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1.
J Am Heart Assoc ; 10(7): e015816, 2021 04 06.
Article En | MEDLINE | ID: mdl-33759539

Background To evaluate the cost-effectiveness of combination pulmonary arterial hypertension specific therapy in systemic sclerosis-related PAH. Methods and Results Health outcomes and costs were captured through data linkage. Health utility was derived from Medical Outcomes Study Short Form-36 scores. A probabilistic discrete-time model was developed to simulate lifetime changes in costs and health utility. Mortality was predicted using a Gompertz parametric survival model. For both treatment arms, the simulations were started using the same cohort of 10 000 patients. Probabilistic sensitivity analysis was performed using the Monte Carlo simulation with 1000 sets of sampled parameter values. Of 143 patients with systemic sclerosis-related pulmonary arterial hypertension, 89 were on monotherapy and 54 on combination therapy. Mean simulated costs per patient per year in monotherapy and combination therapy groups were AU$23 411 (US$16 080) and AU$29 129 (US$19 982), respectively. Mean life years and quality-adjusted life years from pulmonary arterial hypertension diagnosis to death of patients receiving monotherapy were 7.1 and 3.0, respectively, and of those receiving combination therapy were 9.2 and 3.9, respectively. Incremental costs per life year and quality-adjusted life year gained of combination therapy compared with monotherapy were AU$47 989 (US$32 920) and AU$113 823 (US$78 082), respectively. At a willingness-to-pay threshold of AU$102 000 (US$69 972) per life year gained, and of AU$177 222 (US$121 574) per quality-adjusted life year gained, the probability of combination therapy being cost-effective was 0.95. Conclusions The incremental cost per quality-adjusted life year gained of combination therapy compared with monotherapy was substantial in the base case analysis. Given the fatal prognosis of systemic sclerosis-related pulmonary arterial hypertension and the incremental cost per life year of AU$47 989 (US$32 920), combination therapy could be considered cost-effective in systemic sclerosis-related pulmonary arterial hypertension.


Antihypertensive Agents , Drug Therapy, Combination , Pulmonary Arterial Hypertension , Scleroderma, Systemic , Vasodilator Agents , Antihypertensive Agents/classification , Antihypertensive Agents/economics , Antihypertensive Agents/therapeutic use , Australia/epidemiology , Cost-Benefit Analysis , Drug Therapy, Combination/economics , Drug Therapy, Combination/methods , Female , Humans , Male , Medication Therapy Management/statistics & numerical data , Medication Therapy Management/trends , Middle Aged , Prognosis , Pulmonary Arterial Hypertension/drug therapy , Pulmonary Arterial Hypertension/economics , Pulmonary Arterial Hypertension/epidemiology , Pulmonary Arterial Hypertension/etiology , Scleroderma, Systemic/complications , Scleroderma, Systemic/mortality , Survival Analysis , Treatment Outcome , Vasodilator Agents/classification , Vasodilator Agents/economics , Vasodilator Agents/therapeutic use
2.
Am J Perinatol ; 38(14): 1505-1512, 2021 12.
Article En | MEDLINE | ID: mdl-32615617

OBJECTIVE: While advanced therapies for severe persistent pulmonary hypertension of the newborn (PPHN) such as inhaled nitric oxide (iNO) and extracorporeal membrane oxygenation (ECMO) are standard treatments in high-income countries, these therapies are often unavailable in resource-limited settings such as middle-income countries. However, there are small clinical trials illustrating the efficacy of sildenafil at reducing mortality in PPHN. This analysis sought to determine the cost-utility of enteral sildenafil for the treatment of severe PPHN. STUDY DESIGN: A Markov-state transition model was constructed for the two clinical approaches to compare costs, clinical outcomes, and quality of life: (1) "conventional," (2) "sildenafil." The impact of sildenafil was modeled as a relative risk modifier of the conventional strategy's mortality risk. Transitional probabilities, costs, and utility metrics were extracted from the literature. Sensitivity analyses for each model input as well as 100-patient Monte Carlo simulations were used to test the durability of the model conclusion. RESULTS: The sildenafil strategy was cost-effective for upper but not lower middle-income countries with an incremental cost-effectiveness ratio of $2,339 per quality-adjusted life year. This conclusion was durable across a wide-range of model assumptions; the sildenafil strategy only failed to meet criteria for cost-effectiveness when sildenafil therapy had a mortality relative risk efficacy of >0.89, if life expectancy in that country is <40 years, or if the lifetime forecasted costs of a survivor's life was quite high. CONCLUSION: Enteral sildenafil is a cost-effective intervention for severe PPHN for upper middle-income countries where ECMO and iNO are not available. KEY POINTS: · PPHN is a common life-threatening condition in newborns.. · Sildenafil improves survival of PPHN.. · Sildenafil is cost-effective for upper-middle income countries..


Cost-Benefit Analysis , Health Care Costs , Persistent Fetal Circulation Syndrome/drug therapy , Sildenafil Citrate/economics , Vasodilator Agents/economics , Developing Countries , Humans , Income , Infant, Newborn , Models, Biological , Quality of Life , Quality-Adjusted Life Years , Sildenafil Citrate/therapeutic use , Vasodilator Agents/therapeutic use
3.
Rev. esp. cardiol. (Ed. impr.) ; 73(5): 361-367, mayo 2020. tab, graf
Article Es | IBECS | ID: ibc-194543

INTRODUCCIÓN Y OBJETIVOS: La insuficiencia cardiaca (IC) avanzada conlleva altas tasas de hospitalización y mortalidad. El estudio LION-HEART fue un ensayo clínico aleatorizado y controlado con placebo que evaluó la eficacia y la seguridad de la administración intravenosa de dosis intermitentes de levosimendán en pacientes ambulatorios con IC avanzada. El objetivo del presente estudio es realizar un análisis de costes para determinar si la menor tasa de hospitalizaciones por IC observada en pacientes tratados con levosimendán en el estudio LION-HEART puede generar ahorros para el Sistema Nacional de Salud, en comparación con la opción de no tratar a los pacientes con IC avanzada. MÉTODOS: Se realizó un modelo económico que incluyó las tasas de hospitalización por IC del estudio LION-HEART y los costes de hospitalización por IC y de adquisición y administración intravenosa de levosimendán. El horizonte temporal del análisis fue de 12 meses. Se realizaron 2 análisis, uno determinístico y otro probabilístico (simulación de Monte Carlo de segundo orden). RESULTADOS: Según el análisis determinístico, el ahorro total por cada paciente tratado con levosimendán ascendería a -698,48 euros. En el análisis probabilístico, el ahorro por paciente tratado con levosimendán sería de -849,94 (IC95%, 133,12 a -2.255,31) euros. La probabilidad de que se produzcan ahorros con levosimendán en comparación con la opción de no tratar sería del 94,8%. CONCLUSIONES: El tratamiento ambulatorio intermitente con levosimendán puede generar ahorros para el Sistema Nacional de Salud, en comparación con la opción de no tratar a los pacientes con IC avanzada


INTRODUCTION AND OBJECTIVES: Advanced heart failure (HF) leads to high hospitalization and mortality rates. The LION-HEART study was a randomized, placebo-controlled clinical trial that evaluated the safety and efficacy of intravenous administration of intermittent doses of levosimendan in outpatients with advanced HF. The aim of the present study was to perform a cost analysis to determine whether the lower rate of hospitalizations for HF, observed in patients treated with levosimendan in the LION-HEART study, can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF. METHODS: An economic model was used that included IC hospitalization rates from the LION-HEART study, the costs of hospitalization due to HF and those of the acquisition and intravenous administration of levosimendan. The time horizon of the analysis was 12 months. Two analyses were carried out, one deterministic and the other probabilistic (second-order Monte Carlo simulation). RESULTS: In the deterministic analysis, the total saving for each patient treated with levosimendan would amount to−€698.48. In the probabilistic analysis, the saving per patient treated with levosimendan would be−€849.94 (95%CI, €133.12 to−€2,255.31). The probability of savings with levosimendan compared with the no treatment option would be 94.8%. CONCLUSIONS: Intermittent ambulatory treatment with levosimendan can generate savings for the Spanish national health system compared with the option of not treating patients with advanced HF


Humans , Male , Female , Aged , Heart Failure/economics , Simendan/economics , Vasodilator Agents/economics , Ambulatory Care/economics , Heart Failure/drug therapy , Simendan/therapeutic use , Vasodilator Agents/therapeutic use , Hospitalization/economics , Hospitalization/statistics & numerical data , Cost-Benefit Analysis , Infusions, Intravenous/economics
4.
J Comp Eff Res ; 9(6): 405-412, 2020 04.
Article En | MEDLINE | ID: mdl-32301331

Aim: The cost-effectiveness of isosorbide-5-mononitrate (5-ISMN) and isosorbide dinitrate (ISDN) in real-world use in patients with coronary heart disease (CHD; either angina pectoris or myocardial infarction) was retrospectively compared. Method: In this retrospective real-world evaluation, patients with established CHD satisfying the following criteria were selected from information system of two tertiary hospitals in China: with pharmacy claiming for at least one injection of 5-ISMN or ISDN between July 2008 and May 2017; and, CHD patients. By using propensity score matching (PSM), we compared clinical aspects of efficacy, safety, length of hospital stay and cost during hospitalization between 5-ISMN and ISDN group. All data were processed by R statistical package v.2.13.1 (R Foundation for Statistical Computing, Vienna, Austria). Result: Of 5609 patients selected, 4047 received 5-ISMN and 1562 received ISDN. After PSM, we acquired 1555 pairs based on balancing of age, sex, insurance and comorbidities on admission. The frequency (4.2 ± 6.6-times vs 6.5 ± 9.5-times; p < 0.05) and total dosage (47.5 ± 153.4 vs 136.4 ± 261.0 mg; p < 0.05) of sublingual nitroglycerin use decreased and hypotension incidence lowered (8.0 vs 13.0%; p < 0.05) in 5-ISMN group compared with ISDN group. Hospital stay (16.0 ± 11.3 days vs 17.7 ± 13.2; p < 0.05) and hospitalization expenditure ([the ratio of cost in the study to the average hospitalization cost in the city] [odds ratio: 2.5 vs 2.6; p < 0.05]) were reduced in 5-ISMN group as with that of ISDN group. Moreover, the main component of hospitalization cost was medical consumables and medications in both the groups. Conclusion: In the present retrospective real-world evaluation, by using PSM analysis, we found that newer injection agent of 5-ISMN was associated with fewer use of sublingual nitroglycerin, less hypotension incidence, shorter length of hospital stay and less hospitalization expenditure related to its comparator ISDN in patients with established CHD. Further evaluation and clinical experience are need in different circumference for the usage of ISDN.


Coronary Disease/drug therapy , Health Care Costs/statistics & numerical data , Isosorbide Dinitrate/analogs & derivatives , Isosorbide Dinitrate/therapeutic use , Isosorbide/therapeutic use , Administration, Sublingual , Aged , Aged, 80 and over , China/epidemiology , Coronary Disease/economics , Cost-Benefit Analysis , Female , Humans , Hypotension/epidemiology , Incidence , Isosorbide/economics , Isosorbide Dinitrate/economics , Length of Stay/economics , Male , Middle Aged , Nitric Oxide Donors/economics , Nitric Oxide Donors/therapeutic use , Nitroglycerin/administration & dosage , Pragmatic Clinical Trials as Topic , Propensity Score , Retrospective Studies , Vasodilator Agents/economics , Vasodilator Agents/therapeutic use
5.
Semin Cardiothorac Vasc Anesth ; 24(1): 67-73, 2020 Mar.
Article En | MEDLINE | ID: mdl-31451092

In heart transplantation, pulmonary hypertension and increased pulmonary vascular resistance followed by donor right ventricular dysfunction remain a major cause of perioperative morbidity and mortality. In lung transplantation, primary graft dysfunction remains a major obstacle because it can cause bronchiolitis obliterans and mortality. Pulmonary vasodilators have been used as an adjunct therapy for heart or lung transplantation, mainly to treat pulmonary hypertension, right ventricular failure, and associated refractory hypoxemia. Among pulmonary vasodilators, inhaled nitric oxide is unique in that it is selective in pulmonary circulation and causes fewer systemic complications such as hypotension, flushing, or coagulopathy. Nitric oxide is expected to prevent or attenuate primary graft dysfunction by decreasing ischemia-reperfusion injury in lung transplantation. However, when considering the long-term benefit of these medications, little evidence supports their use in heart or lung transplantation. Current guidelines endorse inhaled vasodilators for managing immediate postoperative right ventricular failure in lung or heart transplantation, but no guidance is offered regarding agent selection, dosing, or administration. This review presents the current evidence of inhaled nitric oxide in lung or heart transplantation as well as comparisons with other pulmonary vasodilators including cost differences in consideration of economic pressures to contain rising pharmacy costs.


Heart Transplantation/methods , Lung Transplantation/methods , Vasodilator Agents/administration & dosage , Administration, Inhalation , Cost-Benefit Analysis , Heart Transplantation/economics , Humans , Hypertension, Pulmonary/drug therapy , Hypertension, Pulmonary/etiology , Lung Transplantation/economics , Nitric Oxide/administration & dosage , Nitric Oxide/economics , Primary Graft Dysfunction/prevention & control , Pulmonary Circulation/drug effects , Vasodilator Agents/economics , Ventricular Dysfunction, Right/drug therapy , Ventricular Dysfunction, Right/etiology
6.
BMC Health Serv Res ; 19(1): 573, 2019 Aug 14.
Article En | MEDLINE | ID: mdl-31412857

BACKGROUND: This study aims to assess the cost-effectiveness and budget impact of adopting sildenafil to the benefits package for the indication of pulmonary arterial hypertension (PAH), compared to beraprost. METHODS: Based on a societal perspective, a model-based economic evaluation was performed using local and international data to quantify the potential costs and health-related outcomes in terms of life years (LYs) and quality-adjusted life years (QALYs). RESULTS: The economic model calculated the incremental cost-effectiveness ratio (ICER) per QALY gained for using sildenafil as first-line therapy compared to beraprost for the patient in functional class (FC) II and III, i.e. USD 3098 and USD 2827, respectively. The results indicated that in spite of sildenafil being more expensive than beraprost, generic sildenafil could potentially be a good value for money since ICER per QALY is below one times gross domestic product (GDP) per capita in Indonesia. Furthermore, budget impact analysis estimated that the incremental budget needed within 5 years for including sildenafil compared to beraprost for PAH patients starting in FC II and FC III was USD 436,775 and USD 3.6 million, respectively. CONCLUSIONS: Compared to beraprost, sildenafil would be preferable for the treatment of PAH patients in FC II and FC III in Indonesia. The additional budget for adopting sildenafil compared to beraprost as the treatment of PAH in the benefits package was estimated at around USD 4.0 million.


Epoprostenol/analogs & derivatives , Hypertension, Pulmonary/drug therapy , Sildenafil Citrate/economics , Vasodilator Agents/economics , Budgets , Cost-Benefit Analysis , Epoprostenol/economics , Epoprostenol/therapeutic use , Humans , Hypertension, Pulmonary/economics , Indonesia , Sildenafil Citrate/therapeutic use , Vasodilator Agents/therapeutic use
7.
J Cardiovasc Pharmacol Ther ; 24(2): 113-119, 2019 03.
Article En | MEDLINE | ID: mdl-30081658

OBJECTIVES: In the follow-up of patients in a trial of intracoronary sodium nitrite given during primary percutaneous coronary intervention (PCI) after acute myocardial infarction (AMI), we found a reduction in the incidence of major adverse cardiac events (MACEs). Specifically, MACE rates were 5.2% versus 25.0% with placebo at 3 years ( P = .013). Such MACE reductions should also be associated with economic benefit. Thus, we assessed the cost utility of sodium nitrite therapy versus standard primary PCI only. METHODS AND RESULTS: We developed a model to simulate costs and quality-adjusted life years (QALYs) over the first 36 months after ST-Segment Elevation Myocardial Infarction (STEMI). Decision tree analysis was used to assess different potential cardiovascular outcomes after STEMI for patients in both treatment groups. Model inputs were derived from the NITRITE-AMI study. Cost of comparative treatments and follow-up in relation to cardiovascular events was calculated from the United Kingdom National Health Service perspective. Higher procedural costs for nitrite treatment were offset by lower costs for repeat revascularization, myocardial infarction, and hospitalization for heart failure compared to primary PCI plus placebo. Nitrite treatment was associated with higher utility values (0.91 ± 0.19 vs 0.82 ± 0.30, P = .041). The calculated incremental cost-effectiveness ratio of £2177 per QALY indicates a cost-effective strategy. Furthermore, positive results were maintained when input parameters varied, indicating the robustness of our model. In fact, based on the difference in utility values, the cost of nitrite could increase by 4-fold (£2006 per vial) and remain cost-effective. CONCLUSION: This first analysis of sodium nitrite as a cardioprotective treatment demonstrates cost-effectiveness. Although more comparative analysis and assessment of longer follow-up times are required, our data indicate the considerable potential of nitrite-mediated cardioprotection.


Drug Costs , Myocardial Infarction/economics , Myocardial Infarction/prevention & control , Myocardial Reperfusion Injury/economics , Myocardial Reperfusion Injury/prevention & control , Percutaneous Coronary Intervention/economics , ST Elevation Myocardial Infarction/economics , ST Elevation Myocardial Infarction/therapy , Sodium Nitrite/administration & dosage , Sodium Nitrite/economics , Vasodilator Agents/administration & dosage , Vasodilator Agents/economics , Clinical Decision-Making , Cost Savings , Cost-Benefit Analysis , Heart Failure/economics , Heart Failure/etiology , Heart Failure/therapy , Hospital Costs , Humans , Models, Economic , Myocardial Infarction/etiology , Myocardial Reperfusion Injury/etiology , Percutaneous Coronary Intervention/adverse effects , Progression-Free Survival , Quality-Adjusted Life Years , Retreatment/economics , Sodium Nitrite/adverse effects , State Medicine/economics , Time Factors , United Kingdom , Vasodilator Agents/adverse effects
8.
Pediatr Cardiol ; 40(3): 650-657, 2019 Mar.
Article En | MEDLINE | ID: mdl-30547294

Right ventricular (RV) failure is a potentially fatal complication following heart transplantation (HTx). Inhaled nitric oxide (iNO) is a selective pulmonary vasodilator that is used to decrease pulmonary vascular resistance immediately post-HTx to reduce the risk of RV failure. The aim of this study was to describe utilization patterns, costs, and outcomes associated with post-transplant iNO use in children. All pediatric HTx recipients (2002-2016) were identified from a unique linked PHIS/SRTR dataset. Post-HTx iNO use was determined based on hospital billing data. Utilization patterns and associated costs were described. The association of iNO support with post-HTx survival was assessed using the Kaplan-Meier method and a multivariable Cox proportional hazards model was used to adjust for risk factors. A total of 2833 pediatric HTx recipients from 28 centers were identified with 1057 (36.5%) receiving iNO post-HTx. Post-HTx iNO use showed significant increase overall (17.2-54.7%, p < 0.001) and wide variation among centers (9-100%, p < 0.001). Patients with congenital heart disease (aOR 1.4, 95% CI 1.2, 1.6), requiring mechanical ventilation at HTx (aOR 1.3, 95% CI 1.1, 1.6), and pre-transplant iNO (aOR 9.3, 95% CI 5.4, 16) were more likely to receive iNO post-HTx. The median daily cost of iNO was $2617 (IQR $1843-$3646). Patients who required > 5 days of iNO post-HTx demonstrated inferior 1-year post-HTx survival (p < 0.001) and iNO use > 5 days was independently associated with worse post-HTx survival (AHR 1.6, 95% CI 1.2, 2.1; p < 0.001). There is wide variation in iNO use among centers following pediatric HTx with use increasing over time despite significant incremental cost. Prolonged iNO use post-HTx is associated with worse survival, likely serving as a marker of residual illness severity. Further research is needed to define the populations that derive the greatest benefit from this costly therapy.


Health Care Costs/statistics & numerical data , Heart Transplantation/adverse effects , Nitric Oxide/administration & dosage , Practice Patterns, Physicians'/statistics & numerical data , Vasodilator Agents/administration & dosage , Administration, Inhalation , Adolescent , Child , Child, Preschool , Female , Heart Transplantation/mortality , Heart Transplantation/statistics & numerical data , Humans , Infant , Male , Nitric Oxide/economics , Practice Patterns, Physicians'/economics , Proportional Hazards Models , Registries , Retrospective Studies , Risk Factors , Survival Analysis , Treatment Outcome , Vasodilator Agents/economics
9.
Health Technol Assess ; 23(70): 1-72, 2019 12.
Article En | MEDLINE | ID: mdl-31912780

BACKGROUND: Retained placenta is associated with postpartum haemorrhage and can lead to significant maternal morbidity if untreated. The only effective treatment is the surgical procedure of manual removal of placenta, which is costly, requires skilled staff, requires an operative environment and is unpleasant for women. Small studies suggest that glyceryl trinitrate may be an effective medical alternative. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of sublingual glyceryl trinitrate spray compared with placebo in reducing the need for manual removal of placenta in women with retained placenta after vaginal delivery following the failure of current management. DESIGN: A group-sequential randomised double-blind placebo-controlled trial with a cost-effectiveness analysis. SETTING: There were 29 obstetric units in the UK involved in the study. PARTICIPANTS: There were 1107 women (glyceryl trinitrate group, n = 543; placebo group, n = 564) randomised between October 2014 and July 2017. INTERVENTIONS: Glyceryl trinitrate spray was administered to 541 women in the intervention group, and a placebo was administered to 563 women in the control group. MAIN OUTCOME MEASURES: Four primary outcomes were defined: (1) clinical - the need for manual removal of placenta, (2) safety - measured blood loss, (3) patient sided - satisfaction with treatment and side effects and (4) economic - cost-effectiveness of both treatments using the UK NHS perspective. Secondary clinical outcomes included a > 15% decrease in haemoglobin level, time from randomisation to delivery of placenta in theatre, the need for earlier manual removal of placenta than planned, increase in heart rate or decrease in blood pressure, requirement for blood transfusion, requirement for general anaesthesia, maternal pyrexia, and sustained uterine relaxation requiring additional uterotonics. RESULTS: No difference was observed between the glyceryl trinitrate group and the control group for the placenta remaining undelivered within 15 minutes of study treatment (93.3% vs. 92%; odds ratio 1.01, 95% confidence interval 0.98 to 1.04; p = 0.393). There was no difference in blood loss of > 1000 ml between the glyceryl trinitrate group and the control group (22.2% vs. 15.5%; odds ratio 1.14, 95% confidence interval 0.88 to 1.48; p = 0.314). Palpitations were more common in the glyceryl trinitrate group than in the control group after taking the study drug (9.8% vs. 4.0%; odds ratio 2.60, 95% confidence interval 1.40 to 4.84; p = 0.003). There was no difference in any other measures of patient satisfaction between the groups. There was no difference in costs to the health service between groups (mean difference £55.30, 95% confidence interval -£199.20 to £309.79). Secondary outcomes revealed that a fall in systolic or diastolic blood pressure, or an increase in heart rate, was more common in the glyceryl trinitrate group than in the control group (odds ratio 4.9, 95% confidence interval 3.7 to 6.4; p < 0.001). The need for a blood transfusion was also more common in the glyceryl trinitrate group than in the control group (odds ratio 1.53, 95% confidence interval 1.04 to 2.25; p = 0.033). CONCLUSIONS: Glyceryl trinitrate spray did not increase the delivery of retained placenta within 15 minutes of administration when compared with the placebo, and was not cost-effective for medical management of retained placenta. More participants reported palpitations and required a blood transfusion in the glyceryl trinitrate group. Further research into alternative methods of medical management of retained placenta is required. TRIAL REGISTRATION: Current Controlled Trials ISRCTN88609453. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 70. See the NIHR Journals Library website for further project information.


A retained placenta is diagnosed when, following the birth of a baby, the placenta is not delivered. When this situation occurs, women are at risk of bleeding heavily. The only way to treat a retained placenta is for a trained doctor to remove it by an operation in theatre. This procedure can be painful and upsetting. Furthermore, the timing of the operation can interrupt mother­baby bonding immediately after giving birth. The study tested if the use of glyceryl trinitrate spray, given as two puffs under the woman's tongue following the diagnosis of retained placenta, may help the placenta to deliver without an operation. The study also tested if glyceryl trinitrate was safe, assessed what women thought about the treatment and compared the costs of glyceryl trinitrate with those of current operative management. This study included 1107 women diagnosed with retained placenta following the birth of their baby. Half of the women were treated with glyceryl trinitrate spray and the other half were treated with a dummy spray, which looked identical but did not contain the active treatment. If the placenta delivered within 15 minutes of the study treatment being taken, this was considered a success. However, if the placenta did not deliver within 15 minutes and the woman had to have her placenta removed by an operation, then this was viewed as unsuccessful. Neither the woman nor the clinical staff knew if the treatment given was the glyceryl trinitrate spray or the dummy spray. The results indicate that, although women were happy to be involved in the trial and the treatment was safe, the use of glyceryl trinitrate spray did not reduce the need for the placenta to be manually removed by an operation in theatre. Furthermore, glyceryl trinitrate spray was not cost-effective.


Cost-Benefit Analysis , Nitroglycerin/administration & dosage , Obstetric Surgical Procedures/economics , Placenta, Retained/drug therapy , Vasodilator Agents/administration & dosage , Administration, Sublingual , Adolescent , Adult , Blood Transfusion , Cost-Benefit Analysis/economics , Double-Blind Method , Female , Humans , Nitroglycerin/economics , Postpartum Hemorrhage , Pregnancy , Technology Assessment, Biomedical , Vasodilator Agents/economics , Young Adult
10.
Can Respir J ; 2018: 1015239, 2018.
Article En | MEDLINE | ID: mdl-30581511

Objectives: Although many studies have reported on the cost-effectiveness of bosentan for treating pulmonary arterial hypertension (PAH), a systematic review of economic evaluations of bosentan is currently lacking. Objective evaluation of current pharmacoeconomic evidence can assist decision makers in determining the appropriate place in therapy of a new medication. Methods: Systematic literature searches were conducted in English-language databases (MEDLINE, EMBASE, EconLit databases, and the Cochrane Library) and Chinese-language databases (China National Knowledge Infrastructure, WanFang Data, and Chongqing VIP) to identify studies assessing the cost-effectiveness of bosentan for PAH treatments. Results: A total of 8 published studies were selected for inclusion. Among them were two studies comparing bosentan with epoprostenol and treprostinil. Both results indicated that bosentan was more cost-effective than epoprostenol, while the results of bosentan and treprostinil were not consistent. Four studies compared bosentan with other endothelin receptor antagonists, which indicated ambrisentan might be the drug of choice for its economic advantages and improved safety profile. Only two economic evaluations provided data to compare bosentan versus sildenafil, and the results favored the use of sildenafil in PAH patients. Four studies compared bosentan with conventional, supportive, or palliative therapy, and whether bosentan was cost-effective was uncertain. Conclusions: Bosentan may represent a more cost-effective option compared with epoprostenol and conventional or palliative therapy. There was unanimous agreement that bosentan was not a cost-effective front-line therapy compared with sildenafil and other endothelin receptor antagonists. However, high-quality cost-effectiveness analyses that utilize long-term follow-up data and have no conflicts of interest are still needed.


Bosentan/therapeutic use , Endothelin Receptor Antagonists/therapeutic use , Hypertension, Pulmonary/drug therapy , Antihypertensive Agents/economics , Antihypertensive Agents/therapeutic use , Bosentan/economics , Cost-Benefit Analysis , Endothelin Receptor Antagonists/economics , Epoprostenol/analogs & derivatives , Epoprostenol/therapeutic use , Humans , Phenylpropionates/economics , Phenylpropionates/therapeutic use , Pyridazines/economics , Pyridazines/therapeutic use , Sildenafil Citrate/therapeutic use , Vasodilator Agents/economics , Vasodilator Agents/therapeutic use
11.
Farm. hosp ; 42(2): 62-67, mar.-abr. 2018. tab
Article Es | IBECS | ID: ibc-171663

Objetivo: Evaluar la eficiencia de la protocolización y centralización de la elaboración de mezclas intravenosas de fármacos vasoactivos en el tratamiento del paciente crítico. Método: Se realizó un estudio prospectivo, de intervención (julio 2012-diciembre 2014) para medir el impacto de la protocolización de mezclas intravenosas en el coste del tratamiento del paciente crítico. Para realizar el análisis económico se compararon los costes directos (fijos y variables) de la preparación de mezclas intravenosas de fármacos vasoactivos en el Servicio de Farmacia versus preparación en planta. Se midieron las variables tiempo y coste de elaboración de una mezcla intravenosa. Para la determinación del coste final de elaboración se incluyeron medicamento, diluyente, material fungible, personal y utilización de las cabinas de flujo laminar. Los costes se midieron en euros. Resultados: La diferencia encontrada en los tiempos de elaboración entre el Servicio de Farmacia y la Unidad de Enfermería (2,10 versus 2,86 minutos) fue estadísticamente significativa y favorable a la elaboración centralizada en el Servicio de Farmacia. El coste medio de elaboración por mezcla fue 5,24 ± 1,45 euros en el Servicio de Farmacia y 5,62 ± 1,55 euros en planta, aunque la diferencia encontrada no alcanzó la significación estadística. Al incluir en el análisis el coste de las mezclas intravenosas caducadas antes de su utilización, la preparación centralizada en el Servicio de Farmacia supuso un coste superior (2.174 euros/año). Conclusiones: La elaboración en el Servicio de Farmacia supone un ahorro significativo de tiempo en comparación con la preparación en planta. La diferencia de coste de esta alternativa, debida principalmente al impacto de las mezclas intravenosas caducadas, se eliminaría al optimizar la producción en la Unidad de Mezclas Intravenosas y al minimizar las pérdidas por caducidad (AU)


Objective: To evaluate the efficiency of the protocolization and centralization of the preparation of intravenous vasoactive drug mixtures in the treatment of critically ill patients. Method: A prospective interventional study (July 2012-December 2014) was conducted to measure the impact of different vasoactive drug protocols on costs in the treatment of critically ill patients. The economic impact was measured by comparing the direct costs (fixed and variable) of the preparation of intravenous vasoactive drug mixtures in the Pharmacy Department with their traditional preparation in hospital care units. The variables time and cost of preparation of an intravenous mixture were measured. Costs included pharmaceutical product, diluent, medical supplies, cost of manpower, and use of laminar flow cabinets in the Pharmacy Department. Costs were measured in Euros. Results: A statistically significant difference was found between processing times in the Pharmacy Department and those in the hospital care unit (2.10 vs 2.86 minutes). Centralized preparation in the Pharmacy Department was more efficient. The average cost of preparation was euros5.24±1.45 in the Pharmacy Department and euros5.62±1.55 in the hospital care unit, although this difference did not reach statistical significance. If the analysis had included the cost of intravenous mixtures that had expired prior to their use, the centralized preparation of the mixtures in the Pharmacy Department would have entailed a higher cost (euros2174/y). Conclusions: The centralized preparation of intravenous mixtures in the Pharmacy Department entails significant time savings compared with their preparation in the hospital care unit. The increased cost of their preparation in the Pharmacy Department would be prevented by optimizing production in this department and reducing losses due to expired intravenous mixtures (AU)


Humans , Vasodilator Agents/economics , Vasodilator Agents/therapeutic use , Critical Illness/therapy , Critical Care/economics , Infusions, Intravenous/economics , Infusions, Intravenous , Prospective Studies , Drug Costs/standards , 35170/economics
12.
BMJ Open ; 7(9): e017134, 2017 09 18.
Article En | MEDLINE | ID: mdl-28928192

INTRODUCTION: A retained placenta is diagnosed when the placenta is not delivered following delivery of the baby. It is a major cause of postpartum haemorrhage and treated by the operative procedure of manual removal of placenta (MROP). METHODS AND ANALYSIS: The aim of this pragmatic, randomised, placebo-controlled, double-blind UK-wide trial, with an internal pilot and nested qualitative research to adjust strategies to refine delivery of the main trial, is to determine whether sublingual glyceryl trinitrate (GTN) is (or is not) clinically and cost-effective for (medical) management of retained placenta. The primary clinical outcome is need for MROP, defined as the placenta remaining undelivered 15 min poststudy treatment and/or being required within 15 min of treatment due to safety concerns. The primary safety outcome is measured blood loss between administration of treatment and transfer to the postnatal ward or other clinical area. The primary patient-sided outcome is satisfaction with treatment and a side effect profile. The primary economic outcome is net incremental costs (or cost savings) to the National Health Service of using GTN versus standard practice. Secondary outcomes are being measured over a range of clinical and economic domains. The primary outcomes will be analysed using linear models appropriate to the distribution of each outcome. Health service costs will be compared with multiple trial outcomes in a cost-consequence analysis of GTN versus standard practice. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the North-East Newcastle & North Tyneside 2 Research Ethics Committee (13/NE/0339). Dissemination plans for the trial include the Health Technology Assessment Monograph, presentation at international scientific meetings and publication in high-impact, peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISCRTN88609453; Pre-results.


Nitroglycerin/therapeutic use , Placenta, Retained/drug therapy , Placenta, Retained/surgery , Vasodilator Agents/therapeutic use , Administration, Sublingual , Blood Volume , Cost Savings , Cost-Benefit Analysis , Double-Blind Method , Female , Health Care Costs , Humans , Nitroglycerin/administration & dosage , Nitroglycerin/economics , Obstetric Surgical Procedures/economics , Patient Satisfaction , Placenta, Retained/economics , Postpartum Hemorrhage/etiology , Pregnancy , Research Design , United Kingdom , Vasodilator Agents/administration & dosage , Vasodilator Agents/economics
14.
Pharmacotherapy ; 37(6): 657-661, 2017 Jun.
Article En | MEDLINE | ID: mdl-28475259

STUDY OBJECTIVE: To compare the frequency of adverse events in patients undergoing myocardial perfusion imaging (MPI) with either regadenoson or dipyridamole. DESIGN: Single-center, retrospective cohort study. SETTING: Large community teaching hospital. PATIENTS: A total of 568 adults who underwent single-photon emission tomography MPI with either regadenoson (284 patients) or dipyridamole (284 patients) as a vasodilator agent, following an institution conversion from regadenoson to dipyridamole in the MPI protocol on July 15, 2013, for cost-saving purposes. MEASUREMENTS AND MAIN RESULTS: Data were collected from the patients' electronic medical records. The primary endpoint was the composite occurrence of any documented adverse event in each group. Secondary endpoints were individual components of the primary endpoint, reason for termination of the MPI examination (protocol completion or premature end due to an adverse event), use of an interventional agent to an treat adverse event, and cost-related outcomes. A higher proportion of patients in the regadenoson group experienced an adverse event than those who received dipyridamole (84.9% vs 56.7%, p<0.0001). None of the patients in either group required early MPI study termination due to an adverse event. No significant differences were noted between groups regarding use of aminophylline or other interventions to treat adverse events. The overall drug cost savings in the postconversion dipyridamole group was $51,526. CONCLUSION: Dipyridamole was associated with fewer adverse events than regadenoson in patients undergoing MPI. Dipyridamole offers a safe and cost-effective alternative to regadenoson for cardiac imaging studies.


Adenosine A2 Receptor Agonists/adverse effects , Dipyridamole/adverse effects , Myocardial Perfusion Imaging/adverse effects , Purines/adverse effects , Pyrazoles/adverse effects , Vasodilator Agents/adverse effects , Adenosine A2 Receptor Agonists/economics , Aged , Cohort Studies , Cost-Benefit Analysis/methods , Dipyridamole/economics , Dyspnea/chemically induced , Dyspnea/economics , Female , Gastrointestinal Diseases/chemically induced , Gastrointestinal Diseases/economics , Heart Diseases/diagnostic imaging , Heart Diseases/economics , Humans , Male , Middle Aged , Myocardial Perfusion Imaging/economics , Myocardial Perfusion Imaging/methods , Purines/economics , Pyrazoles/economics , Retrospective Studies , Vasodilator Agents/economics
15.
Int J Pharm Compd ; 21(1): 22-27, 2017.
Article En | MEDLINE | ID: mdl-28346194

An adult diabetic male with three toes amputated on his right foot presented with an ulcer infection on his left foot, unresponsive to conventional antifungal oral medication for over two months. The ulcerated foot wound had a large impairment on the patient's quality of life, as determined by the Wound-QoL questionnaire. The compounding pharmacist recommended and the physician prescribed two topical compounded medicines, which were applied twice a day, free of charge at the compounding pharmacy. The foot ulcer infection was completely resolved following 13 days of treatment, with no longer any impairment on the patient's quality of life. This scientific case study highlights the value of pharmaceutical compounding in current therapeutics, the importance of the triad relationship, and the key role of the compounding pharmacist in diabetes care.


Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Antifungal Agents/administration & dosage , Diabetic Foot/drug therapy , Vasodilator Agents/administration & dosage , Vitamin B Complex/administration & dosage , Wound Healing/drug effects , Wound Infection/drug therapy , Administration, Cutaneous , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Anti-Inflammatory Agents, Non-Steroidal/chemistry , Anti-Inflammatory Agents, Non-Steroidal/economics , Antifungal Agents/adverse effects , Antifungal Agents/chemistry , Antifungal Agents/economics , Clotrimazole/administration & dosage , Cost Savings , Cost-Benefit Analysis , Diabetic Foot/diagnosis , Diabetic Foot/economics , Diabetic Foot/microbiology , Drug Combinations , Drug Compounding , Drug Costs , Humans , Ibuprofen/administration & dosage , Male , Metronidazole/administration & dosage , Middle Aged , Nifedipine/administration & dosage , Pantothenic Acid/administration & dosage , Pantothenic Acid/analogs & derivatives , Time Factors , Treatment Outcome , Vasodilator Agents/adverse effects , Vasodilator Agents/chemistry , Vasodilator Agents/economics , Vitamin B Complex/adverse effects , Vitamin B Complex/chemistry , Vitamin B Complex/economics , Wound Infection/diagnosis , Wound Infection/economics , Wound Infection/microbiology
16.
Pharmacotherapy ; 37(1): 54-64, 2017 01.
Article En | MEDLINE | ID: mdl-27995636

Pharmaceutical costs for patients in the intensive care unit (ICU) constitute a large portion of hospital drug budgets. Unfortunately, prices for medications commonly used in the ICU are on the rise for a variety of reasons. In particular, the U.S. Food and Drug Administration's Unapproved Drugs Initiative, generic manufacturers cornering the marketplace, drug shortages, and regulatory device changes are major drivers of pharmaceutical price escalation affecting costs in the ICU. Furthermore, traditional high acquisition cost items still pose challenges to controlling costs. To offer strategies to mitigate the rising costs of pharmaceuticals in the ICU setting, we searched the PubMed/Medline and International Pharmaceutical Abstracts databases and other related sources to identify published cost-saving protocols concerning specific medications that are affected by rising prices or have traditional high acquisition costs. In the absence of specific protocols, we offer possible cost-saving initiatives based on published literature regarding specific agents or based on our own diverse set of experiences. Finally, we review suggested clinical and operational activities at an institutional level to address these rising drug costs in the ICU setting.


Critical Care , Drug Costs , Health Expenditures , Pharmacy Service, Hospital , Cost Savings , Dexmedetomidine/economics , Factor VIIa/economics , Humans , Intensive Care Units , Vasodilator Agents/economics
17.
Circ Cardiovasc Imaging ; 9(10)2016 Oct.
Article En | MEDLINE | ID: mdl-27894070

BACKGROUND: Computed tomography coronary angiography (cTCA) and stress cardiac magnetic resonance (stress-CMR) are suitable tools for diagnosing obstructive coronary artery disease in symptomatic patients with previous history of revascularization. However, performance appraisal of noninvasive tests must take in account the consequent diagnostic testing, invasive procedures, clinical outcomes, radiation exposure, and cumulative costs rather than their diagnostic accuracy only. We aimed to compare an anatomic (cTCA) versus a functional (stress-CMR) strategy in symptomatic patients with previous myocardial revascularization procedures. METHODS AND RESULTS: Six hundred patients with chest pain and previous revascularization included in a prospective observational registry and evaluated by clinically indicated cTCA (n=300, mean age 68.2±9.7 years, male 255) or stress-CMR (n=300, mean age 67.6±9.7 years, male 263) were enrolled and followed-up in terms of subsequent noninvasive tests, invasive coronary angiography, revascularization procedures, cumulative effective radiation dose, major adverse cardiac events, defined as a composite end point of nonfatal myocardial infarction and cardiac death, and medical costs. The mean follow-up for cTCA and stress-CMR groups was similar (773.6±345 versus 752.8±291 days; P=0.21). Compared with stress-CMR, cTCA was associated with a higher rate of subsequent noninvasive tests (28% versus 17%; P=0.0009), invasive coronary angiography (31% versus 20%; P=0.0009), and revascularization procedures (24% versus 16%; P=0.007). Stress-CMR strategy was associated with a significant reduction of radiation exposure and cumulative costs (59% and 24%, respectively; P<0.001). Finally, patients undergoing stress-CMR showed a lower rate of major adverse cardiac events (5% versus 10%; P<0.010) and cost-effectiveness ratio (119.98±250.92 versus 218.12±298.45 Euro/y; P<0.001). CONCLUSIONS: Compared with cTCA, stress-CMR is more cost-effective in symptomatic revascularized patients.


Computed Tomography Angiography , Coronary Angiography/methods , Coronary Artery Disease/therapy , Coronary Vessels/diagnostic imaging , Magnetic Resonance Imaging/methods , Myocardial Revascularization , Vasodilator Agents/administration & dosage , Aged , Cause of Death , Computed Tomography Angiography/economics , Coronary Angiography/economics , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/economics , Coronary Artery Disease/physiopathology , Coronary Vessels/physiopathology , Cost-Benefit Analysis , Female , Health Care Costs , Humans , Italy , Magnetic Resonance Imaging/economics , Male , Middle Aged , Myocardial Infarction/etiology , Myocardial Revascularization/adverse effects , Myocardial Revascularization/economics , Myocardial Revascularization/mortality , Predictive Value of Tests , Prospective Studies , Radiation Dosage , Radiation Exposure , Registries , Reproducibility of Results , Time Factors , Treatment Outcome , Vasodilator Agents/economics
19.
J Stroke Cerebrovasc Dis ; 25(9): 2290-4, 2016 Sep.
Article En | MEDLINE | ID: mdl-27315743

BACKGROUND: The mainstay of acute management of intracerebral hemorrhage (ICH) is blood pressure reduction. Intravenous (IV) nicardipine is an effective but costly intervention for blood pressure reduction in the intensive care unit (ICU). Earlier transition to oral (PO) antihypertensive agents may reduce ICU length of stay (LOS) and associated costs. We sought to study the effectiveness of an interdisciplinary intervention to start earlier transition to PO antihypertensives. METHODS: From July 2011 to July 2012, patients with ICH who received IV nicardipine were reviewed and screened for eligibility by an interdisciplinary team including physicians and pharmacists. These patients were compared to a control group 1 year prior to this intervention. The duration of nicardipine treatment (median hours), estimated costs, and ICU LOS were measured. RESULTS: A total of 35 patients and 44 controls were studied. The median hours of IV nicardipine use were significantly decreased from a baseline mean of 118 to 30 hours (P < .001); total cost savings per year was $433,566 ($18,475 per patient). The average LOS remained similar (8.4 versus 8.9 days, P < .990). In a follow-up study 1 year later, after the intervention was no longer used, a sample of 21 consecutive patients was reviewed and the duration of IV nicardipine treatment had increased to a mean of 96 hours. CONCLUSION: A physician and pharmacist-led project to initiate oral antihyperintensive medications earlier was successful in reducing the duration of IV nicardipine treatment in patients with ICH while leading to substantial cost savings.


Cerebral Hemorrhage/drug therapy , Cerebral Hemorrhage/economics , Nicardipine/administration & dosage , Nicardipine/economics , Vasodilator Agents/administration & dosage , Vasodilator Agents/economics , Administration, Intravenous , Aged , Aged, 80 and over , Cost-Benefit Analysis , Female , Follow-Up Studies , Humans , Intensive Care Units , Length of Stay , Male , Middle Aged , Retrospective Studies , Statistics, Nonparametric , Time Factors
20.
Ann Pharmacother ; 50(1): 22-6, 2016 Jan.
Article En | MEDLINE | ID: mdl-26438636

BACKGROUND: Direct comparisons of inhaled nitric oxide (iNO) to inhaled epoprostenol (iEPO) in patients with acute pulmonary hypertension (PHT) following cardiac surgery are lacking. OBJECTIVE: To compare the relative efficacy, safety, and cost of iNO versus iEPO in patients with acute PHT following cardiac surgery. METHODS: This is a single-center, retrospective, observational, cohort study comparing iNO to iEPO for acute postoperative PHT following cardiac surgery. The primary outcome was reduction of mean pulmonary artery pressure (mPAP) to < 30 mm Hg, 6 hours after ICU admission from the operating room. Secondary outcomes, included ICU and hospital length of stay, duration of mechanical ventilation, bleeding complications, hypotension, in-hospital mortality, and cost. RESULTS: A total of 98 patients met inclusion criteria (iNO, n = 49; iEPO, n = 49). There was no difference in the primary outcome of reduction of mPAP to < 30 mm Hg 6 hours after ICU admission (iNO, 33 [67%] vs iEPO, 35 [71%]; P = 0.83) or in the incidence of adverse events collected (iNO, 10 [20%] vs iEPO, 11 [22%]; P = 1.00). Based on cost estimates, the median cost of iEPO per patient was $363.53 ($226-$864.60) versus $2562.50 ($1875-$8625) for iNO (P < 0.01). CONCLUSIONS: The relative efficacy of iEPO appeared to be similar to that of iNO in reducing mPAP following cardiac surgery, in this retrospective review. Significant cost savings were associated with the use of iEPO.


Cardiac Surgical Procedures/adverse effects , Epoprostenol/administration & dosage , Hypertension, Pulmonary/drug therapy , Nitric Oxide/administration & dosage , Vasodilator Agents/administration & dosage , Administration, Inhalation , Adult , Aged , Blood Pressure/drug effects , Cohort Studies , Epoprostenol/economics , Female , Hemorrhage/prevention & control , Hospital Mortality , Humans , Hypertension/complications , Hypertension, Pulmonary/economics , Hypertension, Pulmonary/physiopathology , Length of Stay , Male , Middle Aged , Nitric Oxide/economics , Respiration, Artificial , Retrospective Studies , Vasodilator Agents/economics
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