Real-world evaluation of weekly subcutaneous treatment with semaglutide in a cohort of Italian diabetic patients

Abstract

Purpose Registered trials and real-world evidence (RWE) studies provided evidence on the efficacy of once-weekly (OW) semaglutide on hyperglycaemia and cardiovascular risk factors as add-on or de-novo treatment in type 2 diabetes (T2D). Methods In a retrospective analysis of electronic data files from 258 T2D patients, this RWE study aimed to explore the impact of OW semaglutide on biochemical and anthropometric outcomes after 6 and 12 months in patients receiving at least one prescription of OW semaglutide between September 2019 and May 2021. Results During the study period, 154 and 56 consecutive patients completed the 6 and 12 months of OW semaglutide treatment. HbA1c levels decreased by -1.02±0.1% after 6 months and -1.1±0.1% after 12 months of OW semaglutide (p<0.0001 for both). At these time-points, HbA1c values were <7% in 61% and 57% of cases. HbA1c reduction was greater in patients with higher baseline HbA1c levels and it occurred irrespective of gender, age, insulin therapy and complications. The residual number of cases with HbA1c ≥9% by the study end was low (5.3% vs 18.9% at baseline). Weight loss occurred in 73.5% and 78.1% of cases and, compared to baseline, it was ≥5% in 21.2- 25.4% and ≥10% in 6.8-18.2% after 6 and 12 months, respectively. Significant predictors of HbA1c reduction after 6 months of OW semaglutide treatment were baseline HbA1c (p<0.0001), bodyweight reduction (p<0.0001) and disease duration (p<0.001), while baseline HbA1c was the only predictor of HbA1c response after 12 months (p<0.0001). Reported adverse events were consistent with the known safety profile of semaglutide. Conclusions Real-world evaluation of weekly subcutaneous treatment with semaglutide in a cohort of Italian diabetic patients.

Effectiveness and Safety of Once-Weekly Semaglutide in Japanese Patients with Type 2 Diabetes in Treatment Intensification: A Retrospective Observational Single-Center Study

“…The current study data showed that baseline HbA1c and disease duration of diabetes were predictors of effectiveness. The results of several real-world studies have shown that higher baseline HbA1c was associated with a greater effect of OW semaglutide [20,24,25], consistent with our results (Table 2, Supplemental Fig. 1).…”

“…1). Marzullo et al reported that the shorter duration of diabetes was a significant predictor of a good response after 6 months OW semaglutide induction [25]. Since the retention of GSIS capacity in patients with T2DM is inversely correlated with the duration of diabetes [26], it is speculated that longer duration is responsible for the attenuated effect of insulin secretagogues.…”

Real world effectiveness of subcutaneous semaglutide in type 2 diabetes: A retrospective, cohort study (Sema-MiDiab01)

“…However, it is important to note that relevant clinical benefits on metabolic parameters and CV risk factors have been achieved also with intermediate dosage. These results are consistent with those of other real-world studies based on cohorts followed in other settings, all documenting effectiveness and safety of OW semaglutide (32,35,(40)(41)(42)(43)(44)(45)(46)(47).…”

Once‐weekly semaglutide use in patients with type 2 diabetes: Real‐world data from the SURE Italy observational study

“…6,7 The results of the SURE Italy study are consistent with efficacy and safety data from the SUSTAIN RCTs [13][14][15][16][17][18] and the SURE studies in Canada, 22 Denmark/Sweden, 23 Spain, 24 Switzerland 25 and the UK 26 and pooled analyses of these studies, 27 the latter of which showed that OW semaglutide use in routine clinical practice was associated with clinically relevant improvements in glycaemic control (-0.2-to -2.5%-point) and body weight (-2.5 to -5.6 kg) and was well tolerated in a wide range of adults with T2D. Regional, small and retrospective RW observational studies of semaglutide in clinical practice in Italy have shown similar results, [28][29][30][31][32] increasing the body of evidence for the benefits of OW semaglutide treatment in adults with T2D in RW settings. Moreover, as reported by Di Dalmazi et al, semaglutide was associated with greater reductions in HbA1c and weight versus the maximum doses of OW exenatide and dulaglutide that are available in Italy.…”