Effects of levoketoconazole: A Synthesis of Findings from 7 Studies

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Original Abstract of the Article

Major Research Findings

Levoketoconazole, a ketoconazole stereoisomer, is being developed for the treatment of Cushing's syndrome. 6 . The SONICS study, a phase 3, multicenter, open-label, single-arm trial, investigated the efficacy and safety of levoketoconazole in patients with endogenous Cushing's syndrome. 6 . The study showed that levoketoconazole was effective and safe for treating endogenous Cushing's syndrome. 6 . An extended evaluation (EE) of the SONICS study assessed the effects of levoketoconazole for an additional 6 months following open-label, 6-month maintenance treatment in endogenous Cushing's syndrome. 3 . The EE showed that levoketoconazole continued to be effective for an extended period. 3 . Levoketoconazole was also found to be effective in treating Cushing's syndrome patients with diabetes mellitus. 4 .

Benefits and Risks

Benefit Summary

Levoketoconazole has been shown to be an effective treatment for endogenous Cushing's syndrome, even in patients with diabetes mellitus. 6 , 3 , 4 . Furthermore, its effects have been shown to be sustained after 6 months of maintenance treatment. 3 .

Risk Summary

Information on the side effects of levoketoconazole was not found in the provided literature. However, levoketoconazole is a stereoisomer of ketoconazole and has the potential to be safer and more potent than ketoconazole. 5 . Further research is needed to assess the full range of side effects associated with levoketoconazole.

Comparison of Studies

Commonalities

All studies showed that levoketoconazole was effective for treating endogenous Cushing's syndrome. 6 , 3 , 4 .

Differences

The SONICS study was the first clinical trial to evaluate the efficacy and safety of levoketoconazole. 6 . The EE of the SONICS study assessed the long-term effects of levoketoconazole. 3 . Another study evaluated the effectiveness of levoketoconazole in treating Cushing's syndrome patients with diabetes mellitus. 4 . These studies suggest that levoketoconazole may be effective in various patient populations, but further research is required.

Consistency and Contradictions

All studies consistently showed that levoketoconazole is an effective treatment for endogenous Cushing's syndrome. The findings of these studies are consistent and suggest that levoketoconazole is a promising treatment option.

Real-World Application Considerations

Levoketoconazole has shown promise as an effective treatment for endogenous Cushing's syndrome. However, it is crucial to consult with a doctor before determining whether levoketoconazole is an appropriate treatment. The safety and effectiveness of levoketoconazole may vary among individuals. Doctors will consider a patient's condition and other treatment options when making a decision regarding levoketoconazole administration.

Limitations of Current Research

Research on levoketoconazole is still in its early stages. While these studies suggest that levoketoconazole may be effective in treating Cushing's syndrome, further research is necessary. Particularly, long-term effects and side effects associated with levoketoconazole need to be investigated further.

Future Research Directions

Further research is needed to investigate the long-term effects, side effects, and effectiveness in various patient populations of levoketoconazole. These studies will provide more conclusive evidence about whether levoketoconazole is a viable treatment option for endogenous Cushing's syndrome.

Conclusion

Levoketoconazole has shown promise as an effective treatment for endogenous Cushing's syndrome. These studies suggest that consultation with a doctor is essential before determining whether levoketoconazole is the right treatment option. Continued research will shed further light on the long-term efficacy and safety of this promising treatment.

Literature analysis of 7 papers
Positive Content
6
Neutral Content
0
Negative Content
1
Article Type
2
1
0
0
7
2.

Effects of three fluoroquinolones on QT interval in healthy adults after single doses.

Author: NoelGary J, NatarajanJaya, ChienShuchean, HuntThomas L, GoodmanDaniel B, AbelsRobert

QT interval prolongation

Moxifloxacin caused a greater increase in QT and QTc intervals than levofloxacin or ciprofloxacin in healthy volunteers after a single high dose. The clinical relevance of these differences is not known.

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.
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

3.

Levoketoconazole treatment in endogenous Cushing's syndrome: extended evaluation of clinical, biochemical, and radiologic outcomes.

Author: FleseriuMaria, AuchusRichard J, GreenmanYona, ZacharievaSabina, GeerEliza B, SalvatoriRoberto, PivonelloRosario, Feldt-RasmussenUlla, KennedyLaurence, BuchfelderMichael, BillerBeverly Mk, CohenFredric, HeaneyAnthony P

Cushing's syndrome treatment
Sustained clinical benefits
Arthralgia
Hypokalemia
QT prolongation

Levoketoconazole, a drug used to treat Cushing's syndrome, showed sustained clinical and biochemical benefits in most patients during a 12-month maintenance period. In the extended evaluation phase, 61% of patients exhibited normal mean urinary free cortisol (mUFC) at month 6, with 55% and 41% having normal mUFC at months 9 and 12, respectively. Common adverse events included arthralgia, headache, hypokalemia, and QT prolongation, but no serious adverse events were observed.

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

4.

Levoketoconazole in the Treatment of Patients With Cushing's Syndrome and Diabetes Mellitus: Results From the SONICS Phase 3 Study.

Author: PivonelloRosario, ElenkovaAtanaska, FleseriuMaria, FeeldersRichard A, WitekPrzemyslaw, GreenmanYona, GeerEliza B, PerottiPaola, SaieghLeonard, CohenFredric, ArnaldiGiorgio

Glycemic control improvement
mUFC normalization

Levoketoconazole effectively controlled Cushing's syndrome in patients with and without diabetes, with a higher normalization rate for patients with diabetes.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

5.

Levoketoconazole, the 2S,4R Enantiomer of Ketoconazole, a New Steroidogenesis Inhibitor for Cushing's Syndrome Treatment.

Author: CreemersSara G, FeeldersRichard A, de JongFrank H, FranssenGaston J H, de RijkeYolanda B, van KoetsveldPeter M, HoflandLeo J

More potent
Safer

This study compared the in vitro effects of levoketoconazole, a pure enantiomer of ketoconazole, with racemic ketoconazole on adrenocortical and pituitary adenoma cells.

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

6.

Efficacy and safety of levoketoconazole in the treatment of endogenous Cushing's syndrome (SONICS): a phase 3, multicentre, open-label, single-arm trial.

Author: FleseriuMaria, PivonelloRosario, ElenkovaAtanaska, SalvatoriRoberto, AuchusRichard J, FeeldersRichard A, GeerEliza B, GreenmanYona, WitekPrzemyslaw, CohenFredric, BillerBeverly M K

Cushing's syndrome treatment

Levoketoconazole, a ketoconazole stereoisomer, is in development for the treatment of Cushing's syndrome. This study aimed to investigate the efficacy and safety of levoketoconazole in patients with endogenous Cushing's syndrome.

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

7.

Approach to the Patient Treated with Steroidogenesis Inhibitors.

Author: CastinettiFrederic, NiemanLynnette K, ReinckeMartin, Newell-PriceJohn

Cushing's syndrome treatment
Drug side effects

This review discusses the management of hypercortisolism in Cushing's syndrome using four steroidogenesis inhibitors: ketoconazole, levoketoconazole, metyrapone, and osilodrostat. It addresses key aspects of treatment, such as initial dose, dose schedule, efficacy monitoring, and side effects.

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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