A post-authorisation safety study (PASS) to evaluate cardiovascular events in adult patients with obstructive sleep apnoea (OSA) treated with solriamfetol (JZP865-401)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  SUNOSI
• Study drug International non-proprietary name (INN) or common name:
  SOLRIAMFETOL HYDROCHLORIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (N06BA14) solriamfetol

  solriamfetol
• Medical condition to be studied:
  Obstructive sleep apnoea syndrome

Population studied

• Short description of the study population:
  Feasibility carried out in France and Germany suggests the study will have 13,800 and 3,328 patients, respectively, eligible within the solriamfetol group.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  17128

Study design details

• Main study objective:
  The study objectives differ slightly between the descriptive and prevalent new user designs. Prevalent new user: To estimate and compare the incidence rate of MACE in adults newly exposed to solriamfetol plus PAP vs patients exposed only to PAP (France). Descriptive: To estimate the incidence rate of MACE in adults newly exposed to solriamfetol irrespective of PAP use (France and Germany).
• Outcomes:
  Prevalent new user: The primary outcome is a composite measure of MACE, i.e., the first event of the following: non-fatal acute myocardial infarction (MI), non-fatal stroke, and all-cause mortality. ; ; Descriptive: The primary outcome is a composite measure of MACE, defined as the first event of the following: (fatal or non-fatal) acute MI, (fatal or non-fatal) stroke, and all-cause mortality.; ; Individual MACE components & other CV events of interest (arrhythmic events, unstable angina, heart failure, hospitalisation for revascularisation procedures) analysed separately. Serious psychiatric events assessed from hospitalisation records analysed. Outcomes include psychotic/manic symptoms, aggressive and hostile behaviour, anxiety, agitation/ tension, major depressive disorder, irritability
• Data analysis plan:
  For both approaches an exploratory descriptive analysis will be conducted. Continuous variables described using mean, standard deviation, median, first and third quartiles, minimum, maximum. Categorical variables described by the number and % of patients/category. The number of patients with missing data/variable reported. Estimates of incidence rates (with 95% CI) calculated. In the prevalent new user design, effect measure will be multivariable adjusted Hazard Ratio of MACE outcome comparing those exposed to solriamfetol plus PAP vs PAP only. This comparative analysis will be performed by identifying the comparator PAP patients for each patient newly exposed to solriamfetol plus PAP based on the duration of PAP use. Constructing time-conditional propensity scores to identify the comparator PAP only users most similar to the users of solriamfetol plus PAP. Cox proportional hazards model used to study the association between exposure and outcome by adjusting to time-fixed covariates.