propranolol and Abnormalities, Multiple studies

Propranolol: A widely used non-cardioselective beta-adrenergic antagonist. Propranolol has been used for MYOCARDIAL INFARCTION; ARRHYTHMIA; ANGINA PECTORIS; HYPERTENSION; HYPERTHYROIDISM; MIGRAINE; PHEOCHROMOCYTOMA; and ANXIETY but adverse effects instigate replacement by newer drugs.
propranolol : A propanolamine that is propan-2-ol substituted by a propan-2-ylamino group at position 1 and a naphthalen-1-yloxy group at position 3.

Abnormalities, Multiple: Congenital abnormalities that affect more than one organ or body structure.

Research Excerpts

Excerpt	Relevance	Reference
"There are recent reports of effective treatment of cutaneous hemangiomas with Propranolol."	7.75	Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. ( Denoyelle, F; Enjolras, O; Garabedian, EN; Harris, R; Leboulanger, N; Roger, G, 2009)
"Prior to propranolol the systemic treatment for haemangiomas was prednisolone and then the concern was the opposite, namely hypertension."	5.42	Propranolol and prednisolone combination for the treatment of segmental haemangioma in PHACES syndrome. ( Batul Syed, S; Gnarra, M; Harper, J; Solman, L, 2015)
"PHACE syndrome is a neurocutaneous disorder with large facial segmental hemangionas associated with anomalies of the brain, eye, heart and aorta."	5.37	Use of propranolol for treatment of hemangiomas in PHACE syndrome. ( Deming, D; Hopper, A; Merritt, TA; Ninnis, J; Solomon, T, 2011)
"There are recent reports of effective treatment of cutaneous hemangiomas with Propranolol."	3.75	Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. ( Denoyelle, F; Enjolras, O; Garabedian, EN; Harris, R; Leboulanger, N; Roger, G, 2009)
"Prior to propranolol the systemic treatment for haemangiomas was prednisolone and then the concern was the opposite, namely hypertension."	1.42	Propranolol and prednisolone combination for the treatment of segmental haemangioma in PHACES syndrome. ( Batul Syed, S; Gnarra, M; Harper, J; Solman, L, 2015)
"PHACE syndrome is a neurocutaneous disorder with large facial segmental hemangionas associated with anomalies of the brain, eye, heart and aorta."	1.37	Use of propranolol for treatment of hemangiomas in PHACE syndrome. ( Deming, D; Hopper, A; Merritt, TA; Ninnis, J; Solomon, T, 2011)

Research

Studies (12)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Allergy/Immunology Adverse Events

Timeframe	Studies, this research(%)	All Research%
pre-1990	4 (33.33)	18.7374
1990's	0 (0.00)	18.2507
2000's	1 (8.33)	29.6817
2010's	7 (58.33)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Banganho, D	1
Oliveira, I	1
Machado, C	1
Póvoas, M	1
Rokugo, Y	1
Ota, C	1
Kimura, M	1
Sasahara, Y	1
Léauté-Labrèze, C	1
Bronzetti, G	1
Patrizi, A	1
Giacomini, F	1
Savoia, F	1
Raone, B	1
Brighenti, M	1
Bonvicini, M	1
Neri, I	1
Gargiulo, GD	1
Gnarra, M	1
Solman, L	1
Harper, J	1
Batul Syed, S	1
Yu, X	1
Zhang, J	1
Wu, Z	1
Liu, M	1
Chen, R	1
Gu, Y	1
Li, M	1
Yao, Z	1
Denoyelle, F	1
Leboulanger, N	1
Enjolras, O	1
Harris, R	1
Roger, G	1
Garabedian, EN	1
Solomon, T	1
Ninnis, J	1
Deming, D	1
Merritt, TA	1
Hopper, A	1
La Selve, P	1
Louis, JJ	1
Feit, JP	1
Guibaud, P	1
Larbre, F	1
Kaler, SG	1
Patrinos, ME	1
Lambert, GH	1
Myers, TF	1
Karlman, R	1
Anderson, CL	1
Andersen, ED	1
Krasilnikoff, PA	1
Overvad, H	1
Pivetti-Pezzi, P	1
Virno, M	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Propranolol vs Prednisolone for Infant Hemangiomas-A Clinical and Molecular Study[NCT00967226]	Phase 2	19 participants (Actual)	Interventional	2009-07-31	Terminated (stopped due to Serious adverse events with prednisolone, primarily temporary growth retardation, <5th percentile.)
A Comparative Study of the Use of Beta Blocker and Oral Corticosteroid in the Treatment of Proliferative and Involuting Cutaneous Infantile Hemangioma[NCT01072045]	Phase 2	50 participants (Actual)	Interventional	2010-01-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Number of allergy/immunology AE per study arm (NCT00967226)
Timeframe: enrollment through study closeout or study withdrawal up to 9 months

Constitutional Adverse Events

Intervention	Adverse Events (Number)
Allergy/Immunology Events Propranolol	1
Allergy/Immunology Events Prednisolone	1

Number of constitutional AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study close out or withdrawal up to 9 months

Decrease in Size of Hemangioma (Length x Width) in Square mm

Intervention	Adverse Events (Number)
Constitutional AEs Propranolol	2
Constitutional AEs Prednisolone	3

A priori primary outcome was proportional change in the total surface area as measured by lesion's outer margin length x width at baseline minus the same measure at 4 months with surrogate data used at 5 months if 4 months not available. (NCT00967226)
Timeframe: 4-5 months after initiating therapy

Dermatologic Adverse Events

Intervention	mm squared (Mean)
Propranolol	0.57
Prednisolone	0.63

Number of Dermatologic Adverse Events in each study arm. (NCT00967226)
Timeframe: enrollment to study close out or withdrawal up to 9 months

Endocrinologic Adverse Events

Intervention	Adverse Events (Number)
Dermatologic AEs Propranolol	2
Dermatologic AEs Prednisolone	1

Number of Endocrinologic AEs (of which adrenal crisis does not overlap). (NCT00967226)
Timeframe: enrollment to close out or study withdrawal up to 9 months

Gastrointestinal Adverse Events

Intervention	Adverse Events (Number)
Endocrine AEs Propranolol	0
Endocrinologic AEs Prednisolone	7

Number of Gastrointestinal AEs in each arm (NCT00967226)
Timeframe: enrollment to study withdrawal or study close out up to 9 months

Growth and Development Adverse Events

Intervention	Adverse Events (Number)
Gastrointestinal AEs Propranolol	6
Gastrointestinal AEs Prednisolone	6

Number of Growth and Development AEs in each study arm (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

Infectious Adverse Events

Intervention	Adverse Events (Number)
Growth/Developoment AEs Propranolol	0
Growth/Development AEs Prednisolone	1

Number of infectious AEs in each study arm (i.e. conjunctivitis, thrush, fever) (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

Metabolic or Laboratory AEs

Intervention	Adverse Events (Number)
Infectious AEs Propranolol	5
Infectious AEs Prednisolone	3

Number of Metabolic or Laboratory AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

Number of Serious Adverse Events (SAEs)

Intervention	Adverse Events (Number)
Metabolic/Laboratory AEs Propranolol	1
Metabolic/Laboratory AEs Prednisolone	0

Number of serious adverse events experienced by the participants in each treatment arm within the categories adrenal crisis, growth/development, constitutional. Serious adverse events are defined as events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity, or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned. (NCT00967226)
Timeframe: enrollment until study close out or withdrawal up to 9 months

Pulmonary/Respiratory Adverse Events

Intervention	Serious Adverse Events (Number)
Number of Serious Adverse Events in Propranolol	1
Number of Serious Adverse Events in Prednisolone	11

Number of pulmonary/respiratory adverse events (CTCAE 22) in each study arm (NCT00967226)
Timeframe: enrollment through study close out or withdrawal, up to 9 months

Vascular Adverse Events

Intervention	Adverse Events (Number)
Pulmonary/Respiratory AEs Propranolol	14
Pulmonary/Respiratory AEs Prednisolone	4

Number of Vascular AEs in each study arm. (NCT00967226)
Timeframe: enrollment to study withdrawal or close out up to 9 months

Tolerability of Medication

Intervention	Adverse Events (Number)
Vascular AEs Propranolol	3
Vascular AEs Prednisolone	4

All adverse events relating to medication tolerability including: adrenal crisis, growth/development, constitutional (dehydration), allergy/immunology, dermatologic, endocrine, GI, infection, metabolism/labs, pulmonary, vascular. (NCT00967226)
Timeframe: enrollment until study close out or withdrawal up to 9 months

Article	Year
[Infantile hemangioma: update and treatment]. Archives de pediatrie : organe officiel de la Societe francaise de pediatrie, 2013, Volume: 20, Issue:5 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Early Medical Intervention; Esthetics; Follow-	2013
A PHACES syndrome unmasked by propranolol interruption in a tetralogy of Fallot patient: case report and extensive review on new indications of beta blockers. Current medicinal chemistry, 2014, Volume: 21, Issue:27 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Female; Humans; Infant; Propranolol; Tetralogy	2014
LUMBAR syndrome: A case manifesting as cutaneous infantile hemangiomas of the lower extremity, perineum and gluteal region, and a review of published work. The Journal of dermatology, 2017, Volume: 44, Issue:7 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Biopsy; Buttocks; Female; Hemangioma; Humans;	2017

Article	Year
Microphthalmia with linear skin defects syndrome (MIDAS). BMJ case reports, 2019, Apr-23, Volume: 12, Issue:4 Topics: Abnormalities, Multiple; Anti-Arrhythmia Agents; Chromosomes, Human, X; Female; Genetic Diseases, X-	2019
Preoperative administration of propranolol reduced the surgical risks of PHACES syndrome in a 14-month-old girl. BMJ case reports, 2019, Apr-29, Volume: 12, Issue:4 Topics: Abnormalities, Multiple; Administration, Oral; Adrenergic beta-Antagonists; Airway Obstruction; Aort	2019
Propranolol and prednisolone combination for the treatment of segmental haemangioma in PHACES syndrome. The British journal of dermatology, 2015, Volume: 173, Issue:1 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Antineoplastic Agents, Hormonal; Blepharoptosi	2015
Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. International journal of pediatric otorhinolaryngology, 2009, Volume: 73, Issue:8 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Female; Hemangioma; Humans; Infant; Laryngeal	2009
Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. International journal of pediatric otorhinolaryngology, 2009, Volume: 73, Issue:8 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Female; Hemangioma; Humans; Infant; Laryngeal	2009
Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. International journal of pediatric otorhinolaryngology, 2009, Volume: 73, Issue:8 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Female; Hemangioma; Humans; Infant; Laryngeal	2009
Role of Propranolol in the therapeutic strategy of infantile laryngotracheal hemangioma. International journal of pediatric otorhinolaryngology, 2009, Volume: 73, Issue:8 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Female; Hemangioma; Humans; Infant; Laryngeal	2009
Use of propranolol for treatment of hemangiomas in PHACE syndrome. Journal of perinatology : official journal of the California Perinatal Association, 2011, Volume: 31, Issue:11 Topics: Abnormalities, Multiple; Adrenergic beta-Antagonists; Facial Neoplasms; Female; Hemangioma; Humans;	2011
[A case of leprechaunism]. Pediatrie, 1982, Volume: 37, Issue:8 Topics: Abnormalities, Multiple; Adult; Blood Glucose; Dwarfism; Female; Glucagon; Humans; Infant, Newborn;	1982
Hypertrichosis and congenital anomalies associated with maternal use of minoxidil. Pediatrics, 1987, Volume: 79, Issue:3 Topics: Abnormalities, Drug-Induced; Abnormalities, Multiple; Captopril; Female; Humans; Hypertension; Hyper	1987
Intermittent muscular weakness, extrasystoles, and multiple developmental anomalies. A new syndrome? Acta paediatrica Scandinavica, 1971, Volume: 60, Issue:5 Topics: Abnormalities, Multiple; Anodontia; Blepharoptosis; Cardiac Complexes, Premature; Child; Cleft Palat	1971
[Behavior of intraocular pressure in 2 cases of Marchesani's syndrome after treatment with local propranolol (inderal)]. Bollettino d'oculistica, 1970, Volume: 49, Issue:9 Topics: Abnormalities, Multiple; Adolescent; Child; Female; Fingers; Glaucoma; Humans; Propranolol; Toes	1970

propranolol and Abnormalities, Multiple