Hajjar I, Hart M, Wan S-H, et al. Safety and blood pressure trajectory of short-term withdrawal of antihypertensive medications in older adults: Experience from a clinical trial sample. Journal of the American Society of Hypertension 2013;7(4):289–93-89–93
PubMed link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3799869/
Full text article: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3799869/pdf/nihms-479799.pdf
| Methods | Study design: Before-and-after study as a wash-out phase to a randomized controlled trial
Number of groups: One group |
| Participants | Number of participants: 53 enrolled
Age: 71 ± 7 years Gender: 34 female, 19 male Participants with dementia: No Inclusion criteria: · 60 years or older · Hypertension: defined as a systolic blood pressure of 140 mm Hg or greater or diastolic blood pressure 90 mm Hg or greater or receiving antihypertensive medications · Early cognitive impairment without dementia defined as executive impairment (measured by the executive clock draw test (CLOX)) or early memory impairment (measured by the repeatable battery for the assessment of neuropsychological status) Exclusion criteria: · Intolerance to two of the study medications · Systolic blood pressure >200 or diastolic blood pressure >110 mm Hg if not on-treatment or SBP > 180/DBP > 100 mm Hg if on antihypertensive therapy · Mini-Mental-Status-exam <20 or a clinical diagnosis of dementia or Alzheimer’s disease · Elevated serum creatinine or serum potassium at baseline · Receiving >2 antihypertensives · Comorbid illnesses (congestive heart failure, diabetes mellitus stroke) · Inability to perform study procedures. Country: United States of America Setting: Community – greater Boston area and evaluated at the cardiovascular research laboratory at the Institute for Aging Research at Hebrew SeniorLife and Harvard Medical School |
| Interventions | Medicine: Antihypertensives
Withdrawal schedule: Tapered over 3 weeks · Week 1: Dose reduced by 25%–50% · Week 2: Dose reduced by 50%–75% · Week 3: Cease Comparator: None |
| Outcomes | Adverse drug withdrawal effects
Blood pressure (systolic and diastolic) |
| Dates | Dates: Not described
Follow-up duration: 3 weeks |
| Funding sources | Dr. Hajjar and the AVEC trial were supported by grant1 K23 AG030057 from the National Institute on Aging and a generous donation from Hinda Marcus to the Cardiovascular Research Laboratory at Hebrew SeniorLife and Harvard Medical School. |
| Notes | Authors stated: “Conflict of interest: None.” |
Risk of bias table
| Bias | Authors’ judgment | Support for judgment |
| Random sequence generation (selection bias) | High risk | This observational study was conducted before randomization for the main study. |
| Allocation concealment (selection bias) | High risk | It was an open study. |
| Blinding of participants and personnel (performance bias) | 5 out of 5 | It was an open study. |
| Blinding of outcome assessment (detection bias) | 5 out of 5 | As above. |
| Incomplete outcome data (attrition bias) | 1 out of 5 | It appears that there was 100% follow-up. |
| Selective reporting (reporting bias) | Unclear risk | This appears to be opportunistic rather than pre-specified. However, the outcomes are simplistic, and do not include a report of how many remained normotensive after the three weeks (instead reporting only mean and standard deviation of systolic and diastolic blood pressure).
Few pre-specified outcomes but those measures mentioned in the method were reported. |
| Confounding (non-randomized) | 5 out of 5 | No control group. |
| Other bias | Low risk | |
| Newcastle-Ottawa scale | ||
| Selection bias | Representativeness of the exposed cohort | The intervention cohort appeared truly representative of older adults with mild cognitive impairment. |
| Selection of the non-exposed cohort | There was no concurrent control group.
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| Ascertainment of exposure | Ascertainment of exposure was by secure record.
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| Demonstration that outcome of interest was not present at start of study | The outcome of interest was not demonstrated not to be present at the start of the study. | |
| Comparability bias | Comparability of cohorts on the basis of the design or analysis | The study controlled for withdrawal of antihypertensive medicine. |
| Outcome bias | Assessment of outcome | Assessment of outcome by self-report. |
| Was follow-up long enough for outcomes to occur | The follow-up duration was unlikely to have been of sufficient duration for | |
| Adequacy of follow-up of cohorts | Complete participant follow-up; all subjects accounted for. | |
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