Safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension: a sub-group analysis based on Japan post-marketing surveillance

Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Suzuki, Naohiko; Murakami, Masahiro

doi:10.1080/03007995.2017.1354832

Cited by 15 publications

(13 citation statements)

References 18 publications

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“…Yamazaki et al investigated the efficacy of tadalafil in pediatric PAH patients and reported that the incidence of side effects of tadalafil was significantly lower in children in comparison to adults. They also reported that there was improvement in WHO functional class, decline in mPAP and survival rates at 1 and 2 year were 98.3 % and 93.7%, respectively (24). In our study a total of 7 patients (3 iPAH and 4 ES), were given tadalafil.…”

Section: Discussionsupporting

confidence: 65%

Evaluation of pediatric patients with severe pulmonary arterial hypertension

Epçaçan¹,

Ramoğlu²,

Şişli³

et al. 2019

Eastern J Med

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Pulmonary arterial hypertension (PAH) is an important cause of morbidity and mortality. Congenital heart disease associated PAH (APAH-CHD) and idiopathic PAH are classified in Group 1 PAH. There are limited studies about pediatric patients with PAH. The aim of our study is to evaluate the clinical, diagnostic and treatment characteristics of pediatric PAH. 53 consecutive patients with PAH in a 7 years' study period were retrospectively analyzed. Clinical, echocardiographic and cardiac catheterization findings and targeted treatment modalities were noted. Thirty (56.6%) patients were male and mean age at diagnosis was 5.2±4.30 years. All patients were classified as group 1 consisting of APAH-CHD and idiopathic PAH. Patients with Eisenmenger syndrome w ere the largest group. Ventricular septal defect was the most CHD associated with PAH overall. Atrial septal defect, patent ductus arteriosus, atrioventricular septal defect, aortopulmonary window, double inlet left ventricle, double outlet right ventricle, d-transposition of great arteries and truncus arteriosus were other congenital heart malformat ions were detected. Targeted therapy were given to 34 patients (%64.1%), of them, 22 were under monotherapy, while 12 were under combined therapy. Bosentan was the most chosen drug in all. NYHA FC, exercise capacity with 6MWT improved well by targeted therapy. Life quality and survey are improved with the targeted therapies in pediatric patients with PAH. Single drug or combination therapies including bosentan, tadalafil and inhaled iloprost are effective, safe and well tolerated with rare and minor side effects in pediatric patients with group 1 PAH.

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Section: Discussionsupporting

confidence: 65%

Evaluation of pediatric patients with severe pulmonary arterial hypertension

Epçaçan¹,

Ramoğlu²,

Şişli³

et al. 2019

Eastern J Med

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“…Among 391 patients included in the safety analysis, the overall incidence rate of ADRs was 16.6%. Regarding effectiveness, the incidence of WHO functional class improvement at 3 months, 1 year, and 2 years after the initiation of tadalafil and last observation in pediatric patients were 16.5%, 19.7%, and 16.3%, respectively (42).…”

Section: Phosphodiesterase 5 Inhibitorsmentioning

confidence: 93%

“…Japanese post-marketing surveillance data was used to assess safety and effectiveness of tadalafil in patients <18 years (42). Among 391 patients included in the safety analysis, the overall incidence rate of ADRs was 16.6%.…”

Section: Phosphodiesterase 5 Inhibitorsmentioning

confidence: 99%

Treatment of pulmonary arterial hypertension in children

Gorenflo

Ziesenitz

2021

Cardiovasc Diagn Ther

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Pulmonary arterial hypertension (PAH) is a devastating illness causing already significant morbidity in childhood. Currently approved treatment options for children comprise the endothelin receptor antagonist bosentan, as well as the phosphodiesterase-5 inhibitor sildenafil. But PAH treatment has advanced significantly over the past decade, and new classes of targeted drug therapies, such as stimulators of the soluble guanylate cyclase (riociguat) or prostacyclin receptor agonists (selexipag), are currently evaluated regarding their efficacy and safety in children, in order to limit off-label use. Due to the different etiologies in children, such as PAH-CHD, there is no evidence that initial combination therapy in children is superior to a mono-therapy with respect to survival. Special attention should also be paid to the pharmacology of PAH drugs in children, which might be impacted by ontogeny or drug-drug-interactions. Therapeutic drug monitoring may be useful in pediatric patients. There is a clear need for more controlled studies of PAH medications, alone or in combination therapy in the pediatric age group. Data from clinical trials as well as from patient registries should be pooled to optimize drug development and evaluation, trial design, and evidence-based pharmacotherapy in pediatric patients with PAH. In this review, the current treatment options of pediatric PAH are summarized, and an overview of new treatment concepts, which are already evaluated in adults, is presented.

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“…There are no randomized controlled trials studying tadalafil in the pediatric PAH population. However, three studies suggest that tadalafil 1 mg/kg (maximum 40 mg) daily is well‐tolerated and demonstrates efficacy in the pediatric PAH population 26–28 . Compared with sildenafil, tadalafil has a longer half‐life and is administered once daily, making it an attractive agent from a compliance standpoint.…”

Section: Pde5‐inhibitorsmentioning

confidence: 99%

Opportunities and challenges of pharmacotherapy for pulmonary arterial hypertension in children

Kam

Ruiz

2020

Pediatric Pulmonology

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Pediatric pulmonary hypertension (PAH) is a rare disease that carries a poor prognosis if left untreated. Although there are published guidelines for the treatment of children with pulmonary hypertension, due to the limited number of robust pediatric clinical trials, recommendations are often based on limited data or clinical experience. Furthermore, many practical aspects of care, particularly for the pediatric patient, are learned through experience and best navigated with a multidisciplinary team. While newer PAH therapies have been approved for adults, there is still limited but expanding experience in pediatrics. This new information will help improve the targets of goal‐oriented therapy. Lastly, this review highlights practical aspects in the use of the different therapies available for the treatment of pediatric pulmonary hypertension.

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Safety and effectiveness of tadalafil in pediatric patients with pulmonary arterial hypertension: a sub-group analysis based on Japan post-marketing surveillance

Abstract: This manuscript reveals the use of tadalafil in the real-world pediatric population with an acceptable safety profile in Japan.

Cited by 15 publications

References 18 publications

Evaluation of pediatric patients with severe pulmonary arterial hypertension

Evaluation of pediatric patients with severe pulmonary arterial hypertension

Treatment of pulmonary arterial hypertension in children

Opportunities and challenges of pharmacotherapy for pulmonary arterial hypertension in children

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