Population-based assessment of adverse events associated with long-term glucocorticoid use

OBJECTIVE: The frequency of many adverse events (AEs) associated with low-dose glucocorticoid use is unclear. We sought to determine the prevalence of glucocorticoid-associated AEs in a large US managed care population. METHODS: Using linked administrative and pharmacy claims, adults receiving >or=60 days of glucocorticoids were identified. These individuals were surveyed about glucocorticoid use and symptoms of 8 AEs commonly attributed to glucocorticoid use. RESULTS: Of the 6,517 eligible glucocorticoid users identified, 2,446 (38%) returned the mailed survey. Respondents were 29% men with a mean +/- SD age of 53 +/- 14 years; 79% were white and 13% were African American. Respondents had a mean +/- SD of 7 +/- 3 comorbid conditions and were prescribed a mean +/- SD prednisone-equivalent dosage of 16 +/- 14 mg/day. More than 90% of individuals reported at least 1 AE associated with glucocorticoid use; 55% reported that at least 1 AE was very bothersome. Weight gain was the most common self-reported AE (70% of the individuals), cataracts (15%) and fractures (12%) were among the most serious. After multivariable adjustment, all AEs demonstrated a strong dose-dependent association with cumulative glucocorticoid use. Among users of low-dose therapy (相似文献   

Serious adverse event following immunization and thromboembolic events associated with COVID19 vaccination: An analysis of nationwide causality assessment from India

BackgroundVaccines against the COVID-19 pandemic were introduced in late 2020. The present study has been conducted to study the serious Adverse Events Following Immunization (AEFIs) reported for COVID-19 vaccines from India.MethodsSecondary data analysis of the causality assessment reports for the 1112 serious AEFIs published by the Ministry of Health & Family Welfare, Government of India, was conducted. For the current analysis, all the reports published till 29.03.2022 were included. The primary outcome variables analyzed were the consistent causal association and the thromboembolic events.ResultsThe majority of the serious AEFIs assessed were either coincidental (578, 52%) or vaccine product related (218, 19.6%). All the serious AEFIs were reported among the Covishield (992, 89.2%) and COVAXIN (120, 10.8%) vaccines. Among these, 401 (36.1%) were deaths, and 711 (63.9%) were hospitalized and recovered. On adjusted analysis, females, the younger age group and non-fatal AEFIs showed a statistically significant consistent causal association with COVID-19 vaccination. Thromboembolic events were reported among 209 (18.8%) of the analyzed participants, with a significant association with higher age and case fatality rate.ConclusionDeaths reported under serious AEFIs were found to have a relatively lower consistent causal relationship with the COVID-19 vaccines than the recovered hospitalizations in India. No consistent causal association was found between the thromboembolic events and the type of COVID-19 vaccine administered in India.     

The prevalence of adverse events associated with double-balloon enteroscopy from a single-centre dataset in Japan

BackgroundThere are few comprehensive reports detailing the prevalence of major adverse events associated with a double-balloon enteroscopy procedure.MethodsWe retrospectively investigated the prevalence of major adverse events in 538 patients (262 males and 276 females; median age, 65 years; age range, 12–95 years) who underwent double-balloon enteroscopy at our Institution between April 2008 and October 2011.ResultsOf the 17 adverse events recorded (3.2%), acute pancreatitis (n = 5; 0.9%) occurred during both diagnostic (n = 3) and therapeutic (n = 2) anterograde double-balloon enteroscopy, and all of them were treated conservatively. For these cases, the average duration of the examination was 135 min, which was longer than for the other patients (97 min) (P = 0.046). Intestinal bleeding (1.3%) was observed in 6 cases after endoscopic polypectomy and in 1 case following a biopsy procedure during a diagnostic double-balloon enteroscopy. The prevalence rates of intestinal perforation and other complications were 0.2% and 0.7%, respectively.ConclusionsThe rate of adverse events associated with double-balloon enteroscopy was high compared to that associated with conventional upper/lower gastrointestinal endoscopy (0.042%/0.078%). The occurrence of acute pancreatitis may be significantly dependent on the duration of double-balloon enteroscopy examination.     

Factors associated with the use of institutional long‐term care in Japan

Aim: Institutionalization is a potential cost burden for long‐term care (LTC) systems in many developed countries. Japan implemented an LTC insurance system in April 2000 and control of institutionalization has been one of its major issues. This study used over 2.1 million national representative administrative records to determine the factors that contribute to care use and the availability of local LTC facilities associated with the use of institutional LTC in Japan. Methods: Factors associated with the 1‐year institutional use of individuals were examined by a multivariate logistic regression analysis. In addition, we determined the impact of the regional capacities of LTC and medical institutions and the regional deviations of institutional LTC use using standardized use rates estimated from the demography and disability levels of regional LTC users. Results: We found that subjects aged 85 years or older had more than twice as high a risk as those aged less than 74 years and that the risk of use increased more than eight times at the highest disability level. In addition, the regional capacity of LTC institutions promoted the use of those institutions, whereas that of general beds had a suppressive effect on such use, possibly due to social hospitalization. Conclusion: Our results suggest that the use of LTC institutions is accelerated by the age and disability level of users as well as the regional availability of such institutions and that an appropriate supply of LTC institutions could increase their use and potentially improve the efficiency of medical care. Geriatr Gerontol Int 2012; 12: 72–79.     

Sex‐based differences in bleeding and long‐term adverse events after percutaneous coronary intervention in older patients with coronary artery disease

Objectives

Differences in outcomes for women and men after percutaneous coronary intervention (PCI) in older patients remain controversial. Herein, we compared 2‐year outcomes by sex in Chinese older patients undergoing PCI.

Methods

A total of 4926 consecutive patients (33.6% women, age ≥60 years, mean age 67.4 ± 5.7 years) who underwent PCI at a single center in China from January 2013 to December 2013 were included in this study. The primary endpoint was 2‐year risk of bleeding according to the Bleeding Academic Research Consortium definitions. The secondary endpoints included 2‐year risk of major adverse cardiovascular and cerebrovascular events (MACCE). Hazard ratios were generated using multivariable Cox regression.

Results

Compared with men, women had significantly higher rates of in‐hospital all‐cause mortality (0.8% vs 0.2%, P = 0.001), cardiac death (0.5% vs 0.1%, P = 0.006), MACCE (2.4% vs 1.5%, P = 0.017), and bleeding (0.4% vs 0.1%, P = 0.015). At 2‐year follow up, there were no differences between men and women for all‐cause mortality (1.9% vs 1.8%, P = 0.839) and 2‐year MACCE (13.1% vs 11.8%, P = 0.216). However, women had a higher risk of 2‐year bleeding (9.2% vs 6.2%, P < 0.001), which persisted after adjusting for baseline differences and treatment characteristics (hazard ratio 1.35, 95% confidence interval 1.06‐1.71; P = 0.014).

Conclusion

We found that older women undergoing PCI were at increased risk of 2‐year bleeding compared with men. Further dedicated studies are needed to confirm these findings.

     

Factors associated to modification of first-line antiretroviral therapy due to adverse events in people living with HIV/AIDS

Antiretroviral therapy (ART) has modified the outcome of patients with HIV infection, providing virological control and reducing mortality. However, there are several reasons as to why patients may discontinue their antiretroviral therapy, with adverse events being one of the main reasons reported in the literature. This is a case-control nested in a cohort of people living with HIV/AIDS, conducted to identify the incidence of ART modification due to adverse events and the associated factors, in two referral services in Recife, Brazil, between 2011 and 2014. Of the modifications occurred in the first year of ART, 25.7% were driven by adverse events. The median time elapsed between initiating ART and the first modification due to adverse events was 70.5 days (95% CI: 26-161 days). The main adverse events were dermatological, neuropsychiatric and gastrointestinal. Dermatological events were the earliest to appear after initiating ART. Efavirenz was the most prescribed and most modified drug during the study period. The group of participants who used zidovudine, lamivudine, and efavirenz had a 2-fold greater chance (adjusted OR: 2.16 95% CI: 1.28-3.65) of switching ART due to adverse events when compared to the group that used tenofovir with lamivudine and efavirenz.     

肾功能与急性冠状动脉综合征患者住院期间不良事件相关性的研究

目的:探讨急性冠状动脉综合征(ACS)患者,不同程度的肾功能降低与住院期间不良事件的关系。方法:对连续入选的629例ACS患者进行回顾性分析,依据适合中国人的改良MDRD方程估算的肾小球滤过率(e GFR)水平,将患者分为肾功能正常(90 m L·min-1·1.73m-2)轻度降低(60~89 m L·min-1·1.73m-2)、中度降低(30~59 m L·min-1·1.73m-2)和重度降低(29 m L·min-1·1.73m-2)四组,分析不同程度肾功能损害患者住院期间不良事件发生率。结果:肾功能降低组(e GFR90 m L·min-1·1.73m-2)较肾功能正常组年龄偏大,多合并高血压、糖尿病,住院期间发生不良事件的比例明显高于正常组,两组比较差异有统计学意义。肾功能正常组与轻度、中度、重度降低组患者住院期间不良事件发生率分别为14.5%、25.8%、45.6%及44.4%,不良事件发生率随肾功能降低而呈逐渐增高趋势(P0.001)。Logistic回归分析证实肾功能降低是住院期间不良事件的独立危险因素(OR=2.224,95%CI:1.445~3.423,P0.001)。结论:肾功能降低ACS患者住院期间不良事件的发生率明显升高,且肾功能降低越显著,则不良事件的发生率越高;肾功能降低是住院期间不良事件的独立危险因素。     

Introducing seasonal influenza vaccine in low‐income countries: an adverse events following immunization survey in the Lao People's Democratic Republic

Objective

In 2012, Lao PDR introduced seasonal influenza vaccine in pregnant women, persons aged ≥50 years, persons with chronic diseases, and healthcare personnel. We assessed adverse events following immunization (AEFI).

Methods

We used a multistage randomized cluster sample design to interview vaccine recipients.

Findings

Between April and May 2012, 355 902 were vaccinated. Of 2089 persons interviewed, 261 (12·5%) reported one or more AEFI. The most commonly reported AEFIs were local reactions. No hospitalizations or deaths were reported; 16% sought medical care. Acceptance and awareness of vaccination were high.

Conclusions

Following the introduction of seasonal influenza vaccine in Lao PDR, self-reported adverse events were mild.     

The effect of CYP3A5 genetic polymorphisms on adverse events in patients with ulcerative colitis treated with tacrolimus

BackgroundTacrolimus is an immunosuppressive agent, used in the remission induction therapy of ulcerative colitis (UC).AimsWe investigated the correlation between CYP3A5 genetic polymorphisms and the adverse events in patients with UC. The pharmacokinetics of tacrolimus after oral administration were also analyzed.MethodsWe enrolled 29 hospitalized patients with UC received oral tacrolimus. Genotyping for CYP3A5 A6986G (rs776746) was performed using Custom TaqMan^® SNP genotyping assays. Adverse events, concentration and dose (C/D) ratios and clinical outcomes were investigated.ResultsCYP3A5 expressers and non-expressers were 16 and 13, respectively. C/D ratios of CYP3A5 expressers were significantly lower compared to non-expressers. The response rate in CYP3A5 non-expressers was relatively higher in the early phase of treatment compared to expressers, but not statistically significant. The incidence of overall adverse events was significantly higher in CYP3A5 expressers than in non-expressers (P = 0.034, chi-squared test). In particular, the incidence of nephrotoxicity was significantly higher in CYP3A5 expressers compared to non-expressers (P = 0.027, chi-squared test). All of the nephrotoxicity were reversible and resolved by discontinuation or dose reduction of tacrolimus.ConclusionThe adverse events especially nephrotoxicity were frequently observed in CYP3A5 expressers. CYP3A5 expressers should be paid attention to the onset of nephrotoxicity.     

Immunogenicity,efficacy and adverse events of adalimumab in RA patients

To assess the immunogenicity of adalimumab, a human anti-TNF-α mAb, we evaluated the formation of antibodies to adalimumab, efficacy and adverse events among 15 patients with highly active rheumatoid arthritis. Four patients were treated with adalimumab as monotherapy, and 11 patients with concomitant DMARDs. Disease activity was measured by DAS28. The antibodies were detected by ELISA. Thirteen (87%) patients withdrew from therapy within 45 weeks and overall 13 (87%) patients showed antibodies to adalimumab including 11 patients who withdrew from therapy. In four patients without concomitant DMARDs and in nine patients with concomitant DMARDs, we detected anti-adalimumab antibodies. Overall, five of seven patients with adverse drug reactions and all nine patients with lack of efficacy were associated with the formation of antibodies. Two antibody-positive patients developed an exantheme. The results indicate that adalimumab is, in spite of its fully human sequences, immunogenic and induces antibodies in a high rate of adalimumab-treated patients.     

Modelling the adverse effects associated with ecstasy use

Aims Ecstasy, the street name for 3,4‐meththylenedioxymethamphetamine, has been associated with a range of psychiatric symptoms and impaired psychological health in both problem and recreational users. The purpose of the present paper is to determine how these impairments are related to the history of polydrug use, and the conditions under which individuals ingest ecstasy. Design Associations between the variables of interest were investigated utilizing negative binomial regression. Setting Liverpool and Preston in the North West of England. Participants A convenience sample of 159 recreational ecstasy/polydrug users (80 males, 79 females). The sample was composed primarily of undergraduates. Measurements The dependent variable was the number of reported ecstasy‐related adverse effects. Independent variables included quantitative aspects of ecstasy and other drug use, and the various beliefs and behaviours associated with ecstasy use. Findings The number of adverse effects was associated positively with life‐time exposure to ecstasy and negatively with period of abstinence from the drug. Adverse effects were more common among those who consumed ecstasy and alcohol concurrently, but were unrelated to other aspects of polydrug use. They were unaffected by whether the user took precautions when using the drug, and only weakly related to prior beliefs concerning the effects of ecstasy. Conclusions Greater life‐time exposure to ecstasy and consuming the drug concurrently with alcohol increase the likelihood of experiencing adverse effects, including paranoia, poor general health, irritability, confusion and moodiness. Adverse effects decrease with the period of abstinence from the drug.