The efficacy of etodolac (600 mg/day) and placebo were compared in a 4-week double-blind, parallel-group study involving 104 patients with osteoarthritis of the knee and 106 with osteoarthritis of the hip. Most patients had improvement of their symptoms during the study, but significantly more improvement was seen in the patients taking etodolac. Patients with osteoarthritis of the knee taking etodolac had significantly (p less than 0.05) more improvement than placebo-treated patients in joint swelling, weight-bearing pain, and patient's overall assessment. Patients with osteoarthritis of the hip taking etodolac had significantly (p less than 0.05) greater improvement than placebo-treated patients in hip abduction, weight-bearing pain, joint tenderness, investigator's overall assessment, and patient's overall assessment. The frequency of adverse events was not statistically different in the two treatment groups. However, significantly (p = 0.05) more etodolac-treated patients (n = 9) than placebo-treated patients (n = 2) reported indigestion. The incidence of adverse events was similar in patients aged 65 years and older to that in patients younger than 65 years. Results of laboratory evaluations indicated that etodolac therapy was associated with no more hepatic or renal enzyme abnormalities than was placebo.

The efficacy and safety of etodolac and piroxicam were compared in a double-blind, randomized, parallel-group outpatient study at four sites. Patients with active osteoarthritis of the knee were assigned to receive etodolac 600 mg/day (57 patients) or piroxicam 20 mg/day (59 patients) for 6 weeks. Efficacy assessments were made at the pretreatment screening, at baseline, and at treatment weeks 2, 4, and 6 for patient and physician global evaluations, night pain, spontaneous pain intensity, weight-bearing pain variables, measures of inflammation, morning stiffness, and knee flexion. An analysis was also done based on each patient's final evaluation, regardless of the week at which it occurred. Safety assessments were made before treatment and at the completion of therapy. A therapeutic response was obtained in both treatment groups by the end of the second week of treatment. At the final evaluation, both groups showed significant improvement (P less than or equal to 0.05) from baseline for most efficacy assessments. The physician's global assessment indicated improvement in the condition of 60% of the etodolac-treated patients and 39% of the piroxicam-treated patients at the final evaluation. There was no significant difference between treatment groups in the number of patient withdrawals due to adverse reactions or in the number of patients reporting side effects. The results of this study indicate that, compared with piroxicam 20 mg/day, etodolac 600 mg/day is effective and well tolerated in the treatment of patients with osteoarthritis.

The efficacy and tolerability of etodolac and indomethacin were compared in patients with osteoarthritis of the knee. Sixty-four patients entered a double-blind, parallel trial and were randomly assigned to receive 300 mg etodolac twice daily (n = 31) or 50 mg indomethacin 3-times daily (n = 33) for 6 weeks. Both groups showed significant (p less than or equal to 0.05) improvement from baseline in all efficacy assessments at the final evaluation. However, significantly (p less than or equal to 0.05) greater decreases from baseline were seen for etodolac than for indomethacin in patients' global evaluation, pain intensity, night pain, standing pain, walking pain, pain getting up from a chair, tenderness on pressure, and knee flexion. In addition, 67% of the patients in the etodolac group indicated improvement in their condition at the final evaluation, compared with 53% of the patients who received indomethacin. No patients in the etodolac group withdrew because of adverse reactions compared to 4 patients in the indomethacin group. Furthermore, significantly more patients in the indomethacin group (52%) than in the etodolac group (19%) reported drug-related adverse reactions. Thus, the results of this study strongly indicate that etodolac is more effective and produces fewer side-effects than indomethacin in the treatment of patients with osteoarthritis.

A double-blind, randomized study of 137 patients compared the effectiveness of single doses of etodolac, 200 and 400 mg, zomepirac, 100 mg, and placebo in relieving moderate to severe pain following third molar extractions. Throughout the 12-hour evaluation period, doses of both etodolac and zomepirac were significantly superior to placebo for total analgesic effect, as measured by the sum of pain intensity difference (SPID) and sum of pain relief (TOTPAR) scores. However, there were no significant differences among the active drugs. It was concluded that etodolac, 200 and 400 mg, provides analgesic efficacy comparable to that of zomepirac, 100 mg, and superior to that of placebo.

Single doses of the study drugs were evaluated for 12 hours by 201 out-patients reporting moderate or severe pain following oral surgery. The results of this double-blind study indicated that 50, 100, and 200 mg of etodolac as well as 650 mg of aspirin were significantly more effective than placebo. A dose-response relationship was found for the three doses of etodolac, which was significant for summed pain relief scores for up to 8 hours. In terms of total analgesic effect, etodolac 200 mg was significantly superior to placebo for 8 hours, while aspirin and the two lower doses of etodolac were similarly effective in the range of 3-6 hours postdrug. All doses showed a favorable onset of analgesia (½-1 hour). Etodolac 200 mg resulted in a duration of action which was approximately twice as long as aspirin's and also produced a peak pain relief which was significantly greater than the lower doses of etodolac and aspirin. All study medications were well tolerated with no reports of significant adverse side effects. No dose-related effects were observed with etodolac

A study was conducted to compare the analgesic activity of single oral doses of etodolac (25, 50, 100, 200, and 400 mg) with 650 mg aspirin and placebo. A total of 146 patients with moderate or severe pain from orthopedic or urologic interventions received one of the test medications 13-25 h after the beginning of surgery and according to a randomized allocation balanced as to initial pain intensity. Data for pain intensity and pain relief were collected at 1/2 h and then hourly for 8 h. Vital signs and adverse reactions were also recorded. One hundred and forty-two patients completed the study: four were excluded because of protocol deviations. The average response to 100, 200, and 400 mg of etodolac was superior to that of placebo. On the basis of SPID, TOTPAR, and duration of analgesia, 400 mg etodolac was also significantly more effective than 650 mg aspirin. Mild side effects probably or possibly related to etodolac were reported by three patients. This study provides evidence that etodolac in doses of 100 mg and higher is an effective and well-tolerated analgesic.

A multicenter, parallel-group, double-blind, randomized, outpatient study compared the efficacy and safety of etodolac versus naproxen in patients with osteoarthritis of the knee. After a washout period free of nonsteroidal anti-inflammatory drugs, 254 patients self-administered etodolac 400 mg (n = 86), naproxen 500 mg (n = 82), or placebo (n = 86) twice daily for 4 weeks. Compliance exceeded 90% in all three groups. Primary efficacy variables improved progressively from baseline in all three groups. The extent of improvement was greater in the etodolac and naproxen groups than in the placebo group (P < or = 0.003), except with respect to target joint tenderness (P = 0.028, etodolac vs placebo; P = 0.013, naproxen vs placebo). There were no statistical differences between active treatment groups (P > 0.1). At end point, twice as many patients responded in the etodolac (59%) and naproxen groups (51%) than in the placebo group (26%; P < or = 0.01). There were no significant between-group differences in the numbers of patients who had an adverse experience, a serious adverse experience, or an adverse experience leading to study discontinuation; there were also no significant between-group differences in the distribution of adverse experiences. There were no unexpected clinical or laboratory experiences. Etodolac 400 mg twice daily was as effective and safe as naproxen 500 mg twice daily and both were superior to placebo in the management of osteoarthritis of the knee.

Objetivo: Verificar la eficacia de etodolac por vía oral comparado con piroxicam en el tratamiento de la dismenorrea primaria. Material y métodos: Se seleccionaron 31 adolescentes de un colegio de clase social media, con edades entre 10-24 años, con ciclos regulares y una menarquía de un año de evolución. Antecedentes de dismenorrea moderada a severa. Se descartó embarazo o masas pélvicas o uso de anticonceptivos. Se solicitó ecografía pélvica previa, cuadro hemático, parcial de orina, glicemia, proteinas totales. El estudio se diseño en forma doble-ciega-cruzada, durante 4 meses donde la paciente tenía la oportunidad de recibir la medicación en forma alterna en dos ocasiones. En un cuestionário tanto personal como por los investigadores se evaluó la eficacia y tolerancia de los 2 productos. Para la valoración de significancia se utilizó la prueba de Kruskal-Wallis. Resultados: Edad de la menarquia: fue de 12,8 años, ciclos de 29,8 ñ 3,2 y duración de 4-5 días. La dismenorrea (leve) se presentó en 9,6 por ciento. Grado II (moderada), 58,1 por ciento y grado III (severa), 32,2 por ciento. En forma aleatoria el 48,4 por ciento recibió tratamiento con etodolac y 51,6 por ciento, piroxicam. La mejoría en la intensidad del dolor fue del 29,4 por ciento para etodolac y para el piroxicam, 32,5 por ciento, sin evidencia de diferencias estadísticamente significativas. Los exámenes paraclínicos previos estuvieron dentro de limites normales. Los efectos secundarios fueron mínimos, sin obligar a suspender la medicación durante los 4 días de tratamiento. Conclusión: Estos resultados nos permiten afirmar que tanto el etodolac como el piroxicam son eficaces en el tratamiento de la dismenorrea primaria. Los efectos secundarios fueron minimos

We compared the longterm efficacy and safety of 2 dosages of etodolac with that of ibuprofen in the treatment of active rheumatoid arthritis (RA). The ability of etodolac to retard, arrest, reverse, or heal joint damage due to RA was also evaluated. Patients in the early stages of RA were assigned randomly to 3 parallel groups for up to 3 years of therapy: etodolac at 150 mg bid, etodolac at 500 mg bid, and ibuprofen 600 mg qid. Concurrent disease modifying antirheumatic drugs were not permitted; established low dosage corticosteroid therapy could be continued. A total of 1446 patients was enrolled. About 50% of patients completed one year; dropout rates were comparable between groups. Both etodolac dosages provided comparable efficacy to that of ibuprofen during the first 2 months; longterm assessment showed that 1000 mg/day of etodolac produced superior improvement as assessed by patients' opinions and number of swollen joints. About 2% of patients in each group achieved remission, and radiographs showed no difference in disease progression between treatments. The incidences of adverse events were comparable, although dyspepsia and rash occurred less frequently with 300 mg/day of etodolac than with 2400 mg/day ibuprofen. A higher incidence of gastrointestinal ulcers and bleeding was seen with ibuprofen. Changes in hepatic and renal function were of minor clinical significance and were similar between the 3 groups. Both dosages of etodolac were comparable to 2400 mg/day ibuprofen in treating RA. All 3 treatment regimens were well tolerated.

The analgesic efficacy of etodolac (Ultradol) was evaluated in 168 patients experiencing moderate to severe pain following oral surgery. The patients were given either etodolac 100 mg, etodolac 200 mg, aspirin 650 mg, or placebo. There was a minimum of forty patients in each drug group. Patients recorded pain intensity and pain relief at 1/2 hour and then hourly for up to 12 hours after medication. The efficacy variables analyzed were the sum of pain-intensity differences, total pain relief, onset of analgesia, and the patient's opinion of the study drug. Time-effect curves were made from the pain-relief and pain-intensity difference scores. The analgesic potency of both 100 and 200 mg of etodolac was comparable to 650 mg of aspirin and superior to placebo. Like aspirin, both doses of etodolac showed significant analgesia within one hour and a significantly longer duration of action than placebo.