Effects of anagrelide: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Main Research Findings

Anagrelide has been studied for its efficacy, safety, and tolerability as a second-line treatment for essential thrombocythemia (ET) in high-risk Japanese patients. 3 A single-arm study involving 53 patients found that 67.9% experienced a platelet response (<60 × 10(4)/μL) and 45.3% achieved platelet count normalization (≤40 × 10(4)/μL) after receiving anagrelide therapy. 1 Anagrelide has been evaluated for its efficacy, safety, and tolerability in Japanese ET patients as both a monotherapy and in combination with hydroxycarbamide. These studies suggest that anagrelide can effectively reduce platelet counts in Japanese ET patients.

While anagrelide can be effective in lowering platelet counts in ET patients, it comes with potential side effects. Common side effects reported include anemia, headache, palpitations, and diarrhea. 3 In addition, 7 reported a case of Takotsubo cardiomyopathy developing during anagrelide therapy, highlighting the potential for cardiovascular side effects.

Anagrelide may be a viable treatment option for ET patients, but its use should be approached cautiously. Factors such as platelet count levels, patient history, and interactions with other medications should be carefully considered before administering anagrelide. 15 reports a case of anagrelide-induced nonischemic cardiomyopathy.

Benefits and Risks

Benefits Summary

Anagrelide has shown potential for reducing platelet counts in ET patients. 3 , 1 This reduction may help minimize the risk of thrombosis and bleeding associated with ET.

Risks Summary

Anagrelide use comes with the risk of side effects, including anemia, headache, palpitations, and diarrhea. 3 There is also a potential for serious adverse events like Takotsubo cardiomyopathy and nonischemic cardiomyopathy. 7 , 15 Caution is necessary when using anagrelide.

Study Comparison

Study Commonalities

These studies suggest that anagrelide can effectively reduce platelet counts in Japanese ET patients. 3 , 1 They also indicate that anagrelide can cause side effects like anemia, headache, palpitations, and diarrhea. 3 These side effects are often mild or moderate.

Study Differences

3 was a single-arm study involving high-risk ET patients, while 1 was a retrospective study comparing anagrelide as a monotherapy and in combination therapy. The studies differed in their approach to anagrelide administration and the endpoints they evaluated. Therefore, direct comparisons of these research findings are not feasible.

Consistency and Discrepancies of Findings

These studies suggest that anagrelide can effectively reduce platelet counts in ET patients. However, research on anagrelide's safety and effectiveness remains ongoing and more extensive investigation is needed. 7 , 15 These studies point to the potential of anagrelide to impact the heart, and its use requires careful consideration.

Real-World Application Considerations

Anagrelide has shown potential for reducing platelet counts in ET patients. 3 , 1 However, the possibility of cardiovascular complications associated with anagrelide use necessitates cautiousness. 7 , 15 Before considering anagrelide treatment, a thorough discussion with a physician to understand the benefits and risks is crucial.

Limitations of Current Research

These studies, while informative, are relatively small and lack comprehensive data on anagrelide's long-term safety and effectiveness. 3 , 1 Further research is necessary to gain a deeper understanding of anagrelide's long-term effects and optimize its use.

Future Research Directions

Future studies should investigate the long-term safety and effectiveness of anagrelide. Research focused on determining the optimal dosage and administration methods for anagrelide is also warranted. 3 , 1 Furthermore, more in-depth research on anagrelide's impact on the cardiovascular system is needed. These research efforts could pave the way for anagrelide to become a safer and more effective treatment option for ET patients.

Conclusion

Anagrelide demonstrates the potential to reduce platelet counts in ET patients. 3 , 1 However, its use should be approached with caution due to potential cardiac complications. 7 , 15 Before considering anagrelide treatment, it is vital to consult with a physician to understand the benefits and risks associated with its use.

Literature analysis of 24 papers
Positive Content
19
Neutral Content
1
Negative Content
4
Article Type
1
0
0
2
23
1.

Clinical Evaluation of the Efficacy and Safety of Anagrelide Used with or without Hydroxycarbamide in Japanese Patients with Essential Thrombocythemia-A Retrospective Single-Center Study of 35 Cases.

Author: SekiguchiYasunobu, WakabayashiMutsumi, TakizawaHaruko, IizukaHiroko, SakajiriSakura, SugimotoKeiji, InanoTadaaki, FukudaYasutaka, HamanoYasuharu, TomitaShigeki, IzumiHiroshi, OkuboMitsuo, NakamuraNoriko, SawadaTomohiro, NoguchiMasaaki

ET treatment

This study aimed to evaluate the efficacy, safety, and tolerability of anagrelide monotherapy and combined anagrelide plus hydroxycarbamide in Japanese patients with essential thrombocythemia.

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

Language : English

2.

Observational retrospective study of vascular modulator changes during treatment in essential thrombocythemia.

Author: PiccinAndrea, SteurerMichael, FeistritzerClemens, MurphyCiaran, EakinsElva, Van SchilfgaardeMuriel, CorvettaDaisy, Di PierroAngela Maria, PuscedduIrene, MarcheselliLuigi, GambatoRoberto, LangesMartin, VeneriDino, PerbelliniOmar, PacquolaEnrica, GottardiMichele, GherlinzoniFilippo, MegaAndrea, TauberMartina, MazzoleniGuido, PivaElisa, PlebaniMario, KramperaMauro, GastlGünther

Reduced PLT count

Essential thrombocythemia (ET) is a blood disorder that increases the risk of blood clots. This study investigated the effects of hydroxyurea (HU) and anagrelide (ANA), two common treatments for ET, on microparticle generation and endothelial activity. The study found that both HU and ANA reduced platelet count, but affected endothelial modulators differently. HU increased nitric oxide (NO) and adrenomedullin (ADM) levels, promoting vasodilation, while ANA reduced endothelin-1 (ET-1) levels, impairing vasoconstriction.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

3.

Phase III, single-arm study investigating the efficacy, safety, and tolerability of anagrelide as a second-line treatment in high-risk Japanese patients with essential thrombocythemia.

Author: KanakuraYuzuru, MiyakawaYoshitaka, WildePaul, SmithJonathan, AchenbachHeinrich, OkamotoShinichiro

ET treatment
Platelet count normalization
Anemia
Diarrhea
Headache
Palpitations

This study evaluated the efficacy and safety of anagrelide in high-risk Japanese patients with essential thrombocythemia who were intolerant or refractory to first-line cytoreductive therapy. Anagrelide showed significant efficacy in reducing platelet counts, with a safety profile consistent with European guidelines.

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

Language : English

4.

Anagrelide in Essential Thrombocythemia (ET): Results from 150 patients over 25 years by the "Ph1-negative Myeloproliferative Neoplasms Latium Group".

Author: MazzucconiMaria Gabriella, BaldacciErmina, LatagliataRoberto, BrecciaMassimo, PaoloniFrancesca, Di VeroliAmbra, CedroneMichele, AnaclericoBarbara, VillivàNicoletta, PorriniRaffaele, MontefuscoEnrico, AndrianiAlessandro, MontanaroMarco, ScaramucciLaura, SpadeaAntonio, RagoAngela, CiminoGiuseppe, SpiritoFrancesca, SantoroCristina

Platelet Count Reduction

This study evaluated the real-life use of anagrelide in patients with essential thrombocythemia (ET) over 25 years.

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.

Language : English

5.

Characterization of different regimens for initiating anagrelide in patients with essential thrombocythemia who are intolerant or refractory to their current cytoreductive therapy: results from the multicenter FOX study of 177 patients in France.

Author: ReyJérôme, ViallardJean-François, KeddadKarim, SmithJonathan, WildePaul, KiladjianJean-Jacques,

Essential thrombocythemia treatment

Anagrelide, a second- or third-line treatment for essential thrombocythemia, is often used in regimens that deviate from standard recommendations. Further research is needed to assess the impact of these variations.

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.
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

7.

[Takotsubo cardiomyopathy developing during anagrelide therapy in a patient with essential thrombocythemia].

Author: NagashimaTakahiro, HaradaShinpei, KimuraHiroyuki

Takotsubo cardiomyopathy

Takotsubo cardiomyopathy (Tako) is a heart condition that mimics a heart attack but is not caused by blocked coronary arteries. This case report describes a 76-year-old woman taking anagrelide for essential thrombocythemia who developed Tako. While Tako is usually attributed to stress, the only potential stressor in this case was the anagrelide therapy. The report highlights the importance of considering Tako as a possible side effect of anagrelide therapy.

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 : Japanese

8.

Leukemic transformation and second cancers in 3649 patients with high-risk essential thrombocythemia in the EXELS study.

Author: BirgegårdGunnar, FolkvaljonFolke, GarmoHans, HolmbergLars, BessesCarlos, GriesshammerMartin, GugliottaLuigi, WuJingyang, AchenbachHeinrich, KiladjianJean-Jacques, HarrisonClaire N

ET treatment
Leukemogenic risk

A study of 3,460 patients with essential thrombocythemia found that hydroxycarbamide (HC) treatment was associated with higher rates of acute leukemia transformation compared to anagrelide (ANA) treatment. This study strengthens concerns regarding possible leukemogenic risk with HC treatment.

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.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

10.

[Two clinical cases of essential thrombocythemia complicated by thrombosis in parturients].

Author: Vygovs'kaIa I, Karol'Iu S, IevstakhevichIu L, DiakivH L, BuzherakN F, Vygovs'kaO Ia, MasliakZ V

Thrombosis

Essential thrombocythemia (ET) can lead to thrombosis, especially in pregnant women. Two cases of ET diagnosed only postpartum, after experiencing thrombotic complications, highlight the importance of careful monitoring for thrombosis in younger ET patients, even with low-risk pregnancies.

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 : Ukrainian

11.

Successful replantation of 2 digits in a patient with thrombocytosis after splenectomy: A case report.

Author: HwangJae Ha, KimDong Wan, KimKwang Seog, LeeSam Yong

Replantation success
Thrombosis

Replantation can be attempted in patients with digital amputation, even when thrombocytosis is expected, when requested by the patient. The platelet count should be actively controlled with medication.

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

12.

[Treatment outcome of patients with essential thrombocythemia at our department in Hungary].

Author: IványiJános László, MartonÉva, PlanderMárk, SzendreiTamás

Lower incidence of bleeding
Lower incidence of thrombotic episodes

Cytoreductive drugs such as hydroxyurea and anagrelide can lower the risk of bleeding and thromboembolic complications in patients with essential thrombocythemia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Observational StudyResearch that observes and collects data on participants' behavior and outcomes in their natural state, without intervention.

Language : Hungarian

13.

Cardiovascular safety of anagrelide in healthy subjects: effects of caffeine and food intake on pharmacokinetics and adverse reactions.

Author: Martínez-SellésManuel, DatinoTomás, Figueiras-GrailletLourdes, GamaJoubert G, JonesChristopher, FranklinRichard, Fernández-AvilésFrancisco

Platelet count reduction

Anagrelide is a medication used to reduce high platelet counts in essential thrombocythaemia (ET), a rare blood disorder. Anagrelide is broken down by the body's CYP1A2 enzyme. Previous studies on how food affects anagrelide absorption were conducted before the active metabolite, 3-hydroxyanagrelide, was identified.

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

14.

Efficacy and safety of cytoreductive therapies in patients with essential thrombocythaemia aged >80 years: an interim analysis of the EXELS study.

Author: KiladjianJean-Jacques, BessesCarlos, GriesshammerMartin, GugliottaLuigi, HarrisonClaire, CollRuth, SmithJonathan, BirgegårdGunnar

ET treatment
Very elderly ET management

Hydroxycarbamide was the most frequently prescribed cytoreductive therapy for very elderly patients with essential thrombocythaemia, with a median platelet count of ~430 × 10(9)/L.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
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.

Language : English

15.

A Case of Anagrelide-Induced Nonischemic Cardiomyopathy in a Patient With Essential Thrombocythemia.

Author: SinghPritpal

Cardiovascular adverse events

A 52-year-old man with essential thrombocythemia (ET) presented with an ejection fraction (EF) of 18% after 2 years of anagrelide therapy. His EF increased from 18% to 55% 3 months after discontinuation of anagrelide.

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

16.

Pharmacokinetics and tolerability of anagrelide hydrochloride in young (18 - 50 years) and elderly (≥ 65 years) patients with essential thrombocythemia.

Author: BessesCarlos, ZellerWolfgang, Alvarez-LarránAlberto, CollRuth, TroySteven, PurkayasthaJaideep, MartinPatrick, FreitagChristian

There were differences observed in anagrelide and 3-hydroxy-anagrelide pharmacokinetics between young and elderly patients with essential thrombocythemia, but they do not justify using a different dosing regimen.

Clinical Trial, Phase IIA Phase II trial is a trial that further evaluates the efficacy and safety of a new drug or treatment, whose safety has been confirmed to some extent in a Phase I trial, in a small number 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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

17.

Effects of anagrelide on megakaryopoiesis and platelet production.

Author: ThieleJuergen, KvasnickaHans Michael, Schmitt-GraeffAnnette

Thrombocythemia treatment
Leukemogenic potential

Anagrelide, a thromboreductive agent, was studied for its effects on megakaryopoiesis and myelofibrosis in patients with essential thrombocythemia. Anagrelide was found to arrest megakaryocyte maturation at lower ploidy stages without stimulating myelofibrosis.

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

19.

Cardiovascular Safety of Anagrelide Hydrochloride versus Hydroxyurea in Essential Thrombocythaemia.

Author: GoticMirjana, EgyedMiklos, GerchevaLiana, WarzochaKrzysztof, KvasnickaHans Michael, AchenbachHeinrich, WuJingyang

Controlled platelet counts
ET treatment
Thrombohaemorrhagic events

This study found that anagrelide is a safe and effective treatment option for high-risk essential thrombocythaemia, without adverse effects on cardiac function.

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.
Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Equivalence TrialA clinical trial designed to show that a new treatment is equivalent in efficacy/safety to an existing treatment.
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

20.

Essential Thrombocythemia: The Dermatologic Point of View.

Author: CozzaniEmanuele, IurloAlessandra, MerloGiulia, CattaneoDaniele, BurlandoMartina, PierriIvana, GugliottaLuigi, ParodiAurora

Early ET diagnosis
Effective ET treatment
Acrocyanosis
Actinic keratoses
Alopecia
Bleeding
Erythromelalgia
Hyperpigmentation
Itching
Leg ulcers
Livedo reticularis
Photosensitivity
Pruritus
Raynaud's phenomenon
Xerosis

Essential thrombocythemia (ET) is a myeloproliferative neoplasm associated with an increased risk of vascular events. Common cutaneous manifestations include itching, erythromelalgia, and livedo reticularis. While treatment with hydroxycarbamide, interferon-alfa, and anagrelide can be associated with skin lesions, anagrelide has the fewest reported dermatologic 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

21.

Therapeutic thrombocytapheresis for extreme thrombocytosis after chemotherapy in essential thrombocytosis.

Author: Almeida-DiasRaquel, GarroteMarta, CidJoan, MustielesMaria-Jesús, AlbaCristina, LozanoMiquel

Thrombocytosis treatment

Therapeutic thrombocytapheresis is a safe and efficient treatment for patients with extremely high platelet counts, especially when other treatments like hydroxyurea are not effective. This case report details the use of thrombocytapheresis in a patient with essential thrombocytosis and acute myeloid leukemia, demonstrating its effectiveness in reducing platelet count.

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.

Language : English

22.

Combination therapy of hydroxycarbamide with anagrelide in patients with essential thrombocythemia in the evaluation of Xagrid(R) efficacy and long-term safety study.

Author: GugliottaLuigi, BessesCarlos, GriesshammerMartin, HarrisonClaire, KiladjianJean-Jacques, CollRuth, SmithJonathan, AbhyankarBrihad, BirgegårdGunnar

Essential thrombocythemia treatment
Intolerance
Lack of efficacy
Side effects

This analysis evaluated the use of cytoreductive combination therapy in high-risk patients with essential thrombocythemia, a blood disorder. The study found that combination therapy, typically hydroxycarbamide plus anagrelide, was used in approximately 10% of patients and may be beneficial for those who do not respond well to monotherapy.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
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

23.

Treatment of essential thrombocythemia in Europe: a prospective long-term observational study of 3649 high-risk patients in the Evaluation of Anagrelide Efficacy and Long-term Safety study.

Author: BirgegårdGunnar, BessesCarlos, GriesshammerMartin, GugliottaLuigi, HarrisonClaire N, HamdaniMohamed, WuJingyang, AchenbachHeinrich, KiladjianJean-Jacques

Improved pregnancy outcomes
Reduced thrombosis
Acute leukemia
Hemorrhage
Myelofibrosis

Anagrelide is a medication for essential thrombocythemia. This study evaluated its long-term safety and efficacy in a large cohort of patients. The study found that anagrelide was associated with a lower risk of thrombosis compared to other cytoreductive therapies, but it was also more commonly associated with hemorrhage.

Clinical Trial, Phase IVPost-marketing surveillance. Monitors long-term safety/efficacy after approval.
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

24.

Anagrelide-associated Cardiomyopathy and Heart Failure in a Patient with Essential Thrombocythemia: A Case Report and Literature Review.

Author: SugawaraMasafumi, OkadaSho, KandaMasato, IsekiTohru, SakaidaEmiko, KobayashiYoshio

Anagrelide cardiomyopathy

Anagrelide, a drug for essential thrombocythemia (ET), can cause cardiomyopathy and heart failure (HF) even in otherwise healthy patients, regardless of nationality, comorbidities, or treatment duration. This case highlights the need for close monitoring of cardiac function in patients treated with anagrelide.

ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.
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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