Effect of Clinoril (sulindac, MSD), piroxicam and placebo on the hypotensive effect of propranolol in patients with mild to moderate essential hypertension.

One hundred ten patients of both sexes with mild to moderate essential hypertension were studied in this double-blind, multicenter study. In the double-blind portion of this study, which covered weeks 11 to 14, 71 patients were evaluated to determine the effect of Clinoril (sulindac, MSD), piroxicam, and placebo on the hypotensive effect of propranolol. All 110 patients were considered for safety evaluation. Patients treated with propranolol alone were distributed randomly into three groups (Clinoril, piroxicam and placebo) and compared in a 15-week study with four periods (I through IV). Having fulfilled the criteria for hypertension (I) and having been successfully controlled with propranolol alone (II), patients were entered into a double-blind period (III) comparing the three drug treatments during four weeks followed by one week of propranolol alone (IV). During period III, patients treated with piroxicam had significantly greater (p less than 0.05) increases in supine and standing diastolic blood pressure than patients treated with Clinoril. No clinical difference was shown between patients treated with Clinoril and placebo. At the end of period IV patients treated with piroxicam maintained the increase in their diastolic blood pressure, in contrast to Clinoril and placebo where no clinical difference was noted. Significantly more patients treated with piroxicam than Clinoril had a 10 mmHg or greater increase of their supine diastolic blood pressure. These results show that Clinoril does not blunt the antihypertensive effect of propranolol in patients with mild to moderate hypertension in contrast to piroxicam. This is an extension of a report previously published in Advances in Therapy, Vol. 2, No. 4, July/August 1985.(ABSTRACT TRUNCATED AT 250 WORDS)

A multi-centre, double-blind randomized study to assess the efficacy and tolerance of sulindac versus placebo in the symptomatic treatment of patients with upper respiratory tract infection.

A multi-centre, double-blind, randomized, placebo-controlled study was carried out to compare the efficacy and tolerance of sulindac (200 mg twice daily) with placebo in the symptomatic treatment for 7 days of 312 adult patients with upper respiratory tract infection. Investigators and patients rated sulindac superior to placebo in the overall evaluations of response to treatment, but the differences were not significant. In general, patients treated with sulindac had greater mean decreases from baseline scores for individual signs and symptoms than did placebo patients. Fever was relieved better by sulindac than by placebo. The mean decrease from baseline pain scores was also greater in the sulindac group. More patients receiving sulindac reported clinical adverse experiences compared with those on placebo, the most common adverse experiences reported being in the digestive system.

'Osmosin': a multi-centre evaluation of a technological advance in the treatment of osteoarthritis.

A multi-centre, double-blind trial was carried out in 272 out-patients with osteoarthritis of the knee(s) to compare the efficacy and tolerability of 'Osmosin', the osmotic release system for indomethacin (7 mg per hour for approximately 10 hours), with that of conventional indomethacin capsules (25 mg 3-times daily) over a period of 12 weeks. The results, as assessed by the subjective and objective clinical variables and laboratory parameters studied, showed that 'Osmosin' provided not only comparable overall therapeutic response but also a preferable tolerability profile to the indomethacin capsule regimen. At completion of the study, 89% of patients treated with 'Osmosin' were being maintained on one dose daily, and 80% of these patients were rated as having a good or excellent response. The results indicate that 'Osmosin' given once daily is a well-tolerated and efficacious therapy for patients with osteoarthritis.

'Osmosin' (sodium indomethacin trihydrate) in the treatment of elderly patients with osteoarthritis.

A 12-week, double-blind, multi-centre trial was carried out in 402 out-patients with osteoarthritis to compare the efficacy and tolerability of the osmotic-release formulation of indomethacin ('Osmosin') with that of indomethacin capsules. Data from a sub-set of 178 patients aged 60 years or over were analyzed separately. The results indicated that 'Osmosin', releasing the equivalent of 7 mg indomethacin per hour over approximately 10 hours, provided efficacy comparable to or better than that of indomethacin capsules (25 mg 3-times daily) and had a better tolerance profile. Fewer patients treated with 'Osmosin' developed adverse experiences (p less than 0.05), especially central nervous system symptoms (p less than 0.05), and fewer were withdrawn from treatment because of adverse experiences (p less than 0.05). A reduction in the number of patients having gastro-intestinal symptoms was also identified. The majority of the patients maintained on one daily dose of 'Osmosin' had a good or excellent therapeutic response.

A double-blind trial comparing indomethacin sustained release capsules (Indocid-R) with indomethacin capsules in patients with rheumatoid arthritis.

A double-blind, controlled and completely randomized trial was conducted in four European rheumatology clinics. Eighty-six patients with a diagnosis of rheumatoid arthritis and prior treatment of at least six months' duration with indomethacin 150 mg/day were studied. Comparisons of the clinical efficacy, tolerability and safety of a new, oral sustained-release formulation of indomethacin were made with a conventional formulation of indomethacin. In all clinical indices of response, the indomethacin sustained-release 75 mg capsule b.i.d. was found to provide relief of symptoms similar to the conventional 50 mg capsule t.i.d. The incidence of overall adverse clinical and laboratory effects was comparable for the two treatments.

Indomethacin or prednisolone at night in rheumatoid arthritis?

Indomethacin, 100 mg orally, was compared with prednisolone, 5 mg, as addititional therapy at night, in a two-week, double-blind, between-patient study in twenty-four in-patients with rheumatoid arthritis. Both therapies proved equally effective, and significantly lessened morning stiffness and increased grip strenght. Two patients with dyspepsia were discontinued from the indomethacin group. Using indomethacin at night avoided the central nervous system side-effects frequently seen with this compound.

Comparison of sulindac and aspirin in rheumatoid arthritis.

Thirty-one out-patients with rheumatoid arthritis took part in a 10 week double-blind comparison of sulindac (cis-5-fluoro-2-methyl-1-[p-(methylsulphinyl)-benzylidene]-indene-3-acetic acid) 200 mg twice daily and aspirin 3.6 g daily, with a 2-week placebo control period. Both drugs were superior to placebo. The incidence of side-effects was approximately the same on the two drugs, but there was a higher drop-out rate due to side-effects on aspirin.

Indomethacin--aspirin interaction: a clinical appraisal.

Plasma profiles of indomethacin after a 50-mg oral dose were constructed in six healthy volunteers before and after a week of aspirin treatment. Aspirin did not interfere with indomethacin plasma levels. To examine the clinical effect of concurrent indomethacin and aspirin treatment 20 patients with seropositive rheumatoid arthritis were given indomethacin 100 mg/day, aspirin soluble 4 g/day, and the two drugs taken together in random order. Analysis of the clinical indices of inflammation--articular index and mean pain score--and of the efficacy of each treatment showed no significant differences between the three treatment groups. With the proliferation in the number of anti-rheumatic drugs available, the case for giving two or more nonsteroidal anti-inflammatory drugs concurrently remains unproved.