Effects of pasireotide injection: A Synthesis of Findings from 24 Studies

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Original Abstract of the Article

Major Research Findings

Pasireotide is a somatostatin analog that has been shown to be effective in treating various hormonal disorders. 17 demonstrated that pasireotide improved biochemical control of hypersomatotropism and diabetes mellitus in cats. 20 assessed the pharmacokinetics and safety of pasireotide in healthy volunteers and found it to be safe and well tolerated. 14 suggested that pasireotide may be a potential treatment for malignant insulinoma. These studies highlight the potential benefits of pasireotide in treating various hormonal disorders.

Benefits and Risks

Benefit Summary

Pasireotide has shown potential benefits in treating a range of hormonal disorders, including acromegaly, Cushing's disease, and insulinoma. 16 indicated that pasireotide is effective in controlling growth hormone and IGF-I levels in patients with acromegaly, leading to improved quality of life. 7 reported that pasireotide improved adipose function in patients with Cushing's disease. 14 suggests pasireotide as a potential treatment for malignant insulinoma. These findings suggest that pasireotide could be a valuable treatment option for various hormonal disorders.

Risk Summary

Pasireotide may cause adverse effects, including hyperglycemia, diarrhea, nausea, gallstones, QT prolongation, and bradycardia. 24 reported these adverse events associated with pasireotide treatment. 11 highlighted the potential for pasireotide to induce hyperglycemia in patients with Cushing's disease and acromegaly. It's crucial to be aware of these potential risks and monitor patients closely during pasireotide treatment.

Comparison of Studies

Similarities

Multiple studies suggest that pasireotide is a promising treatment option for various hormonal disorders, including acromegaly, Cushing's disease, and insulinoma. These studies consistently demonstrate the effectiveness of pasireotide in controlling hormone levels and improving associated symptoms.

Differences

Pasireotide research encompasses a range of studies with varying target conditions, treatment methods, and evaluation criteria, making direct comparisons challenging. For instance, 17 focused on feline hypersomatotropism, whereas other studies targeted human conditions. Additionally, 22 specifically investigated the potential of pasireotide to prevent postoperative pancreatic fistula, which diverges from the focus of other studies.

Consistency and Contradictions in Results

While most studies suggest the efficacy of pasireotide in managing hormonal disorders, 6 demonstrated that pasireotide was not effective in preventing postoperative pancreatic fistula. This inconsistency highlights the potential for pasireotide's effectiveness to vary depending on the specific condition, treatment approach, and evaluation criteria used.

Implications for Real-World Application

Pasireotide has shown potential for treating hormonal disorders, but it's crucial to consider its potential adverse effects, particularly hyperglycemia. 11 emphasized the need for careful monitoring and management of hyperglycemia in patients receiving pasireotide treatment. Close collaboration between patients and healthcare providers is essential to optimize treatment outcomes while minimizing potential risks.

Limitations of Current Research

Further research is necessary to fully understand the long-term safety and effectiveness of pasireotide, as well as the optimal dosage and its interaction with other treatments. The mechanisms by which pasireotide exerts its effects on various hormonal disorders also require further investigation.

Future Research Directions

Future research should focus on establishing the long-term safety and efficacy of pasireotide, determining the optimal dosage, and investigating the potential for combining pasireotide with other treatment modalities. Additionally, research aimed at elucidating the mechanisms underlying pasireotide's effects on various hormonal disorders is warranted.

Conclusion

Pasireotide shows promise as a treatment for hormonal disorders, but its potential adverse effects must be carefully considered. It's crucial to monitor patients closely during pasireotide treatment to ensure safe and effective management. Further research is necessary to fully understand the long-term safety and efficacy of this drug, and to optimize its use in treating various hormonal disorders.

Literature analysis of 24 papers
Positive Content
20
Neutral Content
1
Negative Content
3
Article Type
8
0
0
5
23
1.

Pharmacokinetics and Safety of Long-Acting Release Formulations of Pasireotide (SOM230) in a Male Population Who Are Hyperendemic Hepatitis B/C and Chronic Kidney Disease: An Open-Label, Phase I Study.

Author: HuangChun-Jui, LuChieh-Hua, ShihKuang-Chung

Pasireotide pharmacokinetic evaluation

Pasireotide is a drug used for treating various neuroendocrine tumors. This phase I study investigates the pharmacokinetic profiles and safety of subcutaneous (SC) and long-acting release (LAR) intramuscular injections of pasireotide in Taiwanese volunteers with hyperendemic hepatitis B/C and chronic kidney disease (CKD). The study likely examines drug absorption, elimination, and potential adverse effects in this specific patient population.

Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.

Language : English

2.

Pasireotide treatment for severe congenital hyperinsulinism due to a homozygous ABCC8 mutation.

Author: MooijChristiaan F, TackeCarline E, van AlbadaMirjam E, BarthlenWinfried, BikkerHennie, MohnikeKlaus, OomenMatthijs W N, van TrotsenburgA S Paul, Zwaveling-SoonawalaNitash

CHI treatment
Central adrenal insufficiency

Pasireotide, a second-generation somatostatin analogue, was used off-label to treat a boy with severe, therapy-resistant congenital hyperinsulinism (CHI) due to a homozygous ABCC8 mutation. Pasireotide treatment slightly improved glycemic control but was not sufficient to prevent near-total pancreatectomy.

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

3.

Is pasireotide-induced diabetes mellitus predictable? A pilot study on the effect of a single dose of pasireotide on glucose homeostasis.

Author: BarbotMattia, RegazzoDaniela, MondinAlessandro, ZilioMarialuisa, LizzulLaura, ZaninottoMartina, PlebaniMario, ArnaldiGiorgio, CeccatoFilippo, ScaroniCarla

Cushing's disease treatment
Diabetes mellitus onset

Pasireotide (PAS) is an effective treatment for Cushing's disease (CD) but it can cause diabetes mellitus (DM) in a high number of patients. This study investigated the effect of a single subcutaneous injection of PAS on glucose metabolism in CD and looked for factors that could predict the onset of DM.

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.

Drug design strategies for Cushing's syndrome.

Author: UsanovS A, KliuchenovichA V, StrushkevichN V

CS treatment
injection only
side effects

This article discusses recent drug developments for the medical treatment of Cushing's syndrome (CS), focusing on selective inhibitors of CYP11B1 and glucocorticoid receptor (GR) antagonists. The article highlights the unmet need for new compounds that target these pathways selectively.

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

5.

The effect of pasireotide on intestinal anastomotic healing with and without whole-body irradiation in a rat model.

Author: SeifertGabriel J, LeitholdGunnar, KulemannBirte, HolznerPhilipp A, GlatzTorben, HoeppnerJens, KirsteSimon, MarjanovicGoran, LaessleClaudia

Reduced inflammation
Decreased wound healing
Increased mortality

Whole-body irradiation decreased the quality of intestinal anastomotic wound healing and increased mortality in rats. Pasireotide, while reducing inflammation following irradiation, did not significantly lessen the detrimental effects on wound healing or mortality.

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

Language : English

6.

Pasireotide does not prevent postoperative pancreatic fistula: a prospective study.

Author: ElliottIrmina A, DannAmanda M, GhukasyanRazmik, DamatoLauren, GirgisMark D, KingJonathan C, HinesO J, ReberHoward A, DonahueTimothy R

Nausea

Pasireotide was not validated as a preventive measure for pancreatic fistula.

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

Language : English

7.

Insulin sensitivity and secretion and adipokine profile in patients with Cushing's disease treated with pasireotide.

Author: GuarnottaV, PizzolantiG, CiresiA, GiordanoC

Adipose function improvement
Weight loss
Insulin secretion impairment

Pasireotide treatment for Cushing's disease for 12 months impaired insulin secretion and improved adipose function without affecting insulin sensitivity.

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

8.

Efficacy and safety of long-acting pasireotide or everolimus alone or in combination in patients with advanced carcinoids of the lung and thymus (LUNA): an open-label, multicentre, randomised, phase 2 trial.

Author: FerollaPiero, BrizziMaria Pia, MeyerTim, MansoorWasat, MazieresJulien, Do CaoChristine, LénaHervé, BerrutiAlfredo, DamianoVincenzo, BuikhuisenWieneke, GrønbækHenning, Lombard-BohasCatherine, GrohéChristian, MinottiVincenzo, TiseoMarcello, De CastroJavier, ReedNicholas, GislimbertiGabriella, SinghNeha, StankovicMiona, ÖbergKjell, BaudinEric

Carcinoid tumor control
Asthenia
Diarrhea
Hyperglycemia
Stomatitis
Weight loss

Long-acting pasireotide, everolimus, and their combination were all effective in treating advanced carcinoids of the lung or thymus. The proportion of patients progression-free at month 9 was significantly higher in the combination group (58.5%) compared to the long-acting pasireotide group (39.0%) and the everolimus group (33.3%). The safety profiles were consistent with the known safety profiles of the drugs.

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.
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.

Population Pharmacokinetics of Subcutaneous Pasireotide in Healthy Volunteers and Cushing's Disease Patients.

Author: NedelmanJerry, FischRoland, HuKe, PauleInes, ZhouJocelyn

Cushing's treatment

This analysis characterizes the population pharmacokinetics of subcutaneous pasireotide in both healthy volunteers and Cushing's disease patients, evaluating the effects of age, body size, and population on pasireotide pharmacokinetics.

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

10.

Safety and tolerability of pasireotide long-acting release in acromegaly-results from the acromegaly, open-label, multicenter, safety monitoring program for treating patients who have a need to receive medical therapy (ACCESS) study.

Author: FleseriuMaria, RuschElisha, GeerEliza B,

Manageable hyperglycemia
Safe treatment option for acromegaly
Hyperglycemia related adverse events

Grade ≥3 adverse events were reported in 25.0% of acromegaly patients treated with pasireotide long-acting release. Hyperglycemia-related adverse events were reported in 45.5% of patients, but were typically manageable.

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.

Language : English

11.

Hyperglycemia induced by pasireotide in patients with Cushing's disease or acromegaly.

Author: SilversteinJulie M

CD and acromegaly treatment
Hyperglycemia

Pasireotide, a multireceptor-targeted somatostatin receptor ligand, is used to treat Cushing's disease and acromegaly. However, hyperglycemia is a common side effect. This review highlights the importance of monitoring blood sugar levels and managing hyperglycemia in patients receiving pasireotide.

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

12.

Current and future medical treatments for patients with acromegaly.

Author: MaffezzoniFilippo, FormentiAnna Maria, MazziottiGherardo, FraraStefano, GiustinaAndrea

Acromegaly treatment

Acromegaly is a rare condition caused by excess growth hormone, leading to significant morbidity and mortality if untreated. Treatment options include surgery, medical therapies (dopamine agonists, somatostatin receptor ligands, pegvisomant), and radiotherapy. However, approximately 50% of patients are not adequately controlled.

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

13.

Evaluation of the Effects of Pasireotide LAR Administration on Lymphocele Prevention after Axillary Node Dissection for Breast Cancer: Results of a Randomized Non-Comparative Phase 2 Study.

Author: ChéreauElisabeth, UzanCatherine, Boutmy-DeslandesEmmanuelle, ZoharSarah, BézuCorinne, MazouniChafika, GarbayJean-Rémi, DaraïEmile, RouzierRoman

Pasireotide effective
Hyperglycemia

This phase 2 trial evaluated the efficacy of pre-operative pasireotide (a somatostatin analog) in reducing post-operative symptomatic lymphocele formation after total mastectomy with axillary lymph node dissection. A trend towards a reduction in lymphoceles was observed, but pasireotide did not achieve a response rate centered on 80%.

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.
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.

Language : English

14.

Pasireotide for malignant insulinoma.

Author: TiroshAmit, StemmerSalomon M, SolomonovEvgeny, ElnekaveEldad, SaegerWolfgang, RavkinYelena, NirKobi, TalmorYeela, ShimonIlan

Hypoglycemic events

Pasireotide, a somatostatin analog with improved affinity for SSTR5, may be a potential treatment option for malignant insulinoma, a rare and aggressive tumor of the pancreas. While the standard treatments, octreotide and lanreotide, have limited efficacy in controlling hypoglycemia, pasireotide shows promise as a more potent agent.

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

15.

Circulating Transcript Analysis (NETest) in GEP-NETs Treated With Somatostatin Analogs Defines Therapy.

Author: ĆwikłaJarosław B, BodeiLisa, Kolasinska-ĆwikłaAgnieszka, SankowskiArtur, ModlinIrvin M, KiddMark

Predicts SSA responses

This prospective cohort study investigates the potential of circulating neuroendocrine tumor transcripts (NETest) to predict responses to somatostatin analogs (SSAs) in neuroendocrine neoplasm/tumor management.

Comparative StudyResearch that compares multiple groups/interventions to determine differences/similarities in outcomes/characteristics.
Evaluation StudyResearch that systematically evaluates the effectiveness of a particular program or policy. It measures its outcomes and provides important information for future decision-making.
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.

Adverse events associated with somatostatin analogs in acromegaly.

Author: GrassoLudovica F S, AuriemmaRenata S, PivonelloRosario, ColaoAnnamaria

Acromegaly treatment
Quality of life improvement

Somatostatin analogs are effective in controlling growth hormone and IGF-I levels in patients with acromegaly.

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

17.

Pasireotide for the Medical Management of Feline Hypersomatotropism.

Author: ScudderC J, GostelowR, ForcadaY, SchmidH A, ChurchD, NiessenS J M

Decreased IGF-1
Increased insulin sensitivity

Short-acting pasireotide rapidly decreased IGF-1 in cats with hypersomatotropism (HST) and insulin-dependent diabetes, associated with increased insulin sensitivity.

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

Language : English

18.

Aspiration sclerotherapy combined with pasireotide to improve reduction of large symptomatic hepatic cysts (SCLEROCYST): study protocol for a randomized controlled trial.

Author: WijnandsTitus F M, GeversTom J G, KoolLeo J Schultze, DrenthJoost P H

Hepatic cyst reduction
Symptom relief

Aspiration sclerotherapy, a treatment for hepatic cysts, can be combined with the somatostatin analogue pasireotide to improve cyst reduction rates, leading to greater symptomatic relief and reduced cyst recurrence. This approach aims to address the common problem of incomplete cyst reduction after sclerotherapy by inhibiting post-procedural cyst fluid secretion.

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

19.

The role of an acute pasireotide suppression test in predicting response to treatment in patients with Cushing's disease: findings from a pilot study.

Author: TrementinoL, ZilioM, MarcelliG, MichettiG, BarbotM, CeccatoF, BoscaroM, ScaroniC, ArnaldiG

Cushing's disease treatment

This study evaluated the value of an acute pasireotide suppression test (PST) in predicting response to medium/long-term treatment in Cushing's disease.

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

20.

Pharmacokinetics and safety of subcutaneous pasireotide and intramuscular pasireotide long-acting release in Chinese male healthy volunteers: a phase I, single-center, open-label, randomized study.

Author: ChenXia, ShenGuoxiang, JiangJi, LiuHongzhong, HuKe, DarsteinChristelle, LasherJanet, HuPei

The pharmacokinetic properties and safety of subcutaneous (SC) and intramuscular (IM) long-acting release (LAR) formulations of pasireotide were evaluated in Chinese healthy volunteers.

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

Language : English

21.

Up-to 5-year efficacy of pasireotide in a patient with Cushing's disease and pre-existing diabetes: literature review and clinical practice considerations.

Author: TrementinoLaura, CardinalettiMarina, ConcettoniCarolina, MarcelliGiorgia, BoscaroMarco, ArnaldiGiorgio

Cushing's disease treatment
Hyperglycemia

Pasireotide, a multi-receptor-targeted somatostatin analogue, is approved for the treatment of Cushing's disease (CD). The report discusses predicting a positive treatment response to pasireotide in CD and managing diabetes mellitus (DM) during pasireotide treatment.

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.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.
ReviewAn article that critically examines existing research on a particular topic and summarizes the current state of knowledge in the field.

Language : English

22.

Pasireotide for postoperative pancreatic fistula.

Author: AllenPeter J, GönenMithat, BrennanMurray F, BucknorAdjoa A, RobinsonLindsay M, PappasMarisa M, CarlucciKate E, D'AngelicaMichael I, DeMatteoRonald P, KinghamT Peter, FongYuman, JarnaginWilliam R

Pasireotide for pancreatic fistula

Pasireotide is a somatostatin analogue that can reduce pancreatic exocrine secretions. This study suggests that it may prevent postoperative pancreatic fistula, a serious complication after pancreatic surgery.

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.
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

23.

Pharmacokinetics, pharmacodynamics, and safety of pasireotide LAR in patients with acromegaly: a randomized, multicenter, open-label, phase I study.

Author: PetersennStephan, BollerslevJens, ArafatAyman M, SchopohlJochen, SerriOmar, KatznelsonLaurence, LasherJanet, HughesGareth, HuKe, ShenGeorge, ReséndizKarina Hermosillo, GiannoneVanessa, BeckersAlbert

Acromegaly treatment
Gastrointestinal adverse events

Pasireotide LAR is a long-acting formulation of pasireotide, a somatostatin analogue used for acromegaly. This study showed that it is well-tolerated and effective in controlling hormone levels and symptoms.

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.
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

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