ABSTRACT
The present double-blind, placebo-controlled study was conducted to compare the safety and efficacy of tenidap in patients with rheumatoid arthritis (RA). Patients with flare of active RA following NSAID withdrawal were randomized to receive either placebo (n = 67) or tenidap (n = 131; 40-200 mg/day). The mean changes from baseline in efficacy and biochemical variables were compared between treatment groups at endpoint (4 weeks). The improvements in four of the five primary efficacy variables were significantly greater in the tenidap group compared with the placebo group (p < 0.01). Tenidap was also associated with an 18% reduction in erythrocyte sedimentation rate (ESR) and a marked, 51%, reduction in serum C-reactive protein (CRP) level, both of which were significantly greater than the changes in the placebo group (p < 0.05). The percentage of patients who discontinued because of side effects was the same in both groups (3%). In conclusion, tenidap 40-200 mg/day was effective and well tolerated in the treatment of patients with RA for 4 weeks.
Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Arthritis, Rheumatoid/drug therapy , Cyclooxygenase Inhibitors/therapeutic use , Indoles/therapeutic use , Administration, Oral , Adult , Aged , Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/adverse effects , Cyclooxygenase Inhibitors/administration & dosage , Cyclooxygenase Inhibitors/adverse effects , Digestive System/drug effects , Double-Blind Method , Female , Humans , Indoles/administration & dosage , Indoles/adverse effects , Male , Middle Aged , Oxindoles , Treatment OutcomeABSTRACT
Benoxaprofen, 400 to 600 mg daily, was compared to aspirin, 4,000 to 6,000 mg daily, or ibuprofen, 1,600 to 2,400 mg daily, in 2 multicolor clinical trials. The study design was double-blind and provided 28 wk of active drug therapy. Statistical analysis of the results showed benoxaprofen to be at least as effective as the 2 control drugs. More patients taking ibuprofen or aspirin discontinued therapy than patients taking benoxaprofen. Side effects occurred more frequently and lasted longer in patients who took aspirin during the study. Clinical laboratory examinations supported the long-term safety of benoxaprofen.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Aspirin/therapeutic use , Benzoxazoles/therapeutic use , Ibuprofen/therapeutic use , Propionates/therapeutic use , Adult , Aged , Analysis of Variance , Anti-Inflammatory Agents/blood , Anti-Inflammatory Agents/toxicity , Aspirin/toxicity , Benzoxazoles/blood , Benzoxazoles/toxicity , Blood Sedimentation , Clinical Trials as Topic , Double-Blind Method , Female , Hematocrit , Hemoglobins/analysis , Humans , Ibuprofen/toxicity , Male , Middle Aged , Patient Compliance , Propionates/blood , Propionates/toxicity , Time FactorsABSTRACT
Plasma and urine concentrations of 2-(3-chloro-4[3-pyrrolinyl]phenyl) propionic acid, pirprofen, a new nonsteroidal anti-inflammatory compound, are described for normal male volunteers receiving one or more doses of the drug. Orally administered pirprofen is rapidly and almost completely absorbed from the gastrointestinal tract, resulting in maximum plasma levels in 1 to 2 hr. Mean peak levels are 23 microng/ml after an oral pirprofen dose of 200 mg; lower doses given proportionally lower levels. Administration 1 hr after a meal slightly delays the peak plasma level, but the extent of absorption is not affected significantly. Administration of pirprofen, 150 mg, 4 times daily, or 200 mg, 3 times daily, results in nearly identical plasma levels at steady-state. Pirprofen has an apparent elimination half-life of about 7 hr. The results obtained from a 200-mg pirprofen-14C dose indicate that excretion of the drug occurs primarily by the renal route in the form of metabolites and is essentially complete within 24 hr. In urine, less than 5% of the administered dose is accounted for as unchanged drug.
Subject(s)
Anti-Inflammatory Agents/metabolism , Phenylpropionates/metabolism , Adolescent , Adult , Biopharmaceutics , Drug Administration Schedule , Humans , Male , Middle Aged , Phenylpropionates/blood , Phenylpropionates/urine , Pyrroles/blood , Pyrroles/metabolism , Pyrroles/urineABSTRACT
In the management of rheumatic diseases, the use of corticosteroids should be reserved for active arthritis. Phenylbutazone (Butazolidin) is probably the drug of choice for acute gout and is also effective in ankylosing spondylitis, Reiter's syndrome, and psoriatic arthritis. Indomethacin (Indocin) also is useful in these conditions. Ibuprofen (Motrin) is only slightly more efficacious than aspirin. Aspirin is still the preferred treatment for rheumatoid arthritis and should be tried before ibuprofen. Osteoarthritis of the cervical or lumbar spine calls for a full program of physical therapy. Experimental procedures for total replacement of joints other than hip and knee show promise.
Subject(s)
Rheumatic Diseases/drug therapy , Adrenal Cortex Hormones/therapeutic use , Arthritis, Rheumatoid/drug therapy , Arthritis, Rheumatoid/therapy , Aspirin/therapeutic use , Calcinosis/drug therapy , Carpal Tunnel Syndrome/drug therapy , Colchicine/therapeutic use , Gout/drug therapy , Hip Joint , Humans , Ibuprofen/therapeutic use , Indomethacin/therapeutic use , Joint Prosthesis , Osteoarthritis/surgery , Osteoarthritis/therapy , Phenylbutazone/therapeutic use , Spondylitis, Ankylosing/drug therapy , Tendinopathy/drug therapyABSTRACT
In a case of rheumatic disease, the patient's history and a careful physical examination should yield most of the information needed to identify the specific disorder present. A convenient classification is based on four differentiating features: number of joints affected, acuteness or chronicity of disease, absence of joint involvement, and anatomic distribution.
Subject(s)
Rheumatic Diseases/diagnosis , Arteritis/diagnosis , Arthritis/diagnosis , Arthritis, Infectious/diagnosis , Arthritis, Juvenile/diagnosis , Arthritis, Reactive/diagnosis , Arthritis, Rheumatoid/diagnosis , Carpal Tunnel Syndrome/diagnosis , Chondrocalcinosis/diagnosis , Diagnosis, Differential , Fibromyalgia/diagnosis , Gout/diagnosis , Humans , Joint Diseases/diagnosis , Knee Joint , Male , Osteoarthritis/diagnosis , Polymyalgia Rheumatica/diagnosis , Psoriasis/diagnosis , Reflex Sympathetic Dystrophy/diagnosis , Rheumatic Fever/diagnosis , Shoulder Joint , Spinal Diseases/diagnosis , Spondylitis, Ankylosing/diagnosis , Tendinopathy/diagnosisABSTRACT
The pooled data of a multi-clinic, double-blind, crossover study (16 weeks' duration), comparing fenoprofen and aspirin in 116 patients with active rheumatoid arthritis are reported. Each patient received fenoprofen (400 mg Q6H) and aspirin (1,000 mg Q6H) for six-week periods, in random fashion. Usual objective and subjective parameters were used to evaluate rheumatic activity. Side effects were obtained by daily telephone interviews, and appropriate laboratory tests were performed during weekly out-patient evaluations. Both fenoprofen and aspirin were significantly more effective than placebo in controlling rheumatoid activity. At the dosage level employed, no significant differences were noted between the two anti-inflammatory agents in regard to efficacy. However, fewer side effects were observed with fenoprofen than with aspirin. The data indicate that fenoprofen is an additional valuable agent for rheumatoid arthritis.
Subject(s)
Arthritis, Rheumatoid/drug therapy , Aspirin/therapeutic use , Fenoprofen/therapeutic use , Phenylpropionates/therapeutic use , Adolescent , Adult , Aspirin/adverse effects , Clinical Trials as Topic , Female , Fenoprofen/adverse effects , Humans , Male , Middle AgedABSTRACT
Pirprofen was compared to placebo in a double-blind crossover study in 12 rheumatoid arthritis patients. Two approaches--univariate and multivariate--were used to analyze the study results which were in the form of arithmetic changes from pretreatment levels of six efficacy measurements. The univariate analysis failed to permit a single decision to be made regarding the further investigation and use of pirprofen in rheumatoid arthritis. However, the multivariate analysis which treats the efficacy variables simultaneously showed a clear differentation from placebo. Thus, multivariate analysis enabled the clinical pharmacologist to evaluate the new therapeutic agent in a complete and comprehensive manner. It allowed for a single decision to be made regarding the merits of pirprofen compared to placebo.
