A randomized, double-blind, multicenter, phase III study on the efficacy and safety of a combination treatment involving fimasartan, amlodipine, rosuvastatin in patients with essential hypertension and dyslipidemia who fail to respond adequately to fimasartan monotherapy

Table 5 Overall summary of AE and ADR

Variable	FMS/ALD + RSV group^a (n = 46)	FMS/ALD group^b (n = 46)	FMS + RSV group^c (n = 44)	Total (n = 136)
AE	8 (17.39) [9]	4 (8.70) [5]	13 (29.55) [16]	25 (18.38) [30]
95% CI	6.44–28.34	0.55–16.84	16.06–43.03	11.87–24.89
P-value				0.038
Severity (mild, moderate, severe)	8, 1, 0	5, 0,0	14, 1, 1	27, 2, 1
ADR	3 (6.52) [4]	2 (4.35) [3]	3 (6.82) [4]	8 (5.88) [11]
Exact 95% CI	1.37–17.90	0.53–14.84	1.43–18.66	2.57–11.26
P-value				0.9074
Severity (mild, moderate, severe)	4, 0, 0	3, 0, 0	4, 0, 0	11, 0, 0
Drug related adverse reactions
Headache	0	0	2 (4.55) [2]	2 (1.47) [2]
Essential tremor	1 (2.17) [1]	0	0	1 (0.74) [1]
Asthenia	0	1 (2.17) [1]	0	1 (0.74) [1]
Oedema peripheral	0	1 (2.17) [1]	0	1 (0.74) [1]
Blood creatine phosphokinase increased	0	0	1 (2.27) [1]	1 (0.74) [1]
Blood lactate dehydrogenase increased	0	0	1 (2.27) [1]	1 (0.74) [1]
Pruritus	1 (2.17) [1]	0	0	1 (0.74) [1]
Rash	1 (2.17) [1]	0	0	1 (0.74) [1]
Nausea	1 (2.17) [1]	0	0	1 (0.74) [1]
Hot flush	0	1(2.17) [1]	0	1 (0.74) [1]

Data are presented as number of patients (%) and [case]
AE Adverse event, ADR Adverse drug reaction, CI Confidence interval
^a FMS/ALD + RSV; study group, fimasartan 60 mg/amlodipine 10 mg + rosuvastatin 20 mg treatment
^b FMS/ALD; control 1 group, fimasartan 60 mg/amlodipine 10 mg treatment
^c FMS + RSV; control 2 group, fimasartan 60 mg + rosuvastatin 20 mg treatment

ISSN: 2056-5909