George J, Kitzis I, Zandorf D, et al. Safety of nitrate withdrawal in angina-free and hemodynamically stable patients with coronary artery disease. Chest 2003;124:1652-57
PubMed link: https://www.ncbi.nlm.nih.gov/pubmed/14605030
Full text article: https://www.sciencedirect.com/science/article/pii/S0012369215333924?via%3Dihub
| Methods | Study design: Open-label randomized controlled study with a parallel-design
Number of groups: Two groups |
| Participants | Number of participants: 120 randomized
· Intervention deprescribing group: 80 randomized · Control group: 40 randomized Age: 65.5 ± 11 years Sex: 54 female, 66 male Participants with dementia: No Inclusion criteria: · Individuals with coronary artery disease · Receiving long-term nitrates for manifestations of angina or its equivalents · Hemodynamically stable · Free of anginal symptoms requiring short-acting nitrates for at least 3 months Exclusion criteria: · Significant angina (Canadian Cardiothoracic Society functional classes III-IV) at any time before recruitment, · Significant heart failure (ejection fraction, 35%) · Uncontrolled hypertension · Non-compliant Additional information: Functional heart failure class I (88%) and early class II (12%) (Canadian Cardiothoracic Society functional classes) Concomitant medicines included: beta-blockers, alpha-blockers, calcium blockers, angiotensin-converting enzyme inhibitors, diuretics, cardiac glycosides, hypolipidaemic agents, aspirin Country: Israel Setting: Community – Cardiology out-patient clinic of a university-affiliated municipal hospital |
| Interventions | Medicine: Nitrates, average daily dose of nitrates ( mg, range)
· Active group 41 ± 17mg, range 20 to 90mg · Control group 45 ± 14mg, range 20 to 80mg Withdrawal schedule: Abruptly withdrawn Comparator: Continued medicine |
| Outcomes | Successful deprescribing
Relapse Characteristics of participants who relapsed Cardiovascular events Death |
| Dates | Dates: Not described
Follow-up duration: Three months |
| Funding sources | Not described |
| Notes |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | Limited detail, but appears to not be a truly random process:
“patients were randomized consecutively with a 2:1 distribution between groups.” |
| Allocation concealment (selection bias) | High risk | Open study |
| Blinding of participants and personnel (performance bias) | High risk | Open study |
| Blinding of outcome assessment (detection bias) | High risk | Open study |
| Incomplete outcome data (attrition bias) | Low risk | Appears to be 100% follow-up. No drop-outs reported. |
| Selective reporting (reporting bias) | Low risk | No pre-published protocol was available. The stated objectives were reported and seem sensible. |
| Other bias | Unclear risk | Recruitment method is unclear, and limited detail is available regarding the setting. It is unclear if this would have affected the risk of bias.
No conflicts or funding information given. As the target symptoms in this study are well-known to be affected by psychological stress, it is more important than usual to minimize psychological confounding factors e.g. a placebo arm is necessary. |
Leave a Reply