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Etienneemile Baulieu - One of the best experts on this subject based on the ideXlab platform.
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early termination of pregnancy with mifepristone ru 486 and the orally active Prostaglandin misoprostol
The New England Journal of Medicine, 1993Co-Authors: Remi Peyron, Louise Silvestre, Maguy Renault, Andre Ulmann, E Aubeny, Veronique Targosz, Francois Elkik, Philippe Leclerc, Etienneemile BaulieuAbstract:Background and Methods The combination of mifepristone (RU 486) and a Prostaglandin Analogue given either intramuscularly or intravaginally is effective in terminating early pregnancy, but the Prostaglandin component of the regimen is cumbersome to administer and has side effects. We conducted two studies to determine the efficacy of 600 mg of mifepristone followed by a small dose of misoprostol, an orally active Prostaglandin E1 Analogue, for the same purpose. In the first study, 505 women who had had amenorrhea for less than 50 days received 400 μg of misoprostol 48 hours after receiving mifepristone, if the pregnancy was not terminated within that period. In the second study, 390 women initially received the same treatment, but if the pregnancy was not terminated within four hours after the administration of misoprostol, they were offered an additional 200-μg dose of misoprostol. Results In study 1, the rate of success (termination of pregnancy and complete expulsion of the conceptus) was 96.9 percent ...
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medical termination of early pregnancy with mifepristone ru 486 followed by a Prostaglandin Analogue study in 16 369 women
Acta Obstetricia et Gynecologica Scandinavica, 1992Co-Authors: Andre Ulmann, Louise Silvestre, Yvonne Rezvani, Laurence Chemama, Marguerite Renault, Claude J Aguillaume, Etienneemile BaulieuAbstract:We report the results of a large-scale trial with mifepristonc (RU 486) followed by the administration of a Prostaglandin (PG) Analogue for the medical termination of early pregnancy. Altogether, 16,173 patients from 300 centers were evaluated. 48 women (0.3%) were lost to follow-up prior to, and 416 (2.6%) after the PG administration, and therefore the efficacy was evaluated in 15,709 women. Overall. the success rate was 95.3%. with no statistical difference regarding the nature and dose of PG used. The median duration of bleeding was 8 days, being 12 days or less in 89.7% of the women. Bleeding was significant cnough to necessitate a vacuum aspiration or a dilatation and curettage in 0.8% of the cases. A blood transfusion was necessary in 0.1% of the women (11 patients). Serious cardio-vascular side-effects were reported in 4 cases after the PG (sulpro/tonc) injection: they consisted of one acute myocardial infarction attributed to a coronary spasm. and in marked hypotension in the other 3 woman. All pa...
Johan Stjernschantz - One of the best experts on this subject based on the ideXlab platform.
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bimatoprost the prodrug of a Prostaglandin Analogue
British Journal of Ophthalmology, 2008Co-Authors: C B Camras, N A Sharif, Martin B Wax, Johan StjernschantzAbstract:We congratulate the authors of their adequately designed study1 that demonstrates the high concentration of the free acid (the product of hydrolysis) of bimatoprost (BP), an amide, in the aqueous humour of patients receiving a single drop of BP 1, 3 or 6 h prior to cataract surgery. This important study confirms the results found in previous studies.2 3 However, despite providing important confirmatory data, Cantor et al 1 appear to reach conclusions that are not supported by their own data. Whereas the two previous studies2 3 conclude that BP is a prodrug that is hydrolysed to its free acid to account for its ocular hypotensive effect by activation of known F-type Prostaglandin (FP) receptors, the current publication1 surprisingly concludes that BP is not a prodrug and acts directly as an amide to reduce intraocular pressure (IOP). The clinical studies cited above1–3 are not the only ones that have demonstrated the hydrolysis of BP in ocular tissues. Previous studies have demonstrated its hydrolysis in vitro in rabbit, bovine and human ocular tissues4–7 and after topical application in vivo in rabbit and monkey ocular tissues.8 The hydrolysis of BP to produce sufficient concentrations of its very potent free acid, a well-described FP receptor agonist, provides clear evidence of its prodrug properties. Studies in FP receptor knockout mice have clearly demonstrated the importance of FP receptors for effective IOP reduction after topical application of FP receptor agonists, including BP.9–12 The three clinical studies1–3 provide very consistent data. Each demonstrates equal or higher levels of the free acid than the intact amide of BP in aqueous humour. Each demonstrates peak levels occurring within the first few hours after topical application of BP, …
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studies on ocular inflammation and development of a Prostaglandin Analogue for glaucoma treatment
Experimental Eye Research, 2004Co-Authors: Johan StjernschantzAbstract:This review summarizes the Ernst H. Barany Prize Lecture given at the meeting of the International Society of Eye Research in Geneva 2002. In the paper the path from the author's early studies on neurogenic inflammation in the eye to the search for a suitable Prostaglandin Analogue for glaucoma treatment, and the development of latanoprost are described. In particular the solution to the nociceptive and hyperemic side-effects of naturally occurring Prostaglandins in the eye, the mechanism of action of FP prostanoid receptor agonists as well as the selection of dose for glaucoma treatment are discussed. In addition, pharmacokinetical aspects of latanoprost, and the melanogenic side-effect of Prostaglandins in the iris are addressed. The paper is primarily focused on studies performed by the author and complete reference to other previous, or contemporary studies is therefore not always given as the purpose is not to present a comprehensive review article.
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studies on ocular inflammation and development of a Prostaglandin Analogue for glaucoma treatment
PMID, 2004Co-Authors: Johan StjernschantzAbstract:Studies on ocular inflammation and development of a Prostaglandin Analogue for glaucoma treatment
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increased pigmentation of iridial melanocytes in primates induced by a Prostaglandin Analogue
Experimental Eye Research, 1999Co-Authors: Nils Gunnar Lindquist, Bengt Larsson, Johan StjernschantzAbstract:The melanocytes in the mammalian eye have been thought to produce melanin only during fetal development and in the very young individual. The recent discovery that latanoprost, a Prostaglandin Analogue used in the treatment of glaucoma, causes increased pigmentation of the iris in monkeys and in humans indicates that the iridial melanocytes can produce melanin in adult individuals. Using microautoradiography of HG-(3)H-methimazole, a false melanin precursor, we observed in an earlier study that there seems to be an ongoing melanogenesis in adult mice in the iridial melanocytes and in the iridial pigment epithelium. In the present study latanoprost (13,14-dihydro-17-phenyl-18,19,20-trinor-PGF(2alpha)-isoprop yl ester) was applied once daily to the right eye of seven cynomolgus monkeys; the left eye served as an untreated control. Two animals developed clear-cut increased pigmentation of the iris in the treated eye during the first three months of treatment. These animals were injected intravenously with G-(3)H-methimazole and were killed 24 hr after the injection. The eyes were removed, fixed in 4% formalin supplemented with 10% acetic acid and embedded in paraffin or Polybed 812. Sections from the eyes were used for microautoradiography and light microscopic examination. A high uptake of radioactivity was observed in a few melanocytes in the iris of the untreated eye. There were also a low uptake in the melanocytes in the stroma of the ciliary body and the choroid. No accumulation was observed in the iridial or retinal pigment epithelium. In the iris of the treated eye the only observed difference from the untreated eye was an increased amount of melanin in the iridial melanocytes and an increased uptake of radioactivity in a great number of these cells. Thus it seems likely that treatment with latanoprost in some individuals causes an increase of the low normal melanin synthesis in iridal melanocytes.
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intraocular pressure reduction with phxa34 a new Prostaglandin Analogue in patients with ocular hypertension
Archives of Ophthalmology, 1992Co-Authors: Carl B Camras, Johan Stjernschantz, Robert A Schumer, Anders Marsk, Jacqueline S Lustgarten, Janet B Serle, Laszlo Z Bito, Steven M PodosAbstract:• In a randomized, double-masked, parallel study, one drop of 0.003% (1 μg; n=9) or 0.01% (3 μg; n=10) PhXA34, a new phenyl-substituted Prostaglandin F2αAnalogue (13,14-dihydro-15[R,S]-17-phenyl18,19,20-trinor-Prostaglandin F2α-1-isopropyl ester), or its vehicle (n=10) was applied topically twice daily for 6 days to one eye in each of 29 patients with ocular hypertension. Compared with either baseline, contralateral, or vehicle control values, PhXA34 caused a significant (P
Anastasios G P Konstas - One of the best experts on this subject based on the ideXlab platform.
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a new look at the safety and tolerability of Prostaglandin Analogue eyedrops in glaucoma and ocular hypertension
Expert Opinion on Drug Safety, 2021Co-Authors: Andreas Katsanos, Gabor Hollo, Francesco Oddone, Luciano Quaranta, Ivano Riva, Banu Bozkurt, Murat Irkec, Gordon N Dutton, Anastasios G P KonstasAbstract:Introduction In the last 25 years, topical Prostaglandin Analogues (PGAs) have emerged to become first line and first choice therapeutic options in the management of glaucoma and ocular hypertension (OHT). Although the short-term efficacy and safety of PGAs has been extensively investigated, less is known about their long term safety and tolerability. This gap in current knowledge is clinically relevant, because treatment-related adverse events and long-term tolerability issues are key determinants of the overall success of long-term therapy and the final outcome of a lifelong, symptomless disease like glaucoma. Areas covered We include selected evidence pertaining to the safety and tolerability of available and emerging PGA formulations. We also outline PGA formulations with different concentrations of the active ingredient, different preservatives, and preservative-free (PF) options. Expert opinion Undoubtedly PGAs will continue to play a major role in the medical therapy of glaucoma and OHT. Despite extensive literature and prolonged clinical experience with these agents worldwide, a number of areas that warrant further research have been identified in the present review. Recently launched novel PGAs, or those still in development offer new opportunities and future challenges.
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safety and efficacy of travoprost solution for the treatment of elevated intraocular pressure
Clinical Ophthalmology, 2015Co-Authors: Luciano Quaranta, Andreas Katsanos, Ivano Riva, Irene Floriani, Marco Centofanti, Anastasios G P KonstasAbstract:Travoprost is a Prostaglandin Analogue widely used for reducing intraocular pressure (IOP) in patients affected with glaucoma and ocular hypertension. It exerts its ocular hypotensive effect through the Prostaglandin FP receptors, located in the ciliary muscle and the trabecular meshwork. Several studies have shown that topical administration of travoprost induces a mean IOP reduction ranging from 25% to 32%, and sustained throughout the 24-hour cycle. When compared with timolol, travoprost is more effective at reducing IOP, while generally no difference has been found in the head-to-head comparison with other Prostaglandin Analogues. The fixed combination of travoprost and timolol has demonstrated a hypotensive efficacy comparable to the concomitant administration of the two drugs. Recently, a new preservative-free formulation of travoprost 0.004% has been marketed for reducing tolerability-related problems in subjects affected with ocular surface disease. Low rates of topical and systemic adverse reactions, strong ocular hypotensive efficacy, and once-a-day dosing make travoprost a first-line treatment for patients affected with elevated IOP.
Andre Ulmann - One of the best experts on this subject based on the ideXlab platform.
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early termination of pregnancy with mifepristone ru 486 and the orally active Prostaglandin misoprostol
The New England Journal of Medicine, 1993Co-Authors: Remi Peyron, Louise Silvestre, Maguy Renault, Andre Ulmann, E Aubeny, Veronique Targosz, Francois Elkik, Philippe Leclerc, Etienneemile BaulieuAbstract:Background and Methods The combination of mifepristone (RU 486) and a Prostaglandin Analogue given either intramuscularly or intravaginally is effective in terminating early pregnancy, but the Prostaglandin component of the regimen is cumbersome to administer and has side effects. We conducted two studies to determine the efficacy of 600 mg of mifepristone followed by a small dose of misoprostol, an orally active Prostaglandin E1 Analogue, for the same purpose. In the first study, 505 women who had had amenorrhea for less than 50 days received 400 μg of misoprostol 48 hours after receiving mifepristone, if the pregnancy was not terminated within that period. In the second study, 390 women initially received the same treatment, but if the pregnancy was not terminated within four hours after the administration of misoprostol, they were offered an additional 200-μg dose of misoprostol. Results In study 1, the rate of success (termination of pregnancy and complete expulsion of the conceptus) was 96.9 percent ...
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medical termination of early pregnancy with mifepristone ru 486 followed by a Prostaglandin Analogue study in 16 369 women
Acta Obstetricia et Gynecologica Scandinavica, 1992Co-Authors: Andre Ulmann, Louise Silvestre, Yvonne Rezvani, Laurence Chemama, Marguerite Renault, Claude J Aguillaume, Etienneemile BaulieuAbstract:We report the results of a large-scale trial with mifepristonc (RU 486) followed by the administration of a Prostaglandin (PG) Analogue for the medical termination of early pregnancy. Altogether, 16,173 patients from 300 centers were evaluated. 48 women (0.3%) were lost to follow-up prior to, and 416 (2.6%) after the PG administration, and therefore the efficacy was evaluated in 15,709 women. Overall. the success rate was 95.3%. with no statistical difference regarding the nature and dose of PG used. The median duration of bleeding was 8 days, being 12 days or less in 89.7% of the women. Bleeding was significant cnough to necessitate a vacuum aspiration or a dilatation and curettage in 0.8% of the cases. A blood transfusion was necessary in 0.1% of the women (11 patients). Serious cardio-vascular side-effects were reported in 4 cases after the PG (sulpro/tonc) injection: they consisted of one acute myocardial infarction attributed to a coronary spasm. and in marked hypotension in the other 3 woman. All pa...
Chloe Gottlieb - One of the best experts on this subject based on the ideXlab platform.
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uveitis and cystoid macular oedema secondary to topical Prostaglandin Analogue use in ocular hypertension and open angle glaucoma
British Journal of Ophthalmology, 2020Co-Authors: Brian Y Hong, Chloe GottliebAbstract:Background Of the side effects of Prostaglandin Analogues (PGAs), uveitis and cystoid macular oedema (CME) have significant potential for vision loss based on postmarket reports. Caution has been advised due to concerns of macular oedema and uveitis. In this report, we researched and summarised the original data suggesting these effects and determined their incidence. Methods Preferred Reporting Items for Systematic review and Meta-Analyses guidelines were followed. Studies evaluating topical PGAs in patients with ocular hypertension or open angle glaucoma were included. MEDLINE, PubMed, EMBASE, CINAHL, Web of Science, Cochrane Library, LILACS and ClinicalTrials.gov were searched between 1946 and 2019. Experimental studies, animal studies and randomised studies with other intraocular pressure-lowering eye drops were excluded. Results 214 studies (28 232 patients) met the inclusion criteria. Using prospective data, the incidence of uveitis and CME among PGA users were 62/28 232 (0.22%) and 25/28 232 (0.09%), respectively. A higher frequency of both uveitis and CME were found among latanoprost users compared with bimatoprost. There were 21 case studies reporting CME including 48 eyes in 43 patients. 47 of 48 eyes (97.9%) had previous incisional ocular surgery. 8 eyes were re-challenged, of which 7 (87.5%) recurred. 7 case studies reported uveitis in 15 eyes of 10 patients. 7 of 15 eyes (46.7%) were either pseudophakic or aphakic. 6 eyes were re-challenged, and all 6 (100%) recurred. Conclusions Cases of uveitis or CME revealed a confounding effect of ocular surgery, aphakia or subluxed intraocular lens. PGAs may be used in non-surgical patients without concern of causing CME or uveitis. The incidences of PGA-associated CME and uveitis are rare with limited prospective studies on the cause-effect relationship.
