Diabetes weighs a lot! Lilly trulicity has been approved by the US FDA as the first hypoglycemic drug to reduce cardiovascular risk in patients with or without cardiovascular disease

Eli Lilly recently announced that the US Food and Drug Administration (FDA) has approved once a week the glp-1ra hypoglycemic drug, dulaglutide, for type 2 diabetes mellitus with cardiovascular disease or multiple cardiovascular risk factors In adults, the risk of major adverse cardiovascular events (MACE) was reduced It is worth mentioning that this approval makes trulicity the first and only type 2 diabetes drug approved to reduce the risk of mace in primary and secondary prevention population This new indication reflects the differentiated population of rewind patients in the trulicity cardiovascular outcome trial Although all participants had cardiovascular risk factors, the study was mainly composed of patients without cardiovascular disease Trulicity significantly reduced the risk of major adverse cardiovascular events (MACE 3: composite end point of nonfatal myocardial infarction [heart attack], nonfatal stroke, and cardiovascular death) by 12% compared with placebo In addition, trulicity had a consistent mace risk reduction effect in the major demographic and disease (including with or without CV disease) subgroups, and CV risk continued to decrease throughout the study The safety of trulicity is consistent with that of glp-1ra, and the most common adverse event leading to trulicity discontinuation is gastrointestinal event According to rewind results, trulicity is the first type 2 diabetes drug to significantly reduce mace events in the majority of patients enrolled who have CV risk factors but no CV disease Diabetics themselves have a higher CV risk This data is important to confirm the therapeutic benefits of trulicity for a wide range of people with type 2 diabetes Hertzel Gerstein, chairman of rewind research, Professor of medicine at McMaster University and deputy director of the Institute of population health at Hamilton School of Health Sciences, said: "this trial aims to study a wide range of people with type 2 diabetes, reflecting the patient population in the general population Therefore, we assessed the impact of trulicity on patients with cardiovascular disease and those with multiple cardiovascular risk factors Worldwide, more than 415 million people suffer from type 2 diabetes, which is a cardiovascular risk factor in itself However, only about a third of patients have cardiovascular disease, which is why this new indication and supporting evidence is important for millions of diabetic patients in the United States " Sherry Martin, Lilly vice president of medical affairs, said: "for the first time, healthcare providers can prescribe a diabetes drug that has been shown to significantly reduce the risk of cardiovascular events for patients with and without type 2 diabetes Trulicity can help patients achieve their blood sugar (A1C) control goals and protect them from cardiovascular events through weekly, easy-to-use treatment options " Trulicity is a glucagon like peptide-1 (GLP-1) receptor agonist (RA), which is injected subcutaneously once a week It is suitable for the combination of diet control and exercise to improve blood glucose control in adult patients with type 2 diabetes GLP-1 RA is one of the most attractive drugs in diabetes GLP-1 RA is not insulin, but a new type of insulin secretion promoting agent Its mechanism is similar to that of natural hormone GLP-1 It can promote the body's own insulin secretion when patients eat It has the advantages of strong hypoglycemic effect, low hypoglycemic risk, weight-loss effect and cardiovascular benefits Since its launch in the US in 2014, trulicity has become the largest prescription glp-1ra In addition to proven hypoglycemic benefits and easy-to-use devices, trulicity can now be used to help patients with type 2 diabetes reduce the risk of cardiovascular events Evaluatepharma, a pharmaceutical market research firm, predicts that trulicity's sales will reach 7.13 billion US dollars in 2024, making it the world's best-selling antidiabetic drug Rewind is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the weekly effect of trulicity 1.5mg versus placebo (all added to standard care) on CV events in adults with type 2 diabetes The primary CV endpoint was major adverse cardiovascular events (MACE 3: including cardiovascular death, nonfatal myocardial infarction , non fatal stroke), and the secondary end point includes each component of the primary CV end point, as well as composite clinical microvascular prognosis including retinal or renal diseases, hospitalization for unstable angina pectoris, heart failure requiring hospitalization, emergency heart failure requiring consultation, and all-cause mortality A total of 9901 patients with type 2 diabetes in 24 countries were enrolled in the study The average duration of these patients was 10.5 years, and the average baseline A1C was 7.2% In this study, although all patients had cardiovascular risk factors, only 31% of patients had CV disease at baseline The results showed that trulicity significantly reduced the risk of mace events (HR = 0.88, 95% CI: 0.79-0.99) compared with placebo in the whole study population, which was consistent in all subgroups: (1) there was CV disease (HR = 0.87, 95% CI: 0.74-1.02) and there was no CV disease (HR = 0.87), 95% CI: 0.74-1.02); (2) baseline A1C ≥ 7.2% (HR = 0.86, 95% CI: 0.74-1.00) and baseline A1C < 7.2% (HR = 0.90, 95% CI: 0.76-1.06); (3) female (HR = 0.85, 95% CI: 0.71-1.02) and male (HR = 0.90, 95% CI: 0.79-1.04) All components of mace 3 showed reduced risk, including cardiovascular death (HR = 0.91, 95% CI: 0.78-1.06), nonfatal heart attack (HR = 0.96, 95% CI: 0.79-1.16), and nonfatal stroke (HR = 0.76, 95% CI: 0.61-0.95) In addition, trulicity further showed a reduction in composite microvascular outcome (HR = 0.87, 95% CI: 0.79-0.95) Analysis of renal outcomes showed that long-term use of trulicity was associated with reduced progression of kidney disease in patients with type 2 diabetes In addition to long-term follow-up to assess cardiovascular outcomes, the rewind study provides additional evidence of the efficacy of trulicity in the treatment of diabetes Trulicity reduced A1C from a median baseline of 7.2% (A1C: - 0.46% [trulicity], + 0.16 [placebo]; body weight: - 2.95kg [trulicity], - 1.49kg [placebo]) compared to placebo In this study, the safety of trulicity was consistent with that of GLP-1 receptor agonists The most common adverse event that resulted in the interruption of trulicity treatment was a gastrointestinal event Rewind study is quite different from other clinical studies of CV prognosis, because fewer patients have been diagnosed with CV disease in this study, which also enables us to evaluate the CV effect of trulicity in a wide range of patients with type 2 diabetes It is important that the rewind study has a median follow-up of more than 5 years (median follow-up of 5.4 years), the longest of all glp-1ra CV prognostic studies In addition, the study is also a study with the lowest baseline A1c (7.2%), a more balanced proportion of women (46.3%) and men (53.7%) in all diabetes CV studies to date This group of patients is more representative of type 2 diabetes patients in clinical practice In contrast, a higher proportion of patients in other CV prognostic studies had a higher baseline A1C and a higher proportion diagnosed CV disease at baseline Rewind is an ambitious study assessing whether trulicity can protect patients without CV disease from experiencing the first CV event, and whether it can prevent subsequent CV events in patients with CV disease The results of this study clearly show that trulicity effectively reduces the risk of mace events in a wide range of type 2 diabetic population, and the data are convincing.