Abstract:
WHAT IS KNOWN AND OBJECTIVE:There are no clinical reports that have compared topiroxostat, a selective xanthine oxidase inhibitor, with allopurinol in serum urate-lowering efficacy. The aim of this study was to compare the efficacy and safety of topiroxostat and allopurinol in Japanese hyperuricemic patients with or without gout. METHODS:A phase 3, multicentre, randomized, double-blind, double-dummy, active-controlled, parallel-group study conducted in Japan. Patients who had inadequate serum urate levels (a gout patient: serum urate level ≥416·4 μmol/L; an asymptomatic hyperuricemic patient with specific complications (urinary lithiasis, hypertension, hyperlipidemia and/or diabetes): serum urate level ≥475·8 μmol/L; and an asymptomatic hyperuricemic patient with no specific complications: serum urate level ≥535·3 μmol/L) were randomized to topiroxostat 120 mg/day or allopurinol 200 mg/day, with an equal allocation ratio, for 16 weeks. To prevent the onset of gouty arthritis by rapid serum urate reduction, these doses were increased in a stepwise manner. The primary efficacy endpoint was the per cent change in serum urate level from baseline to the final visit. RESULTS AND DISCUSSION:Overall, 206 patients were randomly assigned to topiroxostat and allopurinol. Two hundred and three patients (allopurinol: n = 105, topiroxostat: n = 98) received at least one dose of the study drug and had their serum urate level assessed at least once. The baseline characteristics were comparable between groups. The mean age of patients was 53·0 ± 11·4 years and 99% of patients were male. The primary efficacy endpoint was -34·3 ± 11·1% in the allopurinol group (n = 105) and -36·3 ± 12·7% in the topiroxostat group (n = 98). Non-inferiority of the serum urate-lowering efficacy of topiroxostat to allopurinol was proved by the predefined non-inferiority margin (95% confidence interval, -5·3 to 1·3%). The overall incidences of adverse events and adverse drug reactions were similar between both groups. WHAT IS NEW AND CONCLUSION:Topiroxostat 120 mg/day provides non-inferior serum urate reduction compared with allopurinol 200 mg/day and is well tolerated in Japanese hyperuricemic patients with or without gout.
journal_name
J Clin Pharm Therjournal_title
Journal of clinical pharmacy and therapeuticsauthors
Hosoya T,Ogawa Y,Hashimoto H,Ohashi T,Sakamoto Rdoi
10.1111/jcpt.12391subject
Has Abstractpub_date
2016-06-01 00:00:00pages
290-7issue
3eissn
0269-4727issn
1365-2710journal_volume
41pub_type
杂志文章,多中心研究,随机对照试验abstract:INTRODUCTION:Spironolactone is increasingly being used in the treatment of heart failure. However, it has been associated with cases of hyperkalaemia. The common use of angiotensin-converting enzyme (ACE) inhibitors and angiotensin-2 receptor (AT2) antagonists in heart failure increases the risk of hyperkalaemia. OBJE...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2710.2003.00491.x
更新日期:2003-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:With the ageing of the population also comes increasing comorbidities and the use of multiple medications and administration methods, along with greater susceptibility to adverse drug reactions. Dosage form modification to facilitate drug administration in older adults can be potentially pro...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12822
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abstract:OBJECTIVE:To assess the usefulness of dynamic laser scattering for monitoring the stability of ampicillin after reconstitution from commercially available vials with respect to the polymer formation and potency. METHODS:Polymer formation and the remaining potency of the reconstituted ampicillin solution were estimated...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2710.2002.00397.x
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abstract:WHAT IS KNOWN AND OBJECTIVE:Gabapentin, a γ-aminobutyric acid derivative, is used for the treatment of partial onset seizures, postherpetic neuralgia, diabetic neuropathy and a host of other neurological disorders. CASE DESCRIPTION:A 44-year-old woman with spinal stenosis was prescribed gabapentin for pain. Two months...
journal_title:Journal of clinical pharmacy and therapeutics
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更新日期:2019-08-01 00:00:00
abstract:BACKGROUND:Personal imports of unapproved drugs are made by physicians and patients in Japan. Such imports require submission of a request for an import certificate from the Regional Bureau of Health and Welfare (RBHW). So far, there have been few reports on personal imports of drugs in Japan. OBJECTIVE:To assess the ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2008.00941.x
更新日期:2008-10-01 00:00:00
abstract:OBJECTIVE:The quality of 33 formulations of essential antimicrobial and antimalarial drugs (amoxicillin capsules, metronidazole tablets, sulfamethoxazole/trimethoprim tablets, quinine tablets and sulphadoxine/pyrimethamine tablets) marketed in Rwanda and Tanzania was assessed and the influence of tropical storage condi...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2004.00568.x
更新日期:2004-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Teneligliptin is a DPP-4 inhibitor used for the treatment of type 2 diabetes mellitus, commonly prescribed in combination with glimepiride. Teneligliptin is metabolized by CYP3A4, and glimepiride might be partly metabolized by CYP3A4. The aim of the study was to investigate the possible effe...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
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更新日期:2019-10-01 00:00:00
abstract::In this study, the serum vitamin E (total tocopherol) levels in patients with breast cancer (n = 100) and healthy controls (n = 70) were measured. The mean values for vitamin E were found to be 0.44 mg/100 ml in breast cancer patients and 1.108 mg/100 ml in controls. In the statistical evaluation, the vitamin E levels...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1995.tb00645.x
更新日期:1995-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Acquired long QT syndrome secondary to drug-induced QT prolongation and torsades de pointes has been reported for antiviral drugs. However, no studies have reported an association between corrected QT (QTc) prolongation and antiviral therapy in patients with novel coronavirus disease (COVID-...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
doi:10.1111/jcpt.13183
更新日期:2020-10-01 00:00:00
abstract:PURPOSE:To estimate the prevalence of potentially severe drug-drug interactions (DDIs) and their relationship with age, sex and number of prescribed drugs. METHODS:We analysed all prescriptions dispensed from 1 January 2003 to 31 December 2003 to individuals aged 65 or more registered under the Local Health Authority ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2009.01021.x
更新日期:2009-08-01 00:00:00
abstract::A single dose pharmacokinetic study was conducted on two sustained-release formulations (75 mg) of indomethacin (Indocid capsules 'A' and Indogesic tablets 'B'). The study was carried out on 22 healthy male volunteers, who received a single oral dose (75 mg) of each product according to a randomized crossover design. ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1111/j.1365-2710.1994.tb00816.x
更新日期:1994-10-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Pain management for complex regional pain syndrome (CRPS) is challenging. When added to local anaesthetics, dexmedetomidine prolongs the duration of the block and improves analgesia. The effect of long-term dexmedetomidine use in the brachial plexus block (BPB) for CRPS is unknown. CASE DES...
journal_title:Journal of clinical pharmacy and therapeutics
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abstract:WHAT IS KNOWN AND OBJECTIVE:Lemierre's syndrome is often misdiagnosed as a common cold or viral infection. Fusobacterium necrophorum is the most common causative organism. The recommended treatment regimen is 6 weeks of a beta-lactam antibiotic along with metronidazole. CASE DESCRIPTION:We present two cases of Lemierr...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
doi:10.1111/jcpt.12774
更新日期:2019-02-01 00:00:00
abstract:OBJECTIVE:To find out in child abusing mothers whether aggressiveness in general, but which is directed towards their children in particular, could be reduced by giving lithium. METHOD:An open trial of lithium in eight child-abusing mothers. Assessment of aggression using Yudofsky's Overt Aggression Scale. RESULTS:Th...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章
doi:10.1046/j.1365-2710.2001.00357.x
更新日期:2001-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Ceftriaxone is a third-generation cephalosporin with broad-spectrum antibacterial activity. Ceftriaxone-associated urolithiasis and post-renal acute renal failure (PARF) in adults is exceedingly rare and perhaps underappreciated. We report one such case to increase appreciation of this risk ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
doi:10.1111/jcpt.12358
更新日期:2016-06-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Vancomycin is the drug of choice for methicillin-resistant Staphylococcus aureus (MRSA) infection and shows time-dependent bacterial killing. The current study evaluated the pharmacokinetics (PK) and pharmacodynamics (PD) of vancomycin and explored its optimal dosing regimens by modeling and...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
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journal_title:Journal of clinical pharmacy and therapeutics
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doi:10.1111/jcpt.13096
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1111/j.1365-2710.2009.01132.x
更新日期:2010-10-01 00:00:00
abstract:OBJECTIVE:A population analysis of the kinetics of valproic acid (VPA) in children with epilepsy was performed in order to characterize the covariates which influence VPA clearance (CL). METHODS:A total of 770 steady-state serum concentration samples was analysed. These were collected during VPA therapy from 255 child...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1046/j.1365-2710.1999.00202.x
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2710.1999.00238.x
更新日期:1999-10-01 00:00:00
abstract:BACKGROUND:Epilepsy is a disease requiring chronic therapy with antiepileptic drugs (AEDs). Many conventional AEDs currently available have either too rapid an absorption or elimination, requiring the patient to take multiple doses per day, which may adversely impact adherence or cause peak-related side-effects. Conseq...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2009.01117.x
更新日期:2010-08-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.13162
更新日期:2020-08-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.12766
更新日期:2019-02-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type:
doi:10.1111/jcpt.13033
更新日期:2019-12-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:Edoxaban has three dose adjustment factors (creatinine clearance, 15-50 mL/min; body weight, 60 kg or less; and concomitant medication with potent P-glycoprotein inhibitors) to prevent bleeding that results from elevated blood concentrations of the drug. A dose reduction (from 60 to 30 mg/da...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/jcpt.13065
更新日期:2020-04-01 00:00:00
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journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.2008.00993.x
更新日期:2009-04-01 00:00:00
abstract::Isradipine is a potent dihydropyridine calcium channel blocker. It is highly selective for vascular smooth muscle, with very few negative inotropic or chronotropic effects. It may have minor depressant effects on the sinoatrial node, hence reducing the incidence of reflex tachycardia. The drug is extensively metaboliz...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章,评审
doi:10.1111/j.1365-2710.1991.tb00288.x
更新日期:1991-04-01 00:00:00
abstract::To dose the anticonvulsant phenytoin (PHT) in a clinical situation is difficult because of the non-linear metabolism of the drug. Therefore many techniques have been advocated to aid dosage adjustments based on a single-point PHT concentration determined at steady-state (ss). We retrospectively investigated six method...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章
doi:10.1111/j.1365-2710.1988.tb00196.x
更新日期:1988-08-01 00:00:00
abstract:WHAT IS KNOWN AND OBJECTIVE:The HbA1C marker used in assessing diabetes control quality is not sufficient in diabetes patients with thalassaemia. CASE DESCRIPTION:A male diabetic patient with thalassaemia was hospitalized due to distal neuropathic pain, right toe trophic ulcer, unacceptable five-point glycaemic profil...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 杂志文章,评审
doi:10.1111/jcpt.13073
更新日期:2020-04-01 00:00:00
abstract::The efficacy of a novel, proprietary topical formulation of ibuprofen 5% gel (Ibugel) and ibuprofen 400 mg tablets (1200 mg daily) was compared in a double-blind, double-dummy, parallel group study in patients with acute soft tissue injuries. Patients received either active gel plus placebo tablets (n = 50) or active ...
journal_title:Journal of clinical pharmacy and therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1046/j.1365-2710.2002.00439.x
更新日期:2002-12-01 00:00:00