Christine Blank

Blood pressure-lowering medications known to cross the blood-brain barrier produced better memory recall over time compared with other types of blood pressure medications, according to a new study released today.

, is the first meta-analysis to compare the potential impact over time of blood pressure lowering medicines that do versus those that do not cross the blood-brain barrier. The medicines were evaluated for their effects on several cognitive domains, including attention, language, verbal memory, learning, and recall.

“Hypertension occurs decades prior to the onset of dementia symptoms, affecting blood flow not only in the body but also to the brain,” study author Daniel A. Nation, Ph.D., an associate professor of psychological science in the Institute for Memory Impairments and Neurological Disorders at the University of California, Irvine, said in 

. “Treating hypertension is likely to have long-term beneficial effects on brain health and cognitive function later.”

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However, research has been mixed on which medicines have the most benefit to cognition, Nation noted. “Studies of angiotensin II receptor blockers and angiotensin-converting-enzyme (ACE) inhibitors have suggested these medicines may confer the greatest benefit to long-term cognition, while other studies have shown the benefits of calcium channel blockers and diuretics on reducing dementia risk.”

The researchers gathered information from 14 cohorts of nearly 12,900 adults ages 50 years and older in the United States, Australia, Canada, Germany, Ireland, and Japan.

The meta-analysis found that older adults taking blood pressure-lowering medicines that cross the blood-brain barrier had better memory recall for up to three years of follow up compared with those taking medicines that do not cross the blood-brain barrier, even though they had a higher level of vascular risk.

In addition, adults taking hypertension medications that did not cross the blood-brain barrier had better attention for up to three years of follow up.

“These findings represent the most powerful evidence to-date linking brain-penetrant ACE-inhibitors and angiotensin receptor blockers to better memory. It suggests that people who are being treated for hypertension may be protected from cognitive decline if they [take] medications that cross the blood-brain barrier,” said study co-author Jean K. Ho, PhD, a postdoctoral fellow at the University of California, Irvine.

The National Institute on Aging of the National Institutes of Health and the Alzheimer's Association funded the study.

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Adults taking medications that cross the blood-brain barrier had better memory recall.


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Aducanumab (Aduhelm, Biogen)was controversial before the FDA announced it was approving the Alzheimer's drug, and it is proving to be perhaps even more controversial after. 

Three members of the advisory committee of outside experts that voted against approving the drug in November 2020 resigned last week to protest the agency's approval.  The Institute for Clinical and Economic Review in Boston issued a statement that said agency had "failed in its responsibility to protect patients and families from unproven treatments with known harms" by approving Aduhelm.

The Alzheimer's Association, a major patient advocacy organization, split its verdict. The association lauded the approval but criticized Biogen's pricing. The company set the wholesale acquisition cost so the annual price tag for a maintenance dose will be about  $56,000, according to Biogen. The association called that price "simply unacceptable."

“For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity,” the organization said. “We call on Biogen to change this price.”

Biogen says it has entered into value-based agreements with payers and insurers. The price reflects the “overall value this treatment brings to patients, caregivers and society — and one that will enable continuous innovation,” 

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Biogen is committed to not raising Aduhelm’s price for the next four  years, Vounatos said. 

 who resigned are Aaron Kesselheim, M.D., J.D., M.P.H., a Harvard Medical School professor and director of program on drug law and regulations at Harvard-affiliated Brigham and Women's Hospital in Boston; David Knopman, M.D., a neurologist at the Mayo Clinic and an expert on Alzheimer's and frontotemporal degeneration; and Joel Perlmutter, M.D., a neurologist at the Washington University in St. Louis.

In his resignation letter, Kesselheim said the OK of Aduhelm "was probably the worst approval decision in recent U.S. history." He also criticized the agency's 2016 approval of eteplirsen (Exondys 51, Sarepta Therapeutics), a drug for Duchenne muscular dystrophy.

Alzheimer’s Association defended the Aduhelm approval: "As the global nonprofit leader in Alzheimer's research and science we have extensively reviewed the clinical trial data for Aduhelm (aducanumab). Based on the trial data, the treatment demonstrated an efficacious result which has also been confirmed by leading scientists in the Alzheimer's and dementia scientific community and the FDA,” the organization said.

The association said it is committed to working with the Centers for Medicare and Medicaid Services  along with the private payer community to “expedite access for all of those who would likely benefit based on the successful clinical trial.”

The FDA also “appropriately took into account the vast unmet need of the Alzheimer's community,” Alzheimer’s Association said. 

“Aduhelm is certainly not a cure, but at long last it provides many with Alzheimer's disease and their families an effective treatment. The confirmatory trial should begin promptly," the association's statement continued.

Aduhelm was approved under the FDA's Accelerated Approval program. Although critics of the agency and the program say enforcement of the requirement is lax, drugs approved under the program are supposed to be assessed further in clinical trials and removed from the market if the findings on which they were approved don't hold up. 

In his resignation letter, Kesselheim said the FDA switched Aduhelm to the Accelerated Approval program at the last minute. 

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The Alzheimer's Association praises the approval but not the price tag. A Harvard Medical School professor who resigned from an FDA advisory committee says the OK "was probably the worst approval decision in recent U.S. history" in his resignation letter.

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Rimegepant (Nurtec ODT, Biohaven), the migraine medication, is now wearing two hats as both a preventive and treatment migraine drug.

The FDA had previously approved Nurtec ODT for acute treatment in all eligible adult patients with migraine. 

The new indication — cleared by FDA in late May — for preventive treatment in adult patients with less than 15 headaches days per month expands the potential preventive use of the drug to cover around 95% of individuals with migraine, Biohaven, a New Haven, Connecticut, biotech company, said in a 

"I've been practicing medicine for 25 years, and this is the first time we have a single migraine medication that can do both of these things," 

, M.D., said on CNBC’s “Mad Money. "This is going to change the paradigm in which migraine is treated.”

The approved product label was also expanded to include the use of Nurtec ODT 75 mg up to 18 doses per month, allowing for both acute and preventive therapy in the same patient.

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“This new approval makes Nurtec ODT the first oral CGRP [calcitonin gene-related peptide receptor] antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment,” Biohaven said in its press release.

Nurtec ODT’s approval is based on a double-blind, randomized, placebo-controlled Phase 3 clinical trial that demonstrated that the drug decreased monthly migraine days by 4.3 days per month after 3 months versus placebo. The preventive effects of Nurtec were seen as early as the first week of therapy.

In addition, around half of Nurtec ODT-treated patients had a 50% or greater reduction in the number of moderate-to-severe migraine days per month.

Nurtec ODT is the first oral CGRP antagonist approved for migraine prevention, says its maker, Biohaven.

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Semaglutide injection (Wegovy, Novo Nordisk), a 2.4 mg once-weekly injection, is for chronic weight management in adults with obesity or overweight with at least one weight-related condition.

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The weight loss drug will be available later in June. Novo Nordisk’s semaglutide 1 mg injection (Ozempic) was first approved to treat type 2 diabetes in 2017.

“Today’s approval offers adults with obesity or overweight a beneficial new treatment option to incorporate into a weight management program,” said John Sharretts, MD, deputy director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research, in a 

Around 70% of American adults have obesity or overweight, according to FDA.

Wegovy’s safety and efficacy were studied in four 68-week trials. Across the trials in people without type 2 diabetes, an average weight loss of 17-18%sustained over 68 weeks was in patients treated with Wegovy, Novo Nordisk said in a 

In another trial of adults with type 2 diabetes, individuals who received Wegovy lost 6.2% of their initial body weight compared to those who received placebo.

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Wegovy works by mimicking a hormone called glucagon-like peptide-1 (GLP-1) that targets areas of the brain that regulate appetite and food intake. The medication dose must be increased gradually over 16 to 20 weeks to 2.4 mg once weekly to reduce gastrointestinal side effects.

The prescribing information for Wegovy contains a boxed warning to inform healthcare professionals and patients about the potential risk of thyroid C-cell tumors. Wegovy should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with a rare condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), FDA said.

The medication also contains warnings for inflammation of the pancreas (pancreatitis), gallbladder problems (including gallstones), low blood sugar, acute kidney injury, diabetic retinopathy (damage to the eye's retina), increased heart rate and suicidal behavior or thinking.]

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Semaglutide injection is a weekly injection for chronic weight management in adults.