Effects of nilotinib: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Major Research Findings

Nilotinib, an FDA-approved drug for leukemia, has shown preclinical evidence of improving Alzheimer's disease phenotypes. 18 Studies have investigated the safety of nilotinib in Alzheimer's patients, its detectability in cerebrospinal fluid, and its potential to alter biomarkers and clinical decline. 18 Nilotinib, commonly used to treat chronic myeloid leukemia, has been found to potentially impact spermatogenesis and folliculogenesis in mice, leading to potential male or female infertility. 1 Research has explored the effects of famotidine or antacids on nilotinib's pharmacokinetics in healthy individuals, aiming to minimize drug-drug interactions through different dosing schemes. 6 Nilotinib was developed as a more potent ABL tyrosine kinase inhibitor compared to imatinib, demonstrating preclinical effectiveness against many imatinib-resistant BCR-ABL mutations, except for T315I. 9 However, patients already exhibiting imatinib resistance have a higher chance of developing further mutations under the influence of potent ABL TKIs. 9 The impact of nilotinib, alongside other tyrosine kinase inhibitors like PKC412 and imatinib, on PDGFRA mutations associated with gastrointestinal stromal tumors (GIST) has been studied, considering that the sensitivity to imatinib varies depending on the mutation location. 3 Nilotinib has been shown to interact with ABC multidrug transporters (MDR-ABC proteins), which can contribute to multidrug resistance in cancer and potentially affect the effectiveness and pharmacological properties of new targeted agents. 16 Nilotinib has been found to exert a previously uncharacterized effect on CD4+CD25+ regulatory T cells (Tregs), which regulate anti-tumor/leukemia immune responses. 17 Concerns are growing regarding the cardiotoxicity associated with the use of clinically proven tyrosine kinase inhibitors (TKIs) like dasatinib, nilotinib, and sorafenib, used for treating leukemia and hepatocellular carcinoma, and this study aimed to investigate their effects on vascular smooth muscle cells (VSMCs). 10 Nilotinib, developed to manage imatinib resistance in chronic myeloid leukemia (CML) patients, targets similar molecular targets as imatinib but exhibits significantly more potent inhibition of Bcr-Abl. 15 While showing effectiveness against leukemia, nilotinib has been linked to hypophosphatemia, affecting bone metabolism, in up to 30% of patients receiving the drug. 15 An open-label study investigated the long-term safety, tolerability, and potential clinical effects of nilotinib in medically optimized patients with Parkinson's disease. 13 Nilotinib, when combined with interleukin-2 (IL-2), has demonstrated antitumor and immunological effects in a B16 melanoma model. 19 Preclinical studies have indicated that combining nilotinib with imatinib shows beneficial effects in BCR-ABL+ leukemia models. 24 Nilotinib has been shown to ameliorate CCl4-induced liver fibrosis in rats by suppressing RAGE/HMGB1 gene expression and oxidative stress. 7 The molecular requirements for the antiplatelet effects of synthetically optimized analogues of imatinib and nilotinib, anticancer drugs, have been investigated. 23 Data from a developing country has evaluated the response and adverse effects of nilotinib in patients with imatinib-resistant chronic myeloid leukemia (CML). 14 Nilotinib has shown anti-allergic effects in mast cell-mediated anaphylaxis-like reactions. 8 Specific proposals for tailored stratification at baseline and monitoring of cardiovascular effects during follow-up in chronic phase chronic myeloid leukemia patients treated with nilotinib have been outlined. 21 Research has investigated the impact of rifampin and ketoconazole on the pharmacokinetics of nilotinib in healthy volunteers. 20 The effects of imatinib and nilotinib on the whole transcriptome of cultured murine osteoblasts have been analyzed using Sequencing by Oligonucleotide Ligation and Detection next-generation RNA sequencing. 12 A study has investigated the impact of hepatic impairment on the pharmacokinetics of nilotinib in a controlled setting. 4 Research has explored the effects of antioxidants on apoptosis induced by dasatinib and nilotinib in K562 cells. 11 Vibrational microspectroscopy and cell cloning have been used to investigate the effects of nilotinib on leukemia cells. 22 The effects of low doses of nilotinib on safety and pharmacokinetics in patients with Parkinson's disease dementia or dementia with Lewy bodies have been evaluated. 5 The impact of yogurt and applesauce on the oral bioavailability of nilotinib has been studied in healthy volunteers. 2

Benefits and Risks

Benefits Summary

Nilotinib has shown effectiveness in treating chronic myeloid leukemia, particularly in patients who have developed resistance to imatinib. 14 As an ABL tyrosine kinase inhibitor, nilotinib demonstrates preclinical effectiveness against a wide range of imatinib-resistant BCR-ABL mutations, including the T315I mutation. 9 Combining nilotinib with imatinib has shown promising results in preclinical models of BCR-ABL+ leukemia. 24 Nilotinib has been observed to ameliorate CCl4-induced liver fibrosis in rats by suppressing RAGE/HMGB1 gene expression and oxidative stress. 7 Nilotinib has demonstrated anti-allergic effects in mast cell-mediated anaphylaxis-like reactions. 8 Preclinical evidence suggests that nilotinib may improve Alzheimer's disease phenotypes. 18

Risks Summary

Nilotinib, at the dosage used for treating chronic myeloid leukemia, has been linked to potential impacts on spermatogenesis and folliculogenesis in mice, potentially leading to infertility in both males and females. 1 Nilotinib exhibits off-target effects, including hypophosphatemia, affecting bone metabolism, in up to 30% of patients receiving the drug. 15 Concerns are growing about the cardiotoxicity associated with the use of clinically proven tyrosine kinase inhibitors (TKIs) like dasatinib, nilotinib, and sorafenib, used for treating leukemia and hepatocellular carcinoma. 10 Research has investigated the impact of rifampin and ketoconazole on the pharmacokinetics of nilotinib in healthy volunteers. 20

Comparison Across Studies

Research Commonalities

Many studies have investigated the pharmacological properties and potential therapeutic applications of nilotinib, particularly focusing on its effectiveness in treating chronic myeloid leukemia, its potential against other cancer types, and its effects on cardiovascular systems and bone metabolism. 14 9 3 16 17 10 15 20

Research Differences

Differences among studies include the specific mechanisms and targets of nilotinib's action, the diseases or conditions investigated, and the study designs and methodologies. For instance, some studies focus on leukemia, while others focus on liver fibrosis or Alzheimer's disease. 19 18 7 Some studies employ in vitro or in vivo models, while others conduct clinical trials with human patients. 1 6

Consistency and Discrepancies in Findings

Several studies suggest that nilotinib is an effective treatment for chronic myeloid leukemia. 14 However, research has also highlighted off-target effects of nilotinib, including hypophosphatemia, infertility, and potential cardiotoxicity. 1 15 10 These side effects may not affect all patients and can vary in severity. 21 Clinicians must carefully consider the potential benefits and risks of nilotinib to determine the optimal treatment approach for individual patients. 13

Considerations for Real-World Application

Nilotinib should be used under the guidance of a healthcare professional and self-medication should be avoided. 2 Nilotinib may interact with other medications. 20 It's crucial to inform your doctor about your health conditions and any medications you are taking before using nilotinib. 11 Nilotinib may not be effective for everyone. 22 When using nilotinib, carefully monitor for side effects and consult your doctor immediately if you experience any abnormalities. 5

Limitations of Current Research

Many studies on nilotinib have been small and short-term. 12 Therefore, long-term safety and efficacy data for nilotinib are still limited. 4 Moreover, nilotinib may not be effective for all patients. 23 Further research is required. 24

Future Research Directions

Large-scale, long-term clinical trials are needed to evaluate the long-term safety and efficacy of nilotinib. 7 Further research is necessary to investigate the potential effectiveness of nilotinib for various diseases. 19 Development of new treatments and medications aimed at reducing the side effects of nilotinib is also needed. 18

Conclusion

Nilotinib has shown promise as an effective treatment for chronic myeloid leukemia. 14 However, it's essential to be aware of potential side effects. 1 When using nilotinib, follow your doctor's instructions and monitor closely for any adverse reactions. 15

Literature analysis of 24 papers
Positive Content
22
Neutral Content
1
Negative Content
1
Article Type
4
0
0
1
24
2.

Effects of yogurt and applesauce on the oral bioavailability of nilotinib in healthy volunteers.

Author: YinOphelia Q P, RudoltzMarc, GaleticIvana, FilianJeiry, KrishnaArun, ZhouWei, CustodioJoseph, GolorGeorg, SchranHorst

Alternative nilotinib administration

Nilotinib is a tyrosine kinase inhibitor used to treat chronic myeloid leukemia. The drug is currently available as a capsule that must be swallowed whole. This study compared the bioavailability of nilotinib when administered as a whole capsule, dispersed in yogurt, or dispersed in applesauce. Dispersing nilotinib in yogurt modestly increased its bioavailability, while dispersing it in applesauce provided equivalent bioavailability compared to the whole capsule.

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.

Effects of PKC412, nilotinib, and imatinib against GIST-associated PDGFRA mutants with differential imatinib sensitivity.

Author: WeisbergEllen, WrightRenee D, JiangJingrui, RayArghya, MorenoDaisy, ManleyPaul W, FabbroDoriano, Hall-MeyersElizabeth, CatleyLaurie, PodarKlaus, KungAndrew L, GriffinJames D

GIST treatment

This study investigates the effects of three tyrosine kinase inhibitors, PKC412, nilotinib, and imatinib, on two PDGFRA mutants, V561D and D842V, which exhibit differential sensitivity to imatinib.

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

4.

Effects of hepatic impairment on the pharmacokinetics of nilotinib: an open-label, single-dose, parallel-group study.

Author: YinOphelia Q P, GallagherNeil, TanakaChiaki, FisherDeirdre, SethuramanVenkat, ZhouWei, LinTsu-Han, HeumanDouglas, SchranHorst

Treats imatinib-resistant leukemia

Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor for treating imatinib-resistant chronic myeloid leukemia. It's primarily metabolized in the liver by cytochrome P450 3A4. Interpatient variability in systemic nilotinib exposure ranges from 32% to 64%.

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

Language : English

5.

Nilotinib Effects in Parkinson's disease and Dementia with Lewy bodies.

Author: PaganFernando, HebronMichaeline, ValadezEllen H, Torres-YaghiYasar, HuangXu, MillsReversa R, WilmarthBarbara M, HowardHellen, DunnConnell, CarlsonAlexis, LawlerAbigail, RogersSean L, FalconerRamsey A, AhnJaeil, LiZhaoxia, MoussaCharbel

Improved cognitive function
Improved motor function

Low doses of Nilotinib were safe and tolerated in patients with advanced Parkinson’s disease. Nilotinib appears to be able to engage the target Abl.

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

6.

Effects of famotidine or an antacid preparation on the pharmacokinetics of nilotinib in healthy volunteers.

Author: YinOphelia Q P, BédouchaVéronique, McCullochTracey, ZhengCheng, ZhouWei, HussainiAzra, NovickSteven

Neither famotidine nor antacid significantly affected the pharmacokinetics of nilotinib. When concurrent use of an H2 blocker or an antacid is necessary, the H2 blocker may be administered 10 h before and 2 h after nilotinib, or the antacid may be administered 2 h before or 2 h after nilotinib.

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

9.

Combined effects of novel heat shock protein 90 inhibitor NVP-AUY922 and nilotinib in a random mutagenesis screen.

Author: TauchiT, OkabeS, AshiharaE, KimuraS, MaekawaT, OhyashikiK

CML treatment

This study investigated the combination of AUY922, an HSP90 inhibitor, and nilotinib, an ABL tyrosine kinase inhibitor, for overcoming imatinib resistance in chronic myeloid leukemia. The combination demonstrated synergistic effects in reducing the outgrowth of resistant cell clones, including those with the T315I mutation.

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

11.

Effects of antioxidants on apoptosis induced by dasatinib and nilotinib in K562 cells.

Author: DamianoSara, MontagnaroSerena, PuzioMaria V, SeverinoLorella, PagniniUgo, BarbarinoMarcella, CesariDaniele, GiordanoAntonio, FlorioSalvatore, CiarciaRoberto

CML treatment
ROS generation
SERCA receptor functionality

Resveratrol, rMnSOD and δ-tocotrienol reduced lipid peroxidation induced by Nilotinib (NIL) and Dasatinib (DAS), two tyrosine kinase inhibitors for chronic myeloid leukemia. They also increased intracellular ROS levels, leading to apoptosis.

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.

Effects of imatinib and nilotinib on the whole transcriptome of cultured murine osteoblasts.

Author: KirschnerGyöngyi, BallaBernadett, HorváthPéter, KövesdiAndrea, LakatosGergely, TakácsIstván, NagyZsolt, TóbiásBálint, ÁrvaiKristóf, KósaJános Pál, LakatosPéter

Bone metabolism
Novel targets
Bone disease
Bone physiology

This study analyzed the whole transcriptome of cultured murine osteoblasts and determined the changes following treatment with imatinib and nilotinib. The preliminary results suggest the two drugs have different mechanisms of action on osteoblasts.

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

Language : English

13.

Long-Term Safety and Clinical Effects of Nilotinib in Parkinson's Disease.

Author: PaganFernando L, WilmarthBarbara, Torres-YaghiYasar, HebronMichaeline L, MulkiSanjana, FerranteDalila, MatarSara, AhnJaeil, MoussaCharbel

Improved Parkinson's symptoms

This study investigated the safety, tolerability, and potential clinical effects of nilotinib in Parkinson's disease. The study found that nilotinib was safe and tolerated. Exploratory clinical outcomes showed that nilotinib 300mg was remarkably stable from baseline to 27 months using the Unified Parkinson's Disease Scale (UPDRS). A larger study is needed to evaluate the efficacy of nilotinib 300mg in Parkinson's disease.

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

15.

The skeletal effects of the tyrosine kinase inhibitor nilotinib.

Author: O'SullivanSusannah, LinJian-Ming, WatsonMaureen, CallonKaren, TongPak Cheung, NaotDorit, HorneAnne, AatiOpetaia, PorteousFran, GambleGreg, CornishJillian, BrowettPeter, GreyAndrew

Bone density
Hypophosphataemia

This study assessed the effects of nilotinib, a tyrosine kinase inhibitor, on bone cells in vitro and on bone metabolism in patients with chronic myeloid leukemia (CML). Nilotinib potently inhibited osteoblast proliferation and osteoclastogenesis in vitro. In 10 patients receiving nilotinib, levels of bone turnover markers were in the low-normal range and bone density tended to be higher than age and gender-matched normal values.

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

Language : English

16.

Interaction of nilotinib, dasatinib and bosutinib with ABCB1 and ABCG2: implications for altered anti-cancer effects and pharmacological properties.

Author: HegedusC, Ozvegy-LaczkaC, ApátiA, MagócsiM, NémetK, OrfiL, KériG, KatonaM, TakátsZ, VáradiA, SzakácsG, SarkadiB

Cancer treatment
Improved drug efficacy
Drug resistance

ABCB1 and ABCG2 transporters interact with nilotinib, dasatinib, and bosutinib, second-generation Bcr-Abl tyrosine kinase inhibitors, potentially affecting their anticancer efficiency and pharmacological properties.

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

17.

Effects of nilotinib on regulatory T cells: the dose matters.

Author: FeiFei, YuYingzhe, SchmittAnita, RojewskiMarkus T, ChenBaoan, GreinerJochen, GötzMarlies, BunjesDonald, SchmittMichael

Inhibits Treg proliferation
Inhibits Treg suppressive capacity

Nilotinib, a tyrosine kinase inhibitor, did not inhibit the function of regulatory T cells (Tregs) at clinically relevant doses. Further investigation is needed on the long-term effects of nilotinib on Tregs.

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

18.

Nilotinib Effects on Safety, Tolerability, and Biomarkers in Alzheimer's Disease.

Author: TurnerRaymond S, HebronMichaeline L, LawlerAbigail, MundelElizabeth E, YusufNadia, StarrJ Nathan, AnjumMuhammad, PaganFernando, Torres-YaghiYasar, ShiWangke, MulkiSanjana, FerranteDalila, MatarSara, LiuXiaoguang, EspositoGiuseppe, BerkowitzFrank, JiangXiong, AhnJaeil, MoussaCharbel

Alzheimer's disease treatment

This study investigates the safety, cerebrospinal fluid penetration, and potential therapeutic effects of nilotinib, a drug approved for leukemia, in Alzheimer's disease.

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

19.

Nilotinib combined with interleukin-2 mediates antitumor and immunological effects in a B16 melanoma model.

Author: GeislerK, ReischerA, KroegerI, JacobsB, MeinhardtK, BauerR, RyffelB, MackensenA, UllrichE

Antitumor activity
Immune modulation

Nilotinib, a tyrosine kinase inhibitor, combined with interleukin-2, showed superior antitumor activity compared to imatinib in a murine melanoma model. This effect was mediated by IFN-γ-producing CD27+ NK cells.

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

Language : English

20.

Effects of rifampin and ketoconazole on the pharmacokinetics of nilotinib in healthy participants.

Author: TanakaChiaki, YinOphelia Q P, SmithTom, SethuramanVenkat, GroussKaren, GalitzLawrence, HarrellRobert, SchranHorst

Chronic myeloid leukemia treatment

Nilotinib is a drug used to treat chronic myeloid leukemia. It is metabolized by CYP3A4. Strong inducers of CYP3A4, such as rifampin, decrease nilotinib levels by 80%, while strong inhibitors of CYP3A4, such as ketoconazole, increase nilotinib levels by 3-fold.

Controlled Clinical TrialA clinical trial that evaluates the effectiveness of a treatment by comparing a group that receives the intervention with a group that receives a placebo or standard 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

21.

Proposal for a tailored stratification at baseline and monitoring of cardiovascular effects during follow-up in chronic phase chronic myeloid leukemia patients treated with nilotinib frontline.

Author: BrecciaMassimo, ArboscelloEleonora, BellodiAndrea, ColafigliGioia, MolicaMatteo, BergamaschiMicaela, MassaroFulvio, QuattrocchiLuisa, SarocchiMatteo, SpallarossaPaolo, AlimenaGiuliana

CML treatment
Cardiac disorders
Increased cholesterol
Increased glycemia
Vascular disorders

This paper focuses on the optimal procedures to perform at diagnosis in order to identify patients at risk of possible metabolic and cardiovascular adverse events caused by nilotinib, a tyrosine kinase inhibitor used for chronic myeloid leukemia patients. It also explores the correct monitoring procedures to prevent and manage these adverse events.

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

23.

Molecular Requirements for the Expression of Antiplatelet Effects by Synthetic Structural Optimized Analogues of the Anticancer Drugs Imatinib and Nilotinib.

Author: PantaziDespoina, NtemouNikoleta, BrentasAlexios, AlivertisDimitrios, SkobridisKonstantinos, TselepisAlexandros D

Targeted therapy

This review discusses the roles of platelets and tyrosine kinases in cancer progression and metastasis, and the potential of tyrosine kinase inhibitors (TKIs) as anticancer drugs.

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

Language : English

24.

Beneficial effects of combining nilotinib and imatinib in preclinical models of BCR-ABL+ leukemias.

Author: WeisbergEllen, CatleyLaurie, WrightRenee D, MorenoDaisy, BanerjiLolita, RayArghya, ManleyPaul W, MestanJuergen, FabbroDoriano, JiangJingrui, Hall-MeyersElizabeth, CallahanLinda, DellaGattaJamie L, KungAndrew L, GriffinJames D

CML treatment
Imatinib resistance overcome

This study found that the combination of imatinib and nilotinib may be more effective in treating chronic myelogenous leukemia (CML) than either drug alone. The combination was at least additive in antileukemic activity.

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

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