European journal of rheumatology and inflammation最新文献

This randomised, double-blind, placebo-controlled, parallel-group trial was carried out to assess the efficacy and tolerability of a new, locally acting, transcutaneous flurbiprofen preparation (flurbiprofen LATTM, Boots Company PLC) in the treatment of scapulohumeral periarthritis. The new preparation consists of a nonwoven polyester patch supporting a mentholated formulation containing flurbiprofen 40 mg. Eighty patients suffering from the acute, painful phase of scapulohumeral periarthritis entered the trial, three of which failed to provide follow-up data. Each patient applied one patch every 12 hours for the 14 day trial period. Efficacy was assessed in terms of reduction of pain, improvement in shoulder movement and overall clinical assessment of the severity of the condition after treatment. Statistically significant improvements from baseline were observed in both treatment groups, with a constant overall trend in favour of flurbiprofen. The differences between the two treatment groups, however, did not reach statistical significance.

The effectiveness of etodolac in the treatment of patients with osteoarthritis (OA) and with rheumatoid arthritis (RA) has been well documented in controlled clinical trials. The superiority of etodolac, 300 mg twice daily, over placebo has already been established in short-term trials involving patients with OA. During long-term treatment, significant (p < 0.05) improvement was observed in patients with OA and RA as measured by a variety of efficacy parameters. In comparative studies for OA, etodolac was more effective than conventional indomethacin; naproxen, sustained-release diclofenac, and piroxicam were comparably effective. The newer sustained-release formulation of etodolac is as effective as the conventional etodolac formulation when used to treat patients with OA and those with RA.

One hundred and thirty-one male and female outpatients, aged 18-70 yr, with acute pain in the ankle joint caused by a post-traumatic sprain, entered a multicentre, randomised, double-blind, parallel-group, study. The patients were assigned to a 40 mg flurbiprofen patch (n = 65) or a non-medicated (but otherwise identical) control (n = 66), 12-hourly over 7 days, and were assessed at entry and after 3 and 7 days treatment. On day 7, spontaneous pain (the prime efficacy parameter), as evaluated by the patient on a visual analogue scale in the physician's office, showed significant improvement in the 40 mg flurbiprofen patch group compared to control (change from baseline) (p = 0.039), a result corroborated by the evaluation of the periarticular oedema: a reduction of 77.4% was observed in the 40 mg flurbiprofen patch group, compared with 63.8% in the control group (p = 0.025). The other selected efficacy criteria showed changes with a trend in favour of the 40 mg flurbiprofen patch but without statistical significance. Two mild and local adverse events were reported by two flurbiprofen patch patients, but neither patients discontinued the treatment prematurely. Physicians and patients found the flurbiprofen patch to be efficacious and well tolerated. Compliance was excellent in both groups. The efficacy and tolerability of the 40 mg flurbiprofen patch are therefore confirmed in the treatment of acute ankle sprains.

A parallel group study for one month of 392 patients was undertaken to define the optimal dose of nimesulide for the treatment of painful osteoarthritis (OA). By the final visit, the mean values for pain intensity for the nimesulide groups (50 mg, 100 mg and 200 mg bd) were similar and significantly lower than the mean for the placebo group. The onset of analgesia was rapid and continued throughout the 12-hour period after drug intake, a significant analgesic effect was demonstrated with nimesulide 100 mg and 200 mg within 1.5 hours. The patients' and the physicians' overall judgements of the drug efficacy demonstrated significant differences between the treatment groups with the most successful outcomes occurring with nimesulide 100 mg and 200 mg. Nimesulide 50 mg and 100 mg were generally well-tolerated but at the highest dose level, nimesulide 200 mg, the incidence of adverse events was greater although not significantly. Results of this study demonstrate nimesulide 100 mg twice daily to be the optimal dose for the treatment of OA.

The pharmacokinetics of etodolac in healthy normal volunteers has been extensively studied and is well described. Etodolac is characterised by a high oral bioavailability, low clearance, a small volume of distribution, and a 7-hour half-life. It is essentially completely metabolised, therefore little is excreted unchanged. Etodolac is highly protein bound. To investigate the effect of disease states or concomitant drug administration on a patient's response to etodolac, additional pharmacokinetic studies were carried out in special populations. Since etodolac has a well-defined pharmacokinetic-pharmacodynamic relationship, measurement of pharmacokinetic parameters is clinically relevant. Data from studies to date show that disease states, underlying conditions, and concomitantly administered highly protein-bound drugs have essentially no effect on etodolac pharmacokinetics. Therefore, etodolac can generally be given without the need for dosage modifications in special populations such as uncompromised elderly patients, those with moderate renal impairment, and patients with stable hepatic disease.

A growing proportion of patients who require nonsteroidal anti-inflammatory drug (NSAID) therapy are elderly. Data from patients 65 years and older with osteoarthritis or rheumatoid arthritis show that etodolac is as well tolerated in elderly as in younger patients. Of 273 elderly patients treated with at least 600 mg daily, only 12% withdrew because of adverse events, a rate similar to that in the younger age-group. Notably, the incidence of etodolac-associated gastrointestinal events is no higher in elderly than in younger patients. Etodolac was no different from diclofenac and piroxicam regarding incidence and type of adverse events. In both short- and long-term studies, the 400-mg and 600-mg sustained-release etodolac formulations were well tolerated in elderly and younger patients. Thus, etodolac appears to be a first-line choice in elderly patients.

The clinical efficacy and the tolerability of nimesulide (100 mg bid) and naproxen sodium (550 mg bid) in the treatment of tendinitis and bursitis were evaluated in a multicentre double-blind study over a 14-day period. Two hundred and five patients were included in the study. Patients randomised to one of two parallel treatment groups. They were clinically examined at days 1, 7 and 14. Blood analysis was performed at day 1 and at the end of the treatment. The main efficacy criterion was the diminution of pain during active mobilisation measured using a visual analogue scale. The improvement of the scores was obvious and similar between the two groups. The secondary efficacy criteria (pain during motion against resistance, functional impairment and global assessment of efficacy) confirmed these favourable results and did not evidence any statistical difference between the two groups. The side effects observed were mainly gastrointestinal. Their frequency and intensity were slightly higher in the naproxen sodium group but without any statistically significant difference (28 complaints in 16 patients in the nimesulide group and 33 complaints in 22 patients in the naproxen group). There was no statistical difference between the two treated groups regarding the general clinical examination and the biological follow-up.