Effectiveness of Levoamlodipine Maleate for Hypertension Compared with Amlodipine Besylate: a Pragmatic Comparative Effectiveness Study.

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.

Economic evaluation of olmesartan/amlodipine fixed-dose combination for hypertension treatment in China.

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 vs free-dose combinations for the management of hypertension-An analysis of 81 958 patients.

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.

Cost-effectiveness of the polypill versus risk assessment for prevention of cardiovascular disease.

OBJECTIVE: There is an international trend towards recommending medication to prevent cardiovascular disease (CVD) in individuals at increasingly lower cardiovascular risk. We assessed the cost-effectiveness of a population approach with a polypill including a statin (simvastatin 20 mg) and three antihypertensive agents (amlodipine 2.5 mg, losartan 25 mg and hydrochlorothiazide 12.5 mg) and periodic risk assessment with different risk thresholds. METHODS: We developed a microsimulation model for lifetime predictions of CVD events, diabetes, and death in 259 146 asymptomatic UK Biobank participants aged 40-69 years. We assessed incremental costs and quality-adjusted life-years (QALYs) for polypill scenarios with the same combination of agents and doses but differing for starting age, and periodic risk assessment with 10-year CVD risk thresholds of 10% and 20%. RESULTS: Restrictive risk assessment, in which statins and antihypertensives were prescribed when risk exceeded 20%, was the optimal strategy gaining 123 QALYs (95% credible interval (CI) -173 to 387) per 10 000 individuals at an extra cost of £1.45 million (95% CI 0.89 to 1.94) as compared with current practice. Although less restrictive risk assessment and polypill scenarios prevented more CVD events and attained larger survival gains, these benefits were offset by the additional costs and disutility of daily medication use. Lowering the risk threshold for prescription of statins to 10% was economically unattractive, costing £40 000 per QALY gained. Starting the polypill from age 60 onwards became the most cost-effective scenario when annual drug prices were reduced below £240. All polypill scenarios would save costs at prices below £50. CONCLUSIONS: Periodic risk assessment using lower risk thresholds is unlikely to be cost-effective. The polypill would become cost-effective if drug prices were reduced.

[Evaluation of the pharmacoeconomic efficacy of prestance in the treatment of hypertensive patients on the basis of the results of the POTENTIAL program]. / Otsenka farmakoekonomicheskoi effektivnosti preparata prestans pri lechenii bol'nykh arterial'noi gipertoniei na osnove rezul'tatov programmy POTENTsIAL.

AIM: To pharmacoeconomically estimate the use of a fixed-dose combination of perindopril and amlodipine in the treatment of hypertensive patients. MATERIAL AND METHODS: A pharmacoeconomic study was conducted on the basis of the Russian postmarketing observational open program POTENTIAL, which included the estimation of direct and indirect costs associated with the addition of a fixed-dose combination of perindopril and amlodipine to conventional therapy for hypertension in patients who had not achieved adequate blood pressure (BP) control. Cost-difference, cost-effectiveness, and budget-impact analyses were carried out. RESULTS: The addition of prestance to conventional therapy for hypertension can reduce total costs by 5.-5.8 times, direct costs required to achieve 1% of patients with adequate BP control by 20.5-42.1 times, and direct costs to improve a patient's status by one visual analogue scale score by 1.03-2.11 times. Within a 5-year horizon, the administration of prestance can decrease the cost of therapy for high BP and related strokes by 1.39-1.46 times. CONCLUSION: Due its high efficacy, prestance (amlodipine + perindopril) is a pharmacoeconomically preferred alternative only to the conventional therapy for hypertension even if the least costly generics are used, in both the short and medium term.

Clinical effectiveness and safety of low cost versus innovator brand amlodipine in hypertension: A single-blinded, randomized, crossover, noninferiority trial.

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.

Economic evaluation of single-pill combination of indapamide and amlodipine in the treatment of arterial hypertension in the Polish setting.

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.

Clinical outcomes and healthcare costs in hypertensive patients treated with a fixed-dose combination of amlodipine/valsartan.

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.

Generic substitution, financial interests, and imperfect agency.

Policy makers around the world seek to encourage generic substitution. In this paper, the importance of prescribing physicians' imperfect agency is tested using the fact that some Swiss jurisdictions allow physicians to dispense drugs on their own account (physician dispensing, PD) while others disallow it. We estimate a model of physician drug choice with the help of drug claim data, finding a significant positive association between PD and the use of generics. While this points to imperfect agency, generics are prescribed more often to patients with high copayments or low incomes.

Clinical and economic outcomes associated with amlodipine/renin-angiotensin system blocker combinations.

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.

Improving drug adherence using fixed combinations caused beneficial treatment outcomes and decreased health-care costs in patients with hypertension.

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.

[Medical mistakes due to generic substitution]. / Medicineringsfejl ved generisk substitution.

Generic substitution is a major cause of medical mistakes in the general population. Danish legislation obligates pharmacies to substitute prescribed medicine with the cheapest equivalent formulation, despite variations in product name, packaging, shape and colour. Consequently, medical mistakes occur. Scientific evidence on the consequences of generic substitution is sparse. Call upon fellow health workers to report medical mistakes to the national entities and scientific peers, in order to increase awareness and scientific evidence about the problem.

An economic evaluation of antihypertensive therapies based on clinical trials.

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.

An economic evaluation of antihypertensive therapies based on clinical trials

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.

Comparison of real-world adherence, healthcare resource utilization and costs for newly initiated valsartan/amlodipine single-pill combination versus angiotensin receptor blocker/calcium channel blocker free-combination therapy.

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.

[Fixed drug combinations in hypertension: a budget impact analysis for the Spanish Health System on the marketing of a fixed combination of olmesartan/amlodipine]. / Las combinaciones fijas en hipertensión: análisis de impacto presupuestario para el Sistema Nacional de Salud Español de la comercialización de la combinación fija de olmesartan/amlodipino.

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.

Comparison of amlodipine/valsartan fixed-dose combination therapy and conventional therapy.

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.

Análisis del impacto presupuestario para el Sistema Nacional de Salud de la combinación fija de amlodipino 5 o 10mg y atorvastatina 10mg / Analysis of the budget impact for the Spanish National Health System of the fixed combination of amlodipine 5 or 10mg and atorvastatin 10mg

Objetivo Realizar un análisis de impacto presupuestario (AIP) de la introducción en la prestación sanitaria del sistema nacional de salud (SNS) de la combinación fija (CF) de amlodipino 5 o 10mg y atorvastatina 10mg en la indicación aprobada. Material y métodos El AIP se ha realizado desde la perspectiva del SNS para un periodo de 3 años (2009–2011). Se ha diseñado un modelo de decisión tipo árbol (árbol de pacientes) construido a partir de datos epidemiológicos y la literatura científica para estimar la población hipertensa susceptible de tratamiento con la CF. El AIP, por año y en total, se ha calculado imputando el coste a PVP-IVA de la CF al número de pacientes a tratar, del que se sustrae el coste del tratamiento antihipertensivo que se sustituye y el coste por paciente promedio actualizado de los eventos cardiovasculares prevenidos para el SNS por el uso de la CF en el periodo de referencia. Resultados La población susceptible de tratamiento con la CF es de 51.104 pacientes (1.er año), con una tasa de crecimiento entre 1–2% en los sucesivos años, lo que supone un coste (€) anual de 15,9M (2009), 19,9M (2010) y 24,1M (2011), totalizando 60,0M. El AIP se ve compensado mostrando valores de impacto negativo para el SNS cuando se descuentan los costes del tratamiento antihipertensivo sustituido y eventos cardiovasculares prevenidos, mostrando un ahorro de 69,9M € en 3 años. Conclusión El AIP de la CF de atorvastatina y amlodipino muestra que su uso en la indicación aprobada podría generar ahorros netos para el SNS en el periodo 2009–2011 de 9,9M (AU)

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 (1st year), with a growth rate of between 1–2% over the following years, which means an annual cost (€) 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 €69.9M 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 €9.9M for the period 2009–2011 (AU)

[Analysis of the budget impact for the Spanish National Health System of the fixed combination of amlodipine 5 or 10mg and atorvastatin 10mg]. / Análisis del impacto presupuestario para el Sistema Nacional de Salud de la combinación fija de amlodipino 5 o 10mg y atorvastatina 10mg.

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.