The evidence is downgraded due to bias due to deviations from intended intervention, missing outcome data, and in measurement of the outcome
| Reference | Study type | Population | Intervention and comparison | Outcomes | Risk of bias «Additional comments for included studies...»2 |
|---|---|---|---|---|---|
| RCT=randomized controlled trial; SR=systematic review; MA=meta-analysis, MACE= major adverse cardiovascular event | |||||
| «Hamayal M, Shahid W, Akhtar CH, ym. Risk of cardio...»1 | SR | 6 multicenter RCTs with 17,844 adult patients around the world with high cardiovascular risk who had statin-intolerance or had maximally tolerated statin doses. | bempedoic acid vs. placebo, combined therapy with ezetimibe (only one study), or ezetimibe monotherapy (only one study). | 1.MACE 2.Myocardial infarction 3.Angina Pectoris 4.Coronary revascularization |
moderate |
| Reference | Comments |
|---|---|
| «Hamayal M, Shahid W, Akhtar CH, ym. Risk of cardio...»1 | The mean age of the patients ranged from 62.2 years to 68 years. All the studies had a uniform dosage of bempedoic acid (180 mg/day as a single dose). In 4 of the 6 studies there were some concerns of bias. Those 2 studies that were low in bias, one did not report CV endpoint analysis, and the other only weighted 0.1 % of the data, therefore most of the results are from studies that had some concerns of bias (Bias due to deviations from intended intervention, bias due to missing outcome data, or bias in measurement of the outcome). |
Results
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Risk ratio (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to study limitations. I=intervention; C=comparison; CI=confidence interval; MACE= major adverse cardiovascular event |
|||||
| «Hamayal M, Shahid W, Akhtar CH, ym. Risk of cardio...»1 | 5 studies 17401 (9323/8078) | N/A | 942 (10 %) | 1015 (13%) | 0.86 (0.79,0.94) |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Risk Ratio (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: moderate The quality of evidence is downgraded due to study limitations. I= intervention; C=comparison; CI=confidence interval |
|||||
| «Hamayal M, Shahid W, Akhtar CH, ym. Risk of cardio...»1 | 5 studies 17452 (9323/8129) | N/A | 288 (3 %) | 356 (4 %) | 0.76 (0.66,0.89) |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Risk Ratio (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: low The quality of evidence is downgraded due to study limitation and very serious imprecision. I=intervention; C=comparison; CI=confidence interval |
|||||
| «Hamayal M, Shahid W, Akhtar CH, ym. Risk of cardio...»1 | 3 studies 3353 (2243/1110) | N/A | 35 (1.6 %) | 16 (1.4 %) | 0.97 (0.53,1.78) |
| Reference | Number of studies and number of patients (I/C) | Follow-up time | Absolute number of events (%) I | Absolute number of events (%) C | Risk Ratio (95% CI) |
|---|---|---|---|---|---|
| Level of evidence: low The quality of evidence is downgraded due to imprecision. I=intervention; C=comparison; CI=confidence interval |
|||||
| «Hamayal M, Shahid W, Akhtar CH, ym. Risk of cardio...»1 | 3 studies 3388 (2263/1125) | N/A | 65 (2.9 %) | 39 (3.5 %) | 0.78 (0.52,1.15) |