scholarly journals Long-Acting Growth Hormone Preparations – Current Status and Future Considerations

2019 ◽  
Vol 105 (6) ◽  
pp. e2121-e2133 ◽  
Author(s):  
Bradley S Miller ◽  
Eric Velazquez ◽  
Kevin C J Yuen
Keyword(s):  
Current Status ◽  
Term Therapy ◽  
Efficacy And Safety ◽  
Short Term ◽  
Randomized Controlled Clinical Trials ◽  
Serum Peak ◽  
Igf I ◽  
Long Acting ◽  
Relationship Of

Abstract Context Long-acting GH (LAGH) preparations are currently being developed in an attempt to improve adherence. The profile of GH action following administration of LAGH raises practical questions about clinical monitoring and long-term safety and efficacy of these new therapeutic agents. Methods Recent literature and meeting proceedings regarding LAGH preparations are reviewed. Results Multiple LAGH preparations are currently at various stages of development, allowing for decreased GH injection frequency from daily to weekly, biweekly, or monthly. Following administration of LAGH, the serum peak and trough GH and IGF-I levels vary depending upon the mechanism used to prolong GH action. Randomized, controlled clinical trials of some LAGH preparations have reported non-inferiority compared with daily recombinant human GH (rhGH) for improved growth velocity and body composition in children and adults with GH deficiency (GHD), respectively. No significant LAGH-related adverse events have been reported during short-term therapy. Conclusion Multiple LAGH preparations are proceeding through clinical development with some showing promising evidence of short-term clinical efficacy and safety in children and adults with GHD. The relationship of transient elevations of GH and IGF-I following administration of LAGH to efficacy and safety remain to be elucidated. For LAGH to replace daily rhGH in the treatment of individuals with GHD, a number of practical questions need to be addressed including methods of dose adjustment, timing of monitoring of IGF-I, safety, efficacy, and cost-effectiveness. Long-term surveillance of efficacy and safety of LAGH preparations will be needed to answer these clinically relevant questions.

scholarly journals Efficacy of the New Long-Acting Formulation of Lanreotide (Lanreotide Autogel) in the Management of Acromegaly

2002 ◽  
Vol 87 (1) ◽  
pp. 99-104 ◽  
Author(s):  
Ph. Caron ◽  
A. Beckers ◽  
D. R. Cullen ◽  
M. I. Goth ◽  
B. Gutt ◽  
...  
Keyword(s):  
Small Volume ◽  
Large Population ◽  
Fixed Dose ◽  
Efficacy And Safety ◽  
Prefilled Syringe ◽  
Igf I ◽  
D 20 ◽  
Long Acting ◽  
Lanreotide Autogel

Lanreotide Autogel is a new long-acting aqueous preparation of lanreotide for the treatment of acromegaly and is administered by deep sc injection from a small volume, prefilled syringe. The aim of this study was to evaluate the efficacy and safety of this new long-acting formulation in a large population of acromegalic patients previously responsive to lanreotide 30 mg, im (sustained release microparticle formulation). Lanreotide Autogel was administered by deep sc injection every 28 d to 107 patients (54 males and 53 females; mean age, 54 ± 1.2 yr). All patients had been treated with lanreotide (30 mg) for at least 3 months before study entry and had a mean GH level less than 10 ng/ml after at least 4 subsequent im injections every 14 d (48%), 10 d (32%), or 7 d (20%). Treatment was switched from lanreotide 30 mg injected every 14, 10, or 7 d to 60, 90, or 120 mg lanreotide Autogel, respectively, every 28 d. After three fixed dose injections of lanreotide Autogel, mean lanreotide levels were similar to those obtained at steady state with lanreotide 30 mg. During lanreotide Autogel treatment, the control of acromegalic symptoms was comparable with that previously achieved during lanreotide 30 mg treatment. After 3 injections of lanreotide Autogel, mean GH (2.87 ± 0.22 ng/ml) and IGF-I (317 ± 15 ng/ml) values were comparable with those recorded at the end of lanreotide 30 mg treatment (GH, 2.82 ± 0.19 ng/ml; IGF-I, 323 ± 16 ng/ml). GH levels below 2.5 ng/ml and age-/sex-normalized IGF-I were achieved in 33% and 39% of patients during lanreotide 30 mg and lanreotide Autogel treatment, respectively. Diarrhea, abdominal pain, and nausea were reported by 38%, 22%, and 18% of patients during lanreotide 30 mg treatment and by 29%, 17%, and 9% of patients, respectively, during lanreotide Autogel treatment. In conclusion, this clinical study shows that lanreotide Autogel is at least as efficacious and well tolerated as lanreotide 30 mg. This new long-acting lanreotide formulation, lanreotide Autogel, which is administered from a small volume, prefilled syringe by deep sc injection, is therefore likely to improve the acceptability of medical treatment for patients requiring long-term somatostatin analog therapy.

Experience with injectable long-acting risperidone in long-term therapy after an acute episode of schizophrenia: the SPHERE Study

2009 ◽  
Vol 9 (10) ◽  
pp. 1463-1474 ◽  
Author(s):  
Jesús De la Gándara ◽  
Luis San Molina ◽  
Gabriel Rubio ◽  
Alexander Rodriguez-Morales ◽  
Rebeca Hidalgo Borrajo ◽  
...  
Keyword(s):  
Acute Episode ◽  
Term Therapy ◽  
Long Acting ◽  
Long Term Therapy

Outcome of Short-Term and Long Term Antibiotic Prophylaxis in Colostomy Closure

2016 ◽  
Vol 4 (2) ◽  
pp. 43-48
Author(s):  
Md Jamal Saleh Uddin ◽  
Sukumar Chakrabarti ◽  
Md Shahidul Islam
Keyword(s):  
Antibiotic Prophylaxis ◽  
Wound Infection ◽  
Anorectal Malformation ◽  
Hirschsprung's Disease ◽  
Hirschsprung’S Disease ◽  
Colostomy Closure ◽  
Term Therapy ◽  
Short Term ◽  
Sigmoid Colostomy

Background and Objectives: Antibiotic prophylaxis is a common practice in children undergoing colostomy closure for anorectal malformation, Hirschsprung's disease. Traditionally, antibiotics are given for unnecessarily longer period of time, which consumes scarce health resources having alternate efficient use. The present study was undertaken to compare the outcome between short-term and long-term antibiotic prophylaxis in colostomy closure. Materials & Methods: This randomized clinical trial was conducted in Dhaka Shishu Hospital, Dhaka over a period of 15 months from April 2001 to June 2002. Children admitted with anorectal malformation, Hirschsprung's disease for colostomy closures were the study population. However, immuno-compromised children or children already getting antibiotics were excluded from the study. A total of 46 such children were consecutively included and were randomly allocated to long-term group (n = 21) and short-term group (n = 25). The long-term group received antibiotic up to 5th postoperative day, while the short-term group received the same antibiotic up to 2nd postoperative day. Transverse colostomy was the main procedure employed in colostomy closure; however, a few patients required sigmoid colostomy. The outcome measures were incidence of wound infection, hospital stay and cost of treatment. Result: Majority of the children were between 1 - 5 years of age (75% in short-term and 50% in long-term group) followed by under 1 year (10% in short-term and 40% in long-term group) and > 5 years (15% in short-term and 10% in long-term group). The overall male to female ratio was 3:1. Majority (85%) of the patients in both long­term and short-term groups belonged to lower income group. Over half (52.2%) of the children had anorectal malformations (ARM) and the rest (47.8%) had Hirschsprung's disease (HD). Children were generally malnourished according to Gomez classification. Majority (91%) was operated on by transverse colostomy and few (9%) by sigmoid colostomy. Three patients in each group developed postoperative wound infection. Blood culture of none of these patients yielded growth of any organism, though wound swab culture did so in 5 cases out of 6 infected patients. In 2 cases, the organism was E.coli, in 2 cases, it was Pseudomonas and in one case Staph. aureus. Total cost of antibiotics in short-term therapy was less than 50% of that required in long-term therapy. The outcome in terms of recovery, complications and postoperative hospital stay was no different between groups. Conclusion: The study concluded that short-term antibiotic prophylaxis is as efficacious as long-term in preventing wound infection in patients with colostomy closure for anorectal malformation and Hirschsprung's disease. Short-term antibiotic prophylaxis is cost-effective Ibrahim Cardiac Med J 2014; 4(2): 43-48

A directed content analysis of viewpoints on the changing patterns of Lean Six Sigma research

2019 ◽  
Vol 31 (4) ◽  
pp. 641-654 ◽  
Author(s):  
Bryan A. Rodgers ◽  
Jiju Antony ◽  
Zhen He ◽  
Elizabeth A. Cudney ◽  
Chad Laux
Keyword(s):  
Continuous Improvement ◽  
Six Sigma ◽  
Design Methodology ◽  
Lean Six Sigma ◽  
Current Status ◽  
Short Term ◽  
Content Type ◽  
Changing Patterns ◽  
Practical Implications

Purpose The purpose of this paper, builds on previous studies that explored the research patterns over 15 years, is to consider the current status of the integration of Lean and Six Sigma. More specifically, this research addresses whether Lean and Six Sigma are stronger together and explores the reasons why Lean researchers and practitioners may be less likely to integrate Six Sigma in their work. Design/methodology/approach The research utilises a survey of 25 established and respected academics and practitioners from 16 countries. The questionnaire is analysed using a direct content approach and coded in NVivo. Findings The findings suggest that challenges may lie in the perception and understanding of statistics as well as short-term rather than long-term focus on improvement. The findings also suggest that academics and practitioners believe that Lean Six Sigma has developed over time and will continue to develop and improve as a methodology rather than being replaced with a new methodology. Research limitations/implications The survey has a sample size of 25, albeit all respondents are established and very experienced practitioners and academics. Practical implications For organisations that are introducing or refreshing their continuous improvement initiatives, this research identifies some of the challenges and provides the opportunity to address them to maximise the opportunities for success and sustainability. Originality/value The value of this paper is that it further addresses the debate over the integration of Lean and Six Sigma for many organisations which still employ Lean alone, but beyond this it explores how they will continue to develop and whether they are a permanent edition to the quality management landscape or a transition to something else.

scholarly journals Integration of Indonesian Coffee Markets with World Coffee Markets

2021 ◽  
Vol 2 (1) ◽  
pp. 33
Author(s):  
Haposan Orlando Napitupulu ◽  
Ana Arifatus Sa'diyah ◽  
Farah Mutiara
Keyword(s):  
Time Series Data ◽  
Dynamic Equilibrium ◽  
Secondary Data ◽  
Series Data ◽  
Short Term ◽  
Robusta Coffee ◽  
Long Run ◽  
Relationship Of ◽  
Coffee Markets

This study aims to analyze the integration of the Arabica and Robusta coffee markets in Indonesia with world coffee prices. The study uses secondary data in the form of annual time series data during the period 1985 - 2015. The study uses the VECM analysis method. This method explains the relationship of long-term dynamic equilibrium and short-term equilibrium in a system of equations. The analysis shows that Indonesian and world Arabica coffee is not integrated in the long term or the short term. In Robusta coffee VECM estimation analysis shows that there is a significant value at the 10% level in a long-term relationship with a value of 0.08579, which means that there is a short-term relationship between world Robusta coffee prices and domestic Robusta coffee prices in the previous year, but no relationship in the long run.

scholarly journals Analisis Peningkatan Upah Minimum Terhadap Penyerapan Tenaga Kerja di Provinsi Jawa Tengah

2021 ◽  
Vol 10 (3) ◽  
pp. 134-143
Author(s):  
Annisa Yulianti ◽  
Hadi Sasana
Keyword(s):  
Economic Growth ◽  
Minimum Wage ◽  
Time Series Data ◽  
Series Data ◽  
Short Term ◽  
Central Java ◽  
Meaningful Relationship ◽  
Short Time ◽  
Relationship Of

 This study aims to analyze the short-term and long-term relationship of increasing the minimum wage in Central Java on employment. The research method used is ECM. The variables of this study include labor, minimum wages, PMDN, and economic growth. The data used are time-series data from 1990-2020. The results show that the minimum wage has a positive and significant relationship to the employment in the long term but not significantly in the short time. PMDN has a negative but significant correlation in the short and long term. At the same time, the variable economic growth has a positive but not meaningful relationship to employment absorption in the long and short term.

Clinical and Pharmacokinetic Evaluation of Long-Term Therapy With Didanosine in Children with HIV Infection

PEDIATRICS ◽  
1994 ◽  
Vol 94 (5) ◽  
pp. 724-731 ◽  
Author(s):  
Brigitta U. Mueller ◽  
Karina M. Butler ◽  
Vicki L. Stocker ◽  
Frank M. Balis ◽  
Philip A. Pizzo ◽  
...  
Keyword(s):  
Hiv Infection ◽  
Area Under The Curve ◽  
Chronic Administration ◽  
Cd4 Count ◽  
Term Therapy ◽  
Short Term ◽  
Apparent Relationship ◽  
Term Administration ◽  
Long Term Therapy

Background. Didanosine has demonstrated promising antiviral activity and a tolerable toxicity profile in short term studies. We describe a cohort of HIV-infected children who were treated for a prolonged period of time with didanosine. Methods. Children (6 months to 18 years of age) with symptomatic HIV infection or an absolute CD4 count < 0.5 x 109 cells/L, received oral didanosine at doses between 20 mg/m2 to 180 mg/m2 every 8 hours. Clinical, immunological, and virological parameters were assessed at least every 2 months. The pharmacokinetics of didanosine were evaluated in 85 patients. Results. Previously untreated children (n = 51) and children who had received prior antiretroviral therapy (n = 52) were enrolled in the study (median time on study 22.6 months; range 2 to 48). The long-term administration of didanosine was well tolerated and no new toxicities were observed. The absolute CD4 count increased by ≥ .05 x 109 cells/L in 28 of 87 (32%) of patients after 6 months of therapy. Responses were also sustained in 41% of these children after 3 years of therapy. Children entering the study with a CD4 count >0.1 x 109 cells/L (n = 51) had a marked survival advantage (P = .00002) with an estimated survival probability after 3 years of 80% compared to 39% for children with lower CD4 counts. Although the area under the curve of didanosine increased proportionally with the dose, there was considerable interpatient variability at each dose level. There was no apparent relationship between surrogate markers of clinical outcome and plasma drug concentration. Conclusions. Didanosine was well tolerated with chronic administration, and toxicities were uncommon and usually reversible. In 41% of patients, the CD4 count increased and was maintained at the higher level even after years of treatment.

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