Abstract:
BACKGROUND AND OBJECTIVE:Injectable collagenase Clostridium histolyticum is efficacious in correcting Dupuytren's contracture as assessed by changes in the angle of contracture and range of motion (ROM). However, clinically important changes in ROM have not been evaluated in depth. The objective of this secondary analysis of the CORD I trial was to identify severity levels using baseline ROM, estimate a clinically important difference (CID) for ROM, and link the results to collagenase treatment and patient satisfaction. METHODS:In the CORD I trial, patients with Dupuytren's disease and joint contractures ≥20° were randomized to receive a maximum of three collagenase 0.58 mg or placebo injections into the cord of the affected hand at 30-day intervals. The primary endpoint was reduction in contracture to ≤5° 30 days after the last injection (day 30). The secondary endpoints, which are reported in this analysis, were ROM, physician- and patient-rated severity ('normal', 'mild', 'moderate', 'severe') and improvement, and treatment satisfaction. Linear regression was used to model data for severity classification and CID estimation for ROM based on physician and patient ratings. RESULTS:At baseline, mean ROM was 43.9° in the collagenase-treated joints (n = 197) and 45.3° in the placebo-treated joints (n = 102). On day 30, mean ROM was 80.7° in the collagenase-treated joints and 49.5° in the placebo-treated joints. The mean increase in ROM was 36.7° in the collagenase-treated joints (p < 0.001) and 4.0° in the placebo-treated joints (not significant). The estimated CID for ROM was 13.5° (95% CI 11.9, 15.1), reflecting a one-category change in severity. The mean increase in ROM exceeded the CID in the collagenase-treated joints but not in the placebo-treated joints; the difference between collagenase treatment and placebo in the mean increase in ROM also exceeded the CID, implying that the improvement with collagenase was clinically relevant. The severity classification for ROM was: ≥67.0° ('normal'), ≥54.3 and <67.0° ('mild'), ≥41.6 and <54.3° ('moderate'), and <41.6° ('severe'). More collagenase- than placebo-treated patients achieved 'normal' (81% vs 25%; p < 0.0001) status, and more collagenase- than placebo-treated patients reported being 'very/quite satisfied' (87% vs 32%; p < 0.001). CONCLUSION:Injectable collagenase significantly improves ROM and treatment satisfaction versus placebo. ROM improvements are clinically relevant as well as statistically significant. These data support the potential need to include ROM and physician- and patient-rated severity and satisfaction as standard assessments for Dupuytren's contracture treatment outcomes. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT00528606; other study identification number: AUX-CC-857 (Auxilium Pharmaceuticals, Inc.).
journal_name
Clin Drug Investigjournal_title
Clinical drug investigationauthors
Witthaut J,Bushmakin AG,Gerber RA,Cappelleri JC,Le Graverand-Gastineau MPdoi
10.1007/BF03256918subject
Has Abstractpub_date
2011-11-01 00:00:00pages
791-8issue
11eissn
1173-2563issn
1179-1918pii
2journal_volume
31pub_type
杂志文章,随机对照试验abstract::Elbasvir/grazoprevir demonstrated high sustained virologic response rates 12 weeks after the end of treatment (SVR12) across five clinical trials in subjects infected with chronic hepatitis C virus (HCV) genotype 1, including those with advanced chronic kidney disease (CKD), and GT4. Despite favorable results overall,...
journal_title:Clinical drug investigation
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doi:10.1007/s40261-017-0492-5
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abstract:OBJECTIVE:This study aimed to investigate the relative bioavailability and bioequivalence of two omeprazole enteric-coated formulations following repeated doses (steady state) in healthy male and female adult volunteers. DESIGN AND STUDY PARTICIPANTS:The study formulation (Ompranyt® 20mg capsules, Bial-Industrial Farm...
journal_title:Clinical drug investigation
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doi:10.2165/00044011-200121030-00006
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abstract:BACKGROUND AND OBJECTIVE:Hypertension remains a major global health problem, and evidence suggests that the majority of patients will require two or more antihypertensive agents in order to reach specified BP targets. Combining two drugs from different classes has the potential to target different aspects of hypertensi...
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pub_type: 杂志文章,多中心研究,随机对照试验
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abstract:BACKGROUND:European guidelines do not recommend the use of carbamazepine, levetiracetam, phenobarbital, phenytoin, topiramate and valproic acid in patients taking direct oral anticoagulants (DOACs). Little is known regarding the clinical relevance of the interaction between DOACs and antiepileptic drugs. OBJECTIVES:To...
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abstract:BACKGROUND AND OBJECTIVES:Currently evidence about clinical and demographic predictors of response to newer antidepressants such as duloxetine is limited. This study aimed to investigate whether a number of predictors, particularly co-morbid anxiety disorders and anxious depression, are associated with clinical improve...
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abstract:BACKGROUND AND OBJECTIVES:There is little information on the effects of trandolapril on renal function when used in Canadian general practice. We evaluated the use and blood pressure (BP) lowering effectiveness of trandolapril-based therapies in Canadian conditions of actual care and attempted to capture assessments of...
journal_title:Clinical drug investigation
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abstract:BACKGROUND AND OBJECTIVE:The use of fibrinogen concentrate to treat or prevent major bleeding with regard to potential adverse reactions has not been free of controversy. Our objective was to perform a post-authorization safety study to describe the use of Clottafact® (LFB Biomedicaments) fibrinogen concentrate in real...
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abstract:BACKGROUND AND OBJECTIVE:First-line bevacizumab-based therapy has been shown to improve outcomes in patients with advanced non-squamous non-small-cell lung cancer (NSCLC). The recent international phase IV SAiL study (a Study of Avastin [bevacizumab] in combination with platinum-containing chemotherapy in patients with...
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abstract:OBJECTIVE:To evaluate the efficacy and tolerability of alendronic acid 70mg once weekly for the treatment of male osteoporosis. PATIENTS AND METHODS:This randomised, double-blind, placebo-controlled, 12-month trial compared the effect of alendronic acid 70mg once weekly or placebo (randomised 2 : 1) on bone mineral de...
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journal_title:Clinical drug investigation
pub_type: 临床试验,杂志文章
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更新日期:2007-01-01 00:00:00
abstract::Androgenetic alopecia (AGA) is characterized by non-scarring follicle miniaturization. Despite the success of approved therapies, commonly reported side effects and the need for continual use has led to the investigation of alternative therapies. The aim of this paper is to critically review the success of off-label, ...
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pub_type: 杂志文章,评审
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abstract:BACKGROUND AND OBJECTIVE:Several antiviral therapies are now available for patients with chronic hepatitis B (CHB), but the most cost-effective strategy for Chinese patients is unclear. The aim of this study was to estimate the long-term cost effectiveness of the antiviral treatments (lamivudine, adefovir, telbivudine ...
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更新日期:2015-03-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Interferon-alpha treatment is associated with a large number of adverse effects. Depressive symptoms are not unexpected, and potentially dangerous psychiatric adverse effects can induce life-threatening conditions. We compared the incidence of depressive symptoms in patients with chronic hepati...
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更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:Concerns that antiepileptic brand-to-generic interchange results in disruption of seizure control are widespread. The objective of this study was to evaluate the safety and tolerability of the brand-to-generic levetiracetam switch in patients with focal or generalized epilepsy. METHODS:A prosp...
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更新日期:2016-01-01 00:00:00
abstract:BACKGROUND:NSAIDs are widely used for patients presenting with low back pain. A quick-release formulation of lornoxicam, a potent NSAID from the chemical class of oxicams, offers a faster onset of pain relief compared with the standard tablet formulation. METHODS:Time to onset of pain relief with lornoxicam was compar...
journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
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journal_title:Clinical drug investigation
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journal_title:Clinical drug investigation
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abstract:BACKGROUND:Propofol is approved both for anaesthesia and sedation during intensive care. Serious adverse reactions with propofol have recently been reported, but patient exposure to the drug is unknown. OBJECTIVE:To investigate the consumption of propofol in Finnish hospitals and to develop a denominator to estimate p...
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更新日期:2003-01-01 00:00:00
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journal_title:Clinical drug investigation
pub_type: 杂志文章,多中心研究,随机对照试验
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更新日期:2010-01-01 00:00:00
abstract:BACKGROUND:Muscle wasting is common and insidious in end-stage renal disease (ESRD). Loss of muscle quantity and quality reduces quality of life and increases mortality in ESRD patients. Additionally, secondary hyperparathyroidism (SHPT) causes muscle atrophy. Meanwhile, vitamin D, which is used for SHPT treatment, pla...
journal_title:Clinical drug investigation
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更新日期:2013-11-01 00:00:00
abstract:OBJECTIVE:The efficacy and tolerability of acarbose were examined in a postmarketing surveillance study of 27 803 patients with diabetes mellitus (26 044 were diagnosed as having type 2 diabetes) over a 12-week treatment period. PATIENTS AND M ethods: Overall efficacy data were reported for type 1 and type 2 diabetes, ...
journal_title:Clinical drug investigation
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更新日期:2005-01-01 00:00:00
abstract::A pharmacokinetic study was carried out in patients with unresectable colorectal liver metastases who had primarily been included in a phase II trial of intra-arterial cisplatin (DDP) plus intravenous fluorouracil. Ten patients of those accrued for the clinical study underwent the pharmacokinetic investigation upon li...
journal_title:Clinical drug investigation
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abstract:BACKGROUND:The Benign Prostatic Hyperplasia-Patient Impact Measure (BPH-PIM) is a self-reported quality-of-life questionnaire for measuring the impact of urinary/prostate symptoms on the quality of life of patients with BPH. The aim of the present study was to adapt the original instrument to Spanish (for use in Spain)...
journal_title:Clinical drug investigation
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更新日期:2006-01-01 00:00:00
abstract:BACKGROUND AND OBJECTIVES:Despite the introduction of Medicare Part D (MPD) and 2012 Affordable Care Act (ACA), patients have a cost burden due to increases in drug prices. To overcome cost barriers, some patients purchase their medications from Canadian online pharmacies as Canadian prescription drug prices are believ...
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更新日期:2017-10-01 00:00:00
abstract:BACKGROUND AND OBJECTIVE:This real-world study assessed the prevalence, risk factors for, and incidence of seizures in patients with metastatic castration-resistant prostate cancer (mCRPC). METHODS:Patients with mCRPC were selected from MarketScan Commercial and Medicare Supplemental Databases between 1 January 2009 a...
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