In vivo evaluation of enteric-coated naproxen tablets using gamma scintigraphy.

Seven healthy, male volunteers were entered into a randomized, open crossover study of the gastrointestinal transit of two enteric-coated 500-mg naproxen tablets. Two radiolabeled tablets were given to each volunteer on two occasions separated by 7 days, once in the fasted state and once after breakfast. Radiolabeling of tablets was achieved by the incorporation of samarium-152 oxide during manufacture, followed by neutron activation of the tablet to produce the gamma-emitting isotope samarium-153. No loss of tablet integrity was seen in the stomach and all tablets disintegrated in the small intestine. Onset of tablet disintegration was controlled predominantly by gastric emptying. Time in the small intestine prior to tablet disintegration was independent of food intake. Naproxen blood levels with time were consistent with the delayed release of naproxen from the tablets. Overall, transit, disintegration, and absorption were as expected from an enteric-coated tablet.

Enprostil, a prostaglandin E2 analogue, in the treatment of gastric ulcer--a multicentre comparison with pirenzepine.

In a double-blind, multicentre study 77 patients with benign gastric ulcer were randomly allocated to treatment with either enprostil 35 micrograms bd or pirenzepine 50 mg bd. After four weeks of treatment 13/26 (50 per cent) of evaluable enprostil-treated patients and 9/30 (30 per cent) of evaluable pirenzepine-treated patients were healed. Corresponding healing figures after eight weeks were 20/25 (80 per cent) and 25/31 (81 per cent). Both drugs rapidly reduced the severity of ulcer pain and the need for antacid use. No statistically significant differences were detected between the treatments with respect to healing rate or symptom control. Adverse events were reported by eight patients taking enprostil and by 17 patients taking pirenzepine. Two patients withdrew from each treatment group because of adverse events. None of these was serious. In conclusion, enprostil and pirenzepine were equally effective in healing gastric ulcers and no statistically significant differences in safety and efficacy were detected. There was a tendency for earlier healing and fewer side effects in the enprostil-treated patients.

A comparison of phenytoin and pheneturide in patients with epilepsy: a double-blind cross-over trial.

A double-blind cross-over trial between pheneturide and phenytoin in ninety-four outpatients with epilepsy is described. There was no significant difference between the frequency of seizures in the two groups. The difficulties in comparing two anticonvulsants of similar efficacy are discussed particularly in relation to ethical problems, the selection of patients and trial design.

A compliance study in general practice of patients switched from phenylbutazone and oxyphenbutazone to naproxen and other non-steroidal anti-inflammatory drugs.

Fifty-nine patients on long-term treatment with phenylbutazone or oxyphenbutazone for chronic rheumatic conditions were switched to treatment with naproxen and followed-up for 6 months in a compliance study. All patients were started on 500 mg naproxen twice daily but adjustment of the dosage was permitted. During the 6 months of the study only 3 patients returned to treatment with phenylbutazone. Of the remaining 56 patients, 45 were still taking naproxen after 6 months, 9 were changed to other non-steroidal, anti-inflammatory drugs and 2 were lost to follow-up. The study demonstrates that in routine general practice, phenylbutazone and oxyphenbutazone can be successfully replaced by less toxic drugs.

Naproxen and sulindac in the treatment of osteoarthritis of the hip and knee.

Thirty patients with osteoarthritis of the hip or knee were entered into a double-blind, cross-over study of naproxen (750 mg/day) and sulindac (400 mg/day) both given in twice-daily regimens. Patients received each drug for four weeks. Both drugs produced improvements in the patients' overall condition. There were no statistically significant differences between the effects of the two drugs. There were few side-effects. Overall, both drugs proved beneficial and safe.

A comparative trial of flunisolide and sodium cromoglycate nasal sprays in the treatment of seasonal allergic rhinitis.

A trial of flunisolide nasal spray and sodium cromoglycate nasal spray in the treatment of hay fever was carried out during the summer of 1978. Sixty-seven patients all suffering from grass-pollen hay fever were given either flunisolide or sodium cromoglycate nasal sprays for 7 weeks. Patients were seen at 0, 3 and 7 weeks and they also kept a daily record of symptoms. Overall assessment of symptom control and the patients daily records of sneezing showed flunisolide to be significantly superior to sodium cromoglycate. Patients records of symptoms correlated well with daily pollen counts. Side-effects were similar in both treatment groups and consisted mainly of mild naso-pharyngeal irritations.