Table 2.
Mean change (SD) in clinical variables from baseline to three to six and 6–12 months of glucagonlike peptide-1 (GLP-1) receptor agonist treatment initiation and according to prescription recommendations or local health policy for reimbursement.
| Clinical Variable | Endpoint | Overall Mean Change (SD) n = 2251 |
Prescribed According to SmPC? * | Prescribed According to Reimbursement Policy? ** | ||||
|---|---|---|---|---|---|---|---|---|
| Yes n = 1721 |
No n = 1133 |
p-Value | Yes n = 1493 |
No n = 1361 |
p-Value | |||
| HbA1c, % | 6 months | −0.84 (1.66) | −0.99 (1.68) | −0.28 (1.46) | <0.001 | −1.02 (1.70) | −0.46 (1.51) | <0.001 |
| 12 months | −0.88 (1.57) | −1.03 (1.59) | −0.36 (1.39) | <0.001 | −1.03 (1.61) | −0.57 (1.45) | <0.001 | |
| BMI, kg/m2 | 6 months | −1.01 (2.36) | −0.99 (2.25) | −1.04 (2.55) | 0.674 | −1.08 (2.23) | −0.87 (2.59) | 0.062 |
| 12 months | −1.08 (2.22) | −1.07 (2.15) | −1.10 (2.35) | 0.826 | −1.17 (2.08) | −0.89 (2.48) | 0.035 | |
| Weight, kg | 6 months | −2.73 (6.44) | −2.67 (6.17) | −2.85 (6.90) | 0.559 | −2.87 (6.01) | −2.47 (7.19) | 0.212 |
| 12 months | −2.86 (5.99) | −2.79 (5.86) | −2.97 (6.25) | 0.598 | −3.06 (5.57) | −2.44 (6.77) | 0.081 | |
| Total-Cholesterol, mg/dL | 6 months | −6.86 (35.9) | −7.59 (35.6) | −4.13 (36.9) | 0.129 | −8.05 (36.5) | −4.31 (34.6) | 0.052 |
| 12 months | −7.64 (35.3) | −8.31 (35.0) | −5.32 (36.6) | 0.263 | −9.11 (35.5) | −4.57 (34.8) | 0.049 | |
| HDL-Cholesterol, mg/dL | 6 months | 0.09 (7.14) | 0.12 (7.01) | −0.02 (7.58) | 0.764 | 0.14 (7.02) | −0.02 (7.38) | 0.696 |
| 12 months | −0.05 (7.10) | 0.01 (6.96) | −0.27 (7.56) | 0.612 | −0.03 (7.13) | −0.11 (7.04) | 0.859 | |
| LDL-Cholesterol, mg/dL | 6 months | −5.07 (31.2) | −5.60 (30.8) | −3.08 (32.8) | 0.212 | −5.65 (31.6) | −3.83 (30.4) | 0.278 |
| 12 months | −5.83 (30.5) | −6.21 (29.9) | −4.51 (32.6) | 0.471 | −6.42 (30.8) | −4.60 (30.0) | 0.360 | |
| Triglycerides, mg/dL | 6 months | −16.42 (166) | −20.52 (181) | −1.28 (90.3) | 0.004 | −22.41 (174) | −4.50 (149) | 0.022 |
| 12 months | −21.30 (156) | −27.16 (170) | −1.29 (91.6) | 0.001 | −29.41 (163) | −5.59 (141) | 0.006 | |
| SBP, mmHg | 6 months | −0.90 (17.6) | −0.77 (17.3) | −1.11 (18.1) | 0.659 | −1.01 (17.4) | −0.73 (17.7) | 0.710 |
| 12 months | −1.97 (15.7) | −1.92 (15.9) | −2.05 (15.3) | 0.864 | −2.05 (16.1) | −1.83 (15.1) | 0.777 | |
| DBP, mmHg | 6 months | −0.33 (10.5) | −0.32 (10.1) | −0.36 (11.1) | 0.938 | −0.42 (10.2) | −0.21 (10.9) | 0.643 |
| 12 months | −1.07 (9.46) | −1.05 (9.15) | −1.11 (9.98) | 0.917 | −1.11 (9.24) | −1.01 (9.80) | 0.839 | |
| Heart rate, bpm | 6 months | 0.68 (12.8) | 0.58 (12.4) | 0.86 (13.5) | 0.664 | 0.64 (12.4) | 0.73 (13.4) | 0.897 |
| 12 months | 0.55 (11.6) | 0.26 (11.1) | 1.08 (12.6) | 0.250 | 0.36 (11.1) | 0.87 (12.5) | 0.466 | |
| eGFR, mL/min/1.73 m2 | 6 months | −1.63 (11.1) | −1.86 (10.8) | −0.65 (12.1) | 0.083 | −1.70 (11.0) | −1.48 (11.4) | 0.689 |
| 12 months | −1.19 (10.5) | −1.38 (10.5) | −0.41 (10.7) | 0.169 | −1.16 (10.6) | −1.24 (10.3) | 0.884 | |
* GLP-1RAs must be given as add-on therapy in patients with inadequate glycemic control (HbA1c ≥ 7%) with other antidiabetics and in subjects poorly controlled (HbA1c ≥ 7%) and eGFR ≥ 30 mL/min/1.73 m2.. ** GLP-1RAs must be given in combination with other antidiabetics and in subjects poorly controlled (HbA1c ≥ 7%) and with a BMI of ≥30 kg/m2. BMI, body mass index; DBP, diastolic blood pressure; eGFR, estimated glomerular filtration rate using the CDK-Epi equation; HbA1c, glycated haemoglobin A1c; SBP, systolic blood pressure; SD, standard deviation; SmPC, summary of product characteristics.