METHODS: We assessed changes in BP by treatment regimen and evaluated the relative contribution of kidney function and weight gain to these changes among participants in the ADVANCE phase-3 trial clinical trial in South Africa (study dates: January 2017-February 2022). Our primary outcome of interest was a change in systolic BP (SBP) at 96 and 192 weeks, among those not receiving antihypertensive medication. The secondary outcome was treatment-emergent hypertension at these same time points, defined as BP ≥140/90 mmHg on two occasions, or initiation of antihypertensive medication after week 4 among individuals without hypertension at enrolment. We used linear regression to evaluate the relationship between change in estimated glomerular filtration rate (eGFR) and change in SBP; and Poisson regression to evaluate the relationship between change in eGFR and treatment-emergent hypertension at each time point. All models were adjusted for age, sex, treatment group and change in body mass index (BMI).
RESULTS: Over 96 weeks, the average changes in SBP were 1.7 mmHg (95% CI: 0.0-3.4), -0.5 mmHg (95% CI: -2.2 to 1.7) and -2.1 mmHg (95% CI: -3.8 to 0.4) in the TAF/emtricitabine (FTC)/DTG, tenofovir disoproxil fumarate (TDF)/FTC/DTG and TDF/FTC/efavirenz (EFV) groups, respectively. This difference was significant for the TAF/FTC/DTG compared to the TDF/FTC/EFV group (p = 0.002). Over 96 weeks, 18.2% (95% CI: 13.4-22.9), 15.4% (95% CI: 11.0-19.9) and 13.3% (95% CI: 8.9-17.6) of participants developed treatment-emergent hypertension, respectively. In adjusted models, there was no significant relationship between change in eGFR and either outcome. Change in BMI was significantly associated with an increase in SBP, while age was associated with an increased risk of treatment-emergent hypertension. Adjustment for BMI also mitigated the unadjusted relationship between HIV treatment regimen and SBP where present.
CONCLUSIONS: In the ADVANCE cohort, weight gain and age accounted for increases in BP and risk of treatment-emergent hypertension. HIV treatment programmes may need to integrate the management of obesity and hypertension into routine care.
BACKGROUND: NCT03122262.
方法:我们通过治疗方案评估了BP的变化,并评估了南非ADVANCE3期临床试验参与者中肾功能和体重增加对这些变化的相对贡献(研究日期:2017年1月至2022年2月)。我们感兴趣的主要结果是在96周和192周收缩压(SBP)的变化,在那些没有接受降压药的人中。次要结果是在这些相同的时间点治疗引起的高血压,定义为两次BP≥140/90mmHg,在招募时无高血压的个体中,或在第4周后开始使用抗高血压药物。我们使用线性回归来评估估计肾小球滤过率(eGFR)的变化与SBP变化之间的关系;和Poisson回归来评估eGFR变化与每个时间点的治疗引起的高血压之间的关系。所有模型都根据年龄进行了调整,性别,治疗组和体重指数(BMI)的变化。
结果:超过96周,SBP的平均变化为1.7mmHg(95%CI:0.0-3.4),TAF/恩曲他滨(FTC)/DTG中的-0.5mmHg(95%CI:-2.2至1.7)和-2.1mmHg(95%CI:-3.8至0.4),富马酸替诺福韦酯(TDF)/FTC/DTG和TDF/FTC/依法韦伦(EFV)组,分别。与TDF/FTC/EFV组相比,TAF/FTC/DTG的这种差异是显著的(p=0.002)。超过96周,18.2%(95%CI:13.4-22.9),15.4%(95%CI:11.0-19.9)和13.3%(95%CI:8.9-17.6)的参与者出现了因治疗引起的高血压,分别。在调整后的模型中,eGFR的变化与任一结局之间均无显著关系.BMI的变化与SBP的增加显着相关,而年龄与治疗引起的高血压风险增加相关.调整BMI也减轻了HIV治疗方案与SBP之间存在的未调整关系。
结论:在ADVANCE队列中,体重增加和年龄导致血压升高和治疗引起的高血压风险.艾滋病毒治疗方案可能需要将肥胖和高血压的管理纳入常规护理。
背景:NCT03122262。