Open study of a diclofenac sodium prolonged-release in patients suffering from coxarthrosis.
Fourty adult patients with coxarthrosis were treated for 30 days with oral diclofenac sodium at the daily dose of 150 mg: 20 of these were administered one 150 mg prolonged-release capsule per day, the other 20 received one 50 mg enteric-coated tablet every 8 hours. The presence and severity of several symptoms and signs (various pain types, cramps, morning stiffness, impaired function capacity), the intensity of pain through the Visual Analogical Scale and some laboratory tests (Erythrocyte Sedimentation Rate, C-reactive protein, Rheuma test) were controlled to monitor drug efficacy. The routine laboratory tests of blood, liver and kidney function, the gastrointestinal tolerance of the two administered formulations and the appearance of any adverse event were controlled to monitor drug tolerability. Both administration schemes yielded very positive results as to treatment efficacy, although the prolonged-release capsule often induced a somewhat quicker response. At the end of the one-month treatment more than half of patients in both groups registered disappearance of several symptoms and a noticeable reduction of the remainder ones. Systemic tolerability was also good, with superimposable results in the two groups; gastrointestinal tolerance on the contrary was better in the recipients of the prolonged-release capsules (2 cases of dyspepsia) with respect to those treated with the enteric-coated tablets (2 cases of gastric pyrosis and 2 cases of gastralgia). No adverse events were registered.
Varese
C
C
Orthopedic Department C. Forlanini Hospital, Rome, Italy.
Palazzini
A
A
D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004008:Diclofenac / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015207:Osteoarthritis, Hip / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement / Q000187:drug effects
D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D004008:Diclofenac