Clinical therapeutics
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Clinical therapeutics · Mar 2008
Randomized Controlled Trial Multicenter StudyPharmacokinetic, pharmacodynamic, and tolerability profiles of the dipeptidyl peptidase-4 inhibitor alogliptin: a randomized, double-blind, placebo-controlled, multiple-dose study in adult patients with type 2 diabetes.
Alogliptin is a highly selective dipeptidyl peptidase-4 (DPP-4) inhibitor that is under development for the treatment of type 2 diabetes (T2D). ⋯ In these adult patients with T2D, alogliptin inhibited plasma DPP-4 activity and significantly decreased PPG levels. The PK and PD profiles of multiple doses of alogliptin in this study supported use of a once-daily dosing regimen. Alogliptin was generally well tolerated, with no dose-limiting toxicity.
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Clinical therapeutics · Mar 2008
Randomized Controlled Trial Comparative Study Clinical TrialPharmacokinetics, efficacy, and tolerability of fentanyl following intranasal versus intravenous administration in adults undergoing third-molar extraction: a randomized, double-blind, double-dummy, two-way, crossover study.
The aim of this study was to compare the pharmacokinetic profile, as well as the efficacy and tolerability, of i.n. and i.v. administration of fentanyl in acute, episodic pain in patients undergoing third-molar extraction. ⋯ Onsets and durations of analgesia were not significantly different between single doses of i.n. and i.v. fentanyl in these adults undergoing third-molar extraction. Both i.n. and i.v. administration were generally well tolerated.
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Clinical therapeutics · Mar 2008
ReviewClinical and patient-reported outcomes in clinical trials of abatacept in the treatment of rheumatoid arthritis.
Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic joint inflammation, which if left untreated leads to progressive disability and joint destruction. A combination of antiinflammatory agents, steroids, disease-modifying antirheumatic drugs, and biological agents are used to treat RA. Beyond the use of conventional measures of disease activity, such as American College of Rheumatology (ACR) response rates, the importance of patient-reported outcomes (PROs) in assessing therapeutic benefits is gaining increasing emphasis in clinical trials of RA and other chronic illnesses. Clinical trials testing new RA therapeutics generally include health-related quality of life (HRQoL) measures and assessments of function and disability. Abatacept, a costimulation modulator that selectively targets the activation of T cells and downregulates the immune response, has been approved by the US Food and Drug Administration for the treatment of RA, with or without methotrexate. ⋯ These 6 published trials found that abatacept was associated with significant improvements in both conventional measures of disease activity and PROs. Continued assessment of these outcomes will be required to further support the findings of the Phase II and III abatacept clinical trial literature reviewed here.
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Clinical therapeutics · Mar 2008
ReviewUse of Lactobacillus probiotics for bacterial genitourinary infections in women: a review.
Lactobacilli are the dominant bacteria of the vaginal flora and possess antimicrobial properties that regulate other urogenital microbiota. Incomplete cure and recurrence of genitourinary infections lead to a shift in the local flora from a predominance of lactobacilli to coliform uropathogens. Use of Lactobacillus-containing probiotics to restore commensal vaginal flora has been proposed for the treatment and prophylaxis of bacterial urogenital infections. ⋯ Despite enhanced cure rates in some studies, concerns about product stability and limited documentation of strain-specific effects prevent recommendations for the use of Lactobacillus-containing probiotics in the treatment of BV. The results of studies of lactobacilli for the prophylaxis of UTI remain inconclusive as a result of small sample sizes and use of unvalidated dosing strategies.
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Clinical therapeutics · Mar 2008
Randomized Controlled Trial Comparative StudyComparison of sequential and standard triple-drug regimen for Helicobacter pylori eradication: a 14-day, open-label, randomized, prospective, parallel-arm study in adult patients with nonulcer dyspepsia.
The eradication rates of Helicobacter pylori with standard treatments are decreasing worldwide. ⋯ A 14-day sequential treatment regimen achieved a significantly higher eradication rate of H pylori compared with standard PPI-based triple regimen in this small selected population. Large, double-blind, controlled studies are needed to confirm these results.