Heise T.,Profil Institute For Stoffwechselforschung |
Tack C.J.,Radboud University Nijmegen |
Cuddihy R.,International Diabetes Center |
Davidson J.,University of Texas at Dallas |
And 6 more authors.
Diabetes Care | Year: 2011
OBJECTIVE - Insulin degludec/insulin aspart (IDegAsp) is a soluble coformulation of the novel basal analog insulin degludec (IDeg: 70%) and insulin aspart (IAsp: 30%). We compared the safety and efficacy of IDegAsp, an alternative formulation (AF) (55%IDeg and 45% IAsp), and insulin glargine (IGlar) in insulin-naïve subjects with type 2 diabetes inadequately controlled with oral antidiabetic drugs. RESEARCH DESIGN AND METHODS - In this 16-week, open-label trial, subjects (mean age 59.1 years, A1C 8.5%, BMI 30.3 kg/m 2) were randomized to once-daily IDegAsp (n = 59), AF (n = 59), or IGlar (n = 60), all in combination with metformin. Insulin was administered before the evening meal and dose-titrated to a fasting plasma glucose (FPG) target of 4.0-6.0 mmol/L. RESULTS - After 16 weeks, mean A1C decreased in all groups to comparable levels (IDegAsp: 7.0%; AF: 7.2%; IGlar: 7.1%). A similar proportion of subjects achieved A1C <7.0% without confirmed hypoglycemia in the last 4 weeks of treatment (IDegAsp: 51%; AF: 47%; IGlar: 50%). Mean 2-h postdinner plasma glucose increase was lower for IDegAsp (0.13 mmol/L) and AF (0.24mmol/L) than IGlar (1.63 mmol/L), whereasmean FPG was similar (IDegAsp: 6.8mmol/L; AF: 7.4 mmol/L; IGlar: 7.0 mmol/L). Hypoglycemia rates were lower for IDegAsp and IGlar than AF (1.2, 0.7, and 2.4 events/patient year). Nocturnal hypoglycemic events occurred rarely for IDegAsp (1 event) and IGlar (3 events) compared with AF (27 events). CONCLUSIONS - In this proof-of-concept trial, once-daily IDegAsp was safe, well tolerated, and provided comparable overall glycemic control to IGlar at similar low rates of hypoglycemia, but better postdinner plasma glucose control. © 2011 by the American Diabetes Association.
Cariou B.,Nantes University Hospital Center |
Fontaine P.,University Hospital of Lille |
Eschwege E.,French Institute of Health and Medical Research |
Gouet D.,Center Hospitalier Of La Rochelle |
And 4 more authors.
Diabetes and Metabolism | Year: 2015
Aim: DIALOG assessed the prevalence and predictors of hypoglycaemia in patients with type 1 (T1DM) or insulin-treated type 2 diabetes mellitus (T2DM) in a real-life setting. Methods: In this observational study, insulin-treated patients (n= 3048) completed prospective daily questionnaires reporting the frequency and consequences of severe/confirmed non-severe hypoglycaemia over 30 days. Patients (n= 3743) also retrospectively reported severe hypoglycaemia over the preceding year. Results: In this prospective survey, 85.3% and 43.6% of patients with T1DM and T2DM, respectively, reported experiencing at least one confirmed hypoglycaemic event over 30 days, while 13.4% and 6.4%, respectively, reported at least one severe event. Hypoglycaemia frequency increased with longer duration of diabetes and insulin therapy. Strongly predictive factors for hypoglycaemia were previous hypoglycaemia, >2 injections/day, BMI<30kg/m2 and duration of insulin therapy>10 years. HbA1c level was not predictive of hypoglycaemia in either T1DM or T2DM. The confirmed hypoglycaemia rate was increased in the lowest compared with the highest tertile of HbA1c in T1DM, but not T2DM. At the time of enrolment, physicians reported severe hypoglycaemia in 23.6% and 11.9% of T1DM and T2DM patients, respectively, during the preceding year; the retrospective survey yielded frequencies of 31.5% and 21.7%, respectively. Also, severe hypoglycaemia led to medical complications in 10.7% and 7.8% of events in T1DM and T2DM patients, respectively, over 30 days. Conclusion: Using a unique combined prospective and retrospective approach, the DIALOG study found a relatively high frequency of hypoglycaemia among insulin-treated patients. These findings emphasize the importance of a patient-centred approach for managing diabetes in which hypoglycaemia risk evaluation is critical. Trial registration: ClinicalTrials.gov: NCT01628341. © 2014 Elsevier Masson SAS.
Depienne C.,French Institute of Health and Medical Research |
Depienne C.,University Pierre and Marie Curie |
Gourfinkel-An I.,Groupe Hospitalier Pitie Salpetriere |
Saint-Martin C.,French Institute of Health and Medical Research |
And 15 more authors.
Journal of Medical Genetics | Year: 2010
Background: Mutations in SCN1A can cause genetic epilepsy with febrile seizures plus (GEFS+, inherited missense mutations) or Dravet syndrome (DS, de novo mutations of all types). Although the mutational spectra are distinct, these disorders share major features and 10% of DS patients have an inherited SCN1A mutation. Objectives and patients: 19 selected families with at least one DS patient were studied to describe the mechanisms accounting for inherited SCN1A mutations in DS. The mutation identified in the DS probands was searched in available parents and relatives and quantified in the blood cells of the transmitting parent using quantitative allele specific assays. Results: Mosaicism in the blood cells of the transmitting parent was demonstrated in 12 cases and suspected in another case. The proportion of mutated allele in the blood varied from 0.04-85%. In the six remaining families, six novel missense mutations were associated with autosomal dominant variable GEFS+ phenotypes including DS as the more severe clinical picture. Conclusion: The results indicate that mosaicism is found in at least 7% of families with DS. In the remaining cases (6/19, 32%), the patients were part of multiplex GEFS+ families and seemed to represent the extreme end of the GEFS+ clinical spectrum. In this latter case, additional genetic or environmental factors likely modulate the severity of the expression of the mutation.
Kerlan V.,Brest University Hospital Center |
Gouet D.,Center Hospitalier Of La Rochelle |
Marre M.,HOpital Bichat |
Renard T.,Montpellier University
Annales d'Endocrinologie | Year: 2013
Insulin degludec is a new basal insulin analogue with an ultra-long duration of action that provides a flat and stable action profile with a duration of action greater than 42hours. Two clinical trials comparing insulin degludec and insulin glargine in basal-bolus therapy have recently been published. Both were 52-week, multicentre, randomised (3:1), treat-to-target trials in patients already using insulin. In both type1 (n=629) and type2 diabetes (n=1006), insulin degludec was non-inferior to insulin glargine with respect to reduction in HbA1c at 52weeks. There were also no significant differences between treatment groups with respect to fasting plasma glucose. At similar levels of glycaemic control, however, insulin degludec was associated with lower rates of hypoglycaemia than insulin glargine. In type1 diabetes, overall confirmed hypoglycaemia (plasma glucose concentration<3.1mmol/L or severe episodes requiring assistance) was similar in the two treatment groups, but nocturnal confirmed hypoglycaemia (occurring from 00h01 to 05h59) was 25% lower with insulin degludec (P=0.021). In type 2diabetes, overall confirmed hypoglycaemia was 18% lower (P=0.0359) and nocturnal confirmed hypoglycaemia was 25% lower (P=0.0399) with insulin degludec. Reductions in hypoglycaemia could reduce physicians' and patients' fears and encourage them to titrate insulin more aggressively, and to adhere more closely to treatment, with consequent better glycaemic control. The results of these trials suggest that insulin degludec has a place in the French clinical setting in basal-bolus therapy in type1 and type2 diabetes. © 2013 Elsevier Masson SAS.
PubMed | Hopital Saint Louis, CHRU de Lille, Center Hospitalier Of La Rochelle, CHU de Tours and 7 more.
Type: Journal Article | Journal: Journal de gynecologie, obstetrique et biologie de la reproduction | Year: 2016
Develop guidelines for surgery for primary pelvic organ prolapse (POP).Literature review, establishment of levels of evidence, external review, and grading of recommendations by 5French academic societies: Association Franaise dUrologie, Collge National des Gyncologues et Obsttriciens Franais, Socit Interdisciplinaire dUrodynamique et de Pelvi-Prinologie, Socit Nationale Franaise de Colo-proctologie, and Socit de Chirurgie Gyncologique et Pelvienne.It is useful to evaluate symptoms, their impact, womens expectations, and to describe the prolapse prior to surgery (grade C). In the absence of any spontaneous or occult urinary sign, there is no reason to perform urodynamics (grade C). When a sacrocolpopexy is indicated, laparoscopy is recommended (grade B). A bowel preparation before vaginal (grade B) or abdominal surgery (grade C) is not recommended. There is no argument to systematically use a rectovaginal mesh to prevent rectocele (grade C). The use of a vesicovaginal mesh by vaginal route should be discussed taking into account an uncertain long-term risk-benefit ratio (grade B). Levator myorrhaphy is not recommended as a first-line rectocele treatment (grade C). There is no indication for a vaginal mesh as a first-line rectocele treatment (grade C). There is no reason to systematically perform a hysterectomy during prolapse repair (grade C). It is possible to not treat stress incontinence at the time of prolapse repair, if the woman is advised of the possibility of a 2-step surgical treatment (grade C).
Heurgue-Berlot A.,Service dHepato Gastro enterologie |
Feron T.,CRIC U73 |
Jazeron J.-F.,Center Hospitalier Of La Rochelle |
Hoeffel C.,Service de Radiologie |
And 2 more authors.
Clinics and Research in Hepatology and Gastroenterology | Year: 2016
Ménétrier's disease is a rare hypertrophic gastropathy, causing protein leak. An overexpression of transforming growth factor alpha is involved. In inhibiting the epidermal growth factor receptor, cetuximab and somatostatin analogues are the two most promising treatments, allowing to avoid radical gastrectomy. We report the case of a patient with a sustained clinical remission after treatment with lanreotide, but without complete endoscopic healing. We discuss the available therapeutic options and present a literature review of somatostatin analogues for the treatment of Ménétrier's disease. © 2015 Elsevier Masson SAS.
PubMed | Center Hospitalier Of La Rochelle, Service dHepato Gastro enterologie, CRIC U73, Laboratoire Danatomie Et Of Cytologie Pathologiques and Service de Radiologie
Type: Case Reports | Journal: Clinics and research in hepatology and gastroenterology | Year: 2016
Mntriers disease is a rare hypertrophic gastropathy, causing protein leak. An overexpression of transforming growth factor alpha is involved. In inhibiting the epidermal growth factor receptor, cetuximab and somatostatin analogues are the two most promising treatments, allowing to avoid radical gastrectomy. We report the case of a patient with a sustained clinical remission after treatment with lanreotide, but without complete endoscopic healing. We discuss the available therapeutic options and present a literature review of somatostatin analogues for the treatment of Mntriers disease.
Sorel N.,University of Poitiers |
Mayeur-Rousse C.,University of Poitiers |
Deverriere S.,University of Poitiers |
Roy L.,University of Poitiers |
And 4 more authors.
Journal of Molecular Diagnostics | Year: 2010
We identified a novel breakpoint cluster region-ABL rearrangement in a chronic myeloid leukemia (CML) patient. The e14/a2 (b3/a2) type BCR-ABL mRNA incorporated a 42-nucleotide intronic insertion of ABL intron Ib between BCR exon e14 and ABL exon a2. As we hypothesized that the rearrangement between BCR and ABL genes occurred near the inserted sequence and because of the relative small size of BCR intron 14, we determined the BCR-ABL breakpoint at the genomic DNA level. Using a PCR-based method, this analysis revealed that i) BCR intron 14 brought a potential lariat branch point and the polypyrimidine tract, ii) the BCR-ABL breakpoint created a chimeric acceptor site, and iii) the inserted sequence of ABL intron Ib carried at its 3′ end a well-conserved donor splice site. Therefore, the inserted sequence was flanked by canonical consensus splice sites and recognized as a pseudo-exon (as shown by splice site prediction and exon finder software). Moreover, the insertion did not disrupt the reading frame between BCR and ABL and did not produce a premature stop codon. Instead, this novel BCR-ABL chimeric transcript encoded a functional oncoprotein with an in-frame insertion of 15 new amino acids. Copyright © American Society for Investigative Pathology and the Association for Molecular Pathology.
Sechet E.,Nantes University Hospital Center |
Lefranc B.,Center Hospitalier Of La Rochelle |
Guile R.,Nantes University Hospital Center |
Duteille F.,Nantes University Hospital Center |
Sellal K.-O.,Nantes University Hospital Center
Pharmacien Hospitalier | Year: 2010
A new surgical stapler with absorbable staples for subcuticular closure is available for few months. This device could combine the advantages of absorbable suture with those of a mechanical system. In Nantes University Hospital, we conducted an economic assessment by monitoring use of this stapler in Plastic Surgery area during 5 months in 2008. The aim of the study was to determine the hospital ability to support additional costs for this new medical device. We calculated the cost of each hospitalization with use of the stapler and we compared it to the reimbursement received by the institution. The economic framework of the studied hospitalizations was unchanged by the additional cost induced by the absorbable dermal stapler. With a reduction of average lengths of stays, a surgical activity increase and a reimbursement's optimization due to the new rates in 2009, use of this stapler in our institution could be cost effective. From a clinical perspective, the superiority of this new suture technique is not formally proven. If saving time during closure procedures has been well highlighted, data on efficacy and tolerance of staples must be assessed by further studies. © 2010 Elsevier Masson SAS. All rights reserved.
PubMed | Center Hospitalier Of La Rochelle
Type: | Journal: Soins. Gerontologie | Year: 2012
Modelling is an original and creative form of therapy and above all one which is accessible when the limits of cognitive care have been reached. Salt dough is a malleable, sensitive and multi-sensory mediator which is forgiving of errors. Without the use of any known technique or objective as a reference, this activity avoids any notion of failure. This workshop is an area for expression and care and the mediation is interesting for its therapeutic potential.