The impact of infliximab infusion reactions on long-term outcomes in patients with Crohn's disease

Background Little is known about long‐term outcomes in patients who experience infusion reactions while receiving infliximab. Aim To investigate long‐term outcomes in patients who experience infusion reactions while receiving infliximab. Methods Retrospective electronic chart review of long‐term clinical outcomes. Results Clinical data on 287 patients who received infliximab infusions for Crohn’s disease were reviewed, of whom 51 developed at least one infusion reaction (18%). Ileo‐colonic disease (OR 2.2, 95% CI 1.1–4.4) and episodic infliximab (OR 2.4, 95% CI 1.2–4.7) were associated with a higher risk of infusion reactions in univariate analysis, but concomitant azathioprine/mercaptopurine therapy at the initiation of infliximab was associated with a reduced risk (OR 0.4, 95% CI 0.2–0.8). Only the effect of concomitant immunomodulators persisted on multivariate analysis. Patients who experienced infusion reactions were less likely to be in remission at 1 year (OR 0.6, 95% CI 0.3–1.2), 2 years (OR 0.4, 95% CI 0.2–0.8, P = 0.01), or 5 years (OR 0.4, 95% CI 0.1–1.3) and more likely to require surgery (OR 2.2, 95% CI 1.1–4.1, P = 0.01) than those who did not experience such reactions. Conclusions Patients who experienced infusion reactions to infliximab had a high rate of discontinuation of therapy in this cohort. Concomitant immunomodulators and maintenance therapy reduced the risk of infusion reactions.     

Patients' concerns about and problems experienced with discontinuation of antidepressants

Objective Clinical trials and epidemiological studies have shown that premature discontinuation is a major problem during antidepressant therapy. Unfortunately, there is little information on how patients perceive treatment with antidepressants in clinical practice, and it is unclear whether patients perceive discontinuation as a problem. The objective of this study is to assess whether concerns and problems experienced with drug discontinuation occur more frequently in patients using antidepressants than in patients using benzodiazepines, antipsychotics or non‐psychiatric medication. Method All calls to a national telephone medicines information service received between 1990 and 2004 were examined using retrospective examination. Calls about discontinuation were identified and classified either as a general question about discontinuation, or as a problem experienced with discontinuation. These calls were grouped into the following main classes: antidepressants, antipsychotics, benzodiazepines or non‐psychiatric medicines. Key findings Of all 39 786 registered phone calls, 6159 (15,5%) related to antidepressants, 1658 (4.2%) to antipsychotics and 3916 (9.8%) to benzodiazepines. Patients calling about antidepressants called about discontinuation three times as often (odds ratio (OR) 2.8; 95% confidence interval (CI) 2.6–3.0), and reported a problem with discontinuation five times more often (OR 5.4; 95% CI 4.6–6.3), compared to patients who called about non‐psychiatric medicines. The proportion of questions about discontinuation and problems experienced with discontinuation was also higher in patients calling about benzodiazepines and antipsychotics compared to patients calling about non‐psychiatric medication. Conclusion Patients perceive discontinuation of antidepressants, as well as discontinuation of antipsychotics and benzodiazepines, as a problem. Discontinuation seems a general problem for all psychiatric medicines, and needs more attention in the communication between patients and healthcare providers.     

Persistent smoking by Japanese patients within four years from diagnosis of chronic obstructive pulmonary disease

This study ascertained the smoking prevalence and factors affecting continuous smoking by Japanese patients within four years from diagnosis of chronic obstructive pulmonary disease (COPD). Of the 300 patients referred from six hospitals in central Japan, 276 eligible participants (mean age 66.5 years, SD 6.7) were interviewed for their habitual cigarette consumption. Overall, 22.5% of patients were current smokers but the prevalence appeared to decrease from <1 year (24.5%) to 2-4 years (19%) after diagnosis. They had smoked on average for 41 (SD 11) years and 89% of the current smokers smoked daily. Continuous smoking was inversely associated with age (odds ratio (OR)=0.94, 95% CI 0.90-0.98), body mass index (OR=0.88, 95% CI 0.80-0.97) and disease severity (OR=0.29, 95% CI 0.12-0.74 for severe COPD and OR=0.29, 95% CI 0.09-0.92 for very severe COPD). It is alarming to find mild and moderate COPD patients continue to smoke. The implementation of a co-ordinated tobacco control program immediately post diagnosis is needed for the effective pulmonary rehabilitation of COPD patients.     

Depression and treatment with antidepressants are associated with the development of gastro‐oesophageal reflux disease

Aliment Pharmacol Ther 31 , 1132–1140

Summary

Background The roles of depression and antidepressants in triggering reflux symptoms remain unclear. Aim To compare the incidence of gastro‐oesophageal reflux disease (GERD) in individuals with and without a depression diagnosis and to evaluate risk factors for a GERD diagnosis. The relationship between antidepressant treatment and GERD was also assessed. Methods The Health Improvement Network UK primary care database was used to identify patients with incident depression and an age‐ and sex‐matched control cohort with no depression diagnosis. Incident GERD diagnoses were identified during a mean follow‐up of 3.3 years. Furthermore, we performed nested case‐control analyses where odds ratios (OR) with 95% confidence intervals (CI) were estimated by unconditional logistic regression in multivariable models. Results The incidence of GERD was 14.2 per 1000 person‐years in the depression cohort and 8.3 per 1000 person‐years in the control cohort. The hazard ratio of GERD in patients with depression compared with controls was 1.72 (95% CI: 1.60–1.85). Among patients with depression, tricyclic antidepressant use was associated with an increased risk of GERD (OR: 1.71; 95% CI: 1.34–2.20), while selective serotonin reuptake inhibitors were not associated with GERD. Conclusions A depression diagnosis is associated with an increased risk of a subsequent GERD diagnosis, particularly in individuals using tricyclic antidepressants.     

Roflumilast: APTA 2217, B9302-107, BY 217, BYK 20869

Roflumilast [APTA 2217, B9302-107, BY 217, BYK 20869] is a selective phosphodiesterase IV inhibitor. It is being developed by Altana Pharma (formerly Byk Gulden), a subsidiary of Altana Group, as an orally administered therapy for asthma, chronic obstructive pulmonary disease (COPD), allergic rhinitis and psoriasis. The drug is awaiting regulatory approval in Europe for the treatment of asthma and COPD. Byk Gulden has stated that roflumilast relieves asthma symptoms through both an anti-inflammatory effect and a muscle relaxant effect. Roflumilast has potential as first-line long-term therapy in mild-to-moderate COPD and as additive long-term therapy in moderate-to-severe COPD. Altana has stated that roflumilast is to be marketed under the brand name Daxas. Altana Group and Pharmacia Corporation (now Pfizer) signed an agreement on 22 April 2002 to collaborate on the development and commercialisation of roflumilast for the treatment of respiratory disorders, including asthma and COPD. The companies will jointly develop the drug for the US, Europe and other markets. Pharmacia will co-ordinate development in the US and Altana will co-ordinate development in Europe. After approval of the drug, Pharmacia and Altana will jointly launch and promote roflumilast in the US, Europe and elsewhere. Altana will receive an upfront payment and additional milestone payments. Altana additionally has the option to co-promote Pharmacia products in the US and elsewhere. On 16 April 2003, Pharmacia Corporation was acquired by, and merged into, Pfizer. In November 2002, Altana and Tanabe Seiyaku signed an agreement to collaborate on the development and commercialisation of roflumilast for the treatment of respiratory diseases, including asthma and COPD. Tanabe Seiyaku and Altana will develop roflumilast for asthma and COPD in Japan, and will jointly launch and co-promote roflumilast in Japan following regulatory approval. Roflumilast has been in multinational phase III clinical studies in Europe for the treatment of asthma and COPD. In September 2003, Altana announced the completion of a phase III trial in COPD in more than 1400 patients; the trial showed positive results. In the US, roflumilast is in phase III trials for the treatment of asthma and phase II trials for the treatment of COPD. Phase I clinical trials of roflumilast were begun in Japan by Tanabe Seiyaku in the fourth quarter of 2003. Altana has stated that roflumilast has shown significant superiority over placebo in the treatment of asthma in phase II trials. The efficacy of the drug appears to be comparable to low-dose inhaled corticosteroids in the treatment of asthma and at least equal to inhaled corticosteroids in the treatment of COPD. Altana Group presented data from phase II trials in 516 patients with COPD at an analyst meeting [August 2001, Bad Homburg, Germany] that showed that roflumilast 500 microg/day significantly improved FEV(1) at 24 weeks compared with placebo. In March 2004, Altana Pharma presented pharmacokinetic data from a phase I trial of roflumilast at the 60th Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI-2004) [San Francisco, CA, USA]. This open-label, randomised, two-period crossover study investigated the pharmacokinetics of oral roflumilast and its active metabolite, roflumilast N-oxide, among 12 healthy male subjects. Participants received single doses of oral roflumilast 500 microg and intravenous (i.v) roflumilast 150 microg as a 15-min short-term infusion. In November 2002, the combined global market for asthma and COPD products was estimated to be worth >11 billion US dollars. In Japan, products in this market segment reached sales of approximately 1.5 billion US dollars in 2001. Roflumilast has patent protection in Europe and Japan until 2014 and in the US until 2015. The Financial Times in April 2002 claimed that roflumilast is an 'important' product for Altana, due to be listed on the New York Stock Exchange later in the same month. The Altana chairman confirmed that the company had been in talks with Pfizer, Bristol-Myers Squibb and Novartis with regard to future development and commercialisation of roflumilast. In September 2002, Dow Jones Newswires stated that Altana is to file for European approval of roflumilast 1 year later than initially was expected; however, this has not changed the company's outlook for the product, which was said to remain at at 1 billion Euros. In August 2001, the Financial Times reported that roflumilast, for the indication of smoker's cough alone, has the potential to reach sales of more than 500 million US dollars a year. A future co-marketing deal for roflumilast in the US was said to be "a key step towards expanding Altana's presence in the US".     

Long-term use of inhaled corticosteroids and risk of upper respiratory tract infection in chronic obstructive pulmonary disease: a meta-analysis

Recent studies have suggested that inhaled corticosteroids (ICS) may be associated with higher risks of tuberculosis and pneumonia in patients with COPD. However, it is not known whether ICS increases the risk of upper respiratory tract infection (URTI). Aim of this study was to explore the relationship between ICS and URTI. Through a comprehensive literature search of PubMed, EMBASE, Cochrane Library, and Google Scholar from inception to March 2016, we identified randomized controlled trials of ICS therapy lasting at least 6 months. A meta-analysis by the Peto approach was also conducted to generate summary estimates comparing ICS with non-ICS treatment on the risk of URTI. A total of 14 studies involving 19,777 subjects were considered in the meta-analysis. Compared with non-ICS treatment, ICS were associated with a significantly increased risk of URTI (Peto OR: 1.16; 95% CI: 1.05–1.29; I²?=?9%; p?=?.004). Subgroup analyzes were performed for different dose, high-dose ICS was associated with a significantly increased risk of URTI (Peto OR: 1.19; 95% CI: 1.05–1.34; I²?=?0%; p?=?.005), whereas low-dose ICS showed a non-significant increased risk of URTI (Peto OR: 1.10; 95% CI: 0.91–1.33; I²?=?0%; p?=?.32). Moreover, fluticasone was observed with an increased risk of URTI but not mometasone; high-dose fluticasone treatment was associated with a significantly higher risk of URTI but not low-dose. These results suggested to us that ICS use may increase the risk of URTI in patients with COPD, but it should be further investigated.     

Independent clinical correlates of severe alcohol withdrawal

This retrospective cohort study sought to identify clinical variables that independently correlate with severe alcohol withdrawal and to quantify risk in a clinically useful manner. The records of 284 inpatients admitted to an acute detoxification unit at a Veterans Affairs teaching hospital were reviewed. Clinical data were recorded on standardized forms at the time of admission and abstracted by a physician reviewer. Alcohol withdrawal severity was prospectively measured with the revised Clinical Institute Withdrawal Assessment for Alcohol (CIWA‐Ar) scale. Seventy‐one patients (25% of cohort) had severe withdrawal. We identified six independent correlates of severe withdrawal: use of a morning eye‐opener (adjusted odds ratio [OR], 5.6; 95% confidence interval [CI], 1.2–25.9), an initial CIWA‐Ar score ≥ 10 (OR, 5.1; 95% CI, 2.4–10.6), a serum aspartate aminotransferase ≥ 80 U/L (OR, 4.2; 95% CI, 2.0–8.8), past benzo‐diazepine use (OR, 3.6; 95% CI, 1.3–9.9), self‐reported history of “delirium tremens”; (OR, 2.9; 95% CI, 1.3–6.2), and prior participation in two or more alcohol treatment programs (OR, 2.6; 95% CI, 1.3–5.6). Significantly higher risk was observed in subjects with three or more independent correlates. In conclusion, several readily available clinical variables correlate with the occurrence of severe alcohol withdrawal. Ascertainment of these variables early in the course of alcohol withdrawal has the potential to improve triage and treatment decisions.     

Risk of colorectal adenomas in patients with coeliac disease

Aliment Pharmacol Ther 2010; 32: 1037–1043

Summary

Background Coeliac disease is associated with an increased risk of lymphoma and small bowel malignancy, but most studies have found no increased risk of colorectal cancer. Aim To compare the prevalence of colorectal adenomas in coeliac disease patients with that in non‐coeliac disease controls. Methods We identified all coeliac disease patients who underwent colonoscopy at our institution during a 44‐month period. We matched each patient with non‐coeliac disease controls by age, gender and endoscopist. We compared the adenoma prevalence between these groups, and used multivariate analysis to assess the independent association of coeliac disease with adenomas. Results We identified 180 patients with coeliac disease and 346 controls. At least one adenoma was present in 13% of coeliac disease patients and 17% of controls (P = 0.20). On multivariate analysis, age (OR per year 1.04, 95% CI 1.02–1.07) and male gender (OR 2.33, 95% CI 1.36–3.98) were associated with adenomas, while the relationship between coeliac disease and adenomas remained null (OR 0.75, 95% CI 0.41–1.34). Conclusions Coeliac disease is not associated with an increased risk of colorectal neoplasia. The lack of increased risk of colorectal cancer observed in population studies is related to a true average risk of colorectal neoplasia, rather than artifactually reflecting increased colonoscopy and associated polypectomies in the coeliac population.     

Anticoagulation in patients with non-valvular atrial fibrillation: an evaluation of stability and early factors that predict longer-term stability on warfarin in a large UK population

ABSTRACT

Objective: To determine the proportion of patients with non-valvular atrial fibrillation (NVAF) treated with warfarin that achieved a 6‐month period within the target INR range (stability). To then evaluate any associations between stability and outcome and to determine whether stability can be predicted by clinical factors at an early stage in warfarin treatment.

Methods: This study was a record linkage study in 1513 patients with NVAF treated with warfarin for a minimum of 6‐months, carried out in a large UK population. The main outcome measures were stability (defined as six months within the target INR range [2.0–3.0]), thromboembolic and bleeding event rates and mortality. Secondary outcome measures were the predictive value of baseline characteristics and other treatment variables.

Results: Stability was achieved in 52% of the study group. Standardised mean survival was significantly higher in the group who achieved stability (? = 16.91 months, p < 0.001) with a hazard ratio of 4.36 (?p < 0.001). The stable group had a lower rate of both thromboembolic events (0.8% vs. 2.3% per patient year) and bleeds recorded on inpatient diagnoses (0.4% vs. 1.2% per patient year). Failure to achieve stable control was associated with age (Odds Ratio [OR] 1.011 (95% Confidence Interval [CI] 1.001–1.021)) and morbidity at baseline (OR 1.015; 95% CI 1.007–1.022). An increase in mean time between visits (OR 0.939; 95% CI 0.926–0.952) and the percentage time in range (OR 0.889; 95% CI 0.879–0.900) was associated with a decrease in the chance of instability. Greater variability in INR was also associated with a failure to achieve stability (OR 1.518; 95% CI 1.427–1.615). Receiver Operator Characteristic (ROC) analysis using data from the first three months of treatment demonstrated good discrimination of stability using age and morbidity at baseline and percentage time in range and frequency of visits during the first three months of treatment (area under curve [AUC] 0.780; standard error [SE] 0.012; 95% CI 0.757–0.803).

Conclusions: Many patients never achieved a period of 6‐months stability and were at increased risk of thromboembolic events and bleeds. Age, morbidity at baseline and variability of INR control in the first three months could be used to predict instability using warfarin. This study infers that patients should be treated more intensively in the early stages of warfarinisation in order to improve outcome.     

Co-morbid diabetes in patients with Crohn's disease predicts a greater need for surgical intervention

Aliment Pharmacol Ther 2012; 35: 126–132

Summary

Background The prevalence of diabetes is increasing rapidly. Given its pro‐inflammatory nature, comorbid diabetes may affect the course of Crohn’s disease (CD). Aim To determine whether comorbid diabetes influences the natural history of CD. Methods We compared a cohort with CD and comorbid diabetes to a nondiabetic control population and calculated the period prevalence of surgical intervention over a 5‐year period. Unadjusted and adjusted odds‐ratios were calculated regarding the need for surgical intervention using univariate and multivariate logistic regression. Results A total of 240 patients were identified, 16 of whom were diabetics (6.7%). The period prevalence of CD‐specific surgery in the diabetic cases was 75.0% and in the nondiabetic controls, 31.7%. The diabetic patients were more obese than the controls (44% vs. 10%; P < 0.0001) and older than the controls (47.4 years vs. 38.6; P < 0.01). There was no difference in the frequency of biologic therapy use, immunomodulator use, smoking, perianal disease, ileal involvement or corticosteroid use between the diabetics and controls. Univariate analysis revealed that diabetes (OR 6.46 [95% CI 2.01–20.8]), smoking (OR 2.46 [95% CI 1.24–4.90]), ileal disease (OR 2.21 [95% CI 1.15–4.24]) and obesity (OR 2.22 [95% CI 1.04–4.77]) were risk factors for needing surgery. After adjustment for covariates, the OR for surgical intervention in diabetics was 5.4 (95% CI 1.65–17.64). Conclusion Co‐morbid diabetes in patients with Crohn’s disease predicts a greater need for surgical intervention.     

Meta-analysis: ursodeoxycholic acid for primary sclerosing cholangitis

Aliment Pharmacol Ther 2011; 34: 901–910

Summary

Background There is no satisfactory medical treatment for patients with primary sclerosing cholangitis. There are conflicting data regarding the clinical benefit of high doses of ursodeoxycholic acid (UDCA) in primary sclerosing cholangitis. Aim To evaluate using meta‐analysis, if UDCA (standard or high‐dose) is useful in primary sclerosing cholangitis. Methods We searched MEDLINE using the textwords ‘PSC’, ‘treatment’, ‘UDCA’ and retrieved all abstracts from the major Gastroenterology and Liver meetings. We included randomised clinical trials comparing standard or high‐dose of UDCA (>15 mg/kg body weight per day) vs. placebo or no intervention. End‐points: mortality or liver transplantation, pruritus, fatigue, cholangiocarcinoma and histological progression. Results We identified eight randomised clinical trials comprising 567 patients. Five used standard doses and three high doses of UDCA. There was no significant difference in mortality [OR, 0.6 (95% CI, 0.4–1.4)], in pruritus [OR, 1.5 (95% CI, 0.3–7.2)], in fatigue [OR, 0.0 (95% CI, 0.1–7.7)], in cholangiocarcinoma [OR, 1.7 (95% CI, 0.6–5.1)] and in histology stage progression [OR, 0.9 (95% CI, 0.34–2.44)]. No differences were found in the subgroup analyses. Conclusion Neither standard nor high‐dose UDCA influence favourably the progression of primary sclerosing cholangitis.     

Drug safety evaluation of roflumilast for the treatment of COPD: a meta-analysis

ABSTRACT

Introduction: Roflumilast is the only phosphodiesterase 4 inhibitor approved for the treatment of COPD patients with chronic cough and sputum, and a history of exacerbations, but the compliance to treatment is reduced by poorly tolerated adverse events (AEs).

Areas covered: The synthesis of clinical evidences indicates that roflumilast 500μg once-daily increased the risk of AEs, with no impact on the risk of serious AEs (SAEs), compared with placebo. Gastrointestinal AEs were common in patients treated with roflumilast, that may also induce headache, backpain and insomnia. Roflumilast protects against COPD related AEs. The frequency of very SAEs was rare but greater in patients treated with roflumilast than placebo, although factors other than the study drug were related with these SAEs.

Expert opinion: The safety profile of roflumilast administered in combination with further drugs for the treatment of COPD should be investigated through specifically designed RCTs, and the post-marketing surveillance might help to characterize the real risk of very SAEs. Roflumilast may provide more benefit than harm in patients at high risk of severe exacerbations, and the therapy discontinuation may be reduced by a correct education of patients on the generally transient and mild-to-moderate nature of gastrointestinal AEs induced by this drug.     

All-cause hospitalization and associated costs in patients with schizophrenia or bipolar disorder initiating long-acting injectable antipsychotics

Objective: To compare all-cause hospitalization and associated costs among patients with schizophrenia or bipolar disorder (BD) treated with long-acting injectable antipsychotics (LAIs).

Methods: The Truven MarketScan Medicaid claims database was used to identify patients with schizophrenia; MarketScan Medicaid and commercial claims databases were used to identify BD. Adult patients with ≥1 LAI claim from January 1, 2013–June 30, 2014 (ID period) were identified. The first day of LAI initiation was the index date; patients were followed for ≥1 year. Logistic and general linear regression models were used to estimate the risk of hospitalization and associated costs.

Results: Adjusted analyses showed that, in the schizophrenia cohort, risks of hospitalization were statistically significantly higher in the haloperidol [OR (95% CI)?=?1.51 (1.05–2.16); HR (95% CI)?=?1.35 (1.05–1.73)] and risperidone [OR (95% CI)?=?1.58 (1.07–2.33); HR (95% CI)?=?1.33 (1.01–1.74)] cohorts than in the aripiprazole once monthly extended release (AOM 400) cohort. Similarly, in patients with BD, risks of hospitalization were significantly higher in haloperidol [OR (95% CI)?=?1.49 (1.01–2.19); HR (95% CI)?=?1.33 (1.03–1.73)] and risperidone [OR (95% CI)?=?1.78 (1.19–2.66); HR (95% CI)?=?1.33 (1.01–1.75)] than in AOM400. No statistically significant differences in hospitalization costs were observed in either disease group.

Conclusions: Although the study results may be subject to confounding variables that are not contained in claims databases, such as disease severity, it appears that AOM400 may be more effective than haloperidol and risperidone LAIs among patients with schizophrenia or BD.     

Incidence of and Risk Factors for Severe Adverse Events in Elderly Patients Taking Angiotensin‐Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers after an Acute Myocardial Infarction

Study Objective

To assess the incidence of and risk factors associated with severe adverse events in elderly patients who used angiotensin‐converting enzyme inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) after an acute myocardial infarction (AMI).

Design

Retrospective cohort study.

Data Sources

Centers for Medicare & Medicaid Services Chronic Conditions Data Warehouse (Medicare service claims database), American Community Survey of the U.S. Census Bureau, and Multum Lexicon Drug database.

Patients

A total of 101,588 eligible Medicare fee‐for‐service beneficiaries 66 years or older, who were hospitalized for AMI between January 1, 2008, and December 31, 2009, and used ACEIs or ARBs within 30 days after discharge.

Measurements and Main Results

Primary outcomes were hospitalizations for acute renal failure (ARF) and hyperkalemia. The secondary outcome was discontinuation or suspension of ACEI/ARB therapy after a visit to a health care provider. The primary risk factors of interest were age, sex, race/ethnicity, and chronic kidney disease (CKD). Cumulative incidence curves and multivariable Fine‐Gray proportional hazards models with 95% confidence intervals (CIs) were used with death as a competing risk in both intention‐to‐treat (ITT) and as‐treated (AT) analyses. In the study cohort, 2.8% experienced ARF, 0.5% experienced hyperkalemia, and 63.7% discontinued ACEI/ARB therapy within 1 year after hospital discharge. Approximately half of the incidence of ARF and hyperkalemia occurred within 6 months after hospital discharge, but the cumulative incidence increased after 6 months. Patients older than 85 years had a higher rate of ARF (ITT hazard ratio [HR] 1.15, 95% CI 1.04–1.28) and hyperkalemia (ITT HR 1.33, 95% CI 1.05–1.68) compared with those aged 65–74 years. Patients with baseline CKD had higher rates of ARF (ITT HR 1.61, 95% CI 1.42–1.82), hyperkalemia (ITT HR 1.41, 95% CI 1.11–1.77), and ACEI/ARB therapy discontinuation or suspension (ITT HR 1.05, 95% CI 1.02–1.09).

Conclusion

We found a low incidence of ARF and hyperkalemia in elderly patients treated with ACEIs or ARBs after AMI hospitalization. However, a high rate of treatment discontinuation might prevent a higher rate of occurrence of these events. Long‐term careful monitoring of severe adverse events and timely discontinuation of ACEIs or ARBs among elderly patients with advancing age and CKD after an AMI is warranted in clinical practice.