Effects of insulin degludec (rdna origin) injection: A Synthesis of Findings from 6 Studies

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Original Abstract of the Article

Main Research Findings

Several studies have shown that azole antifungal drugs, such as itraconazole and fluconazole, can affect the pharmacokinetics and pharmacodynamics of midazolam. 3 These antifungals inhibit the activity of CYP3A4, an enzyme responsible for metabolizing midazolam, leading to increased midazolam levels in the blood. 5 This increase in midazolam levels can enhance its effects. 3 Specifically, itraconazole and fluconazole significantly increase the AUC (area under the concentration-time curve) and Cmax (peak concentration) of oral midazolam. 3 This means the effects of oral midazolam can be prolonged. 3 On the other hand, the impact of these antifungals on intravenous midazolam is less pronounced. 3 However, caution is advised when using high doses of intravenous midazolam. 3

Itraconazole may be an effective treatment option for Candida and Aspergillus infections in neutropenic patients, potentially even more effective than amphotericin B. 1 However, its absorption can be unreliable in severely ill patients with compromised gastrointestinal function. 1

Combining terbinafine and itraconazole may provide better therapeutic outcomes for fungal skin diseases compared to monotherapy. 6 The combination therapy showed significantly better results in terms of symptom scores, mycological examinations, cure rate, and cure time. 6 No adverse events or relapses were reported during follow-up. 6

Itraconazole significantly increases the plasma concentrations and effects of triazolam. 4 This interaction is dependent on the time interval between ingestion of the two drugs, and it cannot be avoided by increasing the time gap if itraconazole is used daily. 4 The risk of interaction persists for several days after stopping itraconazole therapy. 4

Itraconazole may be a promising alternative to amphotericin B for treating systemic mycoses in neutropenic patients, as it exhibits fewer side effects. 2

Benefits and Risks

Benefit Summary

Azole antifungals can effectively treat fungal infections like Candida and Aspergillus infections. 1 , 2 Combining terbinafine and itraconazole may provide better therapeutic outcomes for fungal skin diseases. 6

Risk Summary

Azole antifungals can inhibit the metabolism of drugs like midazolam, potentially intensifying their effects. 3 , 5 Therefore, dose adjustments for midazolam may be required when using azole antifungals concurrently. 3 Itraconazole absorption can be unpredictable in severely ill patients with gastrointestinal issues. 1

Comparison Between Studies

Commonalities Between Studies

All these studies consistently show that azole antifungals impact the pharmacokinetics of midazolam. 3 , 5 They inhibit CYP3A4, the enzyme responsible for metabolizing midazolam, resulting in higher midazolam levels in the blood. 5

Differences Between Studies

These studies differ in the specific azole antifungals used, the route of midazolam administration, and the patient populations studied. 3 , 5 , 1 , 2 , 6

Consistency and Discrepancies in Results

The findings across these studies are consistent in showing that azole antifungals affect midazolam pharmacokinetics. 3 , 5 However, further research is needed to understand the relative strength of effects from different antifungals and the differences in impact between intravenous and oral midazolam administration. 3 , 5

Practical Applications and Cautions

Dose adjustments for midazolam may be necessary when using azole antifungals concurrently. 3 This is particularly crucial when using oral midazolam, as the drug's effects can be prolonged. 3

Limitations of Current Research

These studies involved a relatively small number of subjects, so generalizing their results requires caution. 3 , 5 Furthermore, they did not delve into specific disease states or drug interactions in detail. 1 , 2 , 6

Future Research Directions

Larger-scale studies are needed to further elucidate the interaction between azole antifungals and midazolam. 3 , 5 Research investigating the specific effects of different antifungals and their impact on intravenous and oral midazolam administration is also crucial. 3 , 5

Conclusion

These studies indicate that azole antifungals can affect the pharmacokinetics of midazolam. 3 , 5 Dose adjustments for midazolam may be necessary when using azole antifungals concurrently. 3

Literature analysis of 6 papers
Positive Content
2
Neutral Content
3
Negative Content
1
Article Type
6
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0
0
6
1.

Itraconazole in neutropenic patients.

Author: van't WoutJ W

Fungal infection treatment
Itraconazole absorption

A study of 32 neutropenic patients with fungal infections compared the effectiveness of itraconazole and amphotericin B. Both treatments were effective against Candida infections, with 9 out of 16 patients responding to amphotericin B and 10 out of 16 responding to itraconazole. Itraconazole was more effective against Aspergillus infections, with 6 out of 8 patients responding compared to 2 out of 5 on amphotericin B. While amphotericin B treatment was associated with three deaths from Aspergillus infections, no deaths occurred in the itraconazole group. The study suggests that itraconazole may be a promising treatment for systemic fungal infections in neutropenic patients, although further research is needed.

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.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

[Therapy of systemic mycoses in neutropenic patients using itraconazole. A comparative, randomized study with amphotericin B].

Author: van't WoutJ W, NovakovaI, VerhagenC A, FibbeW E, de PauwB E, van der MeerJ W

Effective against mycoses
Anaemia
Fever
Hypokalaemia
Hypotension
Nephrotoxicity
Renal tubular acidosis
Shivering
Side effects
Thrombocytopenia
Thrombophlebitis

A randomized comparative investigation was carried out to assess the efficacy of amphotericin B and itraconazole in the treatment of systemic mycoses in neutropenic patients.

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.
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.
English AbstractA summary of a research paper/publication written in English for a wider audience.
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 : German

3.

The effects of the systemic antimycotics, itraconazole and fluconazole, on the pharmacokinetics and pharmacodynamics of intravenous and oral midazolam.

Author: OlkkolaK T, AhonenJ, NeuvonenP J

Sedation
Increased midazolam effects

Itraconazole and fluconazole, azole antimycotics, significantly increased the effects of oral midazolam, raising its AUC and peak concentration by 3.5-fold and two-fold, respectively. This interaction also led to a profound increase in psychomotor effects. While the interaction with IV midazolam was weak, large doses of IV midazolam could still lead to clinically significant interactions. Using oral midazolam with itraconazole and fluconazole should be avoided.

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.
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

4.

The effect of ingestion time interval on the interaction between itraconazole and triazolam.

Author: NeuvonenP J, VarheA, OlkkolaK T

Increased triazolam effects

Itraconazole interacts considerably with triazolam when this hypnotic agent is ingested within 24 hours after itraconazole.

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.

Language : English

5.

Effects of oral posaconazole on the pharmacokinetic properties of oral and intravenous midazolam: a phase I, randomized, open-label, crossover study in healthy volunteers.

Author: KrishnaGopal, MotonAllen, MaLei, SavantIshani, MartinhoMonika, SeiberlingMichael, McLeodJames

Drug interaction

This study aims to determine how the antifungal drug posaconazole affects the pharmacokinetic properties of midazolam, a short-acting benzodiazepine, due to their potential for drug interactions.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
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.
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

6.

Terbinafine Hydrochloride Combined With Itraconazole for Fungal Skin Diseases: A Randomized Controlled Trial.

Author: ZhangDongxing, LiaoWanqing, ChenCanhua, LaiHongtao, LiuShi

Combined therapy efficacy
Fungal skin diseases treatment

Combined treatment with terbinafine and itraconazole achieved better therapeutic effects in patients with fungal skin diseases compared to monotherapy. The combination group had significantly decreased symptom scores, a higher cure rate, and shorter cure time. No adverse events or relapses were reported during follow-up.

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

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