Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension.

OBJECTIVE: To evaluate maternal and neonatal outcomes by type of antihypertensive used in participants of the CHAP (Chronic Hypertension in Pregnancy) trial. METHODS: We conducted a planned secondary analysis of CHAP, an open-label, multicenter, randomized trial of antihypertensive treatment compared with standard care (no treatment unless severe hypertension developed) in pregnant patients with mild chronic hypertension (blood pressure 140-159/90-104 mm Hg before 20 weeks of gestation) and singleton pregnancies. We performed three comparisons based on medications prescribed at enrollment: labetalol compared with standard care, nifedipine compared with standard care, and labetalol compared with nifedipine. Although active compared with standard care groups were randomized, medication assignment within the active treatment group was not random but based on clinician or patient preference. The primary outcome was the occurrence of superimposed preeclampsia with severe features, preterm birth before 35 weeks of gestation, placental abruption, or fetal or neonatal death. The key secondary outcome was small for gestational age (SGA) neonates. We also compared medication adverse effects between groups. Relative risks (RRs) and 95% CIs were estimated with log binomial regression to adjust for confounding. RESULTS: Of 2,292 participants analyzed, 720 (31.4%) received labetalol, 417 (18.2%) received nifedipine, and 1,155 (50.4%) received no treatment. The mean gestational age at enrollment was 10.5±3.7 weeks; nearly half of participants (47.5%) identified as non-Hispanic Black; and 44.5% used aspirin. The primary outcome occurred in 217 (30.1%), 130 (31.2%), and 427 (37.0%) in the labetalol, nifedipine, and standard care groups, respectively. Risk of the primary outcome was lower among those receiving treatment (labetalol use vs standard adjusted RR 0.82, 95% CI, 0.72-0.94; nifedipine use vs standard adjusted RR 0.84, 95% CI, 0.71-0.99), but there was no significant difference in risk when labetalol was compared with nifedipine (adjusted RR 0.98, 95% CI, 0.82-1.18). There were no significant differences in SGA or serious adverse events between participants receiving labetalol and those receiving nifedipine. CONCLUSION: No significant differences in predetermined maternal or neonatal outcomes were detected on the basis of the use of labetalol or nifedipine for treatment of chronic hypertension in pregnancy. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02299414.

Labetalol Ameliorates Experimental Colitis in Rat Possibly Through its Effect on Proinflammatory Mediators and Oxidative Stress.

BACKGROUND: Members of beta blockers drugs possess significant antioxidant activities. The current research is to assess the effect of the labetalol on acetic acid (AA-induced) colitis in rat model. METHODS: Forty adult Wistar rats were separated into 4 groups, including the negative control group, AA group, AA + sulfasalazine (100 mg/kg/day) group, and AA + labetalol (300 mg/kg/day) group. Colitis was induced in rats by the interrectal installation of 2 mL of 4% (v/v) AA. Sulfasalazine and labetalol were administered orally for 7 days after 2 hours of induction. The following parameters were measured: disease activity index (DAI), histopa-thological changes and colon tissue homogenate concentrations of proinflammatory mediators IL-1ß, adhesion molecules ICAM-1, and oxidative stress marker myeloperoxidase (MPO). RESULTS: The treatment with labetalol significantly reduced DAI and histopathological changes induced by AA. Also, labetalol markedly decreased the concentrations of IL-1ß, ICAM-1, and MPO in colonic tissue that were increased by AA. The effects of labetalol were significantly lower than that produced by sulfasalazine as standard drug. CONCLUSIONS: Labetalol exerts ameliorative effects on disease activity and histopathological features of AA-induced colitis in rats possibly through antioxidant effects and inhibition of inflammatory mediators.

Pharmacogenomics of Preeclampsia therapies: Current evidence and future challenges for clinical implementation.

Preeclampsia is a pregnancy-specific disorder, and it is a leading cause of maternal and perinatal morbidity and mortality. The application of pharmacogenetics to antihypertensive agents and dose selection in women with preeclampsia is still in its infancy. No current prescribing guidelines from the clinical pharmacogenetics implementation consortium (CPIC) exist for preeclampsia. Although more studies on pharmacogenomics are underway, there is some evidence for the pharmacogenomics of preeclampsia therapies, considering both the pharmacokinetic (PK) and pharmacodynamic (PD) properties of drugs used in preeclampsia. It has been revealed that the CYP2D6*10 variant is significantly higher in women with preeclampsia who are non-responsive to labetalol compared to those who are in the responsive group. Various genetic variants of PD targets, i.e., NOS3, MMP9, MMP2, TIMP1, TIMP3, VEGF, and NAMPT, have been investigated to assess the responsiveness of antihypertensive therapies in preeclampsia management, and they indicated that certain genetic variants of MMP9, TIMP1, and NAMPT are more frequently observed in those who are non-responsive to anti-hypertensive therapies compared to those who are responsive. Further, gene-gene interactions have revealed that NAMPT, TIMP1, and MMP2 genotypes are associated with an increased risk of preeclampsia, and they are more frequently observed in the non-responsive subgroup of women with preeclampsia. The current evidence is not rigorous enough for clinical implementation; however, an institutional or regional-based retrospective analysis of audited data may help close the knowledge gap during the transitional period from a traditional approach (a "one-size-fits-all" strategy) to the pharmacogenomics of preeclampsia therapies.

Safety and efficacy of continuous intravenous labetalol for blood pressure control in neurosurgical patients.

OBJECTIVES: Current evidence supporting the use of continuous intravenous labetalol for blood pressure (BP) control in neurosurgical patients is limited. This study aims to assess the efficacy and safety of labetalol in neurosurgical patients and identify potential contributing factors to these outcomes. METHODS: We retrospectively reviewed the medical records of neurosurgical patients who received continuous labetalol infusion for BP control. Efficacy was assessed based on the time needed to achieve the target BP (systolic BP ≤ 140 mmHg or diastolic BP ≤ 90 mmHg). Safety was assessed according to adverse events that occurred during labetalol administration. Factors associated with efficacy and safety were analyzed using a logistic regression model. RESULTS: Among 79 patients enrolled in this study, 47 (59.49%) achieved the target BP within 1 hour (early response). No factors were significantly associated with an early response. Hypotension was observed in 11 patients (13.9%), and bradycardia was observed in 8 patients (10.1%). Hypotension was significantly associated with patient age and motor impairment, while bradycardia was significantly associated with diabetes mellitus. CONCLUSION: The efficacy and safety profiles of labetalol infusion suggest this treatment as a promising option for BP control in neurosurgical patients.

A treatment strategy with nifedipine versus labetalol for women with pregnancy hypertension: study protocol for a randomised controlled trial (Giant PANDA).

BACKGROUND: Approximately one in ten women have high blood pressure during pregnancy. Hypertension is associated with adverse maternal and perinatal outcomes, and as treatment improves maternal outcomes, antihypertensive treatment is recommended. Previous trials have been unable to provide a definitive answer on which antihypertensive treatment is associated with optimal maternal and neonatal outcomes and the need for robust evidence evaluating maternal and infant benefits and risks remains an important, unanswered question for research and clinical communities. METHODS: The Giant PANDA study is a pragmatic, open-label, multicentre, randomised controlled trial of a treatment initiation strategy with nifedipine (calcium channel blocker), versus labetalol (mixed alpha/beta blocker) in 2300 women with pregnancy hypertension. The primary objective is to evaluate if treatment with nifedipine compared to labetalol in women with pregnancy hypertension reduces severe maternal hypertension without increasing fetal or neonatal death or neonatal unit admission. Subgroup analyses will be undertaken by hypertension type (chronic, gestational, pre-eclampsia), diabetes (yes, no), singleton (yes, no), self-reported ethnicity (Black, all other), and gestational age at randomisation categories (11 + 0 to 19 + 6, 20 + 0 to 27 + 6, 28 + 0 to 34 + 6 weeks). A cost-effectiveness analysis using an NHS perspective will be undertaken using a cost-consequence analysis up to postnatal hospital discharge and an extrapolation exercise with a lifetime horizon conditional on the results of the cost-consequence analysis. DISCUSSION: This trial aims to address the uncertainty of which antihypertensive treatment is associated with optimal maternal and neonatal outcomes. The trial results are intended to provide definitive evidence to inform guidelines and linked, shared decision-making tools, thus influencing clinical practice. TRIAL REGISTRATION: EudraCT number: 2020-003410-12, ISRCTN: 12,792,616 registered on 18 November 2020.

Comparison of efficacy of intravenous labetalol and intravenous hydralazine for management of pre-eclampsia in pregnant women.

Objectives: To compare the efficacy of intravenous Labetalol and intravenous Hydralazine in reduction of blood pressure in patients with severe pre-eclampsia. Methodology: This comparative study was conducted at the Department of Obstetrics and Gynecology at Ziauddin University Hospital, Karachi from1st June 2019 to 30th June 2020. Total 208 pregnant women having severe pre-eclampsia (systolic pressure ≥160 mmHg and diastolic pressure ≥110mmHg) were included in study. Group A received I/V Labetalol. Group B received I/V Hydralazine. Efficacy of drugs was observed by reduction in blood pressure and the number of doses administered. Data was analysed using SPSS version 26. Results: Systolic blood pressure reduction in Labetalol group was significantly lower than in hydralazine group (105.5 ±11.3 vs. 115.8 ±17.1, p≤ 0.001). Diastolic blood pressure reduction was also lower in labetalol group than in hydralazine group (p= 0.03). Number of dosage of drugs in Group A (Labetalol) was 3.2 ±1.2 vs. Group B (Hydralazine) was 4.4±1.4, p =0.006). Conclusion: The results of this study show that Labetalol is more effective as compared to Hydralazine in terms of reducing the systolic and diastolic blood pressure and number of doses (Drugs) for in patients with severe preeclampsia.

Hypertension in Pregnancy: A Diagnostic and Therapeutic Overview.

Hypertensive disorders in pregnancy are associated with increased risk of maternal, fetal, and neonatal morbidity and mortality. It is important to distinguish between pre-existing (chronic) hypertension and gestational hypertension, developing after 20 weeks of gestation and usually resolving within 6 weeks postpartum. There is a consensus that systolic blood pressure ≥ 170 or diastolic blood pressure ≥ 110 mmHg is an emergency and hospitalization is indicated. The selection of the antihypertensive drug and its route of administration depend on the expected time of delivery. The current European guidelines recommend initiating drug treatment in pregnant women with persistent elevation of blood pressure ≥ 150/95 mmHg and at values > 140/90 mmHg in women with gestational hypertension (with or without proteinuria), with pre-existing hypertension with the superimposition of gestational hypertension, and with hypertension with subclinical organ damage or symptoms at any time during pregnancy. Methyldopa, labetalol, and calcium antagonists (the most data are available for nifedipine) are the drugs of choice. The results of the CHIPS and CHAP studies are likely to reduce the threshold for initiating treatment. Women with a history of hypertensive disorders in pregnancy, particularly those with pre-eclampsia, are at high risk of developing cardiovascular disease later in life. Obstetric history should become a part of the cardiovascular risk assessment in women.

Comparing the efficacy of oral labetalol with oral amlodipine in achieving blood pressure control in women with postpartum hypertension: randomized controlled trial (HIPPO study-Hypertension In Pregnancy & Postpartum Oral-antihypertensive therapy).

De novo - or as a continuum of antenatal hypertension -postpartum hypertension complicates ~2% of pregnancies. Many maternal complications, such as eclampsia and cerebrovascular accidents, occur in the postpartum period. Despite widespread use of antihypertensives during pregnancy and childbirth, there is a paucity of data on preferred medications in the postpartum period. This randomized controlled study enrolled 130 women who were started on antihypertensives. They were randomized to receive oral Labetalol(LAB, maximum 900 mg per day in three doses) or oral Amlodipine(AML, maximum 10 mg per day given in two doses). In the immediate postpartum, all women were closely monitored for neurological symptoms, blood pressure, heart rate, respiratory rate, urine output, and deep tendon reflex. The primary outcome was the time to achieve sustained blood pressure control for 12 h from the initiation of medication; secondary outcomes included side effects of both medications. Mean time to achieve sustained blood pressure control was lower in women who received AML than in those who received LAB-(mean difference 7.2 h; 38 95% CI 1.4, 12.9, p = 0.011). There were fewer severe hypertensive episodes among those with AML than in those who received LAB. However, the proportion of women who continued to require antihypertensives at discharge was higher in the AML group than in the LAB group (55.4% versus 32.3%, p = 0.008). None of the participants developed drug-related side effects. Among women with postpartum persistence or new-onset hypertension, oral AML achieved sustained blood pressure control in a shorter duration, with fewer hypertensive emergencies than oral LAB. (CTRI/2020/02/023236).Trial Registration details: The study protocol was registered with Clinical Trial Registry of India with CTRI Number CTRI/2020/02/023236 dated 11.02.2020. Protocol can be accessed at https://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=40435&EncHid=&modid=&compid=%27,%2740435det%27 .

Reduction of Intravenous Antihypertensives through Clinical Decision Support in a Large Safety Net System.

BACKGROUND: Asymptomatic severe hypertension (also known as hypertensive urgency) is frequently encountered in the hospital. Previous evidence suggests that management with one-time doses of intravenous (IV) antihypertensives may increase adverse events. Despite this, single-dose treatment remains common in the emergency department and inpatient settings. METHODS: This quality initiative was launched at New York City Health + Hospitals, the largest safety net hospital system in the United States. The initiative involved two changes to electronic orders for IV hydralazine and IV labetalol: a nonintrusive advisory statement within the order instructions and a mandatory requirement to document the indication for IV antihypertensive use. RESULTS: This initiative took place from November 2021 to October 2022. Of the indications selected for IV antihypertensive orders, 60.7% were for hypertensive emergency, 15.3% were for patients who were strictly NPO, 21.2% were for other, and 2.8% selected more than one indication. For ED-only encounters, aggregate IV hydralazine and IV labetalol orders per 1,000 patient encounters were 2.53 preintervention and 1.55 postintervention (38.7% reduction, p < 0.001). For inpatient encounters, aggregate IV hydralazine and IV labetalol orders per 1,000 patient-days were 18.25 preintervention and 15.81 postintervention (13.4% reduction, p < 0.001). Similar trends were observed for individual orders of IV hydralazine and IV labetalol. There were significant reductions in 7 of the 11 hospitals in inpatient administration of aggregate IV hydralazine and labetalol orders per 1,000 patient-days. CONCLUSION: This quality improvement initiative successfully reduced unnecessary IV antihypertensive use in an 11-hospital safety net system.

Labetalol, Low-dose Aspirin, and Vitamin E and Calcium for Gestational Hypertension and Influence on MicroRNA-126 and PLGF Levels.

Context: Hypertensive disorders in pregnancy (HDP) are common complications of pregnancy and the main cause of perinatal adverse outcomes. Clinicians mostly adopt comprehensive treatment strategies, including anticoagulants and micronutrients. At present, the clinical effects of a strategy combining labetalol + low-dose aspirin + vitamin E and calcium aren't completely clear. Objective: The study intended to investigate the efficacy of a combined therapy of labetalol + low-dose aspirin + vitamin E and calcium for the treatment of HDP and the relationship of the levels of expression of microRNA-126 and placenta growth factor (PLGF) to outcomes, to provide better treatment strategies for patients. Design: The research team performed a randomized controlled trial. Setting: The study took place in the Department of Obstetrics and Gynecology at Jinan Maternity and Child Care Hospital in Jinan, China. Participants: Participants were 130 HDP patients at the hospital between July 2020 and September 2022. Intervention: The research team divided participants into two groups, with 65 participants each, using the random number table method: (1) a control group that received a combined therapy of labetalol + vitamin E and calcium and (2) an intervention group that received a combined therapy of labetalol + low-dose aspirin + vitamin E and calcium. Outcome Measures: The research team measured clinical efficacy, blood pressure parameters, 24 h urinary protein, microRNA-126, PLGF, and drug-related adverse reactions. Results: The intervention group's efficacy rate was 96.92%, which was significantly higher than that of the control group at 83.08% (P = .009). Postintervention, the intervention group's systolic blood pressure, diastolic blood pressure, and 24 h urinary protein levels were significantly lower than those of the control group (all P < .05), while the microRNA-126 and PLGF levels were significantly higher (both P < .05). No significant differences existed in the rate of drug-related adverse reactions between the groups, at 4.62% and 6.15%, respectively (P > 0.05). Conclusions: The combined therapy of labetalol + low-dose aspirin + vitamin E and calcium had a high efficacy rate and could significantly reduce blood pressure and 24h urine protein and significantly increase microRNA-126 and PLGF levels, with a high safety profile.

Nicardipine versus Labetalol for Hypertension during Acute Stroke: A Systematic Review and Meta-Analysis.

Background and Objective: Current recommendations prescribe either nicardipine or labetalol as the first-line treatment for acute hypertension due to ease of use, availability, and low price. However, it is unclear if these drugs have different effectiveness and safety profiles. This systematic review and meta-analysis aimed to compare the efficacy and safety of labetalol and nicardipine in patients with acute stroke. Materials and Methods: MEDLINE via PubMed, Scopus, Embase, and Google Scholar databases were electronically searched for the eligible publications from inception until March 2022. All full-text journal papers in English which compared the efficacy of nicardipine with that of labetalol on lowering blood pressure (BP; or treating hypertension) in all subtypes of acute stroke were included. The Cochrane Collaboration tool was used to assess the risk of bias. Data were analyzed using specific statistical methods. Results: Following the abstract and full-text screening, this meta-analysis included five retrospective cohorts and one prospective pseudorandomized cohort. Nicardipine's effect on time at goal BP was significantly superior to that of labetalol in patients with acute stroke (0.275 standardized mean difference [SMD], 95% confidence interval [CI]: 0.112-0.438, P = 0.001). The incidence of adverse events was significantly higher in the nicardipine group than that in the labetalol group. The pooled odds ratio (OR) was 1.509 (95% CI: 1.077-2.113, I2 = 0.00%, P = 0.757). The quality of included studies was found to be low. Conclusion: More prospective, comparative trials are needed to investigate the efficacy of BP management as well as clinical outcomes in acute stroke patients receiving continuous labetalol and nicardipine infusions.

Effects of Nifedipine and Labetalol Combined with Magnesium Sulfate on Blood Pressure Control, Blood Coagulation Function, and Maternal and Infant Outcome in Patients with Pregnancy-Induced Hypertension.

Objective: The purpose is to investigate the influence of nifedipine, labetalol, and magnesium sulfate on blood pressure control, blood coagulation, and maternal and infant outcome in those suffering from pregnancy-induced hypertension (PIH). Methods: From January 2019 to April 2021, 100 participants with PIH in our center were randomly assigned to a control group and a research group. As a control, nifedipine combined with magnesium sulfate was administered. Nifedipine, labetalol, and magnesium sulfate were administered to the research group. The curative effect, blood pressure level, blood coagulation function, vascular endothelial function, and pregnancy comparisons were made between the two groups. Results: Based on the results of the study, the effective rate totaled 92.00%, while as for the control group, it was 80.0%, which indicates that there was a statistically significant difference between the effective rates of the research group and that of the control group, and the difference was statistically significant (P < 0.05). Blood pressure and blood coagulation function did not differ significantly between the two groups before treatment, and the difference was not statistically significant (P > 0.05). After treatment, both groups experienced a significant drop in systolic and diastolic blood pressure. After treatment, a higher PT index was found in the research group than in the control group. Likewise, the Fbg, D-D, and PLT were lower compared to those in the control group, and the difference was statistically significant (P < 0.05). Neither group had significantly different vascular endothelial function before treatment, and the difference was not statistically significant (P > 0.05). After treatment, the ET-1 of the two groups decreased, and the level of NO increased. There was a lower ET-1 in the research group than in the control group as well as a higher NO level in the research group than in the control group, and the difference was statistically significant (P < 0.05). Compared with the pregnancy outcome, in comparison to the controls, the research group had a higher vaginal delivery rate. Significantly, fewer cases of fetal distress, intrauterine asphyxia, and placental abruption were reported in the research group than in the control group, and the difference was statistically significant (P < 0.05). Conclusion: Nifedipine, in combination with magnesium sulfate and labetalol, is effective at treating PIH, reducing blood pressure, improving blood coagulation, preventing cardiovascular events and vascular endothelial function, and further improve the pregnancy outcome.

Different dosage regimens of nifedipine, labetalol, and hydralazine for the treatment of severe hypertension during pregnancy: a network meta-analysis of randomized controlled trials.

OBJECTIVES: This network meta-analysis aimed to compare the efficacy and safety of intravenous (IV) hydralazine, oral nifedipine, and IV labetalol with different dosage regimens in the treatment of severe hypertension during pregnancy. METHODS: A comprehensive literature search was performed on PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov for randomized controlled trials (RCTs) exploring the effects of hydralazine, nifedipine, and labetalol in the treatment of severe hypertension during pregnancy. RESULTS: A total of 21 RCTs with 2183 patients comparing 7 regimens (oral nifedipine 50,60,90 mg; hydralazine 15,25 mg; and labetalol 220,300 mg) were identified. Compared with IV labetalol 300 mg, nifedipine 50,60, and 90 mg significantly improved the successful treatment rate of severe hypertension during pregnancy, nifedipine 50 and 90 mg and IV hydralazine 25 mg required significantly fewer doses to achieve target blood pressure (BP), and nifedipine 50 mg took significantly shorter time to achieve target BP. Subgroup analysis showed that only nifedipine 50 mg tablets, not capsules, required a significantly shorter time and fewer doses to achieve target BP than IV labetalol 300 mg. Moreover, nifedipine 60,90 mg showed superior effectiveness than IV hydralazine 15,25 mg in the successful treatment rate of severe hypertension during pregnancy. SUCRA analysis suggested that nifedipine 50,60,90 mg as the better regimens with the lower rates of overall ADR and neonatal complications. CONCLUSION: These findings demonstrated the superiority of oral nifedipine 50,60,90 mg, especially oral nifedipine 50 mg tablets, in the treatment of severe hypertension during pregnancy than IV labetalol 300 mg, while oral nifedipine 60,90 mg also showed superiority in the successful treatment rate of severe hypertension during pregnancy than IV hydralazine 15,25 mg. However, the limitations of the underlying data indicate that future large-scale and rigorous RCTs are needed to confirm such findings.

Efficacy and Safety of Intravenous Labetalol in Acute Hypertensive Crisis in Children.

OBJECTIVE: To determine the efficacy and safety of intravenous (IV) labetalol in the management of hypertensive crisis in children. METHODS: A retrospective chart review of 56 consecutive children (age > 1 mo to ≤ 12 y) with hypertensive crisis admitted to a pediatric intensive care unit (PICU) from July 2009 to 2019. RESULTS: The proportion of children attaining the primary endpoint (target 95th percentile in > 12 to ≤ 48 h) was significantly more in the group receiving labetalol as first-line or add-on (n = 23) as compared to those not receiving labetalol (n = 33) (62% vs. 30.3%, p = 0.03). Higher proportion of neurological recovery was seen in the labetalol group (56.2% vs. 18.7%, p = 0.02). The proportion of children with hypotension before 12 h was similar in both treatment groups (13% vs. 15%, p = 0.82). The practice variations between two periods of 5 y each (2009-2013 and 2014-2019) showed significantly more use of labetalol in the latter cohort (53% for 2014-2019 vs. 25% for 2009-2013, p = 0.03). CONCLUSION: Labetalol, when used alone or as an add-on drug, was more efficacious than IV nitroprusside/nitroglycerine in attaining the primary endpoint in children up to ≤ 12 y of age with hypertensive crisis. Labetalol was safe and associated with higher neurological recovery.

Isotopic response of labetalol-associated lichen planus pemphigoides on an old radiation site: A case report.

Over the years, the occurrences of different types of skin disorders arising from radiation sites have been observed and studied. Examples include autoimmune blistering diseases such as pemphigus, pemphigoid, and interface or inflammatory reaction patterns such as lichen planus, lupus erythematosus, and Stevens-Johnson syndrome. The phenomenon whereby a new skin disorder arises from a previously healed or irradiated site is called an isotopic response, described as a type of Koebner phenomenon. Ionizing radiation itself can profoundly affect the skin. Both early and late changes can present, which typify the progression of changes following irradiation of the skin. Herein, we report a rare case of labetalol-associated lichen planus pemphigoides that occurred at the site treated with radiation for a soft tissue malignancy after 19 years as a result of an isotopic response. The rash was well-controlled after therapy and kept a 4-year remission. The same skin reaction recurred after the reintroduction of labetalol 4 years later.

Blood Pressure Control in Acute Stroke: Labetalol or Nicardipine?

PURPOSE: To assess the safety and efficacy of continuous infusion (CIV)-labetalol compared to -nicardipine in controlling blood pressure (BP) in the acute stroke setting. MATERIALS: Patients were eligible if they had a diagnosis of an acute stroke and were administered either CIV-labetalol or CIV-nicardipine. Study outcomes were assessed within the first 24 h of the antihypertensive infusion. RESULTS: A total of 3,093 patients were included with 3,008 patients in the CIV-nicardipine group and 85 in the CIV-labetalol group. No significant difference was observed in percent time at goal BP between the nicardipine (82%) and labetalol (85%) groups (p = 0.351). There was also no difference in BP variability between nicardipine (37%) and labetalol (39%) groups (p = 0.433). Labetalol was found to have a shorter time to goal BP as compared to nicardipine (24 min vs. 40 min; p = 0.021). While CIV-nicardipine did have a higher incidence of tachycardia compared to labetalol (17% vs. 4%; p <0.001), the incidence of hypotension (13% vs. 15%; p = 0.620) and bradycardia (24% vs. 22%; p = 0.797) were similar. CONCLUSIONS: These results indicate that CIV-labetalol and CIV-nicardipine are comparable in safety and efficacy in controlling BP for patients with acute stroke.

Safety and efficacy of intravenous hydralazine and labetalol for the treatment of asymptomatic hypertension in hospitalised patients: A systematic review.

BACKGROUND: Current guidelines for the management of asymptomatic hypertension (HTN) in the inpatient setting recommend the use of oral antihypertensives. However, in clinical practice, intravenous (IV) antihypertensives are commonly utilised with little supporting evidence. The objective of this study was to evaluate literature examining the safety/efficacy of IV hydralazine and labetalol in hospitalised patients with non-emergent, asymptomatic HTN. METHODS: The PRISMA guidelines were utilised to structure the systematic review. A search strategy composed of drug-, inpatient- and HTN-related terms was conducted utilising PubMed, Embase and Scopus databases through May 2020. Full-text, English-language articles describing IV labetalol and/or hydralazine use for non-emergent HTN in an inpatient setting that focused on clinical outcomes (ie vitals, adverse effects, healthcare utilisation) were included. Identified studies were screened/extracted using DistillerSR by two reviewers at each stage, and studies were evaluated qualitatively for the presence of bias. RESULTS: From 3362 records identified in the search, a final set of 10 articles were identified. Four studies focused on labetalol (40%), five studies on hydralazine and labetalol (50%), and one study on hydralazine (10%). The included studies presented a variety of outcomes, but several trends were identified, including reduction in average blood pressure in eight (80%) studies, a risk of adverse effects in six (60%) and increased length of stay in one (10%). DISCUSSION: The studies identified in this review raise concerns regarding the safety of IV hydralazine and labetalol in non-emergent HTN. Despite relatively broad clinical experience with these drugs, experimental investigations regarding their utility are recommended.

Hemodynamic Safety of Continuous Infusion Labetalol Versus Esmolol Combination Therapies for Type B Aortic Dissections.

BACKGROUND: Medical management for type B aortic dissections (TBADs) require aggressive blood pressure and heart rate control to minimize further dissection extension and to restore perfusion to vital organs. Current guidelines recommend ß-blockers (BB) as first-line therapy, however do not differentiate an ideal agent for use. OBJECTIVE: This study evaluated the hemodynamic safety of continuous infusion labetalol compared to esmolol combination (EC) therapies for TBADs. METHODS: This single-center, retrospective analysis identified patients with a TBAD who received high dose continuous intravenous labetalol (HD-CIVL) or EC therapies. Patients who received HD-CIVL or EC therapies for a minimum of 2 hours, during which a minimum of 4 blood-pressure readings were recorded, were included. The primary end point was the incidence of hemodynamic instability with the use of HD-CIVL versus EC therapies. RESULTS: A total of 20 patients receiving HD-CIVL and 22 patients receiving EC therapy were included in the analysis. Ten (50%) of patients receiving HD-CIVL and 7 (32%) of patients receiving EC therapies met the clinical definition of hemodynamic instability (P = .23). Patients experiencing hemodynamic instability were all due to hypotension, with one also being due to bradycardia. Over half the patients in both groups had discontinued therapy ( P = .06) and were administered bolus fluids (P = .27). Only one patient receiving HD-CIVL required vasopressor administration while none in the EC group (P = .48). CONCLUSION: Our study suggests that HD-CIVL is associated with a nonstatistical significant higher incidence of hemodynamic instability compared to an EC regimen in TBADs. Further studies are warranted in this patient population.

Distinct outcomes of labetalol exposed infants: case reports and systematic review.

BACKGROUND: The adverse effects of long-term maternal exposure of labetalol on neonates have been recognized clinically. But there are few systematic studies on their clinical demonstrations and potential mechanisms. METHODS: A death case of an infant with long-term maternal labetalol exposure was reported and compared with two case reports from the literature. A systematic literature review was carried out followed by a retrospective analysis on neonatal labetalol withdrawal effects. RESULTS: It was discovered that labetalol withdrawal effects initially cause various degrees of hypotension, hypoglycemia, and bradycardia among exposed neonates. Some life-threatening cases can also occur within 1 week after birth. Long-term maternal exposure of labetalol, preterm infants with birth asphyxia, acidosis, hypoalbuminemia, and cardiac defects are their primary features. Possible mechanisms were concluded as labetalol-induced effects on the vascular and sympathetic nervous system as well as tissue oxygen extraction. CONCLUSIONS: Neonatal labetalol withdrawal effects include early-onset and late-onset demonstrations, the latter can be life-threatening. A possible mechanism is multiple factors induced imbalance of sympathetic homeostasis increases neonatal vulnerability to common stresses. Long-term exposed preterm infants complicated with asphyxia, acidosis, hypoalbuminemia and cardiac defects, should be provided with intense care during the first week after birth. Further work is necessary to enrich this hypothesis.