Clinical therapeutics
-
Clinical therapeutics · Aug 2003
Comparative StudyA preliminary comparison of the efficacy and tolerability of botulinum toxin serotypes A and B in the treatment of myofascial pain syndrome: a retrospective, open-label chart review.
Myofascial pain syndrome (MPS) is characterized by acute or chronic regional muscle pain associated with single or multiple trigger points within taut bands of muscle. Botulinum toxins have clinical utility when sustained focal muscle relaxation is required and may be a useful addition to the treatment armamentarium for MPS. ⋯ Patients with MPS who received BTX-A reported significantly greater reductions in pain for longer durations compared with those who received BTX-B. No patients who received BTX-A experienced severe systemic adverse events, compared with 4 patients who received BTX-B. The results of this comparison are consistent with the US Food and Drug Administration-approved labeling indicating that BTX-A is not interchangeable with any other botulinum toxin in terms of biological activity.
-
Clinical therapeutics · Jun 2003
Randomized Controlled Trial Multicenter Study Clinical TrialEfficacy, pharmacokinetic, and safety assessment of adalimumab, a fully human anti-tumor necrosis factor-alpha monoclonal antibody, in adults with rheumatoid arthritis receiving concomitant methotrexate: a pilot study.
Because traditional therapies for rheumatoid arthritis (RA) such as methotrexate (MTX) do not produce an adequate response in many patients, newer therapies that block the proinflammatory cytokine tumor necrosis factor-alpha (TNF-alpha) are increasingly being used in combination with MTX. ⋯ Among patients with active RA who had not had an adequate response to MTX, addition of adalimumab to MTX achieved statistically significant, long-term improvement compared with placebo plus MTX (P < or = 0.05), as indicated by ACR responses at 26 months. The combination was well tolerated. Adalimumab exhibited linear pharmacokinetics. In this selected patient population, adalimumab's long half-life of 15 to 19 days supports every-other-week dosing. Coadministration of adalimumab did not alter serum levels of MTX.
-
Clinical therapeutics · Jun 2003
ReviewInsulin glargine: a systematic review of a long-acting insulin analogue.
Insulin glargine is the first long-acting basal insulin analogue indicated for subcutaneous administration once daily at bedtime in adults with type 1 or type 2 diabetes mellitus and pediatric patients aged > or = 6 years with type 1 diabetes. It differs in structure from native human insulin by 3 amino acids, a structural modification that provides a delayed onset of action and a constant, peakless effect that has a duration of at least 24 hours. ⋯ As a basal insulin replacement, insulin glargine administered once daily demonstrates a steady time-action profile over 24 hours without a pronounced peak. Based on the evidence from published clinical trials, insulin glargine appears to have equal clinical efficacy to NPH insulin, produces similar reductions in HbA(1c), and is associated with lower FPG and FBG levels and a consistent and significant reduction in the incidence of nocturnal hypoglycemia in patients with type 2 diabetes.
-
Clinical therapeutics · Jun 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialHospital resource use and cost of treatment with linezolid versus teicoplanin for treatment of serious gram-positive bacterial infections among hospitalized patients from South America and Mexico: results from a multicenter trial.
Linezolid is a novel oxazolidinone antibiotic that is effective for the treatment of gram-positive bacterial infections. The oral formulation has the potential to reduce length of stay (LOS) when used as a substitute for parenteral glycopeptide antibiotics. In a recent multinational trial comparing linezolid (i.v. followed by oral administration) with teicoplanin (i.v. alone or switched to i.m. administration), linezolid was found to have better efficacy (P = 0.005) and similar safety for treating serious gram-positive infections. ⋯ Linezolid was associated with shorter LOS and duration of IV antibiotic treatment than teicoplanin for serious gram-positive infections in the population studied. Linezolid therapy has the potential to reduce the total cost of treatment.
-
Clinical therapeutics · Jun 2003
Randomized Controlled Trial Clinical TrialThe effect of nateglinide taken with food on gastric emptying rates in healthy subjects.
The aim of this study was to determine the effect of the timing of food intake on the pharmacokinetics and pharmacodynamics of oral nateglinide 60 mg and the effect of nateglinide on the rate of gastric emptying. ⋯ Nateglinide was well tolerated and no treatment-limiting adverse events were reported in the population studied. Nateglinide administration appeared to have no effect on the rate of gastric emptying as indicated by acetaminophen indices, regardless of the time of nateglinide administration. The findings imply that the time for nateglinide administration to obtain optimal pharmacodynamic effects is prior to food consumption.