Efficacy and safety of oral propranolol for infantile hemangioma in Japan

Tsuyoshi Kaneko, Satoru Sasaki, Naoko Baba, Katsuyoshi Koh, Kiyoshi Matsui, Hiroyuki Ohjimi, Nobukazu Hayashi, Atsuko Nakano, Kentaro Ohki, Yoshihiro Kuwano, Akira Morimoto, Zenshiro Tamaki, Mariko Kakazu, Kazuo Kishi, Tomoki Oyama, Atsushi Sato, Rumiko Kato, Takeshi Higuchi

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

Background: There have been few reports on the efficacy and safety of oral propranolol at 3 mg/kg/day for infantile hemangioma (IH) in Japanese patients. Methods: A multicenter, open-label phase III study was conducted to evaluate the efficacy and safety of oral propranolol solution in Japanese infants aged 35–150 days with proliferating IH. Thirty-two patients were enrolled in the study, received propranolol solution for 24 weeks at 3 mg/kg/day, and completed the study. Results: The success rate (complete or nearly complete resolution) at week 24 (primary endpoint) was 78% (95%CI: 60–91%). The improvement rate since the previous visit was 100% (32/32) after week 5. Overall, the IH surface area, maximum diameter, and color intensity all decreased over time. Consistency in assessment between the centralized and the investigator on-site assessments was observed in 26 patients. Of the 32 patients, 11 needed further treatment other than the study drug. The incidence of adverse events (AE) and drug-related AE was 97% and 31%, respectively. AE that occurred in ≥two patients were either typical of propranolol use (such as blood pressure decrease) or common events in infants. AE that resulted in dose reduction were observed in two patients, but no serious AE or AE that led to study drug discontinuation were observed. Conclusion: Oral propranolol solution at 3 mg/kg/day is effective and safe in Japanese IH patients.

Original languageEnglish
Pages (from-to)869-877
Number of pages9
JournalPediatrics International
Volume59
Issue number8
DOIs
Publication statusPublished - 2017 Aug 1

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Hemangioma
Propranolol
Japan
Safety
Drug-Related Side Effects and Adverse Reactions
Pharmaceutical Preparations
Color
Research Personnel
Blood Pressure
Incidence

Keywords

  • clinical trial
  • hemangioma
  • infant
  • Japanese
  • propranolol

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Kaneko, T., Sasaki, S., Baba, N., Koh, K., Matsui, K., Ohjimi, H., ... Higuchi, T. (2017). Efficacy and safety of oral propranolol for infantile hemangioma in Japan. Pediatrics International, 59(8), 869-877. https://doi.org/10.1111/ped.13318

Efficacy and safety of oral propranolol for infantile hemangioma in Japan. / Kaneko, Tsuyoshi; Sasaki, Satoru; Baba, Naoko; Koh, Katsuyoshi; Matsui, Kiyoshi; Ohjimi, Hiroyuki; Hayashi, Nobukazu; Nakano, Atsuko; Ohki, Kentaro; Kuwano, Yoshihiro; Morimoto, Akira; Tamaki, Zenshiro; Kakazu, Mariko; Kishi, Kazuo; Oyama, Tomoki; Sato, Atsushi; Kato, Rumiko; Higuchi, Takeshi.

In: Pediatrics International, Vol. 59, No. 8, 01.08.2017, p. 869-877.

Research output: Contribution to journalArticle

Kaneko, T, Sasaki, S, Baba, N, Koh, K, Matsui, K, Ohjimi, H, Hayashi, N, Nakano, A, Ohki, K, Kuwano, Y, Morimoto, A, Tamaki, Z, Kakazu, M, Kishi, K, Oyama, T, Sato, A, Kato, R & Higuchi, T 2017, 'Efficacy and safety of oral propranolol for infantile hemangioma in Japan', Pediatrics International, vol. 59, no. 8, pp. 869-877. https://doi.org/10.1111/ped.13318
Kaneko T, Sasaki S, Baba N, Koh K, Matsui K, Ohjimi H et al. Efficacy and safety of oral propranolol for infantile hemangioma in Japan. Pediatrics International. 2017 Aug 1;59(8):869-877. https://doi.org/10.1111/ped.13318
Kaneko, Tsuyoshi ; Sasaki, Satoru ; Baba, Naoko ; Koh, Katsuyoshi ; Matsui, Kiyoshi ; Ohjimi, Hiroyuki ; Hayashi, Nobukazu ; Nakano, Atsuko ; Ohki, Kentaro ; Kuwano, Yoshihiro ; Morimoto, Akira ; Tamaki, Zenshiro ; Kakazu, Mariko ; Kishi, Kazuo ; Oyama, Tomoki ; Sato, Atsushi ; Kato, Rumiko ; Higuchi, Takeshi. / Efficacy and safety of oral propranolol for infantile hemangioma in Japan. In: Pediatrics International. 2017 ; Vol. 59, No. 8. pp. 869-877.
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abstract = "Background: There have been few reports on the efficacy and safety of oral propranolol at 3 mg/kg/day for infantile hemangioma (IH) in Japanese patients. Methods: A multicenter, open-label phase III study was conducted to evaluate the efficacy and safety of oral propranolol solution in Japanese infants aged 35–150 days with proliferating IH. Thirty-two patients were enrolled in the study, received propranolol solution for 24 weeks at 3 mg/kg/day, and completed the study. Results: The success rate (complete or nearly complete resolution) at week 24 (primary endpoint) was 78{\%} (95{\%}CI: 60–91{\%}). The improvement rate since the previous visit was 100{\%} (32/32) after week 5. Overall, the IH surface area, maximum diameter, and color intensity all decreased over time. Consistency in assessment between the centralized and the investigator on-site assessments was observed in 26 patients. Of the 32 patients, 11 needed further treatment other than the study drug. The incidence of adverse events (AE) and drug-related AE was 97{\%} and 31{\%}, respectively. AE that occurred in ≥two patients were either typical of propranolol use (such as blood pressure decrease) or common events in infants. AE that resulted in dose reduction were observed in two patients, but no serious AE or AE that led to study drug discontinuation were observed. Conclusion: Oral propranolol solution at 3 mg/kg/day is effective and safe in Japanese IH patients.",
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AU - Kaneko, Tsuyoshi

AU - Sasaki, Satoru

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AU - Matsui, Kiyoshi

AU - Ohjimi, Hiroyuki

AU - Hayashi, Nobukazu

AU - Nakano, Atsuko

AU - Ohki, Kentaro

AU - Kuwano, Yoshihiro

AU - Morimoto, Akira

AU - Tamaki, Zenshiro

AU - Kakazu, Mariko

AU - Kishi, Kazuo

AU - Oyama, Tomoki

AU - Sato, Atsushi

AU - Kato, Rumiko

AU - Higuchi, Takeshi

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N2 - Background: There have been few reports on the efficacy and safety of oral propranolol at 3 mg/kg/day for infantile hemangioma (IH) in Japanese patients. Methods: A multicenter, open-label phase III study was conducted to evaluate the efficacy and safety of oral propranolol solution in Japanese infants aged 35–150 days with proliferating IH. Thirty-two patients were enrolled in the study, received propranolol solution for 24 weeks at 3 mg/kg/day, and completed the study. Results: The success rate (complete or nearly complete resolution) at week 24 (primary endpoint) was 78% (95%CI: 60–91%). The improvement rate since the previous visit was 100% (32/32) after week 5. Overall, the IH surface area, maximum diameter, and color intensity all decreased over time. Consistency in assessment between the centralized and the investigator on-site assessments was observed in 26 patients. Of the 32 patients, 11 needed further treatment other than the study drug. The incidence of adverse events (AE) and drug-related AE was 97% and 31%, respectively. AE that occurred in ≥two patients were either typical of propranolol use (such as blood pressure decrease) or common events in infants. AE that resulted in dose reduction were observed in two patients, but no serious AE or AE that led to study drug discontinuation were observed. Conclusion: Oral propranolol solution at 3 mg/kg/day is effective and safe in Japanese IH patients.

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