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Rees D.A.,University of Cardiff | Jenkins-Jones S.,Pharmatelligence | Morgan C.L.,University of Cardiff
Journal of Clinical Endocrinology and Metabolism | Year: 2016

Context: Polycystic ovary syndrome (PCOS) is the most common cause of anovulatory infertility and may be associated with adverse pregnancy and neonatal outcomes. However, it is difficult to establish how much of this risk is due to PCOS and how much to obesity. Objective: This study aimed to determine the effect of PCOS upon fertility, pregnancy, and neonatal outcomes. Design and Setting: Data were extracted from the Clinical Practice Research Datalink (CPRD), a longitudinal anonymized primary care research database in the United Kingdom. Patients with a diagnosis of PCOS were matched to controls (1:2) by age (±1 y), body mass index (±3 U), and CPRD practice. Standardized fertility ratios before and after diagnosis (index date) were calculated. Rates of miscarriage, pre-eclampsia, gestational diabetes, premature delivery, delivery method, and neonatal outcomes were compared. Results: Nine thousand sixty-eight women with PCOS matched study criteria. Prior to index date the standardized fertility ratio for patients with PCOS was 0.80 (95% confidence interval, 0.77-0.83); following index date it was 1.16 (1.12-1.20). The adjusted odds ratios (95% CI) for miscarriage (1.70; 1.56-1.84), pre-eclampsia (1.32; 1.16-1.49), gestational diabetes (1.41; 1.2-1.66), and premature delivery (1.25; 1.1-1.43) were all increased compared with controls. Of PCOS births, 27.7% were by Caesarean section compared with 23.7% of controls (1.13; 1.05-1.21). Infants born to mothers with PCOS had an increased risk of neonatal jaundice (1.20; 1.03-1.39) and respiratory complications (1.20; 1.06-1.37). Conclusions: PCOS is associated with subfertility but fertility rates are restored to those of the background population following diagnosis. Pregnancy complications and adverse neonatal outcomes are more prevalent for women with PCOS independently of obesity. Copyright © 2016 by the Endocrine Society.

The capsaicin 8% patch can effectively treat neuropathic pain, but application can cause discomfort or a burning sensation. Until March 2013, it was recommended that patients be pretreated with a topical anesthetic, for example lidocaine, before capsaicin patch application. However, speculation existed over the need for pretreatment and its effectiveness in alleviating treatment-associated discomfort. This article compares tolerability to and efficacy of the capsaicin patch in pretreated and non-pretreated patients. All patients received a single capsaicin patch application. Pretreated patients received a lidocaine plaster before and intravenous lidocaine and metamizole infusions during capsaicin patch application. Pain levels, assessed using a Numeric Rating Scale (NRS), were used to determine tolerability and efficacy. All patients (pretreated n = 32; non-pretreated n = 26) completed 100% of the intended capsaicin patch application duration. At the time of capsaicin patch removal, 69% of pretreated and 88% of non-pretreated patients reported an NRS score increase, which returned to baseline by 6 hours post-treatment. There was no significant difference in mean NRS score between patient groups at any time during or after capsaicin patch treatment. Response was similar between patient groups; capsaicin patch treatment provided rapid and significant pain reductions that were sustained over 12 weeks. The same proportion of pretreated and non-pretreated patients reported willingness to receive retreatment with the capsaicin patch. This analysis shows that the capsaicin 8% patch is generally tolerable, and the small discomfort associated with patch application is short-lived. Lidocaine pretreatment does not have a significant effect on tolerability, efficacy, or patient willingness to receive retreatment. © 2013 The Authors. Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.

Morgan C.Ll.,University of Cardiff | Owens D.R.,University of Wales | Aubonnet P.,Abbott Laboratories | Carr E.S.M.,Abbott Laboratories | And 3 more authors.
BMJ Open | Year: 2013

Objectives: To compare the progression of diabetic retinopathy (DR) in people with type 2 diabetes treated with fibrates with that of non-exposed controls. Design: Retrospective, matched cohort study. Setting: UK Clinical Practice Research Datalink (CPRD). Participants: 5038 people with type 2 diabetes with a history of fibrate exposure but without evidence of DR were identified. Three thousand one hundred and seventy-six (63%) people could be randomly matched to one non-exposed control; of these, 2599 (81.8%) were matched without any missing blood pressure or glycated haemoglobin (HbA1c) values. Main outcome measures: The primary endpoint was first recorded DR with a secondary endpoint of allcause mortality or first DR. Time to clinical endpoints was compared using Cox proportional hazards models. Results: Mean follow-up was 5.1 and 5.0 years for fibrate-exposed and non-exposed patients, respectively. For fibrate-exposed participants, there was a reduction in DR: 33.4 events/1000 person-years vs 40.4 (p=0.002), and in death or DR: 50.6 vs 60.2 (p<0.001). For those matched with full systolic blood pressure and HbA1c data, crude event rates were 34.3 versus 43.9 for DR (p<0.001) and 51.2 vs 63.4 (p<0.001) for death or DR. Following adjustment, DR was significantly delayed for those treated with fibrates, with an adjusted HR (aHR) of 0.785 (p<0.001) for participants with complete data and an aHR of 0.802 (p<0.001) for all participants. Conclusions: The treatment with fibrates in people with type 2 diabetes was independently associated with reduced progression to a first diagnosis of DR.

Currie C.J.,University of Cardiff | Peters J.R.,University of Wales | Tynan A.,Eli Lilly and Company | Evans M.,University of Wales | And 4 more authors.
The Lancet | Year: 2010

Background: Results of intervention studies in patients with type 2 diabetes have led to concerns about the safety of aiming for normal blood glucose concentrations. We assessed survival as a function of HbA1c in people with type 2 diabetes. Methods: Two cohorts of patients aged 50 years and older with type 2 diabetes were generated from the UK General Practice Research Database from November 1986 to November 2008. We identified 27 965 patients whose treatment had been intensified from oral monotherapy to combination therapy with oral blood-glucose lowering agents, and 20 005 who had changed to regimens that included insulin. Those with diabetes secondary to other causes were excluded. All-cause mortality was the primary outcome. Age, sex, smoking status, cholesterol, cardiovascular risk, and general morbidity were identified as important confounding factors, and Cox survival models were adjusted for these factors accordingly. Findings: For combined cohorts, compared with the glycated haemoglobin (HbA1c) decile with the lowest hazard (median HbA1c 7·5%, IQR 7·5-7·6%), the adjusted hazard ratio (HR) of all-cause mortality in the lowest HbA1c decile (6·4%, 6·1-6·6) was 1·52 (95% CI 1·32-1·76), and in the highest HbA1c decile (median 10·5%, IQR 10·1-11·2%) was 1·79 (95% CI 1·56-2·06). Results showed a general U-shaped association, with the lowest HR at an HbA1c of about 7·5%. HR for all-cause mortality in people given insulin-based regimens (2834 deaths) versus those given combination oral agents (2035) was 1·49 (95% CI 1·39-1·59). Interpretation: Low and high mean HbA1c values were associated with increased all-cause mortality and cardiac events. If confirmed, diabetes guidelines might need revision to include a minimum HbA1c value. Funding: Eli Lilly and Company. © 2010 Elsevier Ltd. All rights reserved.

Morgan C.L.,University of Cardiff | Jenkins-Jones S.,Pharmatelligence | Currie C.J.,University of Cardiff | Rees D.A.,University of Cardiff
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: Polycystic ovary syndrome (PCOS) is associated with insulin resistance, hyperandrogenism, and dyslipidemia, but the effects of these disturbances on long-term health are not fully understood. Aim: Our aim was to determine the relative risk of type 2 diabetes, cancer, large-vessel disease (LVD), and all-cause mortality for women diagnosed with PCOS. Design: Data were extracted from the General Practice Research Database, a longitudinal, anonymized research database derived from nearly 600 primary-care practices in the United Kingdom. Patients with a diagnosis of PCOS between 1990 and 2010 were selected. Patients were matched to two sets of controls. The first set was matched according to primary-care practice and age, and the second was also matched on body mass index. Primary outcome was first incident record of diabetes. Crude rates for diabetes were presented, and time to diabetes was analyzed using Cox proportional hazard models. Secondary outcomes (cancer, LVD, and mortality) were also modeled. Results: Of 53,303 identified with a diagnosis of PCOS, 21,740 (40.8%) met the eligibility criteria. Median follow-up was 4.7 yr (interquartile range = 2.0-8.6 yr) in those with PCOS and 5.8 yr (2.7-9.6) in the reference group. Crude rates of diabetes were 5.7 and 1.7 per 1000 patient-years for cases and controls, respectively. The corresponding adjusted hazard ratio was 3.015 (95% confidence interval = 2.733-3.327). Of cases matched by body mass index, crude rates of diabetes were 4.7 and 2.4 per 1000 patient-years, respectively. The corresponding adjusted hazard ratio was 1.752 (1.514-2.028). No significant difference in BMI-adjusted risk was evident for cancer, LVD, or all-cause mortality. Conclusions: During this follow-up period, women with PCOS were not at increased risk of LVD, cancer, or death, but they had increased risk of type 2 diabetes. Copyright © 2012 by The Endocrine Society.

Wagner T.,Medizinisches Zentrum Stadteregion Aachen | Poole C.,Pharmatelligence | Roth-Daniek A.,Medizinisches Zentrum Stadteregion Aachen
Pain Medicine (United States) | Year: 2013

Objective: To investigate the response of patients with peripheral neuropathic pain (PNP) to capsaicin 8% patch treatment in a clinical setting. Design: Retrospective analysis. Setting: The Clinic for Pain Therapy and Palliative Medicine at the Medical Centre for the region of Aachen, Germany. Subjects: Patients diagnosed with PNP who attended the clinic for capsaicin 8% patch treatment between January 13, 2010 and February 7, 2011. Outcome Measures: Pain intensity was assessed using the Numeric Pain Rating Scale (NPRS) at baseline and following each capsaicin 8% patch treatment. Changes in prescribed concomitant neuropathic pain (NP) medications and response duration were recorded. Results: Overall, 68 patients with PNP conditions, including facial neuropathy (severe trigeminal neuralgia in V2), polyneuropathy, post-herpetic neuralgia, and mononeuropathies, received 96 treatments with the capsaicin 8% patch. The 53 patients with a follow-up of ≥8 weeks demonstrated a 48.4% mean reduction in NPRS score from baseline to Weeks 1-8. Among the 37 responders (those exhibiting ≥30% reduction in NPRS score from baseline to Weeks 1-8), the median time to re-treatment was 125 days. Following treatment, there was a significant (P<0.001) 54% reduction in the mean number of prescribed concomitant NP medications taken by patients. Conclusions: This analysis demonstrates that in clinical practice, the capsaicin 8% patch provides rapid and sustained pain reductions in patients with a variety of PNP conditions and a significant reduction in prescribed concomitant NP medications. The capsaicin 8% patch can be a valuable addition to the NP treatment armory for certain patients. © 2013 American Academy of Pain Medicine Wiley Periodicals, Inc.

Morgan C.L.,Pharmatelligence | Jenkins-Jones S.,Pharmatelligence | Evans M.,University of Cardiff | Barnett A.H.,NHS England | And 2 more authors.
Diabetes, Obesity and Metabolism | Year: 2012

Aim: This study aimed to describe the pattern of weight change in people with type 2 diabetes (T2DM) over time and when using alternative treatment regimens. Methods: Data were from routine clinical practice in the UK. The weight trend was determined for each year from 1995 to 2010 for both prevalent and incident cases. Baseline weight was compared to absolute (mean Δ) and relative weights (% Δ) at 6, 12 and 24 months. Results: Mean, standardized weight in prevalent cases increased from 83.4 to 92.1 kg for males and from 73.5 to 79.9 kg for females between 1995 and 2010 (p < 0.0001). For incident cases, the respective figures were 86.7 to 93.6 kg for males and 76.0 to 80.7 kg for females (p < 0.001). Between baseline and 6, 12 and 24 months, there were significant changes in weight for the majority of the treatment regimens selected for analysis. The largest weight increase at 12 months was for the patients who were prescribed a combination therapy with insulin and a thiazolidinedione, with a median increase of 4.1 kg (95% CI -0.60 to 8.0, p < 0.001). The largest weight decrease at 12 months was for the patients who were prescribed a combination therapy of metformin and exenatide, with a median decrease of -7.0 kg (95% CI -12.0 to -2.0, p < 0.001). Conclusions: There was a continual increase in body weight in people with T2DM over time, and considerable differences in the impact on weight using alternative treatment regimens. At the same time, glycaemic control remained relatively unchanged. © 2011 Blackwell Publishing Ltd.

Morgan C.Ll.,University of Cardiff | Poole C.D.,University of Birmingham | Evans M.,University of Wales | Barnett A.H.,University of Birmingham | And 2 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: After failure of metformin monotherapy, many second-line, glucose-lowering therapies are available to treat people with type 2 diabetes. Objective: The objective of the study was to compare clinical outcomes using common alternative regimens. Design and Setting: This was a retrospective cohort study using data from the U.K.-based General Practice Research Database. Patients: These were primary care patients with type 2 diabetes who had metformin monotherapy as their first treatment and who then initiated on relevant second-line, glucose-lowering regimens during the study period 2000-2010. A total of 27,457 patients were prescribed a second-line therapy, of whom 26,278 (95.7%) were prescribed a regimen with 1,000 or more observations. Main Outcome Measures: All-cause mortality, major adverse cardiovascular events (MACE), cancer, and a combined end point of any of these were measured. Secondary end points were change in glycosylated hemoglobin between baseline and 12 months. Time to clinical end points was compared using Cox proportional hazards models. Results: Sulfonylurea monotherapy had significantly higher hazard ratios (HRs) for all-cause mortality (HR 1.459, 1.207-1.763); MACE (HR 1.578, 1.187-2.099); stroke (HR 1.444, 1.050-1.987); and the combined end point (HR 1.381, 1.194-1.597). Metformin plus pioglitazone had significantly lower adjusted HRs for all-cause mortality (HR 0.707, 0.515-0.970) and the combined end point (HR 0.747, 0.612-0.911). Mean glycosylated hemoglobin improved between baseline and 12 months for all regimens other than sulfonylurea monotherapy. Conclusion: The combination of metformin plus pioglitazone appears to provide superior clinical outcomes compared with the most commonly used regimen, metformin plus sulfonylurea. Sulfonylurea monotherapy resulted in worse outcome. Copyright ©.

Morgan C.L.,Pharmatelligence | Peters J.R.,University of Wales | Dixon S.,University of Sheffield | Currie C.J.,University of Cardiff
Diabetic Medicine | Year: 2010

Aims Diabetes represents a notable burden to health payers. The purpose of this study was to estimate acute hospital care costs of treating people with diabetes with reference to the costs of treating those without. Methods This was a retrospective study. Data from routine hospital practice were available from a large health region (439 000 people), with an estimated prevalence of diabetes of 3.4%. Common records were identified using probabilistic record linkage. Cost estimates were attributed to admissions using healthcare resource group software. Outpatient costs were attributed using published values. Data described are for 2004, and prices in pounds sterling for 2005. Standardised cost ratios were estimated to compare the costs observed in the diabetes population with those expected from the non-diabetic reference population. Results The total annual cost of admissions was £28 944 811 per 100 000 people, of which £3 650 869 per 100 000 (12.6%) was diabetes related. The standardised cost rate of inpatient treatment was 2.9. The total cost of outpatient attendances was £6 589 971 per 100 000, of which £711 431 per 100 000 (10.8%) was diabetes related. The standardised cost ratio for outpatient care was 4.1. The total cost of hospital care for patients with diabetes was £11 206 986 per 100 000, or 12.3% of acute hospital expenditure. The combined standardised cost ratio was 3.1. Costs of care for inpatient treatment increased from 8.7% of revenue in 1994 to 12.3% in 2004. Conclusions The costs of acute hospital care for treating people with diabetes increased markedly over a decade, and now exceed 12% of revenue. © 2010 Diabetes UK.

Holden S.E.,Pharmatelligence | Poole C.D.,Pharmatelligence | Ll Morgan C.,Pharmatelligence | Currie C.J.,University of Cardiff
BMJ Open | Year: 2011

Introduction: Insulin analogues have become increasingly popular despite their greater cost compared with human insulin. The aim of this study was to calculate the incremental cost to the National Health Service (NHS) of prescribing analogue insulin preparations instead of their human insulin alternatives. Methods: Open-source data from the four UK prescription pricing agencies from 2000 to 2009 were analysed. Cost was adjusted for inflation and reported in UK pounds at 2010 prices. Results: Over the 10-year period, the NHS spent a total of £2732 million on insulin. The total annual cost increased from £156 million to £359 million, an increase of 130%. The annual cost of analogue insulin increased from £18.2 million (12% of total insulin cost) to £305 million (85% of total insulin cost), whereas the cost of human insulin decreased from £131 million (84% of total insulin cost) to £51 million (14% of total insulin cost). If it is assumed that all patients using insulin analogues could have received human insulin instead, the overall incremental cost of analogue insulin was £625 million. Conclusion: Given the high marginal cost of analogue insulin, adherence to prescribing guidelines recommending the preferential use of human insulin would have resulted in considerable financial savings over the period.

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