TABLE 1.
Demographic and Clinical Characteristics of Patients Treated with Olmesartan/Amlodipine Fixed-Dose and Extemporaneous Combinationsa
| Patient Characteristics | FDC Overall (N = 4,522) | 20/5 mg FDC Formulation (n = 2,660) | 40/10 mg FDC Formulation (n = 942) | 40/5 mg FDC Formulation (n = 920) | Extemporaneous Combination (N = 2,090) | P Valueb |
|---|---|---|---|---|---|---|
| Demographics | ||||||
| Mean (SD) age, years | 66.6 (12.6) | 66.4 (12.9) | 66.8 (12.4) | 67 (12.0) | 68.1 (11.6) | 0.002 |
| Female, % | 52.2 | 53.9 | 46.3 | 53.5 | 50.8 | 0.267 |
| Medical history/medical examination, % | ||||||
| Family history of CV diseasesc | 19.2 | 20.2 | 16.7 | 18.9 | 17.4 | 0.077 |
| Obesity | 26.8 | 23.3 | 33.4 | 29.9 | 28.5 | 0.130 |
| Comorbidities, %c | ||||||
| Diabetes mellitus | 29.2 | 25.8 | 39.2 | 28.6 | 30.3 | 0.326 |
| Arrhythmias | 12.8 | 12.7 | 11.7 | 13.9 | 13.7 | 0.294 |
| Peripheral vascular diseases | 15.0 | 13.3 | 19.1 | 16.0 | 14.1 | 0.317 |
| Chronic kidney disease | 8.6 | 7.3 | 10.8 | 10.0 | 9.9 | 0.091 |
| Adrenal gland disorders | 0.3 | 0.3 | 0.3 | 0.5 | 0.6 | 0.084 |
| Dyslipidemia | 32.5 | 30.4 | 34.8 | 36.3 | 32.7 | 0.888 |
| Coronary artery disease | 13.5 | 12.1 | 15.8 | 14.9 | 18.1 | < 0.001 |
| Cerebrovascular diseases | 13.9 | 13.0 | 16.2 | 14.0 | 16.6 | 0.004 |
| Congestive heart failure | 2.6 | 2.5 | 2.4 | 3.2 | 4.2 | 0.001 |
| Thyroid diseases | 20.8 | 20.0 | 20.7 | 23.0 | 18 | 0.008 |
| Gout/hyperuricemia | 10.8 | 9.4 | 14.1 | 11.7 | 10.5 | 0.700 |
| Test resultsd | ||||||
| Mean (SD) systolic BP, mm Hg | 148.3 (18.5) | 146.9 (17.2) | 152 (20.5) | 148.4 (19.2) | 144.7 (17.3) | 0.002 |
| Mean (SD) diastolic BP, mm Hg | 85.2 (11.0) | 84.9 (10.5) | 85.7 (10.8) | 85.6 (12.4) | 83.6 (12.9) | 0.080 |
| Mean (SD) total cholesterol, mg/dL | 202.4 (42.2) | 203.8 (41.6) | 196.4 (41.8) | 205 (43.8) | 203.1 (38.8) | 0.031 |
| Mean (SD) LDL cholesterol, mg/dL | 121.8 (45.0) | 123.3 (50.2) | 116.7 (37.5) | 122.7 (36.4) | 122.4 (34.6) | 0.129 |
| Mean (SD) HDL cholesterol, mg/dL | 52.5 (15.7) | 53.3 (16.6) | 50.8 (14.6) | 52.4 (13.9) | 52.1 (14.3) | 0.471 |
| Mean (SD) Hb1Ac, % | 7.8 (6.4) | 7.6 (6.2) | 7.8 (4.9) | 8.1 (8.4) | 7 (1.3) | < 0.001 |
| Mean (SD) number of hospitalizations | 1.1 (0.3) | 1.1 (0.3) | 1.1 (0.4) | 1.1 (0.4) | 0.2 (0.6) | < 0.001 |
| Mean (SD) number of visits to a specialist | 2.7 (1.9) | 2.7 (2.0) | 2.7 (1.9) | 2.6 (1.8) | 2.6 (2.9) | 0.002 |
| Concomitant therapies, %e | ||||||
| Antihyperglycemic drugs | 22.8 | 19.8 | 31.8 | 22.2 | 24 | 0.268 |
| Antithrombotics | 41.2 | 38.0 | 47.8 | 43.6 | 49.3 | < 0.001 |
| Cardiac drug therapy | 1.4 | 1.1 | 1.6 | 2.0 | 4.6 | < 0.001 |
| Antiarrhythmics | 3.6 | 3.6 | 3.5 | 3.7 | 5.8 | < 0.001 |
| Corticosteroids | 9.6 | 9.7 | 8.9 | 10.0 | 14 | < 0.001 |
| NSAIDs | 33.3 | 34.5 | 31.8 | 31.4 | 45.4 | < 0.001 |
| Antidepressant drugs | 10.3 | 10.0 | 11.4 | 10.2 | 14.7 | < 0.001 |
| Thyroid therapy | 8.2 | 8.4 | 7.1 | 8.6 | 7.6 | 0.415 |
| Oral contraceptives | 0.3 | 0.4 | 0.1 | 0.3 | 0.7 | 0.058 |
| Lipid-modifying agents | 35.2 | 32.8 | 39.3 | 37.9 | 37.5 | 0.063 |
| Mean (SD) number of medications | 8.3 (4.7) | 7.9 (4.6) | 9.3 (5.0) | 8.4 (4.4) | 2.6 (1.8) | < 0.001 |
aPatients prescribed the fixed-dose combination were further stratified by the formulations used (20/5 mg, 40/10 mg, or 40/5 mg).
bP values refer to comparisons between FDC and extemporaneous-combination users.
cIn the period prior to the index date (data have been recorded since 1996).
dRegistered in the 12 months before and/or on the index date.
ePrescribed during the 6 months before and/or on the index date.
BP = blood pressure; CV = cardiovascular; FDC = fixed-dose combination; Hb1Ac = hemoglobin A1c; HDL = high-density lipoprotein; LDL = low-density lipoprotein; mm Hg = millimeters of mercury; NSAID = nonsteroidal anti-inflammatory drug; SD = standard deviation.