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We chose this approach as we believe that a Cox model updating information on exposure would not allow for a correct causal inference structure. We then evaluated the association of each of these cohorts with the risk of subsequent dementia compared with participants who did not start benzodiazepines at a given time point, adjusting for the above mentioned confounders including information on depressive symptoms.
The information on confounders was updated to the respective follow-up time point. Finally, we pooled the five cohorts by using a fixed effect model. Participants still followed at T 8 , without dementia before this date and with an accurate date of diagnosis of dementia, were eligible for a nested case-control analysis in the PAQUID cohort. We defined cases as participants with an incident diagnosis of dementia from T 8 onwards, as in the cohort study. We considered all participants without a diagnosis of dementia at the time point when a case was diagnosed index date as controls.
Participants could be used as controls for cases and later selected as cases if they presented with an incident diagnosis of dementia incidence density sampling. For the nested case-control study, we did not exclude any prevalent benzodiazepine exposure. We first classified participants as ever users if at least one use of benzodiazepine was declared before the index date and never users no declaration of benzodiazepine use before index date.
Among ever users, we then identified recent users reported use at the follow-up visit preceding the index date but never before and past users reported use at least three visits before the index date or earlier. We used conditional logistic regression to evaluate the association between benzodiazepine use and risk of dementia. We built two series of models, each considering one of the definitions retained for exposure to benzodiazepines.
We did analyses using similar adjustment to that used for the main cohort analysis, including depressive symptoms. Models not including information on depressive symptoms showed similar associations. Potential confounding variables were measured at three follow-up time points seven or eight years before the index date. Of the participants in the PAQUID study, were still in active follow-up at the five year visit T 5 , baseline for this study. We excluded participants with prevalent dementia at the five year follow-up visit, participants with a history of benzodiazepine use or prevalent use, and with missing or questionable information on history of benzodiazepine use.
Among the eligible participants, 95 8. No difference existed between new users of benzodiazepines and non-users in terms of age, sex, diabetes mellitus, statin use, and cognitive evolution between inclusion in the PAQUID study T 0 and the three year follow-up visit T 3. Baseline characteristics of participants from PAQUID study included in cohort analysis, according to benzodiazepine use. Values are numbers percentages unless stated otherwise. During the 15 year follow-up median 6.
The incidence rate of dementia during the 15 year follow-up was 4. When further adjusted for depressive symptoms, this result was unchanged hazard ratio 1. Use of the Isaacs or the Benton test instead of the mini-mental state examination yielded similar results hazard ratios 1. In the secondary analysis, we created benzodiazepine new user and non-user cohorts at baseline T 5 and the follow-up time points T 8 , T 10 , T 13 , and T This added a total of new users during follow-up to the 95 new users at baseline.
We then pooled the association between new use of benzodiazepine and risk of incident dementia across the five cohorts baseline and four follow-up cohorts by using a fixed effect model. The pooled multivariable adjusted hazard ratio of dementia was 1. Additional control for symptoms of depression did not alter this result hazard ratio 1. Results adjusted for age, sex, schooling duration, singleness, wine consumption, use of antihypertensive drugs, use of antidiabetic agents, use of statins, use of platelet inhibitors or oral anticoagulants, depressive symptoms, and mini-mental state examination evolution between inclusion T 0 and 3 year follow-up visit T 3.
We identified cases of dementia and controls for the nested case-control analysis which did not exclude prevalent users at T 0 or T 3 , unlike in the cohort analysis. Ever users had an increased risk of dementia adjusted odds ratio 1. We found similar associations in past users adjusted odds ratio 1. Values are numbers percentages. Risk of dementia associated with benzodiazepine use in nested case control study of elderly people form PAQUID study. This result remained stable after adjustment for potential confounding factors, including cognitive decline before starting benzodiazepine and clinically significant symptoms of depression.
It also remained robust when we pooled five cohorts of new benzodiazepine users throughout the 15 year follow-up period and in a complementary nested case-control study. Our findings are consistent with three previous case-control studies that also showed an increased risk of dementia in benzodiazepine users. The results of that study also suggested that the potential excess risk of dementia associated with benzodiazepine use may apply to a population with low benzodiazepine consumption.
However, benzodiazepine users could not be classified as new starters and the sample size was too small to allow for meaningful subgroup analyses for example, 12 participants had exposure of four years or more among the 93 with dementia. In contrast to our results, two studies did not find an increased risk of dementia among elderly people using benzodiazepines. The results of one case-control study, however, showed a similar effect estimate to ours, but this did not reach statistical significance adjusted odds ratio 1.
Our study included a markedly larger number of participants than did the previous long term study on the topic, 9 and we incorporated a run-in time of at least three years to allow adjustment for factors associated with starting benzodiazepines, thereby reducing the possibility of reverse causation. In that sense, an excess risk observed during the early phase of exposure could be congruent with a reverse causation bias, which would not be the case if the increase in risk appeared long after the start of exposure.
Benzodiazepines could also be seen as an early risk marker for dementia that might highlight a particular at risk background in patients, but without playing any causal role in the occurrence of the disease. For example, persistent anxiety in middle age has been shown to be associated with a greater risk of dementia in elderly people. However, in our study, two observations argue against this hypothesis: However, reverse causation cannot be entirely ruled out as an alternative explanation of our findings.
This study has several strengths. Firstly, it was based on a long follow-up period allowing assessment of the delayed effects of exposure to benzodiazepine, which was not possible in previous studies except one 9. Secondly, we defined incident dementia by applying validated criteria DSM-III-R ascertained by senior neurologists who were blind to the study hypothesis.
Lastly, the study was carried out in a large representative cohort of elderly participants, 31 with adjustment on a large number of potential confounders of the benzodiazepine-dementia association. The study also has several limitations. However, the literature contains no suggestion that specific benzodiazepines have differential effects on cognition or dementia. However, the Center for Epidemiologic Studies depression scale includes these items in computation of its global score, and entering three separate scores in the model could have raised a concern about colinearity, as depressive symptoms are often associated with sleep disorders and anxiety, especially in elderly people.
Lastly, people who had missing information for benzodiazepine use during the three to five year run-in period of this study were not included, as they could not be ascertained for exposure status. As these missing data were linked to unperformed follow-up, which has been related to subsequent higher risk of dementia, 44 a potential selection bias could have occurred. However, these ineligible participants had a lower schooling level and were more likely to live alone, two factors known to increase the risk of both benzodiazepine use and incident dementia.
Therefore, a potential selection bias due to exclusion of people with missing information for exposure before the index date would have tended to decrease the strength of the association. The disparity in the incidence of dementia over a comparable time window was similar to that seen in the participants included. Benzodiazepines remain useful for the treatment of acute anxiety states and transient insomnia. Therefore, physicians should carefully assess the expected benefits of the use of benzodiazepines in the light of these adverse effects and, whenever possible, limit prescription to a few weeks as recommended by the good practice guidelines.
Further research should explore whether long term use of benzodiazepines in people under 65 is also associated with an increased risk of dementia and should study possible correlations between dosage or cumulative length of exposure and dementia. The results remained robust after control for potential confounders, in pooled analysis across the follow-up time, and in a nested case-control study. Considering the extent to which benzodiazepines are now prescribed, physicians and regulatory agencies should consider the increasing evidence of the potential adverse effects of this drug class for the general population.
Prescription of benzodiazepines in elderly people is widespread and often chronic in many developed countries, regardless of good practice guidelines. Benzodiazepines can have delayed adverse effects on cognition cognitive decline and dementia , as reported in several case-control studies and a few cohort studies. Benzodiazepine exposure was associated with dementia, even after a long follow-up period.
Adjustment for factors strongly associated with starting benzodiazepines or considered to be markers for a prodrome of early dementia did not alter the association. SBdG did the statistical analysis, interpreted the results, and drafted the manuscript. BB contributed to the design of the study, interpreted the results, and participated in the writing and editing of the manuscript. FB oversaw and contributed to the statistical analysis. HV contributed to definition of benzodiazepine exposure and depressive symptoms and critically revised the manuscript.
TK and AP equally contributed to the study design and protocol development, interpretation of results, and manuscript writing and editing. All the authors made a significant contribution to the research and the development of the manuscript and approved the final version. SBdG and BB are the guarantors. All authors have completed the Unified Competing Interest form at http: BB has received investigator initiated research funding from the French Health Ministry ; he is chair of the scientific committee for two pharmacoepidemiological studies conducted by the contract research organisation LA-SER London: To view a copy of this license, visit http: This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license.
Abstract Objective To evaluate the association between use of benzodiazepines and incident dementia. Design Prospective, population based study. Main outcome measures Incident dementia, confirmed by a neurologist. Introduction Primarily indicated for treating the symptoms of anxiety and sleep disorders over short periods, 1 benzodiazepines are widely prescribed in developed countries. Methods Participants, design, and settings We studied participants in the prospective PAQUID cohort study, which assesses normal and pathological brain ageing.
Exposure definition and measurement Data on drug use, including benzodiazepine use, were collected with a standardised questionnaire at each follow-up visit. Covariates In addition to age and sex, which are risk factors both for benzodiazepine use and for dementia, the covariates used for adjustment at the baseline for this study T 5 included factors considered to be associated with both benzodiazepine use and risk of dementia 32 Statistical analysis Cohort, main analysis We compared the characteristics of new users of benzodiazepines with those of non-users by using numbers and percentages for qualitative variables and median and interquartile range for quantitative variables.
Cohort, secondary analysis To account for potential time varying effects on the association between benzodiazepine use and risk of dementia, we considered new cohorts of benzodiazepines users between the baseline of our study PAQUID T 5 and the following 15 years of follow-up PAQUID T 8 to T 20 in a second analysis. Nested case-control analysis Participants still followed at T 8 , without dementia before this date and with an accurate date of diagnosis of dementia, were eligible for a nested case-control analysis in the PAQUID cohort.
View popup View inline. Main analysis During the 15 year follow-up median 6. Secondary analysis In the secondary analysis, we created benzodiazepine new user and non-user cohorts at baseline T 5 and the follow-up time points T 8 , T 10 , T 13 , and T Comparison with other studies Our findings are consistent with three previous case-control studies that also showed an increased risk of dementia in benzodiazepine users.
Strengths and limitations This study has several strengths. Implication for clinical practice and public health Benzodiazepines remain useful for the treatment of acute anxiety states and transient insomnia. Unanswered questions and future research Further research should explore whether long term use of benzodiazepines in people under 65 is also associated with an increased risk of dementia and should study possible correlations between dosage or cumulative length of exposure and dementia.
What is already known on this topic Prescription of benzodiazepines in elderly people is widespread and often chronic in many developed countries, regardless of good practice guidelines Benzodiazepines can have delayed adverse effects on cognition cognitive decline and dementia , as reported in several case-control studies and a few cohort studies.
What this study adds Benzodiazepine exposure was associated with dementia, even after a long follow-up period Adjustment for factors strongly associated with starting benzodiazepines or considered to be markers for a prodrome of early dementia did not alter the association. Notes Cite this as: No additional data available. Summary of product characteristics for benzodiazepines as anxiolytics or hypnotics.
Ten-year trends in benzodiazepine use in the Dutch population. Soc Psychiatry Psychiatr Epidemiol ; Patterns and correlates of benzodiazepine use in the French general population. Eur J Clin Pharmacol ; Benzodiazepine use in an elderly community-dwelling population: Prevalence and potential consequences of benzodiazepine use in senior citizens: Can J Clin Pharmacol ; Psychotropics use in the Spanish elderly: You may report side effects to Health Canada at List Clonazepam side effects by likelihood and severity.
Before taking clonazepam , tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines such as diazepam , lorazepam ; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication , tell your doctor or pharmacist your medical history, especially of: This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy.
Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Talk to your doctor if you are using marijuana. Before having surgery, tell your doctor or dentist about all the products you use including prescription drugs , nonprescription drugs, and herbal products. Therefore, discuss the risks and benefits of treatment with clonazepam with your doctor.
Older adults may be more sensitive to the effects of this drug, especially drowsiness and confusion. These side effects can increase the risk of falling. During pregnancy , this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor.
If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast -feeding. What should I know regarding pregnancy, nursing and administering Clonazepam to children or the elderly? Drug interactions may change how your medications work or increase your risk for serious side effects.
This document does not contain all possible drug interactions. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers such as codeine, hydrocodone , alcohol, marijuana , drugs for sleep or anxiety such as alprazolam , lorazepam , zolpidem , muscle relaxants such as carisoprodol , cyclobenzaprine , or antihistamines such as cetirizine , diphenhydramine.
Check the labels on all your medicines such as allergy or cough -and-cold products because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. Does Clonazepam interact with other medications? Should I avoid certain foods while taking Clonazepam? If someone has overdosed and has serious symptoms such as passing out or trouble breathing , call Otherwise, call a poison control center right away.
US residents can call their local poison control center at Canada residents can call a provincial poison control center. Symptoms of overdose may include: Do not share this medication with others. It is against the law. Consult your doctor for more details. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up. Store at room temperature away from light and moisture.
Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company. Information last revised September Copyright c First Databank, Inc.
Clonazepam Read Reviews Get Prices. How to use Clonazepam Read the Medication Guide provided by your pharmacist before you start taking clonazepam and each time you get a refill. Tell your doctor if your condition persists or worsens. Related Links What conditions does Clonazepam treat? Side Effects See also Warning section. In the US - Call your doctor for medical advice about side effects.