WOMAC 20, 50, 70 response levels in patients treated with Rofecoxib for osteoarthritis

Aim of study: The goal of this post-hoc analysis was to examine the difference between treatment groups when varying the target response level from at least a 20% improvement from baseline, to at least 50% and 70% improvements in Phase III studies of rofecoxib in patients with osteoarthritis. Methods: The analysis focused on results from two 6-week, placebo-controlled, ibuprofen-comparator, Phase III osteoarthritis studies. These studies employed a flare design requiring a minimum level of symptoms at entry following discontinuation of prior analgesics. Two definitions of ‘‘patient improved’’ from baseline were used: (1) WOMAC-P: a reduction in the WOMAC pain score and (2) WOMAC-PFS: a reduction in the WOMAC pain score and either a reduction in the WOMAC stiffness or function score. The improvement target was increased from 20% to 50% to 70%, relative to baseline, to investigate how the increase affects the ability to detect the differences between treatment groups. Analyses were conducted on the average and last of all measurements collected during a 6-week treatment period. Results: In the ibuprofen-comparator studies, 1545 patients were randomized to placebo, rofecoxib 12.5 mg once daily, rofecoxib 25 mg once daily, and ibuprofen 800 mg three times daily in a 1:3:3:3 ratio. The percentages of patients who met the improvement targets decrease as the target increases from 20% to 50% to 70%. There were meaningful differences between the active treatment and placebo that were inversely related to the improvement target. For example, there was a 31 (P ! 0.001), 21 (P ! 0.001), and 12 (P ! 0.001) percentage-point difference between rofecoxib 25 mg and placebo for the 20%, 50%, and 70% targets for WOMAC-P. For WOMAC-PFS, the differences between rofecoxib 25 mg and placebo were 33 (P ! 0.001), 18 (P ! 0.001), and 9 (P ! 0.01) percentage points for the 20%, 50%, and 70% improvement targets. Conclusions: Meaningful differences between active treatments and placebo were detected at all three response levels associated with the WOMAC-P and WOMAC-PFS endpoints. The differences between groups were more dramatic at the 20% and 50% response levels. The WOMAC (20,50,70)-P and WOMAC (20,50,70)-PFS endpoints further confirm, at an individual patient level, the clinical benefit of rofecoxib in the treatment of osteoarthritis that was previously reported as a difference in means.

Predictors of osteoarthritis(OA) improvement in patients treated with Hylan G-F for knee OA.

Aim of study: Different criteria for treatment response were explored to identify predictors of OA improvement. Analyses were based on data from a previously reported 1-year randomized controlled trial of appropriate care with or without hylan G-F 20 in patients with knee OA. Methods: Five definitions of ‘‘patient responder’’ from baseline to month 12 were examined: at least 20% reduction in WOMAC pain score; at least 20% reduction in WOMAC pain score and at least 20% reduction in either the WOMAC stiffness or function score; OARSI responder criteria (Propositions A and B) for intra-articular drugs; and OMERACT-OARSI responder criteria (Proposition D). As an a posteriori analysis, multivariable logistic regression models for each definition of patient responder were developed using a forward selection method. The following variables were defined prior to modeling and considered in the model along with two-way interactions: age (O65 years), BMI, gender, X-ray grade (0, I, II vs III, IV), co-morbidity (1 or 2 conditions vs 3 or more), duration of OA in study knee (years), previous surgery of study knee, hylan G-F 20 injection technique, WOMAC pain, stiffness and function, and treatment group. Results: Hylan G-F 20 was a predictor of improvement for all patient responder definitions P ! 0.001; odds of improvement were 2.7 or higher for patients in the hylan G-F 20 group compared to appropriate care without hylan G-F 20. For three of the five patient responder definitions, X-ray grade was a predictor of improvement (P ! 0.10; lower X-ray grade increased the odds of improvement). For four of the five patient responder definitions, duration of OA was a predictor of improvement (P ! 0.10; shorter duration of OA increased the odds of improvement). Conclusion: Analyses showed that appropriate care with hylan G-F 20 is the dominant predictor of patient improvement. While high grade structural damage does not preclude a response, patients who are targeted early in the disease process when less structural damage has occurred, may have a greater chance of improvement.

The relative impact of scar and viable tissue in predicting global left ventricular remodeling in medically treated patients

We sought to determine the relative impact of myocardial scar and viability on post-infarct left ventricular (LV) remodeling in medically-treated patients with LV dysfunction. Forty patients with chronic ischemic heart disease (age 64±9, EF 40±11%) underwent rest-redistribution Tl201 SPECT (scar = 50% transmural extent), A global index of scarring for each patient (CMR scar score) was calculated as the sum of transmural extent scores in all segts. LV end diastolic volumes (LVEDV) and LV end systolic volumes (LVESV) were measured by real-time threedimensional echo at baseline and median of 12 months follow-up. There was a significant positive correlation between change in LVEDV with number of scar segts by all three imaging techniques (LVEDV: SPECT scar, r = 0.62, p < 0.001; DbE scar, r = 0.57, p < 0.001; CMR scar, r = 0.52, p < 0.001) but change in LV volumes did not the correlate with number of viable segments. ROC curve analysis showed that remodeling (LVEDV> 15%) was predicted bySPECTscars(AUC= 0.79),DbEscars(AUC= 0.76),CMR scars (AUC= 0.70), and CMR scar score (AUC 0.72). There were no significant differences between any of the ROC curves (Z score

Blood glucose self-monitoring in non-insulin-treated type 2 diabetes:a qualitative study of patients' perspectives

Background: Self-monitoring of blood glucose is controversial in the management of type 2 diabetes. Some research suggests that self-monitoring improves glycaemic control, whereas other research is sceptical about its value for people with type 2 diabetes who are not on insulin. Although blood glucose meters are widely available and used by this group, patients' own views are absent from the debate. Aim: To explore the pros and cons of glucose monitoring from the patients' perspectives. Design of study: Qualitative repeat-interview study. Setting: Patients were recruited from 16 general practices and three hospital clinics within four local healthcare cooperatives in Lothian, Scotland. Method: Interview data from 40 patients diagnosed with type 2 diabetes within the previous 6 months were analysed using thematic analysis informed by grounded theory. We report findings from round 1 and round 2 interviews. Results: Glucose monitoring can heighten patients' awareness of the impact of lifestyle; for example, dietary choices, on blood glucose levels. Glucose monitoring amplifies a sense of 'success' or 'failure' about self-management, often resulting in anxiety and self-blame if glucose readings remain consistently high. Moreover, monitoring can negatively effect patients' self-management when readings are counter-intuitive. Conclusion: Our analysis highlights the importance of understanding the meanings that newly diagnosed patients attach to glucose self-monitoring. To maximise the positive effects of self-monitoring, health professionals should ensure that patients understand the purpose of monitoring and should clarify with patients how readings should be interpreted. © British Journal of General Practice.

What is the prevalence of diabetic macular oedema involving the centre of the macula in patients undergoing digital diabetic retinopathy screening

Free Paper Sessions Design. Retrospective analysis. Purpose. To assess the prevalence of center-involving diabetic macular oedema (CIDMO) and risk factors. Methods. Retrospective review of patients who were screen positive for maculopathy (M1) during 2010 in East and North Birmingham. The CIDMO was diagnosed by qualitative identification of definite foveal oedema on optical coherence tomography (OCT). Results. Out of a total of 15,234 patients screened, 1194 (7.8%) were screen positive for M1 (64% bilateral). A total of 137 (11.5% of M1s) were diagnosed with macular oedema after clinical assessment. The OCT results were available for 123/137; 69 (56.1%) of these had CI-DMO (30 bilateral) which is 0.5% of total screens and 5.8% of those screen positive for M1. In those with CIDMO 60.9% were male and 63.8% Caucasian; 90% had type 2 diabetes and mean diabetes duration was 20 years (SD 9.7, range 2-48). Mean HbA1c was 8.34%±1.69, with 25% having an HbA1c =9%. Furthermore, 62% were on insulin, 67% were on antihypertensive therapy, and 64% were on a cholesterol-lowering drug. A total of 37.7% had an eGFR between 30% and 60% and 5.8% had eGFR <30. The only significant difference between the CIDMO and non-CIDMO group was mean age (67.83±12.26 vs 59.69±15.82; p=0.002). A total of 65.2% of those with CIDMO also had proliferative or preproliferative retinopathy in the worst eye and 68.1% had subsequently been treated with macular laser at the time of data review. Conclusions. The results show that the prevalence of CIDMO in our diabetic population was 0.5%. A significant proportion of macula oedema patients were found to have type 2 diabetes with long disease duration, suboptimal glycemic and hypertensive control, and low eGFR. The data support that medical and diabetic review of CIDMO patients is warranted particularly in the substantial number with poor glycemic control and if intravitreal therapies are indicated.