TABLE 5

Summary of Propranolol Exposure

Manufacturer’s Pooled Clinical Trial Data (Safety Set)a
PropranololPropranolol
1 mg/kg per day (n = 200)3 mg/kg per day (n = 235)All (N = 435)Placebo (N = 55)Literature Data (N = 3766)CUP (N = 1661)
Propranolol dose, mg/kg per dayN = 1587
 Descriptive dataNot applicable; specified dose received according to assigned treatmentTarget doseAverage received
 Mean2.1 (n = 82)2.0
 Median2.0
 Range0.75-4.00.4–4.0
Treatment duration, moN = 236 (Placebo)N = 657 (CUP)
 Descriptive dataActual extent of exposure by dose of propranolol or placebo whatever regimen, and taking all propranololbMean of mean/median (in completers)
 Mean (SD)3.95 (1.62)3.91 (1.45)3.93 (1.53)2.39 (1.30)7.7 (n = 51)c8.6
 Median2.902.902.902.757.3
 Range0.0–7.20.2–6.20.0–7.20.2–5.80.2–32.0 (n = 56)0.1–36.8
Actual extent of exposure, patient-months787.1917.21704.3562.3
  • a Manufacturer’s pooled clinical trial data are presented by dose of propranolol or placebo (whatever the assigned regimen) and for all patients treated with propranolol whatever the dose. Therefore, for those patients assigned to one of the two 3-mo propranolol regimens (followed by 3 mo taking placebo), data are presented within both the propranolol and placebo groups according to the period during which the event occurred. Patients in study 301 who received 2 mg/kg per day of propranolol were analyzed with the 3-mg/kg-per-day group for data described by dose and in the “all propranolol” column describing all patients treated with propranolol whatever the dose.

  • b Note that mean exposure for the manufacturer’s data for 1 and 3 mg/kg per day pooled by dose, both the 1- and 3- mg/kg-per-day doses included patients assigned to the 3- and 6-mo regimens, which is therefore reflected in the mean dose. Refer to the study for further details.16

  • c Estimated mean duration for articles presenting mean duration data (n = 51).