Side Effects of darolutamide: A Synthesis of Findings from 13 Studies

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Original Abstract of the Article

Main Findings

Darolutamide is an androgen receptor inhibitor that is being investigated as a treatment for prostate cancer. It has been shown to delay the time to metastasis in men with castration-resistant prostate cancer. 12 Darolutamide has also been approved for the treatment of nonmetastatic castration-resistant prostate cancer.

A review of several studies found that darolutamide is generally safe and well-tolerated. The side effects are similar to those of other androgen receptor inhibitors, with the exception of enzalutamide, which has a higher risk of high blood pressure and headache. 3 This suggests that close monitoring of blood pressure is important for patients taking enzalutamide. 3

Reasons for Side Effects

Androgen receptor inhibitors block the activity of the androgen receptor, which is important for prostate cancer growth. However, the androgen receptor is also found in other tissues and organs, which can lead to side effects.

Common Side Effects

Fatigue

Fatigue is a common side effect of darolutamide reported in real-world data. 2

Rash

Apalutamide can cause rash as a common side effect. 5

Hypertension

Hypertension is a common side effect of apalutamide. 5 A study using a network meta-analysis found that enzalutamide was ranked the most toxic treatment regarding hypertension outcomes. 3

Hot Flashes

Hot flashes are a common side effect of apalutamide. 5

Kidney Side Effects

New systemic treatments for prostate cancer can cause renal and cardiovascular side effects, with hypertension being most frequent. Renal toxicity is rarer. 9

Heart Side Effects

New systemic treatments for prostate cancer can cause renal and cardiovascular side effects, with hypertension being most frequent. Renal toxicity is rarer. 9

Hypothyroidism

Darolutamide can cause hypothyroidism as a side effect. 8

Managing Side Effects

Fatigue

If you experience fatigue, talk to your doctor.

Rash

If you experience a rash, talk to your doctor.

Hypertension

If you experience hypertension, talk to your doctor. If you are taking medications for hypertension, talk to your doctor.

Hot Flashes

If you experience hot flashes, talk to your doctor.

Kidney Side Effects

If you experience kidney side effects, talk to your doctor. Regular kidney function tests are important.

Heart Side Effects

If you experience heart side effects, talk to your doctor. Regular heart function tests are important.

Hypothyroidism

If you experience hypothyroidism, talk to your doctor. Regular thyroid function tests are important.

Comparison Across Studies

Similarities Across Studies

Multiple studies show that darolutamide can delay the time to metastasis in men with metastatic castration-resistant prostate cancer.

Multiple studies show that darolutamide is generally safe and well-tolerated, with fewer side effects compared to other androgen receptor inhibitors.

Differences Across Studies

There is some variability in the findings on darolutamide's side effects across studies. One study found that darolutamide increases the risk of hypertension and headache. 3 On the other hand, other studies have not shown an increased risk of hypertension or headache with darolutamide. 8

Practical Implications

Darolutamide is an effective treatment for metastatic castration-resistant prostate cancer. However, it can cause a variety of side effects. Therefore, it is important to talk to your doctor about darolutamide and understand its potential side effects. It is also important to have regular checkups with your doctor while taking darolutamide to monitor for any side effects.

Limitations of Current Research

There is still a lack of research on the long-term side effects of darolutamide. Therefore, further research is needed to determine the long-term safety of darolutamide.

Future Research Directions

It is important to continue to conduct research on the long-term side effects of darolutamide. Research is also needed to develop new treatments and preventative measures for the side effects of darolutamide.

Conclusion

Darolutamide is an effective treatment for metastatic castration-resistant prostate cancer. However, it can cause a variety of side effects. Therefore, it is important to talk to your doctor about darolutamide and understand its potential side effects. It is also important to have regular checkups with your doctor while taking darolutamide to monitor for any side effects.

Literature analysis of 13 papers
Positive Content
13
Neutral Content
0
Negative Content
0
Article Type
3
1
1
6
12
1.

Low-dose short-term cyclosporine versus etretinate in psoriasis: improvement of skin, nail, and joint involvement.

Author: MahrleG, SchulzeH J, FärberL, WeidingerG, SteiglederG K

Nail and joint improvement
Psoriasis treatment
Cyclosporine side effects
Relapse risk

Low-dose short-term cyclosporine therapy was highly effective and well tolerated for psoriasis, compared to etretinate. Remission was better preserved by tapering the drug than by discontinuing treatment abruptly.

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.
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

2.

Adverse events related to darolutamide treatment: analysis of "real life" data from EudraVigilance and the Food and Drug Administration database entries.

Author: TemaGiorgia, LombardoRiccardo, CicioneAntonio, NacchiaAntonio, GravinaCarmen, FrancoAntonio, FiasconaroDaniele, SarcinelliLuca, GhezzoNicola, PastoreAntonio, Al SalhiYazan, FuschiAndrea, MartocciaAlessia, TubaroAndrea, DE NunzioCosimo

Safe and effective
Fatigue

Darolutamide is safe in a real-life scenario, with the most frequent side effect being fatigue.

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

Language : English

3.

Adverse Events and Androgen Receptor Signaling Inhibitors in the Treatment of Prostate Cancer: A Systematic Review and Multivariate Network Meta-analysis.

Author: CaoBrent, KimMelissa, ReizineNatalie M, MoreiraDaniel M

Improved prostate cancer outcomes
Headache
Hypertension

A systematic review of 14 randomized controlled trials compared the adverse event profiles of four androgen receptor signaling inhibitor (ARSi) drugs (abiraterone, apalutamide, darolutamide, and enzalutamide) for prostate cancer. The review found that the side-effect profiles were similar except for a higher risk of hypertension and headache with enzalutamide. Close blood-pressure monitoring for enzalutamide is recommended.

Systematic ReviewA review that systematically collects, evaluates, and integrates relevant research to answer a specific research question.
Meta-AnalysisA statistical technique that integrates the results of multiple studies to draw more general conclusions about a particular issue.
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

6.

Next-Generation Androgen Receptor-Signaling Inhibitors for Prostate Cancer: Considerations for Older Patients.

Author: FengZizhen, GraffJulie N

prostate cancer treatment
drug interactions
prostate cancer

This review discusses the mechanism of action, efficacy, and safety of next-generation hormonal therapies for prostate cancer, particularly in older patients, considering their unique challenges.

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

7.

Endocrine consequences of treatment with the new androgen receptor axis-targeted agents for advanced prostate cancer.

Author: PyrgidisNikolaos, VakalopoulosIoannis, SountoulidesPetros

Advanced PCa treatment
Endocrine and metabolic AEs

This review assesses the endocrine and metabolic adverse events associated with treatment using androgen receptor axis-targeted (ARAT) agents in patients with prostate cancer (PCa). The approval of these new agents has altered the course of advanced PCa, but it is essential to consider the potential side effects.

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.

Treatment of non-metastatic castration resistant prostate cancer in 2020: What is the best?

Author: HeideggerIsabel, BrandtMaximilian P, HeckMatthias M

Effective treatment
Side effects

Three new androgen receptor antagonists (enzalutamide, apalutamide, and darolutamide) have been approved by the Food and Drug Administration for the treatment of nonmetastatic castration-resistant prostate cancer. These drugs have shown good clinical efficacy with tolerable side effects in large phase III trials. This review discusses the use of these new treatment options, focusing on patient selection and the impact of new imaging modalities like prostate-specific membrane antigen-positron-emission tomography.

Historical ArticleA research paper that analyzes past events and developments using primary sources and examines them from a historical perspective.
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.

Evaluation of Clinically Relevant Drug-Drug Interactions and Population Pharmacokinetics of Darolutamide in Patients with Nonmetastatic Castration-Resistant Prostate Cancer: Results of Pre-Specified and Post Hoc Analyses of the Phase III ARAMIS Trial.

Author: ShoreNeal, ZurthChristian, FrickeRobert, GieschenHille, GraudenzKristina, KoskinenMikko, PloegerBart, MossJonathan, PrienOlaf, BorghesiGustavo, PetrenciucOana, TammelaTeuvo L, KussIris, VerholenFrank, SmithMatthew R, FizaziKarim

Metastasis-free survival prolongation
Drug interactions

Darolutamide, an androgen receptor antagonist, significantly extended metastasis-free survival compared to placebo in men with nonmetastatic castration-resistant prostate cancer. Though polypharmacy is common in this population, darolutamide has low drug-drug interaction potential, except for substrates of breast cancer resistance protein/organic anion transporter protein (e.g., statins).

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.
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

12.

Darolutamide Slows Metastasis in Prostate Cancer.

Author:

Delayed metastasis
Fewer side effects

Darolutamide, an androgen receptor antagonist, delayed metastasis in men with castration-resistant prostate cancer by a median of 22 months compared to placebo.

NewsMedia reports that provide information on the latest events and information. Newspapers, television, and the Internet are the main media.
CommentA short article/note that provides an opinion/perspective/interpretation on a published paper/topic.

Language : English

13.

Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naïve and CYP17 Inhibitor-naïve Patients: Follow-up from the ARADES and ARAFOR Trials.

Author: ShoreNeal D, TammelaTeuvo L, MassardChristophe, BonoPetri, AspegrenJohn, MustonenMika, FizaziKarim

Antitumor activity
Sustained disease control
Back pain
Diarrhea
Fatigue
Nausea
Pain in extremity

Extended treatment with ODM-201 was well tolerated and provided sustained antitumor activity in chemotherapy-naïve and CYP17i-naïve patients with metastatic castration-resistant prostate cancer.

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

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