Is the current standard of care leading to cost-effective outcomes for patients with type 2 diabetes requiring insulin? A long-term health economic analysis for the UK.

AIMS: The aim of the analysis was to investigate whether insulin intensification, based on the use of intensive insulin regimens as recommended by the current standard of care in routine clinical practice, would be cost-effective for patients with type 2 diabetes in the UK. METHODS: Clinical data were derived from a retrospective analysis of 3185 patients with type 2 diabetes on basal insulin in The Health Improvement Network (THIN) general practice database. In total, 48% (614 patients) intensified insulin therapy, defined by adding bolus or premix insulin to a basal regimen, which was associated with a reduction in HbA1c and an increase in body mass index. Projections of clinical outcomes and costs (2011 GBP) over patients' lifetimes were made using a recently validated type 2 diabetes model. RESULTS: Immediate insulin intensification was associated with improvements in life expectancy, quality-adjusted life expectancy and time to onset of complications versus no intensification or delaying intensification by 2, 4, 6, or 8 years. Direct costs were higher with the insulin intensification strategy (due to the acquisition costs of insulin). Incremental cost-effectiveness ratios for insulin intensification were GBP 32,560, GBP 35,187, GBP 40,006, GBP 48,187 and GBP 55,431 per QALY gained versus delaying intensification 2, 4, 6 and 8 years, and no intensification, respectively. CONCLUSIONS: Although associated with improved clinical outcomes, insulin intensification as practiced in the UK has a relatively high cost per QALY and may not lead to cost-effective outcomes for patients with type 2 diabetes as currently defined by UK cost-effectiveness thresholds.

Incidence of non-severe hypoglycaemia and intensity of treatment among veterans with type 2 diabetes in the U.S.A.: a prospective observational study.

AIM: To quantify the incidence of non-severe hypoglycaemic events among veterans with Type 2 diabetes and its association with primary care provider prescribing behaviour. METHODS: This was a prospective observational study involving 30 primary care providers and patients enrolled with these primary care providers, identified from computerized pharmacy records. Two sampling frames were created consisting of (1) patients not treated with insulin and receiving sulfonylurea treatment (with or without other oral hypoglycaemic agents) and (2) patients treated with insulin (with or without sulfonylureas or other oral hypoglycaemic agents). Patients recorded the frequency, proximal cause of, and response to each hypoglycaemic event over a 12-week period and made three visits to a research coordinator over 24 weeks. Data were provided to the primary care provider before their next visit and charts were reviewed for medication changes. RESULTS: A total of 265 patients were enrolled in study. During the 12 weeks of structured self-monitoring of blood glucose, patients recorded a mean (sd) of 6.9 (10.3) hypoglycaemic events. Duration of diabetes increased monotonically with increasing category of hypoglycaemic event (P < 0.001). Among insulin users, an increased frequency of hypoglycaemic events was associated with a decreased likelihood of dose intensification by primary care providers (relative risk 0.86 per event; P = 0.02) but no significant increase in tendency for dose reduction (relative risk 1.04 per event; P = 0.06). Increased frequency of hypoglycaemic events was associated with an increased likelihood of dose reduction (relative risk 1.12 per event; P = 0.03) in the sulfonylurea treatment group. CONCLUSIONS: Non-severe hypoglycaemia is common among veterans with Type 2 diabetes receiving insulin or sulfonylureas and influences the prescribing behaviour of primary care providers.

Rates and risk of hospitalisation among patients with type 2 diabetes: retrospective cohort study using the UK General Practice Research Database linked to English Hospital Episode Statistics.

AIMS: To investigate the rates and risk of hospitalisations in patients with type 2 diabetes (T2D) mellitus in England. METHODS: This retrospective population-based cohort study used computerised records from the General Practice Research Database linked to Hospital Episode Statistics data in England. Patients with T2D from January 2006 to December 2010 were selected. Primary outcome measures were all-cause, non-diabetes-related, diabetes-related and hypoglycaemia-related hospitalisations. Factors associated with all-cause and diabetes-related hospitalisations were investigated with Cox's proportional hazards models. RESULTS: Amongst 97,689 patients with T2D, approximately 60% had at least one hospitalisation during the 4-year study period. Rates of hospitalisation were as follows: all-cause, 33.9 per 100 patient-years (pt-yrs); non-diabetes-related, 29.1 per 100 pt-yrs; diabetes-related, 18.8 per 100 pt-yrs and hypoglycaemia, 0.3 per 100 pt-yrs. The risk of all-cause hospitalisation increased with hospitalisation in the previous year, insulin use and the presence of major comorbidities. The risk of a diabetes-related hospitalisation increased with age, female gender, insulin use, chronic renal insufficiency, hypoglycaemia (as diagnosed by a general practitioner) and diabetes-related hospitalisation in the previous year. CONCLUSIONS: Patients with T2D are hospitalised at a considerably high rate for causes directly related with diabetes complications and stay longer in hospital. History of hospitalisation and complications of diabetes were found to be predictive of inpatient hospitalisations suggesting previous hospitalisation episodes could serve as points of intervention. This study highlights important areas for healthcare intervention and provides a reminder for vigilance when risk factors for hospitalisation in patients with T2D are present.

Optimization of insulin therapy in patients with type 2 diabetes mellitus: beyond basal insulin.

AIMS: To describe patients with Type 2 diabetes mellitus treated with basal insulin, with or without oral antidiabetics in UK primary care, and evaluate insulin treatment patterns and factors explaining changes in therapy. METHODS: Retrospective analysis of patients with Type 2 diabetes within The Health Improvement Network UK primary care database. Patients receiving basal insulin between January and June 2006 were followed until July 2009. RESULTS: Analysis included 3185 patients, mean age 65.6 years [standard deviation (SD) 12.4], 50.9% men, median diabetes duration 9.6 years, median basal insulin use 1.3 years, 86.5% had received oral antidiabetics in the previous 12 months. Mean follow-up was 2.9 years (SD 1.0), 59.8% patients maintained basal insulin throughout follow-up with a mean HbA(1C) of 69 mmol/mol (SD 19; 8.4%, SD 1.7) at baseline and 65 mmol/mol (SD 17; 8.1%, SD 1.6) during follow-up. During follow-up, 6.9% of patients discontinued, 19.3% intensified with and 14.1% switched to prandial or premixed insulin. Patients who intensified (prandial) had a mean HbA(1c) of 77 mmol/mol (SD 18; 9.2%, SD 1.6) before change and a mean HbA(1c) of 71 mmol/mol (SD 21; 8.6%, SD 2.0) at the end of the study. Those switching to premixed insulin had a mean HbA(1c) of 80 mmol/mol (SD 18; 9.5%, SD 1.7) before change and a mean HbA(1c) of 69 mmol/mol (SD 17; 8.5%, SD 1.5) at the end of the study. Increasing HbA(1c) and longer diabetes duration explained intensification and switch. CONCLUSIONS: The majority of patients had HbA(1c) above the 53 mmol/mol (< 7%) target at baseline and post-intensification/switch. The HbA(1c) levels were reduced by intensification/switch suggesting that insulin changes did have some impact. Most patients did not change insulin treatment despite having higher than recommended HbA(1c) levels. Reasons for not changing treatment in face of unsatisfactory clinical outcomes are unclear. Further research is warranted to explore barriers towards therapy change.

Anti-CD3 monoclonal antibody treatment in newly diagnosed Type 1 diabetes patients: a hypothetical modelling analysis.

AIMS: Although limited clinical data exist for anti-CD3 monoclonal antibody therapies, it is believed that they may influence glycaemic control, endogenous insulin secretion and hypoglycaemic event rates in individuals newly diagnosed with Type 1 diabetes. In the absence of suitable empirical evidence, the objective of this study was to estimate the potential long-term clinical outcomes associated with treatment via a hypothetical modelling analysis. METHODS: Analyses were performed using a published and validated computer simulation model of diabetes in a hypothetical US cohort based on published literature and expert opinion. The efficacy of anti-CD3 monoclonal antibody treatment was estimated from clinical data and expert opinion and simulations were performed over a 60-year time horizon. The impact on quality of life associated with treatment was also captured via published utility values. RESULTS: Assuming that a treatment course of an anti-CD3 monoclonal antibody produced an initial reduction in glycated haemoglobin of -0.8%, and that the effects persisted for up to 5 years, treatment was projected to lead to an increase in undiscounted life expectancy of 0.43 years and an increase in quality-adjusted life expectancy of 0.36 quality-adjusted life years compared with conventional exogenous insulin. CONCLUSIONS: A course of a hypothetical anti-CD3 monoclonal antibody treatment associated with improved glycaemic control and, potentially, the preservation of pancreatic beta-cell function was estimated to lead to improved life expectancy and quality-adjusted life expectancy compared with conventional treatment in patients with newly diagnosed Type 1 diabetes.

Talectomy for equinovarus deformity in myelodysplasia.

Nine patients with myelomeningocele (seventeen involved feet) had talectomy for the correction of equinovarus deformity. The age at surgery ranged from one year and eight months to seven years and four months old. The length of follow-up averaged seven years and four months and ranged from twenty-two months to twelve years. Fifteen feet had a good and two had a poor correction of the deformity of the hind part of the foot, the result being directly related to the intraoperative correction of the equinus deformity. The correction of the fore part of the foot was rated as good in eight, fair in one, and poor in eight feet. Residual deformity of the fore part of the foot compromised the functional result in six feet that had an acceptable correction of the deformity of the hind part.

The thoracic suspension orthosis.

Five year's experience with the thoracic suspension orthosis at Newington Children's Hospital has shown it to be an effective and very useful adjunct in the management of neuromuscular spinal deformity. The orthosis converts the thorax into a weight-bearing structure, thereby reducing the vertical load on the spine and allowing the abdomen and pelvis to act as a corrective distraction force. Fifty-nine of the 64 patients reported here have successfully used the orthosis to control spinal deformity and improve their functional status. Analysis of these 59 patients and the 5 treatment failures has resulted in identification of the specific indications, prerequisites, techniques, precautions, and contraindications necessary for the achievement of stated treatment objectives, often with dramatic success.

Congenital dislocation of the patella.

In 8 congenital patellar dislocations, in 7 patients, the patella was permanently and laterally dislocated, and irreducible or difficult to reduce. The patella usually was hypoplastic and showed absent facets. The intercondylar groove of the femur also was underdeveloped. In all but one patient, knee function was improved by a surgical procudure which involved lateral release of ptella, medial transpositon of patellar tendon, and plication of medial capsule or advancement of vastus medialis.

Treatment for Legg-Perthes disease with the Newington ambulation-abduction brace.

In a series of eighteen patients with Legg-Perthes disease (nineteen hips) the mean age was eight years and six months; all patients were over five and a half years old. The patients were treated in the Newington ambulatory brace. With this treatment the problems of management in ambulatory casts were eliminated and the disadvantages of recumbent abduction treatment were overcome. The results obtained by the ambulatory weight-bearing treatment in the Newington brace were gratifying. When compared with other published non-operative methods, significantly fewer severe deformities of the femoral head resulted.