Comparative Clinical Effectiveness - CV Outcomes
This large randomized cardiovascular outcomes trial evaluated semaglutide 2.4 mg once weekly versus placebo in more than 17,000 adults with obesity and established cardiovascular disease.
What is the SELECT trial?
This tirzepatide trial demonstrated approximately 21% mean weight loss at 72 weeks compared with placebo in adults with obesity or overweight.
What is the SURMOUNT-1 trial?
ICER notes that the evidence base for semaglutide and tirzepatide is constantly evolving as new clinical trials and ____ provide comparative effectiveness data.
What are real-world studies?
In the ICER Evidence Rating Matrix, this rating represents high certainty of a substantial net health benefit compared to the comparator.
What is an A rating?
In trials of semaglutide, this class of side effects was reported far more frequently than with placebo, occurring in about 74% of patients.
What are gastrointestinal side effects?
Unlike the SELECT trial, which compared semaglutide to placebo, the SURPASS-CVOT trial compared tirzepatide to this GLP-1 receptor agonist.
What is dulaglutide?
In the STEP-1 trial, participants receiving semaglutide experienced about this percentage of average weight loss from baseline.
What is 14.9% weight loss?
Trials that measure indicators like liver histology or eGFR instead of patient-important outcomes are using this type of marker/endpoint.
What is surrogate markers (or surrogate outcomes)?
In the ICER Evidence Rating Matrix, the horizontal axis represents the magnitude of this type of benefit when comparing one treatment to another.
What is comparative net health benefit?
In oral semaglutide trials, this gastrointestinal symptom occurred in about 47% of participants.
What is nausea?
Both the SELECT trial and SURPASS-CVOT trial evaluated this composite (compounded) cardiovascular endpoint consisting of cardiovascular death, myocardial infarction, and stroke.
What are major adverse cardiovascular events (MACE)?
In the SURMOUNT-1 trial, participants receiving tirzepatide lost approximately this average percentage of body weight.
What is 20.9% weight loss?
ICER notes that some potential long-term benefits of weight loss, such as preventing joint replacement surgery or cirrhosis, have not yet been demonstrated because of a lack of this type of data.
What is long-term follow-up data?
In the ICER evidence ratings table, injectable semaglutide compared with lifestyle modifications received this rating.
What is an A rating?
This serious inflammatory condition of the pancreas was reported as a rare adverse event in both semaglutide and tirzepatide trials.
What is acute pancreatitis?
The cardiovascular benefit seen in the SELECT trial was primarily driven by reductions in this specific component of the MACE endpoint.
What is nonfatal MI (nonfatal myocardial infarction)?
In the STEP-1 trial, this percentage of participants receiving semaglutide achieved at least 5% weight loss.
What is 86%?
One limitation noted in the STEP and SURMOUNT trials was the underrepresentation of these racial and ethnic groups, which may affect generalizability of results.
Who are Black and Hispanic populations?
This rating in the ICER Evidence Rating Matrix indicates that a treatment likely has a comparable or inferior net health benefit compared with its comparator.
What is C-?
In SURMOUNT-5, these two gastrointestinal symptoms were among the most frequently reported adverse events besides nausea.
What are constipation and diarrhea?
Both SELECT and SURPASS-CVOT demonstrated reductions in this mortality outcome beyond cardiovascular endpoints.
What is all-cause mortality?
Both the STEP-1 and SURMOUNT-1 trials excluded patients with this metabolic disease in order to study weight loss specifically in obesity populations.
What is type 2 diabetes?
ICER reports that stopping treatment with semaglutide or tirzepatide often leads to this outcome.
What is weight regain?
When tirzepatide was compared with injectable semaglutide, ICER assigned this rating indicating the evidence was promising but inconclusive.
What is P/I?
This viral disease was unexpectedly reported as one of the most frequent adverse events in the SURMOUNT-5 trial.
What is COVID-19?