1 Introduction
2 Methods
2.1 Design
2.2 Patients
2.3 Evaluation
2.4 Statistics
3 Results
3.1 Baseline Characteristics
Characteristic | Men and women (n = 14,151) | Men (n = 7,179) | Women (n = 6,972) |
---|---|---|---|
Age, y | 59.0 ± 12.0 | 56.7 ± 11.9 | 61.5 ± 11.7* |
Age >60 y, % | 44.6 | 36.8 | 52.6* |
Body weight, kg | 64.88 ± 10.96 | 70.72 ± 9.97 | 58.8 ± 8.32* |
Height, cm | 162.8 ± 8.76 | 169.07 ± 6.38 | 156.27 ± 5.54* |
Body mass index, kg/m2
| 24.38 ± 2.94 | 24.68 ± 2.75 | 24.07 ± 3.10* |
Obesity, % | 37.6 | 41.5 | 33.5 |
Physical inactivity, % | 66.4 | 65.0 | 67.9 |
Smoking, % | 1,406 (9.94) | 1,310 (18.25) | 96 (1.38)* |
Alcohol use, % | 3,508 (40.31) | 2,859 (64.92) | 649 (15.1)* |
BP | |||
SBP, mmHg | 145.43 ± 18.07 | 146.2 ± 17.62 | 144.63 ± 18.5* |
DBP, mmHg | 88.71 ± 11.8 | 89.83 ± 11.86 | 87.56 ± 11.63* |
Pulse rate, beats/min | 74.38 ± 10.28 | 74.76 ± 10.55 | 73.98 ± 9.97* |
Co-morbidity | |||
Diabetes, % | 18.8 | 19.4 | 18.2 |
Ischemic heart disease, % | 2.1 | 1.7 | 2.4 |
Stroke, % | 1.6 | 1.5 | 1.7 |
Concomitant medication | |||
Antihypertensive drug | |||
ACEI | 295 (2.08) | 161 (2.24) | 134 (1.92) |
β-blocker | 809 (5.72) | 394 (5.49) | 415 (5.95) |
CCB | 3,472 (24.54) | 181 (25.24) | 1,660 (23.81) |
Diuretic | 1,320 (9.33) | 615 (8.57) | 705 (10.11)* |
α-blocker | 28 (0.2) | 19 (0.26) | 9 (0.13) |
Other antihypertensive drug | 388 (2.74) | 198 (2.76) | 190 (2.73) |
Antiplatelet drug | 2,641 (18.66) | 1,308 (18.22) | 1,333 (19.12) |
Oral hypoglycemic drug | 2,371 (16.75) | 1,225 (17.06) | 1,146 (16.44) |
Insulin | 131 (0.93) | 67 (0.93) | 64 (0.92) |
Antidyslipidemic drug | 2,848 (20.13) | 1,352 (18.83) | 1,496 (21.46)* |
Anticoagulant | 279 (1.97) | 110 (1.53) | 169 (2.42) |
Indication, % | |||
Naïvea
| 37.9 | 40.2 | 35.7 |
Changeb
| 53.5 | 51.2 | 56.0 |
Add-onc
| 8.5 | 8.6 | 8.4 |
3.2 Safety
Category | Symptoms | No. | (%) |
---|---|---|---|
Skin and appendage disorders | Skin rash | 2 | (0.38) |
Facial flushing | 2 | (0.38) | |
Itching | 18 | (3.39) | |
Acne | 1 | (0.19) | |
Chloasma | 1 | (0.19) | |
Bruise | 1 | (0.19) | |
Toenail hemorrhage | 1 | (0.19) | |
Cold sweating | 1 | (0.19) | |
Musculoskeletal system disorders | Stiff neck | 2 | (0.38) |
Temporomandibular pain | 1 | (0.19) | |
Back pain | 4 | (0.75) | |
Chest discomfort | 5 | (0.94) | |
Central and peripheral nervous system disorders | Headache | 85 | (16.01) |
Unconsciousness | 1 | (0.19) | |
Menstrual irregularity | 1 | (0.19) | |
Dizziness | 252 | (47.46) | |
Acroparesthesia | 5 | (0.94) | |
Bitter taste | 1 | (0.19) | |
Vision disorders | Visual disturbance | 1 | (0.19) |
Blurred vision | 1 | (0.19) | |
Phlebitis | 1 | (0.19) | |
Hearing and vestibular disorders | Tinnitus | 1 | (0.19) |
Psychiatric disorders | Sleep disorder | 8 | (1.51) |
Photophobia | 1 | (0.19) | |
Delirium | 1 | (0.19) | |
Gastrointestinal system disorders | Periodontal disease | 1 | (0.19) |
Stomatitis | 1 | (0.19) | |
Diarrhea | 3 | (0.56) | |
Constipation | 3 | (0.56) | |
Abdominal pain | 16 | (3.01) | |
Nausea | 14 | (2.64) | |
Vomiting | 2 | (0.38) | |
Heartburn | 3 | (0.56) | |
Dyspepsia | 2 | (0.38) | |
Epigastric soreness | 2 | (0.38) | |
Gas distension | 1 | (0.19) | |
Metabolic and nutritional disorders | Hyperlipidemia | 3 | (0.56) |
Cardiovascular disorders, general | Low blood pressure | 7 | (1.32) |
Hypertension | 3 | (0.56) | |
Heart rate and rhythm disorders | Angina | 1 | (0.19) |
Tachycardia | 5 | (0.94) | |
Vascular disorders | Palpitation | 5 | (0.94) |
Varicose vein | 1 | (0.19) | |
Respiratory disorders | Asthma | 1 | (0.19) |
Dyspnea | 3 | (0.56) | |
Sputum | 1 | (0.19) | |
Shortness of breath | 4 | (0.75) | |
Reproductive disorders | Coughing | 14 | (2.64) |
Body as a whole – general disorders | Erectile insufficiency | 2 | (0.38) |
Fatigue | 18 | (3.39) | |
Anorexia | 2 | (0.38) | |
Weight loss | 2 | (0.38) | |
Dry mouth | 1 | (0.19) | |
Facial edema | 3 | (0.56) | |
Ankle edema | 1 | (0.19) | |
Others | 8 | (1.51) |
3.3 Efficacy
Patients | Before treatment | After treatment | Difference |
---|---|---|---|
Men and women | |||
SBP, mmHg | 145.43 ± 18.07 | 126.77 ± 12.61 | −18.65 ± 18.29* |
DBP, mmHg | 88.71 ± 11.80 | 78.98 ± 8.66 | −9.73 ± 11.67* |
Pulse rate, beats/min | 74.38 ± 10.28 | 71.88 ± 9.19 | −2.5 ± 7.85 |
Men | |||
SBP, mmHg | 146.20 ± 17.62 | 127.49 ± 12.63 | −18.71 ± 17.62* |
DBP, mmHg | 89.83 ± 11.86 | 79.78 ± 8.83 | −10.05 ± 11.67* |
Pulse rate, beats/min | 74.76 ± 10.55 | 72.21 ± 9.40 | −2.55 ± 8.07* |
Women | |||
SBP, mmHg | 144.63 ± 18.50 | 126.03 ± 12.55 | −18.60 ± 18.96* |
DBP, mmHg | 87.56 ± 11.63 | 78.16 ± 8.41 | −9.39 ± 11.65* |
Pulse rate, beats/min | 73.98 ± 9.97 | 71.54 ± 8.95 | −2.45 ± 7.61* |
Patients | Fimasartan 60 mg | Fimasartan 120 mg |
P value |
---|---|---|---|
Men and women | |||
∆ SBP, mmHg | −18.16 ± 17.97 | −20.10 ± 19.14 | <.0001 |
∆ DBP, mmHg | −9.57 ± 11.40 | −10.17 ± 12.41 | 0.0103 |
∆ Pulse rate, beats/min | −2.36 ± 7.62 | −2.91 ± 8.47 | 0.0005 |
Men | |||
∆ SBP, mmHg | −18.23 ± 17.37 | −19.93 ± 18.22 | 0.0003 |
∆ DBP, mmHg | −10.00 ± 11.45 | −10.17 ± 12.22 | 0.5796 |
∆ Pulse rate, beats/min | −2.37 ± 7.78 | −3.00 ± 8.76 | 0.0050 |
Women | |||
∆ SBP, mmHg | −18.09 ± 18.53 | −20.31 ± 20.23 | <.0001 |
∆ DBP, mmHg | −9.16 ± 11.32 | −10.17 ± 12.65 | 0.0039 |
∆ Pulse rate, beats/min | −2.34 ± 7.45 | −2.79 ± 8.11 | 0.0456 |
Variable | ∆SBP | ∆DBP | ∆PR | ||||||
---|---|---|---|---|---|---|---|---|---|
β | SE(β) |
P value | β | SE(β) |
P value | β | SE(β) |
P value | |
Women | −0.42 | 1.67 | 0.801 | 1.27 | 1.02 | 0.211 | 1.49 | 0.64 | 0.021 |
Age | 0.18 | 0.07 | 0.007 | 0.12 | 0.04 | 0.004 | 0.00 | 0.03 | 0.972 |
History of cardiovascular disease | 4.57 | 2.38 | 0.055 | 2.42 | 1.45 | 0.096 | 3.06 | 0.92 | 0.001 |
Smoking | 2.05 | 2.06 | 0.321 | 2.10 | 1.26 | 0.095 | 0.98 | 0.79 | 0.215 |
High BMI | −2.19 | 1.60 | 0.172 | −0.94 | 0.98 | 0.335 | −0.95 | 0.62 | 0.121 |
Abdominal obesity | −0.62 | 1.64 | 0.703 | −0.25 | 1.00 | 0.801 | 0.61 | 0.63 | 0.335 |
Physical inactivity | 0.56 | 1.48 | 0.706 | −0.04 | 0.90 | 0.962 | 0.32 | 0.57 | 0.570 |
Diabetes | 0.10 | 2.24 | 0.965 | 0.23 | 1.36 | 0.865 | −1.91 | 0.86 | 0.027 |
Dyslipidemia | 1.61 | 1.54 | 0.297 | 1.06 | 0.94 | 0.260 | −1.12 | 0.59 | 0.059 |
Family history of hypertension | 1.64 | 1.76 | 0.351 | 0.17 | 1.07 | 0.874 | −0.46 | 0.68 | 0.498 |
Renal dysfunction | −2.76 | 2.84 | 0.331 | −0.61 | 1.73 | 0.725 | −1.46 | 1.09 | 0.181 |
Sleep apnea | 0.20 | 2.10 | 0.925 | −1.20 | 1.28 | 0.352 | −0.33 | 0.81 | 0.683 |
R2
| 0.02 | 0.02 | 0.017 |
3.4 Responder Rate and Goal Rate
Variable | 60 mg | 120 mg | Both |
---|---|---|---|
Responder rate | |||
Naïvea
| 86.1 | 81.2* | 85.0 |
Add-onb
| 88.3 | 86.9 | 87.9 |
Switchc
| 90.9 | 87.7 | 90.1 |
Goal rate | |||
Naïvea
| 77.7 | 68.4* | 75.6 |
Add-onb
| 77.9 | 65.3* | 74.5 |
Switchc
| 81.7 | 74.4* | 79.7 |
3.5 Compliance
Compliance rate | Men | Women | Men and women |
---|---|---|---|
Excellent (100 %) | 67.0 | 69.2 | 68.1 |
Very good (90~99 %) | 27.5 | 26.2 | 26.9 |
Good (80~89 %) | 3.8 | 3.0 | 3.4 |
Poor (<80 %) | 1.7 | 1.7 | 1.7 |
Compliance rate | ∆ SBP | ∆ DBP | ||||
---|---|---|---|---|---|---|
β | SE(β) |
P value | β | SE(β) |
P value | |
Excellent (100 %) | −10.8 | 0.77 | <0.001 | −5.33 | 0.52 | <0.001 |
Very good (90~99 %) | −10.9 | 0.79 | <0.001 | −5.29 | 0.53 | <0.001 |
Good (80~89 %) | −6.60 | 0.93 | <0.001 | −3.78 | 0.63 | <0.001 |
Poor (<80 %) | ||||||
R2
| 0.58 | 0.53 |