Tenidap in patients with rheumatoid arthritis. A 4-week, placebo-controlled study.

The present double-blind, placebo-controlled study was conducted to compare the safety and efficacy of tenidap in patients with rheumatoid arthritis (RA). Patients with flare of active RA following NSAID withdrawal were randomized to receive either placebo (n = 67) or tenidap (n = 131; 40-200 mg/day). The mean changes from baseline in efficacy and biochemical variables were compared between treatment groups at endpoint (4 weeks). The improvements in four of the five primary efficacy variables were significantly greater in the tenidap group compared with the placebo group (p < 0.01). Tenidap was also associated with an 18% reduction in erythrocyte sedimentation rate (ESR) and a marked, 51%, reduction in serum C-reactive protein (CRP) level, both of which were significantly greater than the changes in the placebo group (p < 0.05). The percentage of patients who discontinued because of side effects was the same in both groups (3%). In conclusion, tenidap 40-200 mg/day was effective and well tolerated in the treatment of patients with RA for 4 weeks.

Association between bovine collagen dermal implants and a dermatomyositis or a polymyositis-like syndrome.

OBJECTIVE: To determine whether an excess incidence of dermatomyositis or polymyositis or both exist in patients treated with injectable bovine collagen implants and to characterize the clinical picture. DESIGN: Historical cohort study (July 1980 through June 1988). PATIENTS: Patients were identified from personal experience or adverse reaction reports received by the manufacturer. SETTING: An 8-year period in the United States during which approximately 345,000 patients received implants. RESULTS: Eight patients with dermatomyositis and an additional patient with polymyositis were identified from approximately 345,000 patients receiving injectable bovine collagen implants from July 1980 through June 1988. The nine patients with dermatomyositis or polymyositis were diagnosed an average of 6.4 months (range, 0.7 to 24.9 months) after collagen implant or skin test exposure or both. Eight of the nine patients had a delayed-type hypersensitivity response at the test or treatment sites or both, and five of six patients tested were found to have increased serum antibodies to collagen. Compared with the general population, the incidence of dermatomyositis or polymyositis among collagen-treated patients was statistically increased (standardized incidence ratio, 5.05; 95% CI, 2.31 to 9.59; P < 0.0001). A similar analysis of the eight dermatomyositis case patients produced a standardized incidence ratio of 18.8 (CI, 8.1 to 37.0; P < 0.0001). Using a Monte Carlo simulation, an interval of 6.4 months or less from exposure to onset of disease was found to be an extremely rare event, occurring less than 72 times per one million simulation trials (CI, 57 to 91). CONCLUSIONS: Because these data suggest that an immunologic response to bovine type I or type III collagen or both caused this dermatomyositis or polymyositis-like syndrome, the risks versus benefits for the cosmetic use of collagen implants should be reassessed.

Intramuscular ketorolac and morphine in the treatment of moderate to severe pain after major surgery.

A multicenter, randomized, open, parallel study in 227 patients with moderate or severe postoperative pain compared the analgesic efficacy and safety of multiple intramuscular injections of ketorolac 30 mg (184 patients) and morphine 10 mg (43 patients) administered as needed as often as every 2 hours for a maximum of 40 doses or 10 days. Supplemental standard analgesics, usually opiates, were permitted if additional pain medication was required. When used with supplemental analgesics (averaging less than 1 dose/day), ketorolac afforded equal or superior efficacy to morphine used with other supplemental analgesics. Given alone or with supplemental analgesics, ketorolac was better tolerated than morphine, as reflected by rate of terminations due to adverse events and frequency of common complaints. Intramuscular ketorolac thus provides an important additional approach to management of pain.

Concomitant administration of terazosin and atenolol for the treatment of essential hypertension.

The safety and efficacy of once-daily terazosin hydrochloride administered concomitantly with once-daily atenolol for the treatment of essential hypertension were evaluated in this double-blind, multiclinic, placebo-controlled study. After each patient received 50 mg of atenolol daily for eight weeks, patients with a supine diastolic blood pressure (DBP) of 95 to 110 mm Hg and whose supine DBP had decreased at least 5 mm Hg were randomized to receive either terazosin (plus atenolol) or placebo (plus atenolol) for ten weeks. Patients assigned to the terazosin hydrochloride treatment group received increasing dosages (1,2,5, and 10 mg daily) [corrected] of terazosin at two-week intervals until the maximum dose was reached or until the supine DBP was decreased to less than 90 mm Hg. Terazosin-treated patients (n = 43) had significant mean decreases from the baseline in supine BP (systolic/diastolic = -8.8/-8.5 mm Hg) and standing BP (-10.9/-9.5 mm Hg), whereas the decreases in BP in the placebo-treated patients (n = 49; supine, -2.3/-2.6 mm Hg; standing, -1.4/-1.3 mm Hg) were not significant. When terazosin and placebo were compared, the differences in BP were significant. Terazosin-treated patients had significantly greater decreases in mean percent change of total cholesterol (-4.8%) and low-density lipoprotein plus very-low-density lipoprotein cholesterol (-6.3%) levels, compared with the placebo-treated patients (+0.6% and +1.1%, respectively). Concomitant administration of terazosin and atenolol to patients with essential hypertension was found to be safe and efficacious.

Subclavian vein catheterization for apheresis access.

We have inserted Shiley Vas-Caths into the subclavian veins of 20 patients. These indwelling catheters are used for apheresis and some were maintained up to 3 months. Of the 430 apheresis procedures performed, 30 (6.9%) had good peripheral vein access while 400 (93.1%) required subclavian vein catheterization. No complications, including infection and blood clotting, have been recorded. The only contamination noted was normal skin flora cultured on the outside of the exposed portion of the cannula. We attribute our success to limited catheter manipulation, frequent dressing changes, and adhering to strict, sterile procedures.

Sickle cell disease associated with uric acid deposition disease.

The infrequent occurrence of gout in patients with sickle cell anaemia contrast with the high incidence of hyperuricaemia and impaired renal function. This report records the third case of synovial membrane uric acid deposition and the first case of tophaceous deposits in haemoglobin SS patients. The limitations of a diagnosis of gout on the basis of hyperuricaemia and arthritis are confirmed. Analysis of reported cases suggests the existence of 2 forms of arthritis associated with sickle cell anaemia--noninflammatory and inflammatory. Paradoxically, gout appears to be associated with the former, in which the pathophysiological changes probably prevent or diminish the acute inflammatory response.