Efficacy and Safety of Udenafil for the Treatment of Pulmonary Arterial Hypertension: a Placebo-controlled, Double-blind, Phase IIb Clinical Trial

Chang, Hyuk Jae; Song, Seungkeun; Chang, S.; Kim, Yong Jin; Jung, Hae Ok; Choi, Jung Hyun; Lee, Jae Seung; Kim, Kye Hun; Jeong, Jin Ok; Kim, Duk Kyung

doi:10.1016/j.clinthera.2019.05.006

Cited by 15 publications

(26 citation statements)

References 17 publications

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“…At present, the majority of clinical studies primarily concentrate on vasodilators, phosphodiesterase type 5 inhibitors and endothelin receptor antagonist analogues (e.g., prostacyclin, udenafil and ambrisentan) [ 145 – 147 ]. However, few clinical studies of natural medicine for the management of PAH were found.…”

Section: Clinical Trials For Pahmentioning

confidence: 99%

Bioactivities and mechanisms of natural medicines in the management of pulmonary arterial hypertension

Zhang

Xiao

et al. 2022

Chin Med

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Pulmonary arterial hypertension (PAH) is a progressive and rare disease without obvious clinical symptoms that shares characteristics with pulmonary vascular remodeling. Right heart failure in the terminal phase of PAH seriously threatens the lives of patients. This review attempts to comprehensively outline the current state of knowledge on PAH its pathology, pathogenesis, natural medicines therapy, mechanisms and clinical studies to provide potential treatment strategies. Although PAH and pulmonary hypertension have similar pathological features, PAH exhibits significantly elevated pulmonary vascular resistance caused by vascular stenosis and occlusion. Currently, the pathogenesis of PAH is thought to involve multiple factors, primarily including genetic/epigenetic factors, vascular cellular dysregulation, metabolic dysfunction, even inflammation and immunization. Yet many issues regarding PAH need to be clarified, such as the “oestrogen paradox”. About 25 kinds monomers derived from natural medicine have been verified to protect against to PAH via modulating BMPR2/Smad, HIF-1α, PI3K/Akt/mTOR and eNOS/NO/cGMP signalling pathways. Yet limited and single PAH animal models may not corroborate the efficacy of natural medicines, and those natural compounds how to regulate crucial genes, proteins and even microRNA and lncRNA still need to put great attention. Additionally, pharmacokinetic studies and safety evaluation of natural medicines for the treatment of PAH should be undertaken in future studies. Meanwhile, methods for validating the efficacy of natural drugs in multiple PAH animal models and precise clinical design are also urgently needed to promote advances in PAH. Graphical Abstract

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Section: Clinical Trials For Pahmentioning

confidence: 99%

Bioactivities and mechanisms of natural medicines in the management of pulmonary arterial hypertension

Zhang

Xiao

et al. 2022

Chin Med

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“…Nevertheless, like other well-known PDE inhibitors, sildenafil and tadalafil, udenafil is also commonly being researched for its efficiency in new several indications including pulmonary arterial hypertension, obesity, testicular torsion-related reperfusion ischemia injury and even hair growth. 12,[22][23][24] Furthermore, some authors have clinically reported significant effects of udenafil to reduce Raynaud phenomenon attacks and digital ulcer occurrence in systemic sclerosis patients. 25,26 Udenafil is rapidly absorbed and reaches peak plasma concentrations in 0.8 to 1.3 hours.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies showed that udenafil revealed a similar or lower incidence of adverse effects than other PDE-5 inhibitors such as sildenafil and tadalafil. 23 In this study, stasis zone was treated with udenafil, the only subgroup among PDE inhibitors whose onset of effect starts fastest and reaches the peak plasma concentration in about 1 hour. Unlike other PDE inhibitors, udenafil has a plasma half-life of 7.3 to 12.1 hours.…”

Section: Discussionmentioning

confidence: 99%

The Effect of Udenafil on Stasis Zone in an Experimental Burn Model

Ural

Bilgen

Aykan³

et al. 2022

Ann Plast Surg

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Background: Management of the burn injuries is still a problematic issue because the stasis zone may become necrotic. We hypothesized that udenafil, a potent phospodiesterase inhibitor, can be beneficial in burn treatment by enhancing the viability of the stasis zone. Methods: Fifteen Wistar rats were randomly divided into 3 groups. Comb burn injury model was conducted bilaterally on the back of rats in each subject. Group 1 received 1 mL/d of saline orally for 7 days. Group 2 received 10 mg/kg per day of udenafil for 7 days. Group 3 received 20 mg/kg per day of udenafil for 7 days. At the end of seventh day, gross morphological and histopathological samples of stasis zone survival were evaluated. Results: Histopathological examination of groups 2 and 3 revealed that the stasis zone was mostly viable. The mean necrotic area and severity of inflammation was significantly higher in the control group compared with the treatment groups. Significant differences were determined in treatment groups compared with control group in terms of vital stasis zone area and histopathological parameters. Conclusions: Udenafil treatment improved tissue survival on zone of stasis in. Future experimental studies should be conducted to develop zone of stasis treatment protocols combining udenafil with potent anti-inflammatory and antioxidant drugs.

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“…The improvement in the 6-MWD with udenafil and ERA combination therapy group was found to be better than that of sildenafil and tadalafil in previous trials ( Galiè et al, 2009a ; Galiè et al, 2009b ; Benza et al, 2018 ). Adverse side effects in the udenafil were also found to be mild and in the expected range ( Chang et al, 2019 ).…”

Section: Ongoing Pharmaceutical Research On Nitric Oxide Pathway and Its Implication In Pulmonary Arterial Hypertensionmentioning

confidence: 93%

“…Udenafil, an oral phosphodiesterase-5 inhibitor approved for the treatment of erectile dysfunction has been found by a recent double-blind, placebo-controlled phase IIb clinical trial to improve 6-MWD in patients with PAH, especially those with a history of ERA therapy ( Chang et al, 2019 ). The improvement in the 6-MWD with udenafil and ERA combination therapy group was found to be better than that of sildenafil and tadalafil in previous trials ( Galiè et al, 2009a ; Galiè et al, 2009b ; Benza et al, 2018 ).…”

Section: Ongoing Pharmaceutical Research On Nitric Oxide Pathway and Its Implication In Pulmonary Arterial Hypertensionmentioning

confidence: 99%

Therapy for Pulmonary Arterial Hypertension: Glance on Nitric Oxide Pathway

Tettey

Jiang

et al. 2021

Front. Pharmacol.

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Pulmonary arterial hypertension (PAH) is a severe disease with a resultant increase of the mean pulmonary arterial pressure, right ventricular hypertrophy and eventual death. Research in recent years has produced various therapeutic options for its clinical management but the high mortality even under treatment remains a big challenge attributed to the complex pathophysiology. Studies from clinical and non-clinical experiments have revealed that the nitric oxide (NO) pathway is one of the key pathways underlying the pathophysiology of PAH. Many of the essential drugs used in the management of PAH act on this pathway highlighting its significant role in PAH. Meanwhile, several novel compounds targeting on NO pathway exhibits great potential to become future therapy medications. Furthermore, the NO pathway is found to interact with other crucial pathways. Understanding such interactions could be helpful in the discovery of new drug that provide better clinical outcomes.

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Efficacy and Safety of Udenafil for the Treatment of Pulmonary Arterial Hypertension: a Placebo-controlled, Double-blind, Phase IIb Clinical Trial

Cited by 15 publications

References 17 publications

Bioactivities and mechanisms of natural medicines in the management of pulmonary arterial hypertension

Bioactivities and mechanisms of natural medicines in the management of pulmonary arterial hypertension

The Effect of Udenafil on Stasis Zone in an Experimental Burn Model

Therapy for Pulmonary Arterial Hypertension: Glance on Nitric Oxide Pathway

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