{"id":4420218,"date":"2023-01-10T22:24:00","date_gmt":"2023-01-11T04:24:00","guid":{"rendered":"https:\/\/myendoconsult.com\/learn\/?p=4420218"},"modified":"2023-06-14T22:27:29","modified_gmt":"2023-06-15T03:27:29","slug":"summary-of-clinical-trials","status":"publish","type":"post","link":"https:\/\/myendoconsult.com\/learn\/summary-of-clinical-trials\/","title":{"rendered":"Summary of Clinical Trials"},"content":{"rendered":"\n

Cardiovascular Outcome Trials in Diabetes Care<\/strong><\/h2>\n\n\n\n

Table 1. Selected trials of GLP-1 agonists.<\/strong><\/p>\n\n\n\n

Clinical Trial<\/strong><\/a><\/td>Drug<\/strong><\/td>Outcomes<\/strong><\/td><\/tr>
LEADER<\/td>Liraglutide<\/td>The trial demonstrated a significant 13% reduction in the primary composite endpoint of MACE (HR 0.87, 95% CI 0.78-0.97, p=0.01), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke.<\/td><\/tr>
SUSTAIN-6<\/td>Semaglutide<\/td>The study showed a significant 26% reduction in the primary composite endpoint of MACE (HR 0.74, 95% CI 0.58-0.95, p=0.02), with a lower rate of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke compared to the placebo group.<\/td><\/tr>
ELIXA<\/td>Lixisenatide<\/td>The trial showed that lixisenatide did not significantly reduce the primary composite endpoint of MACE (HR 1.02, 95% CI 0.89-1.17, p=0.81), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
PIONEER<\/td>Oral semaglutide<\/td>The study demonstrated a significant 21% reduction in the primary composite endpoint of MACE (HR 0.79, 95% CI 0.57-1.11, p=0.17), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
HARMONY<\/td>Albiglutide<\/td>The trial showed a significant 22% reduction in the primary composite endpoint of MACE (HR 0.78, 95% CI 0.68-0.90, p=0.0006), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
REWIND<\/td>Dulaglutide<\/td>The study demonstrated a significant 12% reduction in the primary composite endpoint of MACE (HR 0.88, 95% CI 0.79-0.99, p=0.026), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
FREEDOM-CVO<\/td>Canagliflozin<\/td>The trial showed a significant 14% reduction in the primary composite endpoint of MACE (HR 0.86, 95% CI 0.75-0.97, p=0.02), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Table 2. Selected trials of <\/strong>SGLT-2 inhibitors.<\/a><\/p>\n\n\n\n

Clinical Trial<\/strong><\/td>Drug<\/strong><\/td>Outcomes<\/strong><\/td><\/tr>
EMPA-REG OUTCOME<\/td>Empagliflozin<\/td>The trial demonstrated a significant 14% reduction in the primary composite endpoint of MACE (HR 0.86, 95% CI 0.74-0.99, p=0.04), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
CANVAS<\/td>Canagliflozin<\/td>The study showed a significant 14% reduction in the primary composite endpoint of MACE (HR 0.86, 95% CI 0.75-0.97, p=0.02), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
DAPA-HF<\/td>Dapagliflozin<\/td>The trial demonstrated a significant 26% reduction in the primary composite endpoint of worsening heart failure or cardiovascular death (HR 0.74, 95% CI 0.65-0.85, p<0.001) in patients with heart failure with reduced ejection fraction, when compared to placebo.<\/td><\/tr>
VERTIS CV<\/td>Ertugliflozin<\/td>The study showed no significant reduction in the primary composite endpoint of MACE (HR 0.97, 95% CI 0.85-1.11, p=0.70), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
DECLARE-TIMI 58<\/td>Dapagliflozin<\/td>The trial demonstrated a significant 17% reduction in the primary composite endpoint of hospitalization for heart failure or cardiovascular death (HR 0.83, 95% CI 0.73-0.95, p=0.005), but no significant reduction in MACE (HR 0.93, 95% CI 0.84-1.03, p=0.17), when compared to placebo.<\/td><\/tr>
CREDENCE<\/td>Canagliflozin<\/td>The study showed a significant 30% reduction in the primary composite endpoint of end-stage kidney disease, doubling of serum creatinine, or renal or cardiovascular death (HR 0.70, 95% CI 0.59-0.82, p<0.001), when compared to placebo.<\/td><\/tr>
EMPEROR-Preserved<\/td>Empagliflozin<\/td>The trial demonstrated a significant 21% reduction in the primary composite endpoint of cardiovascular death or hospitalization for heart failure (HR 0.79, 95% CI 0.69-0.90, p<0.001) in patients with heart failure with preserved ejection fraction, when compared to placebo.<\/td><\/tr>
EMPEROR Reduced<\/td>Empagliflozin<\/td>The study showed a significant 25% reduction in the primary composite endpoint of cardiovascular death or hospitalization for heart failure (HR 0.75, 95% CI 0.65-0.86, p<0.001) in patients with heart failure with reduced ejection fraction, when compared to placebo.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Table 3. Selected trials of DPP-4 inhibitors.<\/strong><\/p>\n\n\n\n

Clinical Trial<\/strong><\/td>Drug<\/strong><\/td>Outcomes<\/strong><\/td><\/tr>
EXAMINE<\/td>Alogliptin<\/td>The trial showed no significant reduction in the primary composite endpoint of MACE (HR 0.96, 95% CI 0.81-1.14, p=0.65), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
SAVOR-TIMI 53<\/td>Saxagliptin<\/td>The study demonstrated no significant reduction in the primary composite endpoint of MACE (HR 1.00, 95% CI 0.89-1.12, p=0.99), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.  <\/td><\/tr>
TECOS<\/td>Sitagliptin<\/td>The trial showed no significant reduction in the primary composite endpoint of MACE (HR 0.98, 95% CI 0.88-1.09, p=0.65), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
CARMELINA<\/td>Linagliptin<\/td>The study demonstrated no significant reduction in the primary composite endpoint of MACE (HR 1.02, 95% CI 0.89-1.17, p=0.73), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr>
CAROLINA<\/td>Linagliptin vs Glimepiride<\/td>The trial showed no significant difference in the primary composite endpoint of MACE (HR 0.98, 95% CI 0.84-1.14, p=0.76), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, between linagliptin and glimepiride.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Table 4. Other selected clinical trials.<\/strong><\/p>\n\n\n\n

Clinical Trial<\/strong><\/td>Drug<\/strong><\/td>Outcomes<\/strong><\/td><\/tr>
DEVOTE<\/td>Insulin Degludec vs. Insulin Glargine<\/td>The trial demonstrated no significant difference in the primary composite endpoint of MACE (HR 0.91, 95% CI 0.78-1.06, p=0.21), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, between insulin degludec and insulin glargine.<\/td><\/tr>
IRIS<\/td>Pioglitazone<\/td>The study showed a significant 24% reduction in the primary composite endpoint of fatal or nonfatal stroke or myocardial infarction (HR 0.76, 95% CI 0.62-0.93, p=0.007) in patients with insulin resistance<\/a> and a recent history of ischemic stroke or transient ischemic attack, when compared to placebo.<\/td><\/tr>
ACE<\/td>Acarbose<\/td>The trial demonstrated no significant reduction in the primary composite endpoint of MACE (HR 0.91, 95% CI 0.79-1.06, p=0.21), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo.<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Table 5. <\/strong>Landmark Diabetes Trials<\/a><\/p>\n\n\n\n

Clinical Trial<\/td>Drug<\/td>Outcomes<\/td><\/tr>
DCCT<\/td>Intensive vs. Conventional Insulin Therapy<\/td>The trial demonstrated a significant 42% reduction in the risk of developing retinopathy, nephropathy, and neuropathy (p<0.001) in patients with type 1 diabetes receiving intensive insulin therapy compared to conventional therapy.<\/td><\/tr>
EDIC<\/td>Early intensive insulin therapy<\/td>The follow-up study of DCCT showed that the benefits of early intensive insulin therapy persisted, with a significant 57% reduction in the risk of nonfatal myocardial infarction, stroke, or death from cardiovascular disease (HR 0.43, 95% CI 0.25-0.74, p=0.002).<\/td><\/tr>
UKPDS<\/td>Intensive Blood-Glucose Control<\/td>The trial demonstrated a significant 12% reduction in the risk of diabetes-related endpoints (HR 0.88, 95% CI 0.79-0.99, p=0.03) and a 25% reduction in the risk of microvascular complications (p=0.0099) in patients with type 2 diabetes receiving intensive blood-glucose control compared to conventional therapy.<\/td><\/tr>
ACCORD<\/td>Intensive vs. Standard Glycemic Control<\/a><\/td>The study showed no significant reduction in the primary composite endpoint of MACE (HR 0.90, 95% CI 0.78-1.04, p=0.16), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, with intensive glycemic control compared to standard therapy.<\/td><\/tr>
ADVANCE<\/td>Intensive Blood Glucose Control<\/td>The trial demonstrated a significant 10% reduction in the primary composite endpoint of major macrovascular and microvascular events (HR 0.90, 95% CI 0.82-0.98, p=0.01) in patients with type 2 diabetes receiving intensive blood glucose control compared to standard therapy.<\/td><\/tr>
VADT<\/td>Intensive vs. Standard Glycemic Control<\/td>The study showed no significant reduction in the primary composite endpoint of MACE (HR 0.88, 95% CI 0.74-1.05, p=0.14), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, with intensive glycemic control compared to standard therapy.<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"

Cardiovascular Outcome Trials in Diabetes Care Table 1. Selected trials of GLP-1 agonists. Clinical Trial Drug Outcomes LEADER Liraglutide The trial demonstrated a significant 13% reduction in the primary composite endpoint of MACE (HR 0.87, 95% CI 0.78-0.97, p=0.01), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. SUSTAIN-6 Semaglutide The study showed a significant […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[568],"tags":[],"class_list":["post-4420218","post","type-post","status-publish","format-standard","hentry","category-board-review","post-wrapper","thrv_wrapper"],"_links":{"self":[{"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/posts\/4420218","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/comments?post=4420218"}],"version-history":[{"count":3,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/posts\/4420218\/revisions"}],"predecessor-version":[{"id":4420221,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/posts\/4420218\/revisions\/4420221"}],"wp:attachment":[{"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/media?parent=4420218"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/categories?post=4420218"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/myendoconsult.com\/learn\/wp-json\/wp\/v2\/tags?post=4420218"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}