-
The Patient Aug 2018Insulin analog glargine (GLA) has been available as one of the therapeutic options for patients with type 1 diabetes mellitus to enhance glycemic control. Studies have...
INTRODUCTION
Insulin analog glargine (GLA) has been available as one of the therapeutic options for patients with type 1 diabetes mellitus to enhance glycemic control. Studies have shown that a decrease in the frequency of hypoglycemic episodes improves the quality of life (QoL) of diabetic patients. However, there are appreciable acquisition cost differences between different insulins. Consequently, there is a need to assess their impact on QoL to provide future guidance to health authorities.
METHOD
A systematic review of multiple databases including Medline, LILACS, Cochrane, and EMBASE databases with several combinations of agreed terms involving randomized controlled trials and cohorts, as well as manual searches and gray literature, was undertaken. The primary outcome measure was a change in QoL. The quality of the studies and the risk of bias was also assessed.
RESULTS
Eight studies were eventually included in the systematic review out of 634 publications. Eight different QoL instruments were used (two generic, two mixed, and four specific), in which the Diabetes Treatment Satisfaction Questionnaire (DTSQ) was the most used. The systematic review did not consistently show any significant difference overall in QoL scores, whether as part of subsets or combined into a single score, with the use of GLA versus neutral protamine Hagedorn (NPH) insulin. Only in patient satisfaction measured by DTSQ was a better result consistently seen with GLA versus NPH insulin, but not using the Well-being Inquiry for Diabetics (WED) scale. However, none of the cohort studies scored a maximum on the Newcastle-Ottawa scale for quality, and they generally were of moderate quality with bias in the studies.
CONCLUSION
There was no consistent difference in QoL or patient-reported outcomes when the findings from the eight studies were collated. In view of this, we believe the current price differential between GLA and NPH insulin in Brazil cannot be justified by these findings.
Topics: Blood Glucose; Brazil; Cost-Benefit Analysis; Diabetes Mellitus, Type 1; Glycated Hemoglobin; Humans; Hypoglycemia; Hypoglycemic Agents; Insulin Glargine; Insulin, Isophane; Patient Satisfaction; Quality of Life
PubMed: 29322308
DOI: 10.1007/s40271-017-0291-3 -
Journal of Vascular and Interventional... May 2014We provide an assessment of clinical, angiographic, and procedure related risk factors associated with stroke and/or death in patients undergoing carotid artery stent...
BACKGROUND AND PURPOSE
We provide an assessment of clinical, angiographic, and procedure related risk factors associated with stroke and/or death in patients undergoing carotid artery stent placement which will assist in patient stratification and identification of high-stent risk patients.
METHODS
A comprehensive search of Medline from January 1st 1996 to December 31st 2011 was performed with key words "carotid artery stenosis", " carotid artery stenting", "carotid artery stent placement", "death" , " mortality", "stroke", "outcome", "clinical predictors", "angiographic predictors", was performed in various combinations. We independently abstracted data and assessed the quality of the studies. This analysis led to the selection of 71 articles for review.
RESULTS
Clinical factors including age≥80 years, symptomatic status, procedure within 2 weeks of symptoms, chronic renal failure, diabetes mellitus, and hemispheric TIA were associated with stroke (ischemic or hemorrhagic) and death within 1 month after carotid artery stent placement. Angiographic factors including left carotid artery intervention, stenosis > 90%, ulcerated and calcified plaques, lesion length > 10mm, thrombus at the site, ostial involvement, predilation without EPD, ICA-CCA angulation > 60%, aortic arch type III, and aortic arch calcification were also associated with 1 month stroke and/or death. Intra-procedural platelet GP IIb/IIIa inhibitors, protamine use, multiple stents, predilatation prior to stent placement were associated with stroke (ischemic or hemorrhagic) and death after carotid artery stent placement. Intraprocedural use of embolic protection devices and stent design (open versus closed cell design) did not demonstrate a consistent relationship with 1 month stroke and/or death. Procedural statin use, and operator and center experience of more than 50 procedures per year were protective for 1 month stroke and/or death.
CONCLUSIONS
Our review identified risk factors for stroke, death, and MI within 1 month in patients undergoing carotid artery stent placement. Such information will result in better patient selection for carotid artery stent placement particularly in those who are also candidates for carotid endarterectomy.
PubMed: 24920983
DOI: No ID Found -
Journal of Stroke and Cerebrovascular... Oct 2019Administering intravenous IV tissue plasminogen activator (tPA) is the recommended standard of care in acute ischemic stroke (AIS), although it is not recommended to...
INTRODUCTION
Administering intravenous IV tissue plasminogen activator (tPA) is the recommended standard of care in acute ischemic stroke (AIS), although it is not recommended to administer intravenous thrombolysis with tPA following heparin reversal with protamine sulfate in patients with AIS.
METHODS
We describe a case series of three patients and the most comprehensive literature review published to date in this specific subset of AIS patients undergoing thrombolysis following heparin reversal with protamine sulfate. The literature review was based on a scoping review methodology performed on four databases; PubMed, CINAHL, Web of Science, and Cochrane Library. All sources were searched from the inauguration of the database until February 2019. A total of six articles involving eight patients were identified.
RESULTS
The primary safety outcome of no symptomatic intracranial hemorrhage (sICH) was met in all eleven patients, although only seven cases had a good functional outcome at 3 months.
CONCLUSIONS
In appropriately selected AIS patients, coagulopathy correction appears to be safe from an sICH standpoint and may be beneficial. However, given the potential for bias with observational databases, case reports and case series, extreme caution is warranted in applying these results to routine clinical practice.
Topics: Administration, Intravenous; Aged; Aged, 80 and over; Anticoagulants; Blood Coagulation; Brain Ischemia; Female; Fibrinolytic Agents; Heparin; Heparin Antagonists; Humans; Male; Middle Aged; Protamines; Stroke; Thrombolytic Therapy; Tissue Plasminogen Activator; Treatment Outcome
PubMed: 31324409
DOI: 10.1016/j.jstrokecerebrovasdis.2019.06.041 -
Cost Effectiveness and Resource... Oct 2011Compared to conventional human basal insulin (neutral protamine Hagedorn; NPH) the long-acting analogue insulin glargine (GLA) is associated with a number of advantages...
BACKGROUND
Compared to conventional human basal insulin (neutral protamine Hagedorn; NPH) the long-acting analogue insulin glargine (GLA) is associated with a number of advantages regarding metabolic control, hypoglycaemic events and convenience. However, the unit costs of GLA exceed those of NPH. This study aims to systematically review the economic evidence comparing GLA with NPH in basal-bolus treatment (intensified conventional therapy; ICT) of type 1 diabetes in order to facilitate informed decision making in clinical practice and health policy.
METHODS
A systematic literature search was performed for the period of January 1st 2000 to December 1st 2009 via Embase, Medline, the Cochrane Library, the databases GMS (German Medical Science) and DAHTA (Deutsche Agentur für Health Technology Assessment), and the abstract books of relevant international scientific congresses. Retrieved studies were reviewed based on predefined inclusion criteria, methodological and quality aspects. In order to allow comparison between studies, currencies were converted using purchasing power parities (PPP).
RESULTS
A total of 7 health economic evaluations from 4 different countries fulfilled the predefined criteria: 6 modelling studies, all of them cost-utility analyses, and one claims data analysis with a cost-minimisation design. One cost-utility analysis showed dominance of GLA over NPH. The other 5 cost-utility analyses resulted in additional costs per quality adjusted life year (QALY) gained for GLA, ranging from € 3,859 to € 57,002 (incremental cost effectiveness ratio; ICER). The cost-minimisation analysis revealed lower annual diabetes-specific costs in favour of NPH from the perspective of the German Statutory Health Insurance (SHI).
CONCLUSIONS
The incremental cost-utility-ratios (ICER) show favourable values for GLA with considerable variation. If a willingness-to-pay threshold of £ 30,000 (National Institute of Clinical Excellence, UK) is adopted, GLA is cost-effective in 4 of 6 cost utility analyses (CUA) included. Thus insulin glargine (GLA) seems to offer good value for money. Comparability between studies is limited because of methodological and country specific aspects. The results of this review underline that evaluation of insulin therapy should use evidence on efficacy of therapy from information synthesis. The concept of relating utility decrements to fear of hypoglycaemia is a plausible approach but needs further investigation. Also future evaluations of basal-bolus insulin therapy should include costs of consumables such as needles for insulin injection as well as test strips and lancets for blood glucose self monitoring.
PubMed: 21978524
DOI: 10.1186/1478-7547-9-15