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1.
Am J Med ; 132(7): e622, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31400794
3.
Acta Diabetol ; 2019 Jun 15.
Artigo em Inglês | MEDLINE | ID: mdl-31203438

RESUMO

AIMS: To investigate the occurrence of myopathy with oral glucose-lowering drugs (OGLDs) and statins, with a focus on dipeptidyl peptidase-4 inhibitors (DPP4-is). METHODS: The FDA adverse event reporting system (FAERS) was queried (2004-2016) to compare the proportion of adverse events with OGLDs, alone and in combination with statins, using the reporting odds ratio (ROR) with relevant 95% confidence interval (95%Cl), adjusted for sex, age and concomitant presence of other OGLDs/lipid-lowering drugs. Drug-drug interaction is claimed whenever the frequency of an event is enhanced by combination treatment. Consistency/robustness of findings was tested by applying additive/multiplicative models and accounting for competition bias (i.e., adverse events previously known to be associated with OGLDs were removed). RESULTS: Over a 13-year period, we retrieved 142,888 cases of myopathy. The use of DPP4-is alone was not associated with higher reporting of myopathy (no. of cases = 4898; adjusted ROR = 1.00; 95%CI = 0.96-1.04), with the notable exclusion of vildagliptin (262; 1.64; 1.42-1.88). No increased occurrence emerged when used in combination with statins, with consistent findings from additive/multiplicative models for all DPP4-is. Likewise, no increased reporting was found for other OGLDs (28,964; 0.64; 0.62-0.67); data on the interaction with statins were consistent/robust across analyses only for sulfonylureas (the interaction is likely and biologically plausible) and sodium glucose cotransporter-2 inhibitors. CONCLUSIONS: Real-world FAERS data do not raise concern for muscular toxicity with DPP4-is in combination with statins, making a drug interaction very unlikely.

4.
Br J Clin Pharmacol ; 85(9): 2126-2133, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31218710

RESUMO

AIMS: In 2017, concerns regarding adverse events (AEs) associated with the Mirena levonorgestrel intrauterine device were largely echoed in the media in France. This resulted in a tremendous reporting of AEs to pharmacovigilance centres. The aim of this study was to describe the reporting of AEs regarding Mirena in France and to study the impact of media coverage on this reporting. METHODS: All cases reports involving Mirena recorded in the French national pharmacovigilance database from marketing (21 July 1995) until 04 August 2017 were extracted. To allow studying the influence of mediatisation, reports were described separately for the periods preceding and following the observed media coverage peak (15 May 2017). RESULTS: Overall, 3224 reports were considered, 510 (15.8%) recorded before the media coverage peak, and 2714 (84.2%) after. Before the peak, 76.5% of reports originated from health professionals; median time-to-report was of 5.5 months (interquartile range: 1.7-18.6), and median number of AEs per report was 1 (range: 1-17). After the peak, 98.6% originated from patients; median time-to-report was 21 months (interquartile range: 8.1-45.5), and median number of AEs per report was 6 (range: 1-37). After the peak, most reports mentioned anxio-depressive disorders (38.8 vs 10.6% before) or sexual disorders (47.3 vs 6.9%). Other emphasised AEs were weight increase (42.3 vs 10.2%) and pain (gastrointestinal, 19.1 vs 3.5%; musculoskeletal, 22.2 vs 4.5%). CONCLUSION: This study highlighted the importance of mediatisation impact on spontaneous reporting with changes concerning amounts of reports, type of reporter, and type of reported AEs. For Mirena, this led to generate signals regarding anxio-depressive and sexual disorders.

5.
BMJ Open ; 9(4): e026645, 2019 Apr 20.
Artigo em Inglês | MEDLINE | ID: mdl-31005934

RESUMO

OBJECTIVES: To describe (i) the trend in oral anticoagulant (OAC) use following the introduction of non-vitamin K antagonist oral anticoagulant (NOAC) therapy for stroke prevention in atrial fibrillation (AF) patients and (ii) the current patterns of use of NOAC therapy in new users with AF in France. DESIGN: (i) Repeated cross-sectional study and (ii) population-based cohort study. SETTING: French national healthcare databases (50 million beneficiaries). PARTICIPANTS: (i) Patients with identified AF in 2011, 2013 and 2016 and (ii) patients with AF initiating OAC therapy in 2015-2016. PRIMARY AND SECONDARY OUTCOME MEASURES: (i) Trend in OAC therapy use in patients with AF and (ii) patterns of use of NOAC therapy in new users with AF. RESULTS: Between 2011 and 2016, use of OAC therapy moderately increased (+16%), while use of antiplatelet therapy decreased (-22%) among all patients with identified AF. In 2016, among the 1.1 million AF patients, 66% used OAC therapy and were more likely to be treated by vitamin K antagonist (VKA) than NOAC therapy, including patients at higher risk of stroke (63.5%), while 33% used antiplatelet therapy. Among 192 851 new users of OAC therapy in 2015-2016 with identified AF, NOAC therapy (66.3%) was initiated more frequently than VKA therapy, including in patients at higher risk of stroke (57.8%). Reduced doses were prescribed in 40% of NOAC new users. Several situations of inappropriate use at NOAC initiation were identified, including concomitant use of drugs increasing the risk of bleeding (one in three new users) and potential NOAC underdosing. CONCLUSIONS: OAC therapy use in patients with AF remains suboptimal 4 years after the introduction of NOACs for stroke prevention in France and improvement in appropriate prescribing regarding NOAC initiation is needed. However, NOAC therapy is now the preferred drug class for initiation of OAC therapy in patients with AF, including in patients at higher risk of stroke.

6.
Patient Educ Couns ; 102(8): 1427-1438, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30981412

RESUMO

OBJECTIVE: Systematically review the literature regarding media communication about antibiotics and anti-microbial resistance (AMR) to synthesise its key characteristics and impact effectiveness, identifying gaps and areas for further research. METHODS: A comprehensive systematic review covering five international databases for articles published between 1st September 2008 and 1st September 2018 was performed using the registered protocol (PROSPERO: CRD42018116464). The search using terms related to media communication and antibiotics or AMR yielded 19 eligible studies, which were analysed and qualitatively synthesised. RESULTS: Research on media communication regarding antibiotics or AMR has rapidly increased in the last decade. 74% of studies used a media content analysis method, while the remaining studies collected data via surveys. Print media were examined in 53% (n = 10), with 74% (n = 14) focused on English language media. CONCLUSION: Currently, knowledge regarding media communication of antibiotics and AMR is very restricted to English-speaking print media. Further research is required to understand communication on this topic from other media (types and geographical regions) as well as how media effects attitude and behaviour change. PRACTICE IMPLICATIONS: Better understanding of media communication regarding antibiotics and AMR may be crucial for policymakers and public health experts when planning strategies to tackle this issue.

7.
Therapie ; 74(2): 187-197, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30819408

RESUMO

Pharmacoepidemiology is the study of interactions between drugs and human populations, investigating, in real conditions of life, benefits, risks and use of drugs. Pharmacoepidemiology applies to drugs and their pharmacological evaluations, the different methods also used in epidemiology to assess in real conditions of life, benefits, risks and use of drugs. Pharmacoepidemiologic studies are ad-hoc studies or studies on databases. Specific methods exist to measure drug exposure, as well as indicators of compliance and misuse of drugs. Various designs for descriptive and explanatory studies exist, in a context in which a growing proportion of studies are carried out using medico-administrative data. The limits traditionally affecting the study designs are modified in this context, almost any design selected for the conduct of a study from these databases then deriving from a cohort in whom the information has been recorded prospectively and exhaustively.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Farmacoepidemiologia/métodos , Projetos de Pesquisa , Bases de Dados Factuais , Humanos
8.
Contraception ; 99(6): 345-349, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30871933

RESUMO

OBJECTIVE: To compare the risk of all-cause death, hospitalizations (any cause), ectopic pregnancy, pelvic inflammatory disease or infection, uterine perforation, device removal, neuro-psychiatric drugs initiation, or new psychiatric visit(s) between levonorgestrel (LNG) 52 mg intrauterine system (IUS) and copper intrauterine device (IUD) users in France. STUDY DESIGN: We identified a historical cohort of women aged 20-55 years with a first dispensing of either LNG 52 mg IUS or copper-IUD between January 1, 2010, and December 31, 2014, in the French National Claims database, SNDS. We used propensity score matching to balance the two groups on baseline sociodemographic and clinical characteristics to minimize confounding. We estimated Cox proportional hazards models to compare health outcomes between LNG 52 mg IUS and copper-IUDs users. RESULTS: We matched 9318 LNG 52 mg IUS users (mean age 36.2±6.8 years) to 10,185 copper-IUD users (mean age 35.4±7.1 years). After matching and age-adjustment, LNG 52 mg IUS users had a slightly higher risk of anxiolytic drugs initiation (HR 1.08, 95%CI 1.01-1.15) and device removal (HR 1.05, 95%CI 1.01-1.10) compared to copper-IUD users, with no differences for other studied outcomes. CONCLUSION: French IUS users report slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. These results are consistent with a potential pharmacovigilance signal of anxiety-related disorders in LNG 52 mg IUS users. IMPLICATIONS STATEMENT: In French LNG 52 mg IUS users, there was slightly more anxiolytic treatment initiation and IUD removal compared to copper-IUD users. No risk difference was found for all-cause death, hospitalizations, ectopic pregnancy, pelvic disorders, and uterine perforation. We cannot exclude that the associations are related to differences in characteristics of women who chose each type of type of IUD.

9.
Therapie ; 74(4): 469-476, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-30857740

RESUMO

AIM OF THE STUDY: To provide a tool for drug misuse or potential misuse monitoring by using a healthcare insurance database. METHODS: A cross-sectional study repeated quarterly from 2007 to 2014 was conducted using data from a 1/97th random sample of the French national healthcare reimbursement system. For each drug studied, ad hoc indicators were designed to assess drug misuse, defined as prescriptions that did not comply with the label stipulated in the summary of product characteristics, in terms of the drug (e.g., interactions) or the patient (age, medical history). We focused on specifically identified situations of drug misuse involving non-steroidal anti-inflammatory drugs (NSAIDs), antiemetics in patients with Parkinson's disease and antipsychotics in pediatrics; we also focused on direct anticoagulants, asthma and oral antidiabetic drugs but results for these latter are only shown in supplementary materials. RESULTS: At-risk prescribing of NSAIDs in patients treated by diuretics or renin-angiotensin system inhibitors always remained higher than 14% over the study (maximum: 19%; 2014 quarter 4: 15.4%). Off-label prescribing of contraindicated anti-dopaminergic antiemetics with dopaminergic antiparkinson drugs was marginal (maximum: 2.2%; 2014 quarter 4: 0.5%) but represented at least 5.5% of antiemetic prescriptions. Despite the rise in antipsychotic prescriptions in pediatrics, no dramatic increase in misuse related to age was observed during the study period (2007 quarter 1: 16.1%; 2014 quarter 4: 11.1%). The highest degree of misuse was observed for aripiprazole and for second-generation antipsychotics other than risperidone and aripiprazole. CONCLUSION: This study provides a simple tool to monitor drug misuse or potential misuse using information from a health insurance database. The results highlight the need for the Regulator to rethink risk management information campaigns and to modify the official information on products.

10.
PLoS One ; 14(1): e0211118, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30703112

RESUMO

BACKGROUND: Studies using health administrative databases (HAD) may lead to biased results since information on potential confounders is often missing. Methods that integrate confounder data from cohort studies, such as multivariate imputation by chained equations (MICE) and two-stage calibration (TSC), aim to reduce confounding bias. We provide new insights into their behavior under different deviations from representativeness of the cohort. METHODS: We conducted an extensive simulation study to assess the performance of these two methods under different deviations from representativeness of the cohort. We illustrate these approaches by studying the association between benzodiazepine use and fractures in the elderly using the general sample of French health insurance beneficiaries (EGB) as main database and two French cohorts (Paquid and 3C) as validation samples. RESULTS: When the cohort was representative from the same population as the HAD, the two methods are unbiased. TSC was more efficient and faster but its variance could be slightly underestimated when confounders were non-Gaussian. If the cohort was a subsample of the HAD (internal validation) with the probability of the subject being included in the cohort depending on both exposure and outcome, MICE was unbiased while TSC was biased. The two methods appeared biased when the inclusion probability in the cohort depended on unobserved confounders. CONCLUSION: When choosing the most appropriate method, epidemiologists should consider the origin of the cohort (internal or external validation) as well as the (anticipated or observed) selection biases of the validation sample.

12.
Am J Med ; 132(6): 740-748.e7, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-30660573

RESUMO

OBJECTIVES: The benefits of initiating statins in the elderly remains debated. We evaluated the effects of initiating statins in the elderly, according to cardiovascular risk. METHODS: This population-based cohort study used data of the representative sample of the French health care system database for the 2008-2015 period. New users of statins, aged 75 years and older, were dynamically included in the cohort and matched 1:1 to statin nonusers on age, sex, numbers of different drugs dispensed and medical consultations, and cardiovascular history. Patients were classified into 3 cardiovascular risk groups: secondary prevention (history of coronary heart disease), primary prevention with modifiable risk factors (diabetes or cardiovascular medications), and primary prevention without modifiable risk factors (none of the above). Effect of cumulative use of statins on occurrence of acute coronary syndrome or all-cause death was analyzed by using multivariable time-dependent Cox models stratified on cardiovascular risk at inclusion. RESULTS: Among the 7284 patients included, median follow-up was 4.7 years. Cumulative use of statins was associated with a lower risk of outcomes in the primary prevention with modifiable risk factors group (adjusted hazard ratio 0.93 per year of use; 95% confidence interval, 0.89-0.96; P < .01) and in the secondary prevention group (0.75; 0.63-0.90; P < .01), but not in the primary prevention without modifiable risk factors group (1.01; 0.86-1.18; P = .92). CONCLUSIONS: Statin treatment was not associated with a reduction in acute coronary syndrome or all-cause death in elderly without modifiable cardiovascular risk factor treated in primary prevention.

13.
Artigo em Inglês | MEDLINE | ID: mdl-30539229

RESUMO

Benzodiazepines and z-drugs are primarily indicated for the treatment of sleep disorders and anxiety symptoms. Their frequent long-term use contrasts with the international guidelines that limit treatment duration to a maximum of 4 weeks. The objective of this study was to assess the frequency of their use that was not in accordance with guidelines in the French general population between 2007 and 2012 and associated characteristics. A cohort of 67,550 benzodiazepine new users was set up in an exhaustive database for health-care reimbursements and representative of the French population. Benzodiazepine use not in accordance with guidelines was defined as the concomitant dispensation of several benzodiazepines, the dispensation of treatment over a period longer than recommended, or a new dispensing within the 2 months following the end of a previous treatment of maximum recommended duration, considering that French recommendations distinguish between hypnotic (4 weeks) and anxiolytic benzodiazepines (12 weeks). Benzodiazepine use not in accordance with guidelines was high, in about 30% of new hypnotic users and 20% of new anxiolytic users. Its frequency was stable over the study period. Associated characteristics were similar for new hypnotic or anxiolytic users, i.e.. older age, treatment initiation by a psychiatrist, presence of a chronic disease, hospitalization, or another psychotropic treatment. These findings provide a solid basis for establishing a public health policy to reduce benzodiazepine use not compliant with guidelines. They should be further explored in patients most at risk in the present study, e.g., patients treated by a psychiatrist.

14.
Lancet Oncol ; 19(12): 1579-1589, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30442497

RESUMO

BACKGROUND: Immune checkpoint inhibitors (ICIs) have substantially improved clinical outcomes in multiple cancer types and are increasingly being used in early disease settings and in combinations of different immunotherapies. However, ICIs can also cause severe or fatal immune-related adverse-events (irAEs). We aimed to identify and characterise cardiovascular irAEs that are significantly associated with ICIs. METHODS: In this observational, retrospective, pharmacovigilance study, we used VigiBase, WHO's global database of individual case safety reports, to compare cardiovascular adverse event reporting in patients who received ICIs (ICI subgroup) with this reporting in the full database. This study included all cardiovascular irAEs classified by group queries according to the Medical Dictionary for Regulatory Activities, between inception on Nov 14, 1967, and Jan 2, 2018. We evaluated the association between ICIs and cardiovascular adverse events using the reporting odds ratio (ROR) and the information component (IC). IC is an indicator value for disproportionate Bayesian reporting that compares observed and expected values to find associations between drugs and adverse events. IC025 is the lower end of the IC 95% credibility interval, and an IC025 value of more than zero is deemed significant. This study is registered with ClinicalTrials.gov, number NCT03387540. FINDINGS: We identified 31 321 adverse events reported in patients who received ICIs and 16 343 451 adverse events reported in patients treated with any drugs (full database) in VigiBase. Compared with the full database, ICI treatment was associated with higher reporting of myocarditis (5515 reports for the full database vs 122 for ICIs, ROR 11·21 [95% CI 9·36-13·43]; IC025 3·20), pericardial diseases (12 800 vs 95, 3·80 [3·08-4·62]; IC025 1·63), and vasculitis (33 289 vs 82, 1·56 [1·25-1·94]; IC025 0·03), including temporal arteritis (696 vs 18, 12·99 [8·12-20·77]; IC025 2·59) and polymyalgia rheumatica (1709 vs 16, 5·13 [3·13-8·40]; IC025 1·33). Pericardial diseases were reported more often in patients with lung cancer (49 [56%] of 87 patients), whereas myocarditis (42 [41%] of 103 patients) and vasculitis (42 [60%] of 70 patients) were more commonly reported in patients with melanoma (χ2 test for overall subgroup comparison, p<0·0001). Vision was impaired in five (28%) of 18 patients with temporal arteritis. Cardiovascular irAEs were severe in the majority of cases (>80%), with death occurring in 61 (50%) of 122 myocarditis cases, 20 (21%) of 95 pericardial disease cases, and five (6%) of 82 vasculitis cases (χ2 test for overall comparison between pericardial diseases, myocarditis, and vasculitis, p<0·0001). INTERPRETATION: Treatment with ICIs can lead to severe and disabling inflammatory cardiovascular irAEs soon after commencement of therapy. In addition to life-threatening myocarditis, these toxicities include pericardial diseases and temporal arteritis with a risk of blindness. These events should be considered in patient care and in combination clinical trial designs (ie, combinations of different immunotherapies as well as immunotherapies and chemotherapy). FUNDING: The Cancer Institut Thématique Multi-Organisme of the French National Alliance for Life and Health Sciences (AVIESAN) Plan Cancer 2014-2019; US National Cancer Institute, National Institutes of Health; the James C. Bradford Jr. Melanoma Fund; and the Melanoma Research Foundation.

15.
Presse Med ; 47(10): 878-881, 2018 Oct.
Artigo em Francês | MEDLINE | ID: mdl-30454579

RESUMO

Benzodiazepine use remains high in France in 2015, especially among the elders. However, encouraging trend is observed regarding hypnotic benzodiazepines initiation: between 2008 and 2015, incident use of hypnotics, including that of Z-drugs, decreased while incident use of anxiolytics remained stable. Most of new benzodiazepine users (86 %) had treatment duration that complies with guidelines. Owing to the high number of user initiating a treatment each year and associated risks, the remaining 14 % of long-term users is of concern. Roughly half of benzodiazepine users presented with comorbidities and concurrent medications increasing the risk of adverse drug reactions, especially central nervous system depressant effects.

16.
Presse Med ; 47(10): 892-898, 2018 Oct.
Artigo em Francês | MEDLINE | ID: mdl-30454582

RESUMO

Benzodiazepines and Z-drugs have pharmacodynamic effects with tolerance that can occur quickly, after one week to one month of treatment and that concerns hypnotic and anxiolytic properties in particular. Old studies showed a real but poor short-term efficacy of benzodiazepines on anxiety and sleep disturbances. Long-term efficacy of benzodiazepines can be confused with the occurrence of rebound effect, discontinuation symptoms or relapse when the treatment is quitted; they contribute to an apparent efficacy, as well as the symptoms removal when treatment is re-initiated. Pharmacologic tolerance exists with respects to efficacy and side effects that decrease over time, in the first weeks of treatment. Its main associated characteristic is the occurrence of a severe withdrawal syndrome when treatment is quitted. To limit long-term treatments, it is relevant to target treatment initiation of benzodiazepines and to restrict indications and treatment duration. Addiction to benzodiazepines is frequent in patients treated for another addiction; it is associated with more frequent complications, in particular overdoses and suicide attempts. The use of benzodiazepines is necessary to prevent complications during alcohol or benzodiazepine withdrawal, but duration of treatment should be limited and dispensing should be supervised in patients with substance use disorders.

17.
Front Pharmacol ; 9: 1010, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30279658

RESUMO

Classical methods used for signal detection in pharmacovigilance rely on disproportionality analysis of counts aggregating spontaneous reports of a given adverse drug reaction. In recent years, alternative methods have been proposed to analyze individual spontaneous reports such as penalized multiple logistic regression approaches. These approaches address some well-known biases resulting from disproportionality methods. However, while penalization accounts for computational constraints due to high-dimensional data, it raises the issue of determining the regularization parameter and eventually that of an error-controlling decision rule. We present a new automated signal detection strategy for pharmacovigilance systems, based on propensity scores (PS) in high dimension. PSs are increasingly used to assess a given association with high-dimensional observational healthcare databases in accounting for confusion bias. Our main aim was to develop a method having the same advantages as multiple regression approaches in dealing with bias, while relying on the statistical multiple comparison framework as regards decision thresholds, by considering false discovery rate (FDR)-based decision rules. We investigate four PS estimation methods in high dimension: a gradient tree boosting (GTB) algorithm from machine-learning and three variable selection algorithms. For each (drug, adverse event) pair, the PS is then applied as adjustment covariate or by using two kinds of weighting: inverse proportional treatment weighting and matching weights. The different versions of the new approach were compared to a univariate approach, which is a disproportionality method, and to two penalized multiple logistic regression approaches, directly applied on spontaneous reporting data. Performance was assessed through an empirical comparative study conducted on a reference signal set in the French national pharmacovigilance database (2000-2016) that was recently proposed for drug-induced liver injury. Multiple regression approaches performed better in detecting true positives and false positives. Nonetheless, the performances of the PS-based methods using matching weights was very similar to that of multiple regression and better than with the univariate approach. In addition to being able to control FDR statistical errors, the proposed PS-based strategy is an interesting alternative to multiple regression approaches.

18.
J Am Geriatr Soc ; 66(11): 2086-2091, 2018 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-30246861

RESUMO

OBJECTIVES: To assess the risk of hospitalization for trauma associated with use of hypoglycemic glucose-lowering drugs (GLDs) in individuals aged 65 and older. DESIGN: Observational, nested, case-control study. SETTING: The Echantillon Généraliste de Bénéficiaires claims database, a 1/97th representative sample of the population covered by French healthcare insurance. PARTICIPANTS: All persons with a first hospitalization for trauma between 2009 and 2015 were considered as potential cases. They were selected if they had been followed for 365 days or longer at index date, were aged 65 and older, and had no diagnosed cancer. Cases (n=10,743) were matched with up to 10 randomly selected controls on age, sex, and length of follow-up (n=106,629). MEASUREMENTS: GLD exposure was considered globally and according to use of hypoglycemic GLDs alone, nonhypoglycemic GLDs alone, or both types of GLDs. Risk of hospitalization for trauma was estimated using hazard ratios (HRs) and 95% confidence intervals (CIs). RESULTS: Risk of hospitalization for trauma was significantly higher with use of GLDs (HR=1.15, 95% CI=1.08-1.22). Greater risk was found only in individuals treated with hypoglycemic GLDs alone (HR=1.26, 95% CI=1.15-1.38), particularly insulin (HR=1.49, 95% CI=1.32-1.68) and glinides (HR=1.34, 95% CI=1.12-1.61). CONCLUSION: This study highlights the excess risk of serious trauma with the use of insulin and glinides. J Am Geriatr Soc 66:2086-2091, 2018.

20.
Clin Pharmacol Ther ; 2018 Jul 10.
Artigo em Inglês | MEDLINE | ID: mdl-29992538

RESUMO

Eye lens membrane cells require high cholesterol concentrations that might be counteracted by lipid-lowering drugs. Using a nationwide database, we conducted a nested case-control study to evaluate the risk of cataract development associated with the use of lipid-lowering drugs. Patients aged 45 years and over with first cataract surgery in 2014 (cases) and up to four controls matched on age, gender, diabetes, hypothyroidism, glucocorticoid use, cardiovascular risk, and area of residence were included in the study. Among the 2,811 cases and 11,106 matched controls included, analyses showed a significantly increased risk of cataract surgery for a cumulative exposure to fibrates exceeding 5 years (adjusted odds ratio (aOR) 1.58; 95% confidence interval (CI): 1.17-2.15), unlike cumulative exposure to statins, whatever the dose or duration of treatment (aORs from 1.00-1.08, none being significant). This study highlighted an increased risk of cataract surgery with prolonged use of fibrates but not of statins.

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