Sodium Oxybate Alters Sleep Structure, FDA Approves Deutetrabenazine, Associations of Stroke Decreased With Age

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Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Findings from a small-scale, longitudinal study assessing patients with narcolepsy with cataplexy showed that after 3 years of treatment with low to medium doses of sodium oxybate, there were significant differences in sleep structure and an increase in comorbidities that led to drug withdrawal. To the study authors knowledge, this was the longest recorded trial evaluating the effect of sodium oxybate on sleep architecture and comorbidity with video-polysomnography. The trial featured 23 adults with NT1 who were treated with an initial nocturnal dose of 4.5 g of sodium oxybate, with sleep parameters compared after 6 months, 1 year, and 3 years of uninterrupted treatment. Findings on video polysomnography showed an increase in stage N3 in the first sleep cycle and a REM-onset in 90% of patients after the administration of the first dose. When comparing the time spent in the different sleep stages between FU-1 and FU-2, patients increased the time spent in stage N2.

The FDA has given the go-ahead to deutetrabenazine (Austedo XR; Teva Pharmaceuticals) in a once-daily, extended-release formulation for the treatment of adults with tardive dyskinesia (TD) and chorea associated with Huntington disease (HD).1 Teva announced that the new formulation of the previously approved twice-daily therapy is anticipated to become available some time in 2023. Deutetrabenazine is a VMAT2 inhibitor with 3 years’ worth of data for both indications. In October 2022, Teva announced the findings from its phase 3 open-label, single-arm, 2-cohort, multicenter, ARC-HD extension study (NCT01897896) which demonstrated that treatment with deutetrabenazine was safe and improved and maintained chorea in patients with HD over a 3-year treatment period. The new extended-release formulation is expected to be available in 3 tablet strengths: 6 mg, 12 mg, and 24 mg. All 3 can be administered with or without food.

A recently published study in Neurology showed that the known associations of hypertension and diabetes with stroke may decrease with age. The magnitude association for stroke was significantly less in patients at older ages with diabetes (HR decreased between ≈2.0 in younger strata and ≈1.3 in older strata). In addition, the magnitude of stroke risk decreased in older patients with heart disease (between ≈2.0 and ≈1.3), and hypertension, at a threshold of 140/90 mmHg (between ≈1.80 and ≈1.50). However, no age-related difference was observed in the magnitude of the association for smoking, atrial fibrillation or left ventricular hypertrophy.

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