Steroid-induced ocular hypertension in the pediatric age group.

PURPOSE: Comparing the effects of topical Rimexolone versus Dexamethasone and Rimexolone versus Fluorometholone on the intraocular pressure in children <13 years. METHODS: A total of 40 patients (80 eyes) undergoing bilateral recession strabismus surgery were divided into two groups. Group A included 20 children (40 eyes); for each, one eye was randomized to receive 1% Rimexolone and the fellow eye received 0.1% Dexamethasone. Group B included 20 children (40 eyes); for each, one eye was randomized to receive 1% Rimexolone and the fellow eye received 0.1% Fluorometholone. Patients received eye drops for two consecutive weeks. Preoperative and postoperative intraocular pressure values for weeks 1, 2, 3, 4, and 6 were measured. The ocular-hypertensive response of all patients was categorized as either high, intermediate or low (Armaly-Becker Classification). RESULTS: After a 2-week treatment for both groups, peak and maximal intraocular pressure changes were reached. Changes were significantly higher in the Dexamethasone-treated eyes than in the Rimexolone- and Fluorometholone-treated eyes, which had a comparable change. (Week 2 intraocular pressure Group A: 14.15 ± 3.23 mmHg vs 17.95 ± 4.27 mmHg; Group B: 15.1 ± 2.27 mmHg vs 15.2 ± 2.73 mmHg). In both groups, the increase was statistically significant compared to the baseline intraocular pressure (preoperative intraocular pressure Group A: 13.2 ± 3.53 mmHg vs 13.1 ± 3.43 mmHg; Group B: 12.55 ± 2.98 mmHg vs 12.15 ± 3.31 mmHg). Intraocular pressure returned to near preoperative values over the following four consecutive weeks (Week 6 intraocular pressure Group A: 12.25 ± 2.67 mmHg vs 12.55 ± 2.95 mmHg; Group B: 12.15 ± 2.8 mmHg vs 12.00 ± 2.75 mmHg). None of the patients were high responders. CONCLUSION: Dexamethasone caused a higher elevation in intraocular pressure than Rimexolone and Fluorometholone in children. The ocular-hypertensive response was transient after the 2-week course.

Effect of combined topical heparin and steroid on corneal neovascularization in children.

BACKGROUND AND OBJECTIVE: To demonstrate the effect of topical heparin combined with topical steroid on corneal neovascularization (CN) in children. PATIENTS AND METHODS: Four children (5 eyes) with new-onset progressive CN in at least one eye received topical rimexolone or dexamethasone in combination with heparin until complete regression of CN was obtained. The regression of CN was documented by slit-lamp or anterior segment photography. RESULTS: All 5 eyes showed complete regression of CN within 5 months. An anti-angiogenic effect was found as early as 1 week after starting topical combination treatment. No ocular and systemic side effects were detected and treatment was well tolerated by all children. In the 3 eyes with involvement of the optical axis, symmetrical visual acuity was obtained by amblyopia treatment. Recurrence of the CN was detectable in 2 eyes at 1 and 6 months, respectively, after ending combination therapy. Both eyes responded favorably to re-treatment. CONCLUSION: Combination of topical heparin and steroid leads to rapid regression and complete inactivity of CN. This therapeutic approach is promising, especially in children with limited therapeutic alternatives and a high risk for amblyopia.

[0.1% dexamathasone and 1% rimexolone. A comparative study in the postoperative treatment after cataract extraction]. / Dexametasona al 0,1% versus rimexolona al 1%. Estudio comparativo en el postoperatorio de la cirugía de cataratas.

PURPOSE: To compare the efficiency and secondary effects of using 1% rimexolone or 0.1% dexamethasone as postoperative treatment for cataract surgery. MATERIALS AND METHODS: A prospective study performed on a cohort of 37 patients undergoing cataract surgery by phacoemulsification with no intraoperative complications at the Hospital Clínico San Carlos, Madrid. After surgery, 19 of the patients were randomly assigned to receive topical 0.1% dexamethasone (DEX group) as inflammatory treatment and the remaining 18 subjects were treated with 1% rimexolone ( RIMEX group) following the same regime. Twenty four hours and one month after surgery, visual acuity, conjunctival hyperaemia, anterior chamber cells, anterior chamber flare, intraocular pressure, corneal thickness and macular edema were determined in each patient. RESULTS: The repeated measures test performed on 24 hours and 1 month data revealed a significant difference between the two treatments in terms of Tyndall (p = 0.001) and flare (p= 0.034) values; these variables being lower in the dexamethasone group. No differences were observed in the remaining variables examined. CONCLUSIONS: Rimexolone is as efficient and safe as dexamethasone for the treatment of patients undergoing cataract extraction.

Rimexolone 1% versus prednisolone acetate in preventing early postoperative inflammation after cataract surgery.

PURPOSE: To compare the efficacy and safety of rimexolone 1% and prednisolone acetate 1% ophthalmic suspensions in controlling intraocular inflammation in the early period after cataract surgery. METHODS: Eighty patients undergoing cataract extraction with intraocular lens implantation, either planned extra capsular cataract extraction (PECCE) or phacoemulsification surgery, were evaluated in a prospective, randomized, observer-masked, clinical trial in which efficacy in controlling early postoperative inflammation and safety of prednisolone acetate 1% one eye drop every 4 h (n = 36 eyes) was compared with that of rimexolone 1% one eye drop every 4 h (n = 44 eyes) in an eighteen day course. Efficacy was assessed from changes of the anterior chamber cell count, flare, conjunctival hyperemia, and ciliary congestion by means of slit lamp biomicroscopy on days 1, 3, 8, 15, and 18. Intraocular pressure (IOP) and possible side effects were also recorded on each visit. RESULTS: Anterior chamber cell count and flare showed no difference in the two groups at any visits. The rimexolone group was associated with significantly higher score for conjunctival hyperemia on days one and three (P < 0.05) and the prednisolone acetate group was associated with a significantly higher score for corneal edema on day 8 (P < 0,05). However, there were no between group differences in IOP. CONCLUSIONS: Rimexolone 1% ophthalmic suspension was as effective and safe as prednisolone acetate 1% ophthalmic suspension in controlling inflammation in the early period after cataract surgery.

Topical corticosteroids of limited potency promote adenovirus replication in the Ad5/NZW rabbit ocular model.

PURPOSE: To determine the effect of topical therapy with several corticosteroids with limited potency on viral clearance in the adenovirus type 5 (Ad5) rabbit ocular model. METHODS: Sixty rabbits were inoculated in both eyes with Ad5. On the first day, the rabbits were equally divided into four topical treatment groups: 0.12% prednisolone acetate (PA), 0.1% fluorometholone (FM), 1% rimexolone (RMX), and control. Treatment was administered four times daily, in both eyes, for 3 days. All eyes were cultured for virus on days 0, 1, 3, 4, 5, 7, 9, 11, 14, 16, 18, and 21. RESULTS: Compared with the control group, treatment with PA, FM, and RMX significantly increased the number of Ad5 positive eye cultures from days 7-21. Fluorometholone and RMX prolonged the duration of Ad5 shedding, and FM increased the mean combined Ad5 titer from days 1-5 and 7-21. CONCLUSIONS: Treatment of an experimental ocular adenovirus infection with PA, FM, and RMX for 3 days significantly enhanced adenovirus replication compared with the control group. Short-term treatment of EKC with several commercially available topical corticosteroids with limited potency may offer symptomatic relief, but may also delay viral clearance and promote office and community epidemics.

Comparison of ketorolac tromethamine 0.5% and rimexolone 1% to control inflammation after cataract extraction. Prospective randomized double-masked study.

PURPOSE: To compare the efficacy of a topical nonsteroidal anti-inflammatory agent (ketorolac tromethamine 0.5%) with that of a topical steroid (rimexolone 1%) to control inflammation after cataract surgery. SETTING: Storm Eye Institute, Department of Ophthalmology, Medical University of South Carolina, Charleston, South Carolina, USA. METHODS: Thirty-six patients were prospectively and randomly assigned to receive topical treatment with either ketorolac tromethamine 0.5% or rimexolone 1% starting the day after routine cataract extraction. Treatment was masked to both patient and investigator. Each patient had uneventful small incision phacoemulsification with placement of a foldable posterior chamber intraocular lens. Patients used 1 of the 2 antiinflammatory agents 4 times each day starting 24 hours after surgery. No antiinflammatory medications were used preoperatively, intraoperatively, or for 24 hours postoperatively. Signs and symptoms of inflammation, intraocular pressure (IOP), and Kowa cell and flare measurements were evaluated 1, 4, 7, and 30 days postoperatively. RESULTS: There was no statistically significant difference in any measurement of postoperative inflammation between the 2 groups. There was no difference in objective or subjective cell and flare measurements. In addition, there was no difference in IOP measurements between groups. CONCLUSIONS: Ketorolac tromethamine 0.5% was as effective as rimexolone 1% in reducing inflammation after cataract surgery. These results suggest that ketorolac tromethamine 0.5% is a safe and effective antiinflammatory alternative to steroids after cataract extraction.

Lipomatosis due to chronic steroid therapy.

(1) Lipomatosis (development of non encapsulated fatty masses) is a rare complication of chronic systemic steroid therapy. (2) Epidural and mediastinal lipomatosis due to steroid therapy carries a risk of symptomatic compression. (3) A dose reduction or, if possible, cessation of systemic steroid therapy almost always improves or removes the symptoms.

The effects of Rimexolone 1% in postoperative inflammation after cataract extraction. A double-masked placebo-controlled study.

AIM: A multicentre, randomized, placebo-controlled double-masked study was conducted to assess the efficacy and safety of Rimexolone 1% eye drops in reducing inflammation after cataract surgery and intra-ocular lens implantation. METHODS: Rimexolone 1% (124 patients) or placebo (58 patients) was given, four times a day for 14 days starting 22-34 hours after surgery. All patients also received tobramycin 0.3% four times a day for 7 days. The clinical signs of ocular inflammation were recorded on days 1, 3, 8, 15 and 17 or 18. RESULTS: Rimexolone 1% markedly decreased the mean inflammation severity scores, and the sum of clinical assessments of cells and flare in the anterior chamber compared with placebo at each assessment. In addition, the percentage of patients with no anterior chamber inflammation was significantly higher with Rimexolone 1% than with the placebo at each assessment. All these results were statistically significant. Intra-ocular pressure did not rise after treatment with Rimexolone 1%. CONCLUSIONS: The results suggest that Rimexolone 1% ophthalmic solution is an effective and safe steroidal anti-inflammatory agent for topical use following cataract surgery and intra-ocular lens implantation.

Control of ocular inflammation after cataract extraction with rimexolone 1% ophthalmic suspension.

PURPOSE: To assess the efficacy and safety of rimexolone 1% ophthalmic suspension in controlling intraocular inflammation after cataract extraction. SETTING: Twelve independent investigational centers in the United States METHODS: This study comprised 197 patients who had cataract extraction. Postoperatively, patients were randomized to a 2 week regimen of rimexolone 1% ophthalmic suspension or a placebo. Efficacy was analyzed by monitoring total anterior chamber cells and flare, other parameters of inflammation, and treatment failures. Safety was evaluated by monitoring treatment-related adverse events and intraocular pressure (IOP). RESULTS: Rimexolone 1% was clinically and statistically more effective in suppressing cell and flare than the placebo (P < .02). The overall discontinuation rate for treatment-related adverse events was 5.3% in the rimexolone group and 22.2% in the placebo group. There were no between-group differences in IOP. CONCLUSION: Rimexolone 1% ophthalmic suspension was safe and significantly more effective than a placebo in controlling intraocular inflammation after cataract extraction when used four times daily and continued for 2 weeks.

A new therapy for pelvic endometriosis and uterine adenomyosis: local effect of vaginal and intrauterine danazol application.

In order to investigate the effect of the local direct action of danazol upon endometriosis, intravaginal and intrauterine application were tried. A vaginal danazol ring containing 2 g to 3.5 g danazol not only reduced both dysmenorrhea and the extent of pelvic endometriosis in all 35 infertile women, but also resulted in conception in 13 out of 35 infertile women while the vaginal ring was in place. Uterine adenomyosis usually fails to respond to oral danazol therapy, but an intrauterine device containing 175 mg of danazol was effective in reducing the size of the uterus and in inducing pregnancy in 66.6% cases. It is noteworthy that this vaginal or intrauterine danazol therapy did not inhibit ovulation, but still effected atrophy of endometriosis and aided in the establishment of pregnancy. These results clearly demonstrate that the main mode of action of danazol is its direct action on endometriotic cells.

Effects of conjugated equine oestrogens with and without the addition of cyclical medrogestone on hot flushes, liver function, blood pressure and endocrinological indices.

Despite widespread clinical use of conjugated oestrogens, there is a paucity of reported studies concerning the effect of such therapy in sequential combination with the progestin, medrogestone (Colpro; Akromed). In a double-blind study, 22 oestrogen-deficient women who had undergone hysterectomy (mean age 52,8 years) were treated initially for 6 cycles with either conjugated equine oestrogens 0.625 mg (CEE) for 21 days plus a placebo during the last 10 days of each cycle or the same oestrogen regimen with 10 days of medrogestone 5 mg/d. Thereafter the treatments were crossed over for a further 6 cycles. CEE monotherapy resulted in significantly decreased levels of follicle-stimulating hormone (FSH), luteinising hormone (LH), prolactin (PRL) (P less than 0,001) and gamma-glutamyl transferase (P less than 0,01) with an increase in 17 beta-oestradiol (P less than 0,001). Medrogestone had a synergistic effect on the lowering of FSH, LH and PRL. No treatment modality caused any significant changes in blood pressure, fasting glucose value or vaginal cellular percentages. The decrease in hot flush scores, already manifest at the end of the first cycle, were sustained throughout (P less than 0,001).

A randomized, prospective comparison of endocrine changes induced with intranasal leuprolide or danazol for treatment of endometriosis.

A prospective, randomized trial compared hormonal changes induced with intranasal leuprolide 1.6 mg/day to danazol 800 mg/day for treatment of endometriosis. Both regimens induced anovulation and ovarian suppression in all subjects. Mean estradiol (E2) and progesterone (P) levels were suppressed with both regimens, but were lower with leuprolide. There was no difference in cumulative follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels, although at times during treatment mean levels of these hormones were lower with leuprolide. Higher P levels in the danazol group, most likely of adrenal origin, indicated a suppressive effect on adrenal steroidogenesis. Symptomatic improvement was significant in both groups. Laparoscopy after treatment also demonstrated a decrease in endometriosis scores in both groups. At 12 months after treatment, cumulative pregnancy and live birth rates were similar in both groups. Leuprolide offers an attractive alternative to danazol for the medical treatment of endometriosis.

Placebo-controlled comparison of danazol and high-dose medroxyprogesterone acetate in the treatment of endometriosis.

A prospective, double-blind, placebo-controlled study was designed to evaluate the clinical efficacy and tolerance of danazol and high-dose medroxyprogesterone acetate (MPA) in the treatment of mild-moderate endometriosis. After laparoscopical confirmation of endometriosis, 59 patients were randomized to receive danazol (200 mg 3 times daily), MPA (100 mg daily) or placebo for 6 months. Clinical examinations were done before and 1, 3, 6 and 12 months after the beginning of the study, and a 2nd laparoscopy 6 months after termination of the medication. Eighteen patients in the danazol group, 16 in the MPA group and 17 in the placebo group completed the trial. Total or partial resolution of peritoneal implants was observed in 60% of the patients receiving danazol and in 63% of the patients receiving MPA. In the placebo group, resolution was observed in 18%, while the size of the implants was estimated to be increased in 23% of the patients. In relation to placebo, danazol and MPA significantly alleviated endometriosis-associated pelvic pain, lower back pain and defecation pain, but they did not differ from each other in these actions. The appearance of acne, muscle cramps, edema, weight gain and spotting bleeding complicated MPA treatment. The present results indicate that because of good efficacy and tolerance, high-dose MPA is a useful alternative in the hormonal treatment of endometriosis.

A comparative study of various dosages of danazol in the treatment of endometriosis.

The results of a randomized trial to investigate the efficacy of different dosage regimens of danazol in the treatment of endometriosis indicate that for mild endometriosis 200 mg/day of danazol is adequate therapy with less severe side effects than higher dosages. However, more extensive disease requires a higher dose.

Treatment of recurrent cyclical mastodynia in patients with fibrocystic breast disease. A double-blind placebo-controlled study--the Hjørring project.

Thirty premenopausal women with recurrent, pronounced cyclical mastodynia associated with mammographically confirmed fibrocystic disease were studied. All patients had long-standing symptoms, had undergone one previous course of treatment with danazol, and were recruited during long-term follow-up after original treatment, when cyclical mastodynia had again reached similar severity as before the original treatment (mean interval between treatments 9.5 +/- 3.9 (SD) months). Fifteen patients each were randomly allocated to double-blind treatment with either danazol or placebo. During the first month, 2 capsules a day (each containing danazol 100 mg or placebo) were given, thereafter one capsule a day up to 6 months. Danazol caused a marked and sustained decrease in mastodynia, according to the clinician's assessment and according to each patient's self-rating on a visual analogue scale. The response to danazol was fairly uniform and statistically significant (p less than 0.005 or less), whereas the response to placebo was inconsistent and not statistically significant (p greater than 0.10). Danazol proved significantly more effective than placebo (p less than 0.05 or less). Changes in palpatory and/or mammographic findings were also found more consistently after danazol treatment than after placebo. During treatment, there was a modest weight increase, which was statistically significant in the danazol group (p less than 0.01) but not in the placebo group. A greater frequency in menstrual irregularities was observed in the danazol group than in the placebo group, but not to an extent that would have caused 'unblinding' of the study.(ABSTRACT TRUNCATED AT 250 WORDS)

Regression of endometriosis following shorter treatment with, or lower dose of danazol. Comparison of pre- and post-treatment laparoscopic findings in the Scandinavian multi-center study.

One hundred and sixteen patients with laparoscopically confirmed primary or recurrent endometriosis were treated with danazol, either 600 mg daily for 4 months (group A, n = 76) or 600 mg daily for the first 2 months, followed by 400 mg daily for an additional 4 months (group B, n = 40). The only surgery performed before treatment was biopsies, resection of endometriomas greater than or equal to 3 cm and/or adhesiolysis. The extent of endometriosis before and after treatment was established laparoscopically and recorded by means of a modified AFSrecord as mean additive diameter of implants (mean ADI) in millimeters. This provided a uniform and reproducible quantitative registration for each type and location of endometriotic implant. Both treatment schemes resulted in a highly significant (p less than 0.001) reduction of endometriosis, by 79 and 89% in groups A and B, respectively. However, the reduction in mean ADI was significantly greater (p less than 0.025) in group B which had been treated for a longer period. Moreover, the proportion of patients with extensive pre-treatment lesions (mean ADI greater than or equal to 40 mm) was significantly greater in this group. Active residual endometriosis was found in 21 and 17.5% in groups A and B, respectively. These patients had significantly more extensive endometriosis before treatment. The regression of endometriotic implants was independent of type and/or location, i.e. superficial or scarred; peritoneal, ovarian, or tubal. There was no apparent correlation between the quantitative reduction of endometriosis and amenorrhea versus occasional spotting and/or irregular menstruations.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical trial of multiple endocrine therapy for metastatic and locally advanced breast cancer with tamoxifen-aminoglutethimide-danazol compared to tamoxifen used alone.

Multiple-endocrine therapy with combinations of various types of treatment has not been evaluated properly in spite of the success of individual types of hormone treatment. This paper reports the early results of a randomized controlled clinical trial comparing tamoxifen (10 mg 2 times/day)-amino-glutethimide (250 mg 3 times/day)-danazol (100 mg 3 times/day)-hydrocortisone (20 mg 2 times/day) (TAD) with tamoxifen (10 mg 2 times/day). Analysis of the first 107 assessable patients indicates objective response (criteria of the International Union Against Cancer) in 33% of patients receiving tamoxifen versus 50% of patients receiving TAD. Duration of response to TAD is identical to duration of response to tamoxifen alone. TAD is well tolerated, and toxicity, although greater than or tamoxifen, is acceptable.