Abstract
Background: Hypertension is a lifestyle disorder with a target blood pressure (BP) <140/90 mmHg. Amlodipine, a calcium channel blocker (CCB), is the first-line choice of treatment. This study aims to assess the effectiveness, tolerability, and treatment pattern of amlodipine or its combinations in patients with hypertension.
Methodology: This retrospective, electronic medical records (EMR)-based longitudinal study analyzed anonymized data of hypertensive patients with prescriptions for amlodipine or its combinations. The primary aim was to understand the usage patterns, while the secondary goals were to assess effectiveness and tolerability. Outcome measures included changes in mean systolic BP (SBP) and diastolic BP (DBP), and the incidence of pedal edema.
Results: Most of the participants were aged 40 to 64 years (65.47%) and were predominantly male (52.85%). Dyslipidemia and diabetes mellitus (DM) were the most common comorbidities. There was a statistically significant reduction in SBP and DBP from visit 1 to visit 2 with amlodipine or its combination therapies (p < 0.001), irrespective of any comorbid condition. Pedal edema occurred in 0.91% of patients, notably lower than the reported 1.7%-32%.
Conclusion: Amlodipine or its combinations demonstrated a significant reduction in BP with a very low incidence of pedal edema. Hence, amlodipine shows good tolerability and effectiveness in the Indian population.
Keywords: amlodipine, calcium channel blocker, electronic medical records, hypertension, pedal edema
Introduction
The European Society of Hypertension (ESH) 2018 guidelines define hypertension as the level of blood pressure (BP) at which the benefits of treatment (either with lifestyle interventions or drugs) unequivocally outweigh the risks of treatment, as documented by clinical trials [1]. The 2023 ESH guidelines recommend a threshold of >140/90 mmHg (grade 1) for diagnosing hypertension, whereas the American Heart Association (AHA) recommends a lower threshold of >130/80 mmHg (stage 1) [2].
The National Family Health Survey (NFHS)-5 reports the prevalence of hypertension in India to be 18.3% [3]. A recent systematic review reported that, during 2001-2022, only 22.5% of hypertensive patients in India had controlled BP [4]. Despite the rising prevalence and negative consequences of hypertension, awareness and control of hypertension remain poor in India. Long-term studies indicate that hypertensive patients need an average of three drugs for effective BP control, rather than monotherapy [5].
The India Hypertensive Control Initiative (IHCI) recommends amlodipine as the first-line treatment of hypertension, followed by telmisartan and a diuretic [6]. Amlodipine, a third-generation dihydropyridine calcium channel blocker (CCB), lowers peripheral vascular resistance by vasodilating smooth muscle cells. Its high oral bioavailability (60-80%), long half-life (35-50 hours), and lipophilic nature enhance patient compliance [7]. Amlodipine is primarily indicated to treat angina and hypertension [7]. Peripheral edema can occur with amlodipine use; however, administering it at bedtime and in lower doses (2.5 or 5 mg/day) can mitigate this side effect [8]. A review found that amlodipine had a neutral effect across various comorbid conditions in hypertension trials, whether used alone or with diuretics, angiotensin-converting enzyme inhibitors (ACEi), or angiotensin receptor blockers (ARB) [9]. This electronic medical records (EMR) study was planned to understand the usage, effectiveness, and tolerability of amlodipine and its combinations.
Materials and methods
Study design
This was a retrospective, EMR-based study that used anonymized data for the period January 2020 to May 2023. Patients diagnosed with primary hypertension of either gender, aged ≥18 years, prescribed amlodipine or its combinations with or without other antihypertensive agents, and who had a follow-up visit within 10-30 days of the baseline visit were included. Data from patients with hypertension due to secondary causes, such as pregnancy-induced hypertension, and those with incomplete data were excluded.
At the baseline visit (visit 1), the patient was prescribed amlodipine or its combinations with or without other antihypertensive agents. Data for age, gender, body mass index (BMI), comorbidities, systolic BP (SBP), and diastolic BP (DBP) were captured.
At the follow-up visit (10-30 days from baseline), the SBP and DBP values recorded were used to evaluate the change in BP. The complaints section of the EMR was reviewed to identify any adverse events.
The primary outcome measure was to understand the usage of amlodipine or its combinations, while the secondary outcomes were to assess effectiveness and tolerability.
The data were collected using a data collection form. Ethics committee (EC) approval was obtained from the Royal Pune Independent Ethics Committee on August 28, 2023 (IEC no.: RPIEC280823), and the study was registered on the Clinical Trials Registry of India (CTRI/2023/09/057949).
Statistical analysis
Continuous variables are summarized using descriptive statistics (sample size (n), mean, standard deviation (SD)). Categorical variables are presented as the number and percentage of patients. Unless otherwise mentioned, percentages were based on the number of patients from the population, as appropriate. All statistical tests were conducted at a two-sided 5% significance level. For paired continuous data, a paired t-test was used.
Results
From a total of 9,024,599 records in the EMR from 2020 to 2023, 2,178,366 adult (≥18 years) patients (26.6%) were hypertensive. Of these, 502,008 (23.0%) were prescribed amlodipine or its combinations, while only 10,194 patients (2.0%) had a follow-up within 10-30 days (Figure 1).
Figure 1. CONSORT diagram.
CONSORT: Consolidated Standards of Reporting Trials.
Baseline characteristics of patients prescribed amlodipine or its combinations
Of the 10,194 patients meeting the eligibility criteria, 6,675 (65.47%) were aged 40-64 years, and 2,431 (23.84%) were ≥65 years. The majority were male (n = 5,388, 52.85%). Dyslipidemia, DM, and dyslipidemia + DM were the most common comorbidities. Other comorbidities included CKD, CAD, dyslipidemia with CKD, dyslipidemia with CAD, DM with CKD, DM with CAD, CAD with CKD, dyslipidemia with DM and CKD, dyslipidemia with DM and CAD, dyslipidemia with CAD and CKD, DM with CAD and CKD, and dyslipidemia with DM, CAD, and CKD, each accounting for ≤10% of patients in the individual group (Table 1).
Table 1. Summary of demographic characteristics.
| Parameters | Overall | Amlodipine (n=2460) | Amlodipine+ telmisartan (n=2847) | Amlodipine+ atenolol (n=477) | Amlodipine+ bisoprolol (n=639) | Amlodipine+ metoprolol (n=1356) | Amlodipine+ chlorthalidone+ telmisartan (n=429) | Amlodipine+ hydrochlorothiazide+ telmisartan (n=1557) | Amlodipine+ hydrochlorothiazide+ olmesartan (n=429) | |
| Age, N (mean ±SD) | 18-39 | 1,088 (33.91±4.45) | 182 (32.9±4.9) | 264 (34.5±4.2) | 44 (34.6±3.9) | 91 (34.4±3.8) | 174 (33.5±4.6) | 28 (34.7±3.1) | 145 (34.6±3.8) | 36 (34.2±5.0) |
| 40-64 | 6,675 (52.96±6.86) | 1513 (52.9±6.9) | 1882 (53.0±6.8) | 316 (53.2±6.8) | 415 (52.8±6.8) | 894 (52.8±7.0) | 298 (52.9±6.9) | 1079 (53.1±6.9) | 278 (53.4±6.5) | |
| ≥ 65 | 2,431 (70.51±5.21) | 641 (70.9±5.5) | 701 (70.4±5.1) | 117 (70.6±5.7) | 133 (70.8±5.4) | 288 (70.6±4.8) | 103 (71.6±5.7) | 333 (69.8±4.7) | 115 (69.8±5.3) | |
| Gender, n (%) | Male | 5,388 (52.85) | 1334 (54.2) | 1505 (52.9) | 241 (50.5) | 345 (54.0) | 692 (51.0) | 233 (54.3) | 816 (52.4) | 222 (51.7) |
| Comorbities, n (%) | Dyslipidemia | - | 878 (35.69%) | 1051 (36.92%) | 160 (33.54%) | 285 (44.60%) | 550 (40.56%) | 166 (38.69%) | 572 (36.74%) | 179 (41.72%) |
| DM | - | 816 (33.17%) | 1306 (45.87%) | 199 (41.72%) | 222 (34.74%) | 472 (34.81%) | 183 (42.66%) | 691 (44.38%) | 197 (45.92%) | |
| CKD | - | 243 (9.88%) | 65 (2.28%) | 27 (5.66%) | 34 (5.32%) | 98 (7.23%) | 8 (1.86%) | 14 (0.90%) | 7 (1.63%) | |
| CAD | - | 185 (7.52%) | 165 (5.80%) | 39 (8.18%) | 68 (10.64%) | 104 (7.67%) | 25 (5.83%) | 87 (5.59%) | 30 (6.99%) | |
| Dyslipidemia+DM | - | 419 (17.03%) | 601 (21.11%) | 87 (18.24%) | 132 (20.66%) | 265 (19.54%) | 81 (18.88%) | 320 (20.55%) | 103 (24.01%) | |
| Dyslipidemia+CKD | - | 85 (3.46%) | 33 (1.16%) | 15 (3.14%) | 23 (3.60%) | 45 (3.32%) | 3 (0.70%) | 10 (0.64%) | 4 (0.93%) | |
| Dyslipidemia+CAD | - | 150 (6.10%) | 120 (4.21%) | 30 (6.29%) | 54 (8.45%) | 88 (6.49%) | 18 (4.20%) | 69 (4.43%) | 22 (5.13%) | |
| DM+CKD | - | 72 (2.93%) | 30 (1.05%) | 9 (1.89%) | 17 (2.66%) | 44 (3.24%) | 7 (1.63%) | 12 (0.77%) | 3 (0.70%) | |
| DM+CAD | - | 79 (3.21%) | 75 (2.63%) | 18 (3.77%) | 24 (3.76%) | 47 (3.47%) | 9 (2.10%) | 33 (2.12%) | 13 (3.03%) | |
| CAD+CKD | - | 22 (0.89%) | 7 (0.25%) | 2 (0.42%) | 7 (1.10%) | 10 (0.74%) | 1 (0.23%) | 3 (0.19%) | 1 (0.23%) | |
| Dyslipidemia+DM+CKD | - | 38 (1.54%) | 18 (0.63%) | 8 (1.68%) | 13 (2.03%) | 27 (1.99%) | 3 (0.70%) | 8 (0.51%) | 2 (0.47%) | |
| Dyslipidemia+DM+CAD | - | 66 (2.68%) | 57 (2.00%) | 16 (3.35%) | 21 (3.29%) | 43 (3.17%) | 7 (1.63%) | 29 (1.86%) | 11 (2.56%) | |
| Dyslipidemia+CAD+CKD | 17 (0.69%) | 5 (0.18%) | 2 (0.42%) | 5 (0.78%) | 8 (0.59%) | 2 (0.13%) | 1 (0.23%) | |||
| DM+CAD+CKD | 9 (0.37%) | 5 (0.18%) | 1 (0.21%) | 3 (0.47%) | 7 (0.52%) | 1 (0.23%) | 3 (0.19%) | |||
| Dyslipidemia + DM + CAD + CKD | 8 (0.33%) | 3 (0.11%) | 1 (0.21%) | 3 (0.47%) | 6 (0.44%) | 2 (0.13%) | ||||
Change in SBP and DBP from baseline to follow-up
There was a statistically significant reduction in SBP and DBP from visit 1 to visit 2 with amlodipine or its combination therapies (p < 0.001), irrespective of comorbid condition (Appendices).
In patients prescribed amlodipine, the mean ± SD reduction in SBP was 17.8 ± 19.6 mmHg, and in DBP was 9.5 ± 10.7 mmHg.
In patients prescribed amlodipine + telmisartan, the mean ± SD reduction in SBP was 21.6 ± 19.2 mmHg. In patients prescribed amlodipine and a β-blocker, the maximum mean reduction in SBP/DBP was observed with amlodipine + bisoprolol (23.6/12.8 mmHg), followed by amlodipine + atenolol (21.3/11.7 mmHg).
In the case of triple therapy, the maximum mean ± SD reduction in SBP was 25.2 ± 20.9 mmHg with amlodipine + chlorthalidone + telmisartan, followed by 24.9 ± 20.5 mmHg with amlodipine + hydrochlorothiazide + olmesartan. The highest mean ± SD reduction in DBP was 12.9 ± 11.1 mmHg with amlodipine + hydrochlorothiazide + olmesartan, followed by 12.7 ± 10.9 mmHg with amlodipine + chlorthalidone + telmisartan (Table 2).
Table 2. Change in SBP and DBP from baseline to follow-up.
DBP: diastolic blood pressure, SBP: systolic blood pressure, SD: standard deviation.
*Paired t-test was used to test if there is a significant change in means from baseline to follow-up visits.
| Parameters | SBP, mean ± SD | DBP, mean ± SD | ||||||||
| Visit 1 | Visit 2 | Change | T-value | P-value* | Visit 1 | Visit 2 | Change | T-value | P-value* | |
| Amlodipine (n=2460) | 158.6 ± 17.3 | 140.8 ± 16.2 | -17.8 ± 19.6 | 45.15 | <0.001 | 95.0 ± 8.4 | 85.4 ± 9.2 | -9.5 ± 10.7 | 44.37 | <0.001 |
| Amlodipine+ telmisartan (n=2847) | 161.0 ± 16.9 | 139.4 ± 16.6 | -21.6 ± 19.2 | 60.25 | <0.001 | 95.8 ± 8.3 | 84.4 ± 9.0 | -11.4 ± 10.2 | 59.55 | <0.001 |
| Amlodipine+ atenolol (n=477) | 159.5 ± 18.1 | 138.2 ± 17.2 | -21.3 ± 21.1 | 22.1 | <0.001 | 95.3 ± 8.7 | 83.6 ± 9.4 | -11.7 ± 11.5 | 22.36 | <0.001 |
| Amlodipine+ bisoprolol (n=639) | 161.6 ± 17.8 | 137.9 ± 16.1 | -23.6 ± 19.0 | 31.4 | <0.001 | 96.3 ± 8.7 | 83.4 ± 9.3 | -12.8 ± 10.5 | 31.04 | <0.001 |
| Amlodipine+ metoprolol (n=1356) | 160.6 ± 17.1 | 140.7 ± 16.8 | -19.8 ± 19.7 | 37.14 | <0.001 | 95.9 ± 8.7 | 85.5 ± 9.3 | -10.4 ± 10.6 | 35.84 | <0.001 |
| Amlodipine+ chlorthalidone+ telmisartan (n=429) | 163.0 ± 17.3 | 137.8 ± 16.0 | -25.2 ± 20.9 | 24.92 | <0.001 | 96.0 ± 8.6 | 83.2 ± 8.9 | -12.7 ± 10.9 | 24.22 | <0.001 |
| Amlodipine+ hydrochlorothiazide+ telmisartan (n=1557) | 163.2 ± 17.2 | 139.7 ± 16.8 | -23.4 ± 19.9 | 46.42 | <0.001 | 96.6 ± 9.1 | 84.6 ± 9.2 | -12.0 ± 10.6 | 44.48 | <0.001 |
| Amlodipine+ hydrochlorothiazide+ olmesartan (n=429) | 166.3 ± 17.4 | 141.4 ± 17.8 | -24.9 ± 20.5 | 25.2 | <0.001 | 98.0 ± 8.9 | 85.1 ± 9.4 | -12.9 ± 11.1 | 24.23 | <0.001 |
Proportion of patients with pedal edema at follow-up
Patients who presented with complaints of pedal edema at baseline were excluded from this analysis. Of the 10,106 patients considered for this analysis, only 31 (1.28%) of 2,430 patients on amlodipine reported pedal edema. Among patients on amlodipine dual therapy, 20 (0.71%) of 2,835 patients on amlodipine + telmisartan and 27 (1.10%) of 2,454 patients on amlodipine + β-blocker reported pedal edema. Of the 2,387 patients prescribed triple therapy (amlodipine + diuretic + ARB), 14 (5.86%) complained of pedal edema at follow-up (Table 3).
Table 3. Proportion of patients with pedal edema at follow-up.
Patients with pedal edema (n=88) at baseline visit are excluded from the analysis of the incidence of pedal edema.
CI: confidence interval.
| Parameter | Category | Overall (N = 10,106), n (%) | 95% CI for the proportion |
| Patients with pedal edema | Amlodipine (n=2,430) | 31 (1.28%) | (0.83; 1.72) |
| Amlodipine+Atenolol (n=476) | 8 (1.68%) | (0.53; 2.84) | |
| Amlodipine+Bisoprolol (n=638) | 4 (0.63%) | (0.01; 1.24) | |
| Amlodipine+Chlorthalidone+Telmisartan (n=424) | 3 (0.71%) | (-0.09; 1.51) | |
| Amlodipine+Hydrochlorothiazide+Olmesartan (n=425) | 3 (0.71%) | (-0.09; 1.5) | |
| Amlodipine+Hydrochlorothiazide+Telmisartan (n=1538) | 8 (0.52%) | (0.16; 0.88) | |
| Amlodipine+Metoprolol (n=1340) | 15 (1.12%) | (0.56; 1.68) | |
| Amlodipine+Telmisartan (n=2835) | 20 (0.71%) | (0.4; 1.01) |
Discussion
In this study, most hypertensive patients were >40 years, indicating a potential association between the prevalence of hypertension and increasing age [10]. More than 70% of patients were overweight and obese, presenting obesity as one of the major risk factors for hypertension [11]. The most common comorbidities were dyslipidemia and DM, consistent with existing literature [12].
A recent study published by IHCI concluded that simple treatment plans can effectively control BP in a large-scale real-world scenario. It recommends starting with one low-cost medication and, if necessary, adding or switching to another antihypertensive based on availability [13]. In alignment with this, our results highlight that amlodipine and its combinations were effective in controlling BP.
Amlodipine monotherapy significantly reduced SBP and DBP. A meta-analysis that included 85 studies reported a 12 mmHg decrease in SBP with amlodipine compared to placebo. Additionally, patients with DM experienced a mean reduction of SBP of 19.1 mmHg, closely aligning with the current study’s finding of 17.8 mmHg reduction [14]. Randomized, double-blind, placebo-controlled studies have demonstrated the efficacy of amlodipine as monotherapy and in combination with other antihypertensive agents such as ARBs, diuretics, and ACEi. These studies suggested that amlodipine is a safe and effective first-line antihypertensive agent [7,15].
A real-world evidence (RWE) study on 24-hour ambulatory blood pressure (ABP) control reported that factors such as daily amlodipine regimen, gender, hypertension severity, and therapy duration did not significantly impact ABP changes in patients receiving either amlodipine monotherapy or combination therapy for essential hypertension. This showed that, irrespective of these factors, amlodipine is effective in all patients [7]. Evidence suggests that increasing the dose of monotherapy decreases coronary events and cerebrovascular events by 29% and 40%, whereas combining antihypertensive drugs with different mechanisms reduces coronary events and cerebrovascular events by 40% and 54%, respectively [5]. Various guidelines have recommended multidrug treatment for managing hypertension, which has led to the incorporation of FDCs. These combinations offer several advantages, including enhanced efficacy, better adherence, and cost-effectiveness [16]. The ACCOMPLISH trial demonstrated these advantages, where more than 70% of patients on FDC achieved BP <140/90 mmHg [17].
Amlodipine + bisoprolol reduced SBP at visit 2 by 23.6 mmHg. This result is supported by a randomized, multicenter, comparative clinical trial where patients who failed on monotherapy with amlodipine or bisoprolol were administered amlodipine + bisoprolol, leading to a reduction in SBP by 25.3 mmHg [18]. The mean change in SBP/DBP in this study with amlodipine + metoprolol was 19.9/10.4 mmHg. Almost similar results were observed in a study where SBP/DBP reduction was 22.88/13.98 mmHg with amlodipine + metoprolol [19]. In our study, 46.47% of patients on dual therapy were given a β-blocker, though IHCI recommends it only for those with heart attack.
With amlodipine + chlorthalidone + telmisartan, a reduction in SBP of 25.2 mmHg at visit 2 was observed in this study. This is comparable to a phase 3 trial where patients on amlodipine + chlorthalidone + telmisartan showed a 19.1 mmHg reduction in SBP after 8 weeks of treatment [20]. The mean change in SBP/DBP in this study with amlodipine + hydrochlorothiazide + olmesartan was −24.9/−12.9 mmHg at visit 2. Similar mean changes of −17.8/−9.3 mmHg within 4 weeks were observed in a real-world study in patients treated with amlodipine + hydrochlorothiazide + olmesartan [21]. Additionally, amlodipine + hydrochlorothiazide + telmisartan reduced SBP by 23.5 mmHg, similar to an 18.7 mmHg reduction observed in another phase 3 trial [22].
Amlodipine is generally associated with vasodilatory effects and pedal edema, which may lead to its discontinuation. Since this is a dose-dependent effect, low-dose combinations or combinations with ARBs or diuretics can reduce edema, as ARBs can counteract the circulatory changes that cause edema [23]. Although the literature suggests an incidence rate between 1.7% and 32% for pedal edema with CCBs and their combinations, this study found a lower incidence of 0.91% [24,25]. This is supported by another EMR-based RWE study, which showed better tolerability for amlodipine with fewer cases of pedal edema [26]. The lower incidence observed in this study could also be attributed to the action of diuretics.
Amlodipine effectively manages hypertension while reducing major cardiovascular events such as hospitalizations, atherosclerotic changes, transient ischemic attacks, strokes, and non-fatal myocardial infarctions [17]. Unlike other CCBs, amlodipine enhances nitric oxide (NO) production in heart failure. Its antioxidant and anti-inflammatory effects confer a vasoprotective benefit [8]. The IHCI protocol recommends starting amlodipine at 5 mg and increasing to 10 mg if BP remains uncontrolled [6]. In addition to its efficacy in enhancing cardiovascular health and reducing major cardiovascular outcomes, amlodipine is also a cost-effective choice for managing hypertension and is more affordable than many other antihypertensive agents [27,28].
A few limitations of this retrospective real-world study include inconsistent follow-up durations, the presence of missing data, and limited control over patient characteristics and other variables. The absence of a comparison group limits attribution of effect size solely to the intervention. Furthermore, BP reduction was the only primary endpoint considered; clinical outcomes such as cardiovascular events were not assessed.
Conclusions
This study concludes that amlodipine and its combination therapies were associated with a marked reduction in SBP and DBP in patients with hypertension, including those with comorbid conditions such as diabetes mellitus, dyslipidemia, CKD, and CAD. Combination therapies, particularly triple therapy of amlodipine, a diuretic, and an ARB, were associated with the greatest BP reduction, suggesting that the antihypertensive effects are enhanced when agents with complementary mechanisms of action are used. The overall incidence of pedal edema was low, particularly with combination therapies. Amlodipine, being one of the most affordable antihypertensives available, could be considered as an option in various non-communicable disease programs; however, this warrants further validation through controlled trials and cost-benefit analysis studies. Further studies with control over demographics and other variables would be helpful to strengthen the current observations.
Acknowledgments
Authors are thankful to Innvocept Global Solutions for the medical writing support and Ms. Bhaswati Mukherjee from Musigmadelta for the statistical analysis and advice.
Appendices
Table 4. Change in SBP and DBP from baseline to follow-up by comorbidities .
Supplementary Table 1
Comb. 1: Amlodipine+Telmisartan, Comb. 2: Amlodipine+Atenolol, Comb. 3: Amlodipine+Bisoprolol, Comb. 4: Amlodipine+Metoprolol, Comb. 5: Amlodipine+Chlorthalidone+Telmisartan,Comb. 6: Amlodipine+Hydrochlorothiazide+Telmisartan, Comb. 7: Amlodipine+hydrochlorothiazide+Olmesartan.
SBP: systolic blood pressure, DBP: diastolic blood pressure, DM: diabetes mellitus, CAD: coronary artery disease, CKD: chronic kidney disease.
| Comorbidity | Visit | Statistics (N=10,194) | Amlodipine | Comb. 1 | Comb. 2 | Comb. 3 | Comb. 4 | Comb. 5 | Comb. 6 | Comb. 7 |
| Dyslipidemia | Visit 1 SBP | n | 878 | 1051 | 160 | 285 | 550 | 166 | 572 | 179 |
| Mean(SD) | 158.4(17.3) | 159.8(16.5) | 158.9(18.8) | 160.8(18.3) | 159.7(17.2) | 162.3(16.2) | 162.6(16.1) | 166.3(17.4) | ||
| Median | 160.0 | 160.0 | 160.0 | 160.0 | 160.0 | 160.0 | 160.0 | 165.0 | ||
| Min, Max | 122,200 | 121,200 | 125,200 | 124,200 | 121,200 | 121,200 | 121,200 | 121,200 | ||
| Visit 2 SBP | Mean(SD) | 140.7(15.8) | 138.3(15.9) | 139.0(17.8) | 139.0(16.9) | 140.4(17.0) | 139.6(16.7) | 139.3(17.0) | 142.8(17.5) | |
| Median | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | ||
| Min, Max | 100,194 | 70,200 | 100,180 | 101,200 | 90,200 | 93,190 | 94,200 | 108,200 | ||
| Change from Baseline (SBP) | Mean(SD) | -17.8(19.6) | -21.6(18.5) | -19.9(21.4) | -21.8(19.3) | -19.3(20.6) | -22.7(21.5) | -23.3(19.4) | -23.5(21.0) | |
| Median | -18.0 | -20.0 | -20.0 | -20.0 | -20.0 | -23.0 | -20.0 | -20.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | ||
| Dyslipidemia | Visit 1 DBP | n | 878 | 1051 | 160 | 285 | 550 | 166 | 572 | 179 |
| Mean(SD) | 93.9(7.7) | 94.8(8.4) | 94.8(8.4) | 94.9(8.0) | 94.3(7.9) | 94.9(8.2) | 95.6(8.9) | 97.4(9.0) | ||
| Median | 90.0 | 90.0 | 90.0 | 90.0 | 90.0 | 90.0 | 93.0 | 98.0 | ||
| Min, Max | 81,130 | 81,150 | 81,128 | 81,120 | 81,140 | 81,130 | 81,150 | 81,120 | ||
| Visit 2 DBP | Mean(SD) | 84.3(8.8) | 83.3(8.9) | 83.8(9.1) | 83.3(9.4) | 84.4(8.9) | 83.4(8.8) | 83.6(9.1) | 85.1(9.7) | |
| Median | 82.5 | 80.0 | 80.0 | 80.0 | 83.5 | 80.0 | 80.0 | 81.0 | ||
| Min, Max | 60,140 | 60,140 | 60,106 | 60,120 | 60,140 | 62,120 | 60,130 | 60,120 | ||
| Change from Baseline (DBP) | Mean(SD) | -9.6(10.3) | -11.4(10.3) | -11.0(11.2) | -11.7(10.3) | -9.9(10.3) | -11.5(10.2) | -12.0(10.4) | -12.3(10.9) | |
| Median | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | ||
| DM | Visit 1 SBP | n | 816 | 1306 | 199 | 222 | 472 | 183 | 691 | 197 |
| Mean(SD) | 159.6(17.6) | 160.5(16.6) | 159.7(18.5) | 162.8(17.8) | 161.2(17.4) | 162.3(16.8) | 162.9(17.3) | 167.3(17.6) | ||
| Median | 160.0 | 160.0 | 160.0 | 160.0 | 160.0 | 160.0 | 160.0 | 170.0 | ||
| Min, Max | 122,200 | 121,200 | 122,200 | 124,200 | 121,200 | 126,200 | 121,200 | 121,200 | ||
| Visit 2 SBP | Mean(SD) | 141.5(17.2) | 140.5(16.8) | 141.4(16.0) | 140.7(17.6) | 142.6(17.1) | 139.3(15.7) | 140.7(17.0) | 142.6(18.2) | |
| Median | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | ||
| Min, Max | 94,200 | 70,200 | 100,184 | 101,200 | 90,200 | 107,180 | 96,200 | 100,200 | ||
| Change from Baseline (SBP) | Mean(SD) | -18.1(20.0) | -20.0(19.2) | -18.4(20.5) | -22.1(19.4) | -18.6(20.9) | -23.0(21.1) | -22.1(19.8) | -24.6(20.1) | |
| Median | -20.0 | -20.0 | -20.0 | -20.0 | -20.0 | -20.0 | -20.0 | -24.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | ||
| DM | Visit 1 DBP | Mean(SD) | 93.8(7.9) | 94.9(7.9) | 94.0(8.2) | 94.3(6.9) | 94.4(8.2) | 94.9(7.7) | 95.2(8.4) | 96.9(8.3) |
| Median | 90.0 | 92.0 | 90.0 | 90.0 | 90.0 | 90.0 | 92.0 | 98.0 | ||
| Min, Max | 81,137 | 81,150 | 81,128 | 82,120 | 81,140 | 82,120 | 81,138 | 81,120 | ||
| Visit 2 DBP | Mean(SD) | 84.3(8.8) | 83.9(8.7) | 83.4(9.1) | 83.2(9.5) | 84.7(9.2) | 82.9(8.7) | 84.2(8.9) | 85.4(9.1) | |
| Median | 83.0 | 80.0 | 80.0 | 80.0 | 84.0 | 80.0 | 82.0 | 84.0 | ||
| Min, Max | 60,116 | 60,140 | 60,110 | 60,115 | 60,130 | 60,120 | 60,122 | 60,116 | ||
| Change from Baseline (DBP) | n | 816 | 1306 | 199 | 222 | 472 | 183 | 691 | 197 | |
| Mean(SD) | -9.4(10.1) | -11.0(10.0) | -10.6(10.5) | -11.1(10.2) | -9.6(10.5) | -12.0(9.1) | -11.1(10.6) | -11.5(10.9) | ||
| Median | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | ||
| CAD | Visit 1 SBP | n | 185 | 165 | 39 | 68 | 104 | 25 | 87 | 30 |
| Mean(SD) | 161.3(17.9) | 162.4(16.2) | 160.8(21.6) | 163.4(19.1) | 163.0(15.2) | 164.9(10.2) | 164.7(15.8) | 168.7(19.0) | ||
| Median | 160.0 | 160.0 | 160.0 | 161.0 | 160.0 | 170.0 | 165.0 | 170.0 | ||
| Min, Max | 122,200 | 126,200 | 126,200 | 130,200 | 128,200 | 147,180 | 126,200 | 126,200 | ||
| Visit 2 SBP | Mean(SD) | 142.5(17.1) | 139.6(15.7) | 138.4(20.5) | 139.9(17.3) | 141.1(17.8) | 139.6(16.3) | 139.5(17.2) | 145.9(15.3) | |
| Median | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 141.5 | ||
| Min, Max | 94,194 | 110,190 | 100,180 | 90,180 | 100,200 | 113,180 | 96,190 | 120,190 | ||
| Change from Baseline (SBP) | Mean(SD) | -18.8(21.7) | -22.8(19.9) | -22.4(26.2) | -23.5(21.0) | -21.9(20.7) | -25.3(17.8) | -25.2(21.6) | -22.8(23.8) | |
| Median | -18.0 | -20.0 | -20.0 | -22.5 | -20.0 | -20.0 | -24.0 | -20.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | ||
| CAD | Visit 1 DBP | n | 185 | 165 | 39 | 68 | 104 | 25 | 87 | 30 |
| Mean(SD) | 94.9(8.3) | 95.1(8.2) | 97.0(10.7) | 95.5(7.9) | 94.3(7.3) | 95.0(9.0) | 94.8(7.9) | 97.1(9.6) | ||
| Median | 90.0 | 91.0 | 94.0 | 92.5 | 90.0 | 90.0 | 92.0 | 98.0 | ||
| Min, Max | 81,120 | 82,135 | 82,130 | 83,120 | 81,120 | 82,120 | 82,120 | 83,120 | ||
| Visit 2 DBP | Mean(SD) | 84.9(9.6) | 83.0(7.7) | 84.1(8.4) | 84.0(9.9) | 82.9(8.9) | 82.7(9.6) | 83.1(8.7) | 86.8(12.1) | |
| Median | 83.0 | 80.0 | 81.0 | 80.5 | 80.0 | 80.0 | 80.0 | 86.5 | ||
| Min, Max | 60,140 | 68,103 | 60,104 | 65,115 | 68,130 | 62,110 | 60,110 | 69,120 | ||
| Change from Baseline (DBP) | Mean(SD) | -10.1(10.9) | -12.1(9.7) | -12.9(11.1) | -11.4(10.7) | -11.3(10.0) | -12.3(9.5) | -11.8(10.3) | -10.2(10.8) | |
| Median | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | ||
| CKD | Visit 1 SBP | n | 243 | 65 | 27 | 34 | 98 | 8 | 14 | 7 |
| Mean(SD) | 165.2(18.3) | 162.9(16.8) | 161.3(21.7) | 161.8(18.0) | 165.0(18.7) | 157.6(10.5) | 164.5(18.9) | 169.0(15.5) | ||
| Median | 166.0 | 160.0 | 160.0 | 160.0 | 161.5 | 157.5 | 160.0 | 166.0 | ||
| Min, Max | 122,200 | 130,200 | 125,194 | 135,200 | 128,200 | 140,178 | 140,200 | 150,197 | ||
| Visit 2 SBP | Mean(SD) | 145.0(17.7) | 142.8(16.9) | 140.1(20.2) | 142.7(20.0) | 147.9(21.5) | 134.0(29.7) | 146.7(14.2) | 139.1(22.9) | |
| Median | 140.0 | 140.0 | 140.0 | 140.0 | 146.5 | 127.5 | 140.0 | 143.0 | ||
| Min, Max | 100,200 | 100,180 | 100,180 | 120,200 | 90,200 | 94,180 | 120,170 | 110,170 | ||
| Change from Baseline (SBP) | Mean(SD) | -20.2(22.1) | -20.1(21.5) | -21.1(21.9) | -19.1(18.8) | -17.1(24.7) | -23.6(34.9) | -17.8(22.9) | -29.9(22.0) | |
| Median | -20.0 | -19.0 | -20.0 | -16.5 | -19.0 | -35.0 | -19.5 | -37.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.0972 | 0.0123 | 0.0116 | ||
| CKD | Visit 1 DBP | n | 243 | 65 | 27 | 34 | 98 | 8 | 14 | 7 |
| Mean(SD) | 96.8(10.2) | 94.9(8.6) | 92.3(6.9) | 96.9(10.4) | 93.3(7.6) | 98.9(8.7) | 94.6(7.5) | 100.1(7.8) | ||
| Median | 94.0 | 90.0 | 90.0 | 90.0 | 90.0 | 98.0 | 90.0 | 100.0 | ||
| Min, Max | 83,144 | 81,113 | 83,110 | 84,120 | 82,120 | 90,110 | 90,110 | 90,110 | ||
| Visit 2 DBP | Mean(SD) | 85.3(10.6) | 83.4(8.4) | 79.0(11.3) | 82.8(9.2) | 84.0(10.0) | 81.5(15.6) | 86.8(11.4) | 81.7(14.7) | |
| Median | 84.0 | 80.0 | 80.0 | 80.0 | 80.0 | 80.0 | 82.5 | 75.0 | ||
| Min, Max | 60,130 | 68,110 | 60,100 | 64,100 | 60,115 | 60,100 | 70,110 | 65,100 | ||
| Median | -10.0 | -10.0 | -16.0 | -10.0 | -10.0 | -12.5 | -10.0 | -20.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.0038 | 0.0762 | 0.0109 | ||
| Dyslipidemia+DM | Visit 1 SBP | n | 419 | 601 | 87 | 132 | 265 | 81 | 320 | 103 |
| Mean(SD) | 159.3(17.5) | 160.6(16.2) | 159.0(18.6) | 163.0(18.0) | 160.8(17.2) | 162.5(16.6) | 162.6(16.4) | 168.2(17.1) | ||
| Median | 160.0 | 160.0 | 160.0 | 161.5 | 160.0 | 160.0 | 160.0 | 170.0 | ||
| Min, Max | 122,200 | 121,200 | 125,200 | 130,200 | 121,200 | 127,200 | 121,200 | 121,200 | ||
| Visit 2 SBP | Mean(SD) | 140.1(16.0) | 139.4(15.8) | 141.3(15.9) | 142.5(18.5) | 142.1(17.4) | 142.4(15.9) | 140.8(16.9) | 143.0(17.8) | |
| Median | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | 140.0 | ||
| Min, Max | 103,191 | 70,200 | 108,180 | 101,200 | 90,200 | 112,180 | 96,192 | 110,200 | ||
| Change from Baseline (SBP) | Mean(SD) | -19.2(20.2) | -21.2(18.3) | -17.7(19.5) | -20.5(19.3) | -18.8(21.8) | -20.1(22.1) | -21.8(18.9) | -25.1(20.6) | |
| Median | -20.0 | -20.0 | -20.0 | -20.0 | -20.0 | -20.0 | -20.0 | -24.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | ||
| Dyslipidemia+DM | Visit 1 DBP | n | 419 | 601 | 87 | 132 | 265 | 81 | 320 | 103 |
| Mean(SD) | 92.9(7.3) | 94.2(8.0) | 94.2(8.5) | 93.8(6.9) | 93.4(7.9) | 94.1(7.0) | 94.7(8.3) | 96.4(8.6) | ||
| Median | 90.0 | 90.0 | 90.0 | 90.0 | 90.0 | 90.0 | 90.0 | 95.0 | ||
| Min, Max | 82,124 | 81,150 | 81,128 | 82,120 | 81,140 | 83,110 | 81,138 | 81,120 | ||
| Visit 2 DBP | Mean(SD) | 83.3(8.2) | 83.0(8.5) | 83.8(9.3) | 83.9(10.1) | 84.0(8.7) | 82.7(8.7) | 83.6(8.6) | 85.2(9.0) | |
| Median | 80.0 | 80.0 | 80.0 | 84.0 | 82.0 | 80.0 | 81.0 | 82.0 | ||
| Min, Max | 60,110 | 60,140 | 60,106 | 60,115 | 60,130 | 65,120 | 60,117 | 60,110 | ||
| Change from Baseline (DBP) | Mean(SD) | -9.6(9.9) | -11.2(9.9) | -10.4(11.1) | -9.9(11.0) | -9.4(10.1) | -11.4(9.4) | -11.1(10.1) | -11.2(11.0) | |
| Median | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | ||
| Dyslipidemia+CAD | Visit 1 SBP | n | 150 | 120 | 30 | 54 | 88 | 18 | 69 | 22 |
| Mean(SD) | 160.9(18.0) | 162.1(15.6) | 160.6(21.5) | 165.3(18.8) | 162.8(15.0) | 163.5(10.2) | 165.7(15.9) | 169.0(17.8) | ||
| Median | 160.0 | 160.0 | 160.0 | 165.5 | 160.0 | 168.0 | 166.0 | 172.0 | ||
| Min, Max | 122,200 | 126,200 | 126,200 | 130,200 | 128,200 | 147,180 | 126,200 | 126,190 | ||
| Visit 2 SBP | Mean(SD) | 142.8(16.5) | 139.5(16.3) | 139.8(18.7) | 142.1(16.6) | 140.6(17.7) | 137.5(14.7) | 138.1(17.8) | 146.2(16.2) | |
| Median | 140.0 | 137.0 | 140.0 | 140.0 | 140.0 | 138.0 | 138.0 | 141.5 | ||
| Min, Max | 110,194 | 110,190 | 110,180 | 110,180 | 100,200 | 113,170 | 96,190 | 120,190 | ||
| Change from Baseline (SBP) | Mean(SD) | -18.2(22.5) | -22.6(18.9) | -20.8(24.8) | -23.2(21.8) | -22.2(21.4) | -26.0(18.1) | -27.6(21.7) | -22.9(24.9) | |
| Median | -15.0 | -20.0 | -20.0 | -22.5 | -20.0 | -20.5 | -28.0 | -25.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.0003 | ||
| Dyslipidemia+CAD | Visit 1 DBP | n | 150 | 120 | 30 | 54 | 88 | 18 | 69 | 22 |
| Mean(SD) | 94.8(8.3) | 94.8(8.6) | 95.1(8.5) | 95.4(7.4) | 94.0(7.5) | 94.3(9.6) | 94.2(7.8) | 97.8(10.2) | ||
| Median | 90.0 | 90.5 | 91.0 | 92.5 | 90.0 | 90.0 | 90.0 | 100.0 | ||
| Min, Max | 82,120 | 82,135 | 82,110 | 83,116 | 81,120 | 82,120 | 82,120 | 83,120 | ||
| Visit 2 DBP | Mean(SD) | 85.3(9.8) | 82.7(7.7) | 83.6(8.0) | 84.5(10.0) | 82.8(9.1) | 80.4(8.4) | 81.6(8.5) | 87.7(13.1) | |
| Median | 84.0 | 80.0 | 80.0 | 81.5 | 80.0 | 80.0 | 80.0 | 88.0 | ||
| Min, Max | 60,140 | 70,103 | 60,104 | 65,115 | 68,130 | 62,90 | 60,110 | 69,120 | ||
| Change from Baseline (DBP) | Mean(SD) | -9.5(11.0) | -12.2(9.6) | -11.5(9.9) | -10.9(11.1) | -11.2(10.5) | -13.9(8.0) | -12.7(10.7) | -10.1(10.6) | |
| Median | -10.0 | -10.0 | -10.0 | -10.0 | -10.0 | -14.0 | -10.0 | -10.0 | ||
| P value | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | <0.001 | 0.0002 | ||
| Dyslipidemia+CKD | Visit 1 SBP | n | 85 | 33 | 15 | 23 | 45 | 3 | 10 | 4 |
| Mean(SD) | 165.5(18.2) | 161.1(15.4) | 165.5(22.6) | 164.0(17.9) | 161.9(17.0) | 157.7(19.1) | 165.3(17.5) | 166.5(12.5) | ||
| Median | 167.0 | 160.0 | 160.0 | 160.0 | 163.0 | 155.0 | 160.0 | 168.0 | ||
| Min, Max | 122,200 | 130,198 | 126,190 | 140,200 | 128,190 | 140,178 | 140,200 | 150,180 | ||
| Visit 2 SBP | Mean(SD) | 144.7(17.0) | 139.9(15.9) | 145.8(19.9) | 145.0(22.6) | 145.8(22.2) | 141.7(24.7) | 142.4(11.9) | 133.5(16.2) | |
| Median | 140.0 | 140.0 | 145.0 | 140.0 | 142.0 | 130.0 | 140.0 | 135.0 | ||
| Min, Max | 110,181 | 100,175 | 100,180 | 120,200 | 90,200 | 125,170 | 120,160 | 114,150 | ||
| Change from Baseline (SBP) | Mean(SD) | -20.8(21.3) | -21.2(21.7) | -19.7(26.7) | -19.0(17.5) | -16.1(25.2) | -16.0(40.8) | -22.9(17.1) | -33.0(22.8) | |
| Median | -20.0 | -20.0 | -20.0 | -17.0 | -14.0 | -30.0 | -20.0 | -40.0 | ||
| P value | <0.001 | <0.001 | 0.0127 | <0.001 | <0.001 | 0.5674 | 0.0022 | 0.0631 | ||
| Dyslipidemia+CKD | Visit 1 DBP | n | 85 | 33 | 15 | 23 | 45 | 3 | 10 | 4 |
| Mean(SD) | 94.9(8.3) | 94.7(9.4) | 92.6(7.6) | 96.5(10.4) | 92.5(7.8) | 103.3(11.5) | 94.4(6.9) | 101.0(8.4) | ||
| Median | 90.0 | 90.0 | 90.0 | 90.0 | 90.0 | 110.0 | 90.0 | 102.0 | ||
| Min, Max | 83,116 | 81,113 | 84,110 | 84,120 | 82,120 | 90,110 | 90,110 | 90,110 | ||
| Visit 2 DBP | Mean(SD) | 83.1(9.0) | 82.8(8.4) | 80.7(13.1) | 82.5(9.6) | 83.4(9.4) | 86.7(18.9) | 81.5(5.8) | 75.5(10.5) | |
| Median | 80.0 | 80.0 | 80.0 | 80.0 | 80.0 | 95.0 | 80.0 | 73.5 | ||
| Min, Max | 67,110 | 70,110 | 60,100 | 69,100 | 60,103 | 65,100 | 70,90 | 65,90 | ||
| Change from Baseline (DBP) | Mean(SD) | -11.8(10.9) | -11.9(10.0) | -11.9(16.9) | -14.0(9.8) | -9.1(10.6) | -16.7(7.6) | -12.9(10.3) | -25.5(11.7) | |
| Median | -10.0 | -11.0 | -9.0 | -10.0 | -8.0 | -15.0 | -10.0 | -27.0 | ||
| P value | <0.001 | <0.001 | 0.0164 | <0.001 | <0.001 | 0.0634 | 0.0033 | 0.0222 | ||
| DM+CAD | Visit 1 SBP | n | 79 | 75 | 18 | 24 | 47 | 9 | 33 | 13 |
| Mean(SD) | 162.0(18.6) | 161.6(15.6) | 160.5(21.2) | 169.3(17.8) | 164.2(15.2) | 158.2(8.1) | 166.0(16.9) | 169.8(17.1) | ||
| Median | 162.0 | 160.0 | 160.0 | 169.0 | 160.0 | 159.0 | 165.0 | 174.0 | ||
| Min, Max | 122,200 | 130,200 | 130,200 | 138,200 | 140,200 | 150,171 | 136,200 | 135,190 | ||
| Visit 2 SBP | Mean(SD) | 142.9(18.8) | 141.4(15.7) | 144.9(14.1) | 146.7(19.4) | 143.2(20.4) | 131.2(11.4) | 144.5(18.1) | 143.9(12.4) | |
| Median | 142.0 | 140.0 | 143.0 | 150.0 | 137.0 | 136.0 | 140.0 | 140.0 | ||
| Min, Max | 94,192 | 110,180 | 120,170 | 110,180 | 120,200 | 113,150 | 110,190 | 120,166 | ||
| Change from Baseline (SBP) | Mean(SD) | -19.1(23.4) | -20.2(18.8) | -15.6(22.6) | -22.6(21.8) | -21.0(24.4) | -27.0(18.4) | -21.5(19.2) | -25.9(21.9) | |
| Median | -18.0 | -19.0 | -17.0 | -26.5 | -22.0 | -20.0 | -20.0 | -20.0 | ||
| P value | <0.001 | <0.001 | 0.0094 | <0.001 | <0.001 | 0.0023 | <0.001 | 0.0011 | ||
| DM+CAD | Visit 1 DBP | n | 79 | 75 | 18 | 24 | 47 | 9 | 33 | 13 |
| Mean(SD) | 93.2(7.5) | 95.9(8.8) | 95.0(9.8) | 96.2(8.3) | 93.0(6.9) | 90.3(2.9) | 93.2(7.2) | 94.0(6.3) | ||
| Median | 90.0 | 96.0 | 91.0 | 94.0 | 90.0 | 90.0 | 90.0 | 94.0 | ||
| Min, Max | 81,118 | 82,135 | 82,110 | 84,116 | 82,116 | 87,96 | 82,110 | 83,100 | ||
| Visit 2 DBP | Mean(SD) | 83.9(7.8) | 83.4(7.5) | 85.3(6.4) | 85.8(12.5) | 84.2(10.2) | 77.3(6.4) | 83.4(8.5) | 86.4(8.6) | |
| Median | 82.0 | 80.0 | 85.0 | 86.0 | 80.0 | 76.0 | 81.0 | 88.0 | ||
| Min, Max | 60,102 | 70,103 | 74,99 | 65,115 | 70,130 | 70,90 | 66,110 | 69,100 | ||
| Change from Baseline (DBP) | Mean(SD) | -9.3(9.0) | -12.5(8.3) | -9.7(8.3) | -10.4(14.9) | -8.7(8.5) | -13.0(5.3) | -9.8(9.7) | -7.6(6.5) | |
| Median | -10.0 | -11.0 | -10.0 | -10.0 | -10.0 | -13.0 | -10.0 | -10.0 | ||
| P value | <0.001 | <0.001 | 0.0001 | 0.0023 | <0.001 | <0.001 | <0.001 | 0.0011 | ||
| DM+CKD | Visit 1 SBP | n | 72 | 30 | 9 | 17 | 44 | 7 | 12 | 3 |
| Mean(SD) | 165.2(17.6) | 162.5(15.9) | 167.4(18.5) | 166.2(17.0) | 162.5(16.7) | 157.3(11.3) | 161.9(17.3) | 165.3(5.0) | ||
| Median | 170.0 | 168.5 | 170.0 | 160.0 | 160.0 | 155.0 | 156.5 | 166.0 | ||
| Min, Max | 122,200 | 130,198 | 136,190 | 140,200 | 128,200 | 140,178 | 140,200 | 160,170 | ||
| Visit 2 SBP | Mean(SD) | 147.3(18.3) | 144.9(16.4) | 149.0(12.9) | 151.1(22.7) | 148.6(22.6) | 139.7(26.9) | 147.8(15.1) | 133.7(23.7) | |
| Median | 146.5 | 140.0 | 145.0 | 147.0 | 148.0 | 130.0 | 145.0 | 127.0 | ||
| Min, Max | 110,196 | 108,180 | 134,170 | 120,200 | 90,200 | 107,180 | 120,170 | 114,160 | ||
| Change from Baseline (SBP) | Mean(SD) | -17.9(22.2) | -17.6(20.7) | -18.4(26.2) | -15.1(13.1) | -13.8(25.8) | -17.6(32.9) | -14.1(21.1) | -31.7(27.8) | |
| Median | -20.0 | -20.0 | -20.0 | -15.0 | -10.0 | -30.0 | -14.5 | -43.0 | ||
| P value | <0.001 | <0.001 | 0.0679 | 0.0002 | 0.0009 | 0.2069 | 0.0409 | 0.1871 | ||
| DM+CKD | Visit 1 DBP | n | 72 | 30 | 9 | 17 | 44 | 7 | 12 | 3 |
| Mean(SD) | 93.5(7.8) | 94.1(8.5) | 91.6(6.0) | 95.0(9.9) | 90.5(6.1) | 98.7(9.4) | 94.5(7.8) | 98.0(7.2) | ||
| Median | 90.0 | 90.0 | 90.0 | 90.0 | 90.0 | 96.0 | 90.0 | 100.0 | ||
| Min, Max | 83,115 | 82,110 | 84,100 | 86,120 | 82,110 | 90,110 | 90,110 | 90,104 | ||
| Visit 2 DBP | Mean(SD) | 83.8(8.5) | 82.1(8.3) | 82.1(12.4) | 84.1(8.6) | 82.3(9.2) | 84.6(14.0) | 87.5(12.2) | 80.0(18.0) | |
| Median | 80.5 | 80.0 | 80.0 | 80.0 | 80.0 | 80.0 | 85.0 | 75.0 | ||
| Min, Max | 69,110 | 69,100 | 65,100 | 69,100 | 60,100 | 65,100 | 70,110 | 65,100 | ||
| Change from Baseline (DBP) | Mean(SD) | -9.8(9.6) | -12.0(11.6) | -9.4(16.1) | -10.9(8.3) | -8.3(10.3) | -14.1(7.6) | -7.0(16.3) | -18.0(15.7) | |
| Median | -10.0 | -10.0 | -4.0 | -10.0 | -8.0 | -10.0 | -10.0 | -25.0 | ||
| P value | <0.001 | <0.001 | 0.1159 | <0.001 | <0.001 | 0.0027 | 0.1640 | 0.1857 | ||
| CKD+CAD | Visit 1 SBP | n | 22 | 7 | 2 | 7 | 10 | 1 | 3 | 1 |
| Mean(SD) | 160.8(17.9) | 154.6(13.2) | 131.0(7.1) | 167.6(18.8) | 165.9(11.9) | 160.0(.) | 186.7(11.5) | 180.0(.) | ||
| Median | 160.0 | 150.0 | 131.0 | 180.0 | 170.0 | 160.0 | 180.0 | 180.0 | ||
| Min, Max | 122,190 | 140,171 | 126,136 | 140,187 | 150,190 | 160,160 | 180,200 | 180,180 | ||
| Visit 2 SBP | Mean(SD) | 141.5(18.3) | 140.9(21.3) | 146.5(33.2) | 146.4(18.8) | 145.7(30.5) | 120.0(.) | 156.7(5.8) | 143.0(.) | |
| Median | 140.0 | 130.0 | 146.5 | 140.0 | 145.0 | 120.0 | 160.0 | 143.0 | ||
| Min, Max | 120,172 | 120,180 | 123,170 | 120,178 | 100,200 | 120,120 | 150,160 | 143,143 | ||
| Change from Baseline (SBP) | Mean(SD) | -19.3(24.2) | -13.7(28.8) | 15.5(26.2) | -21.1(23.9) | -20.2(33.6) | -40.0(.) | -30.0(17.3) | -37.0(.) | |
| Median | -20.0 | -20.0 | 15.5 | -11.0 | -25.0 | -40.0 | -20.0 | -37.0 | ||
| P value | 0.0012 | 0.2552 | 0.5560 | 0.0576 | 0.0899 | 0.0955 | ||||
| CKD+CAD | Visit 1 DBP | n | 22 | 7 | 2 | 7 | 10 | 1 | 3 | 1 |
| Mean(SD) | 94.7(7.3) | 91.7(8.5) | 94.5(14.8) | 98.1(10.9) | 90.1(4.0) | 90.0(.) | 96.7(11.5) | 110.0(.) | ||
| Median | 90.0 | 90.0 | 94.5 | 91.0 | 90.0 | 90.0 | 90.0 | 110.0 | ||
| Min, Max | 86,110 | 83,110 | 84,105 | 90,116 | 84,100 | 90,90 | 90,110 | 110,110 | ||
| Visit 2 DBP | Mean(SD) | 81.7(7.6) | 84.3(9.8) | 82.5(3.5) | 81.0(3.7) | 80.8(7.5) | 80.0(.) | 86.7(5.8) | 72.0(.) | |
| Median | 80.0 | 80.0 | 82.5 | 80.0 | 80.0 | 80.0 | 90.0 | 72.0 | ||
| Min, Max | 70,100 | 70,100 | 80,85 | 77,89 | 68,90 | 80,80 | 80,90 | 72,72 | ||
| Change from Baseline (DBP) | Mean(SD) | -13.0(9.7) | -7.4(10.9) | -12.0(11.3) | -17.1(8.6) | -9.3(10.2) | -10.0(.) | -10.0(10.0) | -38.0(.) | |
| Median | -10.0 | -8.0 | -12.0 | -14.0 | -9.0 | -10.0 | -10.0 | -38.0 | ||
| P value | <0.001 | 0.1203 | 0.3743 | 0.0019 | 0.0184 | 0.2254 | ||||
| Dyslipidemia+DM+CAD | Visit 1 SBP | n | 66 | 57 | 16 | 21 | 43 | 7 | 29 | 11 |
| Mean(SD) | 160.9(17.9) | 162.1(13.6) | 161.2(22.4) | 172.9(15.9) | 163.2(14.9) | 158.9(8.9) | 166.5(15.6) | 168.7(18.2) | ||
| Median | 162.0 | 162.0 | 160.0 | 170.0 | 160.0 | 159.0 | 168.0 | 174.0 | ||
| Min, Max | 122,200 | 130,190 | 130,200 | 140,200 | 140,200 | 150,171 | 139,200 | 135,190 | ||
| Visit 2 SBP | Mean(SD) | 142.8(17.6) | 139.9(15.6) | 145.2(14.9) | 150.5(17.4) | 142.6(20.0) | 132.1(12.1) | 144.4(19.3) | 141.4(11.2) | |
| Median | 141.0 | 137.0 | 143.5 | 150.0 | 137.0 | 136.0 | 140.0 | 140.0 | ||
| Min, Max | 110,180 | 110,180 | 120,170 | 110,180 | 120,200 | 113,150 | 110,190 | 120,160 | ||
| Change from Baseline (SBP) | Mean(SD) | -18.1(24.0) | -22.2(16.6) | -16.0(24.0) | -22.4(23.3) | -20.6(24.5) | -26.7(20.1) | -22.0(18.8) | -27.4(23.6) | |
| Median | -13.0 | -20.0 | -20.0 | -26.0 | -22.0 | -20.0 | -20.0 | -30.0 | ||
| P value | <0.001 | <0.001 | 0.0175 | 0.0003 | <0.001 | 0.0126 | <0.001 | 0.0032 | ||
| Dyslipidemia+DM+CAD | Visit 1 DBP | n | 66 | 57 | 16 | 21 | 43 | 7 | 29 | 11 |
| Mean(SD) | 93.1(6.9) | 95.5(9.0) | 93.8(9.5) | 97.6(7.8) | 92.7(7.0) | 89.6(2.3) | 92.6(6.7) | 94.0(6.3) | ||
| Median | 90.0 | 96.0 | 90.0 | 96.0 | 90.0 | 90.0 | 90.0 | 94.0 | ||
| Min, Max | 82,110 | 83,135 | 82,110 | 90,116 | 82,116 | 87,94 | 82,110 | 83,100 | ||
| Visit 2 DBP | Mean(SD) | 83.8(7.8) | 82.9(7.8) | 84.9(6.7) | 87.0(12.8) | 84.1(10.5) | 75.1(4.6) | 83.1(8.9) | 85.9(9.3) | |
| Median | 82.5 | 80.0 | 82.0 | 89.0 | 80.0 | 75.0 | 80.0 | 86.0 | ||
| Min, Max | 60,100 | 70,103 | 74,99 | 65,115 | 70,130 | 70,82 | 66,110 | 69,100 | ||
| Change from Baseline (DBP) | Mean(SD) | -9.3(9.0) | -12.6(8.5) | -8.8(8.3) | -10.6(15.6) | -8.5(8.6) | -14.4(5.0) | -9.5(10.1) | -8.1(6.6) | |
| Median | -10.0 | -11.0 | -9.0 | -10.0 | -10.0 | -16.0 | -10.0 | -10.0 | ||
| P value | <0.001 | <0.001 | 0.0007 | 0.0054 | <0.001 | 0.0003 | <0.001 | 0.0023 | ||
| Dyslipidemia+DM+CKD | Visit 1 SBP | n | 38 | 18 | 8 | 13 | 27 | 3 | 8 | 2 |
| Mean(SD) | 164.7(18.7) | 161.4(16.6) | 166.6(19.6) | 170.4(16.8) | 158.1(14.6) | 157.7(19.1) | 161.6(14.3) | 168.0(2.8) | ||
| Median | 170.0 | 166.0 | 165.0 | 166.0 | 157.0 | 155.0 | 160.0 | 168.0 | ||
| Min, Max | 122,200 | 130,198 | 136,190 | 146,200 | 128,190 | 140,178 | 140,180 | 166,170 | ||
| Visit 2 SBP | Mean(SD) | 144.0(16.0) | 143.4(13.5) | 150.9(12.4) | 157.2(22.1) | 146.6(23.4) | 141.7(24.7) | 143.0(13.4) | 120.5(9.2) | |
| Median | 141.0 | 140.0 | 147.5 | 160.0 | 140.0 | 130.0 | 140.0 | 120.5 | ||
| Min, Max | 120,180 | 125,175 | 140,170 | 122,200 | 90,200 | 125,170 | 120,160 | 114,127 | ||
| Change from Baseline (SBP) | Mean(SD) | -20.7(23.0) | -18.0(18.9) | -15.8(26.7) | -13.2(13.0) | -11.5(25.8) | -16.0(40.8) | -18.6(12.5) | -47.5(6.4) | |
| Median | -20.0 | -20.0 | -15.0 | -10.0 | -10.0 | -30.0 | -19.5 | -47.5 | ||
| P value | <0.001 | 0.0008 | 0.1388 | 0.0034 | 0.0292 | 0.5674 | 0.0039 | 0.0601 | ||
| Dyslipidemia+DM+CKD | Visit 1 DBP | n | 38 | 18 | 8 | 13 | 27 | 3 | 8 | 2 |
| Mean(SD) | 93.2(8.2) | 93.2(8.7) | 91.0(6.1) | 96.5(11.0) | 89.0(4.5) | 103.3(11.5) | 94.3(7.3) | 97.0(9.9) | ||
| Median | 90.0 | 90.0 | 90.0 | 91.0 | 90.0 | 110.0 | 90.0 | 97.0 | ||
| Min, Max | 83,110 | 83,110 | 84,100 | 86,120 | 82,105 | 90,110 | 90,110 | 90,104 | ||
| Visit 2 DBP | Mean(SD) | 82.7(8.1) | 81.4(7.3) | 82.4(13.2) | 84.6(9.6) | 81.4(8.9) | 86.7(18.9) | 81.3(6.4) | 70.0(7.1) | |
| Median | 80.0 | 80.0 | 80.0 | 80.0 | 80.0 | 95.0 | 80.0 | 70.0 | ||
| Min, Max | 69,110 | 70,100 | 65,100 | 69,100 | 60,100 | 65,100 | 70,90 | 65,75 | ||
| Change from Baseline (DBP) | Mean(SD) | -10.5(10.4) | -11.7(11.5) | -8.6(17.0) | -11.9(9.0) | -7.7(10.3) | -16.7(7.6) | -13.0(11.6) | -27.0(2.8) | |
| Median | -10.0 | -13.5 | -4.0 | -10.0 | -7.0 | -15.0 | -10.0 | -27.0 | ||
| P value | <0.001 | 0.0005 | 0.1939 | 0.0004 | 0.0007 | 0.0634 | 0.0158 | 0.0471 | ||
| Dyslipidemia+CAD+CKD | Visit 1 SBP | n | 17 | 5 | 2 | 5 | 8 | 2 | 1 | |
| Mean(SD) | 159.4(18.0) | 160.4(10.5) | 131.0(7.1) | 170.6(17.1) | 162.4(9.1) | 180.0(0.0) | 180.0(.) | |||
| Median | 160.0 | 162.0 | 131.0 | 180.0 | 166.5 | 180.0 | 180.0 | |||
| Min, Max | 122,190 | 149,171 | 126,136 | 146,187 | 150,170 | 180,180 | 180,180 | |||
| Visit 2 SBP | Mean(SD) | 141.1(19.5) | 137.2(13.0) | 146.5(33.2) | 149.0(22.4) | 139.6(31.4) | 160.0(0.0) | 143.0(.) | ||
| Median | 140.0 | 130.0 | 146.5 | 152.0 | 132.0 | 160.0 | 143.0 | |||
| Min, Max | 120,172 | 130,160 | 123,170 | 120,178 | 100,200 | 160,160 | 143,143 | |||
| Change from Baseline (SBP) | Mean(SD) | -18.4(25.6) | -23.2(20.1) | 15.5(26.2) | -21.6(25.6) | -22.8(37.2) | -20.0(0.0) | -37.0(.) | ||
| Median | -20.0 | -32.0 | 15.5 | -11.0 | -30.0 | -20.0 | -37.0 | |||
| P value | 0.0093 | 0.0614 | 0.5560 | 0.1320 | 0.1277 | <0.001 | ||||
| Dyslipidemia+CAD+CKD | Visit 1 DBP | n | 17 | 5 | 2 | 5 | 8 | 2 | 1 | |
| Mean(SD) | 94.5(7.9) | 92.4(10.3) | 94.5(14.8) | 95.4(11.5) | 90.1(4.5) | 90.0(0.0) | 110.0(.) | |||
| Median | 90.0 | 90.0 | 94.5 | 90.0 | 90.0 | 90.0 | 110.0 | |||
| Min, Max | 86,110 | 83,110 | 84,105 | 90,116 | 84,100 | 90,90 | 110,110 | |||
| Visit 2 DBP | Mean(SD) | 82.6(7.6) | 86.0(8.9) | 82.5(3.5) | 81.4(4.5) | 79.8(7.7) | 85.0(7.1) | 72.0(.) | ||
| Median | 80.0 | 80.0 | 82.5 | 80.0 | 80.0 | 85.0 | 72.0 | |||
| Min, Max | 70,100 | 80,100 | 80,85 | 77,89 | 68,90 | 80,90 | 72,72 | |||
| Change from Baseline (DBP) | Mean(SD) | -11.9(9.0) | -6.4(11.1) | -12.0(11.3) | -14.0(7.5) | -10.4(11.0) | -5.0(7.1) | -38.0(.) | ||
| Median | -10.0 | -8.0 | -12.0 | -10.0 | -9.0 | -5.0 | -38.0 | |||
| P value | <0.001 | 0.2653 | 0.3743 | 0.0141 | 0.0322 | 0.5000 | ||||
| DM+CAD+CKD | Visit 1 SBP | n | 9 | 5 | 1 | 3 | 7 | 1 | 3 | |
| Mean(SD) | 160.1(23.6) | 150.0(12.7) | 136.0(.) | 175.7(14.0) | 161.3(9.3) | 160.0(.) | 186.7(11.5) | |||
| Median | 170.0 | 149.0 | 136.0 | 180.0 | 163.0 | 160.0 | 180.0 | |||
| Min, Max | 122,189 | 140,171 | 136,136 | 160,187 | 150,170 | 160,160 | 180,200 | |||
| Visit 2 SBP | Mean(SD) | 144.8(21.3) | 145.2(24.4) | 170.0(.) | 163.3(13.3) | 149.6(30.4) | 120.0(.) | 156.7(5.8) | ||
| Median | 147.0 | 136.0 | 170.0 | 160.0 | 150.0 | 120.0 | 160.0 | |||
| Min, Max | 120,172 | 120,180 | 170,170 | 152,178 | 120,200 | 120,120 | 150,160 | |||
| Change from Baseline (SBP) | Mean(SD) | -15.3(32.3) | -4.8(29.9) | 34.0(.) | -12.3(19.7) | -11.7(34.4) | -40.0(.) | -30.0(17.3) | ||
| Median | -10.0 | -19.0 | 34.0 | -2.0 | -6.0 | -40.0 | -20.0 | |||
| P value | 0.1918 | 0.7376 | 0.3907 | 0.4021 | 0.0955 | |||||
| DM+CAD+CKD | Visit 1 DBP | n | 9 | 5 | 1 | 3 | 7 | 1 | 3 | |
| Mean(SD) | 91.4(5.1) | 88.8(3.3) | 84.0(.) | 99.0(14.7) | 88.7(2.2) | 90.0(.) | 96.7(11.5) | |||
| Median | 90.0 | 90.0 | 84.0 | 91.0 | 90.0 | 90.0 | 90.0 | |||
| Min, Max | 86,100 | 83,91 | 84,84 | 90,116 | 84,90 | 90,90 | 90,110 | |||
| Visit 2 DB | Mean(SD) | 80.9(5.3) | 84.0(11.4) | 80.0(.) | 82.0(6.2) | 82.9(7.2) | 80.0(.) | 86.7(5.8) | ||
| Median | 80.0 | 80.0 | 80.0 | 80.0 | 82.0 | 80.0 | 90.0 | |||
| Min, Max | 70,90 | 70,100 | 80,80 | 77,89 | 70,90 | 80,80 | 80,90 | |||
| Change from Baseline (DBP) | Mean(SD) | -10.6(7.9) | -4.8(11.3) | -4.0(.) | -17.0(8.9) | -5.9(7.6) | -10.0(.) | -10.0(10.0) | ||
| Median | -10.0 | -3.0 | -4.0 | -14.0 | -4.0 | -10.0 | -10.0 | |||
| P value | 0.0039 | 0.3977 | 0.0803 | 0.0870 | 0.2254 |
Disclosures
Human subjects: Informed consent for treatment and open access publication was obtained or waived by all participants in this study. Royal Pune Independent Ethics Committee issued approval IEC no.: RPIEC280823.
Animal subjects: All authors have confirmed that this study did not involve animal subjects or tissue.
Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following:
Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work.
Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work.
Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work.
Author Contributions
Concept and design: Rohit Kumar, Sunil Lhila, Arindam Pande , Arti Sanghavi, Sagar Katare , Jay Shah, Swathi Bhureddy
Acquisition, analysis, or interpretation of data: Rohit Kumar, Arti Sanghavi, Sagar Katare , Jay Shah, Snehal Shah, Garima Verma
Drafting of the manuscript: Rohit Kumar, Arti Sanghavi, Sagar Katare , Snehal Shah, Garima Verma
Critical review of the manuscript for important intellectual content: Rohit Kumar, Sunil Lhila, Arindam Pande , Arti Sanghavi, Sagar Katare , Jay Shah, Snehal Shah, Garima Verma, Swathi Bhureddy
Supervision: Rohit Kumar, Sunil Lhila, Arindam Pande , Arti Sanghavi, Sagar Katare , Jay Shah, Snehal Shah, Garima Verma, Swathi Bhureddy
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