METHODOLOGY: A single center, prospective, single-blind randomized trial was conducted to estimate the survival of post-dialysis euvolemic hypertensive patients when treated with lorsartan 50 mg every other day. Post-dialysis euvolemic assessment was done by a body composition monitor. Covariate Adaptive Randomization was used for allocation of participants to the standard or intervention arm, and the follow-up duration was twelve months. The primary end point was achieving targeted blood pressure (BP) of <140/90 mm Hg and maintaining for 4 weeks, whereas secondary end point was all cause of mortality. Pre-, intra-, and post-dialysis session BP measurements were recorded, and survival trends were analyzed using Kaplan-Meier analysis.
RESULTS: Of the total 229 patients, 96 (41.9%) were identified as post-dialysis euvolemic hypertensive. Final samples of 88 (40.1%) patients were randomized into standard (n = 44) and intervention arms (n = 44), and 36 (81.8%) patients in each arm completed a follow-up of 12 months. A total of eight patients passed away during the 12-month follow-up period (6 deaths among standard arm and 2 in intervention arm). However, the probability of survival between both arms was not significant (p = 0.13). Cox regression analysis revealed that chances of survival were higher among the patients in the intervention (OR 3.17) arm than the standard arm (OR 0.31); however, the survival was found not statistically significant.
CONCLUSION: There was no statistical significant difference in 1 year survival of post-dialysis euvolemic hypertensive patients when treated with losartan 50 mg.
OBJECTIVES: The Triple Therapy Prevention of Recurrent Intracerebral Disease Events Trial (TRIDENT) aims to determine the effects of a novel SPC "Triple Pill," three generic antihypertensive drugs with demonstrated efficacy and complementary mechanisms of action at half standard dose (telmisartan 20 mg, amlodipine 2.5 mg, and indapamide 1.25 mg), with placebo for the prevention of recurrent stroke, cardiovascular events, and cognitive impairment after ICH.
DESIGN: An international, double-blind, placebo-controlled, randomized trial in adults with ICH and mild-moderate hypertension (systolic BP: 130-160 mmHg), who are not taking any Triple Pill component drug at greater than half-dose. A total of 1500 randomized patients provide 90% power to detect a hazard ratio of 0.5, over an average follow-up of 3 years, according to a total primary event rate (any stroke) of 12% in the control arm and other assumptions. Secondary outcomes include recurrent ICH, cardiovascular events, and safety.
RESULTS: Recruitment started 28 September 2017. Up to 31 October 2021, 821 patients were randomized at 54 active sites in 10 countries. Triple Pill adherence after 30 months is 86%. The required sample size should be achieved by 2024.
CONCLUSION: Low-dose Triple Pill BP lowering could improve long-term outcome from ICH.
METHODS: We analysed the availability, costs, and affordability of blood pressure-lowering medicines with data recorded from 626 communities in 20 countries participating in the Prospective Urban Rural Epidemiological (PURE) study. Medicines were considered available if they were present in the local pharmacy when surveyed, and affordable if their combined cost was less than 20% of the households' capacity to pay. We related information about availability and affordability to use of these medicines and blood pressure control with multilevel mixed-effects logistic regression models, and compared results for high-income, upper-middle-income, lower-middle-income, and low-income countries. Data for India are presented separately because it has a large generic pharmaceutical industry and a higher availability of medicines than other countries at the same economic level.
FINDINGS: The availability of two or more classes of blood pressure-lowering drugs was lower in low-income and middle-income countries (except for India) than in high-income countries. The proportion of communities with four drug classes available was 94% in high-income countries (108 of 115 communities), 76% in India (68 of 90), 71% in upper-middle-income countries (90 of 126), 47% in lower-middle-income countries (107 of 227), and 13% in low-income countries (nine of 68). The proportion of households unable to afford two blood pressure-lowering medicines was 31% in low-income countries (1069 of 3479 households), 9% in middle-income countries (5602 of 65 471), and less than 1% in high-income countries (44 of 10 880). Participants with known hypertension in communities that had all four drug classes available were more likely to use at least one blood pressure-lowering medicine (adjusted odds ratio [OR] 2·23, 95% CI 1·59-3·12); p<0·0001), combination therapy (1·53, 1·13-2·07; p=0·054), and have their blood pressure controlled (2·06, 1·69-2·50; p<0·0001) than were those in communities where blood pressure-lowering medicines were not available. Participants with known hypertension from households able to afford four blood pressure-lowering drug classes were more likely to use at least one blood pressure-lowering medicine (adjusted OR 1·42, 95% CI 1·25-1·62; p<0·0001), combination therapy (1·26, 1·08-1·47; p=0·0038), and have their blood pressure controlled (1·13, 1·00-1·28; p=0·0562) than were those unable to afford the medicines.
INTERPRETATION: A large proportion of communities in low-income and middle-income countries do not have access to more than one blood pressure-lowering medicine and, when available, they are often not affordable. These factors are associated with poor blood pressure control. Ensuring access to affordable blood pressure-lowering medicines is essential for control of hypertension in low-income and middle-income countries.
FUNDING: Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, Canadian Institutes of Health Research Strategy for Patient Oriented Research through the Ontario SPOR Support Unit, the Ontario Ministry of Health and Long-Term Care, pharmaceutical companies (with major contributions from AstraZeneca [Canada], Sanofi Aventis [France and Canada], Boehringer Ingelheim [Germany amd Canada], Servier, and GlaxoSmithKline), Novartis and King Pharma, and national or local organisations in participating countries.
DESIGN: Analysis of cross-sectional data collected from participants in a prospective cohort study.
SETTING: The Victorian rural towns of Morwell and Sale in 2018-2019.
PARTICIPANTS: A weighted random sample of 1119 eligible participants from Morwell or Sale, aged ≥55-90 years for men and ≥60-90 years for women, was drawn from the Hazelwood Health Study's Adult Survey cohort.
MAIN OUTCOME MEASURES: Blood pressure, body mass index, left ventricular hypertrophy by electrocardiogram, estimated glomerular filtration rate and glycosylated haemoglobin (HbA1c ) were measured. Participants with hypertension were categorised as managed, undermanaged or unmanaged.
RESULTS: Testing undertaken of 498 participants estimated the weighted prevalence of hypertension (defined as blood pressure ≥ 140/90 mm Hg, a self-reported doctor diagnosis of hypertension or taking antihypertensive medication) to be 79.9% (95% confidence interval: 75.7-83.4). Of those, 54.5% (49.4-60.0) had managed hypertension (<140/90 mm Hg), 37.1% (32.3-42.1) undermanaged hypertension and 8.4% (5.9-11.9) a new finding of hypertension (unmanaged hypertension). Current employment (relative risk 1.47, 95% confidence interval: 1.06-2.02) and single marital status (relative risk 1.45, 1.4-1.84) were associated with under- or unmanaged hypertension. Compared with no hypertension, the hypertensive groups were more likely to demonstrate markers of end-organ damage such as left ventricular hypertrophy and impaired renal function.
CONCLUSION: Hypertension is a highly prevalent condition among older rural Australians which is suboptimally identified and managed.
Materials and Methods: A total of 149 and 150 patients were randomized to intervention and usual care (control) groups, respectively. A 12-month task-shifting (nurse-driven) HBFC intervention was administered to intervention group. The mid-term impact of intervention on HRQoL was assessed after 6 months intervention. Data were analyzed with intention-to-treat principle. Treatment effects were measured with the t-tests, analysis of covariance, and multivariate analysis of covariance analysis. Significant levels were set at P < 0.05 and 95% confidence interval.
Results: The between-group treatment effect was not statistically significant (P > 0.05), whereas the within-group treatment effects were statistically significant for both the intervention and control arms (P < 0.05) at 6 months. After controlling for age and baseline HRQoL, the intervention group had an improved physical component of HRQoL than the control group. The intervention group also had statistically significant improvement in blood pressure control, medication adherence, and symptom counts (P < 0.05).
Conclusion: The HBFC intervention for hypertensive patients impacted positively on physical component of HRQoL after controlling for baseline HRQoL and age of the patients at 6 months post-intervention.