Name: Azetukalner (XEN1101) in Focal onset seizures: Natural history, survival, and mortality
Published: 2026-09-21T21:41:53-04:00

Product information and disease description Place of product in therapy Disease description

Natural history, survival, and mortality

6 evidence topics · 4 sources

Standardized mortality ratios in epilepsy

“All of these nine showed significant elevations of their SMRs ranging from 1.6 to 3.0.” (opens the source at this quote in a new tab)
“Among six of these population-based studies representing incidence cohorts including all ages, the weighted median SMR was 2.3.” (opens the source at this quote in a new tab)
“Standard mortality ratios are especially high among people with epilepsy aged <50 years, among those whose epilepsy is categorized as structural/metabolic, those whose seizures do not fully remit under treatment, and those with convulsive seizures.” (opens the source at this quote in a new tab)
“Among deaths directly attributable to epilepsy or seizures, important immediate causes include sudden unexpected death in epilepsy (SUDEP), status epilepticus, unintentional injuries, and suicide.” (opens the source at this quote in a new tab)

Incidence of sudden unexpected death in epilepsy

“SUDEP risk in children with epilepsy (aged 0–17 years) is 0.22/1,000 patient-years (95% CI 0.16–0.31) (high confidence in evidence). SUDEP risk increases in adults to 1.2/1,000 patient-years (95% CI 0.64–2.32) (low confidence in evidence).” (opens the source at this quote in a new tab)
“The major risk factor for SUDEP is the occurrence of generalized tonic-clonic seizures (GTCS); the SUDEP risk increases in association with increasing frequency of GTCS occurrence (high confidence in evidence).” (opens the source at this quote in a new tab)
“Clinicians should inform adult patients with epilepsy that SUDEP typically affects 1 in 1,000 adults with epilepsy per year; therefore, annually 999 of 1,000 adults will not be affected.” (opens the source at this quote in a new tab)
“Clinicians should inform persons with epilepsy that seizure freedom, particularly freedom from GTCS, is strongly associated with decreased SUDEP risk.” (opens the source at this quote in a new tab)

Sudden unexpected death in epilepsy in treatment-resistant populations

“Nine clinic-based studies, mainly representing people with treatment-resistant epilepsy, yielded higher estimates of SUDEP occurrence, ranging from 1.2 to 6.3 cases of SUDEP annually per 1,000 individuals.” (opens the source at this quote in a new tab)

Mortality by seizure control status in drug-resistant focal epilepsy

“An Austrian study found that the standardized mortality ratio for those not seizure free was 3.3 (95% CI 2.6−4.4) compared to 1.4 (95% CI 0.8−2.3) for those seizure free 2 years after diagnosis” (opens the source at this quote in a new tab)
“Clinic-based studies report an estimate of SUDEP in people with drug-resistant focal epilepsy of up to 6.3 per 1000 people” (opens the source at this quote in a new tab)
“People with epilepsy are at a 27-fold higher risk of sudden death than controls, but this falls to a 16-fold risk when adjusted for sex, comorbidities, and the Charlson comorbidity score” (opens the source at this quote in a new tab)

Seizure-related injury, drowning, and suicide

“An observational study of people with epilepsy and convulsive seizures found that ∼60% of the population experienced at least one accidental injury associated with convulsions over 12 months; common injuries in this population included head injuries (35.5%), dental injuries (4.9%), and burns (4.9%)” (opens the source at this quote in a new tab)
“The risk of drowning is also higher in people with epilepsy, with an estimated relative risk ranging from 13- to 19-fold” (opens the source at this quote in a new tab)
“Attempted and completed suicides are estimated to occur in 5−14.3% of people with epilepsy” (opens the source at this quote in a new tab)
“the suicide-specific standardized mortality ratio among those with epilepsy is estimated to be 3.3 (95% CI: 2.8−3.7)” (opens the source at this quote in a new tab)

Global mortality attributable to idiopathic epilepsy

“Global age-standardised mortality rates of idiopathic epilepsy were 1·74 per 100 000 population (1·64–1·87; 1·40 per 100 000 population [1·23–1·54] for women and 2·09 per 100 000 population [1·96–2·25] for men).” (opens the source at this quote in a new tab)