mobiflex and Arthritis--Rheumatoid

Tenoxicam, a new non-steroidal anti-inflammatory agent (NSAID) with a long half-life, has been evaluated in a series of nine clinical studies over the last five years. Early studies against naproxen in osteoarthrosis (OA) and against ibuprofen in rheumatoid arthritis (RA) suggested the drug was efficacious in both of these conditions. A series of faecal blood loss studies showed that the drug produced less gastrointestinal blood loss than aspirin and comparable blood loss to piroxicam. Comparisons of tenoxicam and piroxicam in OA and ankylosing spondylitis (AS) showed both drugs to be approximately equally efficacious. A pharmacokinetic study showed a half-life for tenoxicam of 45 h in synovial fluid when the half-life was 42 h in plasma. A single and multiple oral dose pharmacokinetic study of tenoxicam in the elderly showed no progressive accumulation with peak plasma levels of 2.6 micrograms/ml after the single dose and 12.4 micrograms/ml at steady state.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Humans; Osteoarthritis; Piroxicam

To compare the efficacy and safety of aceclofenac (AC) and tenoxicam (TX) in the treatment of rheumatoid arthritis (RA), a multicentric parallel, randomized, double-blind trial of three months duration was performed in 292 patients: 145 were randomized to the AC treatment group and 147 to the TX treatment group. The trial was completed by 237 (81.1%) patients. Both treatment groups showed amelioration of clinical parameters monitored at 15 days, and this improvement continued until the end of the trial, no statistically significant differences being observed between AC and TX. Twenty-four patients (8.2%, 12 AC and 12 TX) did not complete the trial because of inefficacy, and 15 because of side effects (5.1%, 6 AC and 9 TX), in 7 of them due to gastrointestinal intolerance (2,4%, 1 AC, 6 TX, p = 0.052). These data demonstrate that AC shows similar efficacy to TX in the treatment of rheumatoid arthritis and better safety profile than TX, mainly regarding gastrointestinal tolerability.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Diclofenac; Double-Blind Method; Female; Gastrointestinal Diseases; Humans; Male; Middle Aged; Piroxicam

To assess longterm compliance in patients with rheumatoid arthritis (RA) of 20 mg tenoxicam or 500-1000 mg naproxen taken daily and to evaluate patient computer data collection.. Three hundred and seven patients were treated in a double blind, randomized multicenter study for 6 months. The first 4 weeks of treatment data were collected daily via patient operated computers in parallel with standard assessment at weekly visits to the clinics.. Daily patient data collection was more sensitive than weekly clinical assessments. Six months' compliance was 62% for tenoxicam and 67% for naproxen with comparable rates of withdrawal due to lack of efficacy or adverse drug experiences in both groups. The spectra of adverse drug events found were very similar for both drugs but the rates were higher than in short term studies.. Daily computer data collection by patients is superior to classical clinical evaluation in drug studies. The longterm compliance of tenoxicam and naproxen are comparable when treating patients with RA.

Topics: Age Distribution; Arthritis, Rheumatoid; Data Collection; Double-Blind Method; Female; Humans; Male; Microcomputers; Middle Aged; Naproxen; Patient Compliance; Piroxicam

The clinical relevance of piroxicam-beta-cyclodextrin (PBC) in the long-term treatment of osteoarthritis and rheumatoid arthritis is reviewed. Two hundred and twenty-five patients--one hundred with rheumatoid arthritis and one hundred and twenty five with osteoarthritis--were enrolled in a double-blind, randomised, controlled study versus piroxicam. Drugs were administered once-daily, for twelve weeks. The indices of efficacy (pain intensity, severity of inflammation, functional impairment evaluated at 0,2,4,8 and 12 weeks showed the good analgesic effect of piroxicam without significant differences between its two formulations. Tolerance appeared to be better in the group of patients treated with PBC than in the one treated with piroxicam. Both the incidence and severity of side effects were lower for patients treated with PBC. The majority of side effects were related to the gastrointestinal tract. The study suggests that PBC, used in the long term treatment of rheumatic diseases, improves the safety of piroxicam without affecting its efficacy. In another study, thirty patients with chronic osteoarthritis were randomly assigned to receive PBC or tenoxicam daily for eight weeks. Both drugs effectively reduced pain, inflammation, and functional limitation of the affected joints. Endoscopy revealed minor post-treatment mucosal lesions; these tended to be less severe with PBC than with tenoxicam. The clinical experience in the long-term treatment of rheumatic conditions indicates that the microencapsulation of piroxicam as piroxicam-beta-cyclodextrin has provided a new drug with a superior tolerability compared to the parent compound without affecting its high efficacy on the symptoms of the primary disease.

Topics: Adult; Aged; Aged, 80 and over; Antirheumatic Agents; Arthritis, Rheumatoid; beta-Cyclodextrins; Cyclodextrins; Double-Blind Method; Drug Combinations; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Osteoarthritis; Pain; Piroxicam

Tenoxicam 20 mg OD was compared with piroxicam 20 mg OD for patients with rheumatoid arthritis (RA). One hundred and two patients from 5 centers were enrolled: 51 in the tenoxicam group and 51 in the piroxicam group. Evaluation of the primary efficacy variables demonstrated no difference in efficacy between treatment groups. The overall incidence of adverse clinical/laboratory experiences was similar between treatment groups. Six patients discontinued the study because of gastrointestinal intolerance, 3 from each treatment group. Our study demonstrates that tenoxicam 20 mg OD and piroxicam 20 mg OD have similar efficacy and safety in patients with active RA.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Central Nervous System Diseases; Gastrointestinal Diseases; Humans; Middle Aged; Piroxicam

An open clinical evaluation was carried out in 736 African out-patients suffering from rheumatic and inflammatory disorders to assess the efficacy and tolerability of tenoxicam in relieving the signs and symptoms of their condition. On entry, all previous treatment was discontinued and patients received a simple daily dose of 20 mg tenoxicam orally for 15 days in the case of those with rheumatoid arthritis or tendinitis, or for 30 days in those with osteoarthritis. Paracetamol was allowed as a rescue analgesic. Subjective verbal scale assessments were used to determine levels of pain at rest, on movement and at night, sleep disturbance and functional incapacity, on entry and during treatment. At the end of the study period, both physicians and patients gave an overall opinion of the clinical response to tenoxicam, and patients were asked how their current compared with their previous treatment. The results showed that approximately 90% of patients had an excellent or good response to tenoxicam with marked improvement in all the signs and symptoms evaluated. Moreover, tenoxicam proved to be well tolerated, only a small number of patients reporting adverse events, mainly gastro-intestinal.

Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Bursitis; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Osteoarthritis; Pain Measurement; Piroxicam; Tendinopathy

A four year clinical trial was carried out in 20 patients suffering from rheumatoid arthritis (RA). In the first six months, they received in a double-blind design either tenoxicam or piroxicam 20 mg daily (10 cases per group), in addition to basis therapy with gold salts or D-penicillamine. From months 7-48 all patients received 20 mg tenoxicam daily. Evaluation of analgesic and anti-inflammatory activities showed a significant improvement with both compounds. This continued in the majority of patients for the next 3.5 years of the study, compared with the corresponding ones taken at baseline. Tolerability was found to be excellent to good.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Drug Therapy, Combination; Follow-Up Studies; Gold Sodium Thiomalate; Humans; Pain Measurement; Penicillamine; Piroxicam

Ten patients were recruited for this randomised double-blind pilot study to compare the efficacy and tolerance of tenoxicam 20 mg daily and piroxicam 20 mg daily in patients with rheumatoid arthritis (RA). The change in grip strength over an eight week study period was the primary efficacy variable and measurements were made using a digital pinch/grip analyser (MIE Medical Research Ltd.). There were no significant treatment differences in the change in grip strength (p greater than 0.2), although greater improvements in all efficacy parameters measured were achieved for patients receiving tenoxicam than those receiving piroxicam. Both treatments were well tolerated with few adverse events reported. Further studies with more patients are required to adequately assess whether there are any differences between treatments.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Double-Blind Method; Female; Hand; Humans; Isometric Contraction; Male; Middle Aged; Muscle Contraction; Pilot Projects; Piroxicam; Random Allocation

When rheumatic patients were questioned concerning the most desired attributes for a nonsteroidal anti-inflammatory drug (NSAID), the majority of replies related to tolerability. For example; low frequency of gastrointestinal side-effects, safety in the elderly, a low frequency of renal side-effects and a superior anti-inflammatory effect than other drugs available, were all regarded as important NSAID properties. This focus on safety issues by patients is probably due to problems experienced in recent years with non-steroidals on the market. In particular, the withdrawal of benoxaprofen was of major concern for both doctors and patients, and this together with other events over the last few years has not really contributed to an improvement of the relationship between rheumatic patients and doctors. The NSAIDs which have experienced problems and resulted in withdrawal from the market are as follows: benoxaprofen (Coxigon), indoprofen (Flosin), indomethacin (Osmosin, Osmogit), isoxicam (Pacyl) and oxyphenbutazone (Tanderil). Additionally, there were restrictions on the usage of phenylbutazone. This has resulted in the major authorities requiring more data concerning safety issues. The following paper will discuss an overview of the methodology which is now used in the development of a NSAID, using data and procedures obtained from the evaluation of tenoxicam.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Evaluation Studies as Topic; Female; Humans; Information Systems; Male; Middle Aged; Osteoarthritis; Piroxicam; Product Surveillance, Postmarketing; Sampling Studies

Fifty-eight patients, aged 48-87 years, with impaired renal function and mean initial creatinine clearance of 52.1 mls/min were recruited to a 12-week open study of tenoxicam 20 mg/day for osteoarthrosis or rheumatoid arthritis. Renal function was measured before and after a brief run-in period when patients discontinued all nonsteroidal anti-inflammatory drugs, taking paracetamol alone, prior to monthly monitoring thereafter. Fifty-four % of patients completed the study, the others being withdrawn from lack of efficacy (17%), adverse events (24%) or both (5%). During the run-in period the mean creatinine clearance of 28 patients completing the trial improved to 64.7 mls/min and then dropped to 57.9 mls/min during the course of 12 weeks treatment with tenoxicam. Serial analysis of haematological and biochemical safety parameters showed no drug-induced change of significance. Twenty-three% of patients felt worse and 45% better at the end of treatment. Seventeen patients withdrew because of adverse events. These were normally gastrointestinal and always unrelated to further deterioration in renal function. Tenoxicam, 20 mg/day, can be given safely for a period of at least three months in patients with mild or moderate renal impairment.

Topics: Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Creatinine; Drug Administration Schedule; Female; Humans; Kidney Diseases; Male; Metabolic Clearance Rate; Middle Aged; Multicenter Studies as Topic; Osteoarthritis; Piroxicam

A total of 1,328 patients with osteoarthritis or rheumatoid arthritis were entered into this double-blind, parallel group study of tenoxicam and piroxicam. The patient populations were well matched. An improvement was seen in pain on moving and at night in both groups and in both indications. Stiffness was also improved by both drugs, being most marked in the rheumatoid arthritis group. The primary efficacy variable was global assessment, and this showed tenoxicam to have slightly greater effect in osteoarthritis and the reverse in rheumatoid arthritis. There were no statistically significant differences in any of these findings. There were no significant differences in tolerance ratings, although the more serious gastrointestinal events occurred in the piroxicam group.

Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Double-Blind Method; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Osteoarthritis; Piroxicam

Clofazimine, at concentrations within the therapeutic range (0.01-5 micrograms/ml), stimulated human polymorphonuclear leucocytes (PMNL) to generate increased amounts of reactive oxidants (RO) when activated with the tripeptide leucoattractant N-formyl-L-methionyl-L-leucyl-L-phenylalanine (FMLP), calcium ionophore, phorbol myristate acetate and opsonised zymosan. Clofazimine per se did not activate the membrane-associated oxidative metabolism of PMNL, but rather primed these cells to hyperreact to the various stimuli. To investigate the therapeutic significance of these observations clofazimine was administered to patients with various chronic inflammatory diseases (lichen planus, discoid lupus erythematosus and rheumatoid arthritis) and generation of RO by FMLP-activated phagocytes was measured before and during clofazimine administration. A statistically significant potentiation of RO generation by FMLP-activated phagocytes was observed during clofazimine administration. Since RO are immunosuppressive and antimicrobial the therapeutic mechanisms of clofazimine may be related to pro-oxidative interactions of this agent with phagocytes.

Topics: Adult; Arthritis, Rheumatoid; Clofazimine; Dose-Response Relationship, Drug; Female; Humans; Immunosuppressive Agents; Lichen Planus; Lupus Erythematosus, Discoid; Male; Middle Aged; Neutrophils; Oxidation-Reduction; Phagocytes; Piroxicam; Superoxides

Tenoxicam, a new non-steroidal anti-inflammatory agent (NSAID) with a long half-life, has been evaluated in a series of nine clinical studies over the last five years. Early studies against naproxen in osteoarthrosis (OA) and against ibuprofen in rheumatoid arthritis (RA) suggested the drug was efficacious in both of these conditions. A series of faecal blood loss studies showed that the drug produced less gastrointestinal blood loss than aspirin and comparable blood loss to piroxicam. Comparisons of tenoxicam and piroxicam in OA and ankylosing spondylitis (AS) showed both drugs to be approximately equally efficacious. A pharmacokinetic study showed a half-life for tenoxicam of 45 h in synovial fluid when the half-life was 42 h in plasma. A single and multiple oral dose pharmacokinetic study of tenoxicam in the elderly showed no progressive accumulation with peak plasma levels of 2.6 micrograms/ml after the single dose and 12.4 micrograms/ml at steady state.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Humans; Osteoarthritis; Piroxicam

Topics: Activities of Daily Living; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Piroxicam; Time Factors

Topics: Activities of Daily Living; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Piroxicam; Random Allocation

Topics: Activities of Daily Living; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Humans; Piroxicam; Random Allocation

Topics: Activities of Daily Living; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Latex Fixation Tests; Male; Middle Aged; Piroxicam; Time Factors

Topics: Activities of Daily Living; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Piroxicam

A series of double-blind, parallel, clinical trials was carried out to assess the analgesic and anti-inflammatory effects of tenoxicam and to compare the efficacy and tolerance of this compound with those of piroxicam in patients suffering from osteoarthrosis, rheumatoid arthritis and ankylosing spondylitis. In equivalent once-daily dosage (20 mg), tenoxicam was found to be at least as effective as piroxicam in combating the symptoms of the above arthritic disorders and, even in relatively high dosages of 30 and 40 mg exhibited excellent tolerance, producing fewer adverse reactions than piroxicam. It is concluded that tenoxicam represents a valuable addition to the spectrum of anti-inflammatory agents.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Humans; Osteoarthritis; Piroxicam; Spondylitis, Ankylosing

Thirty patients were allocated in a double-blind study comparing piroxicam 20 mg to tenoxicam 20 mg. Both drugs were administered once daily, before breakfast, for a period of 6 months. Clinical evaluations were performed weekly during the first 6 weeks and then monthly. The following parameters were evaluated: Ritchie articular index, pain on movement, pain at rest, grip strength, functional status, and morning stiffness. Laboratory examinations were performed before, on the 42nd day and on the 6th month of therapy. Efficacy was considered favourable in 10 cases treated with tenoxicam and in 12 with piroxicam and poor in five treated with the former and in three with piroxicam. Three patients of each group presented side effects of slight intensity. Considering the good results seen in the patients receiving tenoxicam, the treatment was maintained in nine cases for a further period of 6 months. Eleven other patients from the piroxicam group also received tenoxicam for a further period of 6 months. The efficacy was maintained in all 20 patients. Regarding adverse reactions, one patient complained of abdominal pain in the twelfth month of therapy and another patient had a brief episode of meteorism in the ninth month.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Follow-Up Studies; Humans; Piroxicam

Seventy-nine patients with arthrosis (40) or rheumatoid arthritis (39) were included in an open, non-comparative multicentric study. All the patients were treated by rectal route with a suppository form of tenoxicam (20 mg/day) during 6 weeks (in the first 3 days the dose was increased to 40 mg). The drug was administered once daily at evening. Clinical evaluation was performed before treatment and thereafter every 2 weeks. In the patients with arthrosis the parameters evaluated for efficacy were: pain on movement, pain at rest, tenderness, spontaneous pain, pain after 1 day of normal activity, flexion, functional status, and time to walk 10 metres. For patients with rheumatoid arthritis the parameters were: articular index, duration of morning stiffness, functional status, spontaneous pain and pain when moving. Efficacy was considered excellent or good in 22 patients with rheumatoid arthritis and moderate or poor in 17. In the group of patients with arthrosis the results were excellent or good in 28 and moderate or poor in 12. Side effects occurred in five cases.

Topics: Administration, Rectal; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Arthritis, Rheumatoid; Clinical Trials as Topic; Female; Humans; Male; Middle Aged; Piroxicam; Suppositories

Topics: Adult; Aged; Anti-Inflammatory Agents; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Male; Middle Aged; Piroxicam; Thiazines

The comparative effects of tenoxicam and indomethacin are studied in 20 patients with rheumatoid arthritis. Ten evolutive parameters were studied after six weeks of treatment. Both drugs showed similar tolerance and efficacy on the evolution of the disease.

Topics: Adult; Aged; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Indomethacin; Locomotion; Male; Middle Aged; Pain; Piroxicam; Thiazines

Tenoxicam (Tilcotil, Mobiflex), a new non-steroidal anti-inflammatory agent of the oxicam group, has been compared at two dose levels (20 mg/day and 4 mg/day) to ibuprofen 800 mg t.d.s. in a double-blind parallel group study of four weeks duration in rheumatoid arthritis. Efficacy results showed no significant difference between the three treatments at two or four weeks though clinical assessments slightly favoured groups treated with tenoxicam in this 30 patient study. No patients withdrew from tenoxicam because of side-effects and there were no withdrawals because of inefficacy. The higher dose (40 mg) of tenoxicam was as well tolerated as the lower dose (20 mg) though plasma levels of tenoxicam suggested that at the lower dose this drug had barely reached optimum plasma levels in a study of relatively short duration.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Ibuprofen; Male; Middle Aged; Piroxicam

This research tries to determine the difference between granular tenoxicam (Tilcotil Roche) and other non-steroidal antiinflammatory drugs administered to patients with rheumatoid arthritis. The research comprised 143 patients with rheumatoid arthritis divided in two groups (71 + 72). As regards patients with rheumatoid arthritis, granular tenoxicam of a twenty-miligram dose daily showed both a good clinical effectiveness and a good bearing in long-term medicine taking, rarely causing gastrointestinal side effects, compared to other nonsteroidal antiinflammatory drugs in peroral taking.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Female; Gastrointestinal Diseases; Humans; Male; Middle Aged; Piroxicam

Using a modified Boyden chambers method, polymorphonuclear leucocyte (pmnl) random migration and chemotactic responsiveness were compared in 20 rheumatoid arthritis patients with that of 10 healthy controls receiving tenoxicam. Random migration and chemotaxis of neutrophils were examined before drug administration, following 2 hours and 7 days of drug administration and one week after the end of the 7-day-administration of this compound. There was no statistically significant difference between the chemotactic migration of neutrophils in healthy volunteers and patients with RA. The mean chemotactic value in patients with RA and healthy controls was significantly low at 2 hours after drug administration when compared with that before drug administration (p < 0.01). The comparison of the decreases in mean chemotactic values in patients with RA and healthy controls showed no statistical difference. At the end of 7-day-administration, neutrophil chemotaxis was significantly decreased in patients with RA (p < 0.01); however, in healthy controls it was decreased as well, but statistical difference could not be obtained. One week after drug withdrawal, neutrophil chemotaxis turned to baseline values in both groups. We suggest that tenoxicam is a potent inhibitor of neutrophil chemotaxis.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Chemotaxis, Leukocyte; Female; Humans; Male; Middle Aged; Neutrophils; Piroxicam

It has been shown previously that cell surface bound fibrinolytic activity on human monocytes is significantly increased in patients with rheumatoid arthritis (RA) as compared to monocytes from healthy volunteers. Studies on the modulation of receptor-bound urokinase type plasminogen activator on peripheral blood monocytes of patients with RA showed that tenoxicam, a non-steroidal antiinflammatory drug with long half life and good tissue permeability, is able to downregulate the total number of urokinase receptors. Furthermore the degree of endogenous occupation of the urokinase receptor was significantly decreased in post-treatment monocytes. These data provide evidence that the non-steroidal antiinflammatory drug tenoxicam is able to downregulate cell bound fibrinolytic activity, known to contribute to pronounced degradation of cartilage and connective tissue in patients with RA.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Down-Regulation; Female; Humans; Male; Middle Aged; Monocytes; Piroxicam; Receptors, Cell Surface; Receptors, Urokinase Plasminogen Activator; Urokinase-Type Plasminogen Activator

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Female; Humans; Piroxicam; Research Design; Sleep Wake Disorders

Thirteen patients with rheumatoid arthritis (mean +/- SD age 55.8 +/- 10.5 years) received 20 mg of tenoxicam daily for 90 days following a 3-7 day "washout" period and 4 days of placebo treatment. Clinical evaluations were conducted at the end of the washout period and at monthly intervals thereafter. All-night polysomnography was performed in a sleep laboratory during the last 2 days of placebo treatment and on days 13, 14, 89, and 90 of tenoxicam treatment. Although there was improvement in the patients' clinical condition, there were no treatment-related changes in any of the sleep parameters. Eight of the 13 patients, however, were found to have primary sleep disorders. Four had periodic leg movements during sleep, 3 had sleep apneas, and 1 had a combination of both disorders. The implications of these findings in the treatment of sleep disorders in patients with rheumatoid arthritis are discussed.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Humans; Piroxicam; Restless Legs Syndrome; Severity of Illness Index; Sleep Apnea Syndromes; Sleep Wake Disorders

The authors present the results of six months treatment with Tenoxicam (Tilcotil) in 30 patients with active rheumatoid arthritis. In no instance was it necessary to discontinue treatment, only one female patient complained of transient vertigo. During the final evaluation of the therapeutic effect as regards painfulness, sensitivity on palpation, oedema, restriction of movements, the author did not observe a satisfactory effect only in 8.5-24%. As regards hand grip, 20 m walk and consumption of analgesics the effect was also very satisfactory. Only four patients used occasionally Paracetamol or Alnagon, 1-2 tablets per day. The results achieved with this treatment indicate that it is a very good preparation suited for prolonged therapy of active rheumatoid arthritis, incl. patients of advanced age. Tenoxicam is particularly suited for a single dose per day (20 mg). It can be recommended also combined with gold therapy and treatment with antimalaric drugs.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Female; Humans; Male; Middle Aged; Piroxicam

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Humans; Osteoarthritis; Piroxicam

Every doctor faced with the task of testing a drug is well aware of the difficulty of making his or her results objective. In designing test procedures, methods need to be found which are unaffected by the subjective views of either the testing doctor or the patients undergoing the treatment. This study was designed taking this into account, using scintigraphic joint measurements in patients with chronic rheumatoid arthritis (RA) to record comparable data. Even this method, however, despite its indisputable scientific accuracy, requires clinical interpretation.

Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Diagnosis, Computer-Assisted; Disability Evaluation; Female; Humans; Joints; Male; Middle Aged; Piroxicam; Radionuclide Imaging; Sodium Pertechnetate Tc 99m

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Humans; Piroxicam

Tenoxicam milk formulation is a new galenical form of a non-steroidal anti-inflammatory drug (NSAID). It is especially suitable for patients having compliance problems or difficulty in swallowing tablets. This formulation has proved to be a useful alternative oral treatment in various rheumatic conditions. Combining rapid onset of action and maintenance of active plasma levels, tenoxicam achieved good clinical efficacy and tolerability in the vast majority of the patients studied.

Topics: Administration, Oral; Animals; Anti-Inflammatory Agents, Non-Steroidal; Arthritis; Arthritis, Rheumatoid; Female; Humans; Male; Milk; Osteoarthritis; Pain Measurement; Periarthritis; Piroxicam

Single oral doses of 40 mg of the nonsteroidal antiinflammatory drug, tenoxicam, were given to four patients (three with rheumatoid arthritis, one with osteoarthritis). The concentrations of the drug in synovial fluid and plasma were measured by a specific high-performance liquid chromatography method. The unbound fractions of the drug in both fluids were determined at pH 7.4 and 37 degrees C by equilibrium dialysis. The possible influence of the pH on the protein binding was also assessed. The total concentration time curves in plasma and synovial fluid were fitted to linear oral 1 and 2 compartment body models with an additional synovial fluid compartment connected to the central compartment. The unbound fractions of drug in synovial fluid and plasma were on average 0.015 and 0.011, respectively: not significantly different from each other. The protein binding of tenoxicam was pH dependent with increased free fractions at pH values less than 7.4. The average peak concentrations of tenoxicam in plasma and synovial fluid were 4.3 and 1.4 micrograms/ml, respectively. The mean ratio of the areas under the total concentration time curves in synovial fluid and plasma was 0.42, which corresponded to the steady state of equilibrium ratio of the total drug concentrations in the two body fluids. Two hypotheses were tested: hypothesis I assuming that equilibration across the synovial tissue takes place between the unbound, unionized tenoxicam molecules; hypothesis II assuming that equilibration across the synovial tissue is established between the unbound (unionized + ionized) tenoxicam molecules. Based on the available evidence hypothesis II was rejected.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Female; Humans; Hydrogen-Ion Concentration; Male; Middle Aged; Osteoarthritis; Piroxicam; Protein Binding; Synovial Fluid

Tenoxicam is a new non-steroidal anti-inflammatory drug with a long half-life. Since such drugs may be particularly prone to accumulate in elderly patients, a group of the population in which anti-inflammatory agents are most commonly prescribed, we have studied the pharmacokinetics of tenoxicam in 18 patients (age range 62-87 years) with osteoarthrosis or rheumatoid arthritis. A pharmacokinetic profile was performed after a single 20 mg oral dose. Patients then took regular medication until they had reached steady-state for chronic dosing (20 mg/day) when a further pharmacokinetic profile was performed. Approximately five-fold accumulation was found at steady-state (mean peak plasma level 2.6 micrograms/ml for a single dose against 12.4 micrograms/ml at steady-state). Twenty percent of the dose was eliminated in the first dose interval. Mean pre-dose plasma level at steady-state was 9.6 micrograms/ml with a coefficient of variation of 11%. Serial haematological and biochemical estimations during the study showed no evidence of drug toxicity.

Topics: Administration, Oral; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Drug Administration Schedule; Female; Humans; Kinetics; Male; Middle Aged; Osteoarthritis; Piroxicam