[Efficacy of Urapidil in treating lower urinary tract symptoms in patients with benign prostatic hyperplasia: A systematic review and meta-analysis].

OBJECTIVE: To investigate the potential application of α-1 blocker (urapidil) in the treatment of lower urinary tract symptoms (LUTS) in male patients with benign prostatic hypertrophy (BPH), we conducted a comprehensive meta-analysis. METHODS: Our study involved identifying and collecting randomized controlled trials (RCT) and clinical observational studies from databases including PubMed、MEDLINE、Web of science、CNKI and Wanfang database. We performed meta-analysis using RevMan 5.2.0 software for both fixed effects model and random effects model. RESULTS: Our analysis included 3 short-term (within 1 month) observational studies and 1 RCT involving 142 patients. We found that urapidil significantly improved the International Prostate Symptom Score (IPSS, MD=－5.57, 95%CI: －7.98～－3.16，P<0.00001), nocturia（MD=－0.7, 95%CI: －1.16～－0.24，P=0.003）, residual urine rate（MD=－6.97；95%CI: －12.57～－1.37，P=0.01）, average flow rate（MD=2.04；95%CI: 0.52～3.56，P=0.008）, and maximum flow rate （MD=4.29；95%CI: 0.58～8.01，P=0.02）of patients. However, there was no significant difference in the residual urine volume（MD=－35.93；95%CI: －78.62～6.76，P=0.10）between pre-treatment and post-treatment groups. CONCLUSION: Urapidil is an effective medication for relieving LUTS in BPH patients. However, due to the limited quantity and quality of current RCT studies, high-quality and large-scale RCT studies are still needed to further confirm this conclusion.

Urapidil: an unknown / known antihypertensive.

Essential arterial hypertension is not a disease that would significantly adversely affect patients in their daily activities. At least mostly. Nonetheless, it has a significant negative impact on cardiovascular morbidity and mortality. The tight correlation with the degree of hypertension, the patients age and, of course, commorbidities and cardiovascular risk factors is obvious. Therefore, the goal of hypertensive therapy is not only to try to achieve optimal reduction of blood pressure, but in a broader sense to reduce the risk of the just mentioned consequences, i.e. to reduce morbidity and reduce mortality. The antihypertensive drug urapidil can also be used in pharmacotherapy, the brief description of which is the subject of this article.

Therapeutic effects of silodosin and urapidil on underactive bladder associated with diabetic cystopathy.

OBJECTIVES: Pharmacological treatment options for underactive bladder (UAB) syndrome are limited. Urapidil is the only alpha1 -adrenoceptor (AR) antagonist that can be used for urinary disorders in women in some countries. However, no studies have directly verified the effects of alpha1 -AR antagonists on the female urethra and UAB-like dysfunctions. We investigated the effects of silodosin (alpha1A -AR antagonist) and urapidil (nonselective alpha1 -AR antagonist) on the voiding function in female rats with diabetes mellitus (DM). METHODS: Changes in intraurethral pressure (IUP) induced by midodrine (alpha1 -AR agonist) and mean blood pressure (MBP) were continuously measured in normal female rats to verify the pharmacological profiles of the drugs. To establish a DM model, rats were administered streptozotocin (STZ; 50 mg/kg, intravenous). Eight weeks after STZ administration, drugs were subcutaneously delivered through an osmotic pump. Four weeks after drug administration, emptied bladder blood flow (BBF), intravesical pressure, and the micturition volume were measured. RESULTS: Both silodosin and urapidil inhibited the midodrine-induced increase in IUP and decreased MBP in a dose-dependent manner. Silodosin had a more substantial effect on the lower urinary tract than on MBP. Twelve weeks after STZ administration, DM rats exhibited UAB-like dysfunction (increased bladder capacity/bladder weight and residual volume and decreased bladder voided efficiency) and decreased BBF. Both drug treatments controlled this dysfunction. CONCLUSIONS: Alpha1 -AR antagonists induced dose-dependent urethral relaxation in female rats. These drugs ameliorated UAB-like dysfunction in STZ-induced DM rats. In addition, alpha1A -AR antagonists such as silodosin, which have limited effects on blood pressure, appear to be useful for treating UAB.

Anaesthetic Management of a Labrador Retriever Undergoing Adrenalectomy for Phaeochromocytoma Excision, a Case Report.

Perioperative management of cases undergoing phaeochromocytoma removal should aim at normalising blood pressure and heart rate, restoring volume depletion, and preventing catecholamine release induced by surgical manipulation. In this case report, a novel pharmacological approach in a dog undergoing surgical tumour excision is described. A 7-year-old 25-kg spayed female Labrador Retriever presented for repeated episodes of generalised weakness, pale mucous membranes, tachycardia, tremor, panting, vomiting, and hypertension over the last month was referred for surgical treatment of a left-sided adrenal tumour with invasion of the caudal vena cava. Severe hypertensive episodes occurred repeatedly, starting early during the anaesthetic period, while clipping and cleaning the abdominal area, and continued intraoperatively when the tumour was handled. Moderate hypotension occurred once the tumour was isolated and worsened during temporary caudal vena cava flow interruption and cavotomy. The patient was treated preoperatively with phenoxybenzamine to prevent hypertensive crises. Intraoperatively, magnesium sulphate and urapidil were used to control blood pressure. This treatment was effective in reducing the magnitude of blood pressure spikes but not sufficient to prevent hypertensive peaks, especially during tumour manipulation. Hypotension was treated with synthetic colloid and crystalloid boli, and noradrenaline continuous infusion. Blood transfusion was performed in response to acute bleeding during cavotomy. The dog recovered successfully from anaesthesia and its quality of life was deemed excellent by the owner at the last follow up, 22 months after surgery. The histopathology confirmed the diagnosis of phaeochromocytoma with an invasion of the phrenicoabdominal vein. In the present case, we obtained a successful outcome but failed to provide haemodynamic stability throughout the procedure.

Identification and characterization of urapidil stress degradation products by LC-Q-TOF-MS and NMR: Toxicity prediction of degradation products.

Urapidil, an antihypertensive drug is subjected to various stress conditions (acidic, basic, neutral, oxidative and photolytic) as per ICH guidelines. A stability indicating HPLC method was developed using InertSustain C8 (250 × 4.6 mm; 5 µm) column and 10 mM ammonium formate (pH 3.5) with gradient elution at a flow rate of 1 mL/min to separate all the DPs. The drug was susceptible to acidic and basic hydrolysis, oxidative and photolytic stress conditions in the solution phase and stable in neutral solution phase and photolytic solid state conditions. A total of five DPs were detected under different stress conditions including DP4 which was previously reported in the literature. An extensive fragmentation pattern of drug and DPs were established using LC-Q-TOF-MS which aided the characterization of DPs. The ambiguity in the position of N-oxide formation in DP5 was confirmed by NMR studies. In silico toxicity of the drug and its DPs were also evaluated. The plausible mechanism of DPs formation was explained.

Urapidil alleviates ovarian torsion detorsion injury via regulating oxidative stress, apoptosis, autophagia, and inflammation.

OBJECTIVES: This study aimed to determine anti-inflammatory, antioxidant, and antiapoptotic properties of urapidil (Ura) against ovarian torsion detorsion (T/D) injury in rats. MATERIALS AND METHODS: 40 female Wistar albino rats were grouped as sham, T/D, T/D+dimethyl sulfoxide (DMSO), T/D+Urapidil (Ura) 0.5 mg/kg (low dose), and T/D+Urapidil (Ura) 5 mg/kg (high dose) groups. In treatment groups, Ura was administered intraperitoneally just before detorsion. Biochemical parameters (TAS, TOS, MDA, MPO, and SOD) and immunohistochemical (IL-1ß, TNF-α, NF-κB, LC3B, and Caspase-3) analyzes were performed. RESULTS: In the T/D group, OSI and MPO levels were elevated significantly while TAS values decreased compared with the sham group. A significant difference occurred in the low dose treatment group in TAS and OSI levels compared with the T/D group. In the high dose treatment group, significant elevation in TAS but reduction in OSI and MDA levels were observed compared with the T/D group. Immunohistochemical staining resulted in IL-1ß, TNF-α, NF-κB, LC3B, and caspase-3 immunopositivity in the T/D group, while Ura treatment decreased those parameters. Intensive congestion and hemorrhage were observed in the T/D group, but contrary to this, treatment groups had alleviated congestion and hemorrhage. CONCLUSION: These results suggest that Ura demonstrated protective effects against ovarian T/D injury via anti-oxidative, anti-inflammatory, and anti-apoptotic features.

Controlled arterial hypotension during resection of cerebral arteriovenous malformations.

BACKGROUND: Resection of cerebral arteriovenous malformations (AVM) is technically demanding because of size, eloquent location or diffuse nidus. Controlled arterial hypotension (CAH) could facilitate haemostasis. We performed a study to characterize the duration and degree of CAH and to investigate its association with blood loss and outcome. METHODS: We retrospectively analysed intraoperative arterial blood pressure of 56 patients that underwent AVM-resection performed by the same neurosurgeon between 2003 and 2012. Degree of CAH, AVM size, grading and neurological outcome were studied. Patients were divided into two groups, depending on whether CAH was performed (hypotension group) or not (control group). RESULTS: The hypotension group consisted of 28 patients, which presented with riskier to treat AVMs and a higher Spetzler-Martin grading. CAH was achieved by application of urapidil, increasing anaesthetic depth or a combination thereof. Systolic and mean arterial blood pressure were lowered to 82 ± 7 and 57 ± 7 mmHg, respectively, for a median duration of 58 min [25% percentile: 26 min.; 75% percentile: 107 min]. In the hypotension group, duration of surgery (4.4 ± 1.3 h) was significantly (p <  0.001) longer, and median blood loss (500 ml) was significantly (p = 0.002) higher than in the control group (3.3 ± 0.9 h and 200 ml, respectively). No case fatalities occurred. CAH was associated with a higher amount of postoperative neurological deficits. CONCLUSIONS: Whether CAH caused neurological deficits or prevented worse outcomes could be clarified by a prospective randomised study, which is regarded as ethically problematic in the context of bleeding. CAH should only be used after strict indication and should be applied as mild and short as possible.

Peri-operative management of pheochromocytoma with intravenous urapidil to prevent hemodynamic instability: A 17-year experience.

BACKGROUND AND AIMS: Surgery for pheochromocytoma (PCC) can cause excessive catecholamine release with severe hypertension. Alpha blockade is the mainstay of preoperative management. The aim of this study was to evaluate the efficacy and tolerance of intra-venous (IV) urapidil, a competitive short acting α1 receptor antagonist, in the prevention of peri-operative hemodynamic instability of patients with PCC. MATERIAL AND METHODS: This retrospective observational study included 75 patients (79 PCC) for PCC removal surgery from 2001 to 2017 at the Bordeaux University Hospital. They received, 3 days before surgery, continuous intravenous infusion of urapidil with stepwise increase to the maximum tolerated dose. Urapidil was maintained during the procedure and stopped after clamping the adrenal vein. Plasma catecholamine concentrations were measured during surgery. Hypertensive peaks (SAP >160 mmHg) and tachycardia >100 beats/min were treated with boluses of nicardipine 2 mg and esmolol 0.5 mg/kg. RESULTS: We recorded 20/79 (25%) cases with systolic arterial pressure (SAP) >180 mmHg. Only 11/79 (14%) had hypotension with SAP <80 mmHg. Peaks of catecholamine secretions were observed preferentially during peritoneal insufflation and tumor dissection (P < 0.05). A correlation was found between tumor size (mm) and the highest norepinephrine levels [r = 0.288, P = 0.015], and between hypertensive peaks (mmHg) and the highest norepinephrine levels [r = 0.45, P = 0.017]. No mortality was reported. The median [range] postoperative hospital stay was 4 [2-9] days. CONCLUSION: IV urapidil limits hypertensive and hypotensive peaks during PCC surgery, and corresponds to surgical imperatives allowing a short hospital stay, due to its "on-off" effect.

Pharmacological management of malignant hypertension.

INTRODUCTION: According to current guidelines, malignant hypertension is one of the emergencies in hypertension. The definition requires the presence of bilateral retinal hemorrhages or exudates, with or without papilledema, acute heart failure and acute deterioration in renal function in severe hypertension. Patients with malignant hypertension are characterized by pronounced target organ damage, including structural and functional cardiac abnormalities and renal insufficiency. AREAS COVERED: Knowledge of the available treatment options is extremely important as we know that we only have a limited time to reduce blood pressure. There are only four drugs dedicated to immediate blood pressure lowering in patients with malignant hypertension, including 'first-line' and alternative drugs. Our review aims to discuss all those drugs and gives practical suggestions on how to properly use them. EXPERT COMMENTARY: The decision of which drug to use depends on numerous factors including the clinical indications, pharmacokinetics, toxicity and drug interactions. Furthermore, frequently, more than one of the recommended drugs is required for the successful lowering of the patient's blood pressure.

Urapidil, but not dihydropyridine calcium channel inhibitors, preserves the hypoxic pulmonary vasoconstriction: an experimental study in pig arteries.

Hypoxic pulmonary vasoconstriction (HPV) is a protective mechanism maintaining blood oxygenation by redirecting blood flow from poorly ventilated to well-ventilated areas in the lung. Such a beneficial effect is blunted by antihypertensive treatment with dihydropyridine calcium channel inhibitors. The aim of the present study was to evaluate the effect of urapidil, an antihypertensive agent acting as an α1 adrenergic antagonist and a partial 5-HT1A agonist, on HPV in porcine proximal and distal pulmonary artery rings, and to characterize underlying mechanisms. Rings from proximal and distal porcine pulmonary artery were suspended in organ chambers and aerated with a 95% O2 + 5% CO2 gas mixture. HPV was induced by changing the gas to a 95% N2 + 5% CO2 mixture following a low level of pre-contraction with U46619. Hypoxia induced a contractile response in both proximal and distal pulmonary artery rings. This effect is observed in the presence of a functional endothelium and is inhibited by a soluble guanylyl cyclase inhibitor (ODQ), a NO scavenger (carboxy-PTIO), and by catalase in proximal pulmonary artery rings. The endothelium-dependent HPV is prevented by nicardipine and clevidipine but remained unaffected by urapidil in both proximal and distal pulmonary artery rings. These findings indicate that urapidil, in contrast to nicardipine and clevidipine, preserves the hypoxia-triggered vasoconstriction in isolated pulmonary arteries. They further indicate the involvement of the NO-guanylyl cyclase pathway and H2 O2 in HPV. Further research is warranted to determine the potential clinical relevance of the preserved hypoxia-induced pulmonary vasoconstriction by urapidil.

Urapidil, compared to nitroglycerin, has better clinical safety in the treatment of hypertensive patients with acute heart failure: a meta-analysis.

OBJECTIVES: The application of urapidil for treating hypertensive patients with acute heart failure in the emergency department remains controversial. Our objective was to organize the relevant articles and assess the clinical indexes between urapidil and nitroglycerin. MATERIALS AND METHODS: PubMed, EMBASE, the Cochrane Library and China National Knowledge Infrastructure were searched for randomized studies that compared urapidil treatment with nitroglycerin treatment for hypertensive patients with acute heart failure. The risk ratio, with 95% CI, was calculated by using a corresponding effects model, according to the value of I 2. RESULTS: Seven randomized controlled trials were identified, in order to compare the clinical indexes. On comparing the clinical indexes, the urapidil group was found to be better than the nitroglycerin group in regard to left ventricular ejection fraction, systolic blood pressure, N-terminal prohormone of brain natriuretic peptide, left ventricular end-diastolic volume, cardiac index, ALT, AST and health complications (P<0.05), but the indexes of creatinine were worse in the urapidil group. Furthermore, the two methods of treatment were comparable in diastolic blood pressure, left ventricular end-systolic volume, left ventricular end-systolic dimension, heart rate, fasting plasma glucose and total cholesterol levels (P>0.05). CONCLUSION: Based on the current evidence, urapidil treatment had better clinical safety features than the traditional pharmaceutical treatment with nitroglycerin. For those indicators with a small amount of data, a greater number of randomized, high-quality controlled trials should be conducted in order to further verify the findings, which could give researchers a more comprehensive evaluation of urapidil treatment.

Development of cerebral anoxia during controlled hypotension with nicardipine or urapidil after ca-rotid endarterectomy / 中华麻醉学杂志

Objective To evaluate the development of cerebral anoxia during controlled hypoten-sion with nicardipine or urapidil after carotid endarterectomy in patients. Methods Forty-four patients of either sex, aged 48-64 yr, scheduled for elective carotid endarterectomy under general anesthesia, requi-ring controlled hypotension after operation, were divided into nicardipine group ( group N ) and urapidil group ( group U) using a random number table method, with 22 patients in each group. Nicardipine at 2. 5μg·kg-1 ·min-1 was intravenously infused in group N, and urapidil 2μg·kg-1 ·min-1 was intravenously infused in group U. After systolic blood pressure was decreased to 130-140 mmHg, the consumption of nicardipine was adjusted to 0. 2 - 0. 5 μg·kg-1 ·min-1 and the consumption of urapidil to 1-2μg·kg-1 ·min-1 in group N and group U, respectively, to maintain systolic pressure at 130-140 mmHg. Heart rate ( HR) , cardiac index ( CI) , bispectral index ( BIS) value, regional cerebral oxygen saturation (rSO2) and end-tidal pressure of carbon dioxide (PETCO2) were recorded after entering the operating room ( baseline) , at the beginning of controlled hypotension ( T1 ) , and at 5, 10, 20, 30, 60 and 120 min af-ter systolic blood pressure was decreased to the target hypotension ( T2-7 ) . Development of cerebral anoxia( the relative decrease in rSO2>12％ of the baseline value) was recorded in controlled hypotension period. Results Compared with the value at T1 , the HR at T2,3 and CI at T3-7 were significantly increased ( P<0. 05), and no significant change was found in rSO2, PETCO2 or BIS value at the other time points in group N (P>0. 05), and rSO2 was significantly decreased at T3-7 (P<0. 05), and no significant change was found in HR, CI, PETCO2 or BIS value at the other time points in group U (P>0. 05). Compared with group N, the HR at T2,3, CI at T3-7 and rSO2 at T3-7 were significantly decreased in group U (P<0. 05). The incidence of cerebral anoxia was significantly higher in group U than in group N ( P<0. 05) . Conclu-sion Controlled hypotension with nicardipine is recommended after carotid endarterectomy in order to avoid the development of cerebral anoxia in the patients.

3D Graphene-Nitrogen Doped Carbon Nanotubes Network Modified Electrode as Sensing Materials for the Determination of Urapidil.

In this work, a three dimensional (3D) graphene-nitrogen doped carbon nanotubes (G-NCNTs) network was successfully fabricated on the surface of a glassy carbon (GC) electrode using the pulse potential method (PPM) in a graphene oxide-nitrogen doped carbon nanotubes (GO-NCNTs) dispersion. The morphological and characteristics of GO-NCNTs and G-NCNTs nanocomposites were investigated by atomic force microscopy (AFM), scanning electron microscopy (SEM), UV-vis spectroscopy, Raman spectroscopy, and electrochemical experiments. The 3DG-NCNTs network was applied as a new voltammetric material for the fabrication of an electrochemical platform for determination of urapidil. Systematic electrochemical tests demonstrate that the 3DG-NCNTs network modified GC electrode can effectively increase the response to the oxidation of urapidil. Under the optimum conditions, the electrochemical response was linear with urapidil concentrations in the range of 1.0 × 10-8~2.0 × 10-6 mol·L-1, while a low detection limit of 5.0 × 10-9 mol·L-1 was obtained for urapidil. Moreover, the proposed sensing platform exhibited good results for sensitivity, reproducibility, selectivity, and stability, which makes it very suitable for use as an ideal inexpensive and rapid analytical method applicable for complex drug matrices.

Acute blood pressure elevation: Therapeutic approach.

International guidelines have suggested to avoid the term "hypertensive crisis" for the description of an acute and severe increase in blood pressure (BP) and to consider the definition of 'hypertensive emergencies' or 'hypertensive urgencies'. These two clinical presentations are characterized by the presence of high BP values but imply a different diagnostic and therapeutic approach. Hypertension awareness, treatment and control are slightly increased in the last years mostly in the United States and in some European nations. Nevertheless the prevalence of hypertensive emergencies is still high and remains associated to a higher mortality. International Guidelines have also given some recommendations regarding the target BP during treatment and the use of antihypertensive drugs in hypertensive emergencies, although the adherence to these indications is frequently suboptimal. The present paper is aimed to update the currently available data on the treatment of hypertensive emergencies.

Comparative study on the effects of urapidil and sodium nitroprusside on blood pressure in patients with hypertensive intracerebral hemorrhage / 中国医师进修杂志

Objective To compare the effects of urapidil and sodium nitroprusside on blood pressure and prognosis in patients with hypertensive intracerebral hemorrhage. Methods One hundred and fifty patients with hypertensive intracerebral hemorrhage from January to December 2017 were divided into urapidil group and sodium nitroprusside group according to the medication, each group with 75 patients. The changes of blood pressure, heart rate, hematoma size and neurological function were compared between the two groups. Results At 10 and 30 min after treatment, the systolic blood pressure and diastolic blood pressure of patients in urapidil group were lower than those in sodium nitroprusside group (P＜0.05). At 60 min after treatment , there was no significant difference on blood pressure between the two groups (P＞0.05). At 10, 30, 60, 120 and 240 min after treatment, the heart rate of patients in urapidil group were significantly lower than those in sodium nitroprusside group (P＜0.05). At 24 and 72 h after treatment, there was no notable difference in the size of hematoma between the two groups (P＞0.05). At 1 month after treatment, the neurological scores between the two groups were significantly different: (10.1 ± 2.1) scores vs. (13.8 ± 5.9) scores, P＜0.05. Conclusions Urapidil can effectively control blood pressure in patients with hypertensive intracerebral hemorrhage. Moreover, it exerts better long-term neuroprotective effect, compared with sodium nitroprusside.

Efficacy and Safety of Intravenous Urapidil for Older Hypertensive Patients with Acute Heart Failure: A Multicenter Randomized Controlled Trial.

PURPOSE: Urapidil is putatively effective for patients with hypertension and acute heart failure, although randomized controlled trials thereon are lacking. We investigated the efficacy and safety of intravenous urapidil relative to that of nitroglycerin in older patients with hypertension and heart failure in a randomized controlled trial. MATERIALS AND METHODS: Patients (>60 y) with hypertension and heart failure were randomly assigned to receive intravenous urapidil (n=89) or nitroglycerin (n=91) for 7 days. Hemodynamic parameters, cardiac function, and safety outcomes were compared. RESULTS: Patients in the urapidil group had significantly lower mean systolic blood pressure (110.1±6.5 mm Hg) than those given nitroglycerin (126.4±8.1 mm Hg, p=0.022), without changes in heart rate. Urapidil was associated with improved cardiac function as reflected by lower N terminal-pro B type natriuretic peptide after 7 days (3311.4±546.1 ng/mL vs. 4879.1±325.7 ng/mL, p=0.027) and improved left ventricular ejection fraction (62.2±3.4% vs. 51.0±2.4%, p=0.032). Patients given urapidil had fewer associated adverse events, specifically headache (p=0.025) and tachycardia (p=0.004). The one-month rehospitalization and all-cause mortality rates were similar. CONCLUSION: Intravenous administration of urapidil, compared with nitroglycerin, was associated with better control of blood pressure and preserved cardiac function, as well as fewer adverse events, for elderly patients with hypertension and acute heart failure.

Protective effect of urapidil on testicular torsion-detorsion injury in rats.

PURPOSE: The aim of this study was to investigate the effect of urapidil and low-molecular weight heparin (LMWH) on testicular torsion-detorsion injury in rats. METHODS: Thirty-two male Sprague-Dawley rats were used. In the torsion-detorsion (T/D) group, the left testis was twisted at 720° for 3 h. After 3 h of reperfusion, the testis was removed. Urapidil or LMWH was administered intraperitoneally 30 min before detorsion in the treatment groups. RESULTS: Unilateral testicular torsion-detorsion caused significant increases in the malondialdehyde level and apoptosis and significant decreases in the superoxide dismutase (SOD) and glutathione peroxidase (GPx) activities in ipsilateral testes (p < 0.001). The rats treated with urapidil had a significant decrease in the malondialdehyde level and apoptosis and significant increases in the SOD and GPx activities in ipsilateral testes compared to the T/D group (p < 0.001). Animals treated with LMWH showed non-significant reductions in malondialdehyde levels and apoptosis compared to the T/D group. In addition, no significant difference in the SOD activities (p = 0.52) between the groups was found. The increase in the GPx activities was significant in the LMWH group compared to the T/D group (p < 0.001). CONCLUSION: The administration of urapidil before detorsion prevents ischemia/reperfusion cellular damage in testicular tissue. LMWH was not found to have a beneficial effect on testicular T/D injury in rats.

Efficacy and Safety of Intravenous Urapidil for Older Hypertensive Patients with Acute Heart Failure: A Multicenter Randomized Controlled Trial

PURPOSE: Urapidil is putatively effective for patients with hypertension and acute heart failure, although randomized controlled trials thereon are lacking. We investigated the efficacy and safety of intravenous urapidil relative to that of nitroglycerin in older patients with hypertension and heart failure in a randomized controlled trial. MATERIALS AND METHODS: Patients (>60 y) with hypertension and heart failure were randomly assigned to receive intravenous urapidil (n=89) or nitroglycerin (n=91) for 7 days. Hemodynamic parameters, cardiac function, and safety outcomes were compared. RESULTS: Patients in the urapidil group had significantly lower mean systolic blood pressure (110.1±6.5 mm Hg) than those given nitroglycerin (126.4±8.1 mm Hg, p=0.022), without changes in heart rate. Urapidil was associated with improved cardiac function as reflected by lower N terminal-pro B type natriuretic peptide after 7 days (3311.4±546.1 ng/mL vs. 4879.1±325.7 ng/mL, p=0.027) and improved left ventricular ejection fraction (62.2±3.4% vs. 51.0±2.4%, p=0.032). Patients given urapidil had fewer associated adverse events, specifically headache (p=0.025) and tachycardia (p=0.004). The one-month rehospitalization and all-cause mortality rates were similar. CONCLUSION: Intravenous administration of urapidil, compared with nitroglycerin, was associated with better control of blood pressure and preserved cardiac function, as well as fewer adverse events, for elderly patients with hypertension and acute heart failure.