Current medical research and opinion
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Comparative Study
Safety of naproxen compared with placebo, ibuprofen and acetaminophen: a pooled analysis of eight multiple-dose, short-term, randomized controlled studies.
Objective: To quantify the rate of adverse events reported with naproxen compared with placebo, ibuprofen and acetaminophen at non-prescription doses in multiple-dose, multi-day (7-10 days) duration clinical trials and further contribute towards current knowledge regarding the safety profile of naproxen. Methods: Safety data were retrospectively collected from eight randomized, controlled trials that included subjects exposed to a fixed dosing regimen of 220-750 mg naproxen per day over 7-10 days. All data on adverse events and their duration, severity and possible relationship to the study drug were taken from the clinical study reports. ⋯ Most events were mild to moderate. The most frequently reported adverse events in all groups were related to the gastrointestinal system (most commonly dyspepsia with naproxen), with no differences between groups. Conclusions: Our pooled analysis did not find an increased risk of adverse events with short-term use of non-prescription doses of naproxen compared with placebo, or compared to other common analgesics.
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Multicenter Study Observational Study
VITALITY: impact of adalimumab on health and disability outcomes in patients with Crohn's disease, rheumatoid arthritis, or psoriasis treated in clinical practice in New Zealand.
Objective: VITALITY, a 6-month, multicenter, prospective, observational study, assessed the effects of originator adalimumab (HUMIRA) on health and disability outcomes in patients with Crohn's disease (CD), rheumatoid arthritis (RA), or psoriasis treated in routine clinical practice in New Zealand (NZ). Methods: Biologic-naïve adults initiating adalimumab in accordance with NZ funding requirements were recruited. The primary endpoint was 6-month change from baseline in World Health Organization Disability Assessment Schedule (WHODAS) 2.0 score in all participants completing the study (full analysis set). ⋯ No new adalimumab safety signals were observed. Conclusions: Health and disability outcomes improved significantly after 6 months of adalimumab use in NZ patients with severe CD, RA, or psoriasis. Clinicaltrials.gov: NCT02451839.
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Objectives: Pathological stage III melanoma patients have variable clinical presentation and outcome when divided by substages, and the number of metastatic lymph nodes is the most significant independent factor. We aimed to determine the clinical features and natural course of node positive melanoma, such as first relapse and final outcome, and other factors influencing them. Methods: A total of 362 node positive melanoma patients were included in the study and reviewed retrospectively. ⋯ Five- and 10 year overall survival (OS) rates were 49% and 40%, respectively. Older age, nodular histopathology, higher mitotic rates and relapse of disease (p = .001) were the independent variables that were inversely correlated with OS for all patients. Conclusion: Comparative analyses of node positive melanoma suggested that there was not only a remarkable heterogeneity in the recurrence and survival rates but also a distinctive pattern among independent prognostic indicators in accordance with the severity of nodal involvement.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of mirogabalin for the treatment of fibromyalgia: results from three 13-week randomized, double-blind, placebo- and active-controlled, parallel-group studies and a 52-week open-label extension study.
Objective: To investigate the efficacy and safety of mirogabalin, an α2δ ligand, in patients with fibromyalgia (FM). Methods: In three 13-week, multicenter, double-blind, phase 3 studies (studies A, B, and C), patients with FM (n = 1293, 1270, and 1301, respectively) were randomized (1:1:1:1) to placebo, pregabalin 150 mg twice daily, mirogabalin 15 mg once daily or mirogabalin 15 mg twice daily. The primary endpoint was the change in weekly average daily worst pain score (ADPS) at week 13. ⋯ Mirogabalin was well tolerated by most patients in the phase 3 studies; no unexpected adverse events occurring during the 52-week extension study. Conclusion: While both mirogabalin doses were well tolerated by most patients and showed potential for reducing pain associated with FM, the primary endpoint of significant pain reduction in patients on mirogabalin compared with placebo was not achieved in any of the three randomized controlled studies. Clinical trial registration: NCT02146430; NCT02187159; NCT02187471; and NCT02234583 (extension study).
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Multicenter Study Clinical Trial
Effects of topical piroxicam and sun filters in actinic keratosis evolution and field cancerization: a two-center, assessor-blinded, clinical, confocal microscopy and dermoscopy evaluation trial.
Background: Actinic keratosis (AK) is considered an "in situ" non-melanoma skin cancer induced by ultraviolet chronic exposure. Sunscreen and topical anti-inflammatory agents like diclofenac could improve the evolution of this kind of lesions. A topical product containing piroxicam 0.8% and sun filters (50 SPF) (ACTX) has been shown to be very effective in reducing AK lesions. ⋯ The product was in general very well tolerated. Conclusion: A 6 month application of ACTX in subjects with AK lesions was associated with an improvement in AK lesion count and with a reduction in the RCM/dermoscopy severity scores of the target lesion. Trial registration number: ISRCTN22070974.