乌鸦传媒

NASHVILLE, Tenn. -- Individuals with idiopathic hypersomnia may face a greater likelihood of heart-related events, a retrospective cohort study suggested.

Compared with matched controls without the rare sleep disorder, patients diagnosed with idiopathic hypersomnia had a twofold higher odds of having a history of cardiovascular disease (OR 2.26, 95% CI 2.14-2.38) or of experiencing a major cardiovascular event (MACE; OR 2.08, 95% CI 1.89-2.30), including significantly increased odds of:

• Stroke: OR 2.07 (95% CI 1.87-2.29)
• Hypertension/use of antihypertensives: OR 2.02 (95% CI 1.93-2.12)
• Heart failure: OR 1.97 (95% CI 1.76-2.20)
• Atrial fibrillation: OR 1.91 (95 CI 1.66-2.20)
• Myocardial infarction: OR 1.74 (95% CI 1.42-2.12)
• Coronary revascularization: OR 1.58 (95% CI 1.12-2.17)

According to findings presented in a poster at Psych Congress 2023 by Wayne Macfadden, MD, of Jazz Pharmaceuticals in Philadelphia, the only cardiovascular condition that wasn't significantly more likely among these patients was cardiac arrest, although this condition still trended higher (OR 1.44, 95% CI 0.91-2.20). Macfadden's group noted that there were fewer than 250 total events of cardiac arrest in this study population.

"Patients with IH [idiopathic hypersomnia] have higher odds of cardiovascular conditions compared with non-IH cohorts, highlighting the importance of cardiovascular health in people with IH, because some therapies that treat IH symptoms carry cardiovascular risks," Macfadden pointed out. "Clinicians should prioritize therapies that treat IH symptoms without increasing cardiovascular risk."

This is echoed in the 's clinical practice guidelines for treatment of hypersomnolence, which advises that "clinicians should individualize treatment selections based on patients' age, pregnancy status and reproductive planning, comorbidities including cardiovascular disease, allergies/history of adverse events, risk of dependency/potential for drug misuse, and goals of care."

Macfadden added that prior to the approval of calcium, magnesium, potassium, and sodium oxybate oral solution (Xywav), there were no other medications specifically indicated for idiopathic hypersomnia.

The drug carries a boxed warning as a central nervous system depressant and for its abuse and misuse potential. Because of these risks, the drug is available only through a risk evaluation and mitigation strategy (REMS) program.

The oral solution has 92% less sodium than sodium oxybate (Xyrem), which was approved in 2002. Previously, stimulants were often prescribed for patients with idiopathic hypersomnia to help them stay awake during the day.

For this retrospective cohort study, Macfadden's group pulled administrative claims from Merative MarketScan from the end of 2013 to early 2020. They included 11,412 patients with idiopathic hypersomnia matched 1:5 with 57,058 controls without idiopathic hypersomnia based on age, sex, location, insurance type, and cohort entry date. The median age was 45 and 65% were female.

All included patients were at least 18 with continuous medical coverage for a year prior and after study entry (75% had commercial insurance), without a medical history of cataplexy.

The most common cardiovascular condition was hypertension or the use of antihypertensives (45.7% of the idiopathic hypersomnia cohort vs 32.3% of the non-idiopathic hypersomnia cohort), followed by cardiovascular disease (24.4% vs 14.1%), MACE (5.7% vs 3.1%), stroke (5.2% vs 2.8%), atrial fibrillation (2.6% vs 1.5%), and myocardial infarction (1.2% vs 0.7%).

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