Table 3. Secondary analysis and sensitivity analysis comparing outcomes during follow between statin users vs active comparators.
| Statin users N (%) | Active comparator N (%) | Adjusted OR* (95%CI) | p-value | |
|---|---|---|---|---|
| Overall Cohort (595,579 statin users and 110,195 active comparators) | ||||
| Renal disease progression composite outcome | 78,966 (13.3) | 7,839 (7.1) | 1.17 (1.14–1.20) | <0.001 |
| Incident Diabetes with ophthalmic manifestations | 30,202 (5.1) | 1,713 (1.6) | 1.33 (1.26–1.40) | <0.001 |
| Incident Diabetes with neurological manifestations | 61,845 (10.4) | 4,969 (4.5) | 1.17 (1.13–1.20) | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 61,160 (10.3) | 4,691 (4.3) | 1.20 (1.16–1.24) | <0.001 |
| Healthy Cohort (148, 509 statin users and 39,009 active comparators) | ||||
| Renal disease progression composite outcome | 15,543 (10.5) | 1,944 (5.0) | 1.31 (1. 24–1.38) | <0.001 |
| Incident Diabetes with ophthalmic manifestations | 3,294 (2.2) | 183 (0.5) | 2.09 (1.79–2.44) | <0.001 |
| Incident Diabetes with neurological manifestations | 10,803 (7.3) | 1,024 (2.6) | 1.48 (1.38–1.58) | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 7,226 (4.9) | 713 (1.8) | 1.45 (1.33–1.57) | <0.001 |
| Intensive cholesterol lowering statin users in comparison to nonusers in the overall cohort (38,823 statin users and 110,195 active comparators) | ||||
| Renal disease progression composite outcome | 6,534 (16.8) | 7,839 (7.1) | 1.66 (1.60–1.73) | <0.001 |
| Incident Diabetes with ophthalmic manifestations | 2,358 (6.1) | 1,713 (1.6) | 1.76 (1.64–1.89) | <0.001 |
| Incident Diabetes with neurological manifestations | 4,476 (11.5) | 4,969 (4.5) | 1.34 (1.28–1.41) | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 4,760 (12.3) | 4,691 (4.3) | 1.63 (1.55–1.70) | <0.001 |
| Medium-intensity cholesterol lowering statin users in the overall cohort (180,884 statin users and 110,195 active comparators) | ||||
| Renal disease progression composite outcome | 25,621 (14.1) | 7,839 (7.1) | 1.30 (1.26–1.34) | <0.001 |
| Incident Diabetes with ophthalmic manifestations | 8,945 (5.0) | 1,713 (1.6) | 1.25 (1.19–1.33) | <0.001 |
| Incident Diabetes with neurological manifestations | 20,027 (11.1) | 4,969 (4.5) | 1.23 (1.19–1.28) | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 18,673 (10.3) | 4,691 (4.3) | 1.23 (1.18–1.27) | <0.001 |
| Low-intensity cholesterol lowering statin users in comparison to nonusers in the overall cohort (375,872 statin users and 110,195 active comparators) | ||||
| Renal disease progression composite outcome | 46,811 (12.5) | 7,839 (7.1) | 1.13 (1.09–1.16) | <0.001 |
| Incident Diabetes with ophthalmic manifestations | 18,899 (5.0) | 1,713 (1.6) | 1.43(1.36–1.51) | <0.001 |
| Incident Diabetes with neurological manifestations | 37,342 (9.9) | 4,969 (4.5) | 1.17 (1.13–1.21) | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 37,727 (10.0) | 4,691 (4.3) | 1.26 (1.21–1.30) | <0.001 |
| Sensitivity Analysis | ||||
| Overall Cohort after excluding patients with incident diabetes, diabetic complications, or cardiovascular disease within less than 60 days from index date (353,065 statin users and 77,657 active comparators) | ||||
| Renal disease progression composite outcome | 40,115 (11.4) | 4,595 (5.9) | 1.15 (1.11–1.19) | <0.001 |
| Incident Diabetes with ophthalmic manifestations | 11,543(3.3) | 713 (0.9) | 1.28 (1.18–1.38) | <0.001 |
| Incident Diabetes with neurological manifestations | 29,237 (8.3) | 2,553 (3.3) | 1.22 (1.17–1.27) | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 25,147 (7.1) | 2,201 (2.83) | 1.16 (1.11–1.22) | <0.001 |
| Post-Hoc analysis | ||||
| Ever user vs never user cohort (543,403 statin users and 58,019 active comparators) | ||||
| Renal disease progression composite outcome | 73,476 (13.5) | 5,787 (10.0) | 1.05 (1.01–1.08) | 0.003 |
| Incident Diabetes with ophthalmic manifestations | 28,682 (5.3) | 1,176 (2.0) | 1.48 (1.39–1.57) | <0.001 |
| Incident Diabetes with neurological manifestations | 57,057 (10.5) | 3,492 (6.0) | 1.15 (1.11–1.19) | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 57,261 (10.5) | 3,174 (5.5) | 1.26 (1.21–1.31) | <0.001 |
| Incident diabetes complications cohort (513,125 statin users and 98,231 active comparators) | ||||
| Renal disease progression composite outcome | 62,994 (12.3) | 6,447 (6.6) | 1.18 (1.14–1.21) | <0.001 |
| Incident Diabetes with ophthalmic manifestations | 22,236 (4.3) | 1,205 (1.2) | 1.36 (1.28–1.46) | <0.001 |
| Incident Diabetes with neurological manifestations | 51,931 (10.1) | 4,130 (4.2) | 1.19 (1.15–1.24) | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 41,149 (8.0) | 2,965 (3.0) | 1.24 (1.20–1.30) | <0.001 |
| Statin users for < 3 years of statin use vs nonusers (172,123 statin users and110,195 active comparators) | ||||
| Renal disease progression composite outcome | 15,101 (8.8) | 7,839 (7.1) | 1.02 (0.99–1.05)** | 0.17 |
| Incident Diabetes with ophthalmic manifestations | 4,469 (2.6) | 1,713 (1.6) | 1.04 (0.98–0.10)** | 0.16 |
| Incident Diabetes with neurological manifestations | 9,163 (5.3) | 4,969 (4.5) | 0.84 (0.81–0.88)** | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 11,273 (6.6) | 4,691 (4.3) | 1.05 (1.00–1.08)** | 0.02 |
| Statin users for > 3 years of statin use vs nonusers (423,456 statin users and 110,195 active comparators) | ||||
| Renal disease progression composite outcome | 63,865 (15.1) | 7,839 (7.1) | 1.19 (1.16–1.22)** | <0.001 |
| Incident Diabetes with ophthalmic manifestations | 25,733 (6.1) | 1,713 (1.6) | 1.34 (0.27–1.41)** | <0.001 |
| Incident Diabetes with neurological manifestations | 52,682 (12.4) | 4,969 (4.5) | 1.25 (1.20–1.29)** | <0.001 |
| Any retinopathy & its complications (post-hoc outcome) | 49,887 (11.8) | 4,691 (4.3) | 1.19 (1.15–1.23)** | <0.001 |
* Odds ratio adjusted for propensity score except when indicated differently
** Odds ratio adjusted for propensity score and duration of follow up