Online First articles

A Real-World Study of Patients With Type 2 Diabetes Initiating Basal Insulins via Disposable Pens


Lin Xie, Wenhui Wie, Chunshen Pan, Juan Du, Onur Baser

DOI: 10.1007/s12325-011-0074-5

Adv Ther. 2011;28(11). In press.

Abstract | Full text

Introduction: Real-world data comparing outcomes of type 2 diabetes mellitus (T2DM) patients initiating different insulin regimens can help with treatment decisions and patient management. Clinical and economic outcomes following initiation with insulin glargine disposable pen (GLA-P) or insulin detemir disposable pen (DET-P) in T2DM patients were compared over 1-year follow-up. Methods: This retrospective cohort analysis was conducted on data in a US national managed care claims database (July 2006 to September 2010) from patients initiating insulin treatment with GLA-P or DET-P. Treatment persistence, adherence, glycated hemoglobin (A1C), hypoglycemic events, and healthcare costs during follow-up were compared. Results: In all, 1682 patients were identified; 1016 (60.4%) started using GLA-P, 666 (39.6%) started using DET-P. After 1:1 propensity score matching, each cohort comprised 640 patients. Patients initiating GLA-P were significantly more likely to persist and adhere to treatment, and used a lower daily consumption dose. Over the last quarter of follow-up, fewer GLA-P users switched to DET-P compared with those switching from DET-P to GLA-P. GLA-P was associated with lower A1C levels and higher reduction of A1C levels from baseline, with no significant difference in the number of patients having hypoglycemic events. Patients in both cohorts had similar total and diabetes-related healthcare costs, but healthcare costs were lower in the GLA-P cohort for each 1% reduction in A1C from baseline. Conclusion: This real-world study demonstrates that patients initiating GLA-P were more likely to persist with and adhere to treatment, with better glycemic control and similar overall hypoglycemia rate at no increase in healthcare cost.

Cost Associated with D-Dimer Screening for Acute Aortic Dissection


Theodoros Moysidis, Marc Lohmann, Sarah Lutkewitz, Guido Kemmeries, Knut Kröger

DOI: 10.1007/s12325-011-0069-2

Adv Ther. 2011;28(11). In press.

Abstract | Full text

Introduction: D-Dimer (DD) has been described as a useful predictor of both morphologic changes in acute thoracic aortic dissection (TAD) and of TAD-associated mortality. This study analyzed the use of DD screening to screen patients with chest pain for acute (TAD) to determine if it improves diagnosis and cost effectiveness. This study also looked at the association of DD levels with diagnoses frequently seen in patients with dyspnea or chest pain. Methods: At the Helios Hospital, Krefeld, the authors analyzed the data of all patients (n=1053, age (mean, SD) 62±19 years, 49% males) admitted for chest pain to the nonsurgical emergency department (ED) in February 2010. Chest pain was the second most frequent symptom causing 138 (13.1%) admissions, 102 of which had DD testing (Inniovance® D-Dimer Assay, Dade Behring/Siemens, Germany). To assess the diagnostic reliability of DD testing, the sensitivity, specificity, and odds ratio, including 95% confidence interval, were estimated. Results: None of the patients admitted were found to have acute TAD. Had the authors used a computerized tomography (CT) scan to rule out TAD in every patient with chest pain, actual costs would have been €12,328. A restriction of CT scans to patients with elevated DD levels would have lowered costs to €5360. The actual costs were €670.30 for CT scans and €540.60 for DD tests. On analyzing the association with other diagnoses, both sensitivity and specificity were low, with the exception of pneumonia. Conclusion: Owing to the low incidence of TAD, DD screening increases diagnostic efforts and costs but it remains unclear whether it would actually speed up TAD diagnosis. In a clinical setting DD did not help to discriminate other relevant diagnoses. Despite the high sensitivity of DD for aortic dissection published in the literature, the physician’s clinical judgment remains paramount.

The “MESACA” Study: Methylsulfonylmethane and Boswellic Acids in the Treatment of Gonarthrosis


Angela Notarnicola, Silvio Tafuri, Lucrezia Fusaro, Lorenzo Moretti, Vito Pesce, Biagio Moretti

DOI: 10.1007/s12325-011-0068-3

Adv Ther. 2011;28(10):894-906.

Abstract | Full text

Introduction: Osteoarthritis is a chronic rheumatoid disease mediated by metalloproteinases and inflammatory cytokines. Methylsulfonylmethane (MSM) and boswellic acids (BA) each show promise in the treatment of inflammatory processes, but the efficacy of combined treatment with these substances in the treatment of arthritis has not yet been studied. Methods: In this prospective randomized clinical trial, MESACA (for “methylsulfonylmethane and boswellic acids in the treatment of knee arthritis”), 60 subjects affected by arthritis of the knee were randomly assigned to an experimental group treated for 60 days with 5 g of MSM and 7.2 mg of BA daily, or a control group which was administered a placebo. At 2 and 6 months follow-up (FU), the efficacy of combined treatment with these two dietary supplements was assessed using the visual analog pain scale (VAS) and the Lequesne index (LI) for joint function, as well as monitoring the use of anti-inflammatory drugs (nonsteroidal anti-inflammatory drugs and anti-cyclooxygenase-2). Results: Pain, assessed with the VAS scale, was worse in the group treated with MSM and BA as compared with the placebo group at 2 months FU (3.8 vs. 2.7; P=0.04), whereas no difference between the two groups was observed at 6 months FU (2.7 vs. 3.6; P=0.2). No statistically significant differences were found in the LI between the two groups at either FU (2 months: 4.8 vs. 4.2; P=0.51; 6 months: 4.4 vs. 4.5; P=0.91). By contrast, a statistically significant difference in patients need for anti-inflammatory drugs was seen in the experimental as compared to the placebo group, even by 2 months FU (0.2 vs. 0.6 tablets/day; P<0.0001), that persisted up to the end of the study (0.1 vs. 0.6 tablets/day; P<0.0001). Conclusions: Although the combined administration of MSM and BA in the treatment of gonarthrosis was not shown to be more efficacious than placebo in the management of the clinical and functional picture, it significantly reduced patients need for anti-inflammatory drugs.

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