Publications by authors named "Cushman W"
Importance: Hypertension is a risk factor for the development and progression of chronic kidney disease (CKD). It is unclear whether different thiazide diuretics have a differential impact on kidney outcomes.
Objective: To compare kidney outcomes in patients with hypertension taking chlorthalidone and hydrochlorothiazide.
Article Synopsis
- The Diuretic Comparison Project (DCP) was a pragmatic trial in the VA healthcare system that compared two diuretics, chlorthalidone and hydrochlorothiazide, to see which better prevents major cardiovascular events in hypertensive patients.
- The study analyzed data from participating and non-participating medical centers to determine factors influencing their decision to join, including socio-economic status and hospital performance metrics.
- Findings revealed that urban centers, those with higher incomes, and hospitals with prior research experience were more likely to participate, suggesting that improving engagement with lesser-involved facilities could enhance future recruitment for clinical trials.*
Background: Single-pill combinations (SPCs) of three low-dose antihypertensive drugs can improve hypertension control but are not widely available. A key issue for any combination product is the contribution of each component to efficacy and tolerability. This trial compared a new triple SPC called GMRx2, containing telmisartan, amlodipine, and indapamide, with dual combinations of components for efficacy and safety.
View Article and Find Full Text PDFArticle Synopsis
- A study utilizing data from the Veterans Health Administration examined trends in the initial treatment regimens for newly diagnosed hypertension from 2000 to 2019, focusing on the use of monotherapy versus dual therapy.
- Initial monotherapy prescriptions increased across all levels of pretreatment systolic blood pressure, while the use of dual therapy declined over the same period.
- The findings highlight a gap between recommended treatment guidelines and the actual medications prescribed to Veterans with high blood pressure, particularly those with systolic BP levels of 160 mm Hg or higher.
Background: Antihypertensive medication use patterns have likely been influenced by changing costs and accessibility over the past 3 decades. This study examines the relationships between patent exclusivity loss, medication costs, and national health policies on antihypertensive medication use.
Methods: Using 1996 to 2021 Medical Expenditure Panel Survey data of US adults with hypertension taking at least 1 antihypertensive medication, we conducted a cross-sectional analysis.
Article Synopsis
- A clinical trial tested a new single-pill combination of low-dose medications (telmisartan, amlodipine, and indapamide) to treat hypertension, comparing two doses against a placebo over four weeks.
- Results showed significant reductions in home systolic blood pressure (SBP) for both medication doses compared to placebo, with reductions of -7.3 mm Hg and -8.2 mm Hg, respectively, and a notable increase in blood pressure control rates among those taking the medications.
- Safety observations indicated low treatment discontinuation rates, with the ¼ dose showing only 1.6% discontinuations due to adverse effects, while the ½ dose had a 5
Article Synopsis
- In the Systolic Blood Pressure Intervention Trial (SPRINT), long-term kidney failure rates were low, primarily linked to patients' initial kidney function.
- Intensive blood pressure treatment resulted in higher but not statistically significant rates of dialysis or transplantation compared to standard treatment.
- The study analyzed 9,279 participants over roughly 8.6 years, finding that most kidney failure cases occurred in patients with poor baseline kidney function, and intensive treatment did not notably raise the overall risk of kidney failure.
Importance: Patients with prior myocardial infarction (MI) or stroke have a greater risk of recurrent cardiovascular (CV) events.
Objective: To evaluate the association of chlorthalidone (CTD) vs hydrochlorothiazide (HCTZ) with CV outcomes and noncancer deaths in participants with and without prior MI or stroke.
Design, Setting, And Participants: This was a prespecified secondary analysis of the Diuretic Comparison Project (DCP), a pragmatic randomized clinical trial conducted within 72 participating Veterans Affairs health care systems from June 2016 to June 2021, in which patients aged 65 years or older with hypertension taking HCTZ at baseline were randomized to continue HCTZ or switch to CTD at pharmacologically comparable doses.
Two recent large trials showed the potential of single pill combinations (SPCs) with ≥3 low-dose components among people with hypertension who were untreated or receiving monotherapy. In both trials, these 'hypertension polypills' were superior to usual care, achieving >80% BP control without increasing withdrawal due to side effects. However, there are no such products available for prescribers.
View Article and Find Full Text PDFBackground: In a post hoc analysis, we examined whether postrandomization diuretics use can explain and/or mediate the beneficial effects of intensive systolic BP lowering on cardiovascular disease and all-cause mortality in the Systolic Blood Pressure Intervention Trial (SPRINT).
Methods: SPRINT was a randomized, controlled trial of 9361 participants comparing the effects of intensive (systolic BP target <120 mm Hg) versus standard (systolic BP target <140 mm Hg) BP control on a primary composite cardiovascular end point in participants aged 50 years or older with systolic BP of 130-180 mm Hg. In time-varying multivariable Cox analyses, we assessed hazard ratios (HRs) of cardiovascular end points and all-cause mortality in participants on thiazide type, loop and/or potassium (K) sparing, or no diuretics.
Background: Pragmatic trials are gaining popularity as a cost-effective way to examine treatment effectiveness and generate timely comparative evidence. Incorporating supplementary real-world data is recommended for robust outcome monitoring. However, detailed operational guidelines are needed to inform effective use and integration of heterogeneous databases.
View Article and Find Full Text PDFImportance: There are ongoing concerns about the benefits of intensive vs standard blood pressure (BP) treatment among adults with orthostatic hypotension or standing hypotension.
Objective: To determine the effect of a lower BP treatment goal or active therapy vs a standard BP treatment goal or placebo on cardiovascular disease (CVD) or all-cause mortality in strata of baseline orthostatic hypotension or baseline standing hypotension.
Data Sources: Individual participant data meta-analysis based on a systematic review of MEDLINE, EMBASE, and CENTRAL databases through May 13, 2022.
Article Synopsis
- Participant diversity enhances study validity and generalizability in comparative effectiveness research.
- The study analyzed the effectiveness of a centralized electronic health record (EHR) system for recruiting hard-to-reach participants in a clinical trial involving antihypertensives.
- Results showed successful recruitment of over 13,500 patients, including a significant percentage from rural areas and underrepresented demographics, highlighting the EHR model's operational efficiency and broad geographic reach.
Article Synopsis
- This study investigated whether blood pressure-lowering treatments impact cardiovascular outcomes differently for men and women, especially when blood pressure is not very high.
- Researchers analyzed data from 51 clinical trials with nearly 359,000 participants, finding that a reduction of 5 mm Hg in systolic blood pressure decreased the risk of major cardiovascular events similarly for both sexes over an average follow-up of 4.2 years.
- The findings indicate that there are no significant differences in the effectiveness of blood pressure treatments between men and women, regardless of initial blood pressure levels or the types of medications used.
Objectives: Racial/ethnic disparities have been found in prior literature examining enrolment in Medicare medication therapy management programs. However, those studies were based on various eligibility scenarios because enrolment data were unavailable. This study tested for potential disparities in enrolment using actual MTM enrolment data.
View Article and Find Full Text PDFBackground: Single-pill combination (SPC) antihypertensive products improve blood pressure control and medication adherence among patients with hypertension. It is unknown to what degree commercially available SPC products could be used to target an intensive systolic blood pressure goal of <120 mm Hg.
Methods: This cross-sectional analysis included participants randomized to the intensive treatment arm (goal systolic blood pressure <120 mm Hg) of the Systolic Blood Pressure Intervention Trial (SPRINT) using ≥2 antihypertensive medication classes at the 12-month postrandomization visit.
Article Synopsis
- Pragmatic clinical trials, like the Diuretic Comparison Project (DCP), aim to lessen the burden on patients and staff while promoting a learning healthcare system, with telephone consent reducing clinical staff workload.
- The DCP focused on comparing the effectiveness of two diuretics in elderly patients, but faced challenges with telephone consent that required continuous adjustments from the study team.
- By highlighting the technical and operational obstacles encountered, the DCP provides valuable lessons for future trials, enabling a more efficient telephone consent process going forward.
Objective: Medicare Part D Star Ratings are instrumental in shaping healthcare quality improvement efforts. However, the calculation metrics for medication performance measures for this program have been associated with racial/ethnic disparities. In this study, we aimed to explore whether an alternative program, named Star Plus by us that included all medication performance measures developed by Pharmacy Quality Alliance and applicable to our study population, would reduce such disparities among Medicare beneficiaries with diabetes, hypertension, and/or hyperlipidemia.
View Article and Find Full Text PDFBackground Fixed-dose combination (FDC) antihypertensive products improve blood pressure control and adherence among patients with hypertension. It is unknown to what degree commercially available FDC products meet the current hypertension management prescription patterns in the United States. Methods and Results This cross-sectional analysis of the National Health and Nutrition Examination Surveys 2015 to March 2020 included participants with hypertension taking ≥2 antihypertensive medications (N=2451).
View Article and Find Full Text PDFIntroduction: The COVID-19 pandemic had significant impact on clinical care and clinical trial operations, but the impact on decentralized pragmatic trials is unclear. The Diuretic Comparison Project (DCP) is a Point-of Care (POC) pragmatic trial testing whether chlorthalidone is superior to hydrochlorothiazide in preventing major cardiovascular (CV) events and non-cancer death. DCP utilized telephone consent, data collection from the electronic health record and Medicare, forwent study visits, and limited provider commitment beyond usual care.
View Article and Find Full Text PDFArticle Synopsis
- The US Department of Veterans Affairs conducted a Point of Care Clinical Trial comparing hydrochlorothiazide and chlorthalidone for reducing major cardiovascular events in hypertensive patients, overcoming various cultural, technical, regulatory, and logistical challenges.
- Patients were recruited from 72 healthcare systems, with minimal disruption to routine care, and their management continued under their regular clinical providers without additional study visits or recommendations.
- The trial successfully enrolled over 13,500 subjects and maintained a 5-year follow-up, highlighting the importance of collaboration among researchers, clinicians, and administrative staff to tailor study procedures to local practices.
Background: The Medicare Part D medication therapy management (MTM) program has positive effects on medication and health service utilization. However, little is known about its utilization, much less so about the use among racial and ethnic minorities.
Objective: To examine MTM service utilization among older Medicare beneficiaries and to identify any racial and ethnic disparity patterns.
Background: Describing the antihypertensive medication regimens used in the SPRINT (Systolic Blood Pressure Intervention Trial) would contextualize the standard and intensive systolic blood pressure (SBP) interventions and may inform future implementation efforts to achieve population-wide intensive SBP goals.
Methods: We included SPRINT participants with complete medication data at the prerandomization and 12-month visits. Regimens were categorized by antihypertensive medication class.
Background: Whether chlorthalidone is superior to hydrochlorothiazide for preventing major adverse cardiovascular events in patients with hypertension is unclear.
Methods: In a pragmatic trial, we randomly assigned adults 65 years of age or older who were patients in the Department of Veterans Affairs health system and had been receiving hydrochlorothiazide at a daily dose of 25 or 50 mg to continue therapy with hydrochlorothiazide or to switch to chlorthalidone at a daily dose of 12.5 or 25 mg.