International journal of clinical practice
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Int. J. Clin. Pract. · Jun 2005
Randomized Controlled Trial Clinical TrialEfficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease.
This randomised, double-blind, placebo (PBO)-controlled study evaluated the efficacy and safety of ezetimibe (EZE) co-administered with ongoing atorvastatin (ATV) therapy in 450 hypercholesterolemic patients with coronary heart disease (CHD) who had not achieved their low-density lipoprotein cholesterol (LDL-C) goal < or =2.60 mmol/l while on a stable dose of ATV 10 or 20 mg/day for > or =6 weeks. After a 4-week diet/baseline active run-in period, patients with LDL-C >2.60 mmol/l and < or =4.20 mmol/l were stratified by ATV dose and randomised (1 : 1) to EZE 10 mg or PBO for 6 weeks while continuing open-label ATV. ⋯ Compared to PBO, co-administration of EZE with ongoing ATV led to significantly (p < or = 0.001) greater reductions in LDL-C, total cholesterol, triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B; HDL-C was significantly (p < or = 0.05) increased. Co-administration of EZE and ATV was well tolerated, with an overall safety profile similar to ATV alone.
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Int. J. Clin. Pract. · Feb 2005
Randomized Controlled Trial Clinical TrialCophenylcaine spray vs. placebo in flexible nasendoscopy: a prospective double-blind randomised controlled trial.
Practices vary across the UK on the use of topical preparation prior to flexible fibreoptic nasendoscopy. In this double-blind study, we randomised 98 patients to receive cophenylcaine or placebo nasal spray before flexible nasendoscopy. A visual analogue scale (1-100) was used to record pain, unpleasantness of taste and overall discomfort experienced. ⋯ There was no significant difference in pain or overall discomfort experienced between the two groups; however, the sensation of bad taste was significantly worse in the cophenylcaine group. In linear regression, factors that predicted the overall unpleasantness of the experience were primarily pain experienced and secondarily unpleasantness of taste. We conclude that the routine use of cophenylcaine for nasal preparation is not justified before flexible nasendoscopy.
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Int. J. Clin. Pract. · Oct 2004
Randomized Controlled Trial Clinical TrialEffect of ascorbic acid on surgical stress response in gynecologic surgery.
Surgical stress may cause neural, endocrine, metabolic and humoral responses depending on the severity of the procedure. In this study, we aimed to study the effect of the preoperatively given ascorbic acid (AA), which is an antioxidant, and its role in the biosynthesis of neuropituitary hormones on the surgical stress response. Twenty-two American Society of Anaesthesiologists I and II patients ageing between 18 and 40, who have no endocrine and metabolic disease, and undergoing abdominal operation for non-malignant diseases were allocated to the study. ⋯ Whereas, patients in Group II had higher levels of cortisol than the control group at sixth hour, which were in normal limits, and there was no decrease in osteocalcin concentration. ACTH level was increased at the second and sixth hours, which was statistically significant, but at twelfth and twenty-forth hours, they were close to control group levels. As a result, we conclude that AA given before anaesthesia achieved by etomidate is not sufficient for the prevention of surgical stress response and that AA induction before anaesthesia should be preferred, particularly for the prevention of decrease in osteocalcin levels.
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Int. J. Clin. Pract. · Mar 2004
Randomized Controlled Trial Comparative Study Clinical TrialAnalgesic efficacy of a single dose of lumiracoxib compared with rofecoxib, celecoxib and placebo in the treatment of post-operative dental pain.
This randomised, double-blind, placebo-controlled, parallel-group study compared the efficacy and tolerability of lumiracoxib (a novel COX-2 selective inhibitor) with rofecoxib, celecoxib and placebo in patients with moderate-to-severe post-operative dental pain. Following third molar extraction, patients received single oral doses of lumiracoxib 400 mg, rofecoxib 50 mg, celecoxib 200 mg or placebo (n = 355). Additional patients from a similar study, assigned to lumiracoxib, rofecoxib or placebo (n = 155), were included for analysis of the primary variable, Summed Pain Intensity Difference over the first 8 h post dose (SPID-8). ⋯ Patient global evaluation of lumiracoxib was comparable to rofecoxib and superior to celecoxib and placebo. All treatments were well tolerated. Lumiracoxib 400 mg provides rapid, effective and sustained relief of post-operative dental pain, comparable or superior to rofecoxib.
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Int. J. Clin. Pract. · Mar 2004
Randomized Controlled Trial Clinical TrialAnalgesic efficacy of single oral doses of lumiracoxib and ibuprofen in patients with postoperative dental pain.
This randomised, double-blind study compared single dose lumiracoxib (a cyclooxygenase-2 selective inhibitor) 100 and 400 mg, ibuprofen 400 mg and placebo in patients with postoperative dental pain over 12 h. The primary efficacy variable was pain intensity difference. Lumiracoxib 400 mg and ibuprofen were superior to placebo from 1 to 12 h post dose while lumiracoxib 100 mg was superior from 1.5 to 9 h. ⋯ Median time to rescue medication (h) was longer for lumiracoxib 400 mg (> or = 12), lumiracoxib 100 mg (approximately 7) and ibuprofen (approximately 8) than placebo (approximately 2; all p < or = 0.001 vs. placebo). Patients rated lumiracoxib 400 mg superior to the other active treatments (p < 0.05); lumiracoxib 100 mg was comparable with ibuprofen and superior to placebo (p < 0.001). Lumiracoxib provided rapid, effective and well-tolerated analgesia.