COMPARISON OF PYRITINOL AND AURANOFIN IN THE TREATMENT OF RHEUMATOID ARTHRITIS

The efficacy and tolerability of pyritinol (PY) and auranofin(AU) were compared in a multicentre double-blind study. Patientswith RA received 600 mg/day PY or 6 mg/day AU for 1 year. Responsewas rated by a defined improvement in at least four of the following:Ritchie index, joint swelling index, rating scales for painand general well-being, functional index, morning stiffness,ESR. Of the 139 fully evaluable PY patients 61 (44%) dropped outdue to adverse events or response failure compared with 44 (31%) of the 142 AU patients. In patients treated for 1 year efficacyparameters improved more in the PY than in the AU group, withsignificant differences for the general well-being (P = 0.022),ESR (P = 0.029) and haemoglobin (P = 0.0042). The response ratefor PY (61/78 patients, 78%) was significantly superior to AU(58/98 patients, 59% P = 0.009). An intention-to-treat analysiscorroborated this result (P = 0.030). Adverse events (AE) occurredin 64% of PY patients and in 58% of AU patients: main AE weremucocutaneous symptoms (PY 36%, AU 23%) and gastrointestinalcomplaints (PY 30% AU 37%). Single cases of proteinuria, hepaticand haematological abnormalities were noted in both groups. KEY WORDS: Rheumatoid arthritis, Comparative study, Double-blind study, Disease modifying drugs, Pyritinol, Auranofin ^*European Multicentre Study Group, participating centres: Germany-BadAibling, Dr P. Heimstaät (     

Endemic pemphigus foliaceus in western Parana, Brazil (1976–1988)

Endemic pemphigus foliaceus or fogo selvagem (FS) is a blistering autoimmune disease indigenous to certain states of Brazil. In the state of Parana the disease has been reported in the north-central regions where a total of 632 cases were documented in the period of 1940-80. The present study describes a new focus of FS in the western region of the state of Parana. This focus includes a total of 213 new cases of FS and only 11 cases of pemphigus vulgaris seen in this region from February 1976 to July 1988. Over 90% of these patients were peasants working in agriculture or involved in other outdoor activities.     

Long-term survival in a randomized study of nonplatinum therapy versus platinum in advanced epithelial ovarian cancer

The purpose of this study was to compare long-term survival in first-line chemotherapy with and without platinum in advanced-stage ovarian cancer. From July 1987 to November 1992, 161 untreated patients with FIGO stage III-IV epithelial ovarian cancer were randomized: 81 patients received no platinum and 80 received platinum combination. Residual disease after surgery was <2 cm in 61 patients without platinum, 59 with platinum. Median age was 58 years in nonplatinum arm and 55 years in platinum arm (range: 15-73). Complete and partial responses were 51% and 10% for nonplatinum arm and 51% and 8% for platinum arm, respectively (P= 0.7960). Stable disease was observed in 18% of patients in nonplatinum arm and 15% of patients in platinum arm and progression in 20% of nonplatinum- and 21% of platinum-treated cases. Ten-year disease-free survival was 37% for therapy without platinum and 31% for platinum combination (P= 0.5679); 10-year overall survival was 23% without platinum and 31% with platinum combination (P= 0.2545). Fifteen-year overall survival showed a trend of short duration in favor of platinum (P= 0.0678). Relapses occurred after 60 months in ten patients (seven with and three without platinum). The overall and disease-free survivals at 5, 10, and 15 years show no statistically significant long-term advantage from the addition of cisplatin; however, there is a slight trend in its favor.     

Treatment of Acute Childhood Leukemia: Comparison of Two Methods of Remission Maintenance

Thirty-five previously untreated children suffering from acutelymphocytic leukemia were enrolled in sequence between April1972 and October 1973 and randomly put on drug protocol 721,consisting of three phases; induction with vincristine and predonisolone,prophylactic intrathecal medication with methotrexate, and maintenance:high-dose infusion of MTX (Group A) or sequential-complementaryregimen (Group B). Complete marrow remission (M1) was achieved in the 35 cases(100%). During the phase of prophylactic intrathecal medication,two patienls had bone marrow relapses and one had CNS-leukemia.Of the 33 who had continuing marrow remission, 17 were randomlyselected into Group A and 16 into Group B. In Group A, nine patients (47%) remained in complete remissionover three years, in contrast with four patients in Group B.CNS-leukemia occurred in 10 children in Group B and in fourchildren in Group A. Therapy with high-dose infusion of MTX (Group A) was more effectivefor remission maintenance in children with acute lymphocyticleukemia than those with sequential-complementary regimen (p<0.05).No significant toxi-cities occurred in either of the regimens,and these maintenance regimens did not require any unusual supportivecare. ^*Members of the study group: Takeo Fuji-moto, M.D. (Dept. ofPediatrics, Kyushu Univ. School of Med.), Keiko Hasegawa, M.D.(Dept. of Pediatrics, Fukuoka Univ. School of Med.), NagahideGoya, M.D. (Dept. of Pediatrics, Kyushu Univ. School of Med.),Yasuhiko Hiyoshi, M.D. (Dept. of Pediatrics, Kurume Univ. Schoolof Med.), Takashi Yokoyama, M.D. (Dept. of Pediatrics, KurumeUniv. School of Med.), Masanobu Ito, M.D. (Dept. of Pediatrics,Nagasaki Univ. School of Med.), Masanori Yanai, M.D. (Dept.ofPediatrics, Nagasaki Univ. School of Med.) and Kenshi Furusho,M.D. (Dept. of Pediatrics, Kokura Memorial Hospital). Presentedin part at the 66th Annual Meeting of the American Associationfor Cancer Research, San Diego, California, May 9, 1975. Thiswork was supported in part by a Grant-in-Aid for Cancer Researchfrom the Childhood Cancer Association of Japan. Reprint requests:Dr. Takeo Fujimoto, Dept. of Pediatrics, Kyushu Univ. Schoolof Med., 3-1-1, Maedashi, Higashi-ku, Fukuoka 812, Japan.     

European infarction study (EIS): A secondary prevention study with slow release oxprenolol after myocardial infarction

The European Infarction Study (EIS) is a multicentre, double-blindplacebo-controlled, randomised clinical trial planned to involve4000 postinfarct patients. It was designed to test the efficacyof slow release oxprenolol 160 mg twice daily in the preventionof death and non-fatal cardiac events in the period 2–52weeks following acute myocardial infarction. In a subsectionof patients, 24 h ECG monitoring at specified intervals wasundertaken in an attempt to determine the influence of treatmenton the incidence of dysrhythmias and their relation to cardiacdeath in the patients studied. Recruitment to the study was terminated on 6 July 1981, on theadvice of the Review Committee. At the time the recruitmentclosed, 1741 patients had been admitted.     

A SHORT-TERM, MULTICENTER, RANDOMIZED DOUBLE-BLIND DOSE TITRATION STUDY OF THE EFFICACY AND ANTICHOLINERGIC SIDE EFFECTS OF TRANSDERMAL COMPARED TO IMMEDIATE RELEASE ORAL OXYBUTYNIN TREATMENT OF PATIENTS WITH URGE URINARY INCONTINENCE

PURPOSE: We compared the short-term efficacy, safety and tolerability of transdermal versus oral oxybutynin in adults with urge urinary incontinence. MATERIALS AND METHODS: Volunteers with detrusor instability currently responding to oral immediate release oxybutynin were enrolled in our study. Those patients presenting with recurrence of incontinent symptoms after a 2-week washout underwent confirmatory cystometrogram with subsequent randomization to transdermal or oral treatment. Matching active and placebo medications included matrix patches applied twice weekly and capsules taken 2 or 3 times daily. Dose titration was based on anticholinergic symptoms. Outcome measures included comparison of baseline to 6 week changes in incontinence episodes on a 3 day urinary diary, a visual analog scale for efficacy and anticholinergic symptoms reported on a questionnaire. Safety monitoring included adverse events and skin tolerability of the transdermal system. RESULTS: A total of 76 patients were enrolled and 74 completed at least 4 weeks of treatment. Mean age in the transdermal and oral groups was 64 and 63 years, and 87% and 97% were female, respectively. Daily incontinent episodes decreased in the transdermal and oral groups (7.3 to 2.4 [66%] and 7.4 to 2.6 [72%], respectively, p = 0.39). The visual analog scale reduction in urinary leakage improved from washout in both groups (p <0.0001) with no difference between them (p = 0.9). Dry mouth occurred in significantly fewer patients in the transdermal (38%) compared with those in the oral group (94%, p <0.001). Of the patients in the transdermal group 67% noticed a reduction in dry mouth severity compared with previous oral treatment, and 90% had none or mild skin erythema. CONCLUSIONS: Transdermal delivery of oxybutynin resulted in comparable efficacy and a significantly improved anticholinergic side effect profile compared with oral administration in adults with urge urinary incontinence.