Antihypertensive Treatment May Improve Target Organ Damage in Patients with Masked Hypertension
Phase IV study finds antihypertensive therapy guided by ambulatory blood pressure monitoring improves target organ damage in patients with masked hypertension.
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Antihypertensive medications may improve target organ damage (TOD) in patients with masked hypertension compared to placebo, according to data from the Phase IV ANTI-MASK clinical trial (NCT02893358) published by The Lancet eClinicalMedicine.1,2
Hypertension is among the most common health conditions worldwide and increases the risk of heart attack, heart disease, and stroke. The 2017 American College of Cardiology/American Heart Association Guidelines define hypertension as systolic blood pressure (BP) above 130 mmHg or a diastolic BP more than 80 mmHg.3 The Centers for Disease Control and Prevention estimates that 119.9 million adults have hypertension, comprising 48.1% of the population; however, just 25% of adults with hypertension have their blood pressure under control.4
“Population studies across all races and ethnicities highlight that hypertension is the major modifiable driver of cardiovascular complications and by far the leading risk factor causing death and disability,” the authors of the current study wrote. “Current guidelines propose that the management of hypertension requires out-of-office (BP) monitoring. Masked hypertension is a normal office BP, as measured by a physician or nurse in a medical environment, such as a general practice or an out-patient clinic, combined with an elevated out-of-office BP, recorded by ambulatory or home BP monitoring. Masked hypertension carries a risk similar to that associated with sustained hypertension, i.e., hypertension on office and out-of-office BP measurement.”1
The multicenter, randomized, double-blind, placebo-controlled clinical trial was conducted at 15 hospitals in China and included untreated outpatients aged 30–70 years with an office BP of <140/<90 mm Hg and 24-h, daytime or nighttime ambulatory BP of ≥130/≥80, ≥135/≥85, or ≥120/≥70 mm Hg. A total of 320 patients (43.1% women; mean age ± SD 53.7 ± 9.7 years) were randomly assigned in a 1:1 ratio to receive antihypertensive therapy or placebo, with both patients and investigators masked to group assignment. Antihypertensive treatment involved allisartan at a starting dose of 80 mg per day, which increased to 160 mg per day at the start of the second month, and was combined with amlodipine 2.5 mg per day at the start of month four if ambulatory BP remained uncontrolled.
The results show that baseline office and 24-hour BP averaged 130 ± 6.0/81 ± 5.9 mm Hg and 136 ± 8.6/84 ± 6.1 mm Hg, respectively. Prevalence of increased brachial-ankle pulse wave velocity, urinary albumin-to-creatinine ratio, and left ventricular hypertrophy were 97.5%, 12.5%, and 7.8%, respectively. Twenty-four-hour BP dropped an average (±SE) of 10.1 ± 0.9/6.4 ± 0.5 mm Hg in 153 patients in the active treatment cohort compared to 1.3 ± 0.9/1.0 ± 0.5 mm Hg in 167 patients in the placebo cohort.
Investigators observed improved TOD in 79 patients in the active treatment cohort compared to 49 patients in the placebo cohort, with results of 51.6% (95% CI 43.7%, 59.5%) versus 29.3% (22.1, 36.5%; p < 0.0001), respectively. Adverse events (AEs) were reported by 38 (25.3%) patients in the treatment cohort and 43 (26.4%) patients in the placebo cohort (p = 0.83). These AEs were generally deemed mild in nature, according to the investigators.
“In conclusion, the double-blind placebo-controlled ANTI-MASK trial addressed the question whether antihypertensive treatment guided by ambulatory BP monitoring improves TOD in patients with masked hypertension,” the study authors wrote. “Compared to placebo, active treatment reduced office and ambulatory BP and improved TOD. The clinical implication is that in keeping with current guidelines out-of-office BP monitoring is required for the management of hypertension in patients with suspected masked hypertension and that in such patients the BP lowering treatment should be guided by the out-of-office BP.”1
References
1. Huang JF, Zhang DY, An DW, Li MX, Liu CY, Feng YQ, Zheng QD, Chen X, Staessen JA, Wang JG, Li Y; ANTI-MASK Investigators. Efficacy of antihypertensive treatment for target organ protection in patients with masked hypertension (ANTI-MASK): a multicentre, double-blind, placebo-controlled trial. EClinicalMedicine. 2024 Jul 18;74:102736. doi: 10.1016/j.eclinm.2024.102736. PMID: 39091669; PMCID: PMC11293515.
2. Antihypertensive Treatment in Masked Hypertension for Target Organ Protection (ANTI-MASK). ClinicalTrials.gov ID. September 28, 2021. https://clinicaltrials.gov/study/NCT02893358
3. Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71(6):e13-e115. doi:10.1161/HYP.0000000000000065
4. Centers for Disease Control and Prevention. Facts about Hypertension. Centers for Disease Control and Prevention. September 27, 2021. Accessed August 2, 2024. https://www.cdc.gov/bloodpressure/facts.htm
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