IntroductionIn the Liraglutide Effect and Action in Diabetes (LEAD) randomized clinical trials (RCTs) assessing liraglutide in type 2 diabetes mellitus (T2DM), glycated hemoglobin (A1c) was reduced by 7–16 mmol/mol and weight by up to 3.4 kg. As real-life efficacy data on liraglutide is limited, the authors assessed clinical effects in a real-life cohort.MethodsIn this retrospective analysis from the Israeli Health Maintenance Organization Maccabi, of patients with T2DM, treated with liraglutide ≥6 months during 2011–2012, evaluations were performed at baseline and 6 months.ResultsInsulin-naïve patients (n = 1,101) treated with liraglutide with at least one A1c or weight measurement were identified. In 933 patients with an additional A1c value after 6 months, A1c decreased by 9 mmol/mol (p < 0.0001, 95% CI 7–11) from 72 mmol/mol. In patients receiving >2 oral antidiabetic drugs (OADs) prior to liraglutide treatment (80.7% patients), A1c decreased by 7 mmol/mol, and in those receiving ≤2 OADs, by 12 mmol/mol. In 453 patients with baseline data available, weight decreased by 2.55 kg (p < 0.0001); 173 patients (38.18%) achieved ≥1% A1c reduction. Furthermore, 91 patients (20.1%) achieved National Institute for Health and Care Excellence (NICE) criteria (decreased A1c ≥1%; weight ≥3%). Weight reduction was marginally correlated with A1c reduction.ConclusionsEvidence from real-life use of liraglutide demonstrated clinical effects similar to those demonstrated in RCTs.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-014-0062-2) contains supplementary material, which is available to authorized users.
Autologous hematopoietic stem cell transplantation (ASCT) improves survival in multiple myeloma (MM). However, many individuals are unable to collect optimal CD34+ hematopoietic stem and progenitor cell (HSPC) numbers with granulocyte colony-stimulating factor (G-CSF) mobilization. Motixafortide is a novel cyclic-peptide CXCR4 inhibitor with extended in vivo activity. The GENESIS trial was a prospective, phase 3, double-blind, placebo-controlled, multicenter study with the objective of assessing the superiority of motixafortide + G-CSF over placebo + G-CSF to mobilize HSPCs for ASCT in MM. The primary endpoint was the proportion of patients collecting ≥6 × 106 CD34+ cells kg–1 within two apheresis procedures; the secondary endpoint was to achieve this goal in one apheresis. A total of 122 adult patients with MM undergoing ASCT were enrolled at 18 sites across five countries and randomized (2:1) to motixafortide + G-CSF or placebo + G-CSF for HSPC mobilization. Motixafortide + G-CSF enabled 92.5% to successfully meet the primary endpoint versus 26.2% with placebo + G-CSF (odds ratio (OR) 53.3, 95% confidence interval (CI) 14.12–201.33, P < 0.0001). Motixafortide + G-CSF also enabled 88.8% to meet the secondary endpoint versus 9.5% with placebo + G-CSF (OR 118.0, 95% CI 25.36–549.35, P < 0.0001). Motixafortide + G-CSF was safe and well tolerated, with the most common treatment-emergent adverse events observed being transient, grade 1/2 injection site reactions (pain, 50%; erythema, 27.5%; pruritis, 21.3%). In conclusion, motixafortide + G-CSF mobilized significantly greater CD34+ HSPC numbers within two apheresis procedures versus placebo + G-CSF while preferentially mobilizing increased numbers of immunophenotypically and transcriptionally primitive HSPCs. Trial Registration: ClinicalTrials.gov, NCT03246529
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