Amlodipine Monotherapy Research Articles

Phase III randomized clinical trial of efficacy and safety of amlodipine and candesartan cilexetil combination for hypertension treatment

Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone.

P147 EFFICACY AND SAFETY OF SACUBITRIL/VALSARTAN VERSUS AMLODIPINE IN JAPANESE PATIENTS WITH ESSENTIAL HYPERTENSION: A RANDOMIZED, OPEN-LABEL, MULTICENTER STUDY (PARASOL STUDY)

Background and Objective: Sacubitril/valsartan, an angiotensin receptor-neprilysin inhibitor, is shown to be superior to renin-angiotensin system inhibitors in terms of blood pressure (BP) lowering effect in several clinical trials. However, there is limited evidence on the BP-lowering effect of sacubitril/valsartan in comparison with amlodipine, a widely used calcium channel blocker (CCB), and potent BP-lowering effect. This study is to investigate the efficacy and safety of sacubitril/valsartan monotherapy compared with amlodipine monotherapy in Japanese patients with essential hypertension. (jRCTs051220165) Methods: This was a multicenter, randomized, open-label, parallel-group, and active-controlled study conducted in Japan. Male or female Japanese patients aged 18 to 79 with either treated or untreated mild to moderate essential hypertension were eligible for this study and randomly assigned to the sacubitril/valsartan 200 mg group or amlodipine 5 mg group. Each study drugs were administered once daily for eight weeks. The primary endpoint was to demonstrate the non-inferiority of sacubitril/valsartan versus amlodipine in mean change from baseline for 24-h systolic blood pressure (SBP) after eight weeks of treatment. Results: A total of 359 patients were randomized in this study (sacubitril/valsartan group n=182, amlodipine group n=177; mean age was 58.3 and 58.1 years, 75.3% and 74.0% were male, baseline BPs were described in Table). At week 8, mean reductions from baseline for mean 24-h SBP in sacubitril/valsartan were non-inferior to that in amlodipine (between-treatment difference: −0.6 mmHg [95% CI: −3.2 to 2.0; P=0.003 for non-inferiority, independent t-test]). In addition, other BP parameters in sacubitril/valsartan were comparable to those in amlodipine (Table). For the investigator-reported adverse events, seven hypotension-related events (3.8%) were observed in sacubitril/valsartan and three events (1.7%) in amlodipine. Conclusions: In Japanese patients with essential hypertension, the BP-lowering effect of sacubitril/valsartan was non-inferior to that of amlodipine, and no marked differences in tolerability were observed. Early initiation of sacubitril/valsartan in hypertensive patients is expected to achieve good BP control, similar to the widely used CCB.

Observing the uncertainty of the Amlodipine-Candesartan Incremental Cost-Effectiveness ratio using Deterministic Sensitivity Analysis (DSA)

Background: Hypertension treatment is carried out for a long time and can cause quite large costs. This study delves into the economic evaluation of Amlodipine-Candesartan combination therapy, a prominent treatment for hypertension. While the clinical benefits of this regimen are well-documented, its cost-effectiveness remains a critical consideration for healthcare systems. Employing Deterministic Sensitivity Analysis (DSA). This study aimed to discern the uncertainty surrounding the Incremental Cost-Effectiveness Ratio (ICER) associated with Amlodipine-Candesartan through comprehensive examination, next to refine economic assessments and offer insights for healthcare policymakers and practitioners. Method: This retrospective descriptive study at Andalas University Hospital in 2021 analyzed hypertension outpatient data. Of 284 patients, 73 were included. Among them, 28.77% received Amlodipine monotherapy, while 71.23% received Amlodipine-Candesartan combination therapy. Results: The ICER for systolic blood pressure was Rp. 74,738.10 per mmHg decrease, and for diastolic blood pressure, it was Rp. 205,918.24 per mmHg decrease. Both of them are in the northeast quadrant. Next, DSA will be carried out by creating a tornado diagram by providing a change range of 20% (min-max) for the input variables in ICER. Conclusion: The use of amlodipine-candesartan requires a higher cost, but the resulting effect is also better. Our findings contribute to the broader discourse on combination therapies and inform resource allocation strategies for hypertension management. This research attempts to enhance the precision of economic evaluations, ultimately facilitating more informed and efficient healthcare decision-making processes. Keywords: Amlodipine, Candesartan, Cost-effectiveness, ICER, DSA.

A Real-World Study on the Short-Term Efficacy of Amlodipine in Treating Hypertension Among Inpatients.

Hospitalized hypertensive patients rely on blood pressure medication, yet there is limited research on the sole use of amlodipine, despite its proven efficacy in protecting target organs and reducing mortality. This study aims to identify key indicators influencing the efficacy of amlodipine, thereby enhancing treatment outcomes. In this multicenter retrospective study, 870 hospitalized patients with primary hypertension exclusively received amlodipine for the first 5 days after admission, and their medical records contained comprehensive blood pressure records. They were categorized into success (n=479) and failure (n=391) groups based on average blood pressure control efficacy. Predictive models were constructed using six machine learning algorithms. Evaluation metrics encompassed the area under the curve (AUC), accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). SHapley Additive exPlanations (SHAP) analysis assessed feature contributions to efficacy. All six machine learning models demonstrated superior predictive performance. Following variable reduction, the model predicting amlodipine efficacy was reconstructed using these algorithms, with the light gradient boosting machine (LightGBM) model achieving the highest overall performance (AUC = 0.803). Notably, amlodipine showed enhanced efficacy in patients with low platelet distribution width (PDW) values, as well as high hematocrit (HCT) and thrombin time (TT) values. This study utilized machine learning to predict amlodipine's effectiveness in hypertension treatment, pinpointing key factors: HCT, PDW, and TT levels. Lower PDW, along with higher HCT and TT, correlated with enhanced treatment outcomes. This facilitates personalized treatment, particularly for hospitalized hypertensive patients undergoing amlodipine monotherapy.

Clinical outcome in hypertensive patients treated with amlodipine plus bisoprolol or plus valsartan

Objective Several guidelines do not recommend beta-blocker as the first-line treatment for hypertension because of its inferior efficacy in stroke prevention. Combination therapy with beta-blocker is commonly used for blood pressure control. We compared the clinical outcomes in patients treated with amlodipine plus bisoprolol (A + B), a ß1-selective beta-blocker and amlodipine plus valsartan (A + V). Methods A population-based cohort study was performed using data from the Taiwan National Health Insurance Research Database. From 2012 to 2019, newly diagnosed adult hypertensive patients who received initial amlodipine monotherapy and then switched to A + V or A + B were included. The efficacy outcomes included all-cause death, atherosclerotic cardiovascular disease (ASCVD) event (cardiovascular death, myocardial infarction, ischemic stroke, and coronary revascularization), hemorrhagic stroke, and heart failure. Multivariable Cox proportional hazards model was used to evaluate the relationship between outcomes and different treatments. Results Overall, 4311 patients in A + B group and 10980 patients in A + V group were included. After a mean follow-up of 4.34 ± 1.79 years, the efficacy outcomes were similar between the A + V and A + B groups regarding all-cause death (adjusted hazard ratio [aHR] 0.99, 95% confidence interval [CI] 0.83–1.18), ASCVD event (aHR 0.97, 95% CI 0.84–1.12), and heart failure (aHR 1.06, 95% CI 0.87–1.30). The risk of hemorrhagic stroke was lower in A + B group (aHR 0.70, 95% CI 0.52–0.94). The result was similar when taking death into consideration in competing risk analysis. The safety outcomes were similar between the 2 groups. Conclusions There was no difference of all-cause death, ASCVD event, and heart failure in A + B vs. A + V users. But A + B users had a lower risk of hemorrhagic stroke.

Description Of Antihypertensive Drugs Use In Hypertensive Outpatients With Diabetes Mellitus At Panembahan Senopati Bantul Hospital

Hypertension (HT) is still a health problem in the world, including in Indonesia. Hypertension in patients with type 2 diabetes mellitus (T2DM) will have an impact on worsening conditions and multi-complications, including macrovascular, microvascular, and insulin resistance complications. This can be prevented by providing appropriate and rational therapy so that the effectiveness of therapy is achieved and avoid worsening conditions and complications. This study aims to determine the pattern of antihypertensive drug use in HT patients with comorbid T2DM in the outpatient installation of Panembahan Senopati Hospital, Bantul for the period of August 2023. The study was designed with a descriptive non-experimental method, cross-sectional with a retrospective approach. The source of research data is secondary data derived from medical records of HT patients with T2DM for the period of August 2023 with data collection by purposive sampling. A total of 157 HT patients met the inclusion criteria in this study with the prevalence of women (n = 106; 67.50%) and men (n = 51; 32.50%), most ages in the 55-65 year range (n = 57; 36.30%). A total of 66 patients (42.10%) received monotherapy, while 91 (57.90) patients received polytherapy. Candesartan (n=80; 27.68%) and Amlodipine (n=78; 26.99%) monotherapy with oral administration were the most common treatment options in this study. Overall, the most widely used drug classes were Angiotensin Receptor Blockers (ARB) (41.18%), Calcium Channel Blockers (CCB) (32.5%), and Diuretics (14.1%). While the most common combination of drug groups is ARB + CCB (24.8%). This study concluded that the use of drugs mainly was polytherapy and in general the use of antihypertensive drugs consisted of 7 classes of drugs namely Angiotensin Receptor Blockers, Calcium Channel Blockers, Diuretics, ẞ- blockers, Centrally-acting Agents, ACE-Inhibitors, Vasodilators

SYNERGIA-MOROCCO: EFFECTIVENESS OF HYPERTENSION MANAGEMENT WITH AN AMLODIPINE AND PERINDOPRIL ARGININE-BASED STRATEGY IN MOROCCO: STUDY DESIGN AND PRELIMINARY DATA

Objective: In Morocco, 1 in 3 adults currently live with hypertension; over 70%1 are not aware or not effectively treated. Among treated hypertensive patients, many receive monotherapy and remain uncontrolled. WHO recommends the addition of an angiotensin-converting enzyme inhibitor/angiotensin-receptor blocker or a diuretic in patients who are uncontrolled on a calcium-channel blocker and a monthly follow-up after initiation until patients reach targets. However, there is limited evidence from real-world observational studies in Morocco on the effectiveness of this approach on blood pressure control. This study aims to evaluate the effectiveness of an amlodipine and perindopril arginine-based strategy for 90 days in hypertensive patients previously uncontrolled on monotherapy of amlodipine. Design and method: This is a multicenter prospective observational study. Eighty (80) primary care physicians across Morocco will recruit about 1 600 uncontrolled hypertensive adult patients who start perindopril-arginine on top of previous amlodipine monotherapy. During the study, physicians will be free to adapt treatment per their judgement, including dose adaptations, the addition of a third drug or the use of a single pill combination (SPC) as a substitute for the free combination of amlodipine/perindopril at the same dose when patients become controlled. The primary outcome will be the change in sitting office blood pressure between baseline and day 90. Secondary outcomes will include; the change in the blood pressure between baseline and the initiation of the SPC and between the initiation of the SPC and the end of the study, and the difference in the proportion of participants with side effects between the free combination and SPC. Results: The first patient was enrolled in the study on October 30, 2023. On January 10, 2024, 1 400 patients were recruited, and 760 had the 30-day follow-up visit. Conclusions: In Morocco, hypertension is a significant public health issue but current treatment optimisation strategies lack evidence from real-world data. The recruitments started as planned, and this will be the first real-world study from Morocco on the short-term effectiveness of treating hypertension with an amlodipine and perindopril arginine-based combination strategy on blood pressure control.

Efficacy of fosinopril and amlodipine in pediatric primary hypertension: a single-center observational study.

Fosinopril and amlodipine are commonly prescribed as first-line pharmacotherapeutic agents for pediatric hypertension, but there is a lack of comparative studies regarding the efficacy of these two drugs. We aimed to evaluate and compare the efficacy of fosinopril and amlodipine monotherapy in pediatric primary hypertension. This was a single-center, bidirectional observational study. A total of 175 children and adolescents with primary hypertension receiving antihypertensive monotherapy from July 2020 to February 2023 were enrolled. According to antihypertensive drugs, they were divided into the fosinopril group (n = 96) and the amlodipine group (n = 79). Subgroup analysis was performed to compare the efficacy of the two groups in terms of blood pressure (BP) control rates and reductions following a 4-week treatment. After 4 weeks of treatment, both groups achieved significant reductions in systolic BP (SBP) and diastolic BP (DBP) by more than 18 mmHg and 6 mmHg, respectively, with BP control rates of 61.5% in the fosinopril group and 59.5% in the amlodipine group, revealing no significant differences in the antihypertensive efficacy between the two groups except for DBP control rate (FDR adjusted P > 0.05). Further subsequent subgroup analyses revealed that the reductions in SBP and DBP in the fosinopril group were significantly greater than those in the amlodipine group in patients of females and hypo-HDL-cholesterolemia (FDR adjusted P < 0.05), and there was a trend of difference, although not significant, in patients with central obesity and insulin resistance (IR) (FDR adjusted 0.05 < P ≤ 0.1). However, there were no significant differences in treatment efficacy in patients without these characteristics. Furthermore, hypertriglyceridemia did not exhibit a significant association with the difference in treatment efficacy between the two medications (FDR adjusted P > 0.05). Fosinopril and amlodipine monotherapy were both effective in pediatric primary hypertension during a short-term follow-up. Fosinopril may be particularly effective in reducing BP in hypertensive patients of females, central obesity, IR, and hypo-HDL-cholesterolemia. These findings indicate that optimizing antihypertensive medication selection based on the individualized characteristics of children with hypertension may improve the efficacy of antihypertensive treatment.

Efficacy of the calcium channel blocker amlodipine in the treatment of salt-sensitive hypertension in patients with different genetic status

Aim. To study the effectiveness of the calcium channel blocker amlodipine in the treatment of salt-sensitive hypertension (HTN) and compare it with the genotypes of patients.Material and methods. The study involved 96 patients aged 42,7±5,2 years. There were following inclusion criteria: diagnosis — grade 1, stage 1 hypertension with low risk of cardiovascular events (CVEs). Before inclusion in the study, patients had not taken regular antihypertensive therapy for 3 months. Next, all patients underwent assessment of salt sensitivity of blood pressure according to the M. H. Weinberger method and, based on it, the participants were divided into salt-sensitive and salt-resistant. Regardless of the result, all patients were recommended to have a low-salt diet of 3-5 g/day, with subsequent 24-hour ambulatory blood pressure monitoring (ABPM) during the diet. In patients with ineffective diet, amlodipine was prescribed on day 26 at a dose of 2,5-5 mg once a day. The effectiveness of the drug was assessed by repeated ABPM. In addition, a genetic study was performed on 4 polymorphic variants of the genes AGT (T704C), AGT (C521T), AGTR1 (A1166C), AGTR2 (G1675A), ADD1 (G1378T), CYP11B2 (C344T), GNB3 (C825T), NOS3 (T786C), NOS3 (G894T), to determine their association with the effectiveness of a low-salt diet and amplodipine therapy.Results. In patients with grade 1, stage 1 hypertension with low risk of CVEs, the effectiveness of a low-salt diet and amlodipine monotherapy at a dose of 2,55 mg/day was revealed. The results of the study were confirmed by achieving target values of office blood pressure and ABPM. In hypertensive patients not sensitive to salt, amlodipine monotherapy was ineffective. The genotyping revealed a relationship between antihypertensive therapy with amlodipine in salt-sensitive patients and carriage of the GG polymorphism of the AGTR2 gene.Conclusion. The effectiveness of amlodipine and a low-salt diet in salt-sensitive patients with grade 1 hypertension, stage 1, low risk of CVEs with carriage of the GG genotype of the AGTR2 gene.

Efficacy and safety of bisoprolol 5 mg plus amlodipine 5 mg in patients with hypertension uncontrolled on monotherapy with 5 mg of amlodipine, a phase III multicenter, randomized, double-blind, placebo-controlled clinical trial – the AMCOR study

Objective To evaluate the antihypertensive effect and safety of bisoprolol 5 mg (BISO5mg) and amlodipine 5 mg (AMLO5mg) combination in comparison to AMLO5mg in hypertensive subjects uncontrolled with AMLO5mg. Methods Phase III, prospective, randomized, double-blind, placebo-controlled, 8-week trial with parallel design (EudraCT Number: 2019-000751-13). Results 367 patients aged 57.58 ± 14.62 years were randomized to BISO5mg once daily on top of AMLO5mg (n = 181) or placebo on top of AMLO5mg (n = 186). Systolic/diastolic blood pressure (SBP/DBP) in the bisoprolol-treated group was reduced by 7.2 ± 12.74/3.95 ± 8.85 mmHg at 4 weeks (both p < .0001) and by 5.5 ± 12.44/3.84 ± 9.46 mmHg at 8 weeks (p < .0001/p < .0002) compared to placebo control. Bisoprolol-treated group had lower heart rate than placebo control (difference −7.23 ± 9.84/−6.25 ± 9.26 beats per minute at 4 and 8 weeks, respectively, both p < .0001). Both target SBP and DBP was achieved at 4 weeks by 62 vs. 41% (p = .0002) and at 8 weeks by 65 vs. 46% (p = .0004) of bisoprolol-treated patients and placebo group patients, respectively. SBP <140 mmHg was achieved at 4 and 8 weeks in 68 and 69% of bisoprolol-treated patients and 45 and 50% of placebo group patients, respectively. No deaths and serious adverse events were reported. Adverse events occurred in 34 bisoprolol-treated patients vs. 22 patients in the placebo group (p = .064). Bisoprolol was withdrawn due to adverse events in 7 patients, mostly (n = 4) due to asymptomatic bradycardia. Conclusions Addition of bisoprolol to patients uncontrolled with amlodipine monotherapy significantly improves blood pressure control. We can expect additional 7.2/3.95 mmHg SBP/DBP lowering effect by adding bisoprolol 5 mg to amlodipine 5 mg.

Effectiveness of Amlodipine in the Control of 24-Hour Blood Pressure in Mild-to-Moderate Essential Hypertension: A Prospective, Multicenter, Observational Real-World Study from India.

Background Calcium-channel blockers (CCB) are a mainstay in the management of hypertension (HTN), and amlodipine is the preferred CCB due to its longer half-life and better safety. Patients and methods This practice-based, observational, real-world evidence study assessed the 24-hour ambulatory blood pressure (ABP) control in mild-to-moderate essential hypertensive patients (treatment naïve receiving amlodipine monotherapy, or as add-on therapy) in inadequately controlled blood pressure (BP goal not met after one month of existing therapy). One hundred four (62M/42F) patients between 18 and 65 years of age who received amlodipine 5/10 mg/day for >8 weeks were included after obtaining informed written consent. The primary outcome was a change from baseline in the mean 24-hSBP and DBP on ABP monitoring at eight (±1) weeks. Secondary outcomes were different from baseline in the mean morning, day-time, night-time, and last six-hour dosing interval period. Other outcomes assessed BP variability (dippers and non-dippers), and responder rates based on ABP monitoring and in-clinic trough cuff measurements. Safety outcomes included adverse effects reported, electrocardiogram, and laboratory abnormalities (hepatic and renal function). Changes in BP parameters in different sub-groups (age, gender, BMI, physical activity, occupation, duration of hypertension, the total daily dose of amlodipine, type of amlodipine therapy, and hypertension severity at baseline) were estimated. Results Of the 104 patients, 49 patients (completed eightweeks) were included in the per-protocol (PP) data for efficacy analysis. Safety analysis was done on the intent-to-treat (ITT) dataset. Significant reductions (p<0.0001) from baseline in all BP measurements on ABPM were observed at the end of eight weeks. Similar improvements were observed in office BP recordings. There was a marginal but non-significant (p>0.05) increase in the proportion of dippers and extreme dippers with amlodipine at the end of the eight-week treatment period. Conclusions Amlodipine 5/10 mg/day therapy used as monotherapy or adjuvant therapy provided significant reductions in both office BP and ambulatory BP over eight weeks.

PS-C21-6: RENOPROTECTIVE EFFECT OF ALISKIREN MONOTHERAPY IN HYPERTENSIVE PATIENTS WITH OBESITY AND TYPE 2 DIABETES MELLITUS

Objective: Renin-angiotensin system inhibitors have been reported to have protective effects from end-organ damages. However, roles of the direct renin inhibitor monotherapy have been still unknown. Therefore, in the present study, we compared effects of aliskiren monotherapy with those of amlodipine monotherapy on visceral fat area (VFA) and end-organ damages in hypertensive patients with obesity and type 2 diabetes. Design: A single-center, prospective, open-label and randomized study. Methods: Adult hypertensive patients with body mass index ≧ 25 kg/m2 and VFA ≧ 100 cm2 or those with type 2 diabetes, who had an office blood pressure 140–160/90–100 mmHg with or without antihypertensive drugs were randomly allocated to 24-week aliskiren or amlodipine monotherapy. The dose of amlodipine or aliskiren was increased up to 10 mg/day and 300 mg/day, respectively, and only doxazosin could be added at maximum to 8 mg/day if needed. The primary outcome of the study was the changes of waist circumference and VFA at 24 weeks of the study period. Changes in outcomes were analyzed using mixed-effects models for repeated measures, which included treatment, time, treatment-by-time interaction and the baseline values as fixed effects. Results: In a total of 62 participants (age, 57 ± 13 y.o.; 40 men; body mass index, 28.8 ± 4.8 kg/m2; waist circumference, 99.3 ± 11.9 cm; VFA, 134.8 ± 47.0 cm2; blood pressure, 141 ± 16/86 ± 13 mmHg), waist circumference and visceral fat area as a primary endpoint did not significantly change from baseline in both groups. Systolic blood pressure significantly decreased at 12 weeks (change in least squares means: -10 mmHg, P = 0.001) and 24 weeks (-10 mmHg, P = 0.001) in the amlodipine group and at 24 weeks (-11 mmHg, P = 0.001) in the aliskiren group. Diastolic blood pressure significantly decreased at 24 weeks (-6 mmHg, P = 0.009) only in the amlodipine group. Estimated glomerular filtration rates were not statistically different between the groups. Logarithm of urinary albumin excretion significantly decreased at 24 weeks only in the aliskiren group (-0.60, P &lt; 0.001). The 24-weeks-changes in logarithm of serum pentraxin 3 levels, an inflammatory marker, were significantly lower in the aliskiren group than in the amlodipine group (-0.09 vs + 0.09, P = 0.017). Conclusions: These data suggested that aliskiren monotherapy may have a better renoprotective effect than amlodipine monotherapy while it does not affect VFA in hypertensive patients with obesity and type 2 diabetes mellitus.

Effects of Aliskiren Monotherapy versus Amlodipine Monotherapy in Hypertensive Patients with Obesity or Type 2 Diabetes Mellitus

Introduction: Renin-angiotensin system inhibitors have been reported to exert protective effects against organ damage and failure; however, the impact of the direct renin inhibitor as monotherapy has not been assessed. Here, we investigated the effects of 24-week monotherapy with aliskiren compared to amlodipine in hypertensive patients with type 2 diabetes or obesity. Methods: In this randomized intervention study, 62 adult hypertensive patients with visceral obesity (defined as a body mass index [BMI] greater than 25 kg/m2 and a visceral adipose tissue area [VFA] greater than 100 cm2) or type 2 diabetes mellitus (age 57 ± 13, 65% men, BMI 28.8 ± 4.8 kg/m2, VFA 134.8 ± 47.0 cm2, blood pressure 141 ± 16/86 ± 13 mm Hg) were randomized to receive 24-week treatment with aliskiren (max. 300 mg) or amlodipine (max. 10 mg). The primary outcome was the change in VFA at 24 weeks post-treatment. Results: Change in VFA did not differ significantly from baseline in either group. Systolic blood pressure significantly decreased at 12 weeks (−10 mm Hg, p = 0.001) and 24 weeks (−10 mm Hg, p = 0.001) in the amlodipine group and at 24 weeks (−11 mm Hg, p = 0.001) in the aliskiren group. Diastolic blood pressure significantly decreased at 24 weeks (−6 mm Hg, p = 0.009) only in the amlodipine group. Although the estimated glomerular filtration rates did not significantly change in either group, the logarithm of urinary albumin excretion significantly decreased at 24 weeks only in the aliskiren group (−0.60, p < 0.001). The 24-week changes in the urinary albumin excretion significantly correlated with the changes in the plasma renin activity in the aliskiren group (r = 0.51, p = 0.008). Conclusion: Aliskiren monotherapy did not show any superiority to amlodipine monotherapy on VFA, estimated glomerular filtration rates, or urinary albumin excretion in obese or type 2 diabetic hypertensive patients.

A Retrospective, Observational, EMR-Based Real-World Evidence Study to Assess the Incidence of Pedal Edema in Essential Hypertensive Patients on Amlodipine or Cilnidipine.

Introduction Calcium channel blockers have pedal edema as one of the confining factors of treatment. A real-world study may help evident reality of the situation in regular Indian clinical practice. The aim of the study is to assess effectiveness and incidence of pedal edema in essential hypertensive patients treated with amlodipine or cilnidipine monotherapy. Methods Retrospective EMR data of adult essential hypertensive patients, prescribed amlodipine (n = 800) or cilnidipine (n = 800) as monotherapy, were analyzed. Incidence of pedal edema from baseline visit was analyzed in terms of dose and duration of treatment. The changes in systolic (SBP) and diastolic blood pressure (DBP) from baseline and proportion of patients achieving target BP goals were assessed. Results In amlodipine and cilnidipine groups, mean changes in SBP and DBP from baseline to end of the study period were 28.4 and 15.1 mmHg and 24.3 and 13.5 mmHg, respectively (p value <0.05). More than 50% of patients in both groups achieved BP goal at the end of the study (p value 0.266). In amlodipine group, total 23.9% reported pedal edema, while in cilnidipine, 27.6% (p value 0.0863). At the end of the study, 3.5% and 8.2% of patients remain with pedal edema, respectively, in both groups (pvalue <0.005). Conclusion Amlodipine demonstrated greater BP reduction at a lower average dose, better efficacy, and tolerability in terms of pedal edema count as a lesser number of patients reported edema at the end of the study and a higher percentage of patients continued the prescribed baseline dosage regimen as compared to cilnidipine. Thus, the study established amlodipine as an effective and well-tolerated antihypertensive for Indians.

Comparative efficacy of fixed-dose statin and antihypertensive agent combinations: A network meta-analysis of randomized controlled trials

BackgroundThe concurrent administration of statins and antihypertensive agents has been associated with improved cardiovascular outcomes, although the optimal fixed-dose combination remains unclear. This meta-analysis aims to compare the blood pressure and lipid-lowering effects of various statin and antihypertensive drug combinations. MethodsPubMed, Scopus, Web of Science, CENTRAL and Clinicaltrials.gov were systematically searched from inception to 20 March 2021. Randomized controlled trials evaluating the effects of statin-antihypertensive agent combinations on systolic blood pressure or serum lipids were held eligible. A random-effects frequentist model was applied to provide estimates of mean difference of percentage change. ResultsOverall, 18 studies were included, comprising 4450 patients. Compared to statin monotherapy no significant difference in the percentage change of low-density lipoprotein cholesterol was achieved by adding any antihypertensive agent. Compared to amlodipine monotherapy, the addition of moderate-intensity statin resulted in a significantly greater percentage reduction of systolic blood pressure (−2.22%, 95% confidence intervals: [−3.82 to −0.62]). Combined high-intensity statin and amlodipine lead to significant increase of high-density lipoprotein cholesterol (8.34%, 95% confidence intervals: [0.73 to 15.95]), while effective triglyceride reduction was achieved by adding amlodipine and telmisartan to high-intensity statin (−14.68%, 95% confidence intervals: [−28.48 to −0.89]). No significant difference of adverse effects was observed. ConclusionThe present network meta-analysis suggests that the administration of fixed-dose combinations of statins and antihypertensive agents is safe and effective in reducing blood pressure and serum lipids. The optimal dosing strategy to prevent cardiovascular events remains to be determined.

Cost Effectiveness of ACEIs/ARBs versus Amlodipine Monotherapies: A Single-Center Retrospective Chart Review.

The aim of this retrospective chart review study was to examine the cost effectiveness of angiotensin-converting enzyme inhibitors (ACEIs); angiotensin receptor blockers (ARBs); and dihydropyridine calcium channel blockers (CCBs) such as amlodipine, monotherapies in the management of essential hypertension among adult patients (≥18 years) without cancer, cardiovascular disease, and chronic kidney disease in the primary care clinics of a university-affiliated tertiary care hospital. Patients were followed up for at least 12 months from the initiation of therapy. Propensity score bin bootstrapping with 10,000 replications was conducted to generate the 95% confidence intervals (CI) for both treatment outcome (e.g., reduction of the systolic (SBP) and diastolic blood pressures (DBP) in mmHG) and the cost (e.g., costs of drugs, clinic visits, and labs in Saudi riyals (SAR)). Among the 153 included patients who met the inclusion criteria, 111 patients were on ACEIs/ARBs, while 44 patients were on amlodipine. On the basis of the bootstrap distribution, we found that the use of ACEIs/ARBs was associated with an incremental reduction of SBP of up to 4.46 mmHg but with an incremental cost of up to SAR 116.39 (USD 31.04), which results in an incremental cost effectiveness ratio (ICER) of SAR 26.09 (USD 6.95) per 1 mmHg reduction with 55.26% level of confidence. With regard to DBP, ACEIs/ARBs were associated with an incremental reduction of DBP of up to 5.35 mmHg and an incremental cost of up to SAR 144.96 (USD 38.66), which results in an ICER of SAR 27.09 (USD 7.23) per 1 mmHg reduction with 68.10% level of confidence. However, ACEIs/ARBs were less effective and costlier than amlodipine in reducing SBP and DBP with 44.74% and 31.89% levels of confidence, respectively. The findings of this study indicate that the use of ACEI or ARB as a monotherapy seems to be more effective than amlodipine monotherapy in the management of essential hypertension in primary care settings with minimal incremental cost.

Monotherapy treatment with chlorthalidone or amlodipine in the systolic blood pressure intervention trial (SPRINT).

This post hoc analysis of the Systolic Blood Pressure Intervention Trial (SPRINT) examined the performance of chlorthalidone (C) versus amlodipine (A) monotherapies. ANOVA was used to analyze the differences in systolic blood pressure (SBP) response between C and A. Logistic regression was used to examine monotherapy failure (adding a second antihypertensive agent or switching to a different antihypertensive agent) rates. Four hundred ninety‐one participants were treated with C monotherapy (n = 210, mean dose = 22 mg/day) or A monotherapy (n = 281, mean dose = 7 mg/day). There was a significant difference in mean SBP reduction between the C and A monotherapies at the third visit (higher reduction with A, adjusted p = .018). Unadjusted analysis showed a higher failure with C in the standard treatment group. Although the average SBP at failure was higher and above the 140 mm Hg cutoff that indicated monotherapy failure with A (142.60) compared with C (138.40), more participants on C failed despite having SBP below the 140 cutoff. This was probably due to decisions made by the investigative teams to change the antihypertensive regimen, because, in their opinion, the clinical picture required it. After adjusting for baseline characteristics, C had higher failure than A only in the standard treatment group (1.64 odds ratio [OR], 95% CI 1.06–2.56, p = .028). A sub‐analysis including participants who had never used antihypertensive treatment before randomization had similar results (2.57 OR, 95% CI 1.34–5.02, p = .004). Overall, in SPRINT chlorthalidone was associated with higher monotherapy failure than amlodipine in the standard treatment group because of decisions of the investigative teams.

Effectiveness of Amlodipine on Blood Pressure Control in Hypertensive Patients in India: A Real-World, Retrospective Study from Electronic Medical Records.

BackgroundThe effectiveness of amlodipine has been reported in clinical trials in India. However, real-world data on the effectiveness of amlodipine in India is limited.ObjectiveTo provide real-world evidence regarding the effectiveness of amlodipine as monotherapy or in combination with other antihypertensive drugs (AHDs) in Indian patients with essential hypertension.MethodsElectronic medical record data of adult patients who were diagnosed with essential hypertension (≥ 140/90 mmHg) and were prescribed amlodipine as monotherapy or add-on therapy were retrospectively analyzed. Patients were classified based on the number of AHD classes prescribed on initiation of amlodipine. Change in systolic (SBP) and diastolic (DBP) blood pressure from baseline was the primary endpoint. Evaluation of proportion of patients who achieved treatment goals as per 2018 European Society of Cardiology/European Society of Hypertension guidelines was the secondary endpoint. Readings were obtained before initiating amlodipine and after at least a month of therapy with amlodipine.ResultsAmong the 462 included patients, the majority (90.7%) were on amlodipine monotherapy or amlodipine + 1AHD. Mean (95% confidence interval [CI]) change in the amlodipine monotherapy group was: SBP (− 12.1 [− 14.9, − 9.3] mmHg) and DBP (− 7.5 [− 8.9, − 6.1] mmHg) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (− 17.8 [− 21.0, − 14.6] mmHg) and DBP (− 9.5 [− 11.0, − 8.0] mmHg) (P < 0.001 for all). SBP and DBP goals were achieved by 31.4% and 42.9% of patients on amlodipine monotherapy and by 38.9% and 51.8% of patients on amlodipine + 1AHD, respectively. Among patients aged ≤ 45 years, mean (95% CI) change in the amlodipine monotherapy group was: SBP (− 11.7 [− 16.0, − 7.4] mmHg; P < 0.001) and DBP (− 7.2 [− 9.7, − 4.7] mmHg; P < 0.001) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (− 14.6 [− 21.9, − 7.3] mmHg; P < 0.05) and DBP (− 10.6 [− 14.8, − 6.4] mmHg; P < 0.01). SBP and DBP goals were achieved by 35.4% and 33.8% of patients on amlodipine monotherapy and by 48.0% and 56.0% of patients on amlodipine + 1AHD, respectively. Among patients aged ≥ 65 years, mean (95% CI) change in the amlodipine monotherapy group was: SBP (− 13.9 [− 20.2, − 7.6] mmHg; P < 0.01) and DBP (− 8.5 [− 11.4, − 5.7] mmHg; P < 0.001) and mean (95% CI) change in the amlodipine + 1AHD group was: SBP (− 22.4 [− − 28.8, − 16.0] mmHg; P < 0.001) and DBP (− 10.8 [− 14.0, − 7.6] mmHg; P < 0.001). SBP and DBP goals were achieved by 25.5% and 13.7% of patients on amlodipine monotherapy and by 29.8% and 14.0% of patients on amlodipine + 1AHD.ConclusionAmlodipine prescribed as monotherapy or add-on therapy during routine clinical practice significantly reduced BP in ≤ 45- and ≥ 65-year-old Indian patients with mild to moderate hypertension, emphasizing that amlodipine may be a good candidate for BP control in Indian patients with essential hypertension in these age groups.

A Study to Evaluate Pharmacoeconomics of Antihypertensive Drugs in a Tertiary Care Teaching Hospital

Background: Hypertension is a major public health problem associated with large health burden as well as high economic burden at individual and population levels. A prospective observational study carried out in in-patients admitted to general medicine department of tertiary care hospital to evaluate the most cost effective therapy among the monotherapy of Amlodipine and combination therapy of telmisartan + hydrochlorthiazide.&#x0D; Methods: A total of 120 Hypertensive patients case records prescribed with monotherapy of Amlodipine and combination therapy of Telma H were reviewed and evaluated using descriptive statistics and ‘p’ value and assessed for their financial burden based on the cost per tablet for an year, Cost effectiveness ratio for the patients with controlled Blood Pressure by using a particular drug.&#x0D; Results: Out of 120 patients females were more (59.2%) and most of them were under the age group of 41-60 years. Majority of the patients had a known history of hypertension (65%). Most of the patients were prescribed with Telma H 40/12.5mg (40%) followed with Amlong 5mg (35.8%). There was a significant positive correlation (i.e., p value= 0.05) between persistence patterns of patients with drug therapy. Probability of patients with controlled Blood Pressure taking Amlong 10 mg were 82.35% followed by patients with Amlong 5mg.&#x0D; Conclusion: This study clearly showed that monotherapy of amlodipine is the most cost effective therapy than combination therapy of Telma H in order to reduce financial burden to the patient as well as to decrease the complications.&#x0D; Keywords: Hypertension, Pharmacoeconomics, Cost effectiveness, Blood Pressure.

Safety of Candesartan, Amlodipine, and Atorvastatin in Combination: Interaction Study in Healthy Subjects

For efficient cardiovascular risk protection antihypertensive treatment is often combined with cholesterol-lowering treatment, although solid data of interaction and side effects are missing. This is a prospective, single-center interaction study conducted in a fixed sequence design at steady state of candesartan, amlodipine, and atorvastatin. Five-day monotherapy of candesartan 8 mg was followed by 5-day atorvastatin 40 mg monotherapy and subsequently 9-day amlodipine 5 mg monotherapy; each treatment separated by washout phases. Immediately after amlodipine monotherapy, all 3 drugs were administered concomitantly for 5 days. Pharmacokinetic parameters as well as safety were assessed. Eighteen healthy subjects enrolled and completed the study. No significant difference in the maximum concentration (Cmax ) and the area the under plasma concentration-time curve (AUC) for amlodipine and AUC of atorvastatin was detected following combination versus monotherapy. Cmax of atorvastatin decreased slightly but clinically not relevantly when given in combination. A statistically significant but not below 0.80-fold decrease between candesartan following combination vs monotherapy was detected for Cmax and AUC. In general, all treatments were well tolerated. Concluding, systemic exposure of candesartan, amlodipine, and atorvastatin is not clinically significantly changed upon coadministration. These data support a fixed-dose combination of the 3 components for dual cardiovascular risk prevention.