Half of patients with disabling ischemic stroke recovered within 18 months, and recovery was greatest within 6 months. Significant predictors of recovery included the severity of the index stroke and no history of ischemic stroke, peripheral artery disease, or diabetes.
BackgroundThe 'Perception of Anti-Coagulant Treatment Questionnaire' (PACT-Q) was developed to assess patients' expectations of, and satisfaction with their anticoagulant treatment. This questionnaire needs to be finalised and psychometrically validated.MethodsThe PACT-Q was included in the United States, the Netherlands and France into three phase III multinational clinical trials conducted to evaluate efficacy and safety of a new long-acting anticoagulant drug (idraparinux) compared to vitamin K antagonist (VKA). PACT-Q was administered to patients with deep venous thrombosis (DVT), atrial fibrillation (AF) or pulmonary embolism (PE) at Day 1, to assess patients' expectations, and at 3 and 6 months to assess patients' satisfaction and treatment convenience and burden. The final structure of the PACT-Q (Principal Component Analysis – PCA – with Varimax Rotation) was first determined and its psychometric properties were then measured with validity of the structure (Multitrait analysis), internal consistency reliability (Cronbach's alpha coefficients) and known-group validity.ResultsPCA and multitrait analyses showed the multidimensionality of the "Treatment Expectations" dimension, comprising 7 items that had to be scored independently. The "Convenience" and "Burden of Disease and Treatment" dimensions of the hypothesised original structure of the questionnaire were combined, thus resulting in 13 items grouped into the single dimension "Convenience". The "Anticoagulant Treatment Satisfaction" dimension remained unchanged and included 7 items. All items of the "Convenience" and "Anticoagulant Treatment Satisfaction" dimensions displayed good convergent and discriminant validity. The internal consistency reliability was good, with a Cronbach's alpha of 0.84 for the "Convenience" dimension, and 0.76 for the "Anticoagulant Treatment Satisfaction" dimension. Known-group validity was good, especially with regard to occurrence of thromboembolic events within 3 months from randomisation.ConclusionThe PACT-Q is a valid and reliable instrument that allows the assessment of patients' expectations and satisfaction regarding anticoagulant treatment, as well as their opinion about treatment convenience of use. Its two-part structure – assessment of expectations at baseline in the first part, and of convenience, burden and treatment satisfaction in the second – was validated and displays good and stable psychometric properties. These results are not sufficient to recommend the use of satisfaction as primary endpoint in clinical trials; further validation work is needed to support the interpretation of PACT-Q dimension scores. However, this first validation makes the PACT-Q an appropriate measure for use in clinical and pharmacoepidemiological research, as well as in real-life studies.Trial Registration(ClinicalTrials.gov numbers, NCT00067093, NCT00062803 and NCT00070655).
Background: Low-molecular-weight heparins have been shown to be effective and safe in the treatment of deep vein thrombosis. To our knowledge, there have been no direct comparisons of such treatment on an outpatient vs an inpatient basis.
Platelet inhibition with clopidogrel in patients for up to one year after presentation with an acute coronary syndrome is both effective and cost-effective.
OBJECTIVE -The aim of this study was to determine the most cost-effective time point for initiation of irbesartan treatment in hypertensive patients with type 2 diabetes and renal disease.
RESEARCH DESIGN AND METHODS-This study was a Markov model-simulated progression from microalbuminuria to overt nephropathy, doubling of serum creatinine, endstage renal disease, and death in hypertensive patients with type 2 diabetes. Two irbesartan strategies were created: early irbesartan 300 mg daily (initiated with microalbuminuria) and late irbesartan (initiated with overt nephropathy). These strategies were compared with control, which consisted of antihypertensive therapy with standard medications (excluding ACE inhibitors, other angiotensin-2 receptor antagonists, and dihydropyridine calcium channel blockers) with comparable blood pressure control, initiated at microalbuminuria. Transition probabilities were taken from the Irbesartan in Reduction of Microalbuminuria-2 study, Irbesartan in Diabetic Nephropathy Trial, and other published sources. Costs and life expectancy, discounted at 3% yearly, were projected over 25 years for 1,000 simulated patients using a third-party payer perspective in a U.S. setting.RESULTS -Compared with control, early and late irbesartan treatment in 1,000 patients were projected to save (mean Ϯ SD) $11.9 Ϯ 3.3 million and $3.3 Ϯ 2.7 million, respectively. Early use of irbesartan added 1,550 Ϯ 270 undiscounted life-years (discounted 960 Ϯ 180), whereas late irbesartan added 71 Ϯ 40 life-years (discounted 48 Ϯ 27) in 1,000 patients. Early irbesartan treatment was superior under a wide-range of plausible assumptions.CONCLUSIONS -Early irbesartan treatment was projected to improve life expectancy and reduce costs in hypertensive patients with type 2 diabetes and microalbuminuria. Later use of irbesartan in overt nephropathy is also superior to standard care, but irbesartan should be started earlier and continued long term.
In patients with type 2 diabetes and hypertension, screening for nephropathy and treatment with a renoprotective-based antihypertensive agent was projected to improve patient outcomes and represent excellent value in a US setting.
trial achieved positive results of reduced itch intensity and other supporting efficacy endpoints in prurigo nodularis patients New Haven, CT, October 13, 2016 -Trevi Therapeutics, Inc. ("Trevi" or the "Company"), a late-stage clinical development company developing oral Nalbuphine ® ER for chronic pruritus conditions, today announced positive results from its Phase 2 trial for the treatment of moderate to severe prurigo nodularis. Prurigo nodularis (PN), a severely pruritic dermatological condition characterized by itchy skin papules and nodules, has significant impact on quality of life and has no approved therapies. Trevi also previously reported statistically significant results from a robust Phase 2/3 trial with Nalbuphine ER in hemodialysis patients with uremic pruritus.
Prurigo nodularis is an itchy skin disease with unknown epidemiology. This study aimed to describe the epidemiology of prurigo nodularis compared with that of psoriasis. The German sickness fund claims database, with 2,783,175 continuously insured patients, included 1,720 patients diagnosed with prurigo nodularis and 51,390 with psoriasis. Patients with prurigo nodularis were averagely 8 years older than psoriasis patients and more often were women (
p
< 0.001). Annual incidence was a constant 0.02% in prurigo nodularis, and decreased steadily from 0.53 to 0.42% in psoriasis; cumulative incidence was 0.1% for prurigo nodularis and 1.9% for psoriasis. Prevalence was 0.1% for prurigo nodularis and 4.7% for psoriasis, with a one-year mortality of 5.4% for prurigo nodularis and 1.2% for psoriasis (
p
< 0.001). The most frequent pre-existing comorbidities in patients with prurigo nodularis were inflammatory dermatoses and depression. This epidemiological study found a low prevalence of prurigo nodularis, manifesting different demographics and comorbidities compared with psoriasis.
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