mobiflex and Osteoarthritis

To obtain a better quantitative and qualitative estimate of the effect of tenoxicam (Tx) compared to piroxicam (Px), diclofenac (Dcl) and indomethacin (Ind) in the treatment of osteoarthritis (OA).. Relevant studies were identified using computerized Medline search, manual search of cited references and correspondence with investigators, colleagues and the manufacturer of Tx. Once the studies were selected and chosen on the basis of predetermined methodologic criteria, the required data were extracted by 2 authors, independently. Eighteen studies met the required eligibility criteria. Meta-analyses were undertaken on 12 studies of Tx vs Px, 3 studies of Tx vs Dcl, and 2 studies of Tx vs Ind. Efficacy was measured in 2 ways: (1) physician global rating scale and (2) pain scale. Safety was measured in 3 ways: (1) physician global rating scale, (2) number of patients with adverse events, and (3) dropouts due to adverse events.. The following findings of the meta-analysis were statistically significant: In Tx vs Px comparisons, efficacy-(1), safety-(1) and safety-(3) were all better with Tx; in Tx vs Ind comparisons, safety-(1) and safety-(2) were better with Tx. All other findings showed no statistically significant differences between Tx and the comparison drug.. Compared to Px, Tx performs better on physician assessment of efficacy and tolerability, but the other comparisons remain inconclusive. Compared to Dcl, there appears not to be a difference. Compared to Ind, Tx is safer.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Female; Humans; Indomethacin; Male; Middle Aged; Osteoarthritis; Piroxicam; Random Allocation

A meta-analysis was done with the final data from three trials that provided the first results relating to efficacy and safety of the new sustained-release (SR) formulation of etodolac versus established nonsteroidal anti-inflammatory drugs (NSAIDs) in the treatment of osteoarthritis (OA) of the knee. The studies were 4-week, double-blind, randomized, parallel-group comparisons of etodolac SR 600 mg (119 patients) against diclofenac SR 100 mg (54 patients), tenoxicam 20 mg (46 patients), or piroxicam 20 mg (18 patients). The primary efficacy parameters (assessed after 2 and 4 weeks of treatment) were physicians' and patients' overall assessments of patients' condition, night pain, and pain intensity. All patients had radiographic and clinical evidence of OA of the knee. For the meta-analysis, the data from the individual etodolac SR studies were pooled and compared with the pooled data for diclofenac SR, tenoxicam, and piroxicam. The homogeneity of the treatments across studies and the changes from baseline between groups were tested using a Cochran-Mantel-Haenszel test and an analysis of variance, including "study," "treatment," and "center within treatment" effects and their interaction. The analysis for the efficacy parameters was based on the final assessment during therapy (last visit). At baseline, the two treatment groups were comparable. Improvement rates were high in both groups (range, 68-81%), indicating that treatments were effective for most patients. No significant treatment difference was observed for the patients' overall assessment, night pain, or pain intensity. Both etodolac SR and the reference preparations were well tolerated. No clinically significant changes were noted in the laboratory data.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Aged; Aged, 80 and over; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Delayed-Action Preparations; Diclofenac; Double-Blind Method; Etodolac; Female; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Pain; Piroxicam; Random Allocation

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

Temporomandibular joint osteoarthritis (TMJ-OA) is a degenerative disease and manifests itself with pain and limitation of movement in the jaws. Arthrocentesis alone or in combination with intraarticular injections is one of the most commonly used treatment methods in these patients. The aim of the study is to examine the effectiveness of arthrocentesis plus tenoxicam injection and to compare it with arthrocentesis alone in patients with TMJ-OA.. Thirty patients with TMJ-OA who were treated randomly with either arthrocentesis plus tenoxicam injection (TX group) or arthrocentesis alone (control group) were examined. Maximum mouth opening (MMO), visual analog scale (VAS) pain values, and joint sounds were the outcome variables, which were evaluated at pre-treatment and at 1, 4, 12, and 24 weeks after treatment. Statistical significance was set at p < 0.05.. The gender distribution and mean age were not significantly different between the two groups. Pain values (p < 0.001), MMO (p < 0.001), and joint sounds (p < 0.001) improved significantly in both groups. However, there was no significant difference between the groups in terms of outcome variables [pain (p = 0.085), MMO (p = 0.174), joint sounds (p = 0.131)].. Arthrocentesis plus tenoxicam injection showed no better outcomes in terms of MMO, pain, and joint sounds compared with arthrocentesis alone in patients with TMJ-OA.. Injection of Tenoxicam Versus Arthrocentesis Alone in the Treatment of Temporomandibular Joint Osteoarthritis, NCT05497570. Registered 11 May 2022. Retrospectively registered, https://register.. gov/prs/app/action/SelectProtocol?sid=S000CD7A&selectaction=Edit&uid=U0006FC4&ts=6&cx=f3anuq.

Topics: Arthrocentesis; Humans; Hyaluronic Acid; Injections, Intra-Articular; Osteoarthritis; Pain; Range of Motion, Articular; Temporomandibular Joint; Temporomandibular Joint Disorders; Treatment Outcome

The aim of this study was to compare the efficacy of intra-articular injections of three different agents with well known anti-inflammatory properties.. Between April 2010 and January 2013 a total of 100 patients who were diagnosed as temporomandibular joint disorder in the Department of Otolaryngology at Bozok University School of Medicine were prospectively studied. Patients with symptoms of jaw pain, limited or painful jaw movement, clicking or grating within the joint, were evaluated with temporomandibular CT to investigate the presence of cartilage or capsule degeneration. In the study group there were 55 female and 45 male patients who were non-responders to conventional anti-inflammatory treatment for TMJ complaints. The patients were randomly divided into four groups consisting of a control group and three different groups who underwent intra-articular injection of one given anti-inflammatory agent for each group. We injected saline solution to intra-articular space in the control group. Of three anti-inflammatory agents including hyaluronic acid (HA, Hyalgan intra-articular injection, Sodium hyaluronate 10 mg/ml, 2 ml injection syringe, Bilim Pharmaceutical Company, Istanbul, Turkey); betamethasone (CS, Diprospan flacon, 7.0 mg betamethasone/1 ml, Schering-Plough Pharmaceutical Company, Istanbul, Turkey) and; tenoxicam (TX, Tilcotil flacon, 20 mg tenoxicam/ml, Roche Pharmaceutical Company, Istanbul, Turkey) were administered intra-articularly under, ultrasonographic guidance. Following the completion of injections the, changes in subjective symptoms were compared with visual analogue scales, (VAS) scores at 1st and 6th weeks' follow-up visits between four groups.. The HA group did significantly better pain relief scores compared to the, other groups at 1st and 6th weeks (p < 0.05). TX and CS groups' pain scores were better than control group values (p < 0.05, for both agents). The pain relief effect of TX was noted to decrease significantly between the 1st and 6th week (p < 0.05) (Fig. 1). We did not observe the same pattern in HA, CS and control (saline) groups between 1st and 6th week (p > 0.05).. We found that HA produced better pain relief scores when compared to the other anti-inflammatory agents studied. The main disadvantage of HA is its relatively higher cost. Additionally it does not have a reimbursement status by state or private health insurance systems in Turkey. Despite the lower VAS scores, intra-articular TX and CS may be assessed as more economic alternatives to intra-articular HA injections.

Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Betamethasone; Double-Blind Method; Female; Follow-Up Studies; Humans; Hyaluronic Acid; Injections, Intra-Articular; Male; Middle Aged; Osteoarthritis; Osteophyte; Pain Measurement; Piroxicam; Prospective Studies; Temporomandibular Joint Disc; Temporomandibular Joint Disorders; Tissue Adhesions; Treatment Outcome; Ultrasonography; Viscosupplements; Young Adult

Etodolac SR is the sustained-release formulation of etodolac, an effective anti-inflammatory drug used in the treatment of various rheumatic diseases. The efficacy and safety of etodolac SR were compared with those of tenoxicam in 120 elderly patients with radiographic and clinical evidence of active osteoarthritis (OA) of the knee and/or the hip. This was a double-blind, double-dummy, randomized, parallel-group, multicentre study conducted at 4 Italian rheumatic-disease units. Sixty patients received 600 mg of etodolac SR once daily (u.i.d.) for 8 weeks; the remaining 60 patients received 20 mg of tenoxicam u.i.d. Significant improvements in all 6 efficacy parameters (viso-analogic scale of the global pain, pain at active movements, night pain, joint tenderness, joint motility, and Lequesne's algofunctional index) were observed within each of the treatment groups even after the first 2 weeks of therapy. There were no significant differences in the therapeutic response between the two groups for any efficacy parameters. Adverse reactions, mostly regarding the G-I tract, were significantly more frequent in the tenoxicam group than in the etodolac group: 23.3% vs 8.3% respectively, albeit in the majority of the cases they were not considered to be so severe as to cause the interruption of the study. There were no clinically important changes from baseline in laboratory tests performed during the study. Endoscopy of the upper G-I tract was performed both at baseline and after 8 weeks of therapy in 30 patients per treatment group in order to obtain a reliable comparative evaluation of the G-I safety of the two drugs. Both drugs were found to be well tolerated; only 2 ulcers were observed after therapy in both groups, but minor lesions were more frequently detected in the mucosa of the stomach in the patients who received tenoxicam. The cumulative endoscopic index that reflected both the erosive and the haemorrhagic lesions found in the stomach taken as a whole was significantly (p < 0.03) higher after therapy in the tenoxicam group. These results indicate that 600 mg of etodolac SR u.i.d. for 8 weeks is as effective as 20 mg of tenoxicam u.i.d. in the treatment of OA of the knee and/or of the hip. Both the overall and the G-I specific safety profiles were found to be more favourable in patients treated with etodolac SR. Renal function was not substantially affected in either treatment group.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Aged; Analysis of Variance; Anti-Inflammatory Agents, Non-Steroidal; Delayed-Action Preparations; Digestive System; Double-Blind Method; Endoscopy; Endoscopy, Gastrointestinal; Etodolac; Female; Hip Joint; Humans; Knee Joint; Male; Osteoarthritis; Pain; Piroxicam; Radiography

To compare signal versus aggregate measurement strategies using the VA3.0S version of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis (OA) Index.. Seventy patients with OA of the knee were asked to identify a signal item for each of the 3 dimensions of the WOMAC OA Index at baseline and termination of a 12-week, double blind, randomized, controlled trial.. The signal method detected statistically significant alterations in health status at relatively small sample sizes and with a relative efficiency close to or at unity. In addition to a low prevalence of deterioration in nonsignal items, we observed some inconsistency in signal selection.. Signal methods of measurement may provide an alternative approach to outcome measurement provided issues of nonsignal deterioration and the consistency of signal selection can be addressed.

Topics: Aged; Data Interpretation, Statistical; Diclofenac; Double-Blind Method; Health Status Indicators; Humans; Knee Joint; Osteoarthritis; Pain; Piroxicam; Severity of Illness Index; Surveys and Questionnaires; Treatment Outcome

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

To conduct the first Canadian study of the comparative efficacy and safety of tenoxicam and diclofenac in patients with primary osteoarthritis (OA) of the knee.. Tenoxicam 20 mg per os once daily (po od) was compared to diclofenac (Voltaren) 50 mg per os 3 times a day (po tid) in a 12-week, double blind, randomized, controlled, multicenter, parallel trial. The primary outcome measure was the pain dimension of the WOMAC OA Index. Following an initial screening visit and a 3 to 7 day NSAID-free washout period (i.e., baseline), patients were assessed at Weeks 2, 4 and 12; assessments including some 15 efficacy variables and safety variables.. Ninety-eight patients [tenoxicam (n = 48), diclofenac (n = 50)] participated in the trial. Statistically significant (p < or = 0.05) improvements in all 3 dimensions of the WOMAC OA Index and six efficacy variables were noted in both treatment groups. No significant between drug differences were noted on any efficacy variable. Significantly fewer patients reported adverse events in the tenoxicam group (21 vs 33, p = 0.03).. Tenoxicam is efficacious and well tolerated in patients with OA of the knee. In this group of patients it was similar in efficacy and superior in tolerability to diclofenac 150 mg/day (50 mg tid). Thus the benefit/risk ratio of tenoxicam was superior to that of diclofenac in this study.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Drug Tolerance; Female; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Piroxicam

A four-week open study was carried out to evaluate the efficacy and tolerability of droxicam, a new NSAID, in the treatment of painful osteoarthritis (OA). The results were compared with those obtained treating a similar group of patients with tenoxicam, at the same dosage of 20 mg/day, orally administered. The study showed that both drugs are effective in treating OA, with a mild predominance of droxicam in decreasing pain, functional limitation and chronic inability score. Tolerability was excellent or good in over 70% of patients and only one subject of each group was dropped out for severe side-effects. According to the Authors droxicam has shown to be an effective analgesic and anti-inflammatory agent as judged by its efficacy on pain relief and joint mobility in OA.

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

After a brief physiopathological research about iontophoresis applications, the authors examine this treatment by two drugs (Tenoxicam and acetylsalicylic acid) in a group of patients suffering from painful osteoarthritis. They came to the conclusion that the treatment is efficacious with both substances though realising a quicker analgesic result in the group treated with tenoxicam.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Female; Humans; Iontophoresis; Male; Middle Aged; Osteoarthritis; Piroxicam; Time Factors

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

Preliminary data concerning the efficacy and tolerability of tenoxicam in a large, multicenter Italian study are presented. In many centres 625 patients (31% of the total) have been evaluated: 283 patients with osteoarthrosis and 342 with extra-articular rheumatism completed the study. Efficacy of tenoxicam (20 mg/die) was stated as equivalent or superior to reference drugs (diclofenac 100 R, piroxicam 20 mg). Tolerability profile has been generally good; tenoxicam, in particular showed the lowest incidence of side effects (7.4%).

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Method; Female; Humans; Male; Middle Aged; Osteoarthritis; Phenylpropionates; Piroxicam; Rheumatic Diseases

In a randomized, double-blind comparative study involving a total of 1630 outpatients, tenoxicam, a new nonsteroidal anti-inflammatory drug belonging to the oxicam group, piroxicam and diclofenac retard were tested for their efficacy und tolerability in the treatment of osteoarthritis and extra-articular rheumatism. Single doses of 20 mg tenoxicam, 20 mg piroxicam or 100 mg diclofenac sodium retard were administered daily. Tenoxicam was found to be as effective as piroxicam and diclofenac-sodium retard in treating degenerative and extra-articular rheumatic disorders of the musculoskeletal system. When baseline values were compared with values obtained at all subsequent examinations, all evaluation parameters for all three substances showed improvement. In analyses of frequency, degree of severity and type of undesired effects tenoxicam proved to be superior to the reference drugs. This was particularly evident from an improved GI and CNS tolerance and a lower rate of withdrawal from treatment. Tenoxicam has a favourable risk-benefit ratio and can be recommended for the treatment of chronic pain due to inflammation resulting from degenerative and extra-articular rheumatic disorders of the musculoskeletal system.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Delayed-Action Preparations; Diclofenac; Double-Blind Method; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Osteoarthritis; Piroxicam; Random Allocation; Rheumatic Diseases

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

A double-blind multicentre study was conducted to compare the efficacy and safety of tenoxicam and ketoprofen in the treatment of osteoarthritis (OA). The study comprised 307 patients and the treatment period was 12 weeks. One-hundred and fifty-five patients received 20 mg tenoxicam once-daily and 152 patients received 100 mg ketoprofen b.i.d. Seventy-seven patients were prematurely withdrawn; 32 patients in the tenoxicam group and 45 in the ketoprofen group (p less than 0.05). There were only small insignificant differences in the efficacy parameters with the exception that significantly more patients in the tenoxicam group took paracetamol tablets during treatment. Adverse events developed in 29.0% of the patients on tenoxicam and in 47.3% of the patients on ketoprofen, this difference was statistically significant (p less than 0.05). The adverse events were predominantly from the gastrointestinal tract and the central nervous system. No serious side-effects occurred and the laboratory parameters showed no clinically relevant changes. The investigator's overall impression of treatment showed no significant difference between groups. Excellent or good results were judged in 55.2% of the patients on tenoxicam and in 62.1% on ketoprofen (p greater than 0.05). Tenoxicam appears to have a reasonable balance between efficacy and side-effects in the treatment of OA.

Topics: Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Female; Humans; Ketoprofen; Male; Middle Aged; Multicenter Studies as Topic; Osteoarthritis; Pain Measurement; Piroxicam; Randomized Controlled Trials as Topic

In a randomised, double-blind comparative study involving a total of 1,630 out-patients, tenoxicam (a new non-steroidal anti-inflammatory drug belonging to the oxicam group), piroxicam and diclofenac retard were tested for their efficacy and tolerability in the treatment of osteoarthritis (OA) and extra-articular rheumatism (EAR). Single doses of 20 mg tenoxicam, 20 mg piroxicam or 100 mg diclofenac sodium retard were administered daily. Tenoxicam was found to be as effective as piroxicam and diclofenac sodium retard in the treatment of degenerative and extra-articular rheumatic disorders of the musculo-skeletal system. When baseline values were compared with values obtained at all subsequent examinations, all evaluation parameters for all three substances showed improvement. In analyses of the frequency, degree of severity and type of undesired effects, tenoxicam proved to be superior to the reference drugs. This was particularly evident from an improved gastrointestinal and central nervous system (CNS) tolerance and a lower rate of withdrawal from treatment. Tenoxicam has a favourable risk/benefit ratio and can be recommended for the treatment of chronic pain due to inflammation resulting from degenerative and extra-articular rheumatic disorders of the musculoskeletal system.

Topics: Aged; Ambulatory Care; Anti-Inflammatory Agents, Non-Steroidal; Delayed-Action Preparations; Diclofenac; Double-Blind Method; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Osteoarthritis; Periarthritis; Piroxicam; Polymyalgia Rheumatica; Randomized Controlled Trials as Topic

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

The effects of a nocturnal nonsteroidal anti-inflammatory drug (tenoxicam) on twelve male osteoarthritic patients were investigated in a randomised, double-blind, placebo-controlled, cross-over study. Tenoxicam produced no significant changes in any of the areas evaluated which included electroencephalographic (EEG) sleep, subjective sleep, pain and early morning stiffness. The selection of patients may have contributed to this unexpected result. There was no evidence to suggest that tenoxicam caused any unwanted side-effects or affected early morning psychomotor performance. The use of the sleep EEG as an objective pain measure is discussed.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Drug Administration Schedule; Electroencephalography; Humans; Male; Middle Aged; Osteoarthritis; Pain Measurement; Piroxicam; Psychomotor Performance; Randomized Controlled Trials as Topic; Sleep Stages

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

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; Aged; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Female; Hip Joint; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Piroxicam; Time Factors

Topics: Activities of Daily Living; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Hip Joint; Humans; Knee Joint; Osteoarthritis; Piroxicam; Time Factors

The long-acting antiphlogistics tenoxicam (Ro 12-0068, Tilcotil) and piroxicam in single daily oral doses of 20 mg are compared in a double-blind, group-comparative, randomised trial planned to last for five years. Results of 12 months' treatment of 108 patients with osteoarthritis of the hip or knee have been reported. This interim analysis focuses mainly on the 12 to 24 month interval. The clinical improvements obtained within the first 12 months persisted during the second year in the 55 patients remaining on treatment. After 24 months, 53 patients had been withdrawn prematurely, three-quarters because of inefficacy or intolerance. Only six patients were withdrawn between 12 and 24 months, three for lack of efficacy, two for side-effects and one for reasons unrelated to therapy. There was no difference between the treatment groups with regard to incidence, time or reason for withdrawal, and only small, insignificant differences in efficacy and tolerability. This trial shows that long-term treatment of osteoarthritis with tenoxicam and with piroxicam is beneficial. Once efficacy and tolerability have been established, maintenance of therapy is feasible.

Topics: Activities of Daily Living; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Female; Hip Joint; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Piroxicam; Random Allocation; Time Factors

Topics: Activities of Daily Living; Aged; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Piroxicam; Time Factors

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Diclofenac; Double-Blind Method; Female; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Piroxicam

A double-blind, parallel group study was carried out in 30 patients with osteoarthrosis to compare the efficacy and tolerance of tenoxicam (40 mg/day) and piroxicam (40 mg/day) given over a period of 4 weeks. All had previously been treated with a variety of non-steroidal anti-inflammatory agents and/or analgesics. Patients were allocated at random to one or other treatment group. Clinical and laboratory assessments were made on entry and after 2 and 4 weeks of treatment. The results showed that both drugs improved general pain, the improvement being somewhat greater with tenoxicam. Little change was noted in other symptoms with either treatment. Side-effects reported were mainly gastro-intestinal. Six of the 15 piroxicam-treated patients stopped treatment because of adverse reactions, 1 because of treatment failure and 1 because he preferred previous treatment. Three of the 15 tenoxicam-treated patients discontinued because of adverse reactions. The remaining patients (7 on piroxicam and 12 on tenoxicam) elected at the end of the trial period to remain on their respective treatment instead of their previous medication.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Drug Tolerance; Female; Gastrointestinal Diseases; Humans; Male; Middle Aged; Osteoarthritis; Piroxicam; Random Allocation; Thiazines; Time Factors

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

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Double-Blind Method; Female; Hip Joint; Humans; Knee Joint; Male; Middle Aged; Osteoarthritis; Piroxicam

Tenoxicam (TILCOTIL, MOBIFLEX) 40 mg/day has been compared to piroxicam 40 mg/day in a double-blind, parallel group study of 4 weeks duration in 30 patients with osteoarthrosis. Both drugs were well tolerated, tenoxicam slightly better than piroxicam. Both drugs improved general pain, improvement being greater with tenoxicam. Little improvement of other symptoms was seen with either treatment. At the end of the study, 12 tenoxicam-treated patients and seven piroxicam-treated patients elected to remain on their respective treatment.

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

The efficacy and tolerability of tenoxicam, given as a 20 mg tablet once daily for 24 months, were studied in two groups of patients. Group I (N = 29) with gonarthrosis and coxarthrosis, and Group II (N = 30) with lumbarthrosis. Parameters of pain were measured at each monthly and subsequent two-monthly consultations. In Group I, there was improvement in all parameters, especially nocturnal and end-of-day pain, and after 24 months pain had diminished in 82% of patients. Group II also showed improvement in all parameters, especially nocturnal pain and pain on waking, and although no patient's symptoms completely disappeared, 90% showed a clinical effect. Few side effects were observed; seven patients discontinued therapy for reasons unconnected with tenoxicam. Tenoxicam is well-suited to the long-term treatment of these degenerative diseases. The dose was sufficient to produce a beneficial effect in most cases, and even higher doses did not produce side effects.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Female; Follow-Up Studies; Humans; Male; Middle Aged; Osteoarthritis; Piroxicam

Topics: Adult; Aged; Anti-Inflammatory Agents; Arthritis; Double-Blind Method; Female; Humans; Male; Middle Aged; Osteoarthritis; Piroxicam; Thiazines

The main aim is to develop transcutaneous tenoxicam (TNX) loaded vesicles to control osteoarthritis (OA) without common side effects. Different vesicles were prepared by the emulsification technique, where poloxamer and glyceryl monooleate used for cubosomes. Then, hyalcubosomes were prepared by adding sodium hyaluronate to cubosomes components. Different characterization techniques were used. The selected formulations were tested using an ex-vivo permeation study to evaluate the ability to penetrate and retained in skin layers. Also, in-vitro cell studies using human skin fibroblasts were evaluated the safety of the formulation. The anti-inflammatory efficiency was tested using an in-vivo carrageenan-induced rat paw edema model. Finally, the efficiency to control OA symptoms was tested on three patients with a medical history of knee OA. Results confirmed the successful development of spherical cubosomes with particle size <250 nm, -14.5 mV, high entrapment efficiency percentage (>90%). Moreover, the addition of sodium hyaluronate to selected cubosomes improved viscosity and spreadability. Permeation study confirmed drug penetration and deposition. Cell studies proved the safety of the selected formulation. The animal model showed high anti-inflammatory activity. Finally, the preliminary clinical study demonstrates the potential efficacy and safety of the formulation in controlling OA symptoms over 8 weeks of therapy.

Topics: Administration, Cutaneous; Animals; Humans; Osteoarthritis; Particle Size; Piroxicam; Poloxamer; Rats

1. As nonsteroidal anti-inflammatory drugs may impair the ability of the chondrocyte to repair its damaged extracellular matrix, we explored the changes in the metabolism of newly synthesized proteoglycan (PG) and hyaluronan (HA) molecules produced by tenoxicam and aspirin in human normal cartilage explants and in osteoarthritic (OA) cartilage from age-matched donors. 2. Explants were sampled from the medial femoral condyle and were classified by use of Mankin's histological-histochemical grading system. Cartilage specimens were normal in 10 subjects, exhibited moderate OA (MOA) in 10 and had severe OA (SOA) in 10. 3. Cartilage explants were pulsed with [3H]-glucosamine and chased in the absence and in the presence of either aspirin (190 micrograms ml-1) or tenoxicam (4-16 micrograms ml-1). After papain digestion, the labelled chondroitin sulphate ([3H]-PGs) and HA([3H]-HA) molecules present in the tissue and media were purified by anion-exchange chromatography. 4. In normal cartilage as well as in explants with MOA and SOA aspirin reduced more strongly PG and HA synthesis than the loss of [3H]-HA and [3H]-PGs. 5. In normal cartilage, tenoxicam did not affect PG metabolism whereas it reduced HA synthesis in a dose-dependent manner and did not change or even increased the net loss of [3H]-HA. In contrast, in OA cartilage, tenoxicam produced a stronger reduction in the loss of [3H]-PGs than in PG synthesis and this decrease occurred at lower concentrations in cartilage with SOA (4-8 micrograms ml-1) than in cartilage with MOA (8-16 micrograms ml-1). In cartilage with MOA, the metabolic balance of HA was unaffected by tenoxicam whereas in cartilage with SOA, the drug decreased the loss of [3H]-HA and concomitantly did not change or even increased HA synthesis.6. The data obtained in short-term in vitro cultures indicate that aspirin may produce OA-like changes in normal cartilage and is likely to worsen the disease process in OA tissue. On the other hand, although tenoxicam may reduce the HA content of normal cartilage, and, in so doing, may produce OA-like lesions, this drug should not per se accelerate joint failure in OA.

Topics: Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Aspirin; Cartilage, Articular; Chondroitin; Humans; Hyaluronic Acid; In Vitro Techniques; Middle Aged; Osteoarthritis; Piroxicam; Proteoglycans

The authors report their experience with short-term (10 days) tenoxicam treatment in 20 patients with osteoarthritis at various localizations. The drug was administered at the following dosages: 20 mg twice daily for the first two days, and 20 mg daily for the following 8 days. Treatment proved effective in controlling pain and functional impairment. No dropouts due to side effects nor significant changes of laboratory parameters were observed. Therefore, tenoxicam may be considered an effective and well tolerated non steroid antiinflammatory agent for the treatment of active stages of osteoarthritis.

Topics: Aged; Anti-Inflammatory Agents, Non-Steroidal; Drug Tolerance; Female; Follow-Up Studies; Humans; Male; Osteoarthritis; Piroxicam; Time Factors

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