluation of the efficacy of a psychoeducational navigation program to reduce symptoms of anxiety and depression in Mexican women with breast cancer

Objetivo:El cáncer de mama (CAM) es un problema de salud pública mundial. La ansiedad y depresión son las principales comorbilidades que aquejan a este sector, el programa psicoeducativo de navegación (PPN) se presenta como una estrategia psicosocial eficaz en hospitales públicos de México. Método: Se realizó la adaptación del PPN y la evaluación de eficacia en 47 mujeres con CAM de tres hospitales de la Zona Metropolitana de Guadalajara. El PPN integró acompañamiento emocional, educación para la salud y técnicas de relajación. Se evaluaron los síntomas y los niveles de ansiedad y depresión, pre-post intervención con la Escala Hospitalaria de Ansiedad y Depresión (HADS). Resultados: Se encontró una disminución en los síntomas de ansiedad pre-test (M= 6,79, DT= 4,01) y pos-test (M= 4,19, DT= 3,03), igual que en los síntomas de depresión antes (M= 6,02, DT= 4,07) y después (M= 4,23, DT= 3,05). Se obtuvieron diferencias estadísticamente significativas entre las evaluaciones pre y post intervención tanto en las dimensiones, como en la puntuación global (p<0,001). Conclusiones: El PPN mostró eficacia para disminuir los síntomas y los niveles de ansiedad y depresión en mujeres mexicanas con CAM. Sugerimos replicar el programa en otros contextos de atención oncológica en seguimiento a las normativas nacionales (AU)

Objective: Breast cancer (BC) is a public health problem. Anxiety and depression are the main comorbidities that afflict this sector, the navigation psychoeducational program (NPP) is presented as an effective psychosocial strategy in public hospitals in Mexico.Method: The NPP was adapted and its efficacy evaluated in 47 women with BC from three hospitals in the Guadalajara Metropolitan Area. The NPP integrated emotional accompaniment, health education and relaxation techniques. Symptoms and levels of anxiety and depression were evaluated pre-post intervention with the Hospital Anxiety and Depression Scale (HADS). Results: A decrease was found in anxiety symptoms pre-test (M= 6.79, SD= 4.01) and post-test (M= 4.19, SD= 3.03), the same as in depression symptoms before (M= 6.02, SD= 4.07) and after (M= 4.23, SD= 3.05). Statistically significant differences were obtained between the pre- and post-intervention evaluations both in the dimensions and in the global score (p<0.001).Conclusions: The NPP showed efficacy in reducing symptoms and levels of anxiety and depression in Mexican women with BC. We suggest replicating the program in other cancer care contexts in compliance with national regulations (AU)

Prescription of transdermal patches in Colombia: A real-world evidence study.

BACKGROUND: Transdermal drug delivery has contributed positively to medical practice. However, prescriptions that do not meet minimum quality criteria and medication errors are common. OBJECTIVE: The objective was to determine how transdermal patches are being prescribed to a group of patients in Colombia, the compliance with established requirements of such prescriptions and the comparisons between correct and incorrect prescriptions. METHODS: This was a cross-sectional study of prescriptions for transdermal patches using data from a population-based drug dispensing database between December 1 and 31, 2019. Medical prescriptions were randomly reviewed, establishing whether the drugs were appropriately prescribed by the manufacturer's indications or national regulations. Descriptive and bivariate analysis was performed. RESULTS: A total of 415 prescriptions were reviewed; the prescription was provided to 412 patients with a median age of 76.9 years, and 63.3% were women. Rivastigmine was the most prescribed transdermal patch (57.8%). 66.3% of all prescriptions did not meet the minimum appropriate prescribing standards, especially those for rivastigmine (97.1%). The 7.0% of all prescriptions had posology errors, especially prescriptions for buprenorphine (43.8%). Older patients (84.4% vs 52.5%), from the Pacific region (34.4% vs 23.7%), with manual formulations (22.1% vs 0.8%), dementia (49.0% vs 6.8%), and in management with lipid-lowering drugs (41.8% vs 30.5%), presented incorrect transdermal patch formulations more frequently (p < 0.05). CONCLUSION: The high proportion of inappropriately prescribed transdermal patches should draw the attention of those responsible for health care to improve the training of physicians and create prescription quality verification systems.

Effectiveness, persistence of use, and safety of orlistat and liraglutide in a group of patients with obesity.

BACKGROUND: To determine the effectiveness, persistence of use, adverse reactions, interactions of orlistat and liraglutide taken for weight loss by a group of obese patients in Colombia. RESEARCH DESIGN AND METHODS: A retrospective follow-up study of a cohort of patients with obesity treated with orlistat or liraglutide. Sociodemographic, clinical, and pharmacological variables were identified. The effectiveness for weight loss at 12-16 and 52 weeks, persistence of use, and safety were determined. RESULTS: A total of 294 patients were followed up. At 12-16 weeks after starting orlistat and liraglutide, weight losses of -1.2kg (p=0.002) and -4.1kg (p<0.001) were observed, respectively, and at 52 weeks, reductions of -1.6kg (p=0.208) and -7.8kg (p<0.001) were observed. A total of 8.8% and 31.3% of patients treated with orlistat and liraglutide, respectively, persisted with treatment 1 year after initiation. A total of 17.3% had adverse drug reactions. Older adults with grade II or III obesity who performed physical activity and those treated with liraglutide were more likely to have lost at least 5% of their body weight at 12-16 weeks. CONCLUSION: Orlistat and liraglutide users presented weight loss at 12-16 weeks. However, this effect was greater and sustained with liraglutide, especially when combined with physical activity.