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1.
J Sex Med ; 17(2): 238-248, 2020 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-31862174

RESUMEN

INTRODUCTION: The effect of intensive blood pressure control upon erectile function in men with hypertension, but without diabetes, is largely unknown. AIM: To examine the effects of intensive systolic blood pressure (SBP) lowering on erectile function in a multiethnic clinical trial of men with hypertension. METHODS: We performed subgroup analyses from the Systolic Blood Pressure Intervention Trial ([SPRINT]; ClinicalTrials.gov: NCT120602, in a sample of 1255 men aged 50 years or older with hypertension and increased cardiovascular disease risk. Participants were randomly assigned to an intensive treatment group (SBP goal of <120 mmHg) or a standard treatment group (SBP goal of <140 mmHg). MAIN OUTCOME MEASURE: The main outcome measure was change in erectile function from baseline, using the 5-item International Index of Erectile Function (IIEF-5) total score, and erectile dysfunction ([ED]; defined as IIEF-5 score ≤21) after a median follow-up of 3 years. RESULTS: At baseline, roughly two-thirds (66.1%) of the sample had self-reported ED. At 48 months after randomization, we determined that the effects of more intensive blood pressure lowering were significantly moderated by race-ethnicity (p for interaction = 0.0016), prompting separate analyses stratified by race-ethnicity. In non-Hispanic whites, participants in the intensive treatment group reported slightly, but significantly better change in the IIEF-5 score than those in the standard treatment group (mean difference = 0.67; 95% CI = 0.03, 1.32; P = 0.041). In non-Hispanic blacks, participants in the intensive group reported slightly worse change in the IIEF-5 score than those in the standard group (mean difference = -1.17; 95% CI = -1.92, -0.41; P = 0.0025). However, in non-Hispanic whites and non-Hispanic blacks, further adjustment for the baseline IIEF-5 score resulted in nonsignificant differences (P > 0.05) according to the treatment group. In Hispanic/other participants, there were no significant differences in change in the IIEF-5 score between the two treatment groups (P = 0.40). In a subgroup of 280 participants who did not report ED at baseline, the incidence of ED did not differ in the two treatment groups (P = 0.53) and was without interaction by race-ethnicity. CLINICAL IMPLICATIONS: The effect of intensive treatment of blood pressure on erectile function was very small overall and likely not of great clinical magnitude. STRENGTH & LIMITATIONS: Although this study included a validated measure of erectile function, testosterone, other androgen, and estrogen levels were not assessed. CONCLUSION: In a sample of male patients at high risk for cardiovascular events but without diabetes, targeting a SBP of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in statistically significant effects on erectile function that differed in accordance with race-ethnicity, although the clinical importance of the differences may be of small magnitude. Foy CG, Newman JC, Russell GB, et al. Effect of Intensive vs Standard Blood Pressure Treatment Upon Erectile Function in Hypertensive Men: Findings From the Systolic Blood Pressure Intervention Trial. J Sex Med 2020;17:238-248.

2.
J Am Geriatr Soc ; 68(3): 496-504, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-31840813

RESUMEN

OBJECTIVES: To evaluate the effect of intensive systolic blood pressure (SBP) control in older adults with hypertension, considering cognitive and physical function. DESIGN: Secondary analysis. SETTING: Systolic Blood Pressure Intervention Trial (SPRINT) PARTICIPANTS: Adults 80 years or older. INTERVENTION: Participants with hypertension but without diabetes (N = 1167) were randomized to an SBP target below 120 mm Hg (intensive treatment) vs a target below 140 mm Hg (standard treatment). MEASUREMENTS: We measured the incidence of cardiovascular disease (CVD), mortality, changes in renal function, mild cognitive impairment (MCI), probable dementia, and serious adverse events. Gait speed was assessed via a 4-m walk test, and the Montreal Cognitive Assessment (MoCA) was used to quantify baseline cognitive function. RESULTS: Intensive treatment led to significant reductions in cardiovascular events (hazard ratio [HR] = .66; 95% confidence interval [CI] = .49-.90), mortality (HR = .67; 95% CI = .48-.93), and MCI (HR = .70; 95% CI = .51-.96). There was a significant interaction (P < .001) whereby participants with higher baseline scores on the MoCA derived strong benefit from intensive treatment for a composite of CVD and mortality (HR = .40; 95% CI = .28-.57), with no appreciable benefit in participants with lower scores on the MoCA (HR = 1.33 = 95% CI = .87-2.03). There was no evidence of heterogeneity of treatment effects with respect to gait speed. Rates of acute kidney injury and declines of at least 30% in estimated glomerular filtration rate were increased in the intensive treatment group with no between-group differences in the rate of injurious falls. CONCLUSION: In adults aged 80 years or older, intensive SBP control lowers the risk of major cardiovascular events, MCI, and death, with increased risk of changes to kidney function. The cardiovascular and mortality benefits of intensive SBP control may not extend to older adults with lower baseline cognitive function. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT01206062. J Am Geriatr Soc 68:496-504, 2020.

3.
JAMA Netw Open ; 2(12): e1917141, 2019 Dec 02.
Artículo en Inglés | MEDLINE | ID: mdl-31825502

RESUMEN

Importance: Androgen deficiency is common among male opioid users, and opioid use has emerged as a common antecedent of testosterone treatment. The long-term health outcomes associated with testosterone therapy remain unknown, however. Objective: To compare health outcomes between long-term opioid users with testosterone deficiency who filled testosterone prescriptions and those with the same condition but who did not receive testosterone treatment. Design, Setting, and Participants: This cohort study focused on men in the care of the Veterans Health Administration (VHA) facilities throughout the United States from October 1, 2008, to September 30, 2014. It included male veterans who were long-term opioid users, had low testosterone levels (<300 ng/dL), and received either a testosterone prescription or any other prescription. It excluded male patients with HIV infection, gender dysphoria, or prostate cancer and those who received testosterone in fiscal year 2008. Data were analyzed from April 1, 2017, to April 30, 2019. Exposure: Prescription for testosterone. Main Outcomes and Measures: All-cause mortality and incidence of major adverse cardiovascular events (MACE), vertebral or femoral fractures, and anemia during the 6-year follow-up through September 30, 2015. Results: After exclusions, 21 272 long-term opioid users (mean [SD] age, 53 [10] years; n = 16 689 [78.5%] white) with low total or free testosterone levels were included for analysis, of whom 14 121 (66.4%) received testosterone and 7151 (33.6%) did not. At baseline, compared with opioid users who did not receive testosterone, long-term opioid users who received testosterone treatment were more likely to have obesity (43.7% vs 49.0%; P < .001), hyperlipidemia (43.0% vs 48.8%; P < .001), and hypertension (53.9% vs 55.2%; P = .07) but had lower prevalence of coronary artery disease (15.9% vs 12.9%; P < .001) and stroke (2.4% vs 1.3%; P < .001). After adjusting for covariates, opioid users who received testosterone had significantly lower all-cause mortality (hazard ratio [HR] = 0.51; 95% CI, 0.42-0.61) and lower incidence of MACE (HR = 0.58; 95% CI, 0.51-0.67), femoral or hip fractures (HR = 0.68; 95% CI, 0.48-0.96), and anemia (HR = 0.73; 95% CI, 0.68-0.79) during the follow-up period of up to 6 years, compared with their counterparts without a testosterone prescription. In covariate-adjusted models, men who received opioids plus testosterone were more likely to have resolved anemia compared with those who received opioids only during the 6-year follow-up (HR = 1.16; 95% CI, 1.02-1.31). Similar results were obtained in propensity score-matched models and when analyses were restricted to opioid users with noncancer pain or those who did not receive glucocorticoids. Conclusions and Relevance: This study found that, in the VHA system, male long-term opioid users with testosterone deficiency who were treated with opioid and testosterone medications had significantly lower all-cause mortality and significantly lower incidence of MACE, femoral or hip fractures, and anemia after a multiyear follow-up. These results warrant confirmation through a randomized clinical trial to ascertain the efficacy of testosterone in improving health outcomes for opioid users with androgen deficiency.

4.
J Am Geriatr Soc ; 2019 Nov 28.
Artículo en Inglés | MEDLINE | ID: mdl-31778222

RESUMEN

OBJECTIVES: Concern about falling is common among older hypertension patients and could impact decisions to intensify blood pressure therapy. Our aim was to determine whether intensive therapy targeting a systolic blood pressure (SBP) of 120 mm Hg is associated with greater changes in concern about falling when compared with standard therapy targeting an SBP of 140 mm Hg. DESIGN: Subsample analysis of participants randomized to either intensive or standard therapy in the Systolic Blood Pressure Intervention Trial (SPRINT). SETTING: Approximately 100 outpatient sites. PARTICIPANTS: A total of 2313 enrollees in SPRINT; participants were all age 50 or older (mean = 69 y) and diagnosed with hypertension. MEASUREMENTS: Concern about falling was described by the shortened version of the Falls Efficacy Scale International as measured at baseline, 6 months, 1 year, and annually thereafter. RESULTS: Concern about falling showed a small but significant increase over time among all hypertension patients. No differences were noted, however, among those randomized to intensive vs standard therapy (P = .95). Among participants younger than 75 years, no increase in concern about falling over time was noted, but among participants aged 75 years and older, the mean falls self-efficacy score increased by .3 points per year (P < .0001). No differences were observed between the intensive and standard treatment groups when stratified by age (P = .55). CONCLUSION: Intensive blood pressure therapy is not associated with increased concern about falling among older hypertension patients healthy enough to participate in SPRINT.

5.
Hypertension ; : HYPERTENSIONAHA11912907, 2019 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-31256717

RESUMEN

Total medication burden (antihypertensive and nonantihypertensive medications) may be associated with poor systolic blood pressure (SBP) control. We investigated the association of baseline medication burden and clinical outcomes and whether the effect of the SBP intervention varied according to baseline medication burden in SPRINT (Systolic Blood Pressure Intervention Trial). Participants were randomized to intensive or standard SBP goal (below 120 or 140 mm Hg, respectively); n=3769 participants with high baseline medication burden (≥5 medications) and n=5592 with low burden (<5 medications). Primary outcome: differences in SBP. Secondary outcomes: 8-item Morisky Medication Adherence Scale and modified Treatment Satisfaction Questionnaire for Medications measured at baseline and 12 months and incident cardiovascular disease events and serious adverse events throughout the trial. Participants in the intensive group with high versus low medication burden were less likely to achieve their SBP goal at 12 months (risk ratio, 0.91; 95% CI, 0.85-0.97) but not in the standard group (risk ratio, 0.98; 95% CI, 0.93-1.03; Pinteraction<0.001). High medication burden was associated with increased cardiovascular disease events (hazard ratio, 1.39; 95% CI, 1.14-1.70) and serious adverse events (hazard ratio, 1.34; 95% CI, 1.24-1.45), but the effect of intensive versus standard treatment did not vary between medication burden groups ( Pinteraction>0.5). Medication burden had minimal association with adherence or satisfaction. High baseline medication burden was associated with worse intensive SBP control and higher rates of cardiovascular disease events and serious adverse events. The relative benefits and risks of intensive SBP goals were similar regardless of medication burden. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT01206062.

6.
J Sex Med ; 16(2): 235-247, 2019 02.
Artículo en Inglés | MEDLINE | ID: mdl-30655182

RESUMEN

INTRODUCTION: Erectile function, an important aspect of quality of life, is gaining increased research and clinical attention in older men with hypertension. AIM: To assess the cross-sectional association between blood pressure measures (systolic blood pressure [SBP]; diastolic blood pressure [DBP]; and pulse pressure [PP]) and (i) sexual activity and (ii) erectile function in hypertensive men. METHODS: We performed analyses of 1,255 male participants in a larger randomized clinical trial of 9,361 men and women with hypertension aged ≥50 years. MAIN OUTCOME MEASURES: The main outcome measures were self-reported sexual activity (yes/no) and erectile function using the 5-item International Index of Erectile Function (IIEF-5). RESULTS: 857 participants (68.3%) reported being sexually active during the previous 4 weeks. The mean (SD) IIEF-5 score for sexually active participants was 18.0 (5.8), and 59.9% of the sample reported an IIEF-5 score <21, suggesting erectile dysfunction (ED). In adjusted logistic regression models, neither SBP (adjusted odds ratio = 0.998; P = .707) nor DBP (adjusted odds ratio = 1.001; P = .929) was significantly associated with sexual activity. In multivariable linear regression analyses in sexually active participants, lower SBP (ß = -0.04; P = .025) and higher DBP (ß = 0.05; P = .029) were associated with better erectile function. In additional multivariable analyses, lower PP pressure was associated with better erectile function (ß = -0.04; P = .02). CLINICAL IMPLICATIONS: Blood pressure is an important consideration in the assessment of erectile function in men with hypertension. STRENGTHS & LIMITATIONS: Assessments of blood pressure and clinical and psychosocial variables were performed using rigorous methods in this multi-ethnic and geographically diverse sample. However, these cross-sectional analyses did not include assessment of androgen or testosterone levels. CONCLUSIONS: Erectile dysfunction was highly prevalent in this sample of men with hypertension, and SBP, DBP, and PP were associated with erectile function in this sample. Foy CG, Newman JC, Berlowitz DR, et al. Blood Pressure, Sexual Activity, and Erectile Function in Hypertensive Men: Baseline Findings from the Systolic Blood Pressure Intervention Trial (SPRINT). J Sex Med 2019;16:235-247.

7.
Am J Manag Care ; 24(11): 536-540, 2018 11.
Artículo en Inglés | MEDLINE | ID: mdl-30452210

RESUMEN

OBJECTIVES: The aim of this study was to evaluate whether veterans in Massachusetts receiving opioids and/or benzodiazepines from both Veterans Health Administration (VHA) and non-VHA pharmacies are at higher risk of adverse events compared with those receiving opioids at VHA pharmacies only. STUDY DESIGN: A cohort study of veterans who filled a prescription for any Schedule II through V substance at a Massachusetts VHA pharmacy. Prescriptions were recorded in the Massachusetts Department of Public Health Chapter 55 data set. METHODS: The study sample included 16,866 veterans residing in Massachusetts, of whom 9238 (54.8%) received controlled substances from VHA pharmacies only and 7628 (45.2%) had filled prescriptions at both VHA and non-VHA pharmacies ("dual care users") between October 1, 2013, and December 31, 2015. Our primary outcomes were nonfatal opioid overdose, fatal opioid overdose, and all-cause mortality. RESULTS: Compared with VHA-only users, more dual care users resided in rural areas (12.6% vs 10.6%), received high-dose opioid therapy (26.3% vs 7.3%), had concurrent prescriptions of opioids and benzodiazepines (34.8% vs 8.2%), and had opioid use disorder (6.8% vs 1.6%) (P <.0001 for all). In adjusted models, dual care users had higher odds of nonfatal opioid overdose (odds ratio [OR], 1.29; 95% CI, 0.98-1.71) and all-cause mortality (OR, 1.66; 95% CI, 1.43-1.93) compared with VHA-only users. Dual care use was not associated with fatal opioid overdoses. CONCLUSIONS: Among veterans in Massachusetts, receipt of opioids from multiple sources was associated with worse outcomes, specifically nonfatal opioid overdose and mortality. Better information sharing between VHA and non-VHA pharmacies and prescribers has the potential to improve patient safety.


Asunto(s)
Analgésicos Opioides/envenenamiento , Benzodiazepinas/envenenamiento , Sobredosis de Droga/epidemiología , Trastornos Relacionados con Opioides/epidemiología , Farmacias/estadística & datos numéricos , Veteranos/estadística & datos numéricos , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Sobredosis de Droga/mortalidad , Femenino , Humanos , Masculino , Massachusetts , Trastornos Mentales/epidemiología , Salud Mental , Persona de Mediana Edad , Trastornos Relacionados con Opioides/mortalidad , Características de la Residencia , Factores Sexuales , Factores Socioeconómicos , Estados Unidos , United States Department of Veterans Affairs/estadística & datos numéricos
9.
Gerontologist ; 58(4): e291-e301, 2018 07 13.
Artículo en Inglés | MEDLINE | ID: mdl-29718195

RESUMEN

Background and Objectives: For nursing home residents, positive interactions with staff and engagement in daily life contribute meaningfully to quality of life. We sought to improve these aspects of person-centered care in an opportunistic snowball sample of six Veterans Health Administration nursing homes (e.g., Community Living Centers-CLCs) using an intervention that targeted staff behavior change, focusing on improving interactions between residents and staff and thereby ultimately aiming to improve resident engagement. Research Design and Methods: We grounded this mixed-methods study in the Capability, Opportunity, Motivation, Behavior (COM-B) model of behavior change. We implemented the intervention by (a) using a set of evidence-based practices for implementing quality improvement and (b) combining primarily CLC-based staff facilitation with some researcher-led facilitation. Validated resident and staff surveys and structured observations collected pre and post intervention, as well as semi-structured staff interviews conducted post intervention, helped assess intervention success. Results: Sixty-two CLC residents and 308 staff members responded to the surveys. Researchers conducted 1,490 discrete observations. Intervention implementation was associated with increased staff communication with residents during the provision of direct care and decreased negative staff interactions with residents. In the 66 interviews, staff consistently credited the intervention with helping them (a) develop awareness of the importance of identifying opportunities for engagement and (b) act to improve the quality of interactions between residents and staff. Discussion and Implications: The intervention proved feasible and influenced staff to make simple enhancements to their behaviors that improved resident-staff interactions and staff-assessed resident engagement.


Asunto(s)
Envejecimiento/psicología , Hogares para Ancianos/normas , Casas de Salud/normas , Participación del Paciente , Relaciones Profesional-Paciente , Calidad de Vida , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Motivación , Participación del Paciente/métodos , Participación del Paciente/psicología , Atención Dirigida al Paciente/normas , Mejoramiento de la Calidad , Compromiso Laboral
10.
AIDS Care ; 30(10): 1207-1214, 2018 10.
Artículo en Inglés | MEDLINE | ID: mdl-29557189

RESUMEN

Testosterone supplementation has been widely used in those infected with human immunodeficiency virus (HIV) for hypogonadism, and wasting. But with effective antiretroviral therapy and increasing recognition of atherosclerotic disease and adults infected with HIV, the risks of inappropriate testosterone use in HIV-infected patients are far better recognized than previously. Testosterone use has expanded among U.S. males, but few studies have examined prescribing in those infected with HIV. In a national cohort of males with at least one outpatient prescription in the Veterans Health Administration (VHA), we examined 9475 HIV-infected males, including 2484 who had received testosterone and a randomly selected 6991 who had not. For comparison, we identified 1,387,241 uninfected males (189,369 had received testosterone and a randomly selected 1,197,872 had not). We determined rates of new and prevalent testosterone use, and also examined the adequacy of the diagnostic evaluation that had preceded testosterone initiation among our HIV-infected and uninfected testosterone groups. Our main results were as follows. HIV-infected men had higher rates of initiation (0.8% vs. 0.4% in FY09; p < 0.001) and prevalence of testosterone use (2.2% vs. 0.8% in FY08; p < 0.001) compared to the uninfected men across the entire period. Trends of prescribing for both groups followed a similar pattern, rising from FY08, reaching a peak in FY13, and then dipping in FY 14. Only 1.1% of HIV-infected patients had a fully guideline-concordant workup before starting testosterone therapy, compared to 3.5% of uninfected patients (p < 0.001). In conclusion, testosterone use among HIV-infected patients in the VHA system rose to a peak in FY13 and has decreased somewhat since. Only a small minority of HIV-infected patients who receive testosterone therapy from VHA have undergone an appropriate workup before starting therapy, suggesting an opportunity for improvement.


Asunto(s)
Infecciones por VIH/complicaciones , Hipogonadismo/tratamiento farmacológico , Testosterona/uso terapéutico , Veteranos , Adulto , Estudios de Cohortes , Humanos , Hipogonadismo/complicaciones , Masculino , Persona de Mediana Edad , Guías de Práctica Clínica como Asunto , Estados Unidos , United States Department of Veterans Affairs
11.
Nat Rev Dis Primers ; 4: 18014, 2018 03 22.
Artículo en Inglés | MEDLINE | ID: mdl-29565029

RESUMEN

Systemic arterial hypertension is the most important modifiable risk factor for all-cause morbidity and mortality worldwide and is associated with an increased risk of cardiovascular disease (CVD). Fewer than half of those with hypertension are aware of their condition, and many others are aware but not treated or inadequately treated, although successful treatment of hypertension reduces the global burden of disease and mortality. The aetiology of hypertension involves the complex interplay of environmental and pathophysiological factors that affect multiple systems, as well as genetic predisposition. The evaluation of patients with hypertension includes accurate standardized blood pressure (BP) measurement, assessment of the patients' predicted risk of atherosclerotic CVD and evidence of target-organ damage, and detection of secondary causes of hypertension and presence of comorbidities (such as CVD and kidney disease). Lifestyle changes, including dietary modifications and increased physical activity, are effective in lowering BP and preventing hypertension and its CVD sequelae. Pharmacological therapy is very effective in lowering BP and in preventing CVD outcomes in most patients; first-line antihypertensive medications include angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, dihydropyridine calcium-channel blockers and thiazide diuretics.


Asunto(s)
Antihipertensivos/farmacocinética , Hipertensión/complicaciones , Antihipertensivos/uso terapéutico , Bloqueadores de los Canales de Calcio/uso terapéutico , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/fisiopatología , Diuréticos/uso terapéutico , Humanos , Hipertensión/epidemiología , Hipertensión/fisiopatología , Calidad de Vida , Sistema Renina-Angiotensina/efectos de los fármacos , Sistema Nervioso Simpático/efectos de los fármacos
12.
Gerontologist ; 58(2): e15-e24, 2018 03 19.
Artículo en Inglés | MEDLINE | ID: mdl-28499032

RESUMEN

Purpose of Study: To develop a structured observational tool, the Resident-centered Assessment of Interactions with Staff and Engagement tool (RAISE), to measure 2 critical, multi-faceted, organizational-level aspects of person-centered care (PCC) in nursing homes: (a) resident engagement and (b) the quality and frequency of staff-resident interactions. Design and Methods: In this multi-method psychometric development study, we conducted (a) 120 hr of ethnographic observations in one nursing home and (b) a targeted literature review to enable construct development. Two constructs for which no current structured observation measures existed emerged from this phase: nursing home resident-staff engagement and interaction. We developed the preliminary RAISE to measure these constructs and used the tool in 8 nursing homes at an average of 16 times. We conducted 8 iterative psychometric testing and refinement cycles with multi-disciplinary research team members. Each cycle consisted of observations using the draft tool, results review, and tool modification. Results: The final RAISE included a set of coding rules and procedures enabling simultaneously efficient, non-reactive, and representative quantitative measurement of the interaction and engagement components of nursing home life for staff and residents. It comprised 8 observational variables, each represented by extensive numeric codes. Raters achieved adequate to high reliability with all variables. There is preliminary evidence of face and construct validity via expert panel review. Implications: The RAISE represents a valuable step forward in the measurement of PCC, providing objective, reliable data based on systematic observation.


Asunto(s)
Envejecimiento/psicología , Actitud del Personal de Salud , Técnicas de Observación Conductual/métodos , Hogares para Ancianos , Casas de Salud , Participación del Paciente , Calidad de Vida , Anciano , Anciano de 80 o más Años , Femenino , Evaluación Geriátrica/métodos , Humanos , Masculino , Participación del Paciente/métodos , Participación del Paciente/psicología , Relaciones Profesional-Paciente , Psicometría/métodos , Reproducibilidad de los Resultados
14.
J Clin Endocrinol Metab ; 102(9): 3226-3233, 2017 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-28911150

RESUMEN

Context: Testosterone prescribing rates have increased substantially in the past decade. However, little is known about the context within which such prescriptions occur. Objective: We evaluated provider- and site-level determinants of receipt of testosterone and of guideline-concordant testosterone prescribing. Design: This study was cross-sectional in design. Setting: This study was conducted at the Veterans Health Administration (VA). Participants: Study participants were a national cohort of male patients who had received at least one outpatient prescription within the VA during fiscal year (FY) 2008 to FY 2012. A total of 38,648 providers and 130 stations were associated with these patients. Main Outcome Measure: This study measured receipt of testosterone and guideline-concordant testosterone prescribing. Results: Providers ranging in age from 31 to 60 years, with less experience in the VA [all adjusted odds ratio (AOR), <2; P < 0.01] and credentialed as medical doctors in endocrinology (AOR, 3.88; P < 0.01) and urology (AOR, 1.48; P < 0.01) were more likely to prescribe testosterone compared with older providers, providers of longer VA tenure, and primary care providers, respectively. Sites located in the West compared with the Northeast [AOR, 1.75; 95% confidence interval (CI), 1.45-2.11] and care received at a community-based outpatient clinic compared with a medical center (AOR, 1.22; 95% CI, 1.20-1.24) also predicted testosterone use. Although they were more likely to prescribe testosterone, endocrinologists were also more likely to obtain an appropriate workup before prescribing compared with primary care providers (AOR, 2.14; 95% CI, 1.54-2.97). Conclusions: Our results highlight the opportunity to intervene at both the provider and the site levels to improve testosterone prescribing. This study also provides a useful example of how to examine contributions to prescribing variation at different levels of the health care system.


Asunto(s)
Prescripciones de Medicamentos/estadística & datos numéricos , Utilización de Medicamentos/estadística & datos numéricos , Personal de Salud , Hospitales de Veteranos , Testosterona/uso terapéutico , Adulto , Factores de Edad , Estudios Transversales , Bases de Datos Factuales , Encuestas de Atención de la Salud , Humanos , Incidencia , Modelos Logísticos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Estados Unidos , Veteranos/estadística & datos numéricos
15.
N Engl J Med ; 377(8): 745-755, 2017 08 24.
Artículo en Inglés | MEDLINE | ID: mdl-28834469

RESUMEN

BACKGROUND: In the Systolic Blood Pressure Intervention Trial (SPRINT), adults at high risk for cardiovascular disease who received intensive systolic blood-pressure control (target, <120 mm Hg) had significantly lower rates of death and cardiovascular disease events than did those who received standard control (target, <140 mm Hg). On the basis of these data, we wanted to determine the lifetime health benefits and health care costs associated with intensive control versus standard control. METHODS: We used a microsimulation model to apply SPRINT treatment effects and health care costs from national sources to a hypothetical cohort of SPRINT-eligible adults. The model projected lifetime costs of treatment and monitoring in patients with hypertension, cardiovascular disease events and subsequent treatment costs, treatment-related risks of serious adverse events and subsequent costs, and quality-adjusted life-years (QALYs) for intensive control versus standard control of systolic blood pressure. RESULTS: We determined that the mean number of QALYs would be 0.27 higher among patients who received intensive control than among those who received standard control and would cost approximately $47,000 more per QALY gained if there were a reduction in adherence and treatment effects after 5 years; the cost would be approximately $28,000 more per QALY gained if the treatment effects persisted for the remaining lifetime of the patient. Most simulation results indicated that intensive treatment would be cost-effective (51 to 79% below the willingness-to-pay threshold of $50,000 per QALY and 76 to 93% below the threshold of $100,000 per QALY), regardless of whether treatment effects were reduced after 5 years or persisted for the remaining lifetime. CONCLUSIONS: In this simulation study, intensive systolic blood-pressure control prevented cardiovascular disease events and prolonged life and did so at levels below common willingness-to-pay thresholds per QALY, regardless of whether benefits were reduced after 5 years or persisted for the patient's remaining lifetime. (Funded by the National Heart, Lung, and Blood Institute and others; SPRINT ClinicalTrials.gov number, NCT01206062 .).


Asunto(s)
Antihipertensivos/economía , Enfermedades Cardiovasculares/prevención & control , Costos de la Atención en Salud , Hipertensión/tratamiento farmacológico , Años de Vida Ajustados por Calidad de Vida , Adulto , Antihipertensivos/administración & dosificación , Enfermedades Cardiovasculares/economía , Enfermedades Cardiovasculares/mortalidad , Costo de Enfermedad , Análisis Costo-Beneficio , Humanos , Hipertensión/economía , Modelos Económicos
16.
N Engl J Med ; 377(8): 733-744, 2017 08 24.
Artículo en Inglés | MEDLINE | ID: mdl-28834483

RESUMEN

BACKGROUND: The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here. METHODS: We randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment group among all participants and among participants stratified according to physical and cognitive function. RESULTS: Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood-pressure care was high in both treatment groups, and we found no significant difference in adherence to blood-pressure medications. CONCLUSIONS: Patient-reported outcomes among participants who received intensive treatment, which targeted a systolic blood pressure of less than 120 mm Hg, were similar to those among participants who received standard treatment, including among participants with decreased physical or cognitive function. (Funded by the National Institutes of Health; SPRINT ClinicalTrials.gov number, NCT01206062 .).


Asunto(s)
Antihipertensivos/administración & dosificación , Enfermedades Cardiovasculares/prevención & control , Hipertensión/tratamiento farmacológico , Medición de Resultados Informados por el Paciente , Anciano , Antihipertensivos/efectos adversos , Presión Sanguínea/efectos de los fármacos , Quimioterapia Combinada , Femenino , Estado de Salud , Humanos , Hipertensión/complicaciones , Masculino , Cumplimiento de la Medicación , Persona de Mediana Edad , Evaluación del Resultado de la Atención al Paciente , Satisfacción del Paciente
17.
JAMA Intern Med ; 177(4): 500-507, 2017 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-28166324

RESUMEN

Importance: Intensive blood pressure (BP) control confers a benefit on cardiovascular morbidity and mortality; whether it affects physical function outcomes is unknown. Objective: To examine the effect of intensive BP control on changes in gait speed and mobility status. Design, Setting, and Participants: This randomized, clinical trial included 2636 individuals 75 years or older with hypertension and no history of type 2 diabetes or stroke who participated in the Systolic Blood Pressure Intervention Trial (SPRINT). Data were collected from November 8, 2010, to December 1, 2015. Analysis was based on intention to treat. Interventions: Participants were randomized to intensive treatment with a systolic BP target of less than 120 mm Hg (n = 1317) vs standard treatment with a BP target of less than 140 mm Hg (n = 1319). Main Outcomes and Measures: Gait speed was measured using a 4-m walk test. Self-reported information concerning mobility was obtained from items on the Veterans RAND 12-Item Health Survey and the EQ-5D. Mobility limitation was defined as a gait speed less than 0.6 meters per second (m/s) or self-reported limitations in walking and climbing stairs. Results: Among the 2629 participants in whom mobility status could be defined (996 women [37.9%]; 1633 men [62.1%]; mean [SD] age, 79.9 [4.0] years), median (interquartile range) follow-up was 3 (2-3) years. No difference in mean gait speed decline was noted between the intensive- and standard-treatment groups (mean difference, 0.0004 m/s per year; 95% CI, -0.005 to 0.005; P = .88). No evidence of any treatment group differences in subgroups defined by age, sex, race or ethnicity, baseline systolic BP, chronic kidney disease, or a history of cardiovascular disease were found. A modest interaction was found for the Veterans RAND 12-Item Health Survey Physical Component Summary score, although the effect did not reach statistical significance in either subgroup, with mean differences of 0.004 (95% CI, -0.002 to 0.010) m/s per year among those with scores of at least 40 and -0.008 (95% CI, -0.016 to 0.001) m/s per year among those with scores less than 40 (P = .03 for interaction). Multistate models allowing for the competing risk of death demonstrated no effect of intensive treatment on transitions to mobility limitation (hazard ratio, 1.06; 95% CI, 0.92-1.22). Conclusions and Relevance: Among adults 75 years or older in SPRINT, treating to a systolic BP target of less than 120 mm Hg compared with a target of less than 140 mm Hg had no effect on changes in gait speed and was not associated with changes in mobility limitation. Trial Registration: clinicaltrials.gov Identifier: NCT01206062.


Asunto(s)
Antihipertensivos/administración & dosificación , Hipertensión , Limitación de la Movilidad , Velocidad al Caminar/efectos de los fármacos , Anciano , Anciano de 80 o más Años , Presión Sanguínea/efectos de los fármacos , Determinación de la Presión Sanguínea/métodos , Prueba de Esfuerzo/métodos , Femenino , Humanos , Hipertensión/diagnóstico , Hipertensión/tratamiento farmacológico , Hipertensión/fisiopatología , Masculino , Autoinforme , Autoevaluación , Resultado del Tratamiento
18.
J Gen Intern Med ; 32(3): 304-311, 2017 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-27995426

RESUMEN

BACKGROUND: There has been concern about the growing off-label use of testosterone. Understanding the context within which testosterone is prescribed may contribute to interventions to improve prescribing. OBJECTIVE: To evaluate patient characteristics associated with receipt of testosterone. DESIGN: Cross-sectional. SETTING: A national cohort of male patients, who had received at least one outpatient prescription within the Veterans Affairs (VA) system during Fiscal Year 2008- Fiscal Year 2012. PARTICIPANTS: The study sample consisted of 682,915 non-HIV male patients, of whom 132,764 had received testosterone and a random 10% sample, 550,151, had not. MAIN MEASURES: Conditions and medications associated with testosterone prescription. KEY RESULTS: Only 6.3% of men who received testosterone from the VA during the study period had a disorder of the testis, pituitary or hypothalamus associated with male hypogonadism. Among patients without a diagnosed disorder of hypogonadism, the use of opioids and obesity were the strongest predictors of testosterone prescription. Patients receiving >100 mg/equivalents of oral morphine daily (adjusted odds ratio = 5.75, p < 0.001) and those with body mass index (BMI) >40 kg/m2 (adjusted odds ratio = 3.01, p < 0.001) were more likely to receive testosterone than non-opioid users and men with BMI <25 kg/m2. Certain demographics (age 40-54, White race), comorbid conditions (sleep apnea, depression, and diabetes), and medications (antidepressants, systemic corticosteroids) also predicted a higher likelihood of testosterone receipt, all with an adjusted odds ratio less than 2 (p < 0.001). CONCLUSIONS: In the VA, 93.7% of men receiving testosterone did not have a diagnosed condition of the testes, pituitary, or hypothalamus. The strongest predictors of testosterone receipt (e.g., obesity, receipt of opioids), which though are associated with unapproved, off-label use, may be valid reasons for therapy. Interventions should aim to increase the proportion of testosterone recipients who have a valid indication.


Asunto(s)
Andrógenos/uso terapéutico , Uso Fuera de lo Indicado/estadística & datos numéricos , Pautas de la Práctica en Medicina/estadística & datos numéricos , Testosterona/uso terapéutico , Veteranos/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Analgésicos Opioides/administración & dosificación , Andrógenos/sangre , Índice de Masa Corporal , Estudios de Casos y Controles , Comorbilidad , Estudios Transversales , Humanos , Hipogonadismo/epidemiología , Masculino , Persona de Mediana Edad , Obesidad/complicaciones , Oportunidad Relativa , Testosterona/sangre , Estados Unidos , United States Department of Veterans Affairs , Adulto Joven
19.
J Am Geriatr Soc ; 64(11): 2302-2306, 2016 11.
Artículo en Inglés | MEDLINE | ID: mdl-27640987

RESUMEN

OBJECTIVES: To determine the extent of concern about falling in older adults with hypertension, whether lower blood pressure (BP) and greater use of antihypertensive medications are associated with greater concern about falling, and whether lower BP has a greater effect on concern about falling in older and more functionally impaired individuals. DESIGN: Secondary analysis involving cross-sectional study of baseline characteristics of participants enrolled in the Systolic Blood Pressure Intervention Trial (SPRINT). SETTING: Approximately 100 outpatient sites. PARTICIPANTS: SPRINT enrollees aged 50 and older (mean age 69) diagnosed with hypertension (N = 2,299). MEASUREMENTS: Concern about falling was determined using the shortened version of the Falls Efficacy Scale International as measured at the baseline examination. RESULTS: Mild concern about falling was present in 29.3% of participants and moderate to severe concern in 17.9%. Neither low BP (systolic BP<120 mmHg, diastolic BP <70 mmHg) nor orthostatic hypotension was associated with concern about falling (P > .10). Participants with moderate to severe concern about falling were taking significantly more antihypertensive medications than those with mild or no concern. After adjusting for baseline characteristics, no associations were evident between BP, medications, and concern about falling. Results were similar in older and younger participants; interactions between BP and age and functional status were not significantly associated with concern about falling. CONCLUSION: Although concern about falling is common in older adults with hypertension, it was not found to be associated with low BP or use of more antihypertensive medications in baseline data from SPRINT.


Asunto(s)
Accidentes por Caídas , Antihipertensivos/uso terapéutico , Hipertensión/tratamiento farmacológico , Actividades Cotidianas , Anciano , Comorbilidad , Estudios Transversales , Demografía , Femenino , Evaluación Geriátrica , Humanos , Hipotensión/inducido químicamente , Hipotensión/complicaciones , Hipotensión Ortostática/complicaciones , Masculino , Persona de Mediana Edad , Calidad de Vida
20.
J Sex Med ; 13(9): 1333-1346, 2016 09.
Artículo en Inglés | MEDLINE | ID: mdl-27555505

RESUMEN

INTRODUCTION: Sexual function, an important component of quality of life, is gaining increased research and clinical attention in older women with hypertension. AIM: To assess the association between systolic blood pressure (SBP) and other variables, and sexual activity and sexual dysfunction in hypertensive women. METHODS: Baseline analysis of 635 women participants of a larger randomized clinical trial of 9361 men and women. MAIN OUTCOME MEASURES: Self-reported sexual activity (yes/no), and sexual function using the Female Sexual Function Inventory (FSFI). RESULTS: 452 participants (71.2%) reported having no sexual activity during the previous 4 weeks. The mean (SD) FSFI score for sexually active participants was 25.3 (6.0), and 52.6% of the sample reported a FSFI score ≤26.55 designating sexual dysfunction. In logistic regression models, SBP was not significantly associated with sexual activity (AOR = 1.002; P > .05). Older age (AOR = 0.95, P < .05), and lower education (AOR for < high school vs college degree = 0.29, P < .05) were associated with lower odds of being sexually active, as was living alone versus living with others (AOR = 0.56, P < .05). Higher weekly alcohol consumption was associated with increased odds of being sexually active (AOR = 1.39; P < .05). In logistic regression models among sexually active participants, SBP was not associated with sexual dysfunction (AOR = 1.01; P > .05). Higher depressive symptoms from the Patient Health Questionnaire-9 (PHQ-9) was associated with higher odds of sexual dysfunction (AOR = 1.24, P < .05), as was increased number of physical comorbidities (AOR = 1.25, P < .05). Diuretic use was associated with lower odds of being sexually active in participants with chronic kidney disease (AOR = 0.33, P < .05). CONCLUSION: Younger age, higher education, living with others, and higher weekly alcohol consumption were significantly associated with higher odds of being sexually active in a sample of middle-aged and older women with hypertension. Increased depressive symptoms and increased physical comorbidities were significantly associated with increased odds of sexual dysfunction. SBP was not significantly associated with sexual activity or sexual dysfunction.


Asunto(s)
Hipertensión/complicaciones , Calidad de Vida , Disfunciones Sexuales Fisiológicas/etiología , Disfunciones Sexuales Psicológicas/etiología , Adulto , Anciano , Presión Sanguínea , Femenino , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Conducta Sexual , Disfunciones Sexuales Fisiológicas/diagnóstico , Disfunciones Sexuales Psicológicas/diagnóstico
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