Effectiveness in Real World of Once Weekly Semaglutide in People with Type 2 Diabetes: Glucagon-Like Peptide Receptor Agonist Naïve or Switchers from Other Glucagon-Like Peptide Receptor Agonists: Results from a Retrospective Observational Study in Umbria

Abstract

Introduction To complement results of the SUSTAIN program, this study assessed effectiveness and safety of once weekly subcutaneous semaglutide in people with type 2 diabetes (T2D) managed under routine care. Methods This was a multicenter, observational, retrospective study including all patients treated with semaglutide. Changes in clinical outcomes from baseline to 6 and 12 months were assessed in patients who were glucagon-like peptide receptor agonist (GLP-1RA) naïve or switching from another GLP-1RA. Discontinuation rate was assessed. Results Overall, 216 patients (mean age 64 years, 65.7% men) were evaluated: 135 (61.5%) naïve and 81 (38.5%) switchers from another GLP-1RA. In the naïve cohort, after 6 months from semaglutide initiation, levels of HbA1c significantly decreased by − 1.31% ( p < 0.0001). All obesity indices improved, with mean reductions in body weight of − 3.92 kg, in BMI of − 1.43 kg/m 2 , and in waist circumference of − 5.03 cm. In the switcher cohort, statistically significant improvements in HbA1c (− 0.78%), body weight (− 2.64 kg), and waist circumference (− 3.03 cm) were obtained after 6 months. Reductions were sustained after 12 months in both cohorts (mean semaglutide dose: 0.86 mg in naïve and 0.96 mg in switcher cohort). Blood pressure and lipid profile mean levels decreased after 12 months from semaglutide initiation in both cohorts. No severe hypoglycemia occurred; 6.5% of patients discontinued semaglutide (2.8% due to gastrointestinal side effects). Conclusion Effectiveness and tolerability of semaglutide have been confirmed in the real world irrespective of diabetes duration and severity. As expected, more marked reductions in HbA1c and obesity indices were obtained in naïve patients, but it is noteworthy that relevant improvements were also obtained in patients already treated with GLP-1RAs. Supplementary Information The online version contains supplementary material available at 10.1007/s13300-022-01218-y.

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).…”

“…Furthermore, improvements in FBG, BMI, SBP, total and LDL cholesterol, and triglycerides were documented, in line with existing knowledge (4,9,20,(32)(33)(34)(35)(36)(37)(38). Renal parameters (eGFR and ACR) were unchanged after 12 months of treatment, confirming the renal safety of GLP1-RAs which were demonstrated to prevent the onset of macroalbuminuria and slow the decline of eGFR (39).…”

Effects of semaglutide on cardiovascular risk factors and eating behaviors in type 2 diabetes

“…After 32 weeks of treatment, HbA1c levels and body weight significantly decreased ( − 1.38% and − 6.03 kg, respectively) and the entity of the reduction was in line with results obtained in the SUSTAIN program [ 13 , 19 , 20 ], where HbA1c was reduced from 1.1 to 1.5% with semaglutide 0.5 mg and from 1.4 to 1.8% with semaglutide 1 mg; weight was reduced from 3.5 to 4.6 kg with semaglutide 0.5 mg and from 4.5 to 6.5 kg with semaglutide 1 mg. In addition, real-world studies conducted in US and Europe confirmed the effectiveness and safety of semaglutide when administered under routine clinical practice conditions, although the magnitude of benefits varied based on patient profiles and settings [ 21 – 27 ].…”

Effectiveness and Tolerability of Once-Weekly GLP-1 Receptor Agonists in Clinical Practice: A Focus on Switching Between Once-Weekly Molecules in Type 2 Diabetes

“…Recently, the SURE program evaluated the use of OW semaglutide in populations of T2DM patients from four different countries (50-53): our findings are comparable with those obtained in the SURE program, even if patients enrolled in the SURE program had higher basal HbA1c and BMI as compared to our population. A similar paper recently published by Di Loreto and collaborators confirmed effectiveness and tolerability of semaglutide in clinical practice, irrespective of diabetes duration and severity (54). It should be emphasized that, compared to this work, our analysis is based on a wider case history and has the advantage of analyzing the weekly GLP1-RAs currently on the market in Italy.…”