Search

BACKGROUND: 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. Antihypertensive medication data were collected using pill bottle review by research coordinators, and regimens were categorized by the unique combinations of antihypertensive classes. We calculated the proportion of regimens used, which are commercially available as one of the 7 SPC class combinations in the United States as of January 2023. RESULTS: Among the 3833 SPRINT intensive arm participants included (median age, 67.0 years; 35.5% female), participants were using 219 unique antihypertensive regimens. The 7 regimens for which there are class-equivalent SPC products were used by 40.3% of participants. Only 3.2% of all medication class regimens used are available as a class-equivalent SPC product (7/219). There are no SPC products available with 4 or more medication classes, which were used by 1060 participants (27.7%). CONCLUSIONS: Most SPRINT participants in the intensive arm used an antihypertensive medication regimen, which is not commercially available as a class equivalent SPC product. To achieve the SPRINT results in real-world settings, maximize the potential benefit of SPCs, and reduce pill burden, improvements in the product landscape are needed. REGISTRATION: URL: https://www.clinicaltrials.gov/ct2/show/NCT01206062; Unique identifier: NCT01206062. [ABSTRACT FROM AUTHOR]

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. Analyses were stratified by treatment group (standard goal SBP <140 mm Hg versus intensive goal SBP <120 mm Hg). Results: Among 7860 participants (83.7% of 9361 randomized), the median number of classes used at the prerandomization visit was 2.0 and 2.0 in the standard and intensive groups (P =0.559). At 12-months, the median number of classes used was 3.0 and 2.0 in the intensive and standard groups (P <0.001). Prerandomization, angiotensin-converting enzyme inhibitor (ACE), or angiotensin-II receptor blocker (ARB) monotherapy was the most common regimen in the intensive and standard groups (12.6% versus 12.2%). At 12-months, ACE/ARB monotherapy was still the most common regimen among standard group participants (14.7%) and was used by 5.3% of intensive group participants. Multidrug regimens used by the intensive and standard participants at 12 months were as follows: an ACE/ARB with thiazide (12.2% and 7.9%); an ACE/ARB with calcium channel blocker (6.2% and 6.8%); an ACE/ARB, thiazide, and calcium channel blocker (11.4% and 4.3%); and an ACE/ARB, thiazide, calcium channel blocker, and beta-blocker (6.5% and 1.2%). Conclusions: SPRINT investigators favored combining ACEs or ARBs, thiazide diuretics, and calcium channel blockers to target SBP <120 mm Hg, compared to ACE/ARB monotherapy to target SBP <140 mm Hg. Registration: URL: https://clinicaltrials.gov; Unique identifier: NCT01206062. [ABSTRACT FROM AUTHOR]

BACKGROUND Recent US blood pressure (BP) guidelines recommend using ambulatory BP monitoring (ABPM) or home BP monitoring (HBPM) to screen adults for masked hypertension. However, limited evidence exists of the expected long-term effects of screening for and treating masked hypertension. METHODS We estimated the lifetime health and economic outcomes of screening for and treating masked hypertension using the Cardiovascular Disease (CVD) Policy Model, a validated microsimulation model. We simulated a cohort of 100,000 US adults aged ≥20 years with suspected masked hypertension (i.e. office BP 120–129/<80 mm Hg, not taking antihypertensive medications, without CVD history). We compared usual care only (i.e. no screening), usual care plus ABPM, and usual care plus HBPM. We projected total direct healthcare costs (2021 USD), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios. Future costs and QALYs were discounted 3% annually. Secondary outcomes included CVD events and serious adverse events. RESULTS Relative to usual care, adding masked hypertension screening and treatment with ABPM and HBPM was projected to prevent 14.3 and 20.5 CVD events per 100,000 person-years, increase the proportion experiencing any treatment-related serious adverse events by 2.7 and 5.1 percentage points, and increase mean total costs by $1,076 and $1,046, respectively. Compared with usual care, adding ABPM was estimated to cost $85,164/QALY gained. HBPM resulted in lower QALYs than usual care due to increased treatment-related adverse events and pill-taking disutility. CONCLUSIONS The results from our simulation study suggest screening with ABPM and treating masked hypertension is cost-effective in US adults with suspected masked hypertension. [ABSTRACT FROM AUTHOR]

BACKGROUND The PRedicting Out-of-OFfice Blood Pressure (PROOF-BP) algorithm accurately predicted out-of-office blood pressure (BP) among adults with suspected high BP in the United Kingdom and Canada. We tested the accuracy of PROOF-BP in a diverse US population and evaluated a newly developed US-specific algorithm (PROOF-BP-US). METHODS Adults with ≥2 office BP readings and ≥10 awake BP readings on 24-hour ambulatory BP monitoring from 4 pooled US studies were included. We compared mean awake BP with predicted out-of-office BP using PROOF-BP and PROOF-BP-US. Our primary outcomes were hypertensive out-of-office systolic BP (SBP) ≥130 mm Hg and diastolic BP (DBP) ≥80 mm Hg. RESULTS We included 3,058 adults, mean (SD) age was 52.0 (11.9) years, 38% were male, and 54% were Black. The area under the receiver-operator characteristic (AUROC) curve (95% confidence interval) for hypertensive out-of-office SBP was 0.81 (0.79–0.82) and DBP was 0.76 (0.74–0.78) for PROOF-BP. For PROOF-BP-US, the AUROC curve for hypertensive out-of-office SBP was 0.82 (0.81–0.83) and for DBP was 0.81 (0.79–0.83). The optimal predicted out-of-office BP ranges for out-of-office BP measurement referral were 120–134/75–84 mm Hg for PROOF-BP and 125–134/75–84 mm Hg for PROOF-BP-US. The 2017 American College of Cardiology/American Heart Association BP guideline (referral range 130–159/80–99 mm Hg) would refer 93.1% of adults not taking antihypertensive medications with office BP ≥130/80 mm Hg in the National Health and Nutrition Examination Survey for out-of-office BP measurement, compared with 53.1% using PROOF-BP and 46.8% using PROOF-BP-US. CONCLUSIONS PROOF-BP and PROOF-BP-US accurately predicted out-of-office hypertension in a diverse sample of US adults. [ABSTRACT FROM AUTHOR]

Background: Angiotensin II receptor blockers (ARBs) and angiotensin-converting enzyme inhibitors (ACEIs) may positively or negatively impact outcomes in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. We investigated the association of ARB or ACEI use with coronavirus disease 2019 (COVID-19)-related outcomes in US Veterans with treated hypertension using an active comparator design, appropriate covariate adjustment, and negative control analyses. Methods and findings: In this retrospective cohort study of Veterans with treated hypertension in the Veterans Health Administration (01/19/2020-08/28/2020), we compared users of (A) ARB/ACEI vs. non-ARB/ACEI (excluding Veterans with compelling indications to reduce confounding by indication) and (B) ARB vs. ACEI among (1) SARS-CoV-2+ outpatients and (2) COVID-19 hospitalized inpatients. The primary outcome was all-cause hospitalization or mortality (outpatients) and all-cause mortality (inpatients). We estimated hazard ratios (HR) using propensity score-weighted Cox regression. Baseline characteristics were well-balanced between exposure groups after weighting. Among outpatients, there were 5.0 and 6.0 primary outcomes per 100 person-months for ARB/ACEI (n = 2,482) vs. non-ARB/ACEI (n = 2,487) users (HR 0.85, 95% confidence interval [CI] 0.73–0.99, median follow-up 87 days). Among outpatients who were ARB (n = 4,877) vs. ACEI (n = 8,704) users, there were 13.2 and 14.8 primary outcomes per 100 person-months (HR 0.91, 95%CI 0.86–0.97, median follow-up 85 days). Among inpatients who were ARB/ACEI (n = 210) vs. non-ARB/ACEI (n = 275) users, there were 3.4 and 2.0 all-cause deaths per 100 person months (HR 1.25, 95%CI 0.30–5.13, median follow-up 30 days). Among inpatients, ARB (n = 1,164) and ACEI (n = 2,014) users had 21.0 vs. 17.7 all-cause deaths, per 100 person-months (HR 1.13, 95%CI 0.93–1.38, median follow-up 30 days). Conclusions: This observational analysis supports continued ARB or ACEI use for patients already using these medications before SARS-CoV-2 infection. The novel beneficial association observed among outpatients between users of ARBs vs. ACEIs on hospitalization or mortality should be confirmed with randomized trials. [ABSTRACT FROM AUTHOR]

Background: Lisinopril and losartan manufacturer labels recommend twice-daily dosing (BID) if once-daily (QDay) is insufficient to lower blood pressure (BP). Methods and results: Retrospective cohort study of patients taking QDay lisinopril and losartan who experienced a dose-doubling (index date). A text-processing tool categorized BID and QDay groups at the index date based on administration instructions. We excluded: pregnant/hospice, regimens other than BID/QDay, and without BP measurements -6 months/+12 months of the index date. The most proximal BP measurements -6 months and +2 weeks to 12 months of the index date were used to evaluate BP differences. Propensity scores were generated, and differences in BP and adverse events (angioedema, acute kidney injury, hyperkalemia) between BID/QDay groups were analyzed within dosing cohorts using inverse propensity of treatment-weighted regression models. Of 11,210 and 6,051 patients who met all criteria for lisinopril and losartan, 784 (7.0%) and 453 (7.5%) were taking BID, respectively. BID patients were older and had higher comorbidity and medication burdens. There were no differences in systolic/diastolic BP between BID and QDay, with absolute differences in mean systolic BP ranging from -1.8 to 0.7 mmHg and diastolic BP ranging from -1.1 to 0.1 mmHg (all 95% confidence intervals [CI] cross 0). Lisinopril 10mg BID was associated with an increased odds of angioedema compared to lisinopril 20mg QDay (odds ratio 2.27, 95%CI 1.13–4.58). Conclusions: Adjusted models do not support improved effectiveness or safety of BID lisinopril and losartan. [ABSTRACT FROM AUTHOR]

Objective: Early diagnostic prediction in patients with small bowel obstruction (SBO) can improve time to definitive management and disposition in the emergency department. We sought to develop a nomogram to leverage point-of-care ultrasound (POCUS) and maximize accuracy of prediction of SBO diagnosis.Methods: Using data from a prospective cohort of 125 patients with suspected SBO who were evaluated with POCUS in the ED, we developed a nomogram integrating age, gender, comorbidities, prior abdominal surgery, physician's pre-test probability, and POCUS findings to determine post-test risk of SBO. The primary outcome was to develop a nomogram to allow calculating output probabilities for predictive models using POCUS findings. The discriminative ability of the nomogram was tested using a C-statistics, calibration plots, and receiver operating characteristic curves.Results: The derivation cohort included 125 patients with a median age of 54 years who underwent POCUS for a suspected SBO. One-fourth of the patients (25.6% [32/125]) had SBO. Using a retrospective stepwise selection of clinically important variables with the POCUS results, the final nomogram incorporated four relevant factors for the prediction of SBO: small bowel diameter (odds ratio [OR] per 1 mm increase, 1.10; 95% CI, 1.03-1.17; P = 0.001), positive free intraperitoneal fluid between bowel loops (OR, 8.19; 95% CI, 2.62-25.62; P < 0.001), clinician's moderate (OR, 5.94; 95% CI, 0.83-42.57; P = 0.08) or high pretest probability (OR, 11.26; 95% CI, 1.44-88.25; P = 0.02), and patient age (OR per 1 year increase, 1.03; 95% CI, 1.00 to1.07; P = 0.08).The discriminative ability and calibration of the nomogram revealed good predictive ability as indicated by the C-statistic of 0.89 for the SBO diagnosis.Conclusion: A unique nomogram incorporating patient age, physician pretest probability of SBO, and POCUS measurements of small bowel diameter and the presence of free intraperitoneal fluid between bowel loops was developed to accurately predict the diagnosis of SBO in the emergency department. The nomogram should be externally validated in a novel cohort of patients at risk for SBO to better assess predictability and generalizability. [ABSTRACT FROM AUTHOR]