OBJECTIVETo test the hypothesis that exenatide twice daily reduces the relative incidence of cardiovascular disease (CVD) events among patients with type 2 diabetes compared with other glucose-lowering agent(s).RESEARCH DESIGN AND METHODSA retrospective database analysis was performed of the LifeLink database of medical and pharmaceutical insurance claims for June 2005 through March 2009. Patients with no history in the preceding 9 months of myocardial infarction, ischemic stroke, or coronary revascularization procedure were assigned to the exenatide-initiated or non–exenatide-initiated cohorts based on the first new prescription filled and reassigned if exenatide was prescribed or discontinued. Incident CVD events (myocardial infarction, ischemic stroke, or coronary revascularization procedure) were identified by ICD-9-CM diagnosis codes. Patient outcomes were adjusted for differences in clinical and demographic characteristics and compared using propensity score–weighted discrete time survival analysis with time-varying exposure to exenatide.RESULTSA total of 39,275 patients with type 2 diabetes were treated with exenatide twice daily, and 381,218 patients were treated with other glucose-lowering therapies. Patients who initiated exenatide were more likely to have prior ischemic heart disease, obesity, hyperlipidemia, hypertension, and/or other comorbidities at baseline. Exenatide-treated patients were less likely to have a CVD event than non–exenatide-treated patients (hazard ratio 0.81; 95% CI 0.68–0.95; P = 0.01) and lower rates of CVD-related hospitalization (0.88; 0.79–0.98; P = 0.02) and all-cause hospitalization (0.94; 0.91–0.97; P < 0.001).CONCLUSIONSExenatide twice-daily treatment was associated with a lower risk of CVD events and hospitalizations than treatment with other glucose-lowering therapies.

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QW glucose-lowering medications are viewed positively by patients with type 2 diabetes, especially if they are current injection users or are dissatisfied with their current treatments or outcomes. Greater convenience, better medication adherence and improved QOL are commonly endorsed attributes. Clinicians may need to review both the positive attributes of QW medications as well as common patient concerns, when considering this option.

BackgroundTo evaluate the association of treatment with glucagon-like peptide-1 (GLP-1) receptor agonist exenatide and/or insulin on macrovascular outcomes in patients with type 2 diabetes (T2DM).MethodsWe conducted a retrospective longitudinal pharmaco-epidemiological study using large ambulatory care data to evaluate the risks of heart failure (HF), myocardial infarction (MI) and stroke in established T2DM patients who received a first prescription of exenatide twice daily (EBID) or insulin between June 2005 and May 2009, with follow-up data available until December 2012. Three treatment groups were: EBID with oral antidiabetes drugs (OADs) (EBID, n = 2804), insulin with OADs (Insulin, n = 28551), and those who changed medications between EBID and insulin or had combination of EBID and insulin during follow-up, along with OADs (EBID + insulin, n = 7870).Multivariate Cox-regression models were used to evaluate the association of treatment groups with the risks of macrovascular events.ResultsDuring a median 3.5 years of follow-up, cardiovascular event rates per 1000 person-years were significantly lower for the EBID and EBID + insulin groups compared to the insulin group (HF: 4.4 and 6.1 vs. 17.9; MI: 1.1 and 1.2 vs. 2.5; stroke: 2.4 and 1.8 vs. 6.1). Patients in the EBID/EBID + insulin group had significantly reduced risk of HF, MI and stroke by 61/56%, 50/38% and 52/63% respectively, compared to patients in the insulin group (p < 0.01).ConclusionsTreatment with exenatide, with or without concomitant insulin was associated with reduced macrovascular risks compared to insulin; although inherent potential bias in epidemiological studies should be considered.

AimsTo assess treatment satisfaction and weight-related quality of life (QOL) in subjects with Type 2 diabetes treated with exenatide once weekly (QW) or twice daily (BID).MethodsIn this 52-week randomized, multi-centre, open-label study, 295 subjects managed with diet and exercise and/or oral glucose-lowering medications received either exenatide QW or BID during weeks 1–30; thereafter, subjects receiving exenatide BID were switched to exenatide QW, with 258 total subjects receiving exenatide QW during weeks 30–52. Diabetes Treatment Satisfaction Questionnaire—status (DTSQ-s) and Impact of Weight on Quality of Life—Lite (IWQOL-Lite) were assessed at baseline and weeks 30 and 52. Mean group changes from baseline to week 30 were estimated by ancova; changes from week 30 to week 52 were assessed by Student’s t-test.ResultsStatistically significant improvements from baseline to week 30 were observed in both treatment groups for DTSQ-s and IWQOL-Lite measures, with significantly greater reduction in perceived frequency of hyperglycaemia and greater satisfaction with continuing treatment in the QW group compared with the BID group. Effect sizes for change in DTSQ-s total scores were 0.84 QW, 0.64 BID; for IWQOL-Lite: 0.96 QW, 0.82 BID. Treatment satisfaction and QOL improved significantly between weeks 30 and 52 for those switching from BID to QW. Occurrence of adverse events did not affect patients’ improvements in treatment satisfaction and QOL.ConclusionsPatients treated with exenatide QW or BID experienced significant and clinically meaningful improvements in treatment satisfaction and QOL. Patients who switched from exenatide BID to exenatide QW administration reported further significant improvements.

OBJECTIVETo assess change in patient-reported outcomes in subjects with type 2 diabetes treated with exenatide once weekly compared with those treated with sitagliptin or pioglitazone.RESEARCH DESIGN AND METHODSIn this 26-week randomized, multicenter, double-dummy study, 491 subjects received 2 mg of exenatide once weekly or maximum daily doses of sitagliptin (100 mg) or pioglitazone (45 mg) on a background of metformin. Weight-related quality of life, health utility, psychological well-being, and diabetes treatment satisfaction were assessed at baseline and week 26. Mean group changes from baseline to week 26 were estimated by ANCOVA.RESULTSWeight-related quality of life total scores improved significantly in the exenatide once weekly and sitagliptin arms only; the exenatide once weekly group experienced significantly greater improvement than the pioglitazone group in weight-related quality of life total scores and in several domain scores. Health utility scores improved significantly for exenatide once weekly and sitagliptin groups (P < 0.05) with no significant difference between the exenatide once weekly group and either comparison group. All groups experienced significant improvements on the psychological well-being global scale and all six domain scores, with no significant difference between the exenatide once weekly group and either comparator. All groups experienced significant improvements in total diabetes treatment satisfaction scores. The exenatide once weekly group experienced greater improvement than the sitagliptin group in treatment satisfaction total scores.CONCLUSIONSIn combination with clinical outcomes from this study, these results indicate it is possible for patients treated with metformin to initiate exenatide therapy with potential benefits in both clinical and patient-reported outcomes.

BACKGROUND Findings from the Groupe d'Etude des Lymphomes Adultes LNH 98‐5 study showed that rituximab added to combined cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) prolonged progression‐free survival and overall survival in adults age ≥ 60 years with diffuse large B‐cell non‐Hodgkin lymphoma (DLBCL). The current study was conducted to investigate the incremental cost utility of the addition of rituximab to CHOP (R‐CHOP) compared with CHOP alone. METHODS Clinical prognosis of the time to disease progression and death was estimated using published evidence from the LNH 98‐5 study (n = 399 patients) that was linked mathematically to published long‐term outcome data on patients with DLBCL. Drug‐acquisition costs were based on published data from formulary pricing sources, and the costs of cancer surveillance and end‐of‐life care were based on published literature sources. The authors assessed cost utility as the difference in costs between R‐CHOP and CHOP divided by the increase in expected overall survival adjusted for quality of life. RESULTS Over 5 years, it was projected that R‐CHOP would prolong overall survival by 1.04 years. The mean cumulative cost of CHOP was $3358, and the mean cost of R‐CHOP was $17,225, resulting in a cumulative net increase of $13,867. The posttreatment cancer surveillance cost for CHOP was $3950, compared with $5202 for R‐CHOP. It was estimated that R‐CHOP would have a cost‐utility ratio of $19,297 per year of life gained compared with CHOP when adjusted for quality of life. R‐CHOP remained cost effective over wide ranges of variables in sensitivity analyses. CONCLUSIONS Compared with CHOP alone, it was predicted that R‐CHOP would be cost effective in elderly patients with DLBCL. Cancer 2005. © 2005 American Cancer Society.

Background Placebo-controlled clinical trials have demonstrated the efficacy of tocilizumab (TCZ) for remission maintenance and glucocorticoid sparing in patients with giant cell arteritis (GCA). However, limited data exist on the effectiveness and safety of TCZ for GCA in real-world clinical practice. Methods This was a retrospective, single-center analysis of patients with GCA treated with intravenous or subcutaneous TCZ (2010–2018). Outcomes evaluated before and after TCZ initiation included occurrence of flare, time to flare, annualized flare rate, flare characteristics (i.e., polymyalgia rheumatica [PMR] symptoms, cranial manifestations), prednisone use, and safety. Flare was defined as the recurrence of unequivocal GCA manifestations requiring treatment intensification. Subgroup analyses of patients with PMR or visual manifestations at GCA diagnosis were performed. Results Sixty patients with GCA were included. The median (IQR) disease duration before and after the start of TCZ was 0.6 (0.2–1.6) and 0.5 (0.3–1.4) years, respectively. At least 1 flare was observed in 43 patients (71.7%) before and in 18 (30.0%) after TCZ initiation. Median (IQR) time to flare was 0.5 (0.3–0.7) years before TCZ treatment and 2.1 (0.6–2.6) years after TCZ initiation (HR 0.22; 95% CI 0.10–0.50; p = 0.0003). The annualized flare rate significantly decreased following TCZ use (before TCZ 1.4 [95% CI 1.0–2.1]; after TCZ 0.6 [95% CI 0.3–1.0] events/year; p < 0.001). Similar improvements were observed in patients with visual manifestations or PMR symptoms at GCA diagnosis. TCZ reduced the incidence of new visual manifestations, and no flares associated with permanent vision loss occurred while patients were receiving TCZ. Mean (SD) prednisone dose at TCZ onset and at the end of follow-up was 30 (18.3) and 5 (6.9) mg/day, respectively (p < 0.0001). After TCZ initiation, 46.6% of patients successfully discontinued prednisone. The incidence of adverse events, primarily attributed to glucocorticoids, was similar before and after TCZ initiation. Conclusions In this real-world setting, TCZ improved GCA clinical outcomes significantly and demonstrated effectiveness in the subgroups of patients with PMR symptoms and GCA-related visual manifestations at GCA diagnosis. No new cases of blindness occurred after TCZ initiation. Adverse events, many attributable to glucocorticoids, were comparable before and after TCZ treatment.