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Mec3.5
Mecasermin (IGF-1) – Forschung
Überwiegend Mechanismus / Beobachtung
6 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Mecasermin (IGF-1) sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus gemischt-qualitativen Studien, veröffentlicht 1999–2023 mit einer typischen Studiengröße von 76 Teilnehmenden.
Basierend auf 6 Studien · 349 Teilnehmende insgesamt
Konfidenz
Geringe Konfidenz
Nach Outcome
Growth & anabolismVerbessert die Muskelproteinbilanz nur bei katabolen Erkrankungen; bei gesunden Menschen wurde kein Nutzen für Muskulatur oder Leistungsfähigkeit nachgewiesen, und Hypoglykämien treten häufig auf. · Für den Muskelaufbau bei gesunden Erwachsenen nicht belegt
Überwiegend Mechanismus / Beobachtung6 Studien
Glucose & insulin-like activity
Überwiegend Mechanismus / Beobachtung5 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung3 Studien
Aktives Forschungsgebiet
2 Studien in den letzten 5 Jahren
199920112023
1Open-Labeln=76 · small study2007
Height velocity increased from 2.8 cm/yr on average at baseline to 8.0 cm/yr during the first year of treatment (P < 0.0001)... The most common adverse event was hypoglycemia... reported by 49% of treated subjects.
Pivotal long-term trial: 76 children with severe IGF-1 deficiency due to GH insensitivity treated with rhIGF-I (mecasermin) 60–120 µg/kg twice daily for up to 12 years
First-year height velocity roughly tripled (2.8 → 8.0 cm/yr), dose-dependently — the trial-proven benefit in the approved indication
Hypoglycemia was the most common adverse event (49% of subjects); injection-site lipohypertrophy (32%) and tonsillar/adenoidal hypertrophy (22%) followed
The observed mean gain in height was 13.4 cm more than had been expected without treatment... Long-term therapy with IGF-I improves adult height of patients with severe IGFD. Most patients did not bring their heights into the normal adult range.
In most NPP children with SPIGFD, with or without LS, rhIGF1 therapy promotes linear growth... Treatment-emergent AEs were experienced by 65.3% of patients; hypoglycaemia was most common.
Bang P, Woelfle J, Perrot V, Sert C, Polak M. · Eur J Endocrinol (2021)
Large real-world registry (European Increlex Growth Forum Database, n=242) of rhIGF-1 (mecasermin) in severe primary IGF-1 deficiency, including Laron syndrome
Confirmed linear-growth benefit across patients with and without Laron syndrome; younger age at baseline predicted better response
Treatment-emergent adverse events affected 65.3% of patients, with hypoglycaemia the most common — reinforcing the hypoglycemia signal at scale
In practice, the limited clinical benefits of mecasermin do not justify exposure to its potential risks.
Prescrire International (no authors listed). · Prescrire Int (2009)
Independent drug-bulletin appraisal — the best counter-evidence: judged that even in the approved indication the height benefit was modest (mean −6.7 SD at baseline improved only to −5.2 SD after 8 years; growth failure remained very severe)
Catalogues the main short-term harms: hypoglycaemia, headache, and intracranial hypertension; nearly 1 in 5 children developed tonsillar hypertrophy causing otitis and hearing loss
Flags animal findings of organ hypertrophy (kidney, spleen, heart) and carcinogenic effects, with the human risk unknown
5Pilotstudien=10 · very small study1999
Leg protein balance improved with rhIGF-1/IGFBP-3, which was associated with an increase in muscle protein fractional synthetic rate... All patients were euglycemic without electrolyte imbalances.
Debroy MA, Wolf SE, Zhang XJ, Chinkes DL, Ferrando AA, Wolfe RR, Herndon DN. · J Trauma (1999)
Closest thing to a 'muscle' study: a 5-day rhIGF-1/IGFBP-3 infusion in 10 severely burned adults improved leg muscle protein balance and fractional synthetic rate
The anabolic signal was real — and notably occurred WITHOUT glucose abnormalities in this monitored setting
Critical caveat: this is a small, short study in a catabolic clinical state (severe burns), not muscle building in healthy adults
rhIGF-1 was shown to efficiently induce development of Laron patients achieving at least proper rate of growth (compared to healthy group) in 80% of subjects.
Grubczak K, Stożek K, Starosz A, Bossowski F, Pasławska M, Bossowski A, Moniuszko M. · Stem Cell Rev Rep (2023)
Mechanistic human study tracking very-small-embryonic-like (VSEL) and hematopoietic stem cells over 4–5 years of mecasermin therapy in IGF-1-deficient children
IGF-1-deficient patients had initially elevated stem-cell populations that gradually normalized with rhIGF-1 therapy, correlating with SDF-1 and growth parameters
Reconfirms the growth efficacy (≥80% reaching proper growth rate) while probing IGF-1's broader proliferative/developmental biology