Clinical therapeutics
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Clinical therapeutics · Aug 2009
Multicenter StudyLong-term tolerability of the methylphenidate transdermal system in pediatric attention-deficit/hyperactivity disorder: a multicenter, prospective, 12-month, open-label, uncontrolled, phase III extension of four clinical trials.
Short-term treatment with the meth-ylphenidate transdermal system (MTS) has been well tolerated in several clinical trials in children with attention-deficit/hyperactivity disorder (ADHD). However, the effects of long-term use have not been systematically evaluated. ⋯ Slightly less than half (48.0%) of subjects completed this 12-month, open-label extension study of MTS. Most AEs were mild to moderate in severity and, with the exception of application-site reactions, were typical of those previously observed with methylphenidate. ClinicalTrials.gov identifier: NCT00151957.
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Clinical therapeutics · Aug 2009
Randomized Controlled Trial Multicenter Study Comparative StudyComparison of the efficacy and safety of arformoterol 15 microg twice daily and arformoterol 30 microg once daily in COPD: a single-dose, multicenter, randomized, modified-blind, two-way crossover study.
The aim of this study was to compare the efficacy and safety of nebulized arformoterol 15 microg/2 mL twice daily (ARF15 BID) and 30 microg/4 mL once daily (ARF30 QD) in subjects with moderate to severe chronic obstructive pulmonary disease (COPD). ⋯ In these subjects with moderate to severe COPD, single-day administrations of ARF15 BID or ARF30 QD were associated with FEV(1) responses over a period of 24 hours that were considered equivalent per the protocol definition employed in the present study. FEV1 improvement over 12 hours was greater for ARF30 QD after the morning dose and for ARF15 BID after the evening dose. ClinicalTrials.gov Identifier: NCT00571428.
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Clinical therapeutics · Aug 2009
Randomized Controlled TrialEfficacy of roxithromycin in adult patients with rheumatoid arthritis who had not received disease-modifying antirheumatic drugs: a 3-month, randomized, double-blind, placebo-controlled trial.
It has been reported that antibodies to oral anaerobic bacteria are elevated in the serum and synovial fluids of patients with rheumatoid arthritis. Macrolide antibiotics are active against oral anaerobic bacteria. ⋯ In these adult patients with rheumatoid arthritis, 3-month treatment with roxithromycin significantly improved the signs and symptoms of rheumatoid arthritis and was generally well tolerated. Future studies should investigate the relationship between disease activity and serum or joint antibodies to anaerobic bacteria.
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Clinical therapeutics · Aug 2009
Management of fever in children: summary of the Italian Pediatric Society guidelines.
This article summarizes the Italian Pediatric Society guideline on the management of the signs and symptoms of fever in children, prepared as part of the National Guideline Program (NGLP). ⋯ In the health care setting, axillary measurement of body temperature using a digital thermometer is recommended in children aged <4 weeks; for children aged > or =4 weeks, axillary measurement using a digital thermometer or tympanic measurement using an infrared thermometer is recommended. When body temperature is measured at home by parents or care-givers, axillary measurement using a digital thermometer is recommended for all children. Children who are afebrile when seen by the clinician but are reported to have had fever by their caregivers should be considered febrile. In special circumstances, high fever may be a predictive factor for severe bacterial infection. Use of physical methods of reducing fever is discouraged, except in the case of hyperthermia. Use of antipyretics-paracetamol (acetaminophen) or ibuprofen-is recommended only when fever is associated with discomfort. Combined or alternating use of antipyretics is discouraged. The dose of antipyretic should be based on the child's weight rather than age. Whenever possible, oral administration of paracetamol is preferable to rectal administration. Use of ibuprofen is not recommended in febrile children with chickenpox or dehydration. Use of ibuprofen or paracetamol is not contraindicated in febrile children with asthma. There is insufficient evidence to form any recommendations concerning fever in children with other chronic conditions, but caution is advised in cases of severe hepatic/renal failure or severe malnutrition. Newborns with fever should always be hospitalized because of the elevated risk of severe disease; paracetamol may be used, with the dose adjusted to gestational age. Use of paracetamol or ibuprofen is not effective in preventing febrile convulsion or the adverse effects of vaccines.
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Clinical therapeutics · Aug 2009
Randomized Controlled TrialPharmacokinetics and tolerability of single escalating doses of gabapentin enacarbil: a randomized-sequence, double-blind, placebo-controlled crossover study in healthy volunteers.
Gabapentin enacarbil is an actively transported prodrug of gabapentin that provides predictable dose-proportional gabapentin exposure with high (> or =68%) oral bioavailability. ⋯ Gabapentin enacarbil was associated with dose-proportional gabapentin exposure at doses up to 6000 mg and was generally well tolerated in these healthy subjects. These findings support the use of 6000-mg gabapentin enacarbil in a definitive QT/QTc study.