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Maternal warmth has been identified as a contributing factor to the development of child anxiety; however, no studies to date have examined observed maternal warmth longitudinally in this relationship. The present study addressed this knowledge gap by examining the simultaneous development of maternal warmth and child anxiety over time (between-person effects using latent growth curve modeling) and the directionality of associations (within-person effects using autoregressive latent trajectory modeling). Participants included 753 mothers and children. Between-person effects indicated that lower initial levels of anxiety were related to greater levels of maternal warmth over time. Within-person effects showed that maternal warmth in grade 1 predicted subsequent decreases in child anxiety in grade 2 (i.e., a parent effect). Present findings demonstrate the importance of maternal warmth in the early school-age years for decreasing subsequent child anxiety.
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Ansiedad , Relaciones Madre-Hijo , Trastornos de Ansiedad , Niño , Femenino , Humanos , Madres , PadresRESUMEN
PURPOSE OF REVIEW: To review the clinical evidence underlying the efficacy and safety of the use of direct oral anticoagulants (DOACs) for the treatment of patients with valvular atrial fibrillation (AF). RECENT FINDINGS: The recent focused update to the 2014 AHA/ACC/HRS Atrial Fibrillation Guidelines defines valvular AF as AF in the setting of moderate-to-severe mitral stenosis (MS) and/or in the presence of a mechanical heart valve. Landmark clinical trials of DOACs in patients with AF systematically excluded these patient populations. However, there are trial data in both animals and humans regarding the use of DOACs in patients with MS and in those with mechanical heart valves. Based on sub-analyses and meta-analyses of clinical trial data in patients with AF, the use of DOACs in valvular AF is not recommended. Patients with moderate-to-severe MS or a mechanical heart valve and AF should be anticoagulated with dose-adjusted warfarin. DOACs are reasonable alternatives to warfarin in patients with AF and other types of valvular disease, including mild MS and bioprosthetic valves.
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Anticoagulantes/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Accidente Cerebrovascular/prevención & control , Administración Oral , Anticoagulantes/uso terapéutico , Fibrilación Atrial/complicaciones , Enfermedades de las Válvulas Cardíacas , Humanos , Resultado del TratamientoRESUMEN
Purpose In occupational rehabilitation, the biopsychosocial model endorses the role of social factors in worker recovery. We conducted a systematic review to explore three questions examining the role of social support for the return-to-work (RTW) of individuals with work-related injury: (1) What are the worker-identified social barriers and facilitators in RTW; (2) What is the relationship between social factors and RTW; and (3) What is the effectiveness of social interventions for RTW. Methods Systematic searches of six databases were conducted for each research question. These identified 11 studies meeting inclusion criteria for Research Question 1, and 12 studies for Research Question 2. No studies were identified that met inclusion criteria for Research Question 3. A narrative synthesis approach was used to analyse the included studies. Results Research Question 1 identified five themes in social barriers and facilitators to RTW, including contact/communication, person-centred approaches, mutual trust, reaction to injury, and social relationships. Research Question 2 identified moderate support for reaction to injury and social integration/functioning as predictors of RTW and weak evidence for co-worker support. Four studies reported significant associations between social factors and RTW, six reported mixed findings with at least one significant social predictor, and two found no significant relationships. However, conclusions were limited by the inconsistency in measurement of social factors. Conclusions Our findings indicate that social support and integration may influence RTW following work-related injury, and highlights the need for further systematic examination of social factors in the field of occupational rehabilitation.
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Traumatismos Ocupacionales/psicología , Reinserción al Trabajo , Integración Social , Apoyo Social , Humanos , Traumatismos Ocupacionales/rehabilitación , Reinserción al Trabajo/psicología , Reinserción al Trabajo/estadística & datos numéricosRESUMEN
Despite strong evidence of the relationship between conduct disorder (CD) symptoms and substance use, it is unclear how callous-unemotional (CU) traits predict substance use over and above CD symptoms, and their potential interaction. This study used data from 753 participants followed from grade 7 to 2-years post-high school. Latent growth curve models showed that CU traits predicted the onset of cigarette use, alcohol misuse, and a substance use composite at grade 7 only when no CD symptoms were present. Among those without CD symptoms, boys showed greater change in the odds of using cigarettes, and were more likely to misuse alcohol or use any substance at grade 7 than girls. However, CD symptoms, CU traits, and their interaction did not predict the linear rates of growth of substance use over time. Thus, CU traits may uniquely predict adolescent substance use when CD symptoms are not present. This research has implications for predicting onset of adolescent substance use and for incorporating the assessment of CU traits into interventions targeting adolescent substance use.
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Síntomas Afectivos , Trastorno de Personalidad Antisocial/psicología , Trastorno de la Conducta/psicología , Trastornos Relacionados con Sustancias , Adolescente , Síntomas Afectivos/diagnóstico , Síntomas Afectivos/psicología , Síntomas Conductuales , Niño , Femenino , Humanos , Masculino , Psiquiatría Preventiva/métodos , Psicopatología , Trastornos Relacionados con Sustancias/diagnóstico , Trastornos Relacionados con Sustancias/prevención & control , Trastornos Relacionados con Sustancias/psicología , Adulto JovenRESUMEN
IN BRIEF The combination of basal insulin and a glucagon-like peptide 1 receptor agonist is becoming increasingly common and offers several potential benefits to patients with type 2 diabetes. Clinical studies have demonstrated improved glycemic control and low risks of hypoglycemia and weight gain with the combination, which provides a safe and effective alternative to basal-bolus insulin with less treatment burden. Fixed-ratio combination products that administer both agents in a single injection are in the pipeline and will offer additional options for clinicians and patients. This review focuses on the rationale for, clinical evidence on, and implications of using this combination of therapies in the treatment of type 2 diabetes.
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BACKGROUND: The American Diabetes Association (ADA) recommends low-dose aspirin therapy as a primary prevention strategy in patients with type 1 or type 2 diabetes mellitus (DM) at increased cardiovascular risk. However, not all patients who are indicated are taking aspirin therapy, and it is not routinely documented in the electronic health record (EHR). OBJECTIVE: To determine frequencies of appropriate aspirin use and documentation in the EHR in adult patients with DM. METHODS: Adult patients with DM were randomized and contacted for participation in a telephonic survey between January and October 2013. Patients who consented were administered a standardized oral telephone survey regarding aspirin use. Patient demographics, current medications, allergies, past medical history, and pertinent laboratory values were collected. Patients were then stratified by the ADA-defined indication for aspirin. The primary outcomes were rates of appropriate aspirin use and documentation of aspirin therapy in the EHR. RESULTS: Investigators contacted 276 patients for inclusion. Of the 81 patients surveyed, 74% were indicated for aspirin therapy. Nearly all (92.3%) patients reporting aspirin use were indicated for aspirin therapy compared with only 57.1% of patients who did not report aspirin but were indicated (P = 0.0003). Alternatively, 96.7% of patients with aspirin use documented in their EHR were indicated for aspirin therapy compared with only 60.8% of patients who did not have aspirin use documented in the EHR but had an indication (P = 0.0002). Approximately 20% of the patients indicated for and reporting aspirin use did not have aspirin documented in their EHR. CONCLUSIONS: Aspirin use in patients with DM who are indicated for therapy is significantly underutilized and underdocumented.
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Aspirina/uso terapéutico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Enfermedades Cardiovasculares/prevención & control , Recolección de Datos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Prevención Primaria , Factores de Riesgo , Adulto JovenRESUMEN
Objective: A potential interaction between warfarin and divalproex sodium is described. Case Summary: A 65-year-old Arabic-speaking Egyptian woman chronically anticoagulated with warfarin for atrial fibrillation and a history of stroke presented to the anticoagulation clinic with an elevated international normalized ratio (INR) of 3.2. This was an increase of 1.4 over her previous INR of 1.8 only 9 days prior. Discussion with the patient's daughter revealed the addition of divalproex sodium (a derivative of valproic acid) 250 mg twice daily to the patient's medication regimen 6 days prior. Other contributing factors that could cause an elevated INR were ruled out. The patient's total weekly dose (TWD) of warfarin was decreased from 22.5 mg to 20 mg, and the patient was instructed to return for a repeat INR in 1 week. On the day the patient was due to return for a repeat INR, she was admitted to the hospital and her INR was 2.2 on admission. Based on medication reconciliation information, the patient had decreased her warfarin TWD as instructed and had self-discontinued the divalproex sodium due to intolerable fatigue. During this time, the patient received no additional divalproex sodium. She was instructed to resume her previous TWD of warfarin of 22.5 mg on discharge and subsequently had a therapeutic INR (2.6) 11 days later. Discussion: Warfarin and divalproex sodium are commonly prescribed agents with few case reports to describe their interaction. Primary literature supports a multifactorial mechanism, including CYP450 metabolism inhibition and protein-binding displacement, both of which can result in an elevated INR. Use of the Drug Interaction Probability Scale indicated a probable interaction between warfarin and divalproex sodium. Conclusions: Patients receiving concurrent warfarin and divalproex sodium therapy should be monitored closely for changes in INR values as the combination may increase the INR and put the patient at increased risk for bleeding.
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OBJECTIVES: To investigate the concurrent validity of the Saint Louis University Mental Status examination (SLUMS) by comparing the ability of the Mini-Mental State Examination (MMSE) and the SLUMS to predict performance on standard neuropsychological measures of memory and executive functioning. DESIGN: Cross-sectional. SETTING: University-based research clinic. PARTICIPANTS: Community-dwelling adults (N = 170) age 60 years and older (Mage = 73.08; SD = 8.18). MEASUREMENTS: The Trail Making Test (TMT), Rey Auditory Verbal Learning Test, Wisconsin Card Sorting Test (WCST), MMSE, and SLUMS. RESULTS: The distributional properties of the SLUMS and the MMSE were directly compared. The SLUMS showed statistically a smaller mean, lower rank scores, and less skewness than the MMSE. Comparisons of the correlations of the screening tests with the neuropsychological measures indicated that the SLUMS demonstrated stronger relationships with the TMT compared with the MMSE. Multiple regression analyses were conducted to determine the ability of the SLUMS and the MMSE to predict scores on common neuropsychological tests after controlling for demographic variables. Results demonstrated that the SLUMS significantly predicted performance across all measures over the MMSE and demographic variables, with the exception of the WCST's perseverative errors. However, the MMSE does not add to the prediction of neuropsychological functioning over the SLUMS. CONCLUSION: Although the SLUMS and the MMSE are strongly correlated, the SLUMS significantly adds to the prediction of neuropsychological measures beyond the MMSE scores. Our findings suggest that the SLUMS may be an appropriate measure to use as a screening tool among older adults and may have fewer ceiling effects than the MMSE.
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Trastornos del Conocimiento/diagnóstico , Anciano , Anciano de 80 o más Años , Función Ejecutiva , Femenino , Humanos , Masculino , Tamizaje Masivo , Escala del Estado Mental , Persona de Mediana Edad , Psicometría , Reproducibilidad de los Resultados , Prueba de Secuencia AlfanuméricaRESUMEN
One in ten adults worldwide is living with diabetes, with 95% having type 2 diabetes (T2D). Sustained glycaemic control in people with T2D is difficult to achieve despite recent advances in T2D management with the advent of glucagon-like peptide 1 receptor agonists (GLP1RA) and sodium-glucose cotransporter 2 inhibitors (SGLT2i). Tirzepatide represents a first-in-class agent as a dual glucose-dependent insulinotropic polypeptide (GIP)/GLP1RA to be approved in the USA and Europe for the treatment of T2D. This narrative review intends to list and discuss the glycaemic efficacy, key safety and weight loss outcomes related to the treatment of T2D with tirzepatide. Tirzepatide has been evaluated in five published clinical trials (n=6278) within the SURPASS clinical trial programme, with a focus on glycaemic control and weight loss. These trials have demonstrated significant improvements in glycosylated haemoglobin (-1.24% to -2.11% versus placebo and -0.6% to -1.14% versus active comparator) and weight (up to 15.5 kg versus placebo or active comparator) in patients with T2D. Notably, tirzepatide exhibited superior glycaemic control and weight loss when compared directly with a GLP1RA. Adverse events with the use of tirzepatide are similar to other approved GLP1RA and are predominantly gastrointestinal (nausea, vomiting). The tirzepatide cardiovascular outcomes trial (SURPASS-CVOT) is in progress and is expected to be completed in the fall of 2024. Tirzepatide represents an attractive new option and first-in-class agent for the treatment of T2D in people unable to achieve their glycaemic or weight management goals.
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OBJECTIVE: To review the literature and describe the pharmacologic, pharmacokinetic, and pharmacodynamic properties; clinical safety; and efficacy of dapagliflozin, a new drug currently under review by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes. DATA SOURCES: A MEDLINE (1995-November 2011) and ClinicalTrials.gov search was conducted using the terms dapagliflozin, sodium-glucose cotransporter 2 inhibitor, and SGLT2 inhibitor. Reference citations from publications identified were also reviewed. STUDY SELECTION AND DATA EXTRACTION: All English-language studies, including abstracts, evaluating dapagliflozin use in humans were included in this review. DATA SYNTHESIS: Dapagliflozin is the first-in-class oral sodium-glucose cotransporter 2 (SGLT2) inhibitor that represents a new potential therapeutic option for the treatment of type 2 diabetes mellitus. Its mechanism of action is insulin- and insulin-sensitivity independent. Preliminary data suggest that dapagliflozin decreases hemoglobin A(1c), fasting plasma glucose, and postprandial plasma glucose, while also promoting weight loss. In Phase 1, 2, and 3 clinical trials, dapagliflozin has exhibited a safety and tolerability profile similar to that of placebo. CONCLUSIONS: Dapagliflozin is a novel oral antihyperglycemic agent that has demonstrated promise as monotherapy and as synergistic combination therapy with currently available agents in Phase 3 clinical trials. On January 19, 2012, the FDA issued a complete response letter to AstraZeneca and Bristol-Myers Squibb regarding the new drug application for dapagliflozin. The FDA is requesting additional clinical data-from ongoing studies and potentially new clinical trials-to better describe the risk-benefit profile of the drug. Both manufacturers remain committed to the development of dapagliflozin, and there are currently 8 Phase 3 trials ongoing. Dapagliflozin has the potential to be the next new oral agent in the diabetes drug armamentarium.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Glucósidos/uso terapéutico , Hipoglucemiantes/uso terapéutico , Administración Oral , Animales , Compuestos de Bencidrilo , Glucemia/efectos de los fármacos , Ensayos Clínicos como Asunto , Diabetes Mellitus Tipo 2/fisiopatología , Quimioterapia Combinada , Glucósidos/efectos adversos , Glucósidos/farmacocinética , Humanos , Hipoglucemiantes/efectos adversos , Hipoglucemiantes/farmacocinética , Inhibidores del Cotransportador de Sodio-Glucosa 2RESUMEN
OBJECTIVES: To evaluate the literature regarding the use of histamine-1 (H(1)) receptor antagonists and to describe their role in the treatment of insomnia in adult patients, including the elderly. DATA SOURCES: Literature was identified via PubMed and Medline through April 1, 2012, using the search terms insomnia and sleep, each individually combined with histamine antagonist, tricyclic antidepressant, trazodone, mirtazapine, doxepin, amitriptyline, nortriptyline, trimipramine, doxylamine, diphenhydramine, and antihistamine. STUDY SELECTION AND DATA EXTRACTION: Data included randomized double-blind trials that statistically evaluated H(1) receptor antagonist treatment in patients with insomnia compared with a placebo control or Food and Drug Administration-approved insomnia treatment. Trials selected evaluated sleep latency, wake after sleep onset, total sleep time, number of awakenings, and/or sleep efficiency in a subjective or objective manner. A total of 65 trials were evaluated, and 16 met inclusion criteria. DATA SYNTHESIS: With the exception of low-dose doxepin (Silenor-Somaxon), trials evaluating the clinical effectiveness of H(1) receptor antagonists show mixed results and are limited by sample size and generalizability. Large, randomized, appropriately controlled trials are lacking, making it difficult to define the safety and efficacy of these agents. In contrast, low-dose doxepin has been shown to provide consistent sleep benefit compared with placebo. CONCLUSION: Over-the-counter antihistamines may have a role for short-term insomnia treatment in younger adults, but tolerance develops rapidly. Mirtazapine should not be used solely for the treatment of insomnia. Sedating antidepressants can be considered after failure of first-line insomnia treatments. Patients taking these agents chronically should be evaluated for continued efficacy and potential harm. Low-dose doxepin may have a unique role in the treatment of insomnia in elderly patients given its tolerability, documented efficacy, and lack of important adverse effects.
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Antagonistas de los Receptores Histamínicos H1/uso terapéutico , Hipnóticos y Sedantes/uso terapéutico , Trastornos del Inicio y del Mantenimiento del Sueño/tratamiento farmacológico , Antidepresivos Tricíclicos/uso terapéutico , Humanos , Medicamentos sin Prescripción/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVES: To determine predictors of glycemic response to exenatide and to assess change in glycosylated hemoglobin (A1C) and whether a correlation exists between weight loss and glycemic response. DESIGN: Retrospective observational cohort study. SETTING: United States in 2009. PATIENTS: 100 adult patients with type 2 diabetes prescribed exenatide. INTERVENTION: Retrospective chart review of patients to collect demographic data, weight, serum creatinine, diabetes education, and concurrent diabetes medications. MAIN OUTCOME MEASURES: Patients were categorized as responders or nonresponders based on change in A1C. Responders had an A1C decrease of 0.5% or more and nonresponders had an A1C decrease of less than 0.5% from baseline to post-exenatide initiation. Demographic data for each cohort were analyzed. RESULTS: 100 patients met inclusion criteria (61 responders and 39 nonresponders). Responders had a mean A1C decrease of 1.57%, whereas nonresponders had a mean A1C increase of 0.23% (P < 0.001). Post hoc linear regression analysis revealed that baseline A1C was a predictor of response to exenatide (P < 0.001). Binary logistic regression analysis demonstrated that no other variables were predictors of response to exenatide (P > 0.05 for all). No correlation was found between weight loss and exenatide and glycemic response (P = 0.99). CONCLUSION: Our data indicate that patients with a higher baseline A1C are more likely to have a glycemic response to exenatide than patients with a lower baseline A1C.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Péptidos/uso terapéutico , Ponzoñas/uso terapéutico , Adulto , Anciano , Anciano de 80 o más Años , Glucemia/efectos de los fármacos , Estudios de Cohortes , Creatinina/sangre , Diabetes Mellitus Tipo 2/sangre , Diabetes Mellitus Tipo 2/metabolismo , Exenatida , Femenino , Hemoglobina Glucada/metabolismo , Humanos , Masculino , Persona de Mediana Edad , Educación del Paciente como Asunto/métodos , Estudios Retrospectivos , Pérdida de Peso/efectos de los fármacosRESUMEN
Atherosclerotic cardiovascular disease (ASCVD) commonly affects people with type 2 diabetes (T2D). Historically, traditional cardiovascular (CV) risk-lowering therapies in patients with T2D and ASCVD have included antiplatelet agents, blood pressure-lowering therapies, lipid-lowering therapies and healthy lifestyle modifications. In the past decade, multiple antihyperglycaemic agents have emerged as CV risk-lowering therapies in this population as well. This article provides a narrative review on the current non-glycaemic and glycaemic treatment options for CV risk reduction in patients with T2D and ASCVD. The FDA requirement that all new antihyperglycaemic agents undergo cardiovascular outcomes trials has demonstrated increasing evidence to support the role of glucagon-like peptide 1 (GLP1) receptor agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors as first-line agents for both glycaemic control and CV risk reduction in this population.
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BACKGROUND: Statin Therapy for Patients with Cardiovascular Disease (SPC) is a Centers for Medicare & Medicaid Services Star measure added to Medicare Part C (Medicare Advantage) plans in 2019 to incentivize statin use for secondary prevention of cardiovascular disease (CVD). The measure assesses statin dispensing and adherence in patients with atherosclerotic CVD (ASCVD). Clinical pharmacists are well-positioned to affect positively a health system's performance on the SPC measure. OBJECTIVE: To assess the effect of telephone outreach by clinical pharmacists on moderate- or high-intensity statin prescribing in patients with ASCVD. METHODS: Patients in managed care health plans who meet the SPC measure criteria and are not currently receiving a moderate- to high-intensity statin therapy were contacted by a clinical pharmacist through telephone outreach. If appropriate, they were prescribed a statin by a clinical pharmacist. The primary outcome measure was the proportion of patients who meet the SPC measure classification and had 1 confirmed prescription fill for a moderate- or high-intensity statin after intervention by a clinical pharmacist. RESULTS: A total of 84 patients were identified for review and outreach, of whom 35 (41.7%) met the SPC measure criteria. Of these 35 patients, 16 (45.7%) were female and the mean age was 66 years. A total of 22 (62.9%) patients agreed to a statin prescription, and 16 (72.7%) of these patients picked up the prescription within 10 days of prescribing. An additional 4 patients, for a total of 20 (57.1%) of the 35 eligible patients, were eventually dispensed a statin. Healthcare Effectiveness Data and Information Set (HEDIS) vendor data available after the intervention showed a larger SPC measure population than was captured with the health plan's internal report. HEDIS data showed an increase in statin prescribing for patients meeting the SPC measure classification from 24.7% to 56.6% during the study period (P <.001). The mean time spent per patient for chart review and/or outreach by the clinical pharmacist was 27.7 (standard deviation, 9) minutes. CONCLUSION: These results indicate that clinical pharmacists who conduct a telephonic population health intervention can achieve a high rate of success in initiating a moderate- to high-intensity statin therapy in patients with ASCVD.
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The year 2020 was dominated by the COVID-19 pandemic, bringing with it unprecedented advancements in the fields of healthcare and therapeutic interventions as well as in vaccine and drug development. Nevertheless, several other advancements in various fields of medicine also deserve attention. Herein, the Senior Editors of Drugs in Context provide us with their expert opinion on the events of 2020 and what lies ahead in 2021.
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PURPOSE: The use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) to treat hypertension (HTN) during pregnancy presents well-established risks to a developing fetus. A cross-sectional study was conducted to evaluate the current state of antihypertensive prescribing and contraceptive use in females of childbearing age within a large safety-net health system. METHODS: The retrospective cross-sectional study focused on females aged 18-49 years with a documented diagnosis of HTN. The proportion of patients prescribed an ACE inhibitor or ARB and using a documented form of contraception was calculated. Documented forms of contraception included oral contraceptives, intrauterine devices, injections, implants, and surgical intervention. RESULTS: A total of 4,187 patients were identified from the HTN registry; after application of exclusion criteria 3,045 patients were included in the study population. The mean age was 39 years (range, 18-49 years). The most frequently prescribed classes of antihypertensive medications were ACE inhibitors and ARBs (one or the other was used by 1,146 patients [37.6%]), followed by thiazide diuretics (n = 710, 23.3%) and calcium channel blockers (n = 599, 19.7%). Of the 1,146 patients prescribed an ACE inhibitor or ARB, 553 (48%) were using a documented form of contraception. CONCLUSION: Rates of ACE inhibitor or ARB prescribing to females of childbearing age were high despite the teratogenic risks, and fewer than half of patients had documented protection from pregnancy. Provider and patient education and potential creation of best practice alerts in the electronic medical record regarding the risks of using ACE inhibitors and ARBs in females of childbearing age are warranted.
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Antihipertensivos , Hipertensión , Adulto , Antagonistas de Receptores de Angiotensina , Inhibidores de la Enzima Convertidora de Angiotensina/efectos adversos , Antihipertensivos/efectos adversos , Estudios Transversales , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Hipertensión/epidemiología , Embarazo , Estudios RetrospectivosRESUMEN
OBJECTIVE: To compare statin prescribing rates between intermediate-risk people living with human immunodeficiency virus (HIV; PLWH) and intermediate-risk patients without a diagnosis of HIV for primary prevention of atherosclerotic cardiovascular disease (ASCVD). METHODS: Retrospective cohort study . Electronic health record data were used to identify a cohort of PLWH aged 40-75 years with a calculated 10-year ASCVD risk between 7.5%-19.9% as determined by the Pooled Cohort Equation (PCE). A matched cohort of primary prevention non-HIV patients was identified. The primary outcome was the proportion of PLWH who were prescribed statin therapy compared to patients who were not living with HIV and were prescribed statin therapy. RESULTS: 81 patients meeting study criteria in the PLWH cohort were matched to 81 non-HIV patients. The proportion of patients prescribed statins was 33.0% and 30.9% in the PLWH and non-HIV cohorts, respectively (p = 0.74).Conclusion and relevance: This study evaluated statin prescribing in PLWH for primary prevention of ASCVD as described in the 2018 AHA/ACC/Multisociety guideline. Rates of statin prescribing were similar, yet overall low, among intermediate-risk primary prevention PLWH compared to those not diagnosed with HIV.
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OBJECTIVE: To review the possible association between glucagon-like peptide-1 (GLP-1) agonist use and pancreatitis in patients with type 2 diabetes mellitus. DATA SOURCES: A MEDLINE search (1950-January 2010) identified key clinical trials delineating adverse effects associated with GLP-1 agonist use. Key search terms included type 2 diabetes mellitus, pancreatitis, incretins, exenatide, liraglutide, albiglutide, and taspoglutide. Review of references listed in the articles identified was also performed. The Food and Drug Administration (FDA) Web site and Amylin Pharmaceuticals file data were utilized to extract case report information and unpublished clinical development data related to GLP-1 agonist use and pancreatitis. STUDY SELECTION AND DATA EXTRACTION: Phase 2 and 3 clinical trials evaluating exenatide, liraglutide, albiglutide, and taspoglutide that discussed treatmentrelated adverse effects as well as FDA-reviewed case reports of pancreatitis in patients taking these same therapies were included. One study evaluating type 2 diabetes as a risk factor for development of acute pancreatitis was also included. Exenatide case reports and clinical development data were also included. DATA SYNTHESIS: Currently there have been 8 cases during clinical development and 36 postmarketing reports of acute pancreatitis in exenatide-treated patients. Four patients have developed acute (n = 3) or chronic (1) pancreatitis during liraglutide clinical trials. There have been no reports to date of development of acute pancreatitis in patients taking albiglutide or taspoglutide. CONCLUSIONS: Observational reports and clinical trial data suggest an association between GLP-1 agonist use and acute pancreatitis; however, additional clinical trial data and in-depth case report analysis are needed to further evaluate and verify this finding.
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Péptido 1 Similar al Glucagón/agonistas , Hipoglucemiantes/efectos adversos , Pancreatitis/inducido químicamente , Enfermedad Aguda , Ensayos Clínicos como Asunto , Diabetes Mellitus Tipo 2/complicaciones , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Diabetes Mellitus Tipo 2/metabolismo , Humanos , Hipoglucemiantes/farmacología , Hipoglucemiantes/uso terapéutico , Pancreatitis/complicacionesRESUMEN
More than 422 million people worldwide have diabetes, with 90-95% having type 2 diabetes (T2D). Glycemic control of T2D has demonstrated reductions in microvascular complications but recent data have demonstrated improvements in macrovascular outcomes with sodium-glucose cotransporter 2 (SGLT2) inhibitors. Ertugliflozin is the most recent SGLT2 inhibitor approved in the USA and Europe for the treatment of T2D. This narrative review aims to present and discuss the efficacy, safety, cardiovascular (CV), and renal outcomes related to the use of ertugliflozin in T2D. Ertugliflozin has been evaluated in eight clinical trials (n=5248) with a focus on glycemic control. These trials have demonstrated improvement in glycosylated hemoglobin (0.6-1%), fasting plasma glucose (30-50 mg/dL), 2-hour postprandial glucose (60-70 mg/dL), decreased body weight (2-3 kg), and lowering of blood pressure (3-5 mmHg) in patients with T2D when ertugliflozin is used as monotherapy or in addition to metformin, sitagliptin, insulin, and/or sulfonylureas. The findings from the VERTIS-CV trial (n=8246) were recently published and demonstrated that ertugliflozin use in patients with T2D and atherosclerotic CV disease is safe but did not demonstrate superiority in the lowering of major CV events compared to placebo. Other SGLT2 inhibitors, such as empagliflozin and canagliflozin, have demonstrated this benefit. The VERTIS-CV trial demonstrated that the use of ertugliflozin led to a decrease in the number of hospitalizations for heart failure and this lends further support that this benefit is a class effect of SGLT2 inhibitors.