Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment
Abstract
:1. Introduction
2. Patients and Methods
3. Results
3.1. Subjects’ Characteristics
3.2. Changes in Metabolic Parameters from Baseline to 6 Months
3.3. Concomitant Glucose-Lowering Therapy
3.4. Oral Semaglutide Dosing
3.5. Safety Endpoints: Adverse Events and Discontinuation Rate
4. Discussion
Strengths and Limitations of This Study
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Baseline Characteristics of Subjects with Type 2 Diabetes (n = 192) | |
---|---|
Median age (IQR), years | 67 (15) |
Age < 65, % | 42 |
Age ≥ 65, % | 53 |
Female, % | 44 |
Mean baseline HbA1c (SD), % | 7.90 (1.19) |
Mean baseline HbA1c (SD), mmol/mol | 63 (13) |
HbA1c < 7%, % | 14 |
HbA1c < 8%, % | 64 |
HbA1c ≥ 8%, % | 36 |
HbA1c between 7 and 10%, % | 81 |
HbA1c ≥ 10%, % | 5 |
Median FPG (IQR), mg/dL | 146 (42.5) |
Median FPG (IQR), mmol/L | 8.1 (2.4) |
Mean body weight (SD), kg | 82.47 (17.63) |
Mean BMI (SD), kg/m2 | 30.41 (5.86) |
BMI < 25 kg/m2, % | 18 |
BMI 25–30 kg/m2, % | 35 |
BMI ≥ 30 kg/m2, % | 47 |
Mean waist circumference (SD), cm | 108.9 (13.8) |
Mean systolic BP (SD), mmHg | 138.3 (18) |
Mean diastolic BP (SD), mmHg | 76.8 (15) |
Median diabetes duration (IQR), years | 9 (12) |
Diabetes duration < 5 years, % | 32 |
Diabetes duration ≥ 5 years, % | 68 |
Mean creatinine (SD), mg/dL | 0.96 (0.29) |
Mean microalbuminuria (SD), mg/L | 48.85 (103.78) |
Mean eGFR (SD), mL/min/1.73m2 | 76.73 (20.55) |
eGFR< 60 mL/min/1.73m2, % | 21 |
eGFR ≥ 60 mL/min/1.73m2, % | 79 |
Mean total cholesterol (SD), mg/dL | 180 (43.08) |
Mean HDL cholesterol (SD), mg/dL | 48.77 (12.97) |
Mean tryglicerides (SD), mg/dL | 163 (105) |
Mean LDL cholesterol (SD), mg/dL | 101.73 (38.71) |
Mean AST (SD), UI/L | 21.9 (11.7) |
Mean ALT (SD), UI/L | 25.7 (21.4) |
Mean gamma-GT, UI/L | 28.3 (15.7) |
Prescribers: endocrinologists, % | 100 |
Comorbidities/complications (%) | |
Arterial hypertension | 63 |
Dyslipidemia | 65 |
Microangiopathy | 35 |
Retinopathy | 16 |
Nephropathy | 25 |
Neuropathy | 3 |
Peripheral vasculopathy | 6 |
Macroangiopathy | 31 |
Ischemic cardiopathy | 14 |
Heart failure | 4 |
Stroke TIA | 3 |
Concomitant Medication (%) | |
Antiplatelet agents | 36 |
Anticoagulants | 4 |
Antihyperuricemic agents | 14 |
Statins | 53 |
Ezetimibe | 16 |
PCSK9 inhibitors | 0.52 |
Omega-3 fatty acids | 5 |
Fibrates | 4 |
ACE inhibitors and ARBs | 48 |
Beta blockers | 35 |
Calcium antagonists | 23 |
Diuretics | 23 |
Alpha blockers | 6 |
Parameters | Baseline | Follow Up | Change Mean Difference (95% C.I.) | p Value |
---|---|---|---|---|
Mean HbA1c (%) ± SD | 7.90 ± 1.19 | 7.28 ± 0.99 | −0.68% (−0.92; −0.43) | <0.0001 |
Mean Body Weight (kg) ± SD | 82.47 ± 17.63 | 77.90 ± 18.59 | −2.63 (−3.37; −1.90) | <0.0001 |
Mean WC (cm) ± SD | 108.9 ± 13.8 | 106.8 ± 13.8 | −2.1 (−5.60; 1.1) | <0.05 |
Mean Systolic BP (mmHg) ± SD | 138.3 ± 18 | 136 ± 8.9 | −3 (−5.10; 2) | n.s. |
Mean Diastolic BP (mmHg) ± SD | 76.8 ± 15 | 74 ± 11 | −3 (−4.80; 1) | n.s. |
Mean Total Cholesterol (mg/dL) ± SD | 180 ± 43.08 | 159.80 ± 36.1 | −17.41 (−27.01; −7.80) | <0.0001 |
Mean HDL Cholesterol (mg/dL) ± SD | 48.77 ± 12.97 | 47.6 ± 14.8 | −0.49 (−4.60; 3.62) | n.s |
Mean Triglycerides (mg/dL) ± SD | 163 ± 105 | 154 ± 72.8 | −17.20 (−47.09; 12.68) | n.s. |
Mean LDL Cholesterol (mg/dL) ± SD | 101.73 ± 38.71 | 82.95 ± 32.1 | −17.89 (−27.34; −8.44) | <0.0001 |
Mean eGFR (ml/min/m2) ± SD | 76.73 ± 20.55 | 74.5 ± 21.1 | −0.05 (−1.82; 1.99) | n.s |
Mean Microalbuminuria (mg/L) ± SD | 48.85 ± 103.78 | 42 ± 122 | −8 (−27; 49) | n.s. |
Mean AST (UI/L) ± SD | 21.9 ± 11.7 | 19.5 ± 7.6 | −2.40 (−6.38; 1.50) | n.s. |
Mean ALT (UI/L) ± SD | 25.7 ± 21.4 | 22.5 ± 10.4 | −3.19 (−9.76; 3.39) | n.s. |
Mean Gamma GT (UI/L) ± SD | 28.3 ± 15.7 | 24.3 ± 14 | −4 (−1.70; 5.70) | n.s. |
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Baldassarre, M.P.A.; Di Dalmazi, G.; Coluzzi, S.; Carrieri, F.; Febo, F.; Centorame, G.; Cassino, P.; Piacentino, L.; Baroni, M.G.; Consoli, A.; et al. Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment. J. Clin. Med. 2024, 13, 3054. https://doi.org/10.3390/jcm13113054
Baldassarre MPA, Di Dalmazi G, Coluzzi S, Carrieri F, Febo F, Centorame G, Cassino P, Piacentino L, Baroni MG, Consoli A, et al. Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment. Journal of Clinical Medicine. 2024; 13(11):3054. https://doi.org/10.3390/jcm13113054
Chicago/Turabian StyleBaldassarre, Maria Pompea Antonia, Giulia Di Dalmazi, Sara Coluzzi, Federica Carrieri, Fabrizio Febo, Giorgia Centorame, Piergiuseppe Cassino, Luigi Piacentino, Marco Giorgio Baroni, Agostino Consoli, and et al. 2024. "Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment" Journal of Clinical Medicine 13, no. 11: 3054. https://doi.org/10.3390/jcm13113054