Clinical therapeutics
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Clinical therapeutics · Sep 2008
Randomized Controlled Trial Multicenter Study Comparative StudyAn 18-week, prospective, randomized, double-blind, multicenter study of amlodipine/ramipril combination versus amlodipine monotherapy in the treatment of hypertension: the assessment of combination therapy of amlodipine/ramipril (ATAR) study.
A combination of antihypertensive agents of different drug classes in a fixed-dose combination (FDC) may offer advantages in terms of efficacy, tolerability, and treatment compliance. Combination of a calcium channel blocker with an angiotensin-converting enzyme inhibitor may act synergistically to reduce blood pressure (BP). ⋯ In this population of patients with essential hypertension, the amlodipine/ramipril FDC was associated with significantly reduced ambulatory and office-measured BP compared with amlodipine monotherapy, with the exception of office DBP. Both treatments were well tolerated.
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Clinical therapeutics · Aug 2008
Randomized Controlled Trial Multicenter StudyEfficacy and tolerability of exenatide monotherapy over 24 weeks in antidiabetic drug-naive patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, parallel-group study.
Evaluation of exenatide monotherapy in patients with type 2 diabetes may be of clinical interest based on improvements in glycemic control and weight that have been reported with the use of exenatide in combination with oral antidiabetic agents. ⋯ In these patients with type 2 diabetes naive to treatment with antidiabetic agents, exenatide monotherapy was associated with improved HbA(1c), improved fasting and postprandial glucose control, reduced weight, improved beta-cell function (HOMA-B), and improved blood pressure, and was well tolerated. These results suggest that exenatide monotherapy may provide a viable treatment option beyond diet and exercise and support further study of exenatide monotherapy in antidiabetic drug-naive patients with type 2 diabetes.
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Clinical therapeutics · Aug 2008
Randomized Controlled Trial Multicenter StudyEffect of nicotine lozenges on affective smoking withdrawal symptoms: secondary analysis of a randomized, double-blind, placebo-controlled clinical trial.
The suggested mechanism for the effects of nicotine replacement medications such as nicotine lozenges on smoking abstinence is reduction in the withdrawal symptoms of emotional distress and craving (the subjective desire to smoke). ⋯ In high-dependence smokers, the 4-mg nicotine lozenge significantly reduced all affective withdrawal symptoms through the first 4 weeks of treatment. Lozenge-related decreases in craving partially mediated the effect of treatment on abstinence, particularly in high-dependence smokers.
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Clinical therapeutics · Aug 2008
Randomized Controlled Trial Multicenter Study Comparative StudyEfficacy and tolerability of salmeterol/fluticasone propionate versus montelukast in childhood asthma: A prospective, randomized, double-blind, double-dummy, parallel-group study.
Asthma control remains suboptimal in adults and children worldwide. Inhaled salmeterol/fluticasone propionate combination (SFC) and oral montelukast (MON) are 2 treatments available for childhood asthma. ⋯ In these children with uncontrolled asthma previously on short-acting beta(2)-agonist monotherapy (% predicted FEV(1) <80%, frequent asthma symptoms and rescue medication use), treatment with SFC was significantly more effective in improving morning PEF and other measures of asthma control and in decreasing exacerbation rates (in a post hoc analysis) than treatment with MON. The 2 drugs were both well tolerated, with similar numbers and types of AEs reported.
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Clinical therapeutics · Jun 2008
Randomized Controlled Trial Multicenter Study Comparative StudyA 52-week, randomized, open-label, parallel-group comparison of the tolerability and effects of pitavastatin and atorvastatin on high-density lipoprotein cholesterol levels and glucose metabolism in Japanese patients with elevated levels of low-density lipoprotein cholesterol and glucose intolerance.
Statin therapy has been found to produce substantial reductions in low-density lipoprotein cholesterol (LDL-C) levels, resulting in a reduced risk for cardiovascular events. Recently, research interest has focused on modification of high-density lipoprotein cholesterol (HDL-C) levels for the potential prevention of cardiovascular events. The effects of pitavastatin and atorvastatin on HDL-C have not been directly compared. ⋯ In these patients with elevated LDL-C levels and glucose intolerance, 52 weeks of treatment with pitavastatin 2 mg/d was associated with significantly greater increases in HDL-C and Apo A-I levels than atorvastatin 10 mg/d. Both treatments were well tolerated.