Nicardipine or Nitroprusside for Postoperative Blood Pressure Control in Infants After Surgery for Congenital Heart Disease: Single-Center Retrospective Noninferiority and Cost Analysis, 2016-2020.

OBJECTIVES: Postoperative hypertension frequently occurs after surgery for congenital heart disease. Given safety concerns when using calcium channel blockers in infants along with the cost and side-effect profile of nitroprusside, we retrospectively assessed our experience of using nicardipine and nitroprusside for postoperative blood pressure control in infants who underwent surgery for congenital heart disease. We also investigated the cost difference between the medications. DESIGN: This study was a single-center retrospective, pre-post chart review of patients who had surgery for congenital heart disease between 2016 and 2020. The primary aim was a noninferiority comparison of achievement of blood pressure goal at 1-hour post-initiation of an antihypertensive agent. Secondary comparisons included achievement of blood pressure goal at 2 hours after medication initiation, Vasoactive-Inotropic Score (VIS), and blood transfusion, crystalloid volume, and calcium needs. SETTING: Academic quaternary-care center. PATIENTS: Infants under 1 year old who required treatment for hypertension with nitroprusside ( n = 71) or nicardipine ( n = 52) within 24 hours of surgery for congenital heart disease. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: We failed to identify any difference in proportion of patients that achieved blood pressure control at 1-hour after medication initiation (nitroprusside 52% vs. nicardipine 54%; p = 0.86), with nicardipine noninferior to nitroprusside within a 15% margin. Of patients who did not achieve control at 1-hour post-medication initiation, receiving nicardipine was associated with blood pressure control at 2 hours post-medication initiation (79% vs. 38%; p = 0.003). We also failed to identify an association between antihypertensive types and mean VIS scores, blood transfusion volumes, crystalloid volumes, and quantities of calcium administered. Index cost of using nitroprusside was 16 times higher than using nicardipine, primarily due to difference in wholesale cost. CONCLUSIONS: In our experience of achieving blood pressure control in infants after surgery for congenital heart disease (2016-2020), antihypertensive treatment with nicardipine was noninferior to nitroprusside. Furthermore, nicardipine use was significantly less expensive than nitroprusside. Our contemporary practice is therefore to use nicardipine in preference to nitroprusside.

Sodium Nitroprusside as a Hyperinflation Drug and Therapeutic Alternatives.

Sodium nitroprusside (SNP) is a generically available and rapid-acting intravenous (IV) vasodilator that has been used clinically for decades. Prior to 2013, the cost of SNP was relatively low, and SNP was an affordable option for the treatment of acute hypertension. However, from 2013 to 2017, average wholesale prices for SNP rose to as high as US$900 per vial, earning the drug its status as a "hyperinflation drug." Hyperinflation drugs pose a significant challenge for pharmacy departments. A multidisciplinary effort involving stakeholders from many backgrounds, including pharmacists, physicians, and nurses, is key to developing an effective cost containment strategy. A therapeutic interchange, wherein a drug with similar efficacy is substituted for another, is often an appropriate strategy to address rising drug costs. Fortunately, alternative drugs with a solid evidence base exist for the management of acute hypertension. The dihydropyridine calcium channel blockers, clevidipine and nicardipine, are IV titratable antihypertensive agents with favorable pharmacokinetic and safety profiles. Various studies indicate that clevidipine and nicardipine are effective alternatives to SNP for indications including hypertensive crisis and postoperative hypertension. Some hospitals have reported significant cost savings without adverse outcomes by substituting clevidipine or nicardipine for SNP. This article is intended to serve as a review of the evidence for clevidipine and nicardipine as potential substitutes for SNP and to provide strategies to successfully implement this therapeutic interchange.

Sodium nitroprusside: low price and safe drug to control BP during thrombolysis in AIS.

This study analyzes the use of sodium nitroprusside (SN) as an option to reduce blood pressure (BP) below 180/105 mmHg during the management of acute ischemic stroke (AIS) in patients submitted to intravenous thrombolysis.Method The sample was composed by 60 patients who had AIS and were submitted to intravenous rtPA, split in two groups: half in the control group (CG) with BP < 180/105 mmHg and half in SN group with BP > 180/105 mmHg. Outcome variables were any hemorrhagic transformation (HT); the presence of symptomatic HT, National Institute of Health Stroke Scale (NIHSS) after 24 hours of treatment; the independence on discharge and death until three months after stroke onset.Results There were no statistical differences between both groups to any of the outcome variables analyzed.Conclusion The SN might be safe for BP control during thrombolysis to AIS.

A cost analysis of the impact of a new intravenous antihypertensive in managing perioperative blood pressure during cardiac surgery.

OBJECTIVE: To examine the impact of intravenous antihypertensive selection on hospital health resource utilization using data from the Evaluation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events (ECLIPSE) trials. METHODS: Analysis of ECLIPSE trial data comparing clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine and unit costs based on the Premier Hospital database to assess surgery duration, time to extubation, and length of stay (LOS) with the associated cost. RESULTS: A total of 1414 patients from the ECLIPSE trials and the Premier hospital database were included for analysis. The duration of surgery and postoperative LOS were similar across groups. The time from chest closure to extubation was shorter in patients receiving clevidipine group compared with the pooled comparator group (median 7.0 vs 7.6 hours, P = 0.04). There was shorter intensive care unit (ICU) LOS in the clevidipine group versus the nitroglycerin group (median 27.2 vs 33.0 hours, P = 0.03). A trend toward reduced ICU LOS was also seen in the clevidipine compared with the pooled comparator group (median 32.3 vs 43.5 hours, P = 0.06). The costs for ICU LOS and time to extubation were lower with clevidipine than with the comparators, with median cost savings of $887 and $34, respectively, compared with the pooled comparator group, for a median cost savings of $921 per patient. CONCLUSIONS: Health resource utilization across therapeutic alternatives can be derived from an analysis of standard costs from hospital financial data to matched utilization metrics as part of a randomized controlled trial. In cardiac surgical patients, intravenous antihypertensive selection was associated with a shorter time to extubation in the ICU and a shorter ICU stay compared with pooled comparators, which in turn may decrease total costs.

Sodium nitroprusside: low price and safe drug to control BP during thrombolysis in AIS / Nitroprussiato de sódio: uma droga segura e de baixo custo para o controle de PA durante a trombólise em AVC isquêmico

This study analyzes the use of sodium nitroprusside (SN) as an option to reduce blood pressure (BP) below 180/105 mmHg during the management of acute ischemic stroke (AIS) in patients submitted to intravenous thrombolysis.Method The sample was composed by 60 patients who had AIS and were submitted to intravenous rtPA, split in two groups: half in the control group (CG) with BP < 180/105 mmHg and half in SN group with BP > 180/105 mmHg. Outcome variables were any hemorrhagic transformation (HT); the presence of symptomatic HT, National Institute of Health Stroke Scale (NIHSS) after 24 hours of treatment; the independence on discharge and death until three months after stroke onset.Results There were no statistical differences between both groups to any of the outcome variables analyzed.Conclusion The SN might be safe for BP control during thrombolysis to AIS.

Este estudo analisa o uso de nitroprussiato de sódio (NS) como uma opção para reduzir a pressão arterial (PA) durante o tratamento do AVC isquêmico agudo (AVCi) em pacientes submetidos à trombólise intravenosa (rtPA).Método A amostra foi composta por 60 pacientes que tiveram AVCi e foram submetidos a rtPA, dividida em dois grupos: 30 pacientes no grupo controle (GC), com PA < 180/105 mmHg e 30 pacientes no grupo NS com PA > 180/105 mmHg. As variáveis analisadas foram qualquer transformação hemorrágica (TH); a presença de TH sintomática, NIHSS após 24 horas de tratamento; a independência na alta e morte até três meses após o AVCi.Resultados Não houve diferença estatística entre os dois grupos para qualquer das variáveis de desfecho analisadas.Conclusão O NS pode ser seguro para o controle da pressão arterial durante a trombólise no AVCi.

A multicenter comparison of outcomes associated with intravenous nitroprusside and nicardipine treatment among patients with intracerebral hemorrhage.

INTRODUCTION: No clinical data exist to compare outcomes between patients with intracerebral hemorrhage (ICH) treated with different intravenous antihypertensive agents. This study was performed to compare outcomes among patients with ICH who were treated with intravenous infusion of different antihypertensive medications during the first 24 hours after admission. METHODS: We analyzed one-year data (2005-2006) from the Premier database which is a nationally representative hospital discharge database containing data pertaining to admissions in the United States. We compared discharge outcomes, length of stay, and cost of hospitalization between groups of patients who were treated using either intravenous nicardipine or nitroprusside infusion. Chi-square and ANOVA were used for univariate analysis. Logistic and linear regression analyses were performed to adjust for baseline risk of mortality between the two groups. RESULTS: A total of 12,767 admissions with primary diagnosis of ICH were identified. Nicardipine was administered in 926 patients (7.3%) and nitroprusside was administered in 530 (4.3%) patients. There was no difference in baseline disease severity or risk of mortality among patients who were administered nicardipine or nitroprusside. After adjustment for baseline risk of mortality, the risk of in-hospital mortality (odds ratio [OR] 1.7, 95% confidence interval [95% CI] 1.3-2.2) was higher among patients treated with nitroprusside compared with nicardipine. The risk of in-hospital mortality was also higher after adjustment for baseline risk of mortality and hospital characteristics in patients treated with nitroprusside (OR 1.6, 95% CI 1.2-2.1). After exclusion of patients who died during hospitalization, there was no difference in length of stay and total hospital cost in the multivariate analysis. CONCLUSION: Use of nicardipine compared with nitroprusside infusion during the first 24 h after ICH may be associated with reduced risk of in-hospital mortality without any increase in the hospitalization cost or length of stay.

Fenoldopam versus nitroprusside for the treatment of hypertensive emergency.

BACKGROUND: While sodium nitroprusside remains first-line therapy for hypertensive emergency (HEM), fenoldopam is increasingly being used because of its benign safety profile and potential renal protective effects. OBJECTIVE: To compare the efficacy, safety, and cost of sodium nitroprusside versus fenoldopam for the treatment of HEM. METHODS: This study was a retrospective analysis of consecutive patients with HEM admitted to a university-affiliated, level 1 trauma center from 1999 to 2001 and treated with either nitroprusside (n = 21) or fenoldopam (n = 22) for >30 minutes. Time to reach mean arterial pressure (MAP) goal, change in MAP over time, time to initiation of oral antihypertensive therapy, change in renal function, incidence of cyanide toxicity, and cost of therapy were compared between groups. RESULTS: Demographic parameters were similar between groups, except renal failure, which was more prevalent in the fenoldopam group (10% vs 46%; p = 0.009). Neither the mean +/- SD pretreatment MAP (nitroprusside 168 +/- 19; fenoldopam 163 +/- 19; p = 0.45), time to reach MAP goal (3.6 [0.4-30] vs 4 [1-22] h; p = 0.51), nor infusion duration (18 [0.7-113] vs 18 [3-74] h; p = 0.45) differed between the patient groups. Time to initiation of oral antihypertensive therapy was similar between nitroprusside--(4.5 h [0.5-22] and fenoldopam--(6.5 h [1-100] treated patients; p = 0.65). Additional intravenous antihypertensives were administered to 16 patients in each group (p = 0.80). Change in creatinine clearance and incidence of tachycardia did not differ between groups. No symptoms of cyanide toxicity were detected. Cost of drug therapy was greater with fenoldopam (597.60 dollars, 199.20-6675.20 dollars); than nitroprusside (2.66 dollars, 1.68-3.48 dollars; p < 0.001). CONCLUSIONS: Treatment of HEM with fenoldopam appears to result in patient outcomes equivalent to those with nitroprusside but at a substantially higher cost. Further study is required to delineate the exact role of fenoldopam for treatment of HEM.