The Journal of antimicrobial chemotherapy · 2025
Hypertension and blood pressure changes with dolutegravir or comparator antiretroviral therapy in randomized trials through 96 weeks.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Patel Parul, Milinkovic Ana, Grove Richard, Govan Lindsay, McKenna Michael, Wynne Brian, Henegar Cassidy, Martinez Esteban, Dimondi Paul, Chow Ken, Payvandi Nassrin, Jones Bryn
Аннотация
BACKGROUND: To date, there are limited published data from randomized trials evaluating the effects of integrase strand transfer inhibitor-based regimens, including dolutegravir-based antiretroviral therapy (ART), on blood pressure (BP) in people with HIV-1 (PWH).
OBJECTIVES: This analysis evaluated BP changes from baseline and incident hypertension among ART-naive PWH randomized to dolutegravir-based three-drug ART or alternative comparator ART (cART) across pooled Phase 2/3 studies.
METHODS: In this post hoc analysis of Phase 2/3 SPRING-1, SPRING-2, SINGLE and FLAMINGO clinical trials, BP was assessed at baseline, Week (W) 48 and W96. In PWH without evidence of hypertension at baseline, incident hypertension was defined as a single systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg measured after a 5 min rest, a hypertension adverse event and/or antihypertensive medication use during follow-up. Baseline factors associated with incident hypertension at W96 were assessed through multivariate analyses. BP changes between dolutegravir and cART were also assessed.
RESULTS: Among 2345 randomized participants, 1815 (77%) had no evidence of hypertension at baseline; 927 received dolutegravir-based ART and 888 received cART. Through W96, incident hypertension did not differ between groups [dolutegravir, 23% (n = 180/779); cART, 21% (n = 139/665); adjusted OR, 1.02; 95% CI, 0.79-1.33]; ∼1% of participants initiated antihypertensive medication through W96 (dolutegravir, n = 3; cART, n = 1). At W96, no significant BP changes from baseline were observed (systolic BP, P = 0.741; diastolic BP, P = 0.683).
CONCLUSIONS: Relative to non-dolutegravir-containing cART, dolutegravir-containing three-drug ART did not show any impact on incident hypertension in ART-naive PWH without evidence of hypertension at baseline through W96.
OBJECTIVES: This analysis evaluated BP changes from baseline and incident hypertension among ART-naive PWH randomized to dolutegravir-based three-drug ART or alternative comparator ART (cART) across pooled Phase 2/3 studies.
METHODS: In this post hoc analysis of Phase 2/3 SPRING-1, SPRING-2, SINGLE and FLAMINGO clinical trials, BP was assessed at baseline, Week (W) 48 and W96. In PWH without evidence of hypertension at baseline, incident hypertension was defined as a single systolic BP ≥ 140 mmHg and/or diastolic BP ≥ 90 mmHg measured after a 5 min rest, a hypertension adverse event and/or antihypertensive medication use during follow-up. Baseline factors associated with incident hypertension at W96 were assessed through multivariate analyses. BP changes between dolutegravir and cART were also assessed.
RESULTS: Among 2345 randomized participants, 1815 (77%) had no evidence of hypertension at baseline; 927 received dolutegravir-based ART and 888 received cART. Through W96, incident hypertension did not differ between groups [dolutegravir, 23% (n = 180/779); cART, 21% (n = 139/665); adjusted OR, 1.02; 95% CI, 0.79-1.33]; ∼1% of participants initiated antihypertensive medication through W96 (dolutegravir, n = 3; cART, n = 1). At W96, no significant BP changes from baseline were observed (systolic BP, P = 0.741; diastolic BP, P = 0.683).
CONCLUSIONS: Relative to non-dolutegravir-containing cART, dolutegravir-containing three-drug ART did not show any impact on incident hypertension in ART-naive PWH without evidence of hypertension at baseline through W96.