Can dementia drugs cause fainting?

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Cholinesterase inhibitors and hospitalization for bradycardia: a population-based study.
PLoS Med. 2009 Sep;6(9):e1000157. PubMed. SOURCE:

Memory drugs for Alzheimer's cause slower heart rates and even fainting. The magnitude of these risks are not always made clear to patients. Learn about side-effects, avoiding a pacemaker and injuries from falls.

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Side effects associated with several commonly-prescribed dementia drugs may be putting elderly Canadians at risk, says Queen's University Geriatrics professor Sudeep Gill.

Cholinesterase inhibitors are often prescribed for people with Alzheimer's disease and related dementias because they increase the level of a chemical in the brain that seems to help memory. These include Aricept^®, Exelon^® and Reminyl, known generically as donepezil, rivastigmine and galantamine.

Drugs for Early to Midstage

Brand Name	Generic Name
Aricept®	donepezil
Exelon®	rivastigmine
Remynil or Razadyne®	galantamine

Although such drugs are known to provoke slower heart rates and fainting episodes, the magnitude of these risks are not always made clear to patients.

"This is very troubling, because the drugs are marketed as helping to preserve memory and improve function," says Dr. Gill, who is an Ontario Ministry of Health and Long-term Care Career Scientist, working at Providence Care's St. Mary's of the Lake Hospital in Kingston. "But for a subset of people, the effect appears to be the exact opposite."

In a large study using province-wide data, Dr. Gill and his colleagues discovered that people who used cholinesterase inhibitors were hospitalized for fainting almost twice as often as people with dementia who did not receive these drugs. Experiencing a slowed heart-rate was 69 per cent more common amongst cholinesterase inhibitor users. In addition, people taking the dementia drugs had a 49 per cent increased chance of having permanent pacemakers implanted and an 18 per cent increased risk of hip fractures.

Unfortunately, Dr. Gill continues, this class of drugs is one of the few effective dementia treatments available today. Acknowledging that these drugs do have an important role in the management of dementia, he suggests that people who are already at a higher risk (for example, those who have had previous episodes of fainting or slowed heart rate) may want to ask their doctors to reassess the value of taking the drugs.

Slowing of the heart rate from cholinesterase inhibitors, if significant, may cause a person to faint and suffer fall-related injuries such as a broken hip - often debilitating and sometimes fatal for seniors. ( See the related article: 14 Ways to Prevent Falling at Home ) However, many physicians aren't aware of the connection between these problems and the dementia drugs, Dr. Gill notes.

If the association with dementia drugs is not identified, people who faint may be prescribed a permanent pacemaker: an invasive procedure that can involve serious complications for seniors. Both the injuries incurred from falling and the risks from pacemaker implants are "downstream consequences" of not recognizing this drug-induced phenomenon. 

REFERENCE: Park-Wyllie LY, Mamdani MM, Li P, Gill SS, Laupacis A, Juurlink DN.
Cholinesterase inhibitors and hospitalization for bradycardia: a population-based study.

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Family Practice News

The NMDA (N-methyl-d-aspartate) receptor antagonist memantine is also approved for patients with mild to moderate Alzheimer’s, with optimal dosing titration to 10 mg b.i.d. "Side effects are quite rare, but can include somnolence, headache, and dizziness," said Dr. Cummings, who is also chair of neurotherapeutics at the Cleveland Clinic’s Neurological Institute. "Most patients, by the time they reach mid-disease, are on both a cholinesterase inhibitor and memantine."

Other treatment options include the medical foods CerefolinNAC and Axona, which are generally recognized as safe by the Food and Drug Administration and are available by prescription. "No demonstration of clinical benefit is required for these agents," Dr. Cummings said. "The data set supporting medical foods is not as robust as the data set supporting cholinesterase inhibitors."

CerefolinNAC is a combination of vitamin B6, vitamin B12, and folate that Dr. Cummings uses for hyperhomocysteinemia. "I know that high levels of homocysteine are correlated with cognitive impairment, so I try to reduce that by giving CerefolinNAC," he said. "However, there are no data which prove that lowering will necessarily improve the prognosis of the patient. What you are doing is piecing together various types of data to support that use, but it’s not as strong as a double-blind, placebo-controlled trial showing a direct benefit."

Axona is a proprietary formulation of medium-chain triglycerides that increase plasma concentrations of ketone bodies. "This is considered an energy source for neurons," Dr. Cummings said.

Dr. Cummings disclosed that he has provided consultation to the following pharmaceutical companies: Abbott, Acadia, Adamas, Anavex, Astellas, Avanir, Bayer, BMS, Eisai, EnVivo, ExonHit, Janssen, Forest, Genentech, GSK, Lundbeck, Merck, Neurokos, Novartis, Otsuka, Pfizer, Prana, QR Pharma, Sanofi-Aventis, and Takeda.

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If you’re stumped about which cholinesterase inhibitor to prescribe for your patients with newly diagnosed Alzheimer’s disease, rest assured that the clinical effects are similar with all such agents.

"There is no substantive scientific evidence that says one of the cholinesterase inhibitors is better than another, so get comfortable with one or two of them," Dr. Jeffrey L. Cummings advised during a psychopharmacology conference sponsored by the Nevada Psychiatric Association. "The effect is demonstrable late in the disease, so if you take patients with Mini-Mental State Exam scores of less than 10, you still get the same response that you do in somebody whose Mini-Mental State Exam score is 20. There’s no proven effect on the underlying disease state."

Clinical evidence from nearly 20 years of cholinesterase inhibitor use suggests that 25% of patients who take them will experience modest cognitive improvements, defined as a 2-4 point increase on the Alzheimer’s Disease Assessment Scale-cognitive subscale or a 1-2 point increase on the Mini-Mental State Exam. This "makes it very difficult to see a response if it’s not on the upper end of that [response]," Dr. Cummings said. "But about 80% of patients on cholinesterase inhibitors have a delay in decline of 6-9 months. That’s worthwhile, because patients are usually only on therapy for about 5 or 6 years over the course of their disease. So if you can delay almost 20% of that, that’s fantastic."

Dr. Cummings, director of the Cleveland Clinic’s Lou Ruvo Center for Brain Health, lets convenience drive the choice of which cholinesterase inhibitor to prescribe. "I sit with the patient and the caregiver and I ask: ‘Do you want a pill or a transdermal patch?’ If they say, ‘I want a pill,’ I give them donepezil. If they say, ‘I want a patch,’ I give them the rivastigmine transdermal patch," he said.

"I’m trying to respond to the perceived convenience of the caregiver. That’s the question I pose, and those are the two drugs I use."

He went on to note that donepezil "is more likely to give you diarrhea than rivastigmine is, and the rivastigmine patch will give you a rash in 5-10% of patients. Bradycardia is a contraindication for all cholinesterase inhibitors."

Donepezil is available in 5-mg, 10-mg, and 23-mg formulations. The 23-mg form is approved only for patients with moderate to severe disease. "There is more diarrhea with the 23-mg dose; maybe 15% of patients will get diarrhea with that higher dose," he said. "To ameliorate this, for 1 month I have patients go from 10 mg to 15 mg before jumping to the 23-mg dose. I think that helps rather than going directly from 10 mg to 23 mg."

Rivastigmine is approved for mild to moderate Alzheimer’s and for patients with mild to moderate Parkinson’s disease dementia. It’s available in 1.5-mg, 3-mg, 4.5-mg, and 6-mg capsules, or as a 4.6-mg or 9.5-mg transdermal patch.

Galantamine is another cholinesterase inhibitor approved for patients with mild to moderate Alzheimer’s disease, and it has dosing options of 6 mg, 8 mg, or 12 mg b.i.d. Extended formulations are available in 12-mg and 24-mg doses.

Half of Patients With Alzheimer's Disease Adhere to Cholinesterase Inhibitors After 1 Year: Presented at ANA

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DG Dispatch

By Charlene Laino

BALTIMORE, Md -- About half of patients with Alzheimer's disease who have been prescribed oral cholinesterase inhibitors are still taking the medication after 1 year, researchers said here at the American Neurological Association (ANA) 134th Annual Meeting.

"Optimal compliance and persistence rates of oral cholinesterase inhibitors -- rivastigmine, galantamine, and donepezil -- are important factors contributing to the beneficial impact of these therapies," said Francis Vekeman, MA, BSc, Groupe d'analyse, Ltee, Montreal, Quebec, Canada, in his October 13 poster presentation.

Vekeman, a specialist in health economics and health policy, said, "Based on real-world data from a large cohort of Alzheimer's disease patients initiated on cholinesterase inhibitors, 50% were compliant during the first year following cholinesterase treatment initiation."

But persistence in taking the medication was lower, he said. After 1 year, just 36% of patients completed criteria for persistence in taking their medication. The researchers defined persistence as continuous drug use without a gap of 30 days or more between medication refills at any time after treatment initiation.

"Only 20% of the patients were persistent with their oral cholinesterase inhibitors at 2 years after initiating therapy," he said.

The researchers accessed the MedSatat MarketScan database and reviewed data on 17,717 patients who were prescribed rivastigmine, donepezil, or galantamine between January 2004 and June 2008v

During the study period, the researchers found that 15,008 patients began therapy using donepezil, 1,480 patients initiated therapy on galantamine, and 1,240 patients initiated therapy with rivastigmine. Vekeman also noted that 3,370 of the patients were being treating with antipsychotics at the time they initiated cholinesterase inhibitor therapy.

After 12 months, Vekeman determined that compliance for all patients was 49.9%. If the patients were taking memantine in addition to their cholinesterase inhibitor therapy, the compliance rate was higher, at 59.3%. But if patients were just taking 1 of the 3 oral cholinesterase inhibitors, the compliance rate was 45.9%.

Vekeman said the study, based on pharmacy claims, includes some inherent limitations, including that a filled pharmacy prescription does not guarantee that patients actually took the medication. He said that these studies also cannot assure that the billing diagnoses and pharmacy dispensing data are accurate. He added that the study did not give researchers the ability to determine the severity of illness among the patients.

The research was supported by Novartis Pharmaceuticals Corporation, East Hanover, New Jersey