International journal of clinical practice
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Int. J. Clin. Pract. · Aug 2007
Randomized Controlled Trial Multicenter StudyThe safety and tolerability of duloxetine in depressed elderly patients with and without medical comorbidity.
The impact of medical comorbidity on the efficacy and tolerability of duloxetine in elderly patients with major depressive disorder (MDD) was investigated in this study. Data were obtained from a multicentre, randomised, double-blind, placebo-controlled study in 311 patients with MDD aged 65-89. The primary outcome measure was a prespecified composite cognitive score based on four cognitive tests: (i) Verbal Learning and Recall Test; (ii) Symbol Digit Substitution Test; (iii) 2-Digit Cancellation Test and (iv) Letter-Number Sequencing Test. Secondary measures included the Geriatric Depression Scale (GDS), 17-Item Hamilton Depression Scale (HAMD17), Clinical Global Impression-Severity (CGI-S) Scale, Visual Analogue Scale (VAS) for pain and 36-Item Short Form Health Survey (SF-36). Tolerability measures included adverse events reported as the reason for discontinuation and treatment-emergent adverse events (TEAEs). The consistency of the effect of duloxetine vs. placebo comparing patients with and without medical comorbidity (vascular disease, diabetes, arthritis or any of these) was investigated. ⋯ The present analyses suggested that the efficacy of duloxetine on cognition and depression in elderly patients, and its tolerability, were not largely affected by the comorbidity status. These results further support the use of duloxetine in elderly patients with MDD.
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Int. J. Clin. Pract. · Feb 2007
Randomized Controlled TrialThe role of antibiotic prophylaxis in elective tension-free mesh inguinal hernia repair: results of a single-centre prospective randomised trial.
Hernia repair is one of the so-called clean operations. Many surgeons, however, use antibiotics, especially in the mesh repair era, without strong evidence to support this policy. We conducted a single-centre prospective randomised trial with a view to clarify this issue on a scientific basis. ⋯ The wound was opened in some cases. Mesh removal was not required in any of the cases. From the results of this study it does not appear that antibiotic prophylaxis offers any benefits in the elective mesh inguinal hernia repair.
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Int. J. Clin. Pract. · Jan 2007
Randomized Controlled TrialEfficacy and tolerability of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy over 12 weeks in patients with type 2 diabetes.
The aim of this study was to assess the efficacy and tolerability of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes who have inadequate glycaemic control on diet and exercise. In a randomised, double-blind, placebo- and active-controlled study, 743 patients with type 2 diabetes and a mean baseline HbA(1c) of 7.9% were randomised to receive one of six treatments for 12 weeks: placebo, sitagliptin 5, 12.5, 25 or 50 mg b.i.d., or glipizide 5 mg/day (electively titrated up to 20 mg/day). At week 12, treatment with sitagliptin at all doses tested led to a significant (p < 0.001) reduction in HbA(1c) relative to placebo, with the largest reductions occurring in the 50-mg b.i.d. group. ⋯ There was a modest weight gain observed with glipizide treatment relative to placebo. Hypoglycaemia adverse experiences were reported with the highest incidence in the glipizide group (17%) compared with the placebo (2%) or sitagliptin groups (0-4%, not dose-dependent). In summary, in this study sitagliptin improved glycaemic control, with 50 mg b.i.d. being the most effective dose, and was generally well-tolerated in patients with type 2 diabetes.
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Int. J. Clin. Pract. · Oct 2006
Randomized Controlled TrialThe consistency of emergency physicians' and cardiologists' ECG interpretation and likelihood classification of chest pain patients.
Patients presenting to the emergency department with chest pain are evaluated by emergency physicians in hospitals without cardiology cover 24 h a day. The purpose of this study is to determine the consistency of electrocardiography (ECG) interpretation and chest pain likelihood classification between emergency physicians and cardiologists. This randomised prospective cross-sectional study was performed in a tertiary care university hospital emergency department. ⋯ The consistency for the likelihood classification between two groups for predicting the pain as angina or non-cardiac was 90.8% (kappa = 0.30), for classifying as acute coronary syndrome or stable angina pectoris (SAP) was 95.6% (kappa = 0.26) and for classifying patients as low likelihood or intermediate-high likelihood was 86.3% (kappa = 0.61). A strong consistency was shown between the emergency physicians' and cardiologists' ECG interpretation especially in determining the ST segment elevation. And also, there is a strong concordance in the likelihood classification of chest pain patients.
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Int. J. Clin. Pract. · Aug 2006
Randomized Controlled Trial Multicenter Study Comparative StudyTreatment persistence with once-monthly ibandronate and patient support vs. once-weekly alendronate: results from the PERSIST study.
Osteoporosis is a common and debilitating condition associated with significant morbidity and mortality. The efficacy and safety of oral bisphosphonates for the treatment of osteoporosis are well established. However, patient adherence and persistence on treatment are suboptimal. ⋯ Secondary endpoint measurements of adherence (e.g. proportion of patients remaining on treatment at study end; proportion of patients discontinuing from the study) were also significantly different in favour of ibandronate plus patient support. In summary, the PERSIST study demonstrated that persistence on treatment was increased in patients receiving once-monthly ibandronate plus patient support compared with once-weekly alendronate. Increased persistence on bisphosphonate treatment is expected to improve patient outcomes and decrease the social and economic burden of osteoporosis.