Side Effects of riociguat: A Synthesis of Findings from 16 Studies

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Original Abstract of the Article

Main Research Findings

Riociguat was evaluated in a non-interventional registry to assess its impact on clinical parameters and quality of life in patients with chronic thromboembolic pulmonary hypertension (CTEPH) that was inoperable or persistent/recurrent after pulmonary endarterectomy (PEA). 10 . Riociguat is a novel therapeutic agent for both PAH and CTEPH, and clinical trial data show that it significantly improves exercise capacity as well as hemodynamic parameters in PAH/CTEPH. 6 . Riociguat is used to switch patients with PAH and CTEPH from sildenafil, and symptoms improved in some patients, while others experienced worsening symptoms. 5 . Riociguat was well-tolerated and effective in patients with CTEPH of advanced age and with risk factors for heart failure with preserved ejection fraction (HFpEF). 1 . Riociguat was shown to increase sensitivity to cisplatin in head and neck squamous cell carcinoma cells. 15 . Riociguat can cause vaginal bleeding by increasing endometrial thickness and blood flow to the endometrium, therefore, it should be used with care especially for patients who have a history of dysfunctional uterine bleeding. 7 . A meta-analysis showed that riociguat is effective and safe for the treatment of CTEPH. 9 . Switching to riociguat in real-world clinical practice was investigated in a study called CAPTURE. 12 . Riociguat has been shown to be safe compared to other NO pathway targeting drugs. 4 . Riociguat has been shown to be successful in transitioning from phosphodiesterase type 5 inhibitors without a washout period in patients with pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension. 13 . Riociguat was shown to prevent hyperoxia-induced lung injury and pulmonary hypertension in neonatal rats without effects on long bone growth. 11 . Riociguat may require individualized dose titration as a PAH treatment. 3 . Riociguat had the most adverse drug reports among the cardiovascular disease medications approved by the US Food and Drug Administration (FDA) between 2012 and 2017. 2 .

Reasons for Side Effects

Riociguat is a drug that lowers pulmonary artery pressure by dilating blood vessels by activating soluble guanylate cyclase (sGC). However, activation of sGC can also dilate other blood vessels, leading to side effects such as hypotension and headache. 7 . In addition, riociguat inhibits platelet aggregation and may increase the risk of bleeding. 7 .

Common Side Effects

Hypotension

Riociguat can cause hypotension due to its vasodilating effects. Caution is needed especially when used in combination with other pulmonary hypertension drugs such as sildenafil. 6 .

Headache

Riociguat can cause headache. 6 .

Gastrointestinal Symptoms

Riociguat can cause gastrointestinal symptoms such as nausea, vomiting, and abdominal pain. 6 .

Bleeding

Riociguat inhibits platelet aggregation and may increase the risk of bleeding. 7 .

Countermeasures for Side Effects

Hypotension

It is important to check your blood pressure regularly when taking riociguat. Consult your doctor if you experience hypotension. It is also important to inform your doctor about the use of other medications before taking riociguat. 6 .

Headache

Consult your doctor if you have a severe headache. If you take headache medication, follow your doctor's instructions. 6 .

Gastrointestinal Symptoms

Consult your doctor if you are concerned about gastrointestinal symptoms. You may be able to receive appropriate treatment such as diet therapy or medication. 6 .

Bleeding

Consult your doctor if you are at high risk of bleeding. You may need to consider preventive measures for bleeding. 7 .

Comparison between Studies

Common Points of Studies

Many studies have shown that riociguat is an effective treatment for patients with CTEPH and has been shown to improve exercise capacity and hemodynamic parameters. 6 10 1 .

Differences between Studies

The effects of riociguat vary from patient to patient, and some patients have been reported to experience worsening symptoms. 5 . In addition, the effects of riociguat may be affected by its use in combination with other drugs such as sildenafil. 6 .

Notes on Application to Real Life

Riociguat is an effective treatment for patients with CTEPH, but it is important to understand that there is a risk of side effects. 7 . When taking riociguat, it is important to always follow your doctor's instructions and make efforts to detect side effects early, such as measuring blood pressure regularly. 6 .

Limitations of Current Research

Research on riociguat is still insufficient. In particular, there is a lack of research on long-term side effects and drug interactions. 7 .

Future Research Directions

Research on the long-term safety and effectiveness of riociguat and drug interactions is needed. 7 . Research is also needed to investigate how riociguat affects the effects of other pulmonary hypertension medications in combination. 6 .

Conclusion

Riociguat is an effective treatment for patients with CTEPH, but it is important to understand that there is a risk of side effects. 7 . When taking riociguat, it is important to always follow your doctor's instructions and make efforts to detect side effects early, such as measuring blood pressure regularly. 6 .

Literature analysis of 16 papers
Positive Content
13
Neutral Content
2
Negative Content
1
Article Type
0
2
0
2
15
1.

Riociguat in Patients with CTEPH and Advanced Age and/or Comorbidities.

Author: BarnikelMichaela, KneidingerNikolaus, ArnoldPaola, WaeldeAndrea, BehrJürgen, MilgerKatrin

CTEPH treatment
Efficacy
Tolerability
Hypotension
Side effects

Riociguat was well-tolerated and effective in patients with chronic thromboembolic pulmonary hypertension (CTEPH), regardless of age or risk factors for heart failure with preserved ejection fraction (HFpEF).

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

3.

Titration of pulmonary arterial hypertension therapeutics: Experience-based recommendations.

Author: LombardiSandra, KingmanMartha, DuncanMaribeth, BerngardSamuel Clark, FernandesTimothy

Exercise capacity
Quality of life
Time to clinical worsening
Adherence challenges
Catheter-related infections
Infusion site pain

This article provides recommendations for dose titration schemes for pulmonary arterial hypertension (PAH) medications that require individualized dosing in adult patients. It emphasizes the importance of careful titration to maximize therapeutic effectiveness while minimizing side effects, considering different routes of administration and potential challenges they present. The article stresses the critical role of patient education, frequent monitoring, and treatment adherence for optimal outcomes.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
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.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

4.

Comparative Safety of Drugs Targeting the Nitric Oxide Pathway in Pulmonary Hypertension: A Mixed Approach Combining a Meta-Analysis of Clinical Trials and a Disproportionality Analysis From the World Health Organization Pharmacovigilance Database.

Author: KhouriCharles, LepelleyMarion, RoustitMatthieu, MontastrucFrançois, HumbertMarc, CracowskiJean-Luc

PAH treatment

This review compares the safety profiles of sildenafil, tadalafil, and riociguat in pulmonary hypertension. These medications are commonly used to treat pulmonary hypertension, and the review highlights important considerations for clinicians when choosing among these treatment options.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

7.

Unusual Bleeding Due to Riociguat Use in a Patient With Chronic Thromboembolic Pulmonary Hypertension.

Author: SonmezAsli, SunbulMurat, YildizeliBedrettin, MutluBulent

Pulmonary hypertension treatment
Vaginal bleeding

This case report presents a 27-year-old female patient with chronic thromboembolic pulmonary hypertension and dysfunctional uterine bleeding who experienced severe vaginal bleeding under riociguat treatment.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

8.

Perspectives on oral pulmonary hypertension therapies recently approved by the U.S. Food and Drug Administration.

Author: HillNicholas S, BadeschDavid, BenzaRaymond L, D'ElettoThomas A, FarberHarrison W, Gomberg-MaitlandMardi, HassounPaul M, PrestonIoana

CTEPH treatment
PAH treatment
Drug interactions
Side effects

This review discusses the recent approval of macitentan, riociguat, and treprostinil as oral agents for pulmonary arterial hypertension (PAH), with riociguat being the first approved for chronic thromboembolic pulmonary hypertension (CTEPH). While these agents offer new therapeutic options, they also have potential drug interactions, adverse effects, dosing complexities, and costs. The review provides details on these aspects for each drug.

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

9.

Efficacy and safety of riociguat in the treatment of chronic thromboembolic pulmonary arterial hypertension: A meta-analysis.

Author: YingMiaofa, SongJin, GuShenglong, ZhaoRui, LiMingxing

CTEPH treatment

Riociguat, a soluble guanylate cyclase stimulator, shows promise for treating chronic thromboembolic pulmonary hypertension (CTEPH), but further research is needed to confirm its efficacy and safety.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.

Language : English

11.

Riociguat prevents hyperoxia-induced lung injury and pulmonary hypertension in neonatal rats without effects on long bone growth.

Author: DondaKeyur, ZambranoRonald, MoonYounghye, PercivalJustin, VaidyaRuben, Dapaah-SiakwanFredrick, LuoShihua, DuncanMatthew R, BaoYong, WangLuqing, QinLing, BennyMerline, YoungKaren, WuShu

BPD prevention
Long bone growth
PH prevention

Riociguat was found to be beneficial in preventing hyperoxia-induced lung injury and pulmonary hypertension (PH) in newborn rats without affecting long bone growth. This suggests that riociguat may be a potential novel agent for preventing bronchopulmonary dysplasia (BPD) and PH in neonates.

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

12.

Real-World Switching to Riociguat: Management and Practicalities in Patients with PAH and CTEPH.

Author: GallHenning, VachiéryJean-Luc, TanabeNobuhiro, HalankMichael, Orozco-LeviMauricio, MielniczukLisa, ChangMiKyung, VogtländerKai, GrünigEkkehard

Riociguat switching

This study (CAPTURE) investigates how physicians manage the switching of patients with pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH) to riociguat in real-world clinical practice. The study aims to assess whether recommendations in the riociguat prescribing information are reflected in clinical practice.

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

13.

Successful Transition From Phosphodiesterase-5 Inhibitors to Riociguat Without a Washout Period in Patients With Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension: A Pilot Cohort Study.

Author: KurodaKazuhiro, AkagiSatoshi, NakamuraKazufumi, SarashinaToshihiro, EjiriKentaro, ItoHiroshi

PAH treatment
Riociguat effectiveness
Haemodynamic instability

This article explores the transition from phosphodiesterase type 5 inhibitors (PDE5i) to riociguat, both drugs used to treat pulmonary arterial hypertension (PAH), in patients who do not respond to combination therapy or experience side effects. It highlights the importance of washout periods to minimize haemodynamic instability during the transition.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

14.

Druggability of Coronary Artery Disease Risk Loci.

Author: TraganteVinicius, HemerichDaiane, AlshabeebMohammad, BrænneIngrid, LempiäinenHarri, PatelRiyaz S, den RuijterHester M, BarnesMichael R, MooreJason H, SchunkertHeribert, ErdmannJeanette, AsselbergsFolkert W

Drug repurposing
Identification of targets

Two pipelines have been developed to identify drugs suitable for repurposing for coronary artery disease and myocardial infarction, using integrated data on genome-wide association studies loci, drug-gene interactions, side effects, and chemical interactions.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, N.I.H., ExtramuralResearch funding provided by the NIH to external research institutions and researchers.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

16.

Unusual Bleeding Due to Riociguat Use in a Patient With Chronic Thromboembolic Pulmonary Hypertension.

Author: SonmezAsli, SunbulMurat, YildizeliBedrettin, MutluBulent

Pulmonary hypertension treatment
Vaginal bleeding

This case report presents a 27-year-old female patient with chronic thromboembolic pulmonary hypertension and dysfunctional uterine bleeding who experienced severe vaginal bleeding under riociguat treatment.

Case ReportsIn the medical field, a report that describes in detail a unique case, an unusual medical condition, or the effect of a treatment. Provides new insights and possibilities for treatment through individual patient cases.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

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