Hemangiol in infantile haemangioma: A paediatric post‐marketing surveillance drug study

Socchi, Floriane; Bigorre, M.; Normandin, Marion; Captier, Guillaume; Bessis, Didier; Mondain, M.; Blanchet, C.; Akkari, M.; Amédro, Pascal; Gavotto, Arthur

doi:10.1111/bcp.14593

Cited by 4 publications

(5 citation statements)

References 50 publications

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“…The trial evaluated the safety, effectiveness, tolerance, and cardiological changes. The results obtained showed that no severe adverse events occurred in the rapid protocol and that there was good cardiac tolerance [ 63 ].…”

Section: Propranolol As Adjuvant Therapy At Single Administration In ...mentioning

confidence: 99%

Propranolol: A “Pick and Roll” Team Player in Benign Tumors and Cancer Therapies

Albiñana

Gallardo-Vara

Casado‐Vela

et al. 2022

JCM

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Research on cancer therapies focuses on processes such as angiogenesis, cell signaling, stemness, metastasis, and drug resistance and inflammation, all of which are influenced by the cellular and molecular microenvironment of the tumor. Different strategies, such as antibodies, small chemicals, hormones, cytokines, and, recently, gene editing techniques, have been tested to reduce the malignancy and generate a harmful microenvironment for the tumor. Few therapeutic agents have shown benefits when administered alone, but a few more have demonstrated clear improvement when administered in combination with other therapeutic molecules. In 2008 (and for the first time in the clinic), the therapeutic benefits of the β-adrenergic receptor antagonist, propranolol, were described in benign tumors, such as infantile hemangioma. Propranolol, initially prescribed for high blood pressure, irregular heart rate, essential tremor, and anxiety, has shown, in the last decade, increasing evidence of its antitumoral properties in more than a dozen different types of cancer. Moreover, the use of propranolol in combination therapies with other drugs has shown synergistic antitumor effects. This review highlights the clinical trials in which propranolol is taking part as adjuvant therapy at single administration or in combinatorial human trials, arising as a good pick and roll partner in anticancer strategies.

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Section: Propranolol As Adjuvant Therapy At Single Administration In ...mentioning

confidence: 99%

Propranolol: A “Pick and Roll” Team Player in Benign Tumors and Cancer Therapies

Albiñana

Gallardo-Vara

Casado‐Vela

et al. 2022

JCM

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“…This is the largest study objectively assessing sleep in infants treated with propranolol for IH. Our data show that propranolol exposure mainly affects infants' nighttime sleep [2,[4][5][6][7] and publications on adult patients reporting increased nighttime awakenings, insomnia, and nightmares while on propranolol and other beta-blockers [40][41][42][43]. However, infant 24-hour Total Sleep was not affected by propranolol.…”

Section: Discussionmentioning

confidence: 52%

“…As a lipophilic molecule, propranolol can cross the blood-brain barrier, leading to concerns for a potentially negative impact on central nervous system (CNS) function [3,4]. Indeed, parents have reported sleep disturbances such as insomnia, night restlessness, hypersomnia, and nightmares/night terrors in up to 30% of treated infants [2,[5][6][7][8]. Intolerable sleep problems are the most frequent reason for early propranolol discontinuation, which may result in a poorer overall outcome of treated IH [9].…”

Section: Introductionmentioning

confidence: 99%

Sleep behavior of infants with infantile hemangioma treated with propranolol—a cohort study

et al. 2021

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Sleep problems are frequently reported in infants treated with propranolol for infantile hemangiomas, possibly serving as a marker for a negative impact on central nervous system function. In this cohort study, we objectively investigate the sleep behavior of infants with infantile hemangiomas on propranolol compared to a healthy, untreated control group. Sleep of propranolol-treated infants and controls was investigated using ankle actigraphy and a 24-h diary for 7–10 days at ages 3 and 6 months. The main outcome measures were the Number of Nighttime Awakenings and Sleep Efficiency. The main secondary outcome measures included 24-hour Total Sleep, daytime sleep behavior, and parent-rated infant sleep quality and behavioral development based on the Brief Infant Sleep Questionnaire (BISQ) and the age-appropriate Ages-and-Stages Questionnaire (ASQ), respectively. Fifty-four term-born infants were included in each cohort. No group difference in any investigated parameter was seen at age 3 months. At age 6 months, the propranolol group exhibited a decrease in Sleep Efficiency and a trend towards an increased Number of Nighttime Awakenings compared to the control group. Treated infants at 6 months also had shorter daytime waking periods. 24-hour Total Sleep was unaffected by propranolol. No negative impact of propranolol on subjective sleep quality and behavioral development was noted.Conclusion: Propranolol exerts a measurable yet mild impact on objectively assessed infants’ sleep measures. Behavioral developmental scores were unaffected. Our results support propranolol as first-line therapy for complicated infantile hemangiomas. What is Known:• Sleep disorders are frequently reported in infants with infantile hemangiomas treated with propranolol and often lead to treatment discontinuation.• Investigations of the sleep pattern in this patient group using objective measures are lacking. What is New:• The sleep pattern of propranolol-treated infants is assessed using actigraphy and a 24-h sleep diary and compared to healthy, untreated controls.• Propranolol leads to a decreased sleep efficiency at night and an increased demand of daytime sleep, yet effects are mild overall.

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“…The common adverse events associated with propranolol (hypoglycemia, hypotension, bradycardia, and bronchospasm) infrequently occurred, with no significant difference in frequency over placebo [ 62 ]. Postmarketing surveillance drug study supports the efficacy and good tolerance of propranolol (Hemangiol) in children with infantile hemangioma [ 64 ].…”

Section: Truly Repurposed Cancer Drugs Whose First Regulatory Labelin...mentioning

confidence: 99%

Does Therapeutic Repurposing in Cancer Meet the Expectations of Having Drugs at a Lower Price?

et al. 2023

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Therapeutic repurposing emerged as an alternative to the traditional drug discovery and development model (DDD) of new molecular entities (NMEs). It was anticipated that by being faster, safer, and cheaper, the development would result in lower-cost drugs. As defined in this work, a repurposed cancer drug is one approved by a health regulatory authority against a non-cancer indication that then gains new approval for cancer. With this definition, only three drugs are repurposed for cancer: Bacillus Calmette–Guerin (BCG) vaccine (superficial bladder cancer, thalidomide [multiple myeloma], and propranolol [infantile hemangioma]). Each of these has a different history regarding price and affordability, and it is not yet possible to generalize the impact of drug repurposing on the final price to the patient. However, the development, including the price, does not differ significantly from an NME. For the end consumer, the product’s price is unrelated to whether it followed the classical development or repurposing. Economic constraints for clinical development, and drug prescription biases for repurposing drugs, are barriers yet to be overcome. The affordability of cancer drugs is a complex issue that varies from country to country. Many alternatives for having affordable drugs have been put forward, however these measures have thus far failed and are, at best, palliative. There are no immediate solutions to the problem of access to cancer drugs. It is necessary to critically analyze the impact of the current drug development model and be creative in implementing new models that genuinely benefit society.

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Hemangiol in infantile haemangioma: A paediatric post‐marketing surveillance drug study

Cited by 4 publications

References 50 publications

Propranolol: A “Pick and Roll” Team Player in Benign Tumors and Cancer Therapies

Propranolol: A “Pick and Roll” Team Player in Benign Tumors and Cancer Therapies

Sleep behavior of infants with infantile hemangioma treated with propranolol—a cohort study

Does Therapeutic Repurposing in Cancer Meet the Expectations of Having Drugs at a Lower Price?

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