Effects of somatropin: A Synthesis of Findings from 23 Studies

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Original Abstract of the Article

Major research findings

Somatropin, also known as human growth hormone (hGH), is a medication used to treat growth hormone deficiency (GHD). 8 found that NNC0195-0092, a reversible, albumin-binding GH derivative, is a potential treatment for adults with GHD that could be administered once weekly. 21 highlighted the growing trend of using somatropin for aesthetic purposes despite insufficient evidence supporting its efficacy and safety for such applications. 7 discussed the complexity of GHD treatment in adults, emphasizing the need for accurate analysis of its entity, appropriateness, and standardization due to the chronic and expensive nature of GH replacement therapy. 17 reported on the heterogeneity of commercially available r-hGH preparations, revealing the presence of a thioether variant in some samples. This variant was found to negatively affect in-vivo biopotency and receptor binding kinetics. 1 investigated the association between somatropin treatment and thyroid function in children with isolated idiopathic GHD, finding that some patients might require transient LT4 supplementation during GH therapy. 5 emphasized the challenges in accurately attributing adverse events to biosimilar medications due to inconsistencies in reporting practices and the lack of a global consensus on biosimilar naming conventions. 2 reported on the long-term safety and efficacy of Omnitrope®, a somatropin biosimilar, in children with growth disturbances, highlighting its favorable safety profile in the Italian interim analysis of the PATRO Children study. focused on the use of somatropin in treating minor growth retardation caused by glucocorticoids. 16 explored the use of GnRH analog therapy in treating central precocious puberty and other childhood disorders affecting growth and puberty, emphasizing its potential in preserving or improving adult height. 3 provided a critical review of somatropin therapy and cognitive function in adults with GHD, highlighting the potential for somatropin replacement therapy to improve cognitive function. 19 showed that jet-delivered growth hormone (JrGH) can improve adherence and growth outcomes in children with GHD. 10 investigated the predictability of growth response to growth hormone treatment in patients with SHOX deficiency using the Cologne prediction model. 9 demonstrated the effectiveness of using NLMEM for pharmacokinetic similarity analysis of biologics. 11 presented a study on somatropin therapy in adults with Prader-Willi syndrome, suggesting beneficial effects on body composition. 20 investigated the stabilization of somatropin using heparin as a stabilizing agent. focused on the use of lonapegsomatropin (Skytrofa) for growth hormone deficiency. 18 analyzed the effect of a year-long rhGH therapy on left ventricle structure and function in adults with severe GHD. 22 evaluated the efficacy and safety of two doses of Norditropin® (somatropin) in treating short stature in Japanese children with Noonan syndrome. 4 presented data from the PATRO Adults study showing no increased risk of glucose metabolism disorders in adults with GHD undergoing long-term treatment with biosimilar somatropin (Omnitrope®). 23 reviewed the use of sermorelin in the diagnosis and treatment of children with idiopathic GHD. 15 showed that rhGH can improve the immune status of rats with septic encephalopathy by activating VEGFR2, which mitigates endoplasmic reticulum stress and enhances blood-brain barrier competency. 14 evaluated the TransCon human growth hormone technology as a potential solution for optimizing the therapeutic effect of daily somatropin in children with GHD. discussed the relationship between somatropin, tumors, and diabetes, and its controversial indication in idiopathic short stature. 6 examined the expression of uncoupling proteins in skeletal muscle and adipose tissue in response to in vivo porcine somatropin treatment. 13 reported on a fatal overdose case from injection of human growth hormone, highlighting its abuse by athletes for doping purposes. 12 provided an overview of growth hormone therapy with Norditropin® (somatropin) in growth hormone deficiency.

Benefits and Risks

Benefits Summary

Somatropin can provide several benefits for patients with growth hormone deficiency, including promoting growth, improving body composition, and potentially enhancing cognitive function. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

Risks Summary

Somatropin can also pose some risks, such as fluid retention, increased insulin resistance, and potential for developing diabetes. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

Comparison Across Studies

Commonalities Among Studies

Many studies have indicated that somatropin can be an effective treatment for patients with growth hormone deficiency. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

Differences Among Studies

The effectiveness of somatropin can vary depending on factors such as patient age, underlying condition, dosage, and duration of treatment. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

Consistency and Discrepancies in Findings

There is a mixture of consistency and discrepancies in research findings regarding the effects of somatropin. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

Points to Consider for Real-World Application

While somatropin can be an effective treatment for individuals with growth hormone deficiency, it’s crucial to proceed with caution, considering factors such as appropriate dosage, duration of treatment, and managing potential side effects. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

Limitations of Current Research

The research on somatropin is still ongoing, and there is a need for more comprehensive studies to thoroughly understand its long-term safety and efficacy, as well as to determine optimal dosages and effectively manage potential side effects. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

Future Research Directions

To gain a deeper understanding of somatropin’s effects, future research should focus on investigating long-term safety and efficacy, determining optimal dosages, and developing effective strategies for managing potential side effects. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

Conclusion

Somatropin is a medication used to treat growth hormone deficiency. While numerous studies have highlighted its potential benefits, including growth promotion, improved body composition, and potential cognitive enhancements, it’s important to acknowledge the associated risks, such as fluid retention, increased insulin resistance, and the possibility of developing diabetes. Continued research is essential to further understand its long-term effects, optimize dosages, and develop effective strategies for managing potential side effects. If considering somatropin treatment, it’s crucial to have a thorough discussion with a healthcare professional to weigh the benefits and risks and ensure appropriate use. 11 、 3 、 23 、 2 、 22 、 10 、 19 、 4 、 15 、

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

Treatment of Isolated Idiopathic Growth Hormone Deficiency in Children and Thyroid Function: Is the Need for LT4 Supplementation a Concern in Long-Term Therapy?

Author: SalazarDaniela, ReyVicente, NevesJoão Sergio, EstevesCésar, Santos SilvaRita, FerreiraSofia, CostaCarla, CarvalhoDavide, Castro-CorreiaCintia

GHD treatment
Hypothyroidism

Patients with isolated idiopathic GHD may transiently need LT4 during GH treatment. Twenty-one percent of children developed hypothyroidism during rhGH therapy, on average 47 months after initiation of rhGH. Properly supplemented patients achieved predicted adult height.

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

Language : English

2.

Long-term safety and efficacy of Omnitrope®, a somatropin biosimilar, in children requiring growth hormone treatment: Italian interim analysis of the PATRO Children study.

Author: IughettiLorenzo, TorneseGianluca, StreetMaria Elisabeth, NapoliFlavia, GiavoliClaudia, AntoniazziFranco, StagiStefano, LuongoCaterina, AzzoliniSara, RagusaLetizia, BonaGianni, ZecchinoClara, AversaTommaso, PersaniLuca, GuazzarottiLaura, ZecchiEmiliano, PietropoliAlberto, ZucchiniStefano

Growth disturbances treatment
None mentioned

This study reports the data from the Italian interim analysis of PATRO Children, an ongoing observational, longitudinal, non-interventional, global post-marketing surveillance study, which is investigating the long-term safety and effectiveness of Omnitrope®, a somatropin biosimilar to Genotropin®, in children with growth disturbances.

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.

Language : English

4.

No increased risk of glucose metabolism disorders in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope®): data from an observational, longitudinal study.

Author: Beck-PeccozPaolo, HöybyeCharlotte, MurrayRobert D, SimsekSuat, ZabranskyMarkus, ZouaterHichem, StallaGünter

Omnitrope® for GHD
Diabetes mellitus

This study found no evidence of an increased risk for diabetes mellitus in adults with GHD treated with Omnitrope® based on data from the PATRO Adults post-marketing surveillance study. Diabetes mellitus was reported in 21 patients (22 events), but most cases were newly diagnosed in patients with pre-existing diabetes mellitus at baseline.

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 : English

5.

Evaluating AE Reporting of Two Off-Patent Biologics to Inform Future Biosimilar Naming and Reporting Practices.

Author: StergiopoulosStella, GetzKenneth

Adverse event misattribution

This study highlights the challenges of accurately attributing adverse events to biosimilar medications and suggests that improved biosimilar naming conventions and reporting practices are needed to ensure proper safety monitoring.

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

7.

Somatropin therapy in italian adults with growth hormone deficiency.

Author: PricciFlavia, RotondiDaniela, VillaMarika, ValerioArianna, AgazioElvira, RoazziPaolo

GHD treatment

The National Register of Growth Hormone Therapy (RNAOC) in Italy is collecting notifications of somatropin prescriptions to monitor the epidemiological surveillance on somatropin therapy for Growth Hormone Deficiency (GHD) in adults.

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

Language : English

8.

Reversible Albumin-Binding GH Possesses a Potential Once-Weekly Treatment Profile in Adult Growth Hormone Deficiency.

Author: RasmussenMichael Højby, JanukonytéJurgita, KloseMarianne, MarinaDjordje, TanvigMette, NielsenLene F, HöybyeCharlotte, AndersenMarianne, Feldt-RasmussenUlla, ChristiansenJens Sandahl

Improved IGF-1 profiles

NNC0195-0092, a once-weekly GH derivative, was found to be safe and effective in treating adult patients with GH deficiency.

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.

Pharmacokinetic similarity of biologics: analysis using nonlinear mixed-effects modeling.

Author: DuboisA, GsteigerS, BalserS, PigeoletE, SteimerJ L, PillaiG, MentréF

This study demonstrated that a pharmacokinetic (PK) similarity analysis can be performed using nonlinear mixed-effects models (NLMEM). The study compared the results of NLMEM-based analysis with those of noncompartmental analysis (NCA) in two studies that compared different biosimilars. Both methods led to similar results, suggesting that PK data can be analyzed by either method.

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.

Growth response to growth hormone treatment in patients with SHOX deficiency can be predicted by the Cologne prediction model.

Author: Hoyer-KuhnHeike, FranklinJeremy, JonesChristine, BlumWerner F, SchoenauEckhard

Short stature treatment

The Cologne prediction model, initially developed for children with GH deficiency, was investigated for its applicability to children with SHOX deficiency undergoing GH treatment. The model accurately predicted height velocity and height standard deviation score changes in these 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

11.

Somatropin therapy in adults with Prader-Willi syndrome.

Author: HöybyeCharlotte, ThorénMarja

Improved body composition
Improved growth
Water retention

This abstract discusses the potential benefits of growth hormone (GH) therapy, specifically somatropin, for adults with Prader-Willi syndrome. While GH therapy has shown benefits for children with the syndrome, its impact on adults is less clear. One published study suggests that somatropin may improve body composition without significant adverse effects, but further research is needed to determine its optimal role and dosage.

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

12.

Growth hormone therapy with norditropin ( somatropin ) in growth hormone deficiency.

Author: Pawlikowska-HaddalAnna

GH deficiency therapy

This article describes Norditropin, a recombinant human growth hormone (rhGH) indicated for therapy of growth hormone deficiency in children and adults.

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.

Fatal overdose from injection of human growth hormone; a case report and review of the literature.

Author: ErfanifarAzam, MahjaniMahsa, GohariSepehr, Hassanian-MoghaddamHossein

HGH toxicity
Rhabdomyolysis

This case report describes the first lethal case of human growth hormone (HGH) acute toxicity. A young athlete who had been using somatropin for 2 years presented to the emergency department with hallucinations and reported abusing 300 mg of HGH via subcutaneous injection. He died despite medical intervention, highlighting the life-threatening complications of HGH misuse.

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

14.

TransCon human growth hormone for children with growth hormone deficiency: a technology evaluation.

Author: Dos SantosJéssica Barreto Ribeiro, Da SilvaMichael Ruberson Ribeiro

Growth hormone deficiency treatment

This study describes the development of a TransCon human growth hormone technology, lonapegsomatropin-tcgd, aimed at optimizing the therapeutic effect of daily somatropin injections for children with growth hormone deficiency.

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

Language : English

17.

Heterogeneity of commercial recombinant human growth hormone (r-hGH) preparations containing a thioether variant.

Author: LispiMonica, DatolaAntonio, BierauHorst, CeccarelliDomenico, CrisciCarmelina, MinariKatia, MendolaDaniele, RegineAniello, CiampolilloCinzia, RossiMara, GiartosioCarlo Emanuele, PezzottiAnna Rita, MustoRaffaella, JoneCarl, ChiarelliFrancesco

Altered receptor binding
Reduced bioactivity

A recently discovered thioether variant in commercially available recombinant human growth hormone (r-hGH) preparations was found in 6 out of 8 lots. This variant showed a significantly reduced in vivo biopotency and altered receptor-binding properties compared with a control. The variant may be generated during the manufacturing process and may require further investigation for its clinical efficacy and safety.

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

Language : English

18.

[The effect of one year of recombinant human growth hormone (rhGH) therapy on left ventricle structure and function in adults with severe growth hormone deficiency].

Author: PłońskaEdyta, Krzyzanowska-SwiniarskaBarbara, GruszczyńskaMirosława, PynkaSławomir, LewandowskiMaciej, Kornacewicz-JachZdzisława, PilarskaKrystyna

Increased LVM
Increased LVMI

One year of somatropin therapy in adults with growth hormone deficiency was associated with a significant positive effect on left ventricular mass and mass index but no significant effect on systolic left ventricular function.

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.

Language : Polish

19.

Improved adherence and growth outcomes with jet-delivered growth hormone.

Author: MichaelidouMaria, WhittenSusan, BajajPriti, KnightAlastair, SpoudeasHelen A

Growth improvement
Recombinant growth hormone deficiency

Adherence to jet-transjection delivery of recombinant growth hormone (rGH) led to significant growth improvement in children over a 3-year period compared to less adherent patients.

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

Language : English

21.

Towards preventive pharmacovigilance through medicine misuse identification: an example with recombinant human growth hormone for aesthetic purposes.

Author: Rodrigues-NetoAlfredo J, Biazoni-AlbaricciCamila, RibeiroAdalton, LimaSilvana, FiguerasAlbert

Not applicable
Adverse reactions
Off-label use

A large proportion of reports of suspected adverse reactions to recombinant human growth hormone (rhGH) in Brazil involved patients aged ≥20 years taking rhGH for off-label uses.

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

Language : English

22.

Efficacy and safety of two doses of Norditropin<sup>&#174;</sup> (somatropin) in short stature due to Noonan syndrome: a 2-year randomized, double-blind, multicenter trial in Japanese patients.

Author: OzonoKeiichi, OgataTsutomu, HorikawaReiko, MatsubaraYoichi, OgawaYoshihisa, NishijimaKeiji, YokoyaSusumu

Favorable safety profile
Increase height

A randomized double-blind trial evaluated the growth-promoting effect and safety of Norditropin in Japanese children with short stature due to Noonan syndrome. The study found that Norditropin, at doses of 0.033 mg/kg/day or 0.066 mg/kg/day, increased height with a favorable safety profile.

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

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