Clinical drug investigation
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Randomized Controlled Trial Multicenter Study
Salmeterol/fluticasone propionate via Diskus once daily versus fluticasone propionate twice daily in patients with mild asthma not previously receiving maintenance corticosteroids.
The efficacy and safety of twice-daily inhaled salmeterol/fluticasone propionate combination (SFC) therapy have been well established in the treatment of adults and adolescents with asthma. Once-daily administration of SFC could also be appropriate in patients with mild persistent asthma. This study aimed to investigate whether once-daily SFC 50 microg/100 microg was at least as effective as fluticasone propionate (FP) 100 microg twice daily, and more effective than twice-daily placebo, over 52 weeks as initial maintenance therapy in patients with mild persistent asthma. ⋯ In patients with mild persistent asthma not previously receiving maintenance therapy, once-daily SFC 50 microg/100 microg is an effective treatment compared with placebo, and was non-inferior to twice-daily FP 100 microg with respect to mean morning PEF. However, in this study, once-daily SFC was not as efficacious as twice-daily FP in reducing asthma exacerbation rates. This study confirms the benefits of regular maintenance treatment in patients with mild persistent asthma.
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Multicenter Study
Prescriptions of NSAIDs to patients undergoing third molar surgery : an observational, prospective, multicentre survey.
Surgical extraction of an impacted third molar is generally followed by acute post-operative pain that has been shown to be primarily inflammatory. Thus, use of NSAIDs in this context is appropriate and has been shown to be effective. Several drugs are employed for this purpose, but no information exists on the reasons why preference is given to one rather than another. The principal objective of this study was to evaluate the pattern of administration of NSAIDs in patients undergoing surgery for impacted third molar extraction. The study also aimed to collect information on the efficacy, onset and duration of the analgesic effect of routinely prescribed NSAIDs and to assess the duration of treatment with these drugs and their tolerability. ⋯ These results confirm nimesulide as an effective reference drug for the treatment of post-operative dental pain and show that it has a positive benefit/risk profile in this setting.
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Randomized Controlled Trial Multicenter Study Comparative Study
Double-blind comparison of escitalopram and duloxetine in the acute treatment of major depressive disorder.
Escitalopram is the most selective serotonin reuptake inhibitor antidepressant; in contrast, duloxetine inhibits both serotonin and norepinephrine reuptake. Double-blind comparison studies may help guide treatment decisions by revealing the relative benefits of different therapeutic approaches. This study evaluated the efficacy and safety of escitalopram versus duloxetine in the acute treatment of patients with moderate to severe major depressive disorder. ⋯ These findings suggest that escitalopram is better tolerated and at least as effective as the serotonin-norepinephrine reuptake inhibitor duloxetine in the treatment of major depressive disorder.
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Randomized Controlled Trial Multicenter Study
Antihypertensive efficacy and safety of manidipine versus amlodipine in elderly subjects with isolated systolic hypertension: MAISH study.
Isolated systolic hypertension (ISH) affects 10-20% of the elderly population and is strongly related to the risk of cardiovascular events. Elevated systolic BP values are primarily caused by reduced large vessel compliance with a consequent increase in total peripheral resistance. Vasodilating drugs, such as calcium channel antagonists, have proven to be effective in controlling ISH in elderly patients. This study set out to compare the antihypertensive efficacy and safety of two different calcium channel antagonists, manidipine and amlodipine, administered once daily in elderly subjects with ISH. ⋯ In elderly patients with ISH, treatment with manidipine for 12 weeks was well tolerated and effective and the antihypertensive effects obtained with manidipine were the same as those obtained with amlodipine.
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Randomized Controlled Trial Multicenter Study Comparative Study
A multicentre, randomised, double-blind study comparing the efficacy and tolerability of intramuscular dexketoprofen versus diclofenac in the symptomatic treatment of acute low back pain.
Low back pain is an important medical problem in Western industrialised countries. NSAIDs are one of the main options for symptomatic pain relief in the early management of this painful condition. Dexketoprofen is an NSAID belonging to the arylpropionic acid group that has demonstrated good analgesic efficacy and a good safety profile in different acute and chronic painful conditions. ⋯ From the results of this study it can be concluded that dexketoprofen 50mg administered twice daily intramuscularly provides a clinically relevant analgesic effect with good tolerability after single and repeated doses in patients with acute severe low back pain.