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Gordon J.,University of Adelaide | Gordon J.,Flinders University | Pockett R.D.,Cardiff Research Consortium | Tetlow A.P.,Cardiff Research Consortium | And 2 more authors.
International Journal of Clinical Practice | Year: 2010

Aims: Insulin is normally added to oral glucose-lowering drugs in people with type 2 diabetes when glycaemic control becomes suboptimal. We evaluated outcomes in people starting insulin therapy with neutral protamine Hagedorn (NPH), detemir, glargine or premixed insulins. Methods: Insulin-nïve people with type 2 diabetes (n = 8009), ≥ 35 years old, HbA 1c≥ 6.5% and begun on NPH (n = 1463), detemir (n = 357), glargine (n = 2197) or premix (n = 3992), were identified from a UK database of primary care records (The Health Improvement Network). Unadjusted and multivariate-adjusted analyses were conducted, with persistence of insulin therapy assessed by survival analysis. Results: In the study population (n = 4337), baseline HbA 1c was 9.5 ± 1.6%, falling to 8.4 ± 1.5% over 12 months (change -1.1 ± 1.8%, p < 0.001). Compared with NPH, people taking detemir, glargine and premix had an adjusted reduction in HbA 1c from baseline, of 0.00% (p = 0.99), 0.19% (p < 0.001) and 0.03% (p = 0.51). Body weight increased by 2.8 kg overall (p < 0.001), and by 2.3, 1.7, 1.9, and 3.3 kg on NPH, detemir, glargine and premix (p < 0.001 for all groups); insulin dose at 12 months was 0.70 (overall), 0.64, 0.61, 0.56 and 0.76 U/kg/day. After 36 months, 57% of people on NPH, 67% on glargine and 83% on premix remained on their initially prescribed insulin. Discussion and Conclusion: In routine clinical practice, people with type 2 diabetes commenced on NPH experienced a modest disadvantage in glycaemic control after 12 months compared with other insulins. When comparing the insulins, glargine achieved best HbA 1c reduction, while premix showed greatest weight gain and the highest dose requirement, but had the best persistence of therapy. © 2010 Blackwell Publishing Ltd.

Gordon J.,University of Adelaide | Gordon J.,Flinders University | Lister S.,Johnson and Johnson Medical | Prettyjohns M.,Cardiff Research Consortium | And 3 more authors.
Journal of Medical Economics | Year: 2012

Objectives: A small but significant proportion of patients with peripheral neuropathic pain (NeP) are refractory to the typical treatments applied in clinical practice, including amitriptyline and gabapentin. Thus, they continue to suffer the debilitating effects of NeP. This study aimed to evaluate the cost-effectiveness of pregabalin in comparison to usual care, in patients with refractory NeP, from a third party payer's perspective (NHS). Methods: A stochastic simulation model was constructed, using clinical data from four non-randomized studies, to generate pain pathways of patients receiving usual care and pregabalin. Treatment effect (pain reduction) was converted to quality-of-life (QoL) data, using a regression analysis based on new utility data, collected from a survey of refractory NeP patients presenting to pain clinics in Cardiff, Wales. All relevant direct costs were estimated using resource use from the survey data (where available) and unit costs from the British National Formulary (BNF). The analysis was run over a 5-year time horizon, with costs and benefits discounted at 3.5%. Study limitations: The use of non-randomized (observational) data to characterize the effectiveness of treatments for NeP. Exclusion of productivity costs and consequences from the analysis. Results: In the base case analysis, an incremental cost-effectiveness ratio (ICER) of £10,803 per quality adjusted life year (QALY) was attained. This result was found to be reasonably insensitive to variations in the key input parameters, with ICERs ranging from £8505 to £22,845 per QALY gained. Conclusions: The analysis shows that pregabalin is a cost-effective alternative to usual care in patients with refractory NeP, with an ICER well below the threshold typically adopted by UK health technology assessment groups, such as NICE. © 2012 Informa UK Ltd.

Pockett R.D.,Cardiff Research Consortium | Castellano D.,Hospital Universitario 12 Of Octubre | Mcewan P.,Cardiff Research Consortium | Oglesby A.,Amgen Inc. | And 2 more authors.
European Journal of Cancer Care | Year: 2010

Metastatic bone disease (MBD) is the most common cause of cancer pain and of serious skeletal-related events (SREs) reducing quality of life. Management of MBD involves a multimodal approach aimed at delaying the first SRE and reducing subsequent SREs. The objective of the study was to characterise the hospital burden of disease associated with MBD and SREs following breast, lung and prostate cancer in Spain. Patients admitted into a participating hospital, between 1 January 2003 and 31 December 2003, with one of the required cancers were identified and selected for inclusion into the study. The index admission to hospital, incidence of patients admitted and hospital length of stay were analysed. There were 28162 patients identified with breast, lung and prostate cancer. The 3 year incidence rates of hospital admission due to MBD were 95 per 1000 for breast cancer, 156 per 1000 for lung cancer and 163 per 1000 for prostate cancer. For patients admitted following an SRE, the incidence rates were 211 per 1000 for breast cancer, 260 per 1000 for lung cancer and 150 per 1000 for prostate cancer. This study has shown that cancer patients consume progressively more hospital resources as MBD and subsequent SREs develop. © 2009 The Authors European Journal of Cancer Care © 2009 Blackwell Publishing Ltd.

Asche C.V.,Illinois College | Bode B.,Atlanta Diabetes Associates | Busk A.K.,Novo Nordisk AS | Nair S.R.,Cardiff Research Consortium
Diabetes, Obesity and Metabolism | Year: 2012

Aim: To study the clinical and economic benefits associated with adequate and early initiation and intensification of insulin in people with type 2 diabetes mellitus (T2DM). Methods: A systematic review was performed using published articles from January 2000 to August 2010 that linked intervention, disease, study design and outcomes. Studies were further classified as initiation and intensification based on predefined criteria. Individual studies in systematic reviews and meta-analysis were searched and included if relevant. Results: A total of 2690 articles were screened with 76 (40 initiation and 36 intensification) studies included. Most initiation studies had mean baseline HbA1c values of >8.5%. The endpoint HbA1c values were reduced with insulin treatment in these studies, with endpoint values ranging from 6.6 to 9.8%. Similar results were seen with the intensification studies (endpoint HbA1c: 6.4-9.6%). Addition of insulin to oral antidiabetics (OADs) resulted in better glycaemic control in most studies. Blood glucose levels reduced substantially with OADs + insulin compared with OADs alone. Quality of life outcomes and treatment satisfaction were reported in six studies and not significantly different for insulin vs. OADs. Hypoglycaemic events were manageable with insulin initiation. However, all insulin types were associated with weight gain although the comparison with OADs elicited varying results. Conclusions: Proactive management with early insulin initiation and intensification should be considered in people with T2DM in inadequate glycaemic control. The economic benefits with early initiation and intensification have to be fully explored. © 2011 Blackwell Publishing Ltd.

Prettyjohns M.,Cardiff Research Consortium | Sandelin R.,Pfizer | Lister S.,Cardiff Research Consortium | Norrefalk J.-R.,Karolinska Institutet
Journal of Medical Economics | Year: 2012

Objectives: Patients refractory to older therapies for neuropathic pain (NeP) have few remaining therapeutic options. This study evaluates the cost-utility of pregabalin in the treatment of patients with refractory neuropathic pain in Sweden, from a healthcare and a societal perspective. Study limitations: The use of non-randomized (observational) data to determine the effectiveness of treatments for NeP. The use of non-Swedish data for some input parameters in the model. Methods: A previously constructed discrete event simulation model was adapted to compare pregabalin combined with usual care to usual care alone in a Swedish setting. Pain profiles were generated using clinical data from five non-randomized pregabalin studies in refractory NeP patients. Utility data were generated from a UK survey of patients with NeP. Cost data were generated from the Swedish Dental and Pharmaceutical Benefits Board (TLV's) product price database, a national NeP register, and a regional registry study. Indirect costs were estimated from published sources. One-way and probabilistic sensitivity analyses evaluated uncertainty in the model's output. Results: The incremental cost-effectiveness ratio (ICER) for pregabalin plus usual care treatment compared to usual care was 51,616 SEK/€5364 and 123,993 SEK/€12,886 with and without indirect costs, respectively. One-way sensitivity analyses confirmed the clinical input data as the main driver of the model; even considerable changes to all other input parameters had only a modest effect on the ICER. The ICER remained well below a conservative threshold of 347,495 SEK /€36,113/£30,000 in all scenarios modelled. Conclusions: This study found pregabalin combined with usual care to be cost-effective compared to usual care in patients with refractory NeP from a Swedish Health Care perspective. Moreover, sensitivity analysis showed pregabalin's cost-effectiveness to be robust in all scenarios modelled. © 2012 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.

Miszczyk L.,Oncology and Radiotherapy Institute | Tukiendorf A.,Cardiff Research Consortium
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: An evaluation of dose-response relationship and an attempt to define predictive factors. Methods and Materials: A total of 137 cases of painful vertebral hemangioma irradiations (101 patients). Fraction dose (fd) varied from 2 to 15 Gy (123 fractionated and 14 radiosurgical treatments), and total dose (TD) from 8 to 30 Gy (111 cases irradiated with fd of 2 GY to TD of 24 Gy). We evaluated pain relief, changes in analgesic requirements, and reossification. Results: Means of pain relief 1, 6, 12, and 18 months after radiotherapy (defined as a decrease of primary pain level expressed in percent) were 60.5%, 65.4%, 68.3%, and 78.4%, respectively. Proportion of patients with no need for analgesics and patients using tramadol were 39%, 40%, 44%, 57%, and 20%, 17%, 22%, and 11% in these times. The proportion of patients experiencing complete/partial pain relief changed from 36/48% 1 month, to 64/22% 1.5 years after radiotherapy. No impact of radiotherapy on reossification was found. The positive impact of fd and TD increase for analgesics uptake reduction and pain relief was found. An increase of the fd by 1 Gy results in 27% chance of analgesics uptake reduction and 3.8% reduction of pain, whereas 14% analgesics uptake reduction and 2.2% of pain reduction in case of the TD. The predictive factors improving results were found: female gender, older age, better performance states (the chance of the lower analgesic treatment decreases over 2.5 times in comparison to the higher Zubrod degree), bigger Hb concentration, shorter symptoms duration and lower analgesics uptake before radiotherapy. Conclusions: The obtained data support the efficacy of radiotherapy in improving pain secondary to vertebral hemangioma, with the degree of pain amelioration being related to increasing fd and TD. The positive predictive factors were defined: female gender, older age, better performance status, increased Hb concentration, shorter symptoms duration, and lower analgesics uptake before radiotherapy. © 2012 Elsevier Inc.

Townsend R.,Cardiff Research Consortium | McEwan P.,Cardiff Research Consortium | Kim R.,Rochester College | Yuan Y.,Bristol Myers Squibb
Value in Health | Year: 2011

Published economic evaluations have reported available treatments for chronic hepatitis C to be cost-effective as part of the current approach to disease management, but as standards of care evolve, their approach to modeling should be reconsidered. This study aimed to review structural frameworks and key model parameters as reported in current economic evaluations for treatments for chronic hepatitis C, and model the impact of variability across parameters on results. A systematic review of studies published from 2000 to 2011 was performed. Studies were retrieved from five electronic databases using relevant search strategies. Model structures, disease progression rates, utilities, and costs were extracted from included studies, and were qualitatively reviewed and incorporated into a cost-utility model. Thirty-four studies were appropriate for data extraction. A common pathway of six disease states was identified. In some studies the early disease stages and/or the decompensated cirrhosis state were further subdivided. Large variability in values used for disease progression rates, utilities, and costs were identified. When incorporated into a model, incremental cost-effectiveness ratios (ICERs) varied: in the least favorable scenario, peginterferon plus ribavirin was dominated by interferon plus ribavirin; and in the most favorable scenario, peginterferon plus ribavirin dominated interferon plus ribavirin ($8,544 per quality-adjusted life year [QALY]; costs are given in 2008 US dollar amounts). Using mean values the ICER was $15,198 per QALY. Current models use a simplistic structure resulting from the lack of available data reflecting patient heterogeneity. Key model parameters are currently based on a small number of studies and the variability across these values can affect the interpretation of results. © 2011 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Pockett R.D.,Cardiff Research Consortium | Adlard N.,Sanofi S.A. | Carroll S.,Sanofi S.A. | Rajoriya F.,Sanofi S.A.
Current Medical Research and Opinion | Year: 2011

Objectives: Infectious intestinal diseases cause substantial morbidity and economic loss in the UK. Rotavirus gastroenteritis (RVGE), a form of gastroenteritis, is the primary cause of severe diarrhoea in children. The primary objective of this study was to examine whether hospitalisation for gastroenteritis, and particularly RVGE, is linked to social deprivation. Methods: A retrospective study relating to hospital admissions in England with rotavirus, gastroenteritis, or type 1 diabetes mellitus (T1DM) was conducted in children aged under 5 years between 1st April 2009 and 31st March 2010 using the CHKS database. Admissions with selected diagnoses were extracted based on ICD-10 coding. Deprivation data were obtained from the Index of Multiple Deprivation (IMD) 2007 for England. Results: A total of 20,571 unique hospital admissions were made by children, in England, with RVGE (n = 1334; 6.5%) together with a diagnosis of infectious gastroenteritis of all causes (n = 19,237; 93.5%), giving an overall hospital admission rate, for those aged under 5 years, of 65.7 per 10,000 population. With 'rank of average score' and the 'rank of average rank' as measures of deprivation, the rate of hospital admissions with gastroenteritis of all causes decreased by 0.346 and 0.287 per 10,000 (p < 0.001) respectively for every unit increase in deprivation rank (decreasing deprivation), though this trend was not observed in patients admitted with RVGE specifically. Conclusions: Hospital admissions with gastroenteritis of all causes increased as deprivation increased. The implementation of a rotavirus vaccination programme would help to reduce the burden of RVGE and gastroenteritis of all causes, and in the context of gastroenteritis, some elements of health and social inequality may be vaccine preventable. Limitations: It is possible that the study is limited by the accuracy and completeness of deprivation indices, and coding within CHKS; the existence of the 'ecological fallacy' must also be considered. © 2011 Informa UK Ltd All rights reserved.

McEwan P.,Cardiff Research Consortium | Evans M.,University of Wales | Bergenheim K.,Astrazeneca
Diabetes, Obesity and Metabolism | Year: 2010

Aim: The attainment of near-normal glycaemia is an important feature in reducing complications in people with type 2 diabetes. Current treatment pathways advocate a failure-driven therapy algorithm for blood-glucose lowering that leads to the sequential addition of therapies. The addition and combination of multiple blood-glucose lowering agents may be associated with significant side effects, such as weight gain and hypoglycaemia, resulting in a detrimental quality of life. The objective of this study is to quantify the overall costs and quality-adjusted life years (QALY) associated with therapy escalation via oral only treatment strategies with different adverse event profiles as a function of target HbA1c achievement. Methods: A previously published model was adapted to run as a non-terminating simulation model. The model is designed to evaluate the cost utility of treatment strategies in a population of type 2 diabetes mellitus patients. Model outputs include incidence of micro- and macrovascular complications, hypoglycaemia and diabetes-specific and all-cause mortality. Results: The total number of vascular events predicted by the model varied little across the four treatment strategies because of the glycaemic profile associated with each therapy strategy being similar. The strategy with sequential addition of thiazolidinediones (TZDs) and sulphonylureas (SUs) to metformin (MF) was associated with greatest predicted hypoglycaemia burden. The addition of SU and dipeptidyl peptidase (DPP-4) inhibitors to MF was associated with the highest estimated QALYs. Conclusions: A treatment strategy involving the sequential addition of SU and TZD to first-line MF therapy is associated with the lowest cost and lowest gain across a population, whereas addition of TZD and SU sequentially to first-line MF therapy resulted in the highest cost and incrementally less QALY gain when compared with treatment strategies involving the addition of a DPP-4 inhibitor and SU to first-line MF (irrespective of the treatment sequence) that were associated with both less cost and greatest QALY gain. © 2010 Blackwell Publishing Ltd.

McEwan P.,Cardiff Research Consortium | Evans M.,University of Wales | Kan H.,Bristol Myers Squibb | Bergenheim K.,Astrazeneca
Diabetes, Obesity and Metabolism | Year: 2010

Background: Current guidelines for the management of type 2 diabetes advocate the attainment of sustained near normal glycaemia levels. Metformin is widely accepted as the treatment of choice for the initiation of pharmacotherapy; however, secondary failure of oral monotherapy occurs in 60% of patients resulting in the need for multiple pharmacotherapies. Therapy-related consequences of treatment, such as weight gain and hypoglycaemia impact on the cost-effectiveness profile of various agents. We therefore sought to ascertain the respective contribution of hypoglycaemia, weight change and improved blood glucose control on second-line therapy options added to metformin.Methods: This study uses a simulation model designed to evaluate the cost utility of new therapies in a population of patients with type 2 diabetes mellitus. Standard model outputs include incidence of micro- and macrovascular complications and diabetes-specific and all-cause mortality.Results: The mean discounted quality-adjusted life year (QALY) predicted by the model was 12.31 years. Reducing Glycosylated haemoglobin (HbA1c) by 1% gave a predicted gain of 0.413 QALYs per patient. A 3-kg weight loss and 30% reduction in hypoglycaemia frequency produced a combined QALY gain of 0.355, whereas the reverse gave a QALY decrement of 0.356.Conclusions: The results of this analysis quantify the QALY decrement that may result from adverse therapy effects. The beneficial effects of improved glycaemic control on QALYs may be offset by characteristic treatment-specific adverse effects, such as weight gain and hypoglycaemia frequency. © 2010 Blackwell Publishing Ltd.

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