A recent study has shown the noninferiority of mandibular advancement device (MAD) to continuous positive airway pressure (CPAP) for reducing 24-h mean arterial blood pressure (BP) at 1 year among individuals with hypertension and increased cardiovascular risk.
“In participants with hypertension, elevated cardiovascular risk, and obstructive sleep apnoea (OSA), treatment with the MAD or CPAP improved BP and excessive daytime sleepiness,” the researchers said.
Some 321 participants with hypertension and increased cardiovascular risk were recruited for polysomnography in this randomized, noninferiority trial. Of these, 220 with moderate-to-severe OSA (apnoea-hypopnoea index [AHI] ≥15 events/h) were randomly allocated to either MAD or CPAP.
Overall, 180 participants (MAD: n=89; CPAP: n=91) completed the 12-month follow-up. The median usage was 5.5 h per night for MAD and 4.9 h per night for CPAP. [Am J Med 2026;139:1375-1384.e4]
At 12 months, the 24-h mean arterial BP decreased by 2.3 mm Hg in the MAD group (p=0.200) and by 1.0 mm Hg in the CPAP group (p=0.999) compared with baseline. The between-group difference was ‒0.6 mm Hg (95 percent confidence interval, ‒2.53 to 1.39; p<0.019), demonstrating noninferiority. Participants in the MAD group showed a greater reduction in asleep BP than those in the CPAP group.
The prevalence of excessive daytime sleepiness decreased from 30.3 percent at baseline to 10.1 percent at 12 months in the MAD group (p=0.001) and from 38.5 percent to 7.7 percent in the CPAP group (p<0.001), with a between-group difference of 10.6 percent (p=0.097).
The prevalence of arrhythmias and plasma levels of cardiac biomarkers did not significantly differ within or between groups.
“In the context of better adherence than CPAP, MAD was found to be noninferior to CPAP in lowering 24-h mean arterial BP, with a between-group difference favouring MAD, particularly for BP during sleep,” the researchers said.
MAD prescription
The American Academy of Sleep Medicine recognizes MAD as an approved treatment for patients with OSA who refuse CPAP therapy regardless of OSA severity. However, sleep practitioners continue to hesitate prescribing MAD for patients with severe disease. [Pulm Ther 2021;7:25-36; J Clin Sleep Med 2015;11:773-827; Adv Exp Med Biol 2022;1384:373-385]
“We confirm that MAD is effective in reducing daytime and asleep BP, in line with a recent meta-analysis,” the researchers said. “In our study, more than two-thirds of the participants had severe disease.” [Sleep Breath 2024;28:1037-1049]
In subgroup analysis, MAD was noninferior to CPAP for both moderate and severe disease. No significant interactions were seen. This finding suggests the viability of MAD as first-line therapy for moderate-to-severe OSA. Furthermore, MAD results in numerically greater BP reduction in participants using at least three antihypertensive agents compared with CPAP, particularly for asleep BP.
“While limited by sample size, these findings suggest that the relative effectiveness of MAD is preserved even in this higher-risk phenotype. In populations with near-target baseline BP, large absolute reductions are generally not expected,” the researchers said.
“We believe treating OSA should not replace BP medication as the primary BP-lowering therapy, but it helps to further improve cardiovascular risk,” they added.