Effectiveness and Safety of a Fixed-Dose Combination of Valsartan and Rosuvastatin (Rovatitan^® Tablet) in Patients with Concomitant Hypertension and Hyperlipidemia: An Observational Study

Figures & data

Figure 1 Study flowchart.

Table 1 Baseline Characteristics

	Total (N=1005)
Age (years)
n	1005
Mean ± SD	66.06 ± 11.14
Median	67.00
Min, Max	26.00, 95.00
Age (years) by category, n (%)
<65 years	436 (43.38)
≥65 years	569 (56.62)
Sex, n (%)
Male	569 (56.62)
Female	436 (43.38)
Menopausal status, n (%)
Yes	412 (94.71)
No	23 (5.29)
BMI (kg/m^2)
n	725
Mean ± SD	25.23 ± 3.47
Median	24.80
Min, Max	16.90, 40.00
BMI (kg/m^2) by category, n (%)
<25 kg/m^2	377 (52.00)
≥25 kg/m^2	348 (48.00)
Smoking history, n (%)
Non-Smoker	634 (63.65)
Former Smoker	244 (24.50)
Current Smoker	118 (11.85)
Alcohol history, n (%)
Non-drinker	787 (78.94)
Drinker	210 (21.06)
Family history of early onset of CAD, n (%)
Yes	25 (2.49)
No	603 (60.00)
Unknown	377 (37.51)
Diabetes comorbidity, n (%)
Yes	322 (32.04)
No	683 (67.96)
Renal disorders comorbidity, n (%)
Yes	50 (4.98)
No	955 (95.02)

Abbreviation: BMI, body mass index.

Figure 2 Treatment target achievement.

Table 2 Percentage of Subjects Who Achieved Target Blood Pressure (BP) and Changes in BP from Baseline at Week 12 by Prior Hypertension Treatment and Hypertension Stage at Baseline

	Yes (N=814)					No (N=97)
Hypertension stage^a	Normal (N=179)	Prehypertension (N=406)	Stage 1 (N=185)	Stage 2 (N=41)	Total (N=814)	Normal (N=3)	Prehypertension (N=22)	Stage 1 (N=48)	Stage 2 (N=23)	Stage 1+2 (N=71)	Total (N=97)
Number of Subjects who achieved target blood pressure at Week 12^b (%)	171 (96.07)	348 (86.35)	144 (77.84)	24 (58.54)	689 (85.06)	3 (100.00)	20 (90.91)	39 (81.25)	15 (65.22)	54 (76.06)	78 (80.41)
Changes in SBP (mmHg) from baseline at Week 12
n	178	403	185	41	807	3	22	48	23	71	96
Mean ± SD	12.23 ± 13.71	0.35 ± 12.90	−10.62 ± 13.81	−18.37 ± 14.31	−0.49 ± 15.93	3.00 ± 14.80	−3.45 ± 15.85	−15.31 ± 16.60	−23.26 ± 16.11	−17.89 ± 16.75	−13.93 ± 17.69
95% CI^c	(10.20, 14.26)	(−0.91, 1.62)	(−12.62, −8.61)	(−22.88, −13.85)	(−1.59, 0.61)	(−33.76, 39.76)	(−10.48, 3.57)	(−20.13, −10.49)	(−30.23, −16.29)	(−21.85, −13.92)	(−17.51, −10.34)
p-value^d	<0.0001	0.9226	<0.0001	<0.0001	0.2309	0.7590	0.3184	<0.0001	<0.0001	<0.0001	<0.0001
Changes in DBP (mmHg) from baseline at Week 12
n	178	403	184	41	806	3	22	48	23	71	96
Mean ± SD	4.72 ± 9.93	−0.28± 9.50	−5.48 ± 10.79	−13.41 ± 11.40	−1.03 ± 10.94	1.33 ± 1.53	−4.27 ± 12.19	−7.73 ± 11.48	−11.91 ± 11.12	−9.08 ± 11.46	−7.66 ± 11.68
95% CI^c	(3.26, 6.19)	(−1.21, 0.65)	(−7.05, −3.91)	(−17.01, −9.82)	(−1.79, −0.27)	(−2.46, 5.13)	(−9.68, 1.13)	(−11.06, −4.39)	(−16.72, −7.10)	(−11.80, −6.37)	(−10.02, −5.29)
p-value^d	<0.0001	0.4020	<0.0001	<0.0001	0.0038	0.2697	0.1150	<0.0001	<0.0001	<0.0001	<0.0001

Notes: ^aClassification according to the JNC-7 guidelines: normal, SBP < 120 mmHg and DBP < 80 mmHg; prehypertension, 120 mmHg ≤ SBP < 140 mmHg or 80 mmHg ≤ DBP < 90 mmHg; stage 1, 140 mmHg ≤ SBP < 160 mmHg or 90 mmHg ≤ DBP < 100 mmHg; stage 2, SBP ≥ 160 mmHg or DBP ≥ 100 mmHg. ^bTarget blood pressure: for patients aged ≥ 60 years, < 150/90 mmHg; for patients aged < 60 years, < 140/90 mmHg. ^c95% CI is a two-sided 95% confidence interval for the mean. ^dp-value using Wilcoxon signed-rank test or Paired t-test. Missing in msSBP (hypertension treatment = “Yes”):- Week 12: Normal (1 subject), Prehypertension (3 subjects). Missing in msDBP (hypertension treatment = “Yes”): - Baseline: Stage 1 HTN (1 subject). - Week 12: Normal (1 subject), Prehypertension (3 subjects).

Table 3 Percentage of Subjects Who Achieved Target LDL-C and Changes in LDL-C from Baseline at Week 12 by Prior Hypertension Treatment and Hypertension Stage at Baseline

LDL-C Stage^a	Yes (N=698)					No (N=213)
	Very High-Risk (N=484)	High-Risk (N=85)	Moderate-Risk (N=115)	Low-Risk (N=14)	Total (N=698)	Very High-Risk (N=41)	High-Risk (N=31)	Moderate-Risk (N=118)	Low-Risk (N=23)	Total (N=213)
Number of subjects who achieved target LDL-C at Week 12^b (%)	126 (55.26)	56 (91.80)	58 (98.31)	8 (100.00)	248 (69.66)	15 (62.50)	18 (94.74)	78 (97.50)	19 (100.00)	130 (91.55)
Changes in LDL-C (mg/dL) from baseline at Week 12
n	196	55	52	6	309	19	19	67	18	123
Mean ± SD	−12.48± 20.82	−10.57 ± 28.18	−12.40 ± 32.58	−32.67 ± 23.85	−12.52 ± 24.64	−44.15 ± 40.49	−61.05 ± 36.22	−64.20 ± 31.91	−65.17 ± 36.05	−60.76 ± 34.92
95% CI^c	(−15.41, −9.55)	(−18.19, −2.96)	(−21.47, −3.33)	(−57.69, −7.64)	(−15.28, −9.76)	(−63.66, −24.63)	(−78.51, −43.60)	(−71.98, −56.42)	(−83.09, −47.24)	(−66.99, −54.52)
p-value^d	<0.0001	0.0071	0.0168	0.0202	<0.0001	0.0002	<0.0001	<0.0001	<0.0001	<0.0001
Percentage changes in LDL-C (%) from baseline at Week 12
n	196	55	52	6	309	19	19	67	18	123
Mean ± SD	−11.64 ± 26.60	−7.48 ± 28.48	−5.87 ± 28.08	−23.97 ± 13.38	−10.17 ± 27.08	−30.64 ± 29.92	−44.28 ± 19.90	−42.33 ± 17.13	−41.96 ± 21.69	−40.77 ± 20.84
95% CI^c	(−15.39, −7.90)	(−15.18, 0.22)	(−13.69, 1.95)	(−38.01, −9.93)	(−13.20, −7.14)	(−45.06, −16.22)	(−53.87, −34.68)	(−46.51, −38.15)	(−52.74, −31.17)	(−44.49, −37.05)
p-value^d	<0.0001	0.0567	0.1378	0.0071	<0.0001	0.0008	<0.0001	<0.0001	<0.0001	<0.0001

Notes: ^aClassification according to the Korean Guidelines for the Management of Dyslipidemia IV: low-risk, one or fewer major risk factors (age, family history of premature CAD, hypertension, smoking, low levels of high-density lipoprotein cholesterol); moderate-risk, two or more major risk factors; high-risk, carotid disease (significant carotid artery stenosis), abdominal aortic aneurysm, or diabetes; very high-risk, CVD (CAD, peripheral artery disease, ischemic stroke, or transient ischemic attack). ^bTarget LDL-C: for very high-risk group, < 70 mg/dL; high-risk group, < 100 mg/dL; moderate-risk group, < 130 mg/dL; low-risk group < 160 mg/dL. ^c95% CI is a two-sided 95% confidence interval for the mean. ^dp-value using Wilcoxon signed-rank test or Paired t-test. Missing in LDL-C (hyperlipidemia treatment = “Yes”): - Baseline: Very high risk group (106 subjects), High risk group (9 subjects), Moderate risk group (24 subjects), Low risk group (5 subjects). - Week 12: Very high risk group (256 subjects), High risk group (24 subjects), Moderate risk group (56 subjects), Low risk group (6 subjects). Missing in LDL-C (hyperlipidemia treatment = “No”): - Baseline: Very high risk group (6 subjects), High risk group (1 subject), Moderate risk group (22 subjects), Low risk group (2 subjects). - Week 12: Very high risk group (17 subjects), High risk group (12 subjects), Moderate risk group (38 subjects), Low risk group (4 subjects).

Table 4 Risk Factors Leading to Failure to Achieve Target BP at Week 12

	Reference	Odds Ratio Estimate	95% CI for Odds Ratio	p-value^a
Age (years)	≥65 years vs <65 years*	0.913	(0.57, 1.46)	0.7038
BMI (kg/m^2)	≥25 kg/m^2 vs <25 kg/m^2 *	1.663	(1.07, 2.59)	0.0246
Smoking	Former smoker vs Non-smoker*	0.966	(0.56, 1.66)	0.9007
	Current smoker vs Non-smoker*	1.421	(0.74, 2.71)	0.2870
Hypertension at baseline	Prehypertension vs Normal*	3.994	(1.53, 10.42)	0.0047
	Stage 1 vs Normal*	7.435	(2.83, 19.55)	<0.0001
	Stage 2 vs Normal*	14.435	(4.95, 42.13)	<0.0001
LDL-C stage at baseline	Very high-risk group vs Low-risk group*	0.443	(0.15, 1.33)	0.1458
	High-risk group vs Low-risk group*	0.863	(0.27, 2.80)	0.8067
	Moderate-risk group vs Low-risk group*	0.792	(0.26, 2.42)	0.6820

Notes: ^aMultiple logistic regression; *Reference level.

Table 5 Risk Factors Leading to Failure to Achieve Target LDL-C at Week 12

	Reference	Odds Ratio Estimate	95% CI for Odds Ratio	p-value^a
Sex	Male vs Female*	1.208	(0.63, 2.31)	0.5693
BMI (kg/m^2)	≥25 kg/m^2 vs <25 kg/m^2 *	1.550	(0.90, 2.67)	0.1146
Smoking	Former smoker vs Non-smoker*	1.274	(0.62, 2.62)	0.5103
	Current smoker vs Non-smoker*	0.745	(0.26, 2.13)	0.5824
LDL-C stage at baseline	Very high-risk group vs Low-risk group*	25.165	(1.44, >99.99)	0.0271
	High-risk group vs Low-risk group*	3.065	(0.15, 61.34)	0.4638
	Moderate-risk group vs Low-risk group*	0.653	(0.03, 15.05)	0.7900
Diabetes comorbidity	Yes vs No*	0.931	(0.53, 1.64)	0.8043
Renal disorder comorbidity	Yes vs No*	1.211	(0.50, 2.96)	0.6735
Prior hypertension and/or hyperlipidemia treatment	Monotherapy for hypertension treatment vs Naive*	0.448	(0.07, 2.80)	0.3904
	Monotherapy for hyperlipidemia treatment vs Naive*	1.399	(0.22, 8.93)	0.7228
	Combination vs Naive*	0.633	(0.12, 3.28)	0.5865

Notes: ^aMultiple logistic regression; *Reference level.

Table 6 Risk Factors Leading to Failure to Achieve Target Blood Pressure and LDL-C Simultaneously at Week 12

	Reference	Odds Ratio Estimate	95% CI for Odds Ratio	p-value^a
BMI (kg/m^2)	≥25 kg/m^2 vs <25 kg/m^2 *	2.024	(1.25, 3.28)	0.0042
Smoking	Former smoker vs Non-smoker*	1.443	(0.83, 2.52)	0.1967
	Current smoker vs Non-smoker*	1.214	(0.54, 2.71)	0.6362
Hypertension at baseline	Prehypertension vs Normal*	1.876	(0.96, 3.65)	0.0636
	Stage 1 vs Normal*	4.173	(1.95, 8.94)	0.0002
	Stage 2 vs Normal*	10.327	(3.47, 30.70)	<0.0001
LDL-C stage at baseline	Very high-risk group vs Low-risk group*	2.324	(0.65, 8.27)	0.1929
	High-risk group vs Low-risk group*	0.696	(0.18, 2.70)	0.6008
	Moderate-risk group vs Low-risk group*	0.621	(0.17, 2.22)	0.4640
Renal disorder comorbidity	Yes vs No*	1.106	(0.46, 2.68)	0.8228
Prior hypertension and/or hyperlipidemia treatment	Monotherapy for hypertension treatment vs Naive*	4.660	(1.23, 17.61)	0.0233
	Monotherapy for hyperlipidemia treatment vs Naive*	5.867	(1.34, 25.73)	0.0190
	Combination vs Naive*	5.504	(1.51, 20.07)	0.0098

Notes: ^aMultiple logistic regression; *Reference level.