Healthcare resource use and costs associated with cervical, vaginal and vulvar cancers in a large U.S. health plan.

OBJECTIVES: To estimate healthcare resource utilization and costs of cervical, vulvar and vaginal cancers in a large U.S. health plan. METHODS: We estimated incremental ambulatory visits, hospitalizations, prescription fills and healthcare costs for cancer cases relative to population controls. Data for cervical (n=2788), vulvar (n=621) and vaginal cancer (n=254) cases and an identical number of controls were obtained from a large U.S. health plan. Cases were identified via diagnostic codes on a healthcare claim and matched to controls. Incremental resource use was assessed using a two-stage regression method developed by Carides, with costs analyzed using Lin's regression method. RESULTS: Through 4 years of follow-up, cervical cancer patients had incremental resource use of 12.0 ambulatory visits, 0.6 hospital admissions and 7.0 prescription fills per case. Cumulative 4-year incremental healthcare costs per case ranged from $8236 for vulvar cancers to $18,799 for cervical cancers. When adjusted to cervical, vulvar and vaginal cancer excess mortality rates observed within the U.S. Surveillance Epidemiology and End Results program, estimated incremental costs were $29,649 for cervical, $11,356 for vulvar and $21,963 for vaginal cancers. There was a significant upward trend in costs with increasing age for cervical cancer, however trends were less consistent for vulvar and vaginal cancers. CONCLUSIONS: Direct medical costs associated with cervical, vulvar and vaginal cancers were observed to be substantial. These data can help inform evaluations of the economic burden and cost-effectiveness of prevention of these cancers, particularly for vulvar and vaginal disease, where such data have not been previously reported.

Reductions in human papillomavirus-disease resource use and costs with quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccination: the FUTURE Study Economic Evaluation.

OBJECTIVE: To examine the short-term impact of quadrivalent human papillomavirus (HPV) (types 6/11/16/18) recombinant vaccination upon HPV disease-related health-care resource utilization and costs among young women. METHODS: We analyzed data from a randomized clinical trial comparing quadrivalent vaccination to placebo, among women (N = 7861) primarily 16 to 23 years of age at enrollment. HPV disease episodes, health-care resource utilization and costs associated with cervical, vaginal, and vulvar precancers, and anogenital warts were analyzed over a period of 2.5 years among women, regardless of baseline HPV status. RESULTS: Overall, there was a 25.9% (P < 0.001) reduction in total HPV disease-related health-care costs among women receiving vaccine versus placebo (absolute reduction $3939 per 100 trial enrollees). We observed similar overall reductions in HPV-disease episodes and resource utilization. There was a statistically significant reduction in HPV 6/11-related disease episode costs of 65.1% ($1837 per 100), and a reduction of 51.4% ($1781 per 100) in HPV 16/18-related episode costs. CONCLUSIONS: Quadrivalent HPV vaccination can reduce HPV disease events, resource use and costs when administered to a broad population of young women 16 to 23 years of age. Prevention of HPV types 6 and 11 yielded similar value in terms of HPV disease cost offsets, compared to protection against HPV 16 and 18, during the years initially after vaccination. Over the short-term, costs of vaccination exceed cost offsets associated with prevention of HPV disease; however, quadrivalent HPV vaccination has previously been shown to be cost-effective in the longer term, when fully accounting for health benefits and cost offsets.

An economic assessment of losartan-based versus atenolol-based therapy in patients with hypertension and left-ventricular hypertrophy: results from the Losartan Intervention For Endpoint reduction (LIFE) study adapted to The Netherlands.

BACKGROUND: The Losartan Intervention For Endpoint reduction (LIFE) study was a randomized, doubleblind trial that compared the effects of losartan-based treatment with those of atenolol-based treatment on cardiovascular disease (CVD)-related morbidity and mortality in 9193 patients with hypertension and left-ventricular hypertrophy (LVH). Compared with atenolol, losartan reduced the combined risk for CVD-related morbidity and mortality by 13% (P = 0.021), and reduced the risk for stroke by 25% (P = 0.001), with comparable blood pressure control in both trial arms. OBJECTIVE: The aim of this study was to analyze the cost-effectiveness of losartan compared with atenolol in the treatment of stroke from the Dutch health care perspective. METHODS: Utilization of losartan and atenolol within the trial period (mean, 4.8 years) and an estimation of direct medical costs of stroke for The Netherlands were combined with estimates of reduction in life expectancy through stroke. Medication costs and stroke incidence during 5.5 years of patient follow-up were estimated separately, adjusted for the baseline degree of LVH and Framingham risk score. To estimate lifetime stroke costs, the cumulative incidence of stroke was multiplied by the lifetime direct medical costs attributable to stroke. All costs are in 2006 Dutch prices and discounted following the former (4% costs and effects) and new Dutch guideline (4% costs, 1.5% effects) for conducting pharmacoeconomic analyses. RESULTS: With 4% discounting, prevention of stroke was associated with a gain of 3.7 life-years. As a consequence, losartan treatment was associated with 0.059 life-year gained (LYG) per patient treated with losartan. Losartan reduced stroke-related costs by 1,076 Euros (US $1,349) per patient. After inclusion of study medication cost, net cost per patient was 51 Euros ($64) higher for losartan than atenolol. The net cost per LYG was 864 Euros ($1083), which is below the Dutch pharmacoeconomic threshold of 20,000 Euros/LYG (~$25,000/LYG) for accepting interventions. The corresponding probability of a cost-effectiveness ratio below this Dutch threshold was 0.95. Discounting money and health following the new Dutch guideline resulted in an even more favorable cost-effectiveness for losartan. CONCLUSIONS: Results from the present analysis suggest that, in The Netherlands, treatment with losartan compared with atenolol may well be a cost-effective intervention based on the reduced risk for stroke observed in the LIFE trial.

[Cost-effectiveness of treatment of high blood pressure with losartan in Denmark]. / Omkostningseffektivitet ved hypertensionsbehandling med losartan i Danmark.

INTRODUCTION: The purpose of this analysis was to evaluate the cost-effectiveness of losartan compared with atenolol for the treatment of hypertension, both from the point of view of society and from that of the health care sector, based on data from the LIFE study. MATERIALS AND METHODS: The computations are based on a simple decision tree model, where the probability of stroke was obtained from the LIFE study, a double-blind, randomised clinical study of 9,193 patients with hypertensive left ventricle hypertrophy. RESULTS: The treatment of hypertension with losartan rather than atenolol entails a cost of DKK 19,668 per gained quality-adjusted life year (QALY), when only the cost of the health care sector is taken into account, and DKK 72,564 if all costs to society are included. CONCLUSION: The analysis shows that treatment with losartan is cost-effective even when the uncertainty in both data and economic evaluations is taken into account.

The impact of losartan on the lifetime incidence of end-stage renal disease and costs in patients with type 2 diabetes and nephropathy.

INTRODUCTION: The RENAAL (Reduction of Endpoints in Non-insulin dependent diabetes with the Angiotensin II Antagonist Losartan) study demonstrated that, in hypertensive patients with type 2 diabetes mellitus and nephropathy, treatment with losartan plus conventional antihypertensive therapy (CT) reduced the relative risk of end-stage renal disease (ESRD) by 29% versus placebo over the time span of the study (mean patient follow-up of 3.4 years). The objective of this study was to project the effect of losartan compared with placebo on the lifetime incidence of ESRD and associated costs (from a US healthcare system perspective). METHODS: To estimate lifetime incidence of ESRD, we used a competing risks method to account for the risk of death without ESRD. We estimated the cost (US dollars, year 2002 values) associated with ESRD by combining the cumulative incidence of ESRD with the lifetime cost associated with ESRD. Total cost was estimated as the sum of the cost associated with ESRD, the cost of losartan study therapy and other costs (non-ESRD/non-losartan) expected for patients with type 2 diabetes. Survival was estimated by weighting the life expectancies with and without ESRD by the cumulative risk of ESRD. Costs and outcomes were discounted by 3% per annum. RESULTS: We projected a lower lifetime incidence of ESRD for losartan patients (66%) compared with placebo patients (83%). This reduction in ESRD resulted in a decrease in cost associated with ESRD of US dollars 31,803 per patient and a gain of 0.99 life-years per patient (0.70 discounted). After accounting for the cost of losartan and the additional cost associated with greater survival, we projected that treatment with losartan would result in a lifetime net saving of US dollars 24,632 per patient. CONCLUSION: Treatment with losartan plus CT in patients with type 2 diabetes and nephropathy reduced the within-trial incidence of ESRD and is projected to result in lifetime reductions in ESRD and associated costs, and increased survival, versus placebo.

Losartan reduces the costs of diabetic end-stage renal disease: an Asian perspective.

OBJECTIVE: To evaluate losartan and conventional antihypertensive therapy (CT) compared with CT alone on the cost associated with end-stage renal disease (ESRD) in Hong Kong, Japan, Korea, Malaysia, Singapore and Taiwan. METHODS: Reduction of end-points in non-insulin-dependent diabetes mellitus with the angiotensin II antagonist losartan (RENAAL) was a multinational, double-blind, randomized, placebo-controlled trial to evaluate the renal protective effects of losartan on a background of CT in patients with type 2 diabetes and nephropathy. The primary composite end-point was a doubling of serum creatinine, ESRD or death. Data on the duration of ESRD for the Asian subgroup of patients enrolled in RENAAL were used to estimate the economic benefits of slowing the progression of nephropathy. The cost associated with ESRD was estimated by combining the number of days each patient experienced ESRD with the average daily cost of dialysis from the third-party payer perspective in Hong Kong, Japan, Korea, Malaysia, Singapore and Taiwan. Total cost, converted to US dollars, was the sum of ESRD and losartan costs. RESULTS: Losartan plus CT reduced the number of days with ESRD by 37.9 per patient over 3.5 years compared with CT alone. This reduction in ESRD days resulted in a decrease in the cost associated with ESRD, which ranges from $910 to $4346 per patient over 3.5 years across the six countries or regions. After accounting for the cost of losartan, the reduction in ESRD days resulted in net savings in each of the six countries or regions, ranging from $55 to $515 per patient. CONCLUSION: Treatment with losartan in patients with type 2 diabetic nephropathy not only reduced the incidence of ESRD among Asian patients, but resulted in direct medical cost savings in countries or regions representing Asia.

The impact of losartan on the lifetime incidence of ESRD and costs in Mexico.

BACKGROUND: The RENAAL (Reduction of Endpoints in Type 2 Diabetes with the Angiotensin II Antagonist Losartan) study demonstrated that treatment with losartan reduced the risk of ESRD by 29% among hypertensive patients with type 2 diabetes and diabetic nephropathy. The objective of this study was to project the effect of losartan compared to placebo on the lifetime incidence of ESRD and associated costs from a third-party payer perspective in Mexico. METHODS: A competing risks method was used to estimate lifetime incidence of ESRD, while accounting for the risk of death without ESRD. The cost associated with ESRD was estimated by combining the cumulative incidence of ESRD with the lifetime cost associated with ESRD. Total cost was estimated as the sum of the cost associated with ESRD from the three main public institutions in Mexico, the lifetime cost of losartan therapy, and other costs (non-ESRD/non-losartan) expected for patients with type 2 diabetes. Survival was estimated by weighting the life expectancies with and without ESRD by the cumulative risk of ESRD. RESULTS: The projected lifetime incidence of ESRD for losartan patients was lower (66%) compared with placebo patients (83%). This reduction in ESRD resulted in a decrease in ESRD-related cost of M dollar 49,737 per patient and a discounted gain of 0.697 life years per patient. After accounting for the cost of losartan and the additional cost associated with greater survival, we projected that treatment with losartan would result in a net savings of M dollar 24,073 per patient. CONCLUSION: Treatment with losartan in patients with type 2 diabetes and nephropathy not only reduced the within-trial incidence of ESRD but is projected to result in lifetime reductions in ESRD, increased survival, and overall cost savings to public institutions in Mexico.

Comparison of losartan and captopril on heart failure-related outcomes and symptoms from the losartan heart failure survival study (ELITE II).

BACKGROUND: Blockade of the renin-angiotensin system with angiotensin-converting enzyme inhibitors improves outcomes and symptoms in patients with heart failure (HF). We compared effects of losartan to captopril on mortality, morbidity, and functional status for patients in the ELITE II study. METHODS AND RESULTS: A total of 3152 patients, aged 60 years or older, with New York Heart Association (NYHA) classes II to IV HF and ejection fraction < or = 40% were assigned to receive losartan 50 mg once daily or captopril 50 mg 3 times daily. Outcome measures included all-cause and HF-related mortality, hospitalizations, and discontinuations; change in NYHA class; and quality of life (QoL). HF-related outcomes were not significantly different between therapies. Similar improvements from baseline (P < .01) in NYHA class were observed within both treatment groups. Among 1856 QoL participants, 1343 patients survived at least 1 year; the QoL for 1-year survivors improved in both treatment groups (P < .001 vs baseline) and did not differ between groups. CONCLUSIONS: In ELITE II, the effects of losartan on HF-related outcomes, NYHA class, and QoL were not superior to those of captopril. Although angiotensin-converting enzyme inhibitors remain the treatment of choice for patients with HF, the similarity of the findings in the present analysis supports a role for angiotensin-receptor antagonists in this patient population.

Cost effectiveness of losartan in patients with hypertension and LVH: an economic evaluation for Sweden of the LIFE trial.

OBJECTIVE: Evaluate the cost effectiveness of losartan compared with atenolol from a Swedish national health system perspective. DESIGN: The Losartan Intervention For Endpoint reduction in hypertension study (LIFE) was a double-masked, randomized trial of losartan versus atenolol in 9193 patients with essential hypertension and left ventricular hypertrophy (LVH) ascertained by electrocardiography. Losartan reduced the primary composite end point of cardiovascular death, myocardial infarction (MI), or stroke by 13% (P = 0.021) and reduced the risk of stroke by 25% (P = 0.001), despite a comparable degree of blood pressure control. METHODS: Life years gained was estimated by combining the absolute risk reduction in stroke with the life years gained by preventing stroke. Quality-adjusted life years (QALYs) gained was estimated by combining the absolute risk reduction in stroke with the QALYs gained by preventing stroke. QALYs were estimated by weighting life years by health-related quality of life (QoL), as measured with visual analogue scale (VAS) data collected in the trial. Net costs were defined as the total of study medication cost, stroke-related costs, and costs of increased survival. Costs are in 2003 Swedish prices. All costs and effects were discounted at a 3% annual rate. RESULTS: Prevention of a stroke resulted in a gain of 5.7 life years and 4.3 QALYs. As a consequence, losartan treatment resulted in a per patient increase of 0.092 life years [95% confidence interval (CI): 0.038, 0.146] and 0.069 QALYs (95% CI: 0.028, 0.109) as compared with atenolol treatment. Losartan reduced direct stroke-related cost per patient by 1141 euros due to a lower cumulative incidence of stroke for losartan at 5.5 years (4.9%) as compared with atenolol (6.5%) (95% CI of difference: 0.7, 2.5). The reduction in stroke-related cost offset 80% of the added cost of losartan drug therapy. After inclusion of study medication cost, net cost per patient was 289 euros higher for losartan than atenolol. The net cost per QALY gained for losartan was 4188 euros (37,813 SEK), which is well within common Swedish benchmark upper values (200-500,000 SEK) for accepted cost-effective interventions. CONCLUSION: Based on the results from the LIFE trial, treatment with losartan compared with atenolol, in hypertensive patients with LVH, is a cost-effective intervention.

The impact of losartan on the lifetime incidence of ESRD and costs in Mexico / El impacto del losartan en la incidencia de por vida de la enfermedad renal de la etapa terminal y sus costos en México

Background. The RENAAL (Reduction of Endpoints in Type 2 Diabetes with the Angiotensin II Antagonist Losartan) study demonstrated that treatment with losartan reduced the risk of ESRD by 29% among hypertensive patients with type 2 diabetes and diabetic nephropathy. The objective of this study was to project the effect of losartan compared to placebo on the lifetime incidence of ESRD and associated costs from a third-party payer perspective in Mexico. Methods. A competing risks method was used to estimate lifetime incidence of ESRD, while accounting for the risk of death without ESRD. The cost associated with ESRD was estimated by combining the cumulative incidence of ESRD with the lifetime cost associated with ESRD. Total cost was estimated as the sum of the cost associated with ESRD from the three main public institutions in Mexico, the lifetime cost of losartan therapy, and other costs (non-ESRD/non-losartan) expected for patients with type 2 diabetes. Survival was estimated by weighting the life expectancies with and without ESRD by the cumulative risk of ESRD. Results. The projected lifetime incidence of ESRD for losartan patients was lower (66%) compared with placebo patients (83%). This reduction in ESRD resulted in a decrease in ESRD-related cost of M$49,737 per patient and a discounted gain of 0.697 life years per patient. After accounting for the cost of losartan and the additional cost associated with greater survival, we projected that treatment with losartan would result in a net savings of M$24,073 per patient. Conclusion. Treatment with losartan in patients with type 2 diabetes and nephropathy not only reduced the within-trial incidence of ESRD but is projected to result in lifetime reductions in ESRD, increased survival, and overall cost savings to public institutions in Mexico.

Antecedentes. El estudio RENAAL (Reducción de los grados o puntos terminales en la diabetes tipo 2 con losartan, el antagonista de la anglotenslna II) demostró que el tratamiento con losartan redujo el riesgo de la ESRD (enfermedad renal de la etapa terminal) en 29% entre pacientes hipertensos con diabetes tipo 2 y neuropatía diabética. El propósito estudiado fue hacer una proyección del efecto del losartan comparándolo con el placebo en la incidencia de por vida de la ESRD y con los costos asociados de un tercer pagador en perspectiva en México. Métodos. Se utilizó un método de riesgos muy competitivo para calcular la incidencia de por vida de la ESRD, al mismo tiempo que se calculaba el riesgo de muerte sin la ESRD. El costo asociado con la ESRD se calculó confirmando la incidencia acumulativa de la ESRD en relación con el costo de por vida de la terapia con losar-tan y otros costos (sin ESRD o sin losartan) con los que se contaba para pacientes con diabetes tipo 2. La supervivencia se calculó esperando las expectativas de vida con y sin ESRD por el riesgo acumulativo de ESRD. Resultados. La proyectada incidencia de por vida de la ESRD en cuanto a los pacientes con losartan fue más baja (66%) comparada con los pacientes que tomaron placebo (83%). Esta reducción de la ESRD tuvo por resultado una disminución en el costo relacionado con la ESRD de $49,737 por paciente y una ganancia descartada de 0.697 años de vida por paciente. Luego de contabilizar el costo del losartan y el costo añadido asociado con una mayor supervivencia, llegamos a la conclusión de que el tratamiento con losartan daría por resultado un ahorro neto de $24,073 por paciente. Conclusión. El tratamiento mediante losartan en pacientes aquejados de diabetes tipo 2 y neuropatía no sólo redujo la incidencia intraexperimental de la ESRD, sino que además nos ha servido para proyectar que resulte en reducciones de por vida en la ESRD, en una supervivencia incrementada y en un ahorro total de costos en cuanto a las instituciones públicas en nuestro país.

Continuum of renoprotection with losartan at all stages of type 2 diabetic nephropathy: a post hoc analysis of the RENAAL trial results.

Renin angiotensin system inhibitor therapy is seldom offered to individuals who have diabetes and advanced chronic kidney disease because of safety concerns. In this post hoc, secondary analysis of the Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) trial, angiotensin antagonism risk/benefit profile was assessed in 1513 individuals with type 2 diabetes and overt nephropathy. Incidence of ESRD, hospitalizations for heart failure, withdrawals for adverse events, and proteinuria during losartan or conventional treatment were compared within three tertiles of baseline serum creatinine concentration (highest, 2.1 to 3.6 mg/dl; middle, 1.6 to 2.0 mg/dl; lowest, 0.9 to 1.6 mg/dl). Losartan decreased the risk of ESRD by 24.6, 26.3, and 35.3% in highest, middle, and lowest tertiles, respectively. For every 100 patients with serum creatinine >2.0, 1.6 to 2.0, or <1.6 mg/dl, respectively, 4 yr of losartan therapy was estimated to save 18.9, 8.4, and 2.9 ESRD events and US$1,502,855, US$1,021,770, and US$528,591 costs for renal replacement therapy. Losartan also decreased the hospitalizations for heart failure by 50.2 and 45.1, in the highest and middle tertile, respectively. Withdrawals for adverse events other than heart failure were comparable between tertiles and treatment groups. Proteinuria decreased more on losartan than on placebo in all tertiles (highest, 24 versus -8%; middle, 16 versus -8%; lowest, 15 versus -10%). In proteinuric individuals with type 2 diabetes, losartan therapy reduced ESRD and hospitalizations for heart failure and was well tolerated at all levels of renal function. Angiotensin II antagonism is a suitable and well-tolerated treatment for individuals with type 2 diabetes even with GFR levels approaching renal replacement therapy.

Losartan and the United States costs of end-stage renal disease by baseline albuminuria in patients with type 2 diabetes and nephropathy.

BACKGROUND: Type 2 diabetes is the leading cause of end-stage renal disease (ESRD). The Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL) study provided the opportunity to estimate costs associated with ESRD by baseline albuminuria from a United States perspective. METHODS: Costs for ESRD in patients with diabetes were estimated by baseline albuminuria using the U.S. Renal Data System by using the number of days each patient experienced ESRD and the daily estimated U.S. cost of ESRD. RESULTS: The losartan-based antihypertensive therapy group experienced a 28.6% (P=0.002) reduction in the risk of the development of ESRD compared with placebo-based conventional antihypertensive therapy. The previously estimated annual ESRD-related cost saving in the losartan group was 5,144 dollars (95% CI 1,701-8,586 dollars, P=0.003) at 3.5 years. With the cost of losartan, the net savings in the losartan group was estimated at 3,522 dollars (143-6,900 dollars, P=0.041) by 3.5 years. More ESRD-free days were observed and reduced ESRD costs estimated with losartan-based treatment over all levels of baseline albuminuria. CONCLUSION: Treatment with losartan in patients with type 2 diabetes and nephropathy in the RENAAL study not only reduces the incidence of ESRD, but is also estimated from a U.S. perspective to result in substantial cost savings over the 3.5-year duration of the trial across all levels of baseline albuminuria.

Impact of indinavir on the quality of life in patients with advanced HIV infection treated with zidovudine and lamivudine.

OBJECTIVE: In AIDS Clinical Trial Group (ACTG) study 320, triple-combination antiretroviral therapy including indinavir significantly slowed progression to acquired immunodeficiency syndrome or death, compared with treatment with dual nucleoside reverse-transcriptase inhibitors (NRTIs) alone, in zidovudine-experienced patients with advanced human immunodeficiency virus (HIV) infection. We examined the impact of indinavir on quality of life in participants from this study. METHODS: A total of 1156 protease inhibitor- and lamivudine-naive patients stratified by CD4 cell count (

Losartan reduces the costs associated with nephropathy and end-stage renal disease from type 2 diabetes: Economic evaluation of the RENAAL study from a Canadian perspective.

BACKGROUND: The Reduction of Endpoints in NIDDM [non-insulin-dependent diabetes mellitus] with the Angiotensin II Antagonist Losartan (RENAAL) study demonstrated the renoprotective effects of losartan in patients with nephropathy from type 2 diabetes. OBJECTIVE: To perform an economic evaluation of the costs associated with end-stage renal disease (ESRD) from a Canadian public health perspective, based on the clinical outcomes reported in the RENAAL study. METHODS: ESRD-related costs were determined by estimating the mean number of days with ESRD multiplied by the daily cost of ESRD (140 dollars); mean days with ESRD were calculated by subtracting the area under the Kaplan-Meier survival curve for time to the first event of ESRD or all-cause mortality from the area under the curve for all-cause mortality. Daily ESRD cost was determined using Canadian specific data sources. ESRD-related cost savings with losartan were obtained by subtracting the ESRD-related costs of the losartan group from those of the placebo group. Net cost savings were ESRD-related cost savings with losartan minus the drug cost of losartan. RESULTS: Losartan reduced the number of ESRD days by 33.6 per patient over 3.5 years (95% CI 10.9 to 56.3) compared with placebo. Losartan reduced ESRD-related costs by 4,695 dollars per randomized patient over 3.5 years (95% CI 1,523 dollars to 7,868 dollars). After accounting for the drug cost of losartan, net cost savings with losartan were 3,675 dollars per randomized patient over 3.5 years. CONCLUSION: Losartan therapy for patients with nephropathy from type 2 diabetes reduces the clinical incidence of ESRD and can result in considerable cost savings for the Canadian public health system.

Losartan reduces the costs associated with diabetic end-stage renal disease: the RENAAL study economic evaluation.

OBJECTIVE: To evaluate the within-trial effect of losartan and conventional antihypertensive therapy (CT) compared with placebo and CT on the economic cost associated with end-stage renal disease (ESRD). RESEARCH DESIGN AND METHODS: The Reduction of End Points in Type 2 Diabetes With the Angiotensin II Antagonist Losartan (RENAAL) study was a multinational double-blind randomized placebo-controlled clinical trial designed to evaluate the renal protective effects of losartan on a background of CT (excluding ACE inhibitors and angiotensin II receptor agonists [AIIAs]) in patients with type 2 diabetes and nephropathy. The primary composite end point was doubling of serum creatinine, ESRD, or death. Data on the duration of ESRD were used to estimate the economic benefits of slowing the progression of nephropathy. The cost associated with ESRD was estimated by combining the days each patient experienced ESRD with the cost of ESRD over time. The cost of ESRD for individuals with diabetes was estimated using data from the U.S. Renal Data System. Total cost was estimated as the sum of the cost associated with ESRD and the cost of study therapy. RESULTS-We estimated that losartan and CT compared with placebo and CT reduced the number of days with ESRD by 33.6 per patient over 3.5 years (P = 0.004, 95% CI 10.9-56.3). This reduction in ESRD days resulted in a decrease in cost associated with ESRD of 5144 US dollars per patient (P = 0.003, 95% CI 1701 to 8587 US dollars). After accounting for the cost of losartan, the reduction in ESRD days resulted in a net savings of 3522 US dollars per patient over 3.5 years (P = 0.041, 143 to 6900 US dollars). CONCLUSIONS: Treatment with losartan in patients with type 2 diabetes and nephropathy not only reduced the incidence of ESRD, but also resulted in substantial cost savings.

Impact of migraine symptoms on health care use and work loss in Canada in patients randomly assigned in a phase III clinical trial.

BACKGROUND: Migraine is prevalent and associated with substantial direct and indirect costs that may vary across geographic and national boundaries. The effects of migraine, self-reported by Canadians, on health care resource use as well as paid and unpaid work loss were examined. PATIENTS AND METHODS: The Migraine Background Questionnaire (MBQ) was self-administered during the screening visit of a phase III clinical trial of rizatriptan (a potent, selective 5-hydroxytryptamine(1B/1D)-receptor agonist or 'triptan'). Patients suffering from moderate to severe migraine in the previous six months were offered the opportunity to participate. Migraine frequency was determined and costs were estimated and assigned based on known direct costs of health care resource utilization, and indirect costs of paid and unpaid work and productivity loss. RESULTS: One hundred thirty-four patients completed the MBQ. In the previous year, 89% of those patients reported visiting a clinic, 23% reported visiting an emergency room and 5% reported being hospitalized for migraine. Patients reported an average of 6.5 days absent from work, 44 days working with migraine headache and 10.4 reduced workday equivalents due to ineffectiveness at work with migraine. Based on data obtained from the Ontario, the average overall annual cost due to migraine was estimated to be 3,025 dollars/patient; most of this (87%) due to indirect costs. CONCLUSION: In Canada, patients with moderate to severe migraine, as identified in a phase III clinical trial, reported lost work days and reduced effectiveness while at work, as well as increased health care resource utilization due to migraine. The associated cost was estimated to be substantial.

Losartan reduces the burden and cost of ESRD: public health implications from the RENAAL study for the European Union.

Type 2 diabetes is the leading cause of end-stage renal disease (ESRD) in most industrialized countries in Europe. The RENAAL (Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan) Study evaluated the renal protective effects of losartan versus placebo on a background of non-ACE-I/non-AIIA conventional antihypertensive therapy in 1513 patients with type 2 diabetes and nephropathy. Losartan reduced the incidence of doubling of serum creatinine, end-stage renal disease (ESRD), or death by 16% (P=0.022) and reduced the risk of progression to ESRD, defined as the initiation of dialysis or transplantation, by 29% (P=0.002). We set out to estimate the potential effect of losartan on the burden and costs associated with ESRD over 3.5 years in the European Union (EU). The risk reduction in new cases of ESRD was calculated by combining type 2 diabetes population estimates for the EU with the percent absolute risk reduction of ESRD in patients treated with losartan as observed in RENAAL. The number of days each patient experienced ESRD was defined as the length of time from onset of ESRD until the minimum of death or 3.5 years. ESRD-free person-years avoided with losartan treatment were calculated by combining the population estimate with the ESRD days avoided divided by number of days in a year. ESRD costs from Germany were used to approximate the potential cost savings from reduced time with ESRD and fewer ESRD cases on a EU wide basis. There are approximately 700,000 diagnosed type 2 diabetes patients with proteinuria (urine albumin/creatinine >or=300 mg/g) in the EU. The addition of losartan to the treatment regimen of these patients is expected to lead to a reduction of 44,100 cases of ESRD, 64,400 fewer person-years with ESRD, and reduce ESRD-related costs by euro 2.6 billion over 3.5 years based on RENAAL data. Treatment with losartan not only reduced the incidence of ESRD, but also can result in substantial cost savings in the European Union.