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Objective: To evaluate the cost-effectiveness of a single-pill combination (SPC) of perindopril/amlodipine/indapamide versus its free equivalent combination (FEC) in adults with hypertension in Italy., Methods: A Markov model was developed to perform a cost-utility analysis with a lifetime horizon and an Italian healthcare payer's perspective. In the model, the additional effect of the SPC on blood pressure level compared with the FEC was translated into a decreased risk of cardiovascular events and CKD, which was modeled via Framingham risk algorithms. Difference in persistence rates of SPC and FEC were modeled via discontinuation rates., Results: A perindopril/amlodipine/indapamide SPC is associated with lower cost and better health outcomes compared to its FEC. Over a lifetime horizon, it is associated with a 0.050 QALY gain and cost savings of €376, resulting from lower cardiovascular event rates. In the alternative scenario, where different approach for modeling impact of adherence was considered, incremental gain of 0.069 QALY and savings of €1,004 were observed. Results were robust to sensitivity and scenario analyses, indicating that use of this SPC is a cost-effective strategy., Conclusions: The findings indicate that a perindopril/amlodipine/indapamide SPC is a cost-saving treatment option for hypertension in Italy, compared to its FEC.

The price and safety of finished pharmaceutical preparations are two major concerns while prescribing medicine. In this work, machine learning-based classification models were developed with respect to the quality attributes of 258 samples covering 9 marketed amlodipine (AMLO) formulations. The quantitation of AMLO and its three sulfonate ester genotoxic impurities of besylate counter ion was settled using a validated high-performance liquid chromatography-diode-array detection method. The classification of correlation between dependent and independent variables was exercised using linear discriminant analysis models. The linear dispersion of acceptable quality attributes was significantly different for AMLO besylate formulation with unit price per tablet "<1 Rs." Although the correlations between price and quality are well-understood associations group centroid distance for price group "2-3 Rs." and "1-2 Rs." reveal that acceptable quality dispersion was similar for both groups. Nonetheless, a higher price could allow storage of the finished formulation to be kept on the shelf for a longer period., (Copyright © 2024 Copyright: © 2024 Indian Journal of Public Health.)

Purpose: Antihypertensive treatment is the most important method to reduce the risk of cardiovascular events in hypertensive patients. However, there is scant evidence of the benefits of levoamlodipine maleate for antihypertensive treatment using a head-to-head comparison in the real-world. This study aims to examine the effectiveness of levoamlodipine maleate used to treat outpatients with primary hypertension compared with amlodipine besylate in a real-world setting., Methods: This was a pragmatic comparative effectiveness study carried out at 110 centers across China in outpatients with primary hypertension treated with levoamlodipine maleate or amlodipine besylate, with 24 months of follow-up. The primary outcomes used for evaluating the effectiveness were composite major cardiovascular and cerebrovascular events (MACCE), adverse reactions, and cost-effectiveness., Results: Among the included 10,031 patients, there were 482 MACCE, 223 (4.4%) in the levoamlodipine maleate group (n = 5018) and 259 (5.2%) in the amlodipine besylate group (n = 5013) (adjusted hazard ratio = 0.90, 95%CI: 0.75-1.08, P = 0.252). The levoamlodipine maleate group had lower overall incidences of any adverse reactions (6.0% vs. 8.4%, P < 0.001), lower extremity edema (1.1% vs. 3.0%, P < 0.001) and headache (0.7% vs. 1.1%, P = 0.045). There was a nearly 100% chance of the levoamlodipine maleate being cost-effective at a willingness to pay threshold of 150,000 Yuan per quality-adjusted life years (QALYs) gained, resulting in more QALYs (incremental QALYs: 0.00392) and cost savings (saving 2725 Yuan or 28.8% reduction in overall costs) per patient., Conclusion: In conclusion, levoamlodipine maleate could reduce cost by 29% with a similar MACCE incidence rate and lower occurrence of adverse reactions (especially edema and headache) compared with amlodipine besylate., Trial Registration: Clinicaltrials.gov NCT01844570 registered at May 1, 2013.

Objectives: To evaluate the cost-effectiveness of olmesartan/amlodipine fixed-dose combination vs olmesartan and amlodipine free combination, amlodipine single drug, and valsartan/amlodipine fixed-dose combination in the treatment of hypertensive patients from payer perspective in China. Methods: A Markov model was constructed, which included five health states of hypertensive patients who are aged 35-84 years at baseline and free of cardiovascular disease. Clinical data were obtained from a network meta-analysis. Epidemiology data, adverse events (AEs), cost, and utility data were obtained from the literature. The cost associated with AEs was estimated based on the cost of same symptoms of hypertensive patients in an electric medical record database. The model projected quality-adjusted life years (QALYs) gained, total costs per patient in a 20-year time horizon, and incremental cost-effectiveness ratios. Probability sensitivity analyses (PSA) and one-way sensitivity analyses were conducted for the main parameters to test the robustness of the model. Results: Compared to olmesartan and amlodipine free combination, amlodipine, and valsartan/amlodipine fixed-dose combination, treatment with olmesartan/amlodipine fixed-dose combination led to fewer CVD events and deaths; resulted in an incremental cost of ¥-5,439 ($-791.36), ¥6,530 ($950.09), and ¥-1,019 ($-148.26) and gained additional QALYs of 0.052, 0.094, and 0.037 per patient, respectively. Compared with olmesartan and amlodipine free combination and valsartan/amlodipine fixed-dose combination, olmesartan/amlodipine fixed-dose combination was dominant. Compared with amlodipine alone, the incremental cost-effectiveness ratios were below the WHO recommended cost-effectiveness threshold, indicating the olmesartan/amlodipine fixed-dose combination was a cost-effective option for hypertensive patients in China. The 10-years' time horizon scenario analysis showed similar results to the 20-years' time horizon. Probabilistic sensitivity analysis and one-way sensitivity analyses showed the robustness of the model results. Conclusions: Olmesartan/amlodipine fixed-dose combination confers better health outcomes and costs less compared with olmesartan and amlodipine free combination and valsartan/amlodipine fixed-dose combination, and is cost-effective compared to amlodipine for hypertension treatment in China.

Fixed-dose combinations (FDC) have been developed to reduce the pill burden for hypertensive patients. Data on fixed-dose or free-dose (freeDC) ramipril/amlodipine (R/A) or candesartan/amlodipine (C/A) combination treatment initiation were assessed. 71 463 patients were prescribed R/A and 10 495 C/A. For both R/A and C/A, FDC patients were younger (both P < .001) and less comorbid. Prior MI (OR: 0.61 and 0.60), prior stroke (OR: 0.68 and 0.70) and CHD (OR: 0.68 and 0.64) were negatively associated with FDC use, whereas hyperlipidemia was positively associated (OR: 1.26 and 1.19). Use of antihypertensive comedication (OR: 0.78; OR: 0.55) and treatment discontinuation within 12 months (HR: 0.65 and 0.82) were less likely in FDC patients, who also showed superior adherence (mean MPR; both P < .001). Cost of the combination was higher for FDCs (both P < .001). FDCs improve persistence and adherence, although they are more commonly prescribed in patients with less cardiovascular disease., (©2018 Wiley Periodicals, Inc.)

Objectives: A single-blinded, randomized, crossover, noninferiority trial was conducted to evaluate clinical effectiveness and safety of low-cost brand (LCB) versus innovator brand (IB) amlodipine in essential hypertension., Materials and Methods: The primary end-point was change of systolic blood pressure (BP) from baseline to study end. Adult patients with Stage 1 hypertension or isolated systolic hypertension were randomized to receive 5 mg amlodipine LCB or IB once daily for 6 weeks in each period in a 2 × 2 crossover manner with three follow-up visits in each sequence. In 28 evaluable patients, the reduction of systolic BP (SBP), diastolic BP, and safety profile between two brands was comparable., Results: The lower bound of the 95% confidence interval of the difference in reduction of SBP (-5.04 mmHg) was within the noninferiority margin of 10 mmHg., Conclusion: LCB amlodipine is noninferior to IB in terms of BP reduction and is a cost-effective alternative as it is less expensive than IB., Competing Interests: There are no conflicts of interest.

Background: Arterial hypertension is a common disorder that affects around 9 million adults in Poland. Single-pill combinations (SPCs) for the treatment of arterial hypertension have significant advantages over the free combinations, resulting in lower risk of cardiovascular events and lower consumption of medical resources. The current ESC/ESH 2013 guidelines for the first time recommend treatment with a combination of thiazide-like diuretic with calcium channel blocker. Currently, no such combination is reimbursed from public funds in Poland., Aim: To assess the economic value of treatment with SPC of indapamide and amlodipine (Tertens-AM®) for hypertensive patients compared with free combination therapy (FC), in the Polish setting., Methods: As there are currently no published data directly estimating the additional effect of using indapamide + amlo-dipine SPC vs. FC, two extreme approaches are presented: with difference in effectiveness due to improved adherence to the treatment estimated from published studies on other molecules used in hypertension such as SPCs and FCs - the base-case approach (1); and assuming no difference of effectiveness or adherence between SPC and FC of indapamide and amlodipine - the conservative approach (2). Modelling was carried out based on the Markov process in lifetime horizon. In the base-case approach, with the difference in effectiveness between SPC and FC, it was assumed that the differences in compliance translate into the differences in systolic blood pressure. Patients' characteristics were correlated with the risk of events associated with cardiovascular disease, based on the prediction algorithms from the Framingham Heart Study. Costs were considered from a National Health Fund (NHF) perspective and NHF and patient's perspective, and therefore direct medical costs were only included., Results: The treatment with SPC of indapamide and amlodipine in place of FC resulted in 7.6 additional days of life in full health and longer overall patient survival by 2.9 days. The replacement of FC with SPC would result in national savings from both NHF perspective and NHF and patient's perspective, irrespective of the assumption of the difference in adherence between SPC and FC. The savings would amount to 1.602-3.954 million PLN and 16.498-19.186 million PLN from NHF perspective and NHF and patient's perspective, respectively., Conclusions: The treatment with SPC of indapamide and amlodipine for hypertensive patients was found to be dominant over FC or at least less expensive than treatment with FC when the difference in effectiveness was neglected. The replacement of FC with SPC would result in savings from both NHF perspective and NHF and patient's perspective.

This retrospective claims database analysis compared two strategies of hypertension treatment in outpatient, emergency, and inpatient departments: a fixed-dose combination (FDC) of amlodipine/valsartan vs free combinations of angiotensin receptor blockers (ARBs) and calcium channel blockers (CCBs) (ARB+CCB group). After a mean follow-up of 15.2 months, the FDC group had significantly lower total healthcare costs (US $1844 vs US $2158; P<.001) and hospitalization rates (14.57% vs 18.43%; P<.001), a higher proportion of days covered (80.35% vs 72.57%; P<.001), and better persistence (266 vs 225 days; P<.001) compared with the ARB+CCB group. The FDC group also had a better major adverse cardiovascular event (MACE)-free survival (hazard ratio, 0.83; 95% confidence interval, 0.73-0.94; P=.003) and decreased rates of heart failure (2.12% vs 3.26%; P<.001), malignant dysrhythmia (0.18% vs 0.42%; P=.021), and percutaneous coronary intervention (0.76% vs 1.26%; P=.015). Compared with free combinations of ARB+CCB, an FDC of amlodipine/valsartan improved MACE-free survival and medication compliance and decreased total healthcare costs and hospitalization rates in hypertensive patients., (© 2014 Wiley Periodicals, Inc.)

Objectives: Since treatment regimen type can influence adherence and other outcomes, this study examined adherence, cardiovascular events, and economic outcomes in patients with hypertension treated with fixed-dose combination (FDC) amlodipine/olmesartan (AML/OM), FDC AML/benazepril (AML/BEN), and loose-dose combination AML plus angiotensin II receptor blockers (LDC AML/ARBs)., Methods: Commercial health plan enrollees aged at least 18 years with index claim(s) for AML/OM, AML/BEN, or LDC AML/ARB were identified. Absence of study drug 6 months pre index, and continuous enrollment for at least 12 months post index were required. Descriptive analyses were executed to make comparisons between treatments, as well as multivariate models adjusting for baseline demographic and clinical characteristics, including propensity for assignment to study drug., Results: Descriptive results suggested mean follow-up adherence was higher in the AML/OM cohort [proportion of days covered (PDC) = 0.63] compared with the AML/BEN (PDC = 0.55; p < 0.001) and LDC AML/ARB cohorts (PDC = 0.34; p < 0.001). The proportion of individuals with an incident follow-up cardiovascular event composite was lower in the AML/OM cohort versus the AML/BEN and LDC AML/ARB cohorts (5.94% versus 7.85% and 16.89% respectively). Adjusted Cox models suggested that patients initiated on LDC AML/ARB (hazard ratio 1.35; p < 0.001), but not on AML/BEN, were at greater risk of a follow-up cardiovascular event (composite) compared with AML/OM. Adjusted generalized linear models suggested that mean follow-up per-member-per-month overall costs were higher in the AML/BEN (cost ratio = 1.169; p < 0.001; unadjusted mean cost US$780) and LDC AML/ARB cohorts (cost ratio = 1.286; p < 0.001; unadjusted mean cost US $1394) compared with the AML/OM cohort (unadjusted mean cost US $740)., Conclusion: The results suggested that treatment with FDC AML/OM was associated with greater likelihood of adherence and lower overall costs than with FDC AML/BEN and LDC AML/ARB, and lower risk of cardiovascular event composite versus LDC AML/ARB.

We enrolled 196 patients with hypertension who were already being treated with free-drug combinations of angiotensin-II receptor blocker (ARB) and amlodipine. The free-drug combinations of ARB and amlodipine were replaced with the same dose of the fixed-dose combinations. The average home blood pressure (BP) in all patients receiving fixed-dose combinations was significantly lower than those receiving free-drug combinations (131 ± 10/75 ± 8 vs. 136 ± 11/77 ± 9 mm Hg, P < .01) accompanied with increasing drug adherence. After lowering BP by fixed-dose combinations, the costs for medications decreased by 31% over the 3 months.

Objective: Hypertension is a major issue in public health, and the financial costs associated with hypertension continue to increase. Cost-effectiveness studies focusing on antihypertensive drug combinations, however, have been scarce. The cost-effectiveness ratios of the traditional treatment (hydrochlorothiazide and atenolol) and the current treatment (losartan and amlodipine) were evaluated in patients with grade 1 or 2 hypertension (HT1-2). For patients with grade 3 hypertension (HT3), a third drug was added to the treatment combinations: enalapril was added to the traditional treatment, and hydrochlorothiazide was added to the current treatment., Methods: Hypertension treatment costs were estimated on the basis of the purchase prices of the antihypertensive medications, and effectiveness was measured as the reduction in systolic blood pressure and diastolic blood pressure (in mm Hg) at the end of a 12-month study period., Results: When the purchase price of the brand-name medication was used to calculate the cost, the traditional treatment presented a lower cost-effectiveness ratio [US$/mm Hg] than the current treatment in the HT1-2 group. In the HT3 group, however, there was no difference in cost-effectiveness ratio between the traditional treatment and the current treatment. The cost-effectiveness ratio differences between the treatment regimens maintained the same pattern when the purchase price of the lower-cost medication was used., Conclusions: We conclude that the traditional treatment is more cost-effective (US$/mm Hg) than the current treatment in the HT1-2 group. There was no difference in cost-effectiveness between the traditional treatment and the current treatment for the HT3 group.

Objective: To carry out a budget impact analysis (BIA) of olmesartan/amlodipine (20/5, 40/5 and 40/10mg) marketed as a fixed combination (FC) in its approved indication for the National Health System (NHS)., Desig: We developed a decision tree model in order to estimate usual hypertension treatment algorithm in Spanish clinical practice., Settings: The BIA has been developed from the perspective of the NHS for a period of 3 years (years 2010-2012)., Participants: Spanish hypertensive population ≥ 35 years old., Interventions: Introduction into the market of a fixed combination (FC) olmesartan/amlodipine in Spain., Primary Measures: Expected costs to be assumed by the Spanish NHS (RRP-VAT) for hypertensive population able to be treated with the FC versus currently assumed costs by the NHS with free combination olmesartan and amlodipine., Results: Estimated pharmaceutical costs in hypertensive population treated with olmesartan and amlodipine (2 pills) would be €25.2M (1(st) year), €26.4M (2011), €27.6M (2012), with a total 3-year period of €79.2M. According to patient tree model, the population able to be treated with FC would be 71,283 patients (2010), with a growth rate of 4.8% in the successive years, which supposes an annual cost of €21.2M (2010), €21.8M (2011) and €22.4M (2012), with a total 3-year period of €65.4M. The BIA shows savings of €13.8M in a total 3-year period., Conclusion: The BIA of FC olmesartan/amlodipine could generate net savings of €13.8M for the NHS in the period ranging from years 2010 to 2012., (Copyright © 2010 Elsevier España, S.L. All rights reserved.)

Objective: To compare adherence, healthcare costs and utilization of valsartan/amlodipine single-pill combination (SPC) and angiotensin-receptor blocker/calcium-channel blocker multiple-pill free-combination (ARB + CCB FC) therapy using real-world data., Methods: A retrospective study (January 1, 2007 to April 30, 2009) was conducted using US commercial healthcare insurance claims. Patients were assigned to two cohorts: 'valsartan/amlodipine SPC cohort' and 'ARB + CCB FC therapy cohort'. The primary endpoints were adherence and persistence. The secondary endpoints were 1-year healthcare costs and utilization., Results: Out of 12,628 eligible patients 3259 (26%) were included in the valsartan/amlodipine SPC cohort and 9369 (%74) in the ARB + CCB FC cohort. Risk-adjusted adherence rates were higher for valsartan/amlodipine SPC patients [OR: 1.38, 95% CI: (1.24, 1.53)]. The Cox proportional hazard model showed that valsartan/amlodipine SPC cohort patients were less likely to discontinue medication (HR: 0.87, p < 0.001). Comparison between the groups also yielded that total healthcare costs of valsartan/amlodipine SPC patients were 16-20% lower than ARB + CCB FC therapy patients (p < 0.0001)., Limitations: Since claims data are collected for payment purposes rather than research purposes, the study is bound by limitations for the retrospective analysis. For example, the presence of a claim for a filled prescription does not indicate that the medication was consumed or taken as prescribed. Data on health behaviors and patient lifestyle were not available. Over-the-counter medications and clinical disease severity were not available in the dataset. Incorrect coding is also a possibility. However, we have used previously validated datasets where these effects are minimal. Heterogeneity of the sample may create bias in our estimates, however, we have used advanced statistical methods to control for observed and unobserved bias., Conclusion: The real-world use of valsartan/amlodipine SPC was associated with better adherence and persistence relative to ARB + CCB FC therapy among patients with hypertension. Moreover, patients taking single-pill combination therapy had lower healthcare costs and utilization.

Objective: To carry out a Budget Impact Analysis (BIA) of the inclusion of the administration, within the Spanish National Health System (SNS), of the fixed combination (FC) of amlodipine 5 or 10mg and atorvastatin 10mg for approved indications., Materials and Methods: A BIA was carried out from the SNS perspective for a 3 year period (2009-2011). A tree type decision model was designed (tree of patients), based on epidemiological data and scientific literature, to estimate the hypertensive population that could be treated with a FC. The total per annum BIA was calculated by attributing the retail price- VAT of the FC to the number of patients to be treated, and deducting the cost of the treatment for hypertension that was replaced and the updated average cost per patient of cardiovascular events (CVEs) prevented by the use of the FC by the SNS during the period of study., Results: The patient population susceptible to treatment with the FC was 51,104 patients (1(st) year), with a growth rate of between 1-2% over the following years, which means an annual cost (euro) of 15.9M (2009), 19.9M (2010) and 24.1M (2011), with a total of 60.0M. The BIA was compensated showing negative impact values for the SNS when the cost of replaced antihypertensive treatment and prevented CVEs was deducted, with savings of euro69.9M over 3 years., Conclusion: The BIA of a FC of atorvastatin and amlodipine shows that the use of this medication for approved indications could generate net savings for the SNS of euro9.9M for the period 2009-2011., (Copyright © 2009 SEFH. Published by Elsevier Espana. All rights reserved.)

Purpose: Single-pill-combination (SPC) antihypertensive drug products have been shown to improve compliance but are associated with higher acquisition costs. This study compared the clinical and economic outcomes associated with the use of an SPC of amlodipine/valsartan (trade name Exforge) with the outcomes from conventional combination therapy in patients failing to respond to initial monotherapy with either a dihydropyridine calcium channel blocker (DHP-CCB) or an angiotensin receptor blocker (ARB)., Design: We conducted a retrospective cohort study of hypertensive patients failing to respond to monotherapy with either a DHP-CCB or an ARB who were switched to an SPC of amlodipine/valsartan (SPC group) or to treatment that could not include any SPC (control group). The groups were matched for age, gender, race, baseline blood pressure (BP), and comorbidities. The primary outcomes of the study included the proportion of patients achieving BP targets, the absolute change in BP from baseline, the proportion of patients discontinuing drug therapy because of side effects, the proportion of patients non-compliant with drug therapy, and health care resource utilization and costs., Principal Findings: Fifty-eight SPC patients achieved BP targets compared with 47 control patients (P = 0.119). The absolute reduction in BP was significantly greater in the SPC group (-22.8 +/- 6.9/-19.3 +/- 5.2 mmHg) than in the control group (-20.6 +/- 6.4/-17.8 +/- 5.6 mmHg) (P < 0.03). Significantly fewer patients discontinued anti-hypertensive therapy because of side effects and noncompliance in the SPC group compared with the control group (both P = 0.042). SPC patients accrued fewer clinic visits, laboratory tests, and electrocardiograms but had higher drug acquisition costs. Median medical therapy costs were significantly lower in the SPC group at the end of the 6-month follow-up, primarily because of lower costs for clinic visits., Conclusion: The use of the SPC of amlodipine/valsartan was associated with greater absolute BP reductions and fewer antihypertensive drug discontinuations because of side effects and noncompliance compared with the use of the individual drugs. Although the acquisition cost of the SPC was greater than that of the individual drugs, SPC combination therapy resulted in fewer clinic visits, laboratory tests, and electrocardiograms. As a result, the total cost of SPC therapy was significantly less than that associated with the use of the individual drug components.

Background: In Korea, the treatment of hypertension and dyslipidemia constitutes an important strategy for the prevention of cardiovascular disease (CVD)., Objective: This study sought to investigate the cost-effectiveness (from the Korean health care system perspective) of prescribing a proprietary formulation single-tablet fixed-dose combination of amlodipine and atorvastatin (at weighted mean doses of 5 mg and 10.25 mg, respectively) to all eligible patients aged > or = 45 years for the primary prevention of CVD (ie, coronary heart disease and ischemic stroke) in Korea, compared with currently observed patterns of blood-pressure and lipid-lowering medication prescription and use., Methods: A Markov model was developed with 4 health states: alive without CVD, alive with CVD, dead from CVD, and dead from non-CVD causes. The model population comprised 244 Koreans aged >/=45 years from the 2005 Korean National Health and Nutrition Examination Survey (KNHNES) without a history of myocardial infarction (MI) or stroke who met current criteria for both blood-pressure and lipid-lowering treatment. From a 2008 baseline, follow-up was simulated for 40 years. Cardiovascular risk was estimated for each subject individually using a multivariate, Asian population-specific equation, and updated with ongoing cycles. Decision analysis compared the effects of prescribing the fixed-dose combination to all subjects versus currently observed patterns of treatment. Data regarding the blood-pressure and lipid-lowering efficacies of combination therapy were drawn from the Respond trial. Costs of the fixed-dose combination tablet and CVD were sourced from pharmaceutical pricing lists and Korean Health Insurance Review and Assessment Services estimates, respectively. Utility values for CVD were obtained from a large Korean utility study., Results: In the model, of the 244 treatment-eligible subjects, 126 (51.6%) and 13 (5.3%) were taking blood-pressure and lipid-lowering therapy, respectively. Use of single-tablet fixed-dose combination amlodipine and atorvastatin by all subjects was associated with estimated incremental cost-effectiveness ratios of 7,773,063 Korean won (KRW) per quality-adjusted life-year gained and 10,378,230 KRW per overall life-year gained (1300 KRW approximately US $1). Sensitivity and uncertainty analyses indicated these results to be robust., Conclusions: In this model, based on data from the 2005 KNHNES, hypertension and dyslipidemia were undertreated among Koreans aged > or = 45 years without a history of MI or stroke. The administration of single-tablet fixed-dose combination amlodipine and atorvastatin to all such individuals was likely to represent a cost-effective means of preventing first-onset CVD (ie, coronary heart disease and ischemic stroke) in this subgroup, compared with current patterns of treatment.

Objectives: To review the pharmacoeconomic impact of the use of amlodipine in coronary artery disease (CAD) patients., Methods: A review of the available outcome trials evaluating the clinical effectiveness of amlodipine in hypertensive patients or in patients with CAD or diabetic nephropathy was carried out to identify pharmacoeconomic studies that quantified the economic impact of using amlodipine instead of another treatment., Results: A combined analysis of two trials comparing angiotensin receptor blockers (ARBs) with a calcium channel blocker amlodipine suggested that amlodipine provided more protection against stroke and myocardial infarction than ARBs. In addition, in keeping with previous meta-analyses, calcium channel blockade with amlodipine also prevented more stroke than angiotensin-converting enzyme inhibitors and old drug classes. Pharmacoeconomic analysis conducted in the US and Europe demonstrated that the use of amlodipine resulted in fewer hospitalisations and the need for fewer invasive surgical procedures in the short and long term and at a modest incremental cost. The use of amlodipine resulted in improved clinical outcomes as well as slight savings in cost., Conclusions: Amlodipine is not only cost effective, but predicted to be cost saving when compared with usual care, warranting its consideration as an agent of choice in patients with CAD.

Background: ASCOT (Anglo-Scandinavian Cardiac Outcomes Trial) showed in hypertensive patients that blood pressure-lowering treatment with an amlodipine-based regimen reduces events compared with an atenolol-based regimen and that atorvastatin was more effective than placebo., Objective: To assess the cost effectiveness of four alternative treatment strategies in patients with hypertension and three or more cardiovascular risk factors in the UK (from the UK NHS perspective) or Sweden (from the societal perspective): amlodipine-based plus atorvastatin, atenolol-based plus atorvastatin, amlodipine-based alone and atenolol-based alone., Methods: Based on the trial data, a Markov model was constructed where the risk of myocardial infarction, revascularization procedures and stroke and the long-term costs, quality of life and mortality associated with these events were estimated. Transition probabilities and costs (euro, 2007 values) were based on the patient-level trial data. Outcomes were reported as life-years gained and QALYs. In the latter case, utility reduction from events was based on a substudy in ASCOT patients. Treatment was applied for the duration of the lipid-lowering arm of the trial (3 years) and patients were then followed to the end of their life., Results: Amlodipine-based therapy plus atorvastatin was the most expensive but also most effective treatment. Compared with amlodipine-based therapy alone, the cost to gain one QALY was euro 11,965 in the UK and euro 8,591 in Sweden. The incremental cost effectiveness of amlodipine-based therapy compared with atenolol-based therapy was euro 9,548 and euro 3,965 per QALY gained in the UK and Sweden, respectively. Atenolol-based therapy plus atorvastatin was eliminated through extended dominance. Applying the threshold values used by the National Institute for Health and Clinical Excellence (NICE) and the Swedish National Board of Health and Welfare, a combination of amlodipine-based therapy and atorvastatin appears to be cost effective in patients with hypertension and three or more additional risk factors.

Hypertension and dyslipidemia are two of the most commonly co-occurring cardiovascular risk factors which together cause an increase in coronary heart disease-related events that is more than simply additive for anticipated event rates with each condition. Data have shown that even relatively small reductions in both blood pressure and cholesterol levels can lead to large reductions in the risk for cardiovascular events. However, though there are robust data on the beneficial effect of concomitant reduction in these risk factors, the reality is that this is achieved in <10% of patients. There is nonadherence with prescribed therapies with up to 50% of patients stopping their medications of their own volition for a variety of reasons. There is a reasonable evidence base to suggest that simplifying drug regimens and reducing pill burden will enhance patient adherence. The fixed-dose combination containing the antihypertensive agent amlodipine besylate and the statin atorvastatin is the first combination of its kind, which is both efficacious and safe and could potentially improve medication compliance, thereby improving the outcomes in these patients.

As recommended by the guidelines such as JSH 2004, combination therapy with multiple agents is now being applied to many patients with hypertension. However, a pharmacoeconomic analysis of each therapy has not been fully undertaken in Japan, despite increasing societal interest. In this study, the cost-effectiveness of two calcium channel blockers, each coadministered with an angiotensin receptor blockade, was compared using data from the ADVANCE-Combi study. The ADVANCE-Combi study was a 16-week double-blind, randomized clinical trial to compare the efficacy and safety of two combination therapies (controlled-release nifedipine [nifedipine CR] plus valsartan vs. amlodipine plus valsartan) on blood pressure (BP) control in patients with moderate to severe essential hypertension. The incremental cost effectiveness of each cohort was compared from the perspective of insurers. The average total cost per patient was Japanese yen (JPY) 31,615 for the nifedipine CR treatment group and JPY 35,399 for the amlodipine treatment group (p < 0.001). The achievement rate of the target BP (SBP/DBP < 130/85 mmHg for patients aged under 60 years; SBP/DBP < 140/90 mmHg for those aged 60 years and over) was significantly higher in the nifedipine CR treatment group (61.2%) than in the amlodipine treatment group (34.6%) (p < 0.001), with no difference in the incidence of drug-related adverse events. Accordingly, the base case economic analysis demonstrated that the nifedipine CR treatment group was dominant (more efficacious and less costly) to the amlodipine treatment group. This result was supported by univariate and probabilistic sensitivity analyses. These results indicate that nifedipine CR-based combination therapy is superior to amlodipine-based combination therapy for the management of essential hypertension in the Japanese population.

Objective: The prevalence of type 2 diabetes, often leading to diabetic nephropathy, has increased globally, especially in Asia. Irbesartan treatment delays the progression of kidney disease at the early (microalbuminuria) and late (proteinuria) stages of nephropathy in hypertensive type 2 diabetics. This treatment has proven to be cost-effective in Western countries. This study assessed the cost-effectiveness of early irbesartan treatment in Asian settings., Methods: An existing lifetime model was reprogrammed in Microsoft Excel to compare irbesartan started at an early stage to irbesartan or amlodipine started at a late stage, and standard treatments from a health-care perspective in China, Malaysia, Thailand, South Korea, and Taiwan. The main effectiveness parameters were incidences of end-stage renal disease, time in dialysis, and life expectancy. All costs were converted to 2004 US$ using official purchasing power parity. Local data were obtained for costs, transplantation,dialysis, and mortality rates. Probabilities regarding disease progression after treatment with the investigated drugs were extracted from two published clinical trials. A probabilistic sensitivity analysis was performed., Results: Early use of irbesartan yielded the largest clinical and economic benefits reducing need for dialysis by 61% to 63% versus the standard treatment, total costs by 9% (Thailand) to 42% (Taiwan), and increasing life expectancy by 0.31 to 0.48 years. Early irbesartan had a 66% (Thailand) to 95% (Taiwan) probability of being dominant over late irbesartan., Conclusion: Although the absolute results varied in different settings, reflecting differences in epidemiology, management, and costs, early irbesartan treatment was a cost-effective alternative in the Asian settings.

Objective: To compare the cost effectiveness of an amlodipine-based strategy and an atenolol-based strategy in the treatment of hypertension in the UK and Sweden., Design: A prospective, randomised trial complemented with a Markov model to assess long-term costs and health effects., Setting: Primary care., Patients: Patients with moderate hypertension and three or more additional risk factors., Interventions: Amlodipine 5-10 mg with perindopril 4-8 mg added as needed or atenolol 50-100 mg with bendroflumethiazide 1.25-2.5 mg and potassium added as needed, Main Outcome Measures: Cost per cardiovascular event and procedure avoided, and cost per quality-adjusted life-year gained., Results: In the UK, the cost to avoid one cardiovascular event or procedure would be euro18 965, and the cost to gain one quality-adjusted life-year would be euro21 875. The corresponding figures for Sweden were euro13 210 and euro16 856., Conclusions: Compared with the thresholds applied by NICE and in the Swedish National Board of Health and Welfare's Guidelines for Cardiac Care, an amlodipine-based regimen is cost effective for the treatment of hypertension compared with an atenolol-based regimen in the population studied.

Based on results of large-scale controlled trials of irbesartan (I), valsartan (V) and amlodipine (A) (PRIME and MARVAL) we carried out the Markov s modeling of their pharmacoeconomic parameters in arterial hypertension (AH) combined with diabetes mellitus type 2 (DM 2) and microalbuminuria (MAU) projected for 8-years perspective. Cost and efficacy was evaluated taking into account years of life gained and outcomes of concomitant diseases and complications. Indexes of cost/efficacy (C/E) were calculated for each drug. Among investigated drugs I appeared to be the most economic at the account of retardation of development of terminal nephropathy and cardiovascular diseases. The use of I compared with V could save 565300 rub/100 patients/year. C/E of I was 26.5 and 37.4% lower that those of V and A, respectively. Costs of year of life saved was 12716, 16432, and 18325 for I, V, and A, respectively. Comparative pharmacoeconomic modeling of 8-year economic perspectives of I, V and A demonstrated financial benefits of I.

Amlodipine/atorvastatin (Caduet) is a once-daily fixed-dose combination of the dihydropyridine calcium channel antagonist amlodipine and the HMG-CoA reductase inhibitor atorvastatin. In Europe, the combination is indicated for the prevention of cardiovascular events in hypertensive patients with three concomitant cardiovascular risk factors and, in the US, it is indicated for the management of hypertension and dyslipidemia in patients for whom treatment with both agents is appropriate. In clinical trials, the fixed-dose combination of amlodipine/atorvastatin effectively managed two important risk factors simultaneously in hypertensive patients at risk of cardiovascular disease or in those with concomitant hypertension and dyslipidemia. The combination is bioequivalent to amlodipine and atorvastatin given alone and does not modify the efficacy of either single agent. Amlodipine/atorvastatin is generally well tolerated, with a tolerability profile consistent with that of each single agent. Compared with the coadministration of each single agent, the convenience of single-pill amlodipine/atorvastatin has the potential to improve patient adherence and the management of cardiovascular risk in selected patients, thereby improving clinical outcomes.

Objectives: To analyse 2-year hospitalization and cost data collected during a prospective, double-blind, randomized, controlled trial comparing amlodipine, enalapril and placebo in normotensive patients with coronary artery disease (CAD)., Methods: All patients who were enrolled in the CAMELOT study were included in this economic substudy. Patients with CAD and normal blood pressure were randomized to amlodipine, enalapril or placebo, and followed up for 24 months (between 1999 and 2004). Data on hospitalizations and medication use were obtained from the clinical trial. Costs were assigned from secondary sources. Total costs ($US, year 2004 values) were estimated as the sum of costs associated with cardiovascular hospitalizations, study medications and concomitant cardiovascular medications. Costs and resource use were analysed by treatment arm overall and for selected patient subgroups. Cost differences were evaluated using nonparametric bootstrap techniques., Results: Of 1991 patients enrolled, 663 were treated with amlodipine, 673 were treated with enalapril and 655 were treated with placebo. Significantly fewer patients were hospitalized for cardiovascular reasons in the amlodipine group (16.4%) than in the placebo group (22.7%; p < 0.01), but not compared with the enalapril group (20.1%; p = 0.09). The amlodipine group also had numerically fewer days in hospital per patient (1.1) than the enalapril (1.3) and placebo (1.5) groups. Mean 2-year per-patient costs in the amlodipine group were estimated to be $US 609 and $US 717 lower than for the placebo and enalapril groups, respectively., Conclusions: These results suggest that use of amlodipine may reduce costs of care among CAD patients with normal blood pressure.

The most frequent cause of mortality and morbidity in industrialized countries is coronary artery disease (CAD), which in Europe alone is responsible for around two million deaths per year. In 2001 it accounted for about 260,000 hospital discharges in Italy. The costs of CAD treatment in Italy--which were borne by the Italian state, the third-party payer--amounted to 800 million euros. We propose to assess the pharmacoeconomic implications of using amlodipine besylate treatment in Italy for patients with coronary artery disease. The study is based on a post-hoc cost-effectiveness analysis that compared standard care supplemented by amlodipine besylate with ordinary standard care over a 36-month time horizon. The clinical outcome data were based on the prospective randomized evaluation of vascular effect of norvasc trial (PREVENT). Direct medical costs referred to the purchase costs of amlodipine besylate and the cost of National Health Service (NHS) hospitalization. The costs were discounted back at an annual rate of 5%. Patients administered amlodipine besylate exhibited a significant risk reduction with respect to any major vascular event or procedure when compared to the placebo group. The reduction mainly referred to unstable angina events and revascularization procedures. We estimated that the total cost of adding amlodipine besylate to standard care amounted to 139,050 euros per 1000 patients treated for 36 months. This represents a cost of 1780 euros per patient remaining free of any vascular event. Results were sensitive to both clinical and economic variables. The incremental costs of the alternative therapy ranged from 296 euros to 5066 per patient free of any event in, respectively, the best and worst scenario. Amlodipine besylate therapy can be a cost-effective strategy for CAD treatment in Italy. Our economic evaluation demonstrated, first, that by reducing vascular events and the need for revascularization procedures savings were achieved in hospital expenditure, and, second, that such savings could significantly offset drug costs.

Hypertension is prevalent in over 25% of populations in developed countries, and poses an increasing economic burden on health resources. Therefore it is predicted that future medical treatment of hypertension will be increasingly affected by cost considerations. Several classes of antihypertensive drugs are used as first-line agents for the treatment of hypertension, but the economic impact of using these agents in different countries remains to be addressed. In this study, we compared health costs associated with treatment of hypertension using the calcium channel blocker amlodipine and the angiotensin-converting enzyme inhibitor enalapril in the US and Japan. Pharmaceutical costs and hospitalization costs were analyzed from established databases. The data for the prevalence of myocardial infarction and stroke were derived from the Framingham study and the Hisayama study. Analysis of the economic impacts using relative risk differences between the calcium channel blocker and angiotensin-converting enzyme inhibitor together with regional hospitalization costs resulted in an apparent 11.2 billion yen health cost reduction in favor of the calcium channel blocker in the case of Japan, in contrast to an apparent 5.7 billion yen reduction in favor of the angiotensin-converting enzyme inhibitor in the case of the US. The trends in Japan for 2000 and 2004 were similar. These results suggest that there are regional differences in the health costs associated with different classes of hypertensive agents, which could affect national policies on the choice of antihypertensive drugs. It is predicted that future treatment of hypertension will be increasingly tailored to the epidemiologic profiles and medical costs of individual communities.

In Italy, revascularization interventions increased from 44,600 in 1996 to more than 100,000 in 2001. In particular, the occurrence of percutaneous transluminal coronary angioplasty (PTCA) increased from 239 cases per million population in 1994 to about 1300 cases per million population in 2001. This trend has caused a concomitant increase in revascularization costs, which have doubled in few years, rising from Euro 421 millions in 1996 to Euro 850 millions in 2001. In 2001, PTCA amounted to 55% of total cost of revascularizations. The aim of this study was to assess the pharmacoeconomic consequences of amlodipine besylate therapy administered in patients at high risk of restenosis after PTCA. We conducted a cost-effectiveness analysis comparing therapy with amlodipine besylate added to standard care versus standard care alone. Information on clinical outcomes was drawn from the Coronary Angioplasty Amlodipine Restenosis Study (CAPARES). Medical costs were estimated with reference to drug therapy and hospitalizations for coronary events and revascularization procedures. The study was conducted from the perspective of the Italian third party payer (National Health Service). The analysis was applied to a time horizon of 4 months. Amlodipine besylate resulted less expensive and more effective than standard care. It reduced mortality, morbidity for coronary reasons and the need of revascularization procedures. The cost per 1000 patients was estimated at Euro 1,166,000 in the placebo and Euro 950,000 in the amlodipine besylate group, resulting into a cost saving of Euro 216,000, that is 18.5% of total cost of standard care. Results are sensitive to the cost of amlodipine besylate and the cost of hospitalizations, but therapy with amlodipine besylate resulted dominant even in the most unfavorable hypothesis.

Aim: To assess antihypertensive efficacy of a low-dose combination of amlodipin with lisinopril in the treatment of patients with arterial hypertension (AH) of the second degree., Material and Methods: A total of 42 patients with the second degree of AH (16 males, 26 females, mean age 55-9 +/- 1.9 years) entered an open, comparative and controlled trial. They were divided into three groups by the treatment. Group 1 (n = 14) received amlodipin (normodipin, Gedeon Richter) monotherapy in a mean dose 8.9 +/- 0.6 mg/day, group 2 (n = 12) - lisinopril (diroton, Gedeon Richter) in a mean dose 17.5 +/- 1.4 mg/day, group 3 (n = 16) was given combined therapy with amlodipin+lisinopril in a dose 6.8 +/- 0.7 and 8.7 +/- 0.6 mg/day, respectively. The drugs were given for 12 weeks. The efficacy of the treatment was assessed by the results of 24-h monitoring of blood pressure, echocardiography, endothelium-related vasodilatation of the brachial artery (ERVD), dopplerographic investigation of circulation in the middle cerebral artery (MCA), heart rate and cost-effect estimation., Results: Combined low-dose treatment with amlodipin and lisinopril for 12 weeks allowed achievement of target blood pressure in more patients and lower systolic and diastolic blood pressure than monotherapy with each of the drugs. There was also a positive effect on E/A index, ERVD, MCA circulation., Conclusion: Low-dose combined treatment with lisinopril and amlodipin is more effective and cost-efficient. Moreover, lisinopril addition to amlodipin corrects side effects of amlodipin on central nervous system.

Objective: Evaluation of the effect of amlodipine on the hospitalizations for cardiovascular events (CVE) and their associated costs in patients with ischemic cardiopathy., Methods: Data from the multicenter, randomized, double-blind, placebo-controlled PREVENT (Prospective Randomized Evaluation of the Vascular Effects of Norvasc Trial) clinical trial were utilized. A tree-type model of decision was used in order to analyze the incremental costs expected from the treatment with amlodipine with regard to placebo. Hospitalization costs were estimated with regard to the DRG weights of the American Medicare adapted for the costs of average stay available in our environment., Results: Amlodipine reduced significantly the incidence of CVE that required hospitalization in contrast to placebo; 0.60 +/- 1.16 versus 0.77 +/- 1.31 (average +/- SD), p < 0.05. The expected direct expenses due to hospitalizations were higher in the placebo group than in the amlodipine group (saving of 205.76 Euro/patient). Total cost for patient in the amlodipine group was 1,723.52 Euro while in the placebo group was 1,929.28 Euro. When the relation cost/price shifted in the sensitivity analysis from 1.20 to 0.66 (cost of every hospitalization ranged between + 20% and -34%), the saving fluctuated from 330.56 Euro to 0. Accordingly, the breakeven point of the cost/price relation it is 0.66, and above this the treatment with amlodipine still generates savings in regard to its cost., Conclusions: Amlodipine is cost-effective in the treatment of the patients with ischemic cardiopathy, being able to reduce the hospital costs related to ischemic episodes in this type of patients.

Background: Irbesartan has been shown to reduce the doubling of serum creatinine (a strong predictor of progression to end-stage renal disease), the onset of end-stage renal disease and all-cause mortality in patients with type 2 diabetes when compared with standard care and amlodipine., Objective: The present study assessed the cost effectiveness of irbesartan, an angiotensin II receptor antagonist, and amlodipine, a calcium channel blocker, in the treatment of Canadian patients with diabetic nephropathy and hypertension., Methods: The analysis was conducted based on a Markov model using Monte Carlo simulation analysis to estimate the expected values for outcomes of interest. Transition probabilities were obtained from a comparative trial of amlodipine, irbesartan and standard care (antihypertensive treatment excluding other angiotensin II receptor antagonists or calcium channel blockers) in patients with overt diabetic nephropathy and hypertension. Canadian costs for the health states studied were obtained from published data., Results: Based on the results of the Monte Carlo simulation, irbesartan was dominant over standard care and amlodipine because it both reduces costs and leads to greater life expectancy. The incremental cost-effectiveness ratio for amlodipine in comparison with standard care was 102,000 dollars. Estimates of net benefit were correlated with transition probabilities relating to progression from the initial health state. The results were insensitive to univariate sensitivity analysis., Conclusions: Irbesartan use would lead to a reduction in medical costs and an increase in life expectancy when compared with amlodipine or standard care.

Objective: To estimate 8-year health and economic outcomes of the angiotensin II receptor blocker valsartan versus the calcium channel blocker amlodipine in therapy of patients with type 2 diabetes and microalbuminuria based on clinical endpoints from a 6-month randomized controlled clinical trial, the MicroAlbuminuria Reduction With VALsartan (MARVAL) study., Methods: We developed a Markov model that utilized urinary albumin excretion rate data to project patient distributions to 7 possible health states over 8 years. For each health state, we identified quality-adjustment weights (health utilities) and medical care costs from public sources. The model then calculated mean quality-adjusted survival, medical care costs, and cost-effectiveness ratios for each treatment arm. Treatment arms were compared with the incremental cost-effectiveness ratio., Results: Patients treated with valsartan gained 7 months (mean) per patient of quality-adjusted survival relative to patients treated with amlodipine (77 versus 70 months; P<0.01); valsartan patients also incurred 32,412 dollars (mean) per patient lower medical costs than amlodipine patients (92,058 dollars versus 124,470 dollars; P<0.01). Model results were consistent for each year of analysis and robust to changes in key model parameters., Conclusion: This research (1) extends 6-month clinical trial outcomes to an 8-year period, (2) translates health outcomes from technical clinical endpoints to quality-adjusted survival, and (3) estimates economic consequences of therapeutic outcomes. The results quantify the favorable long-term health (i.e., quality-adjusted survival) and economic benefits (i.e., lower total medical costs) of therapy with valsartan, an angiotensin II receptor blocker, versus amlodipine, a calcium channel blocker, in the treatment of patients with type 2 diabetes and microalbuminuria based on an extension of the results of a short-term clinical (MARVAL) trial. These research findings are important to the extent patients with type 2 diabetes and microalbuminuria do not receive the recommended antihypertensive agents that block the renin-angiotensin system (angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers).

Adhering to medication regimens has the potential to significantly improve clinical outcomes for persons with high blood pressure. A patient-related factor likely to affect adherence to treatment is the convenience of the prescribed drug regimen. The authors hypothesized that medication adherence would be superior and cost benefits would accrue in subjects who receive a once-daily, single-capsule, fixed-dose combination product for blood pressure control, compared with subjects who receive a similar regimen of separate components. A managed care organization that provides benefits for members enrolled in various health plans provided the data for this retrospective analysis. The database was used to assess medication adherence patterns for two groups of hypertensive subjects. Group 1 included subjects who had been prescribed the single-capsule, fixed-dose combination of amlodipine besylate/benazepril HCl. Group 2 comprised subjects who had been prescribed a regimen including an angiotensin-converting enzyme inhibitor and a dihydropyridine calcium channel blocker as separate drugs. Adherence was measured by the medication possession ratio, and medical resource utilization by the two groups was assessed during the study period. Group 1 (n=2754) and Group 2 (n=2978) were balanced with regard to age (mean, 53 years; range, 18-64 years) and sex (men, 50%; women, 50%). The overall medication possession ratio for Group 1 was significantly higher than that for Group 2 (80.8% vs. 73.8%; p<0.001). The average annual cost of cardiovascular-related care per subject was significantly lower in Group 1 compared with Group 2 (p<0.001). Subjects receiving the once-daily, single-capsule, fixed-dose combination of amlodipine/benazepril HCl demonstrated significantly better medication adherence and required fewer medical resources than did subjects receiving an angiotensin-converting enzyme inhibitor and a dihydropyridine calcium channel blocker as separate components.

Background: This retrospective study compared the efficacy, tolerability, and cost of two dihydropyridine calcium channel blockers., Methods: Charts of patients who had been on continuous antihypertensive therapy with amlodipine or felodipine for at least 6 months were reviewed. Analyses include mean changes in blood pressure, percentage of patients achieving blood pressure (BP) < 140/90 mm Hg, average dose, and cost per day of the two calcium channel blockers, average cost of additional medication, total medication cost per day, and cost to achieve BP control., Results: Eighty-seven percent of amlodipine-treated patients achieved BP control compared with 33% of felodipine-treated patients. Total medication cost to achieve BP control was 0.87 dollars per day for patients on amlodipine compared with 1.79 dollars per day for patients on felodipine., Conclusions: Amlodipine produced BP control in a greater percentage of patients than did felodipine at a lower total cost to achieve BP control. When evaluating the total cost of antihypertensive treatment, the cost of a drug alone can be misleading.

Background: Hypertension is common in older adults (aged > or =65 years). Treatment frequently requires multiple medications and can be expensive., Objective: This study measured the impact of substituting low-dose, fixed-combination therapy using the calcium channel blocker (CCB) amlodipine and the angiotensin-converting enzyme (ACE) inhibitor benazepril for high-dose CCB monotherapy or dual therapy with a CCB and an ACE inhibitor on antihypertensive drug costs, the incidence of adverse events, and blood-pressure control., Methods: A multicenter, pilot pharmacotherapy quality improvement program was undertaken in a long-term care facility setting. Consultant pharmacists reviewed pharmacy records and medical charts from long-term care facilities, identifying older patients with a diagnosis of hypertension who either took CCB concomitantly with an ACE inhibitor or experienced adverse events on high-dose CCB therapy. Eligible patients were identified and their physicians contacted regarding switching them to fixed-dose combination therapy., Results: A total of 51 patients at 17 facilities were switched to fixed-dose amlodipine/benazepril combination therapy; 94.1% were women and 5.9% were men (mean age, 85.1 years; range, 64-99 years). The mean number of comorbidities was 1.6. During the subsequent 2 months, mean blood pressure remained at levels similar to those at baseline. The number of patients reporting at least 1 drug-related adverse event decreased by 81.8% (P < 0.05), and the incidence of edema decreased by 75.0%. The mean per-patient cost of antihypertensive drugs decreased by 33.1% (P < 0.001), a mean per-patient savings of 19.21 US dollars per month., Conclusion: In patients aged > or =65 years with hypertension in long-term care facilities, a change from high-dose CCB monotherapy or CCB/ACE-inhibitor dual therapy to fixed-dose combination amlodipine/benazepril therapy significantly reduced drug costs and the incidence of adverse events and maintained blood-pressure control.

Introduction: The objective of this analysis was to evaluate the health economic benefits of using amlodipine in patients undergoing angioplasty procedures in Canada and Norway., Methods: A decision tree model was constructed to find the total expected cost per patient for a 4-month time period following an initial angioplasty. The model used clinical data from the Coronary Angioplasty Amlodipine Restenosis Study (CAPARES), a prospective, randomized, double blind, placebo-controlled trial conducted to investigate the effects of amlodipine on restenosis and clinical events in patients undergoing percutaneous transluminal coronary angioplasty (PTCA). Outcomes of interest to this analysis included MI, repeat PTCA, CABG, and all-cause mortality. Clinical experts from Canada and Norway were enlisted and a modified Delphi study approach was used to quantify healthcare resources consumed for each clinical outcome., Results: The use of amlodipine decreased the rates of MI, PTCA, and CABG by 2.0, 4.7, and 2.7%, respectively. The total expected cost per patient using amlodipine was $6,398.30 (US$4,323) in Canada and kr 59,993.27 (US$6,846) in Norway. The total expected cost per patient not using amlodipine was $6,519.37 (US$4,405) in Canada and kr 64,292.17 (US$7,337) in Norway. The model demonstrated potential cost-savings over a 4-month follow up period resulting from the improved clinical outcomes for patients using amlodipine with PTCA--$121,071 (US$81,844) per 1000 patients in Canada and kr 4,298,899 (US$490,074) per 1000 patients in Norway., Conclusions: The adjunctive use of amlodipine is a cost-effective therapeutic strategy to achieve more favorable clinical outcomes in patients undergoing PTCAs in Canada and Norway.

The objective of this analysis was to calculate the cost-effectiveness of amlodipine therapy in patients with coronary artery disease in Sweden. It is hypothesised that treatment with amlodipine will have an impact on overall cardiovascular disease treatment costs, resulting in a positive cost-effectiveness profile. A Markov cohort simulation model was constructed to simulate event-related and procedure-related health economic outcomes of coronary artery disease populations on amlodipine versus those on placebo. Patient level data from the Prospective Evaluation of the Vascular Effects of Norvasc Trial was used to populate the model. The total number of adverse cardiovascular clinical outcomes experienced over a three-year period was lower for patient on amlodipine than for those on placebo. The rate of hospitalisation per patient due to angina, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, congestive heart failure, and myocardial infarction in the placebo cohort was 64.7%, while the rate in the amlodipine cohort was 46.9%. The cost per patient was Swedish kroner (SEK)26,600 for amlodipine patients and SEK27,400 for placebo patients. The use of amlodipine resulted in improved clinical outcomes as well as a slight savings in cost over a three-year period.

Objective: To estimate the potential savings in overall cardiovascular disease (CVD) treatment costs for the US population with coronary artery disease (CAD) resulting from the use of amlodipine., Study Design and Methods: Using patient-level data from a retrospective analysis of the Prospective Evaluation of the Vascular Effects of Norvasc Trial (PREVENT), a randomised, placebo-controlled clinical trial (n = 825), we constructed a Markov cohort simulation model to estimate the health economic outcomes of patients with CAD treated with either amlodipine or placebo., Perspective: Healthcare payer perspective., Results: The expected number of CVD events for amlodipine recipients was significantly lower than the number of CVD events in the placebo cohort (p < 0.01). The net present value of the cost per patient for CVD treatment was estimated to be $US14 117 for amlodipine recipients and $US16 683 (1999 values, assuming a 3% discount rate) for placebo recipients over 3 years of follow-up with cost savings realised in the amlodipine cohorts after 6 months., Conclusions: According to the model, amlodipine results in an expected per patient cost savings of $US2566 over a 3-year period, mainly due to a reduction in hospitalisations for cardiovascular-related events and procedures.

Background: High health service expenditure on the one hand, and the politically declared objective of stability of statutory contributions and restriction of public funds on the other hand, have been central points of the political and social discussion for several years. The over-proportional increase in health service expenditure is obvious, compared to the increase in the costs of living., Patients and Methods: Cost-effectiveness of amlodipine in the treatment of coronary atherosclerosis was analysed by applying the results of the PREVENT study to the Swiss health system., Results: Calculation of effectiveness shows an additional life expectancy of 0.083 years in the amlodipine cohort compared to the placebo cohort, over an observation period of 3 years. The cost-effectiveness of amlodipine treatment is approximately CHF 14,650 per life-year gained., Conclusion: The administration of the calcium antagonist amlodipine in CHD patients is cost-effective.

The cost of treating hypertension represents a substantial percentage of total pharmacy expenditures at medical centers and by managed care organizations in the United States. The present study evaluated improvements in blood pressure control and cost savings achieved by switching 543 hypertensive patients from nifedipine gastrointestinal therapeutic system (GITS) to amlodipine and concurrently instituting an educational program directed at prescribers, nursing and pharmacy staff, and patients and family members. Before the switch, 543 patients were being treated with nifedipine GITS: 259 with 30 mg/d, 209 with 60 mg/d, and 75 with 90 mg/d. The total annual cost of primary antihypertensive therapy for this patient population was $184,698. All patients were switched from nifedipine GITS to 5 mg of amlodipine. The pharmacist saw patients at the time of the switch and at 2, 4, and 6 to 8 weeks after the change in antihypertensive therapy. Patients who did not achieve systolic blood pressure < or = 140 mm Hg or diastolic blood pressure < or = 90 mm Hg by 6 to 8 weeks after the switch were titrated to 10 mg/d amlodipine. After the conversion, 417 patients were receiving amlodipine 5 mg/d and 126 patients were ultimately titrated to 10 mg/d. Measurements made during the first 6 to 8 weeks of treatment indicated that amlodipine therapy significantly reduced blood pressure. Overall, amlodipine produced further mean reductions in blood pressure, from 140/82 to 130/76 mm Hg (p < 0.00005). The mean reduction from the time of the switch to 6 to 8 weeks was from 138/81 to 129/74 mm Hg for the patients who received 5 mg/d amlodipine (p < 0.00001) and from 147/85 to 133/79 mm Hg for the patients ultimately titrated to 10 mg/d amlodipine (p < 0.05). The total annual cost for primary antihypertensive therapy after the conversion was $136,854. We observed that conversion from nifedipine GITS to amlodipine enhanced blood pressure control and saved $47,844 in the annual cost of primary antihypertensive medication. For the 543 patients undergoing the switch, annual cost savings was $47,844. When the cost of additional antihypertensive agents discontinued after the switch to amlodipine was added to the analysis, the net annual cost savings increased to $49,578, a 27% reduction in yearly drug costs.

Objective: To make a cost-effectiveness analysis (CEA) comprehensive evaluation for 4 hypotensive drugs, by observing the effects of drugs on blood pressure lowering, symptom improving, and adverse effect and quality of life (QOL) influencing., Methods: Two hundred and ninety-two patients with mild to moderate hypertension were divided into 4 groups at random and treated with compound Lingjiao Jiangya Pill, benazepril, amlodipine and indapamide respectively with a therapeutic course of 6 weeks. QOL was measured with FS-36 questionnaire and efficacy policy model was applied for comprehensive evaluation of CEA., Results: Through CEA a comprehensive evaluation was made in order as follows: indapamide 3.65 which was the best, and then Lingjiao Jiangya Pill 3.55, amlodipine 2.90 and benazepril 2.35., Conclusion: The 4 drugs can not only lower blood pressure but also improve clinical symptoms with less adverse effect. It is of great practical significance to evaluate hypotensive drugs by combining QOL appraisal. The position of Lingjiao Jiangya Pill in CEA order suggests that more attention should be paid to herbal hypotensive drugs.

Study Objective: To compare 24-hour blood pressure control and adverse effects in patients with essential hypertension who were switched from amlodipine to nisoldipine., Design: Open-label, one-way crossover study., Setting: Cardiac clinic and patients' homes., Patients: Twenty-five patients with stage I or II essential hypertension stabilized with amlodipine for at least 3 months, of whom 21 patients completed the study., Intervention: All patients underwent 24-hour ambulatory blood pressure monitoring while receiving amlodipine 5 or 10 mg/day. Patients then were switched to nisoldipine 10 mg/day (> or = 65 yrs old) or 20 mg/day (< 65 yrs old) and returned to the clinic at 2-week intervals to assess cuff blood pressure, heart rate, adverse effects, and compliance. No adverse effects were experienced in 15 of the 25 patients. Lower extremity edema was the most commonly reported adverse effect (four patients). Two patients discontinued treatment because of pulmonary edema in one and chest pain in the other. Two patients were lost to follow-up. After a mean of 10.6 weeks, repeat 24-hour ambulatory monitoring was performed to evaluate blood pressure control with nisoldipine. Systolic and diastolic ambulatory results for daytime, nighttime, and total 24 hours were calculated. For amlodipine versus nisoldipine, no significant differences existed in any of the blood pressure parameters (p>0.05) in the 21 patients who completed the study, except for 24-hour diastolic pressure (p<0.05); however, this latter difference was only 2 mm Hg (nisoldipine 77 mm Hg, amlodipine 75 mm Hg)., Conclusion: Both amlodipine and nisoldipine have similar 24-hour ambulatory blood pressure profiles. The frequency of lower extremity edema was no different after the switch to nisoldipine than when the patients were taking amlodipine.

Background: Recent hypertension trials have demonstrated the importance of achieving goal blood pressures to reduce the risk of target organ damage. In patients with moderate to severe hypertension, the use of high-dose monotherapy and/or combinations of drugs are necessary to achieve these goals. Fixed-dose combination products may be useful in these patients by reducing the number of daily doses required to control blood pressure., Objective: The objective of the present study was to evaluate the efficacy and safety of a therapeutic interchange between high-dose calcium channel blocker therapy and a fixed-dose combination of amlodipine/ benazepril (Lotrel; Novartis Pharmaceuticals, USA) in patients with moderate to severe hypertension., Methods: A total of 75 patients were switched from amlodipine (n = 25), felodipine (n = 25), and nifedipine-GITS (n = 25) to amlodipine/benazepril. Twenty-eight of the 75 patients (37%) were taking either a beta-blocker or a diuretic in addition to the high-dose calcium channel blocker prior to the switch. Blood pressure control, side effects and the cost of the therapeutic interchange were evaluated in the year following the therapeutic interchange., Results: Sixty-six of the 75 (88%) patients were successfully switched with maintenance of blood pressure control and without the development of new dose-limiting side effects. Reasons for treatment failure after the therapeutic interchange included loss of blood pressure control in five patients and the development of new dose-limiting side effects in four patients. These side effects included cough in three patients and rash in one patient. After accounting for differences in drug acquisition cost and costs related to the switch (clinic and emergency room and laboratory tests), a cost savings of $16030 for all 75 patients was realised in the first year. The per patient-per year cost savings was $214., Conclusions: Our data indicate that a therapeutic interchange from selected high-dose calcium channel blockers to a fixed-dose combination of amlodipine/ benazepril can be successfully accomplished in the majority of patients.

A comparison of treatment costs and cost effectiveness was performed retrospectively by using patient-level data from a randomized, controlled, one-year clinical trial of amlodipine and enalapril in the treatment of mild-to-moderate hypertension. Unit costs of amlodipine and enalapril were applied to the daily dosages of individual patients to calculate the total costs and average costs per patient in each treatment group in the clinical trial on an intent-to-treat basis. Efficacy rates were used to calculate the average treatment costs per success in blood pressure control. Although not statistically significant, amlodipine treatment resulted in a higher efficacy (89.5%) vs. enalapril (85.2%). The average costs per amlodipine-treated patient were consistently lower (-$112.30) than for the enalapril-treated patient by week 50. Treatment with amlodipine resulted in an average cost per success of $609 per patient compared with $772 per enalapril-treated patient. A sensitivity analysis revealed that, in the treatment of mild-to-moderate hypertension over the 50-week treatment period, amlodipine would remain less costly than enalapril, with a decrease in the cost of enalapril of up to 17%, and would remain more cost effective, with a 21% decrease in the cost of enalapril.