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Combined with a deteriorating hemodynamic status, it is not surprising that the addition of hemodynamic variables did not significantly improve the model fit. Although the risk for PAH worsening was significantly associated with age at diagnosis by univariate analysis i.e., the younger the child was at the time of diagnosis, the better the outcome was ; , the age at diagnosis was no longer significant once functional class was included in the model. Greater pulmonary vascular medial hypertrophy with less intimal fibrosis and fewer plexiform lesions have been reported in young children in comparison to older PAH patients 22 ; . In addition, younger children have also been reported to acutely respond with vasodilator testing more often than adult IPAH patients 3, 4 ; . The main limitations of this study are its retrospective design and the lack of a control group. However, considering the limited clinical pediatric data currently available, the present retrospective study, which involves a large cohort of children, provides clinical data consistent with long-term safety and efficacy of bosentan for the treatment of pediatric PAH. The inclusion of patients with different PAH etiologies IPAH and PAH associated with CHD or connective tissue disease ; could also be considered a limitation. However, these clinical conditions are known to share many histopathologic, pathobiologic, and clinical similarities 19 ; . Although the median follow-up for hemodynamics was nine months and does not necessarily constitute "long-term" follow-up, we believe these data are meaningful given the lack of previous hemodynamic data in children. Furthermore, whereas the efficacy of bosentan in patients with IPAH has been demonstrated in adults 16 ; , limited clinical data are available on the treatment of patients with PAH associated with CHD. The data from the present study, which include a large proportion of patients with PAH associated with CHD, suggests that bosentan may also benefit these patients. In conclusion, these data suggest that bosentan, an oral endothelin ETA ETB receptor antagonist, with or without concomitant prostanoid therapy, is safe and efficacious for the treatment of PAH in children.
Jamei, M, Yang, J, & Rostami-Hodjegan, A 2004 ; , LogP 2004 Symposium, Zurich-Switzerland . Yu, LX, & Amidon, GL 1999 ; , International Journal of Pharmaceutics, 186, 119-125
Bosentan tracleer ; , a relatively new treatment, widens the lung arteries and reduces blood pressure.
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Figure 5. p53 relocation after Nutlin-3a treatment. A ; Representative p53 localization patterns arrows ; in primary CLL cells from patient no. 5 nuclear accumulation ; and no. 8 cytoplasmic accumulation ; , which were treated with 5 M Nutlin-3a for 6 hours. Cells were stained for p53 green ; and mitochondrial marker protein cytochrome c oxidase IV red ; and visualized by confocal microscopy. Nuclei were counterstained with DAPI blue ; . B ; Preferential translocation of cytoplasmic p53 to mitochondria in CLL cells. Localization of p53 to mitochondria is indicated by the yellow-orange color in the merged image arrowheads and botox.
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Objectives: This study was designed to assess the tolerability and efficacy of the oral endothelin receptor antagonist bosentan in adult patients with pulmonary arterial hypertension PAH ; related to congenital heart disease CHD ; . Background: Severe PAH in the setting of CHD is a debilitating syndrome for which there are limited treatment options. This is the first long-term study experience in adults reporting on the tolerability and efficacy of therapy with bosentan for this patient population. Methods: A 12-month single-center experience with 19 women and 5 men with PAH associated with CHD 79% in New York Heart Association [NYHA] class III ; was analyzed. Hemodynamic responses, exercise capacity, and Borg dyspnea index were assessed prior to the administration of bosentan, and again at 3, 6, and 12 months after the study began. Clinical assessments were performed monthly for up to 12 months. The change from baseline was tested using the Wilcoxon pairs test. Results: There was significant improvement in hemodynamics from baseline to 12 months mean [ SD] systolic pulmonary arterial pressure, 99 30 to 87 0.001]; mean pulmonary arterial pressure, 60 18 to 52 0.001]; mean right atrial pressure, 12 6 to 8 0.001]; mean pulmonary vascular resistance, 663 386 to 504 307 dyne s cm 5 0.01]; pulmonary capillary wedge pressure, 15 5 to 11 0.001] ; . NYHA functional class also improved from baseline to 12 months NYHA class I II range, 17 to 71%; p 0.001 ; . There was a marginally significant trend toward improvement in the mean 6-min walk test distance at 12 months 299 85 to 330 95 m; p 0.05 ; . Three patients needed to discontinue bosentan therapy because of elevated liver function test results. There were no deaths or hospitalizations, and no significant change in arterial oxygen saturation had occurred at 12 months. Conclusions: Bosentan therapy improved hemodynamics and NYHA class in patients with PAH that was associated with CHD. These effects were seen after 3 to 6 months. Bosentan therapy may provide an effective alternative to current therapies in this patient population. CHEST 2006; 129: 1009.
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Individuals with RP suffer from severe pain, with significant impairment of hand function and with serious impact on activities of daily living foremost during winter seasons. The results of previous studies [8] showing that bosentan prevents digital ulcers in SSc, prompted us to use bosentan in a small number of patients with severe RP in the setting of pre-scleroderma and limited SSc independent of a history of digital ulcerations. All patients had previously received calcium-channel blockers and intravenous prostaglandin analogues without sustained benefit. We are aware of the limitations inherent to this study; i.e. it is uncontrolled, observational and involves a small number of patients only. Moreover, endpoints are mainly subjective and placebo responses cannot entirely be ruled out. Yet, pain, Raynaud's disease activity and number severity of Raynaud's attacks significantly decreased, reflected by improved thermoregulation in all patients after the 16-week treatment period. Moreover, all patients preferred to repeat bosentan therapy during the following winter seasons instead of receiving infusions with prostaglandin analogues. Thus, despite the obvious limitations of our study, the response to bosentan in severe secondary RP appears beneficial. In previous trials, no major effects of bosentan on RP have been recognized [8]. This somewhat conflicting result could be explained by the fact that in patients with multiple digital ulcerations as included in the RAPIDS trials end stage microvascular damage and severe sclerodactyly are usually present so that immediate effects of bosentan on RP may not be obvious any more. Infusions with prostaglandin analogues are invasive and require hospitalization. This is associated with dose-related side effects and with complications related to intravenous application. The advantages of bosentan are its oral administration on an out-patient basis, and its lack of severe side effects. The application of bosentan in secondary RP, potentially as an interval therapy during winter seasons, may thus represent a valuable future therapeutic alternative in a condition that can affect patients for many years. Moreover, since bosentan appears to interfere with a key pathogenic process in SSc, it is conceivable that treatment in the setting of pre-scleroderma may potentially decelerate progression towards systemic disease. Cleary, further studies are necessary to substantiate our findings.
Quality Tracleer is presented as film-coated tablets two strengths ; . The quality dossier indicates that the active substance and finished product are manufactured and controlled in a relevant manner, in compliance with current EU and ICH guidelines. Satisfactory information has been provided to demonstrate that the manufacture and control processes routinely and consistently generate a product of uniform quality when used in accordance with the conditions defined in the SPC. At the time of the Opinion, the CPMP concluded that one minor quality issue, which had no impact on the risk benefit balance of the product when used in accordance with the SPC, remained to be resolved and it was agreed that this would be resolved as a follow-up measure to be submitted postauthorisation. Preclinical pharmacology and toxicology The primary pharmacodynamic studies provided adequate evidence that bosentan is a competitive antagonist of ET binding to both ETA and ETB receptors, reducing pulmonary artery pressure. However, the selectivity for pulmonary vessels has not been demonstrated experimentally. Bosentan exerts a concentration-dependent functional cholestatic effect by competing with bile salt elimination via the Bsep. Cholestasis was seen in the rat and dog and was associated with histopathological evidence of hepatocellular damage with increased aminotransferase. Red blood cell parameters were decreased in both non-clinical and clinical studies. The changes were small in magnitude and might possibly be related to the pharmacodynamic properties of the product in decreasing vascular permeability resulting in haemodilution. In rodent carcinogenicity studies, bosentan treatment resulted in a statistically significant increase in the incidence of hepatocellular tumours in male mice adenoma, carcinoma ; and a statistically significant increase in the incidence of thyroid follicular tumours in male rats. The extrapolation of this carcinogenic potential to human remains uncertain. A teratogenic effect has been observed in rats at exposures that could be achieved in humans. Bosentan should be contraindicated in pregnancy and appropriate precautions should be taken for women of childbearing potential. Milk excretion has not been studied. Bosentan is a lipophilic substance for which excretion or even accumulation seems to be highly likely. Nursing women taking Tracleer should be advised to discontinue breast-feeding. Information has been included in the summary of product characteristics accordingly. The Company should provide as follow-up measure, the results of the in vivo study planned to evaluate the effect of each compound and of the combination of bosentan and oestrogens on bile salts in rats. Efficacy Based on the results of the two trials provided in PAH, bosentan showed a significant improvement in exercise capacity and symptoms in patients with primary PAH and secondary pulmonary hypertension related to scleroderma with grade III functional status WHO classification ; . No difference in mortality rate was shown as compared to placebo groups. Data support a maintenance dose of 125 mg twice daily. The benefit risk ratio of 250 mg is acceptable in case of late deterioration despite treatment with Tracleer at 125 mg bid since it may slightly improve their exercise capacity and provided that patients are adequately monitored. The benefit risk balance of bosentan has not been established at early stage of the disease e.g. patients with grade I and grade II functional status. Regarding PAH secondary to scleroderma the indication should be restricted to patients without significant interstitial disease. Moreover, the SPC should mention that no studies have been performed in secondary PAH other than related to connective tissue and buspirone.
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Resting and active tensions of pulmonary arterial strips. J. Appl. Physiol. 22: 1101, 1967. DUKE, H. N.: Pulmonary vascular responses of isolated perfused cat lungs to anoxia and hypercapnia. Quart. J. Exptl. Physiol. 36: 75, 1951. BAKER, G. R.: Reactivity of the vessels of collapsed and ventilated lungs to drugs and hypoxia. Circulation Res. 18: 366, 1966 and busulfan.
Body and Heart Weight Although the mean baseline body weight was comparable among the 3 groups Figure 5, left ; , at 14 days it was significantly higher in the mice treated with bosentan 100 mg kg 1 d 1 than in the other groups. Furthermore, the heart weight body weight ratio was significantly lower in the mice treated with bosentan 100 mg kg 1 d 1 than in the other groups 8.3 1.8 versus 11.2 2.4 and 10.8 2.4, P 0.05, all data expressed 103, Figure 5, right ; . Myocardial Histology The histological scores for myocardial necrosis were 3.0 0.4 in the control group, 2.9 0.3 in mice treated with bosentan 10 mg kg 1 d 1, and 2.0 0.2 in mice treated with 100 mg kg 1 d 1. The respective scores for cellular infiltration were 3.3 0.4, 2.9 and 2.3 0.3. In mice treated with bosentan 100 mg kg 1 d 1, the histological score was significantly lower P 0.05 ; than in the control group Figure 6 and bosentan.
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Only the microenvironment related to the IGF system in the present study, the effects of other growth factors and cytokines should be elucidated further in future studies. Several limitations of the present study should be mentioned. First, this was an observational study and not a randomized controlled trial; hence, patients were selected to undergo different GnRH analogue treatments, and there may be confounding variables that may influence the results. However, the similarity in clinical characteristics such as age, BMI, basal serum FSH levels and the distribution of infertility causes supported that selection bias would be minimal. Second, FF specimens of a single follicle may not truly reflect granulosa or thecal cell production. Third, serum LH levels and FF androgen or estrogen levels were not measured in this study, narrowing the conclusions of the study. There can be an impact of the androgenic environment on FF IGF bioavailability, and we do not know if there is a correlation between the serum E2 levels on the day of hCG and the local E2 levels in this dominant follicle. Fourth, although we are concerned about microenvironment of dominant follicle which is most likely to contain a mature oocyte, results of this dominant follicle may not reflect the other follicles in the ovary. Fifth, in Table III, although the P values showed statistical significance, the mean and SD showed a wide variance of results and a large overlap between the two groups, weakening the clinical significance of these differences. In conclusion, FF IGF-II and IGFBP-4 concentrations and the ratio of IGF-I IGFBP-4 were significantly different when the cycles using GnRHa long protocols and those using GnRHant multiple-dose flexible protocols were compared, which may indicate a difference of follicular microenvironment between the two protocols. However, the difference of the microenvironment does not appear to result in a difference in clinical outcomes. Acknowledgements.
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We thank Margareta Stensdotter for expert technical assistance. This study was supported by the Swedish Medical Research Council no. 10354 ; , the Swedish Heart-Lung Foundation, the Swedish Foundation for Health Care Science and Allergy Research, the AGA Medical Research Fund, the Swedish Asthma and Allergy Association's Research Foundation, and Karolinska Institutet. Bosentan was a kind gift from Dr. Martine Clozel Actelion ; . REFERENCES 1. Advenier C, Sarria B, Naline E, Puybasset L, and Lagente V. Contractile activity of three endothelins ET-1, ET-2 and ET-3 ; on the human isolated bronchus. Br J Pharmacol 100: 168172, 1990. Alving K, Fornhem C, and Lundberg JM. Pulmonary effects of endogenous and exogenous nitric oxide in the pig: relation to cigarette smoke inhalation. Br J Pharmacol 110: 739746, 1993. Alving K, Matran R, Lacroix JS, and Lundberg JM. Capsaicin and histamine antagonist-sensitive mechanisms in the immediate allergic reaction of pig airways. Acta Physiol Scand 138: 4960, 1990. Battistini B, D'Orleans-Juste P, and Sirois P. Endothelins: circulating plasma levels and presence in other biologic fluids. Lab Invest 68: 600628, 1993. Boscoe MJ, Goodwin AT, Amrani M, and Yacoub MH. Endothelins and the lung. Int J Biochem Cell Biol 32: 4162, 2000. Chalmers GW, Little SA, Patel KR, and Thomson NC. Endothelin-1-induced bronchoconstriction in asthma. J Respir Crit Care Med 156: 382388, 1997. Clozel M, Breu V, Gray GA, Kalina B, Loffler BM, Burri K, Cassal JM, Hirth G, Muller M, Neidhart W, et al. Pharmacological characterization of bosentan, a new potent orally active nonpeptide endothelin receptor antagonist. J Pharmacol Exp Ther 270: 228235, 1994. Deffebach ME, Charan NB, Lakshminarayan S, and Butler J. The bronchial circulation. Small, but a vital attribute of the lung. Rev Respir Dis 135: 463481, 1987. Fernandes LB, Henry PJ, and Goldie RG. Endothelin-1 potentiates cholinergic nerve-mediated contraction in human isolated bronchus. Eur Respir J 14: 439442, 1999. Finsnes F, Lyberg T, Christensen G, and Skjonsberg OH. Effect of endothelin antagonism on the production of cytokines in eosinophilic airway inflammation. J Physiol Lung Cell Mol Physiol 280: L659L665, 2001. 11. Finsnes F, Skjonsberg OH, Tonnessen T, Naess O, Lyberg T, and Christensen G. Endothelin production and effects of endothelin antagonism during experimental airway inflammation. J Respir Crit Care Med 155: 14041412, 1997. Goldie RG, D'Aprile AC, Cvetkovski R, Rigby PJ, and Henry PJ. Influence of regional differences in ETA and ETB receptor subtype proportions on endothelin-1-induced contractions in porcine isolated trachea and bronchus. Br J Pharmacol 117: 736742, 1996. Goldie RG, Grayson PS, Knott PG, Self GJ, and Henry PJ. Predominance of endothelinA ETA ; receptors in ovine airway smooth muscle and their mediation of ET-1-induced contraction. Br J Pharmacol 112: 749756, 1994. Goldie RG, Henry PJ, Knott PG, Self GJ, Luttmann MA, and Hay DW. Endothelin-1 receptor density, distribution, and function in human isolated asthmatic airways. J Respir Crit Care Med 152: 16531658, 1995. Haxhiu MA, van Lunteren E, Cherniack NS, and Deal EC. Benzodiazepines acting on ventral surface of medulla cause airway dilation. J Physiol Regul Integr Comp Physiol 257: R810R815, 1989. 16. Hay DW, Luttmann MA, Hubbard WC, and Undem BJ. Endothelin receptor subtypes in human and guinea-pig pulmonary tissues. Br J Pharmacol 110: 11751183, 1993. Hay DW, Luttmann MA, Pullen MA, and Nambi P. Functional and binding characterization of endothelin receptors in J Appl Physiol VOL and campral.
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