Effects of aprocitentan: A Synthesis of Findings from 21 Studies

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Original Abstract of the Article

Main Research Findings

Aprocitentan is a novel, oral, dual endothelin receptor antagonist (ERA) being developed for the treatment of difficult-to-control hypertension. It is an active metabolite of macitentan, an orphan drug used for the treatment of pulmonary arterial hypertension. 8

Several studies have shown that aprocitentan can lower blood pressure. In patients with hypertension who were given 10 mg or 25 mg of aprocitentan, systolic and diastolic blood pressure decreased significantly. 4 13 5

Aprocitentan may also be effective when used in combination with other antihypertensive medications. For example, aprocitentan has been reported to enhance the blood pressure-lowering effects of renin-angiotensin system inhibitors (RAS inhibitors). 8 17

Aprocitentan has also been shown to cause weight gain in healthy subjects on a high-sodium diet. 12 This is thought to be due to aprocitentan promoting fluid retention in the body. Aprocitentan may increase plasma volume, which can lead to weight gain. 13

Benefits and Risks

Benefits Summary

Aprocitentan may be effective in treating hypertension and could offer a new treatment option for patients with resistant hypertension. Aprocitentan has shown the ability to lower blood pressure and may be effective when combined with other antihypertensive drugs. Aprocitentan could become a new treatment option for patients with resistant hypertension, a condition that has previously had limited treatment options. 3

Risks Summary

Aprocitentan may cause side effects such as weight gain and edema. 12 Aprocitentan may also interact with other medications. 14 Aprocitentan is still under development, and its long-term safety is still unknown.

Comparison Across Studies

Commonalities Across Studies

Multiple studies have shown that aprocitentan can lower blood pressure. These studies have confirmed that aprocitentan significantly reduces both systolic and diastolic blood pressure. 4 13 5

Differences Across Studies

There can be differences in dosage, duration of treatment, study participants, and evaluation methods across different studies. Therefore, it can be difficult to directly compare the results of different studies.

Consistency and Contradictions in Findings

Multiple studies have shown that aprocitentan can lower blood pressure, but there are still unknowns regarding the side effects and effectiveness of aprocitentan. Aprocitentan may cause side effects such as weight gain, and further research is needed to assess these risks.

Notes on Practical Application

Aprocitentan is still under development, and further research is needed before it can be used widely. It is essential to follow your doctor's instructions when using aprocitentan. Before starting aprocitentan, it is important to consult your doctor about your medical history and any medications you are currently taking.

Limitations of Current Research

Research on aprocitentan is still limited. In particular, there are still unknowns regarding the long-term safety and efficacy of aprocitentan. Aprocitentan is not yet widely available for general use. Therefore, further research is needed before aprocitentan can be practically implemented.

Future Directions for Research

It is necessary to investigate the safety and efficacy of aprocitentan in more detail. This includes exploring long-term safety and efficacy, side effects, drug interactions, and the effectiveness of aprocitentan in various types of hypertensive patients.

Conclusion

Aprocitentan is a promising new medication that may be effective in treating hypertension. Aprocitentan has shown the ability to lower blood pressure and may be effective when combined with other antihypertensive drugs. Aprocitentan could become a new treatment option for patients with resistant hypertension, a condition that has previously had limited treatment options. However, aprocitentan is still under development, and its long-term safety and efficacy are still unknown. It is essential to follow your doctor's instructions when using aprocitentan.

Literature analysis of 21 papers
Positive Content
21
Neutral Content
0
Negative Content
0
Article Type
7
1
1
8
21
3.

Novel Dual Endothelin Inhibitors in the Management of Resistant Hypertension.

Author: BoutariChrysoula, SiskosFotios

Resistant hypertension treatment

Aprocitentan is a novel, orally active, and well-tolerated dual endothelin receptor antagonist that shows promise in managing resistant hypertension. The drug has demonstrated efficacy and safety in clinical trials, particularly the large PRECISION study published in The Lancet, suggesting that it could address the unmet needs of patients with this challenging condition.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

New Dual Endothelin Receptor Antagonist Aprocitentan in Hypertension: A Systematic Review and Meta-Analysis.

Author: MahfoozKamran, NajeedSyed, TunHan Naung, KhamoshMadina, GrewalDaisy, HussainAftab, OngKenneth, DharmarajanLekshmi, VasavadaAdvait

Hypertension treatment

Aprocitentan is a new drug for resistant hypertension. This study found that it lowered blood pressure in patients with hypertension, even with a dose exceeding 25mg, but its long-term efficacy and safety need further investigation.

Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

5.

Dual endothelin antagonist aprocitentan for resistant hypertension (PRECISION): a multicentre, blinded, randomised, parallel-group, phase 3 trial.

Author: SchlaichMarkus P, BelletMarc, WeberMichael A, DanaietashParisa, BakrisGeorge L, FlackJohn M, DreierRoland F, Sassi-SayadiMouna, HaskellLloyd P, NarkiewiczKrzysztof, WangJi-Guang,

Lower blood pressure

Resistant hypertension is associated with increased cardiovascular risk. This study aimed to assess the blood pressure-lowering efficacy of the dual endothelin antagonist aprocitentan in patients with resistant hypertension.

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

6.

Single-dose pharmacokinetics, safety, and tolerability of the dual endothelin receptor antagonist aprocitentan in subjects with moderate hepatic impairment.

Author: FontesMagda S C, DingemanseJasper, HalabiAtef, Tomaszewska-KiecanaMonika, SidhartaPatricia N

Resistant hypertension treatment
Headache

This study investigated the effect of moderate hepatic impairment on the pharmacokinetics (PK), safety, and tolerability of the dual endothelin receptor antagonist aprocitentan. The PK of aprocitentan were similar in subjects with moderate hepatic impairment and healthy subjects. Aprocitentan was well tolerated, and dose adjustment is not required for patients with mild to moderate hepatic impairment.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

7.

Identifying and treating resistant hypertension in PRECISION: A randomized long-term clinical trial with aprocitentan.

Author: DanaietashParisa, VerweijPierre, WangJi-Guang, DresserGeorge, KantolaIlkka, LawrenceMary Katherine, NarkiewiczKrzysztof, SchlaichMarkus, BelletMarc,

BP lowering

This study, called PRECISION, evaluates the effect of the dual endothelin receptor antagonist aprocitentan on blood pressure (BP) in patients with resistant hypertension (RHT). The study found that a high proportion of patients referred for RHT actually had pseudoresistant hypertension, highlighting the need for careful screening and evaluation.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

8.

Aprocitentan, A Dual Endothelin Receptor Antagonist Under Development for the Treatment of Resistant Hypertension.

Author: AngeliFabio, VerdecchiaPaolo, ReboldiGianpaolo

Resistant hypertension treatment

Aprocitentan is an orally active, dual endothelin-1 (ET-1) receptor antagonist currently under investigation for the treatment of resistant hypertension. The data suggest that aprocitentan has the potential to expand the antihypertensive arsenal and provide broader cardiovascular protection.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

10.

Aprocitentan (a Dual Endothelin-Receptor Antagonist) for Treatment-Resistant Hypertension.

Author: McCoyEmily K, LisenbyKatelin M

TRH treatment

Aprocitentan, a novel oral dual endothelin-receptor antagonist, is being investigated as a potential treatment for treatment-resistant hypertension. Early clinical trials suggest favorable tolerability and safety compared to other endothelin-receptor antagonists.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

11.

Multiple-Dose Pharmacokinetics, Safety, and Tolerability of Aprocitentan, a Dual Endothelin Receptor Antagonist, in Healthy Japanese and Caucasian Subjects.

Author: FontesMagda S C, DingemanseJasper, SidhartaPatricia N

Hypertension treatment

Aprocitentan is a new drug that is being developed for the treatment of resistant hypertension. This study investigated the pharmacokinetics of aprocitentan in Japanese and Caucasian subjects. The study found that the pharmacokinetics of aprocitentan were similar between the two ethnic groups. This suggests that aprocitentan can be administered at the same dose level in all ethnicities.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

12.

Effects of the Dual Endothelin Receptor Antagonist Aprocitentan on Body Weight and Fluid Homeostasis in Healthy Subjects on a High Sodium Diet.

Author: Gueneau de MussyPierre, SidhartaPatricia N, WuerznerGregoire, MaillardMarc P, GuérardNicolas, IglarzMarc, FlamionBruno, DingemanseJasper, BurnierMichel

Weight gain

Aprocitentan, a novel oral dual endothelin receptor antagonist (ERA), produced moderate weight increases in healthy subjects on a high sodium diet, without obvious sodium retention.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

13.

Randomized Dose-Response Study of the New Dual Endothelin Receptor Antagonist Aprocitentan in Hypertension.

Author: VerweijPierre, DanaietashParisa, FlamionBruno, MénardJoël, BelletMarc

Hypertension treatment
Albumin decrease
Hematocrit decrease
Hemoglobin decrease
Plasma volume increase
Uric acid decrease

Aprocitentan, a dual endothelin A/endothelin B receptor antagonist, reduced blood pressure in patients with essential hypertension in a dose-dependent manner.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

14.

Effect of Multiple-Dose Aprocitentan Administration on the Pharmacokinetics of Midazolam in Healthy Male Subjects.

Author: SidhartaPatricia N, DingemanseJasper

Hypertension treatment
Drug interactions

Aprocitentan is a new drug for resistant hypertension. This study examined its potential to interact with cytochrome P450 (CYP) 3A enzymes.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

16.

Single- and multiple-dose tolerability, safety, pharmacokinetics, and pharmacodynamics of the dual endothelin receptor antagonist aprocitentan in healthy adult and elderly subjects.

Author: SidhartaPatricia N, MelchiorMeggane, KankamMartin K, DingemanseJasper

BP reduction
Headache
Weight gain

Aprocitentan, an orally active dual endothelin receptor antagonist, is well tolerated and has a favorable pharmacokinetic profile for once-daily dosing in healthy subjects. Further studies are needed to confirm its efficacy in treating hypertension.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

19.

A Focus on Macitentan in the Treatment of Pulmonary Arterial Hypertension.

Author: BedanMartin, GrimmDaniela, WehlandMarkus, SimonsenUlf, InfangerManfred, KrügerMarcus

PAH treatment efficacy
Reduced adverse effects
Hepatotoxicity
Peripheral edema

This review compares macitentan to other endothelin receptor antagonists in the treatment of pulmonary arterial hypertension (PAH). Macitentan demonstrates higher antagonistic potency and a longer duration of action than bosentan and ambrisentan. It has been shown to reduce morbidity and mortality, improve exercise capacity, and has lower risks of peripheral edema and hepatotoxicity.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

20.

Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension.

Author: KrauseAndreas, ZisowskyJochen, DingemanseJasper

Improved 6MWD
Reduced PVR

Macitentan, an endothelin receptor antagonist, was found to be effective in treating pulmonary arterial hypertension, with higher concentrations associated with improved hemodynamics.

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

21.

Effects of macitentan and its active metabolite on cultured human systemic sclerosis and control skin fibroblasts.

Author: CutoloMaurizio, MontagnaPaola, BrizzolaraRenata, SmithVanessa, AlessandriElisa, VillaggioBarbara, SulliAlberto, TavillaPietro Paolo, PizzorniCarmen, SoldanoStefano

Reduced ECM production
Reduced myofibroblast activation

Macitentan, an endothelin 1 (ET-1) receptor antagonist, reduced the basal level of α-smooth muscle actin (α-SMA) expression and type I collagen synthesis in cultured systemic sclerosis (SSc) skin fibroblasts. Macitentan also antagonized the ability of ET-1 to further induce α-SMA expression, type I collagen, and fibronectin synthesis.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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