Diagnosis and Management of Infantile Hemangioma

Table 17. Key resolution outcomes in studies comparing nadolol and propranolol
Author,
Year
Comparison
Groups (n)
Quality
Pope et al,
2012 101
G1: Nadolol
suspension
up to 4
mg/kg/day
(10)
G2:
Propranolol
maximum
dose 2-3
mg/kg/day
(historical
group) (9)
Quality:
Poor
Age,
months
Type
Age,
mean±SD
G1: 4.1 ±
2.23
G2: 4.8 ±
1.92
Type, n:
Superficial
and deep
G1: 6
G2: 9
Deep
G1: 4
G2: 0
Location
G1+G2:
multiple
Methods and Measures
of
Resolution/Response
• Serial photographs
and clinical
assessment using
100-mm visual
analog scale (VAS);
blinded assessors
(-): 100% worsening
0: no change
(+): 100% shrinkage
where 5 mm
represented 10%
change
Resolution
Outcomes
Percentage IH
shrinkage, mean ±
SD
G1: 97 ± 3.05%
G2: 86 ± 14.82%
G1 vs.G2: p< 0.008
Rebound
Growth/
Recurrence,
n (%)
G = groups; IH = infantile hemangioma; kg = kilograms; mm = millimeter; mg = milligram; n = number; NR = not reported;
SD = standard deviation
Oral Propranolol Compared With Other Dosage Forms
In a fair quality single blinded RCT conducted in Egypt, 45 consecutive patients with
problematic, superficial IH (rapidly progressive, compromising vital or normal physiological
function, or causing disfigurement) were assigned to one of three treatments: oral propranolol (2
mg/kg/day divided into two daily doses, n=15), topical propranolol 1 percent ointment applied
twice daily, or intralesional propranolol (1 mg propranolol hydrochloride as a 1 mL injection,
n=15) repeated weekly (0.2 mL injected per 1 cm lesion diameter to a maximum of 1 mL, doses
divided among multiple lesions, n=15) (Table 18). 93 Twelve (80%) patients treated with oral
propranolol had improvement in their IH: nine (60%) patients showed a complete response; 2
(13.3%) demonstrated a sustained plateau with > 50 percent reduction in size; 1 (6.7%) showed a
sustained plateau with 50
percent reduction in size, 2 (13.3%) showed a sustained plateau with < 50 percent reduction in
size, and five (33.3%) had no response to treatment. Eight (53.3%) patients treated with
intralesional propranolol showed improvement in their IH. Two (13.3%) participants had a
complete response; three (20%) demonstrated a sustained plateau with ≥ 50 percent reduction in
size; three (20%) had a sustained plateau with less than 50 percent reduction in size, seven
children (46.7%) had no response. Rebound growth was documented in one (6.7%), one (6.7%)
and two (13.3%) children treated with oral, topical, and intralesional propranolol, respectively.
Time to achieve initial response and duration of treatment needed to achieve the final response
were significantly greater in both the topical (3-8 weeks to initial response; 5-10 months
treatment duration) and intralesional propranolol (4-8 weeks to initial response; 5-12 months
treatment duration) groups as compared with the oral propranolol group (2-4 weeks to initial
response; 3-9 months treatment duration, p values ≤ 0.01).
NR
53