Cost‐Effectiveness of Tight Control of Inflammation in Early Psoriatic Arthritis: Economic Analysis of a Multicenter Randomized Controlled Trial

Objective

Treat‐to‐target approaches have proved to be effective in rheumatoid arthritis, but have not been studied in psoriatic arthritis (PsA). This study was undertaken to examine the cost‐effectiveness of tight control (TC) of inflammation in early PsA compared to standard care.

Methods

Cost‐effectiveness analyses were undertaken alongside a UK‐based, open‐label, multicenter, randomized controlled trial. Taking the perspective of the health care sector, effectiveness was measured using the 3‐level EuroQol 5‐domain, which allows for the calculation of quality‐adjusted life‐years (QALYs). Incremental cost‐effectiveness ratios (ICERs) are presented, which represent the additional cost per QALY gained over a 48‐week time horizon. Sensitivity analyses are presented assessing the impact of variations in the analytical approach and assumptions on the cost‐effectiveness estimates.

Results

The mean cost and QALYs were higher in the TC group: £4,198 versus £2,000 and 0.602 versus 0.561. These values yielded an ICER of £53,948 per QALY. Bootstrapped uncertainty analysis suggests that the TC has a 0.07 probability of being cost‐effective at a £20,000 threshold. Stratified analysis suggests that with certain costs being controlled, an ICER of £24,639 can be calculated for patients with a higher degree of disease severity.

Conclusion

A tight control strategy to treat PsA is an effective intervention in the treatment pathway; however, this study does not find tight control to be cost‐effective in most analyses. Lower drug prices, targeting polyarthritis patients, or reducing the frequency of rheumatology visits may improve value for money metrics in future studies.

     

Randomized Clinical Trial of Laparoscopic versus Open Fundoplication: Evaluation of Psychological Well-being and Changes in Everyday Life from a Patient Perspective

Background: The laparoscopic approach in antireflux surgery might have an impact on the patient's daily activities and well-being. Methods: Sixty patients were randomized to laparoscopic or open 360° fundoplication. Data were collected by questionnaires and interviews preoperatively, 1 month and 6 months after operation. Results: Five patients in the laparoscopic group were converted to open surgery. Psychological general well-being increased after surgery and reached norm values in both study groups. No significant differences were found between the two types of surgery in the per protocol analysis, while the domain self-control was significantly better after open surgery in the intention-to-treat analysis. There was improvement of diet and sleep in both study groups; after 6 months, disturbed sleep was significantly more uncommon after open surgery. Dysphagia and flatulence were new symptoms that were reported after surgery. Overall perception of the results of the operation did not differ between the groups. Conclusions: Psychological general well-being, diet and sleep improved after both laparoscopic and open surgery. There were only small differences between the groups, but in some respects the results were better after open surgery.     

Evaluation of Aortic Calcification With Lanthanum Carbonate vs. Calcium‐Based Phosphate Binders in Maintenance Hemodialysis Patients With Type 2 Diabetes Mellitus: An Open‐Label Randomized Controlled Trial

Vascular calcification (VC) contributes to cardiovascular disease in hemodialysis (HD) patients, especially with diabetes mellitus (DM) complications. No randomized studies have been published regarding the effect of lanthanum carbonate (LC) on VC progression in DM patients. The aim of this study was to evaluate the effects of lanthanum carbonate on the progression of VC in HD patients with type 2 DM. We conducted a randomized controlled trial comparing LC with calcium carbonate (CC) in 43 HD patients at a single dialysis center. Estimations of aortic calcification index (ACI) by abdominal computed tomography were performed twice for each patient (at baseline and 12 months). Forty‐one patients completed the study (19 LC, 22 CC). When ACI at baseline was ≦0.48 (median of baseline ACI), median change in ACI (Δ%ACI) was 20.44 (11.50–36.80%) in the LC group, and 40.00 (33.30–92.60%) in the CC group (P = 0.026). On the other hand, when ACI at baseline was >0.48, the median change in ACI (Δ%ACI) was 6.42 (3.13–24.40%) in the LC group, and 8.08 (5.68–12.20%) in the CC group (P = 1.000). Serum markers of chronic kidney disease‐mineral and bone disorder (CKD‐MBD), HbA1c, dose of vitamin D analogues, and side‐effects of medications did not change in either group throughout the study except int‐PTH increased in the LC group. This study indicated that administration of LC inhibited the progression of VC in patients receiving HD for type 2 DM, only in cases of slight VC compared with CC.     

One‐Year Clinical Outcome of a Randomized Trial of Polymer‐Free Paclitaxel‐Eluting Stents Versus Biodegradable Polymer‐Based Rapamycin‐Eluting Stents in Patients with Coronary Heart Disease

Background: More widespread use of drug‐eluting stents (DES) to treat coronary heart disease (CHD) has recently generated more attention to thrombosis, which was relative to the polymer. Polymer‐free and biodegradable polymer‐based stents are more frequently studied, but their efficacy on preventing detrimental clinical events is unclear. Methods and Results: To assess whether polymer‐free paclitaxel‐eluting stent (YINYI stent) was noninferior or equivalent to biodegradable polymer‐based rapamycin‐eluting stents (EXCEL stent) in preventing detrimental clinical cardiovascular events, a total of 167 consecutive CHD patients requiring DES implantation were randomly divided into the YINYI group (n = 82) and the EXCEL group (n = 85). The primary end‐point was major adverse cardiac events (MACE). The secondary end‐points included stent thrombosis events, all‐cause mortality, and rehospitalization. The study was designed to test the noninferiority or equivalence of the YINYI stent compared with the EXCEL stent with respect to one‐year MACE according to a noninferiority or equivalence margin of 0.1. One‐year MACE was 6.10% in the YINYI group versus 5.88% in the EXCEL group. The lower limit of the one‐sided 95% confidence interval was ?0.0582 (P = 0.002 from the test for noninferiority). The 95% confidence interval for the equivalence test was [?0.0698, 0.0742] (P₁=0.004 and P₂=0.007 from 2 times the 1‐sided test for equivalence). There was no statistically significant difference in thrombosis events, all‐cause death, and rehospitalization (all P > 0.05). Conclusions: In this small randomized trial, polymer‐free paclitaxel‐eluting stents appear to be noninferior or equivalent to biodegradable polymer‐based rapamycin‐eluting stents. (J Interven Cardiol 2012;25:604–610)