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DANTE: Discontinuing antihypertensive medications did not improve cognitive function in elderly patients
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Discontinuing antihypertensive medications did not improve cognitive, psychological or general daily functioning in elderly patients with mild cognitive defects, according to results from the DANTE Study Leiden.
According to the study background, prior observational studies had shown that lower BP is associated with an increased risk for cognitive decline in the elderly, but whether discontinuing antihypertensive medications would attenuate that link was not known.
Researchers conducted a community-based randomized clinical trial of 385 people aged 75 years or older with mild cognitive deficits, defined as a Mini-Mental State Examination Score of 21 to 27, who were receiving antihypertensive treatment but did not have serious CVD.
They randomly assigned participants to have their antihypertensive treatment discontinued (n = 199) or continued (n = 186). The primary outcome was change in overall cognition compound score, with follow-up at 16 weeks. The compound score was the product of results from the MMSE and other cognitive tests assessing executive function, memory and psychomotor speed. Changes to daily functioning, quality of life and symptoms of apathy and depression were also evaluated.
BP changed, cognition did not
Compared with the continuation group, those in the discontinuation group exhibited a greater increase in systolic BP (difference, 7.36 mm Hg; 95% CI, 3.02-11.69; P = .001) and diastolic BP (difference, 2.63 mm Hg; 95% CI, 0.34-4.93; P = .03) during the study period, according to Justine E.F. Moonen, MD, and colleagues.
Moonen, from the department of psychiatry at Leiden University Medical Center, Leiden, Netherlands, and colleagues observed no difference between the groups in change to overall cognition compound score (discontinuation group, 0.01; 95% CI, –0.14 to 0.16; continuation group, –0.01; 95% CI, –0.16 to 0.14; difference, 0.02; 95% CI, –0.19 to 0.23; P = .84).
They wrote that the discontinuation group also did not differ significantly from the continuation group with regard to the following parameters:
- Executive function: difference, –0.07; 95% CI, –0.29 to 0.15; P = .52.
- Memory: difference, 0.08; 95% CI, –0.12 to 0.29; P = .43.
- Psychomotor speed: difference, –0.85; 95% CI, –1.72 to 0.02; P = .06.
- Apathy symptoms: difference, 0.17; 95% CI, –0.65 to 0.99; P = .68.
- Depression symptoms: difference, 0.14; 95% CI, –0.2 to 0.48; P = .41.
- Functional status: difference, –0.72; 95% CI, –1.52 to 0.09; P = .08.
- Quality-of-life score: difference, –0.09; 95% CI, –0.34 to 0.16; P = .46.
Serious adverse events were similar in both groups, Moonen and colleagues reported.
“Future randomized clinical trials with longer follow-up should determine whether older persons with impaired cerebral autoregulation might benefit from less stringent BP targets,” the researchers wrote.
Modest results, implications for design
“Substantively, the value of the present study is modest,” Michelle C. Odden, PhD, wrote in an invited commentary. “Without a clear beneficial effect, the clinician must wonder whether this result should affect their practice. No adverse effects of discontinuation were found, so perhaps discontinuation would have no net effect on the balance of benefit and harm. However, the study lasted only 16 weeks, so longer follow-up may have been necessary to observe a benefit; conversely, longer follow-up may have put the patient at risk for subsequent [CV] events.”
However, Odden, from the School of Biological and Population Health Sciences at the College of Public Health and Human Sciences, Oregon State University, Corvallis, noted that the study had “enormous” methodological value.
“The discontinuation study design represents a paradigm shift in the way we conduct randomized controlled trials of antihypertensive therapy,” she wrote. “In addition, this design could be extended to examine other typically lifelong medications.” – by Erik Swain
Disclosure: The researchers and Odden report no relevant financial disclosures.
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