Menopause stage was inferred after the trial; multiplicity was not adjusted and formal treatment-by-subgroup interaction testing was not performed.Stadijum menopauze izveden je nakon studije; nije izvršena korekcija za višestruka poređenja niti formalno testiranje interakcije terapije i podgrupe.
The data do not establish that CagriSema works better in women or that menopause stage changes treatment response.Podaci ne utvrđuju da CagriSema deluje bolje kod žena niti da stadijum menopauze menja odgovor na terapiju.
What was reportedŠta je objavljeno
In a post-hoc analysis of all 2,309 women enrolled in REDEFINE 1, investigational CagriSema 2.4 mg/2.4 mg was associated with an estimated average weight change of −25.0% at week 68 under the efficacy estimand, compared with −3.0% for placebo. Mean waist-circumference change was −20.5 cm versus −4.7 cm.U post-hoc analizi svih 2.309 žena uključenih u REDEFINE 1, eksperimentalna CagriSema 2,4 mg/2,4 mg bila je povezana sa procenjenom prosečnom promenom telesne mase od −25,0% u 68. nedelji prema estimandu efikasnosti, naspram −3,0% uz placebo. Prosečna promena obima struka iznosila je −20,5 cm naspram −4,7 cm.
A separate analysis assigned 1,902 women to inferred premenopausal, perimenopausal or postmenopausal groups. Estimated mean changes were −26.7%, −24.8% and −23.1% with CagriSema, respectively, versus −2.1%, −1.7% and −2.6% with placebo.U zasebnoj analizi 1.902 žene su naknadno raspoređene u izvedene premenopauzalne, perimenopauzalne ili postmenopauzalne grupe. Procenjene prosečne promene uz CagriSemu iznosile su redom −26,7%, −24,8% i −23,1%, naspram −2,1%, −1,7% i −2,6% uz placebo.
Safety contextKontekst bezbednosti
Novo reported treatment discontinuation due to adverse events in 5.9% of CagriSema participants versus 3.5% with placebo. Gastrointestinal events were common: nausea was reported in 55.0%, constipation in 30.7% and vomiting in 26.1% of the CagriSema group.Novo je prijavio prekid terapije zbog neželjenih događaja kod 5,9% učesnika koji su primali CagriSemu, naspram 3,5% uz placebo. Gastrointestinalni događaji bili su česti: mučnina je prijavljena kod 55,0%, zatvor kod 30,7%, a povraćanje kod 26,1% učesnika u CagriSema grupi.
How to read the menopause resultKako tumačiti rezultat prema menopauzi
Menopause status was derived post hoc from age, medical history and recorded symptoms rather than prospectively collected reproductive staging or biochemical confirmation. Numerical differences between groups are therefore hypothesis-generating. A prespecified interaction analysis would be needed before claiming that reproductive stage modifies treatment effect.Status menopauze izveden je naknadno iz uzrasta, medicinske istorije i zabeleženih simptoma, umesto prospektivno prikupljenog reproduktivnog stadijuma ili biohemijske potvrde. Brojčane razlike među grupama zato služe za stvaranje hipoteza. Za tvrdnju da reproduktivni stadijum menja efekat terapije bila bi potrebna unapred definisana analiza interakcije.