Biomedical subjects

A Gimona

Publications and source records attributed to A Gimona.

6 recordsLinked to original sources

PubMed2006

Local environmental effects and spatial effects in macroecological studies using mapped abundance classes: the case of the rook Corvus frugilegus in Scotland.

1. The study of the spatial pattern of species abundance is complicated by statistical problems, such as spatial autocorrelation of the abundance data, which lead to the confusion of environmental effects and dispersal. 2. Atlas-derived data for the rook in Scotland are used as a case study to propose an approach for assessing the likely contribution of dispersal and local environmental effects, based on a Bayesian Conditional Autoregressive (CAR) approach. 3. The availability of moist grasslands is a key factor explaining the spatial pattern of abundance. This is influenced by a combination of climatic and soil-related factors. A direct link to soil properties is for the first time reported for the wide-scale distribution of a bird species. In addition, for this species, dispersal seems to contribute significantly to the spatial pattern and produces a smoother than expected decline in abundance at the north-western edge of its distribution range. Areas where dispersal is most likely to be important are highlighted. 4. The approach described can help ecologists make more efficient use of atlas data for the investigation of the structure of species abundance, and can highlight potential sink areas at the landscape and regional scale. 5. Bayesian spatial models can deal with data autocorrelation in atlas-type data, while clearly communicating uncertainty through the estimation of the full posterior probability distribution of all parameters.

Animals↗

PubMed2004

Reduced incidence of gastroduodenal ulcers associated with lumiracoxib compared with ibuprofen in patients with rheumatoid arthritis.

BACKGROUND: Lumiracoxib (Prexige; Novartis Pharma AG, Basel, Switzerland) is a cyclooxygenase-2 selective inhibitor associated with improved gastrointestinal safety compared with nonsteroidal anti-inflammatory drugs, in patients with osteoarthritis. AIM: To compare the gastroduodenal safety of lumiracoxib with ibuprofen and celecoxib in patients with rheumatoid arthritis. METHODS: A total of 893 patients with rheumatoid arthritis were randomized to lumiracoxib 400 mg once daily, lumiracoxib 800 mg once daily, ibuprofen 800 mg three times daily or celecoxib 200 mg twice daily for 13 weeks, in a double-blind randomised controlled clinical trial. The primary endpoint was the cumulative incidence of gastroduodenal ulcers over 13 weeks. RESULTS: The incidence of gastroduodenal ulcers >/=3 mm with lumiracoxib 400 mg once daily (2.8%) or lumiracoxib 800 mg once daily (4.3%) was significantly lower than with ibuprofen (13.6%, all P < 0.01) and not different from celecoxib (1.9%). The incidence of adverse events was similar for lumiracoxib 400, 800 mg and celecoxib (78, 75 and 77%, respectively) and higher with ibuprofen (86%). Discontinuation for adverse events was highest for ibuprofen (12.5% vs. 7.9-8.8% for the other groups). CONCLUSIONS: Lumiracoxib demonstrated gastroduodenal safety superior to ibuprofen and similar to celecoxib in patients with rheumatoid arthritis.

Adolescent↗

PubMed2004

Lumiracoxib is effective in the treatment of osteoarthritis of the knee: a 13 week, randomised, double blind study versus placebo and celecoxib.

OBJECTIVES: To compare the efficacy and safety of lumiracoxib with placebo and celecoxib for osteoarthritis OA in a 13 week, multicentre, randomised, double blind study. METHODS: After a 37 day washout period for nonsteroidal antiinflammatory drugs, 1702 patients with knee OA were randomised to lumiracoxib 200 or 400 mg once daily od, celecoxib 200 mg od, or placebo 2221. A visual analogue scale VAS pain intensity > or =40 mm was required. Primary efficacy variables were OA pain intensity VAS mm in the target knee, patients global assessment of disease activity VAS mm, and WOMAC pain subscale and total scores at 13 weeks. OA pain intensity, patients and physicians global assessment of disease activity, and WOMAC total and all subscale scores were analysed by visit as secondary variables. RESULTS: Lumiracoxib showed significant improvements in all primary and secondary variables compared with placebo. Lumiracoxib 200 mg od and celecoxib 200 mg od achieved similar improvements in OA pain intensity and functional status. Lumiracoxib 400 mg od demonstrated better efficacy for OA pain intensity and patients global assessment of disease activity at weeks 2, 4, and 8 and similar efficacy at week 13 compared with celecoxib 200 mg od. The incidence of adverse events AEs, serious AEs, and discontinuations due to AEs was similar in each group. CONCLUSION: Lumiracoxib demonstrated significant improvement in OA pain intensity, patients global assessment of disease activity, and the WOMAC pain subscale and total scores compared with placebo. Lumiracoxib was well tolerated in this study, with overall tolerability similar to that of placebo and celecoxib.

Adult↗

PubMed2000

A randomized trial of nasal spray salmon calcitonin in postmenopausal women with established osteoporosis: the prevent recurrence of osteoporotic fractures study. PROOF Study Group.

PURPOSE: We conducted a 5-year, double-blind, randomized, placebo-controlled study to determine whether salmon calcitonin nasal spray reduced the risk of new vertebral fractures in postmenopausal women with osteoporosis. SUBJECTS AND METHODS: A total of 1,255 postmenopausal women with established osteoporosis were randomly assigned to receive salmon calcitonin nasal spray (100, 200, or 400 IU) or placebo daily. All participants received elemental calcium (1,000 mg) and vitamin D (400 IU) daily. Vertebral fractures were assessed with lateral radiographs of the spine. The primary efficacy endpoint was the risk of new vertebral fractures in the salmon calcitonin nasal spray 200-IU group compared with the placebo group. RESULTS: During 5 years, 1,108 participants had at least one follow-up radiograph. A total of 783 women completed 3 years of treatment, and 511 completed 5 years. The 200-IU dose of salmon calcitonin nasal spray significantly reduced the risk of new vertebral fractures by 33% compared with placebo [200 IU: 51 of 287, placebo: 70 of 270, relative risk (RR) = 0.67, 95% confidence interval (CI): 0.47- to 0.97, P = 0.03]. In the 817 women with one to five prevalent vertebral fractures at enrollment, the risk was reduced by 36% (RR = 0.64, 95% CI: 0.43- to 0.96, P = 0.03). The reductions in vertebral fractures in the 100-IU (RR = 0.85, 95% CI: 0.60- to 1.21) and the 400-IU (RR = 0.84, 95% CI: 0.59- to 1.18) groups were not significantly different from placebo. Lumbar spine bone mineral density increased significantly from baseline (1% to 1. 5%, P<0.01) in all active treatment groups. Bone turnover was inhibited, as shown by suppression of serum type-I collagen cross-linked telopeptide (C-telopeptide) by 12% in the 200-IU group (P <0.01) and by 14% in the 400-IU group (P<0.01) as compared with placebo. CONCLUSION: Salmon calcitonin nasal spray at a dose of 200 IU daily significantly reduces the risk of new vertebral fractures in postmenopausal women with osteoporosis.

Aged↗

PubMed1996

Osteoporosis prevention clinical study program.

OBJECTIVES: Oestrogens are widely believed to be effective against postmenopausal osteoporosis. However there are some outstanding questions which still need an answer. For example, the minimal effective dose regimen of oestradiol needs to be established and the relationship between oestradiol levels and efficacy on bone turnover and bone mass needs to be further clarified. METHODS: Menorest is being tested in the prevention of postmenopausal bone loss. A phase II/III clinical program, that includes two double blind, dose-ranging, placebo-controlled, parallel group, 2-year studies, has started in 58 centers in Europe and South Africa. Four-hundred eighty women will be enrolled in the two studies (201 and 305). The objective of the studies is to evaluate the efficacy of Menorest at different doses and regimens, in the prevention of bone loss in early postmenopausal women. In study 201, the treatment regimen is 'cyclic sequential' (24 days of transdermal oestradiol during a 28-day cycle with progestin taken during the last 14 days of oestrogen administration). In study 305 the treatment regimen is "continuous sequential' (28 days of transdermal oestradiol during, a 28-day cycle with progestin taken during the last 14 days of oestrogen administration). The doses studied are 50, 75, 100 micrograms/day in study 201, and 25, 50, 75 micrograms/day in study 305, (the two studies are otherwise identical). All 'active-dose' treated groups receive dydrogesterone 20 mg/day during the last 14 days of Menorest administration and placebo tablets are given to the placebo patch group. The main entry criteria are natural or surgical menopause, (with hormonal confirmation) from 1 to 6 years, with no contra-indication to HRT and with a bone mineral density (BMD) at the lumbar spine with a T-score between 0 and -3. Women with severe vasomotor symptoms are excluded from the studies. The primary efficacy variable is the mean change from baseline, measured with dual energy X-ray absorptiometry (DXA) at 2 years, in the lumbar spine BMD (L1-L4). Whole body and hip BMD are also evaluated. Markers of bone turnover (bone-specific alkaline phosphatase, osteocalcin and CrossLaps) are monitored throughout the study. Blood samples are drawn on the third day of patch application at certain visits in order to monitor oestradiol levels and establish any potential correlation with activity on bone (BMD, bone markers). Besides routine safety analysis, lipid profile and coagulation factors are also monitored. Special attention is drawn to endometrial safety with endometrial aspiration or trans vaginal sonography (TVS) performed before study start, after 1 year and at 2 years of treatment. RESULTS: Data presented here refer to 146 patients for whom demographics and clinical data are already available, and to 370 patients for whom baseline DXA data have already been validated. The mean (+/-S.D.) age of the women included in the two studies is 53.4 (+/-3.2) with a menopausal age of 38.3 (+/-19.6) months. None of the women who entered the study had severe postmenopausal symptoms as shown by a mean number of hot flushes of 2.2 (+/-2.6) per day, during the last 14 days before inclusion. The mean (+/-S.D.) lumbar spine (L1-L4) BMD is 0.914 (+/-0.122) g/cm2 which corresponds to a Z-score of -0.26 and a T-score of -1.17. Femoral neck, trochanter and Wards triangle have a BMD which is below the mean of age-matched controls but still within the normal range (Z-scores between 0 and -1). Only the whole body BMD is over the mean of age-matched controls, with a Z-score of 0.32. The in-vivo precision mean (+/-S.D.), was calculated and showed a value of 0.868 (+/-0.872), which can be considered a good performance. CONCLUSIONS: In summary, the use of one of the most recent techniques to assess the bone mineral content/density together with an accurate quality control program on all the densitometers used in the studies will help to improve the in-vivo BMD precision and therefore mak

Administration, Cutaneous↗

PubMedDate not supplied

Efficacy and tolerability of lumiracoxib versus placebo in patients with osteoarthritis of the hand.

OBJECTIVE: This multicentre, randomized, double-blind, placebo-controlled parallel-group study was undertaken to investigate the efficacy, safety and tolerability of lumiracoxib (Prexige), a cyclooxygenase-2 selective inhibitor, in patients with primary osteoarthritis (OA) of the hand. METHODS: The study randomized 594 patients aged > or = 18 years with symptomatic OA of the hand. Patients underwent a 3 to 7-day washout for previous nonsteroidal anti-inflammatory drugs and those with pain intensity > or = 40 mm on a 100 mm Visual Analogue Scale (VAS) in the target hand during the 24 hours prior to baseline and an increase in pain intensity of either > or = 20% or > or = 10 mm VAS since screening (whichever was greater) were randomized to lumiracoxib 200 mg once daily (od) (n=205), lumiracoxib 400 mg od (n=193) or placebo (n=196). The primary efficacy variable was overall OA pain intensity (VAS mm) in the target hand after 4 weeks of treatment. Safety and tolerability assessments were performed. RESULTS: After 4 weeks of treatment, overall OA pain intensity in the target hand was significantly lower for patients treated with lumiracoxib compared with patients treated with placebo (both doses p<0.001). There was no significant difference between lumiracoxib doses in terms of the reduction in overall OA pain intensity. Lumiracoxib was well tolerated. The incidence of adverse events was similar for active treatment groups and placebo. CONCLUSIONS: Lumiracoxib 200 and 400 mg od were effective and well tolerated treatments for OA of the hand. Lumiracoxib significantly improved overall OA pain intensity in the target hand versus placebo, with a tolerability profile similar to placebo.

Aged↗