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AIMS: This study aimed to describe baseline characteristics and adherence among patients with transthyretin amyloid cardiomyopathy (ATTR-CM) treated with tafamidis (VYNDAQEL®) in Japan using the Japanese Medical Data Vision (MDV) database. METHODS AND RESULTS: This study was a non-interventional, retrospective cohort study of adult (≥18 years old) patients in the Japanese MDV claims database diagnosed with ATTR-CM and with at least two tafamidis prescriptions of dose strength 4 × 20 mg/day between 1 March 2019 and 31 August 2021. The date of the first prescription was defined as the index date, with follow-up time defined as the time between the first and last prescription plus the days' supply from the last refill. Baseline characteristics were assessed during a 12 month pre-index period. Adherence was measured using two metrics: (i) the modified medication possession ratio (mMPR), calculated by taking the sum of days supplied for all fills within the follow-up period, divided by the number of days of follow-up, and reported as a percentage, with patients classified as adherent with an mMPR of ≥80%, and (ii) the proportion of days covered (PDC), calculated by taking the total number of days' supply dispensed during the follow-up period divided by the number of days of follow-up, adjusting for any days' supply overlap. A total of 210 patients were identified; the mean (standard deviation) age of the cohort was 77 (5.9) years, and the majority (89%) were male. The most common baseline cardiovascular comorbidities were heart failure (85%), ischaemic heart disease (66%), hypertensive diseases (49%), and diabetes (35%); 75% of patients received heart failure medications in the 12 months prior to index, with the most common being beta-blockers (49%), diuretics (48%), angiotensin receptor blockers (30%), angiotensin-converting enzyme inhibitors (22%), and sodium-glucose cotransporter-2 inhibitors (8.1%). Over an average 14 month follow-up, mean mMPR was 96% with a median of 100% [inter-quartile range (IQR): 97-101%]; 93% of patients were adherent (defined as an mMPR ≥ 80%). In the same follow-up period, mean PDC was 93.6% with a median of 99% (IQR: 93-100%). Persistence was high with 78% of patients having a 0 day gap between prescription refills. CONCLUSIONS: This study found high adherence rates to tafamidis in this real-world Japanese patient population. Adherence rates in this study were similar to those reported by the tafamidis clinical trial and a previously published US commercial claims adherence analysis. Further studies should be conducted to assess the impact of real-world adherence on real-world outcomes.
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Brentuximab vedotin (BV) monotherapy (BV-M) and combination (BV-C) therapies are safe and effective for classical Hodgkin lymphoma (cHL) and CD30-expressing peripheral T-cell lymphomas (PTCLs). Although the sample sizes have been small (12-29 patients), in clinical studies, response rates of 53-88% have been reported for BV retreatment in patients with an initial BV response. We evaluated the real-world characteristics and treatment patterns of cHL/PTCL patients who received BV and were retreated in the United States. Symphony Health Patient Claims (11/2013-1/2022) were retrospectively analyzed to identify cHL/PTCL patients treated with BV and retreated with BV-M, BV-C, or non-BV therapy. Patient characteristics were described by retreatment, and predictors of BV-M retreatment were identified. Among the cHL and PTCL patients treated with BV (n = 6442 and 2472, respectively), 13% and 12%, respectively, were retreated with BV; the median times from initial BV to BV-M retreatment were 5 and 7 months, respectively; and the numbers of BV-M retreatment doses were 4 and 5, respectively. Among cHL patients, the predictors of BV-M retreatment were age (18-39 vs. ≥60 years), sex (women vs. men), and previous stem cell transplantation (yes vs. no). Among PTCL patients, the only predictor of BV-M retreatment was systemic anaplastic large-cell lymphoma subtype (yes vs. no). Real-world data support clinical study results suggesting earlier BV treatment be considered, as BV retreatment may be an option.
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Brentuximab Vedotina , Enfermedad de Hodgkin , Linfoma de Células T Periférico , Humanos , Brentuximab Vedotina/uso terapéutico , Enfermedad de Hodgkin/tratamiento farmacológico , Linfoma de Células T Periférico/tratamiento farmacológico , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Adulto , Estados Unidos , Adulto Joven , Anciano , Retratamiento , Adolescente , Antineoplásicos Inmunológicos/uso terapéuticoRESUMEN
OBJECTIVE: To describe adherence to daily somatropin treatment and impact on height velocity within 1 year of treatment start among patients with pediatric growth hormone deficiency in a real-world US population. METHODS: This retrospective cohort study included pediatric patients aged ≥3 years to <16 years with pediatric growth hormone deficiency prescribed somatropin by a pediatric endocrinologist at a US-based center of excellence between January 1, 2015 and December 31, 2020. Patient data were collected using hospital electronic health records linked to a specialty pharmacy patient prescription records. Adherence, evaluated over 12 months, was measured using the proportion of days covered metric and patients were categorized as adherent if their proportion of days covered ≥80%. Height velocity was annualized to compare across adherent and nonadherent patients. RESULTS: One hundred eighty-one patients were identified and included in this study, of which 70.2% were male,73.5% were white, and mean age (standard deviation [SD]) at index was 12.1 (2.8). In the height velocity analysis, 174 patients were included and the mean (SD) annualized change in height was 10.2 (5.7) cm/y in the adherent group (n = 108) and 9.8 (7.6) in the nonadherent group (n = 66). The difference in height velocity between the groups was not statistically significant. CONCLUSIONS: Minor improvements in average height velocity were observed in the patient group who were adherent to somatropin therapy, although not statistically significant. Lack of observed significance may be due to small sample sizes, short observation period, a likely heterogenous population in terms of growth hormone prescribing, data bias due to single-center origin, or potential patient misclassification.
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The primary purpose of political, civil, socioeconomic, and cultural rights is to protect the dignity of all human beings. Good mental health and well-being is defined by the "social, psychosocial, economic, and physical environment that enables individuals and populations to live a life of dignity, with full enjoyment of their rights and in the equitable pursuit of their potential."1 Stigmatization, discrimination, and negative stereotypes are barriers to mental health and well-being.2 Individuals with mental health problems, including those with drug dependence, suffer stigmatization, which is a direct affront to dignity and may have enduring health impacts. This paper discusses the implications of stigma for a human-rights based approach to improving mental health among those with drug dependence, with a focus on the opioid epidemic now ravaging the United States. It explores the public health burden of stigma related to substance misuse, including stigma in the context of treatment and health care. It also discusses the role of policy initiatives-including decriminalization-in addressing stigma related to substance misuse.
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Derechos Humanos , Salud Pública , Estigma Social , Trastornos Relacionados con Sustancias/psicología , Humanos , Respeto , Trastornos Relacionados con Sustancias/rehabilitación , Estados UnidosRESUMEN
OBJECTIVES: With increasing use and cost of oral oncology medications, patient non-adherence with oral therapy is of concern. This study evaluated non-adherence among patients receiving first-line oral therapy for hepatocellular carcinoma (HCC). METHODS: This retrospective study used the employer-based MarketScan medical and pharmacy claims database (2005-2011) to identify adult patients with two or more diagnoses of HCC (ICD-9 155), and two or more filled prescriptions for sorafenib. Additional eligibility requirements were not having other previous cancers and a 4 month wash-out period prior to the index sorafenib date. Adherence was assessed using a modified proportion of days covered (PDC) measure with patient-specific sorafenib exposure from index date to treatment discontinuation. Non-adherence was categorized as PDC <85% (base case), with sensitivity analyses using an 80% cut-off and allowance for physician-directed therapy gaps. Logistic regression models were estimated to identify predictors of non-adherence. RESULTS: A total of 1127 patients (median age = 61.0 years; 78.4% male) met eligibility criteria. Median duration of enrollment was 223 days and median sorafenib exposure was 121 days. Between 21.1% (PDC < 0.80) and 28.0% (PDC < 0.85) of patients were non-adherent. Higher age (p = 0.022), number of baseline medications (p = 0.003) and number of baseline comorbidities (p = 0.002) were associated with lower non-adherence, while prior procedures were associated with greater non-adherence (p = 0.002). LIMITATIONS: In this study using billing claims data, we were unable to evaluate patient severity in terms of clinical characteristics such as the Child-Pugh score. Similarly, we could not assess clinical outcomes such as tumor response, radiological progression or overall survival, although median duration of sorafenib exposure and duration of health plan enrollment respectively were found to be good proxies. CONCLUSIONS: Using a modified PDC approach, 22-29% of patients were non-adherent. Identified predictors of non-adherence in HCC should be assessed for newly emerging oral therapies, and may be used to guide patient education and other adherence-enhancing initiatives.
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Antineoplásicos/administración & dosificación , Carcinoma Hepatocelular/tratamiento farmacológico , Bases de Datos Factuales , Revisión de Utilización de Seguros , Neoplasias Hepáticas/tratamiento farmacológico , Cumplimiento de la Medicación , Niacinamida/análogos & derivados , Compuestos de Fenilurea/administración & dosificación , Administración Oral , Adolescente , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Niacinamida/administración & dosificación , Estudios Retrospectivos , Factores Sexuales , SorafenibRESUMEN
OBJECTIVE: Since many patients with COPD in the US are managed by primary care physicians, we evaluated adherence to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines in a primary care setting. METHODS: A cross-sectional study was conducted using a random sample of patients (n=50-150 per site) aged 40-89 years with diagnosed COPD. Patients were identified for study inclusion (N=1517) from 11 US primary care sites. Demographic and clinical information was extracted from primary care medical records via retrospective chart review. The main outcome measures were adherence to GOLD primary care guidelines, assessed via three components as follows: 1. Is there a current diagnostic spirometry test measurement available within the patient's medical record during the prior calendar year? 2. Are comorbid conditions, if present, being treated appropriately? 3. Are adequate risk reduction measures being taken? RESULTS: Mean patient age was 67.2 (SD±11.3) years, 54% were female, and 34% were current smokers. Overall, 19% of patients had comorbid asthma, 66% hypertension, 61% dyslipidemia, 30% cardiovascular disease, and 28% diabetes. Mean duration of COPD was approximately 4.8 years. Only 27% of patients had a spirometry test result documented within the past year. More than half (52%) of patients did not have a documented COPD stage; 20% were classified as stage I, 13% stage II, 12% stage III, 3% stage IV. About 63% of patients met at least one guideline component, while only 3% of patients met all components; 27% met diagnostic, 25% comorbid conditions management, and 32% met risk reduction criteria. LIMITATIONS: The retrospective design of our study did not allow evaluation of some possible covariates or causal assessment, and spirometry measurements were unavailable for many patients. CONCLUSIONS: Results suggest that treatment per COPD primary care guidelines was not consistently applied among participating practices (range 0.0%-8.7% for meeting all three components). Educational initiatives may increase primary care providers' knowledge of and adherence to COPD treatment guidelines and recommended patient management strategies.
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Pautas de la Práctica en Medicina , Atención Primaria de Salud , Enfermedad Pulmonar Obstructiva Crónica/terapia , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Enfermedad Pulmonar Obstructiva Crónica/fisiopatologíaRESUMEN
BACKGROUND: Fragmentation within health care systems may negatively impact the quality of chronic disease patient care. We sought to evaluate the relationship between care management processes (CMP), integration of services, and blood pressure (BP) control among diabetic patients. METHODS: Retrospective chart reviews were performed for a random sample of adult diabetic hypertensive patients (n = 2,162) from 28 physician organizations in the United States (US). A modified version of the Physician Practice Connection Readiness Survey (PPC-RS) was completed by the chief medical officer at each site. The PPC-RS measured health system organization, delivery system redesign, decision support, clinical information systems, and self-management support, and an integration scale measured structure, functions, and financial risk. Correlations between PPC and integration scores and BP outcomes were assessed using Spearman correlation coefficients. RESULTS: Approximately 39.9% of diabetic patients had controlled BP. Mean total PPC score across sites was 55, with highest mean scores for health system organization (81), followed by design support (60), clinical information systems (57), self-management support (39), and delivery system redesign (39). Mean integration score was 46 (SD 27, range 4-93), and means of subscores were 64 for structure, 33 for financial risk, and 42 for function. Clinical information systems subscore was correlated with uncontrolled BP (r = -0.38, p < 0.05), while association with total PPC score was strong but not significant at p < 0.05 (r = -0.32). Total integration score and the structure subscore were significantly correlated with BP control (r = 0.38, p < 0.05, and r = 0.49, p < 0.01). CONCLUSIONS: This study suggests that CMP and service integration may be associated with better outcomes in diabetes, though results were mixed and limited by a small number of participating sites. Primary care implementation of integrated electronic medical records may have a beneficial effect on patient outcomes for diabetes and other chronic diseases.
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Presión Sanguínea , Manejo de Caso/organización & administración , Prestación Integrada de Atención de Salud/organización & administración , Complicaciones de la Diabetes/prevención & control , Hipertensión/prevención & control , Evaluación de Procesos y Resultados en Atención de Salud , Anciano , Estudios Transversales , Técnicas de Apoyo para la Decisión , Complicaciones de la Diabetes/complicaciones , Complicaciones de la Diabetes/fisiopatología , Registros Electrónicos de Salud , Femenino , Humanos , Hipertensión/complicaciones , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Análisis Multivariante , Estudios Retrospectivos , Autocuidado , Estadísticas no Paramétricas , Estados UnidosRESUMEN
Care management processes (CMP) may be implemented in health systems to improve chronic disease quality of care. The objective of this study was to assess the relationship between the presence of hypertension-specific CMP and blood pressure (BP) control among hypertensive patients within selected physician organizations in the USA-modified version of the Physician Practice Connection Readiness Survey (PPC-RS), developed by The National Committee for Quality Assurance (NCQA), was administered to chief medical officers at 28 US-based physician organizations in 2010. Hypertension-specific survey items were added to the PPC-RS and focused on medication fill compliance, chronic disease management, and patient self-management. Demographic and clinical cross-sectional data from a random sample of 300 hypertensive patients age 18 years or older were collected at each site. Physician site and patient characteristics were reported. Regression models were used to assess the relationship between hypertension-specific physician practices and patient BP control. Eligible patients had at least a 1-year history of care with the physician organization and had an encounter within the past year of data collection. Of the 28 participating sites, most had electronic medical records that handle total functionality (71.4%) and had more than 50 staff members (78.6%). Across all sites, approximately 61% of patients had controlled BP. Regression analyses found that practices that used physician education as an effort to improve medication fill compliance demonstrated improvement in BP control (changes in systolic BP: beta coefficient = -1.366, P = .034; changes in diastolic BP: beta coefficient = -0.859, P = .056). The use of a systematic process to screen or assess patients for hypertension as a risk factor was also found to be associated with improvements in BP control (changes in diastolic BP: beta coefficient = -0.860, P = .006). In addition, physician practices that maintained a list of hypertensive patients along with the patients' associated clinical data demonstrated better BP control (currently controlled BP: beta coefficient = 0.282, P = .034; currently uncontrolled BP: beta coefficient = -0.292, P = .023). However, use of the following practices had a negative correlation with BP control: case management (changes in systolic BP: beta coefficient 1.649, P = .022; changes in diastolic BP: beta coefficient = 0.910, P = .078), follow-up for missed appointments (changes in systolic BP: beta coefficient = 0.937, P = .041; changes in diastolic BP: beta coefficient = 0.165, P = .627), adopted written evidence-based standards of care to treat hypertension (changes in systolic BP: beta coefficient = 0.985, P = .032; changes in diastolic BP: beta coefficient = 0.346, P = .305), and checklists for tests and interventions (changes in systolic BP: beta coefficient = 1.586, P = .004; changes in diastolic BP: beta coefficient = 0.938, P = .019). Findings from this multisite study provide evidence that the presence of some hypertension-specific CMP in physician organizations may be associated with better BP outcomes among hypertensive patients. In particular, patients may benefit from physician efforts to improve medication fill compliance as well as organizational monitoring of hypertensive patients and their clinical data. Further research is warranted to better assess the relationship between CMP and treatment of chronic diseases such as hypertension over time.
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Manejo de Caso/organización & administración , Manejo de la Enfermedad , Hipertensión/tratamiento farmacológico , Evaluación de Procesos y Resultados en Atención de Salud , Pautas de la Práctica en Medicina/organización & administración , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Estudios Transversales , Femenino , Humanos , Hipertensión/prevención & control , Masculino , Cumplimiento de la Medicación/estadística & datos numéricos , Persona de Mediana Edad , Evaluación de Procesos y Resultados en Atención de Salud/organización & administración , Pautas de la Práctica en Medicina/estadística & datos numéricos , Estados Unidos , Adulto JovenRESUMEN
OBJECTIVE: To assess blood pressure (BP) control among patients with hypertension managed by nurse practitioners (NPs) vs physicians. STUDY DESIGN: Cross-sectional study. METHODS: Retrospective medical record reviews were conducted at 3 independent NP-based practices and at 21 physician-based practices. Investigators at each practice identified a sample of patients 18 years or older with a hypertension diagnosis. The primary outcome was controlled BP (<140/90 mm Hg for patients without diabetes mellitus and <130/80 mm Hg for patients with diabetes mellitus). Propensity score matching was used to minimize potential selection bias between NP-treated and physician-treated patients and to balance differences in patient characteristics. Logistic regression analysis was performed to estimate the odds of controlled BP for NP-treated vs physician-treated patients, adjusting for covariates. RESULTS: The NP-treated sample was composed of 684 patients; their mean age was 54.2 years, 62.6% were female, 59.7% were obese, and 19.2% had diabetes mellitus. Before propensity score matching, physician-treated patients were older, less likely to be female, and more likely to have diabetes. The propensity score-matched cohort (n = 623 in each group) had similar baseline characteristics. Among the NP cohort, 70.5% had controlled BP compared with 63.2% among the physician cohort; the mean number of antihypertensive medications was lower among NP-treated patients (1.6 vs 1.8, P = .01). The adjusted odds of controlled BP were slightly lower for physician-treated patients (odds ratio, 0.76; 95% confidence interval, 0.58-0.99). CONCLUSIONS: Comparable controlled BP rates were observed among patients with hypertension receiving care from an NP vs a comparison group receiving care from a physician; the groups had similar baseline characteristics. Our findings support the increasingly important role of NPs in primary care.
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Hipertensión/tratamiento farmacológico , Enfermeras Practicantes , Presión Sanguínea , Estudios Transversales , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/enfermería , Modelos Logísticos , Masculino , Persona de Mediana Edad , Médicos de Atención Primaria , Atención Primaria de Salud/métodos , Puntaje de Propensión , Estudios RetrospectivosRESUMEN
Chart reviews were conducted at 28 US physician practices to evaluate blood pressure (BP) management. The cross-sectional study included 8250 adult patients diagnosed with hypertension. The primary outcome variable was BP control (BP <140/90 mm Hg for nondiabetic and <130/80 mm Hg for diabetic patients). Mean body mass index was 30.9 kg/m(2), 49% were obese, 54% were women, mean age was 64.9 years, and 25% had diabetes. Mean BP was 132.2/77.8 mm Hg, and 55.8% of study participants had controlled BP. Patients with uncontrolled BP were more likely to be obese or African American, and more than twice as likely to have diabetes. Almost 1 in 5 nondiabetic patients (18%), and 38% of diabetic patients, were above goal BP by >10 mm Hg systolic or >5 mm Hg diastolic; among these patients, 36% used 0 or 1 antihypertensive medication, and 32% used 2 medications. Opportunity exists to improve BP control in this population.
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Antihipertensivos/uso terapéutico , Presión Sanguínea/fisiología , Hipertensión/tratamiento farmacológico , Hipertensión/fisiopatología , Pautas de la Práctica en Medicina , Factores de Edad , Anciano , Estudios Transversales , Complicaciones de la Diabetes/complicaciones , Complicaciones de la Diabetes/fisiopatología , Quimioterapia Combinada , Femenino , Humanos , Hipertensión/etnología , Masculino , Persona de Mediana Edad , Obesidad/complicaciones , Obesidad/fisiopatología , Grupos Raciales/etnología , Estudios Retrospectivos , Resultado del Tratamiento , Estados UnidosRESUMEN
The impact of a hypertension awareness and educational program, BP DownShift, was evaluated among school bus drivers in a southern US state. At baseline (August 2007), blood pressure (BP) measurements, self-reported demographics, and hypertension awareness and management practices were collected from drivers who consented to participate in the study. Interventions included 4 educational mailings, installation of BP machines at all bus terminals, and access to free dietitian consultations and gym memberships. BP was evaluated using Department of Transportation guidelines. BP was remeasured and a survey was administered at follow-up (May 2008). At baseline, 208 drivers consented to the BP screening; 120 (58%) returned for a follow-up assessment. Most participants completing the study were female (73%) and African American (72%). Mean age was 50 years and mean body mass index was 32 kg/m(2); 52% of participants were obese. In all, 58% of participants reported a prior diagnosis of hypertension by a physician, and 63% reported taking antihypertensive medication. Both systolic and diastolic BP (SBP and DBP) were lower at follow-up (135/82 mmHg vs. 145/87 mmHg at baseline; P < 0.001, both comparisons); 42% had a reduction in SBP > 10 mmHg, and 44% had a reduction in DBP > 5 mmHg. At follow-up, 58% were controlled to BP < 140/90, compared to 38% at baseline (P < 0.001). At follow-up, an increased proportion of previously diagnosed drivers reported home BP monitoring, healthy diet, and regular exercise as components of hypertension self-management. The implementation of our hypertension education, self-management, and awareness program was associated with an improvement in BP control, which may positively impact commercial driver's license recertification as well as improve employee health.
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Presión Sanguínea/efectos de los fármacos , Empleo , Hipertensión/tratamiento farmacológico , Transportes , Adulto , Femenino , Promoción de la Salud/métodos , Encuestas Epidemiológicas , Humanos , Masculino , Persona de Mediana Edad , Autocuidado , Estados UnidosRESUMEN
OBJECTIVE: This cross-sectional study sought to determine the prevalence of cardiometabolic risk factor clusters (CMRFCs) and their effect on BP control among hypertensive patients from 28 US physician practices. METHODS: Each participating practice identified a random sample of 150-300 adults aged >or= 18 years diagnosed with hypertension. The primary outcome variable was BP control (BP < 140/90 mmHg for non-diabetic and <130/80 mmHg for diabetic patients). CMRFCs included hypertension in addition to obesity, dyslipidemia, and diabetes. RESULTS: Overall, 6,527 hypertensive patients were identified for study inclusion. More than half (54.3%) were female, and mean age was 64.7 years. Almost half (48.7%) were obese (BMI >or= 30 kg/m2). About 1 in every 4 patients (25.3%) had diabetes, and 60.7% had dyslipidemia. Mean blood pressure was 132.5/77.9 mmHg, and 55.0% of all patients had controlled BP; 62.4% of non-diabetic patients, and 33.3% of diabetic hypertensive patients, had BP controlled to recommended levels. Most (81.7%) hypertensive patients had >or= 1 cardiometabolic risk factor, and 12.2% had all 3 risk factors. As compared to hypertensive patients without additional risk factors, adjusted odds ratios for BP control were significantly lower for all combinations of CMRFCs (ORs 0.15-0.83, all p < 0.04), with the exception of patients who had only dyslipidemia in addition to hypertension (OR = 1.09, p = NS). Prescriber adherence to recommended hypertension treatment guidelines for patients with diabetes, heart failure, or prior myocardial infarction was high. Although patients with risk factors were prescribed more antihypertensive medications than those without, hypertensive patients with all 3 risk factors were prescribed a mean of 2.4 antihypertensive medications compared to 1.7 for those with no risk factors; odds of BP control in these patients, however, was 0.23 [95% CI 0.19-0.29] that of patients with no other CMRFCs. CONCLUSIONS: Across 28 US practices, only 18% of hypertensive patients did not have any additional cardiometabolic risk factors. The high prevalence of CMRFCs presents a challenge to effective hypertension management.
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Presión Sanguínea/fisiología , Diabetes Mellitus/fisiopatología , Cardiopatías/epidemiología , Hipertensión/tratamiento farmacológico , Enfermedades Metabólicas/epidemiología , Médicos , Adulto , Anciano , Índice de Masa Corporal , Estudios Transversales , Complicaciones de la Diabetes/epidemiología , Etnicidad , Femenino , Homeostasis , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Grupos Raciales , Factores de Riesgo , Estados Unidos/epidemiología , Adulto JovenRESUMEN
OBJECTIVE: To assess the impact of African American race on hypertension management among a real-world hypertensive population. DESIGN: Cross-sectional study. SETTING: 28 US physician practices. PATIENTS: Adult patients with a hypertension diagnosis between November 2006 and September 2008. MAIN OUTCOME MEASURES: Blood pressure (BP) control (< 140/90 mm Hg for non-diabetic, and < 130/80 mm Hg for diabetic, patients). RESULTS: African American patients (n = 1,079) were younger than Caucasian patients (n = 3,884) (60.2 vs 66.0 years, P < .01), were more likely to be female (60.1% vs 52.5%, P < .01), were more likely to be obese (55.9% vs 48.5%, P < .01) and had a higher diabetes prevalence (29.4% vs 23.8%, P < .01). African American hypertensive patients had significantly higher BP as compared to Caucasian hypertensive patients (135.2/82.9 mm Hg vs 130.5/76.4 mm Hg, P < .01). Both diabetic and non-diabetic African Americans were prescribed more antihypertensive medications than Caucasians and were more likely to be prescribed combination regimens. African Americans were less likely to be prescribed beta blockers, and more likely to be prescribed calcium channel blockers or diuretics. Among non-diabetic and diabetic patients, African Americans had 54% and 53% lower adjusted odds, respectively, of controlled BP. The use of specific antihypertensive medication classes was not associated with BP control. CONCLUSIONS: Although African Americans were prescribed more aggressive medication regimens, they had lower probability of BP control. While African American race influenced the choice of prescribed antihypertensive medications, those regimens did not affect the probability of BP control. African American race should not deter providers from prescribing specific antihypertensive medication classes, particularly in the presence of compelling indications.
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Hipertensión/etnología , Hipertensión/terapia , Adolescente , Adulto , Anciano , Antihipertensivos/uso terapéutico , Diabetes Mellitus/etnología , Diabetes Mellitus/terapia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Obesidad/etnología , Pautas de la Práctica en Medicina/estadística & datos numéricos , Adulto JovenRESUMEN
Blood pressure (BP) control is a key component of diabetes management. BP control in patients with diabetes was assessed across 4 Colorado health plans. BP was obtained through retrospective chart reviews, and BP control was defined as <130/80 mm Hg. The study included 1,445 diabetic patients in 2004 and 1,423 diabetic patients in 2005. BP control did not improve significantly from 2004 to 2005; in 2004, 33.1% had controlled BP, compared with 35.2% in 2005. Women were more likely to have controlled BP than men, and younger patients were more likely to have controlled BP than older patients. Two of the 4 plans showed significant improvement in BP control, whereas the proportion of patients with BP controlled declined in 2 health plans. More aggressive disease management and pharmacologic treatment of blood pressure is needed to improve the cardiovascular health of patients with diabetes.
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Presión Sanguínea , Diabetes Mellitus/terapia , Programas Controlados de Atención en Salud/organización & administración , Calidad de la Atención de Salud/organización & administración , Adolescente , Adulto , Factores de Edad , Anciano , Antihipertensivos/uso terapéutico , Femenino , Hemoglobina Glucada/análisis , Humanos , Lípidos/sangre , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores SexualesRESUMEN
The role of clinical inertia in the treatment of patients with hypertension was assessed by evaluating health care providers' knowledge, attitudes, and clinical practices regarding hypertension management. A cross-sectional survey was conducted at the Forsyth Medical Group in North Carolina. Participants were physicians (N = 18, 10 sites) and support staff (N = 20, 12 sites), who were surveyed in 2006. Physician and support staff questionnaires consisted of 29 and 15 items, respectively, and were administered by trained interviewers. Though most physicians (94%) cited familiarity with the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC-7) guidelines and affirmed that hypertension management guidelines are relevant to their patients, no physicians interviewed routinely document patient hypertension management plans. Although 1 in 3 physicians cited the inability to devote enough time to patients for the discussion of hypertension management, physicians predominantly cited patient- and support-staff- related factors as most important to patients not attaining blood pressure (BP) goal. Patient lifestyle modification (89%), education (67%), and medication compliance (56%) were cited as the most important reasons for uncontrolled BP. Only one-third of physicians believe that clinical staff always obtain accurate BP measurements, and 61% believe that resistant hypertension is a reflection of inaccurate BP measurement. Many support staff claimed to be rushed when measuring patient BP, and 65% recommended BP competency training. Contradictions were evident between provider knowledge of hypertension management standards and how this knowledge is applied in clinical practice. Standardized collection of BP is critical to measuring clinical improvement in hypertension. Results are being utilized to develop clinical improvement initiatives including staff education and competency training.
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Accesibilidad a los Servicios de Salud/economía , Necesidades y Demandas de Servicios de Salud/economía , Hipertensión/prevención & control , Calidad de la Atención de Salud , Actitud del Personal de Salud , Estudios Transversales , Encuestas de Atención de la Salud , Conocimientos, Actitudes y Práctica en Salud , Humanos , North Carolina , Cooperación del Paciente , Investigación Cualitativa , Encuestas y CuestionariosRESUMEN
OBJECTIVE: To assess glycemic control and secondary failure in patients adding thiazolidinedione or sulfonylurea therapy to a metformin regimen in a managed care setting. STUDY DESIGN: Retrospective cohort study using administrative claims data. METHODS: Participants (mean age, 51.1 years; 55.4% female) were required to have at least 1 prescription claim for a sulfonylurea (n = 300) or a thiazolidinedione (n = 279) between January 1, 2001, and March 31, 2004, as well as metformin use during the prior 6 months and continued metformin use. Secondary failure was measured for patients who initially achieved a glycosylated hemoglobin (A1C) level of less than 7.0% and was defined as a subsequent A1C level of at least 7.0%. RESULTS: The mean baseline A1C level was 8.2% and was higher for the patients receiving a combination of metformin and sulfonylurea (A1C level, 8.4%) compared with patients receiving a combination of metformin and thiazolidinedione (A1C level, 8.0%) (P < .05). Overall, 77.7% of patients had a baseline A1C level of at least 7.0%. The mean A1C level decreased by 1.2 (to 7.0%), and 65.1% of patients with a baseline A1C level of at least 7.0% reached goal A1C level. Therapy intensification via addition of another antihyperglycemic agent occurred in 60.7% of study patients. Approximately 2 in 5 patients (41.5%) who initially achieved goal A1C level experienced secondary failure; the mean time to failure was 1.3 years. CONCLUSION: Although most patients failing metformin monotherapy reached goal A1C level after addition of a sulfonylurea or a thiazolidinedione, 41.5% of patients observed for up to 4 years who initially attained goal A1C level experienced secondary failure.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/administración & dosificación , Metformina/administración & dosificación , Compuestos de Sulfonilurea/administración & dosificación , Tiazolidinedionas/administración & dosificación , Anciano , Glucemia/análisis , Estudios de Cohortes , Diabetes Mellitus Tipo 2/epidemiología , Manejo de la Enfermedad , Quimioterapia Combinada , Femenino , Hemoglobina Glucada/análisis , Hemoglobina Glucada/efectos de los fármacos , Humanos , Hipoglucemiantes/uso terapéutico , Revisión de Utilización de Seguros/estadística & datos numéricos , Masculino , Programas Controlados de Atención en Salud , Metformina/uso terapéutico , Persona de Mediana Edad , Estudios Retrospectivos , Compuestos de Sulfonilurea/uso terapéutico , Tiazolidinedionas/uso terapéutico , Insuficiencia del Tratamiento , Estados Unidos/epidemiologíaRESUMEN
STUDY OBJECTIVES: To examine glycosylated hemoglobin (A1C) values longitudinally in patients who newly started metformin, sulfonylurea, or thiazolidinedione monotherapy; in a subset of patients whose A1C values were 7% or greater before starting therapy (baseline) and who achieved A1C goal (A1C < 7%) during therapy, rates of secondary failure (i.e., A1C value returned to > or = 7% during therapy) were compared for each drug. DESIGN: Four-year retrospective analysis. DATA SOURCE: Administrative database from a large health care plan. PATIENTS: Patients who filled at least one prescription for metformin (5453 patients), sulfonylurea (2373), and thiazolidinedione (1590) therapy, respectively, between January 1, 2001, and March 31, 2004, were enrolled. MEASUREMENTS AND MAIN RESULTS: Patients' demographic and clinical characteristics, baseline A1C values, changes in A1C values (last available result during follow-up minus baseline value), and A1C values before and after the addition of an antidiabetic drug other than the index drug (therapy intensification) were documented. Mean age was 50.7 years; 5027 (53.4%) were men. Mean baseline A1C value was 8.4%, and about 70% of patients had an AIC value of 7% or greater before starting therapy. Mean follow-up was 1.9 years, and mean decrease in A1C values was 1.47% (to 6.91%). The probabilities of attaining A1C goals were similar for patients receiving metformin, sulfonylurea, or thiazolidinedione therapy. The rate of therapy intensification among patients taking metformin (24.7%) was lower than that of patients taking a sulfonylurea (30.1%, p<0.001) but similar to that of those taking a thiazolidinedione (24.6%). Secondary failure occurred in 36.3% of patients; mean time from the start of therapy to its failure was about 1.51 years. Patients receiving a sulfonylurea were 1.25 (95% confidence interval [CI] 1.05-1.50) times more likely than patients receiving metformin to experience secondary failure, whereas failure rates were similar for thiazolidinediones and metformin (odds ratio 0.78, 95% CI 0.62-0.99). CONCLUSION: In the subset of patients assessed for secondary failure, although treatment initially reduced A1C values, more than one third experienced failure. Real-world studies of A1C goal attainment must follow patients on a long-term basis to assess the maintenance of glycemic control over time.
Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hemoglobina Glucada/metabolismo , Hipoglucemiantes/uso terapéutico , Metformina/uso terapéutico , Compuestos de Sulfonilurea/uso terapéutico , Tiazolidinedionas/uso terapéutico , Administración Oral , Adulto , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Insuficiencia del TratamientoRESUMEN
STUDY OBJECTIVE: To determine the rates of concomitant use of drugs known to interact with warfarin by increasing the prothrombin time expressed as the international normalized ratio (INR), decreasing the INR, or increasing bleeding risk without apparent changes in INR in a cohort of patients receiving long-term warfarin therapy. DESIGN: Retrospective, longitudinal cohort study. SETTING: Large pharmacy benefits manager database. PATIENTS: A total of 134,833 patients who were prescribed long-term warfarin from June 1, 1999-May 31, 2000. MEASUREMENTS AND MAIN RESULTS: Longitudinal pharmacy claims from the pharmacy benefits manager database were reviewed to identify coprescription of warfarin and drugs associated with significant interactions with warfarin. Of the 134,833 patients receiving long-term warfarin therapy, 109,998 (81.6%) were prescribed a concurrent prescription for at least one potentially interacting drug, including 87,346 (64.8%) who were prescribed one or more concomitant drugs associated with interactions known to increase the INR. Acetaminophen-containing products, prescribed for 22.7% of patients receiving concomitant prescriptions, and thyroid hormones, prescribed for 17.5%, were the most commonly prescribed concurrent drugs associated with an increased INR response. The most frequently prescribed interacting agents associated with a decreased INR response were trazodone (2.2%) and carbamazepine (1.1%). The most commonly prescribed agents independently associated with increased bleeding risk were cyclooxygenase-2 inhibitors. CONCLUSION: Many patients receiving warfarin therapy are treated with concomitant drugs that may interact with the warfarin. The high percentage of patients taking drugs that may increase INR or bleeding risk is a reminder that bleeding events are a likely adverse outcome of combining drugs that interact with warfarin. Careful warfarin management is necessary to avoid adverse events associated with drug interactions.
Asunto(s)
Anticoagulantes/administración & dosificación , Warfarina/administración & dosificación , Adulto , Anciano , Estudios de Cohortes , Interacciones Farmacológicas , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Warfarina/efectos adversosRESUMEN
BACKGROUND: There is controversy regarding the impact that different antihypertensive regimens, including modern combination therapy, have on the incidence of myocardial infarction, other cardiovascular events, and mortality. OBJECTIVE: The objective of this study was to determine and compare the effects of treatment strategies based on angiotensin-converting enzyme (ACE) inhibitors and long-acting calcium channel blockers (CCBs) on total and cardiovascular mortality in hypertensive patients in a usual-care setting. METHODS: This retrospective, longitudinal cohort study used integrated medical and pharmacy claims data from a geographically diverse administrative database of >8 million persons in the United States. Patients aged > or = 18 years with hypertension were eligible if they had filled a prescription for either an ACE inhibitor or a long-acting CCB between January 1, 1995, and June 30, 1999 (the index prescription). Patients who had a prescription for any antihypertensive agents before the index prescription were excluded, as were eligible ACE inhibitor-treated patients who used CCBs or CCB-treated patients who used ACE inhibitors during the follow-up period. Use of all other antihypertensive medications was permitted. Patients were matched using a propensity score generated from a logistic regression model. A survival-analysis approach was used to compare mortality between groups. The final cohorts were assessed through June 30, 2002. RESULTS: A total of 18,199 patients met the study inclusion criteria; 12,608 (69.3%) used an ACE inhibitor and 5,591 (30.7%) used a CCB. The mean follow-up was approximately 4.4 years. After cohort matching using the propensity score, the study population consisted of 10,926 patients, 5,463 matched patients in each group. The adjusted hazard ratios (95% CIs) for all-cause, cardiovascular, congestive heart disease, and congestive heart failure mortality in the ACE-inhibitor group compared with the CCB group for the entire follow-up period were 0.70 (0.63-0.79), 0.65 (0.53-0.80), 0.47 (0.32-0.70), and 0.74 (0.49-1.12), respectively. CONCLUSION: Analysis of a large medical and pharmacy database suggests that an ACE inhibitor-based treatment strategy is associated with reduced mortality compared with a CCB-based strategy in patients with hypertension in a managed care setting.