Medicines to treat people with vascular dementia and other v | Figure 1
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Medicines to treat people with vascular dementia and other vascular cognitive impairments
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Review question
What is the evidence for cholinesterase inhibitors (medicines designed to improve memory and thinking in people with dementia), when used with people who have vascular dementia?
Background
Vascular dementia (or vascular cognitive impairment) is a term used when a person has problems with memory and thinking that are caused by a disruption of blood supply. There are few drug treatments for vascular dementia.
In this review, we evaluated three drugs from the cholinesterase inhibitor family, donepezil, rivastigmine, and galantamine. These medications are widely used in Alzheimer's dementia but may also be useful in people with vascular dementia. Previous reviews of these cholinesterase inhibitor drugs could not draw definitive conclusions for people with vascular dementia.
Purpose of this review
We wanted to learn whether cholinesterase inhibitors benefit people with vascular dementia. We were interested in their effects on memory, thinking, and daily functioning. We wanted to learn of any harms associated with these drugs.
As some time has passed since the previous reviews, we wanted to update them by searching for new studies. We combined the three previous reviews on donepezil, rivastigmine and galantamine into one review.
What we did
We searched for studies that described the effects of donepezil, rivastigmine, and galantamine for people with vascular dementia. We searched databases of scientific studies and contacted drug manufacturers and experts in vascular dementia. Our search is current to 19 August 2020.
To be included in our review, studies had to randomly assign people with vascular dementia to treatment with a cholinesterase inhibitor, or a dummy pill (placebo) and then compare the two groups. Studies comparing one cholinesterase inhibitor against another were also included. We combined the results of the included studies for each medicine to estimate how effective they were and how likely they were to cause side effects. We assessed how well the studies were conducted and how credible the results were.
We did not find studies which compared different cholinesterase inhibitors with each other. To see whether the different cholinesterase inhibitor drugs differed in their effects, we used a technique called network meta‐analysis, which can provide an idea of how the medicines might perform if they were compared head‐to‐head.
What we found
We found 8 studies including a total of 4373 people with vascular dementia (or vascular cognitive impairment). The studies tested the drug donepezil at two different doses (5mg and 10mg daily), against each other and against placebo. Rivastigmine and galantamine were tested against placebo only. Rivastigmine is available as a skin patch, but the studies only tested the pill version. All eight studies evaluated participants when they first started taking the medicine or placebo and again six months later. Different tests were used to measure the effects. All studies included tests of memory, thinking and reported side effects.
People taking donepezil or galantamine had better scores on memory and thinking tests than people taking placebo, but the benefits were modest and may not be large enough to be evident in daily life. There was no evidence of a difference for rivastigmine, but the evidence was less certain, and the doses taken by some participants may have been too low to show an effect. We found evidence that when compared to placebo, side effects such as nausea and diarrhoea, were more common in people taking donepezil 10mg and galantamine, but probably not donepezil 5mg. We were unable to draw conclusions about side effects of rivastigmine from the studies.
No vascular dementia trials comparing the different cholinesterase against each other have been conducted. Using the information from the individual studies, we made indirect assessments of how the drugs would perform if tested head‐to‐head. The results suggested that donepezil 10 mg had the greatest effect on memory and thinking, but caused more side effects than donepezil 5 mg or galantamine.
There were only a small number of studies for each drug. Certainty in the results varied between drugs and between outcomes, from high to very low certainty. The studies showed only a small benefit at most; however, in the absence of any other treatments, people living with dementia may still wish to consider use of these drugs.
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\ \ Background\ Dementia is the term used to describe a group of illnesses, usually developing in late life, in which there is a deterioration in a person’s ability to think, remember, communicate and manage daily activities independently. It can be caused by several different brain diseases, but the most common form is dementia due to Alzheimer’s disease. At the moment, there are no medical treatments which can prevent dementia or stop it from progressing, but there are two classes of drugs – the cholinesterase inhibitors (donepezil, rivastigmine and galantamine) and memantine ‐ which are approved and widely prescribed to treat some of the symptoms. They are used mainly for dementia due to Alzheimer's disease but also sometimes for other types of dementia. Most of the trials studying the effects of these drugs have been quite short (typically six months) even though dementia usually lasts for years. The drugs can have unwanted side effects in some people. There is uncertainty about their long‐term effects and about how useful they are for severe dementia, with different countries making different recommendations. Therefore it can be difficult for doctors and patients to decide if and when these drugs should be stopped once they have been started.\ What was the aim of this review?\ In this review, we aimed to summarise the best evidence about whether stopping cholinesterase inhibitors or memantine was beneficial or harmful to people with dementia who had been taking them for at least two months.\ What we did\ We searched up to October 2020 for trials which had: recruited people with dementia who were taking a cholinesterase inhibitor or memantine, or both; divided them randomly into a group of patients who continued treatment and a group of patients who stopped treatment; and compared what happened in the two groups.\ What we found\ We found seven trials (759 participants) to include in the review. All of the participants had dementia due to Alzheimer’s disease, but in some trials, the disease was mild to moderate and in others, it was moderate to severe or very severe. Six trials investigated the effects of stopping a cholinesterase inhibitor and one trial investigated stopping either a cholinesterase inhibitor (specifically, donepezil) or memantine. We decided not to pool its results with the other six trials. Effects were measured over different periods of time in different trials. We looked separately at effects in the first 2 months (short term), between 3 and 11 months (medium term), and after a year or more (long term).\ When we looked at the effect on thinking skills and memory, we found that, compared to stopping treatment, continuing treatment with a cholinesterase inhibitor may be beneficial in the short term and medium term and is probably beneficial in the long term. For ability to carry out daily activities, there may be little or no effect in the short term, and the effect in the medium term was very uncertain, but there is probably a benefit to continuing treatment over the longer term. For mood and behavioural problems, continuing treatment may have benefits in the short term and medium term, but not in the long term. We found no clear evidence about the effects of stopping these drugs on patients’ physical health or risk of dying. There was very little evidence about effects on quality of life or on the likelihood of moving to a care home to live. There was not enough evidence for us to see whether results differed with the severity of dementia.\ Our certainty in the results varied from moderate to very low, mainly because of small numbers of trials and participants, some problems with the way the trials were conducted, and imprecise statistical results.\ Our conclusions\ Although there was uncertainty about the results, most of the evidence pointed to benefits of continuing treatment with cholinesterase inhibitors. There was no evidence about types of dementia other than Alzheimer’s disease, and we were unable to draw specific conclusions about continuing or stopping treatment at different stages of the illness. We found no trials that just investigated stopping memantine.\ These results may help patients and their doctors to make decisions about whether or not to continue treatment, although other factors, such as side effects in an individual patient and the patient’s preferences, are also important.](https://app.figure1.com/case-detail/198b6951-39ef-4467-8c9e-7b47373aaab7)
\ \ Why are people sick after an operation?\ Feeling sick (nausea) or being sick (vomiting) is a common unwanted effect of general anaesthesia—medicine that makes people unconscious and unresponsive so they don't move or feel pain during an operation.\ Most unwanted effects of general anaesthesia, including feeling or being sick, happen immediately and stop after a few hours, although some people may continue to feel sick for up to a day. If people carry on feeling or being sick, they might have to stay in hospital longer than expected and may experience other unwanted effects or complications.\ Women are more likely to be sick after an operation, as are people taking opioid painkillers, those who have had motion sickness, and those who have been sick after previous operations.\ Medicines to prevent people from being sick\ Medicines called antiemetics are given to prevent people from feeling or being sick. These medicines may be given before or during anaesthesia.\ Antiemetic medicines are grouped into six main classes based on how they act. Combining medicines from different classes sometimes makes them work better.\ Why we did this Cochrane Review\ We wanted to find out which medicines work best to prevent people from being sick after an operation and cause the fewest unwanted effects. Some unwanted effects of antiemetic medicines include headache, constipation, movement disorders such as tremors, sleepiness, irregular heartbeat, and wound infection.\ What did we do?\ We searched for studies that looked at the use of antiemetic medicines in adults having general anaesthesia to prevent people from being sick afterwards.\ \ We looked for randomized controlled studies, in which the treatments people received were decided at random. This type of study usually gives the most reliable evidence about the effects of a treatment.\ Search date\ We included evidence published up to November 2017; in April 2020, we found another 39 studies, which are not yet included in the analysis.\ What we found\ We found 585 studies in 97,516 people who were given antiemetic medicines before or during general anaesthesia. People included in the studies were more likely to be sick after anaesthesia, as 83% were women and 88% were taking opioid painkillers. Most studies were conducted in Asia, Europe, or North America.\ These studies either measured how many people were sick in the first 24 hours after their operation or how many unwanted effects were reported, or both of these outcomes. Most studies compared medicines (given alone or in combination) with a dummy (placebo) treatment.\ We compared all antiemetic medicines with each other using a mathematical method called network meta‐analysis.\ What were our main results and how reliable are these results?\ Compared with placebo treatment, 10 out of 28 single medicines and 29 out of 36 combinations of medicines prevented people from being sick in the first 24 hours after their operation (282 studies). Combinations of antiemetic medicines generally worked better than single medicines given alone. However, aprepitant, casopitant, and fosaprepitant worked as well alone as most combinations of antiemetics. The single medicine that worked best in the ranking of all medicines was fosaprepitant, followed by casopitant, aprepitant, ramosetron, granisetron, dexamethasone, tropisetron, ondansetron, dolasetron, and droperidol.\ We are confident that aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron prevent people from being sick. We are moderately confident about how well fosaprepitant and droperidol work, but this finding may change when further evidence becomes available. We are uncertain about how well casopitant, tropisetron, and dolasetron work.\ Not all studies looked at serious, life‐threatening unwanted effects. We are uncertain how many of these effects were reported when taking an antiemetic medicine and whether serious, life‐threatening unwanted effects occur at a similar rate or are reduced compared to placebo (28 studies).\ Of the best medicines with most reliable evidence for preventing being sick, granisetron and ondansetron probably made little to no difference in the occurrence of unwanted effects compared to placebo, whereas dexamethasone and droperidol may cause fewer unwanted effects than placebo. We are uncertain about unwanted effects with aprepitant and ramosetron (61 studies). We found no studies looking at unwanted effects for fosaprepitant.\ We are less confident about unwanted effects of other antiemetic medicines because we found little reliable evidence about this. Our results for unwanted effects are likely to change when further evidence is available.\ Conclusions\ For people at higher risk, we found that some antiemetic medicines work well to prevent them from being sick after general anaesthesia. The best antiemetic medicines with reliable evidence were aprepitant, ramosetron, granisetron, dexamethasone, and ondansetron, followed by fosaprepitant and droperidol.\ However, we did not find enough reliable evidence about potential unwanted effects to rank these medicines reliably according to how well they are tolerated.](https://app.figure1.com/case-detail/691082ff-4cbb-4670-8ce2-3f7f9aa8a0be)
\ \ Review question\ Is treatment with cholinesterase inhibitors effective and safe at reducing the severity or duration of delirium for people with delirium (not including those in intensive care units)?\ Cochrane Review; one trial (15 participants with delirium). The average age of the participants was 82.5 years. Seven also had a history of dementia. This trial compared rivastigmine (a type of cholinesterase inhibitor used in the treatment of dementia) with an inactive treatment (placebo)\ Background\ During a period of illness, people can develop symptoms of confusion and altered consciousness, which is known as delirium. Compared to patients with no delirium, patients with delirium spend a longer time in hospital and are less likely to survive their illness. Treatment of delirium should focus on good care of the underlying illness and strategies such as reorientation of the patient. However, medication-based treatments are still often used. Medications used for treating the symptoms of dementia (cholinesterase inhibitors) may have a role in treating delirium.\ Key results\ The trial did not show any difference in effect between those participants given rivastigmine and those given placebo. The study was conducted and reported appropriately, but the small number of participants limits any conclusions that could be made about rivastigmine as a treatment for delirium.](https://app.figure1.com/case-detail/6ac42dc6-d679-4871-a925-5e0eb87ddd4e)
\ \ Background\ Vascular dementia is a common form of dementia caused by poor blood flow to the brain. There are currently no proven and licenced treatments for vascular dementia. Cerebrolysin is a medicine that is made from pig's brains and given as an injection. In some countries, Cerebrolysin is used as a treatment for vascular dementia. A previous summary from 2013 considered all studies of Cerebrolysin and vascular dementia. A definitive conclusion as to whether Cerebrolysin was beneficial could not be made.\ Purpose of this review\ We wanted to learn whether Cerebrolysin can benefit people living with vascular dementia. We were particularly interested in the effects of the medication on memory and thinking; daily functioning; side effects; and and quality of life for people with vascular dementia and their caregivers. As some time has passed since the last review of Cerebrolysin, we wanted to update the review with a search for any new studies.\ What we did\ We searched for studies that described the effect of Cerebrolysin in people living with vascular dementia. We searched databases of scientific studies, including resources from countries where Cerebrolysin is commonly used. To be included in our review, the studies had to randomly decide whether people were treated with Cerebrolysin or a comparison. We combined the results of the included studies to estimate the effect of Cerebrolysin. We also assessed how well the studies were conducted and how credible the results were. The evidence is current to May 2019.\ What we found\ We found six studies including a total of 597 people living with vascular dementia. The method of Cerebrolysin treatment differed across studies, with varying strengths of Cerebrolysin and treatment durations. The studies reported that Cerebrolysin had beneficial effects on memory and thinking and on daily functioning. There was no reported risk of side effects with treatment. None of the studies described quality of life of people living with vascular dementia or their caregivers.\ Although the studies suggested a benefit of Cerebrolysin treatment, the results are not definitive. The included studies had several issues that may have led to misleading results. Even if the benefit reported in the studies is real, the effect was modest and may not be important to people living with dementia. There is a need for a large, well‐conducted study to better understand if Cerebrolysin is a useful treatment for people living with vascular dementia.](https://app.figure1.com/case-detail/7c0d5502-8a24-42c0-99a9-a82828bf2789)
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