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Lix5.0
Lixisenatide – Forschung
Überwiegend Mechanismus / Beobachtung
11 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Lixisenatide sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus hochwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 2012–2019 mit einer typischen Studiengröße von 495 Teilnehmenden.
Basierend auf 11 Studien · 6 Meta-Analysen · 5 RCTs · 8,042 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Blood sugar & glycemic controlKonsistente HbA1c-Senkungen von etwa -0,4 % bis -0,7 % gegenüber Placebo über das gesamte Phase-3-Programm, mit deutlichen Senkungen des postprandialen 2-Stunden-Glukosewerts, die durch eine verzögerte Magenentleerung bedingt sind · Wochen täglicher Einnahme
Überwiegend Mechanismus / Beobachtung11 Studien
Safety & adverse effects
Überwiegend Mechanismus / Beobachtung10 Studien
Weight management
Überwiegend Mechanismus / Beobachtung5 Studien
Cardiovascular outcomes
Überwiegend Mechanismus / Beobachtung3 Studien
Ältere Forschungsbasis
Neueste Studie von 2019 · Neueste Meta-Analyse: 2019
20122019
1Meta-Analyse2019
Overall, GLP-1 receptor agonist treatment reduced MACE by 12% (HR 0.88, 95% CI 0.82-0.94; p<0.0001)... a broad composite kidney outcome by 17% (0.83, 0.78-0.89; p<0.0001)... There was no increase in risk of severe hypoglycaemia, pancreatitis, or pancreatic cancer.
Class-level 12% reduction in MACE (HR 0.88, 95% CI 0.82-0.94), with 12% lower cardiovascular and all-cause mortality and 9% fewer heart-failure hospitalizations
17% reduction in a composite kidney outcome (HR 0.83), mainly driven by reduced urinary albumin excretion
A primary end-point event occurred in 406 patients (13.4%) in the lixisenatide group and in 399 (13.2%) in the placebo group (hazard ratio, 1.02; 95% confidence interval, 0.89 to 1.17), which showed the noninferiority of lixisenatide to placebo (P<0.001) but did not show superiority (P=0.81).
Cardiovascular-outcomes RCT: 6,068 patients with type 2 diabetes and a recent acute coronary syndrome (MI or unstable angina within 180 days), lixisenatide vs placebo added to usual care, median 25 months
Primary MACE composite NEUTRAL — non-inferior but NOT superior to placebo (HR 1.02; 95% CI 0.89-1.17); no cardiovascular benefit demonstrated
No difference in heart-failure hospitalization (HR 0.96) or death (HR 0.94)
Once-daily lixisenatide significantly improved HbA1c (mean baseline 8.0%) in both groups (least squares mean change vs. placebo: -0.54% for 2-step, -0.66% for 1-step; P < 0.0001).
Fonseca VA, Alvarado-Ruiz R, Raccah D, Boka G, Miossec P, Gerich JE; EFC6018 GetGoal-Mono Study Investigators. · Diabetes Care (2012)
Phase-3 double-blind 12-week RCT, 361 drug-naive patients with type 2 diabetes randomized to lixisenatide (two titration regimens) or placebo
Modest but significant HbA1c reduction (LS mean -0.54% to -0.66% vs placebo)
Pronounced postprandial effect — 75% reduction in glucose excursion during a standardized breakfast test
With lixisenatide, the placebo-corrected change of HbA1c from baseline was -0.4% (95% CI -0.6 to -0.2; P = 0.0002), and mean HbA1c at end point was 7.8%.
Riddle MC, Aronson R, Home P, Marre M, Niemoeller E, Miossec P, Ping L, Ye J, Rosenstock J. · Diabetes Care (2013)
Phase-3 double-blind RCT, 495 patients on established basal insulin with inadequate control, add-on lixisenatide 20 µg vs placebo for 24 weeks
Modest placebo-corrected HbA1c reduction of -0.4%; more patients reached HbA1c <7% (28% vs 12%)
Strong postprandial glucose reduction (-3.8 mmol/L after standardized breakfast) and modest weight loss (-1.3 kg) with a small insulin-dose reduction
After 24 weeks, lixisenatide once daily significantly improved HbA1c (-0.56% vs. placebo; p < 0.0001) and increased the proportion of patients achieving HbA1c <7% compared with placebo (52.3% vs. 26.4%).
Pinget M, Goldenberg R, Niemoeller E, Muehlen-Bartmer I, Guo H, Aronson R. · Diabetes Obes Metab (2013)
Phase-3 double-blind RCT, 484 patients insufficiently controlled on pioglitazone ± metformin, lixisenatide 20 µg vs placebo for 24 weeks (+ extension)
Significant but modest HbA1c improvement (-0.56% vs placebo) and improved fasting plasma glucose
Only a small decrease in body weight (no significant difference vs placebo)
A significant reduction in HbA1c at 76 weeks was observed in the intervention arm compared to placebo (LSM difference: -0.41%, 95%CI: -0.51, -0.32, P < .00001)... A bodyweight reduction was observed in the lixisenatide arm (LSM difference -0.40 kg, 95%CI: -0.8, -0.01, P = .05).
Broglio F, Mannucci E, Napoli R, Nicolucci A, Purrello F, Nikonova E, Stager W, Trevisan R. · Diabetes Obes Metab (2017)
Meta-analysis of 76-week results from 5 placebo-controlled GetGoal trials (~3,000 patients) as add-on to various background therapies
Long-term HbA1c reduction modest (-0.41%) and durable; larger decreases in fasting glucose and postprandial excursion
Body-weight reduction was small (-0.40 kg) — confirms lixisenatide is not a meaningful weight-loss agent
Lixisenatide significantly reduced 2-h PPG from baseline (LS mean difference vs. placebo: -4.9 mmol/l, p < 0.001) and glucose excursion (LS mean difference vs. placebo: -4.5 mmol/l, p < 0.001).
Lixisenatide plus basal insulin was significantly more effective than basal insulin alone at reducing HbA1c at 24 weeks... Lixisenatide plus basal insulin was associated with an increased incidence of hypoglycemia versus basal insulin alone.
Charbonnel B, Bertolini M, Tinahones FJ, Domingo MP, Davies M. · J Diabetes Complications (2014)
Meta-analysis pooling 3 GetGoal trials of lixisenatide vs placebo added to basal insulin (± oral agents)
Significant improvement in HbA1c and especially postprandial glucose vs basal insulin alone
Complementary mechanism: lixisenatide controls PPG while basal insulin controls FPG