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Soonjoon Kim, Sun-Ho Lee, Eun-Sang Kim, Whan Eoh
A 42-year-old man was admitted to our hospital with complaints of low back pain and intermittent right thigh pain. Twelve weeks before admission, the patient received intradiscal electrothermal therapy (IDET) at a local hospital. The patient still reported low back pain after the procedure that was managed with narcotic analgesics. Follow-up magnetic resonance imaging (MRI) was performed, and his referring physician thought the likely diagnosis was spondylodiscitis at the L4-5 spinal segment with a small epidural abscess...
January 1, 2017: Journal of Korean Neurosurgical Society
Nandu Thalange, Abdullah Bereket, Lisbeth Bjerring Jensen, Line Conradsen Hiort, Valentina Peterkova
BACKGROUND: To study the long-term development (104 weeks) of insulin antibodies during treatment with insulin detemir (IDet) and insulin aspart (IAsp) in children with type 1 diabetes aged 2-16 years. METHODS: A 52-week, two-arm, randomized trial comparing IDet and neutral protamine Hagedorn insulin, both in combination with IAsp, was followed by a one-arm, 52-week extension trial of the IDet + IAsp arm. The present analysis was conducted in children who completed the randomized trial and entered into the extension trial...
December 2016: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Ronit Koren, Eran Ashwal, Moshe Hod, Yoel Toledano
AIM: To evaluate the safety, efficacy and pregnancy outcomes of insulin detemir (IDet) versus glyburide treatment in women with gestational diabetes mellitus (GDM). METHODS: We conducted a retrospective cohort study of women with GDM who were treated with either glyburide or IDet for GDM in a university-affiliated tertiary hospital. RESULTS: Ninety-one patients with GDM were enrolled, 62 were administered glyburide and 29 IDet. Maternal age, pregestational body mass index (BMI) and rate of abnormal oral glucose tolerance test (OGTT) blood glucose values were not significantly different between groups...
November 2016: Gynecological Endocrinology
Atilla Kircelli, İlker Çöven, Tufan Cansever, Erkin Sonmez, Cem Yilmaz
AIM: Intervertebral disc degeneration can cause severe low back pain. Intradiscal electrothermal therapy (IDET) is a minimally invasive treatment option for patients with symptomatic internal disc disruption unresponsive to conservative medical care. We aimed to evaluate 12-month pain and functional outcomes and predictors of clinical success in patients with discogenic back pain treated with IDET with respect to the Dallas Discogram Scale (DDS). MATERIAL AND METHODS: This was a retrospective analysis of patients undergoing IDET for low back pain from 2009 through 2014 at Baskent University department of Neurosurgery...
December 28, 2015: Turkish Neurosurgery
Abdel Rahman El Shiekh, Hesham A Farrag, Tarek Ashour, Khalid Zaki Alshali, Waleed AbdelFattah
AIM: To evaluate the safety profile of insulin detemir (IDet) in people with Type 2 diabetes mellitus (T2DM) in the Gulf countries in the 32-week, noninterventional LevSafe study. METHODS: People with T2DM whose physicians had opted to start IDet therapy were included in the study. Safety parameters, including serious adverse drug reactions (SADRs) and hypoglycemia, and changes in body weight and glycemic control were evaluated at baseline, week 16 and week 32. RESULTS: A total of 686 patients were exposed to IDet therapy with a mean (±standard deviation) age, body mass index, and diabetes duration of 51...
July 2016: Indian Journal of Endocrinology and Metabolism
I B Hirsch, E Franek, H Mersebach, L Bardtrum, K Hermansen
AIMS: To evaluate the long-term safety and efficacy of a simplified basal-bolus regimen of once-daily insulin degludec/insulin aspart (IDegAsp) with additional IAsp vs. a standard basal-bolus insulin regimen of insulin detemir (IDet) with IAsp in adults with Type 1 diabetes. METHODS: This was an open-label trial comprising a 26-week core phase followed by a 26-week extension phase. Participants were randomized to IDegAsp once daily at the main meal and IAsp at remaining meals (IDegAsp+IAsp), or IDet (once or twice daily) and IAsp at all meals (IDet+IAsp)...
February 2017: Diabetic Medicine: a Journal of the British Diabetic Association
Cristóbal Morales, Daniel de Luis, Antonio Ramírez de Arellano, Maria Giovanna Ferrario, Luis Lizán
INTRODUCTION: An Excel(®) (Microsoft Corporation) model was adapted to estimate the short-term (1-year) cost effectiveness of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) insulin in patients initiating insulin treatment with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) in Spain. METHODS: Clinical benefits included the non-severe hypoglycemia rate for T1DM and T2DM, and weight change for T2DM. Three scenarios were included with different hypoglycemia rates estimated on the basis of clinical trials and observational studies...
November 20, 2015: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
Changyu Pan, Linong Ji, Juming Lu, Wenying Yang, Zhiguang Zhou
OBJECTIVE: To evaluate the effectiveness and safety on once-daily (OD) insulin detemir (IDet) in Chinese patients with type 2 diabetes mellitus (T2DM) who were treated with different types or combinations of oral anti-diabetic drugs (OADs). METHODS: The SOLVE™ study was a 24-week observational study on the initiation of IDet OD in T2DM patients with uncontrolled hyperglycemia on diet, exercise, and one or more OADs. Subjects were grouped based on the numbers of OADs taken before (>2-OAD, 2-OAD, and 1-OAD groups)...
July 2015: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
Kimberly M Herrera, Barak M Rosenn, Janelle Foroutan, Brianne E Bimson, Zainab Al Ibraheemi, Erin L Moshier, Lois E Brustman
OBJECTIVE: We sought to determine if insulin detemir (IDet) is noninferior to insulin neutral protamine Hagedorn (NPH) for the treatment of gestational diabetes mellitus (GDM) and type 2 diabetes mellitus (T2DM) in pregnancy. STUDY DESIGN: We conducted a randomized, controlled noninferiority trial of women with GDM and T2DM who entered our Diabetes in Pregnancy Program from March 2013 through October 2014. Exclusion criteria were type 1 diabetes, age <18 years, and insulin allergy...
September 2015: American Journal of Obstetrics and Gynecology
Ronit Koren, Yoel Toledano, Moshe Hod
INTRODUCTION: Diabetes during pregnancy causes both fetal and maternal complications. Insulin is the most effective pharmacological treatment for controlling hyperglycemia during gestation and can limit adverse outcomes. Insulin detemir (IDet), a novel basal insulin, has already been used for this indication for several years. It was reclassified in 2012 by the FDA from category C to category B for the treatment of pregnant women with diabetes. AREAS COVERED: This article reviews published data regarding the use of IDet during pregnancy...
April 2015: Expert Opinion on Drug Safety
Nandu Thalange, Larry Deeb, Violeta Iotova, Tomoyuki Kawamura, Georgeanna Klingensmith, Areti Philotheou, Janet Silverstein, Stefano Tumini, Ann-Marie Ocampo Francisco, Ona Kinduryte, Thomas Danne
Insulin degludec (IDeg) once-daily was compared with insulin detemir (IDet) once- or twice-daily, with prandial insulin aspart in a treat-to-target, randomized controlled trial in children 1-17 yr with type 1 diabetes, for 26 wk (n = 350), followed by a 26-wk extension (n = 280). Participants were randomized to receive either IDeg once daily at the same time each day or IDet given once or twice daily according to local labeling. Aspart was titrated according to a sliding scale or in accordance with an insulin:carbohydrate ratio and a plasma glucose correction factor...
May 2015: Pediatric Diabetes
Przemyslaw Rys, Piotr Wojciechowski, Agnieszka Rogoz-Sitek, Grzegorz Niesyczyński, Joanna Lis, Albert Syta, Maciej T Malecki
AIMS: A variety of basal insulin preparations are used to treat patients with type 2 diabetes mellitus (T2DM). We aimed to summarize scientific evidence on relative efficacy and safety of insulin glargine (IGlar) and other insulins in T2DM. METHODS: A systematic review was carried out in major medical databases up to December 2012. Relevant studies compared efficacy and safety of IGlar, added to oral drugs (OAD) or/and in combination with bolus insulin, with protamine insulin (NPH) or premixed insulin (MIX) in the same regimen, as well as with insulin detemir (IDet), in T2DM...
August 2015: Acta Diabetologica
Jose Carlos Lynch, Antônio Aversa, Celestino Pereira, Jânio Nogueira, Mariangela Gonçalves, Hélio Lopes
BACKGROUND: The aim of this paper is to report on our surgical strategy and technique and to identify the best management for intracranial dermoids and epidermoids tumors (IDETs). METHODS: We retrospectively reviewed 33 consecutive patients (14 males and 19 females; mean age at surgery, 37.9 years) with pathologically confirmed IDETs who underwent surgical resection, with mean follow-up of 7.2 years. RESULTS: Gross total tumor removal was achieved in 24 cases (72...
2014: Surgical Neurology International
R Malek, F Ajili, S H Assaad-Khalil, A Shinde, J W Chen, E Van den Berg
OBJECTIVE: This study aimed to demonstrate the non-inferiority of 50-week treatment with stepwise insulin intensification of basal-bolus insulin analogues [insulin detemir (IDet) and aspart (IAsp)] versus biphasic insulin aspart 30 (BIAsp30) in insulin-naive type 2 diabetes mellitus (T2DM) patients not controlled by oral glucose-lowering drugs (OGLDs). RESEARCH DESIGN AND METHODS: In this open-label multicentre, multinational, randomized, parallel-arm treat-to-target trial, 403 insulin-naive patients with T2DM in four African countries were randomized to either an IDet+IAsp (n = 200) or BIAsp1-2-3 (n = 203) treatment group...
June 2015: Diabetes & Metabolism
Marc Evans, Phil McEwan, Volker Foos
BACKGROUND: Clinical experience of patients is an additional source of information that can inform prescribing decisions for new therapies in practice. In diabetes, for example, patients with recurrent hypoglycemia may be excluded from trials conducted for regulatory purposes. Using insulin degludec (IDeg), a new basal insulin with an ultra-long duration of action as an example, an interim analysis is presented describing whether the decision to prescribe IDeg to patients experiencing treatment-limiting problems on their existing insulin regimes represented good clinical and economic value...
February 2015: Journal of Medical Economics
Subhash Kumar Wangnoo, Samit Ghosal, Shahid Akhtar, Raman Shetty, Sudhir Tripathi
AIM: To explore the clinical safety and effectiveness of insulin detemir (IDet) in a subgroup of Indian patients with type 2 diabetes (T2D) switched from either insulin glargine (IGlar) or neutral protamine Hagedorn (NPH) insulin in the 24-week, non-interventional A1chieve study. MATERIALS AND METHODS: Indian patients with T2D switching from pre-study IGlaror NPH insulin to IDet were included. Safety and effectiveness outcomes were evaluated by the physicians in local clinical settings...
September 2014: Indian Journal of Endocrinology and Metabolism
Taner Damci, Rifat Emral, Anne Louise Svendsen, Tanzer Balkir, Jiten Vora
BACKGROUND: The purpose of this analysis is to evaluate the safety and effectiveness of insulin initiation with once-daily insulin detemir (IDet) or insulin glargine (IGlar) in real-life clinical practice in Turkish patients with type 2 diabetes mellitus (T2DM). METHODS: This was a 24-week multinational observational study of insulin initiation in patients with T2DM. RESULTS: The Turkish cohort (n = 2886) included 2395 patients treated with IDet and 491 with IGlar...
July 21, 2014: BMC Endocrine Disorders
M J Davies, J L Gross, Y Ono, T Sasaki, G Bantwal, M A Gall, M Niemeyer, H Seino
AIMS: The efficacy and safety of insulin degludec (IDeg) was compared with insulin detemir (IDet), both administered once daily (OD) as basal treatment in participants with type 1 diabetes mellitus (T1DM). The primary outcome was non-inferiority of IDeg to IDet in glycated haemoglobin (HbA1c) reduction after 26 weeks. METHODS: This multinational, 26-week, controlled, open-label, parallel-group trial randomized adults with T1DM to IDeg or IDet as OD basal insulin treatment combined with mealtime bolus insulin aspart (IAsp)...
October 2014: Diabetes, Obesity & Metabolism
Laxmaiah Manchikanti, Sukdeb Datta, Richard Derby, Standiford Helm
The intradiscal electrothermal therapy (IDET) procedure is a minimally invasive technique designed to treat discogenic chronic low back pain. The debate surrounding IDET ranges from the concept of the procedure, the technique and patient selection, to its effectiveness. The procedure provides modest improvement; however, it is considered less invasive and destructive than other modalities of treatments available at the present time, and has lower cost. The effectiveness evidence is limited at the present time, but based on the results of six recently published positive single-arm studies, it appears that patients experienced a perceptible clinical benefit from the IDET procedure...
January 2011: Pain Management
Samar Banerjee, Debasish Maji, Manash Baruah
Insulin aspart (IAsp) has been used in patients for more than a decade. A plethora of data is available, from clinical trials, to document its efficacy and safety and suggest that IAsp is a favorable choice to be used in a basal-bolus regimen. The A1chieve@ was a non-interventional study that explored the safety and effectiveness of initiating or switching to insulin analogues in routine clinical practice in more than 60,000 patients from 28 different countries. In this manuscript, we discuss the findings from the subgroup of the Indian cohort who were treated with insulin aspart (IAsp), in addition to a basal insulin analogue (insulin detemir, IDet)...
January 2013: Journal of the Association of Physicians of India
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