Safety and efficacy of the drug-eluting stent: a double-edged sword?

Like the introduction of bare metal stents (BMS), that of drug-eluting stents (DES) represented a quantum leap in the interventional cardiology community's ongoing efforts to conquer restenosis. However, recent concerns over late thrombosis (LT) have tempered the initial enthusiasm. Nonetheless, when compared with BMS, the slightly higher DES-LT is counterbalanced by the device's markedly lower incidence of restenosis, resulting in net equivalent rates of death, myocardial infarction, and overall major adverse cardiovascular events. This article summarizes for the noncardiology practitioner the benefits and risks of DES, as well as essentials of postprocedural care of the DES patient. We discuss the pathophysiology of stent thrombosis, pivotal DES trials, and adjunct antiplatelet pharmacology. In December 2006, the Food and Drug Administration convened an expert panel to review these devices. Their recommendations, as well as the joint statement from the American College of Cardiology/American Heart Association/Society of Cardiovascular Angiography and Interventions, are outlined.     

Risk Factors for the Relapse of Graves’ Disease Treated With Antithyroid Drugs: A Systematic Review and Meta-analysis

PurposeAntithyroid drugs (ATDs) are the first-line treatment for Graves’ disease (GD). A common problem with ATD treatment is the high relapse rate after drug withdrawal. The goal of this study was to analyze the influencing factors for the relapse of GD patients treated with ATD by using a systematic review and meta-analysis, provide some predictive indexes for the susceptibility of GD recurrence, and then further explore some useful methods to decrease the GD relapse rate after ATD treatment.MethodsArticles published in PubMed, EMBASE, The Cochrane Library, China National Knowledge Infrastructure, Wan Fang, and Chinese Biomedical Literature databases before January 2019 were collected. Patients newly diagnosed with GD, who were aged >16 years, were treated with ATD. Follow-up was then conducted for at least 12 months after ATD withdrawal. Only prospective or retrospective studies were eligible. The primary end point was the recurrence of GD during follow-up. All the data from the trials were analyzed via meta-analysis and meta-regression. p values < 0.05 were considered statistically significant, and statistical heterogeneity was assessed by using I² statistics.FindingsA total of 20 studies and 3242 patients were involved in this meta-analysis, with 1681 patients relapsed (incidence rate, 51.9%) during the follow-up time. Analysis of risk factors suggested that younger age (weighted raw mean difference [RMD], −3.51; 95% CI, −5.74 to −1.29), larger thyroid volume (RMD, 4.38; 95% CI, 1.68 to 7.08), bigger goiter size (1.94% risk; 95% CI, 0.43 to 3.46), higher free triiodothyronine level (RMD, 5.09; 95% CI, 4.42 to 5.77), and higher free thyroxine level (RMD, 4.21; 95% CI, 0.54 to 7.89) were associated with the higher relapse rate of GD. The block-replace ATD regimen (a fixed high dose of an ATD with levothyroxine supplementation to maintain euthyroidism) (risk ratio, 0.64; 95% CI, 0.52 to 0.78) exhibits a lower relapse rate than the titration regimen (an ATD used alone and dose adjusted according to thyroid function tests).ImplicationsThis analysis revealed that certain risk factors were associated with GD relapses such as younger age, larger goiter size or thyroid volume, and the higher free triiodothyronine or free thyroxine level in the diagnosing phase of GD. For patients with these clinical characteristics, early definitive treatment with radioactive iodine or surgery should be offered to those who are unlikely to achieve remission with ATDs only. In addition, more prospective cohort studies with different ATD regimens would help to determine the optimum ATD treatment for patients with GD. PROSPERO identifier: CRD 42019146825.     

Are Antiepileptic Drugs Used in the Treatment of Migraine Associated with an Increased Risk of Suicidality?

Three antiepileptic drugs (AEDs), valproic acid, gabapentin, and topiramate (TPM), are used frequently in the prophylactic treatment of migraines. In December 2008, the US Food and Drug Administration issued a warning suggesting that the use of all AEDs is associated with an increased risk of suicidal ideation and behavior. This warning has been received by the medical community with great skepticism, and the validity of the findings of the meta-analysis that led to its publication has been questioned because of various methodological problems. Yet, migraine by itself is associated with an increased risk of suicidal ideation and behavior as well as with an increased risk of psychiatric disorders that facilitate the development of suicidal behavior. Furthermore, TPM has been associated with psychiatric adverse events that potentially could result in suicidal ideation and behavior. In this article, we review data to determine whether the AEDs used in the prevention of migraine are associated with an increased risk of suicidality.     

Procedural Sedation and Analgesia in the Emergency Department: What Are the Risks?

The practitioner of emergency medicine is routinely faced with patients in need of emergent procedures and pain control and sedation. Our challenge is to make our patients' experiences as painless and as safe as possible, while maximizing our ability to perform the procedure at hand; this is not always an easy task given the propensity of each human body to react differently to interventions and stimuli. We can best meet this challenge by understanding how our patients and pharmaceutical agents intermingle in the risk-benefit equation we formulate before starting our "experiment." Coupling this information with fundamentally sound patient care and monitoring will minimize bad experiences with PSA for both the patient and practitioner.     

Are the 2005 Dietary Guidelines for Americans Associated With Reduced Risk of Type 2 Diabetes and Cardiometabolic Risk Factors?: Twenty-year findings from the CARDIA study

OBJECTIVE

To examine the prospective association between accordance with the 2005 Dietary Guidelines for Americans (DGA) and subsequent diabetes incidence and changes in cardiometabolic risk factors.

RESEARCH DESIGN AND METHODS

The sample consisted of 4,381 black and white young adults examined repeatedly from 1985 to 2005. We used the 2005 Diet Quality Index (DQI) to rate participants’ diets based on meeting key dietary recommendations conveyed by the 2005 DGA.

RESULTS

Overall, we found no association between DQI score and diabetes risk using Cox models adjusted for potential confounders. Higher DQI scores were associated with favorable changes in HDL cholesterol and blood pressure overall (P for trend <0.05), but with increased insulin resistance among blacks (P for trend <0.01).

CONCLUSIONS

Our findings highlight the need for evaluation of the DGA’s effectiveness, particularly among ethnic minority populations. Clinicians should be aware that following the DGA might not lower diabetes risk.The Dietary Guidelines for Americans (DGA) are the basis for federal nutrition programs (1), yet there is little evidence that diets congruent with the guidelines are effective in preventing chronic disease and thus are relevant to clinical care. We examined the prospective association between a diet consistent with the key dietary recommendations of the 2005 DGA and 1) 20-year incidence of type 2 diabetes; and 2) 13-year changes in HDL cholesterol, insulin resistance, blood pressure, and triglycerides in a cohort of black and white Americans.     

CC5-05: Comparative Safety of Infliximab and Etanercept on the Risk of Serious Infections - Does the Association Vary By Patient Characteristics?

Background/Aims Infliximab, a chimeric monoclonal anti-TNF? antibody, has been found to increase the risk of serious infections compared with the TNF receptor fusion protein etanercept in some studies. It is unclear whether the risk varies by patient characteristics. We conducted a study to address this question. Methods We identified members of Kaiser Permanente Northern California who initiated infliximab (n=793) or etanercept (n=2,692) in 1997-2007. Using a Cox model, we estimated the propensity score-adjusted hazard ratio (HR) and 95% confidence interval (CI) of serious infections requiring hospitalization or opportunistic infections comparing infliximab with etanercept following treatment initiation. We estimated the stratum-specific HRs by age (<65 vs. >=65 years), sex, race/ethnicity (Non- Hispanic White, African-American, Hispanic, Asian American, Native American, and other/unknown), body mass index (<25 vs. >=25 kg/m2), and smoking status (non, past, and current smokers); and performed likelihood ratio tests to examine whether the HR differed by these patient characteristics. Results The crude incidence rate of serious infections per 100 person-years was 5.4 (95% CI: 3.8, 7.5) in patients <65 years and 16.0 (10.4, 23.4) in patients >=65 years during the first three months following treatment initiation. Compared with etanercept, the adjusted HR during this period was elevated for infliximab in patients <65 years (HR 3.01; 95% CI: 1.49, 6.07), but not in those >=65 years (HR 0.94; 0.41, 2.13). The test for homogeneity was marginally statistically significant (p-value=0.06). Findings did not suggest that the HR varied by other patient characteristics examined. Discussion An increased risk of serious infections associated with infliximab relative to etanercept did not appear to be modified by patients' sex, race/ethnicity, body mass index, or smoking status. There was an indication that the increased risk might vary by age. Additional studies are warranted to verify or refute this finding.     

Are Patients' Views on Seclusion Associated With Lack of Privacy in the Ward?

The lack of single-bed rooms in psychiatric wards may reduce the possibility of patients getting sufficient rest and privacy and may increase their risk of being overstimulated. This study explored whether residing in single- versus multiple-bed rooms in a psychiatric ward was associated with psychiatric patients' opinions about seclusion. More specifically, it was studied whether patients who had shared a room with other patients prior to seclusion rated seclusion more favorably. It was thought that they would rate seclusion more favorably due to the lack of rest they previously experienced in their regular room. For this, the Patient View-of-Seclusion Questionnaire of Hammill, McEvoy, Koral, and Schneider [Hammill, K., McEvoy, J., Koral, H., & Schneider, N. (1989). Hospitalized schizophrenic patient views about seclusion. Journal of Clinical Psychiatry, 50, 174-177] was completed by 54 secluded adult patients hospitalized in a locked ward of a Dutch psychiatric hospital. A significant association was found between residing in multiple-bed rooms prior to seclusion and a less negative view on seclusion. This finding suggests that the ward environment may have a rather large impact on how seclusion is perceived. The results underline the need for single-bed rooms in the treatment of psychiatric inpatients.     

When is it Effective to Focus on the Alliance? Analysis of a Within-Client Moderator

Contemporary studies on the working alliance seek to move forward from demonstrating an association between alliance and outcome to investigating how alliance can be used to maximize treatment outcome by identifying the clients for whom state-like changes in alliance predict symptomatic change (between-clients moderators). Yet, very little is known empirically on when state-like changes in alliance predict outcome for individual clients (within-client moderators). The present study, based on a sample of 327 clients, demonstrates that state-like changes in alliance at a given session have a significant effect on subsequent session outcome only in the case of higher life satisfaction in that session. This finding suggests that strengthening in the state-like component of the alliance has a greater effect on outcome when the client suffers less from poor life satisfaction.     

Evaluation of Exposure Instructions to Pain: Should Therapist Focus on Fear Reduction or Expectation Violation?

Cognitive Therapy and Research - Exposure elements are highly effective for the treatment of individuals with chronic pain and elevated fear-avoidance. However, different therapeutic instructions...     

Safety Signal Evaluation of a Risk of Syncope and Dizziness Not Related to Bleeding or Stroke in Direct Oral Anticoagulant–treated Patients

PurposeIn clinical studies, rivaroxaban treatment has been associated with increased incidence of syncope not related to bleeding, anemia, or stroke. The study objective was to evaluate the occurrence of dizziness and/or syncope not related to bleeding, anemia, or stroke in patients treated with direct oral anticoagulants (DOACs).MethodsA retrospective, observational, comparative study of adult patients diagnosed with atrial fibrillation and treated with DOACs was conducted using digital retrieval of medical records. Primary outcomes were an emergency department (ED) visit or hospitalization due to syncope, fall, or dizziness. Cases related to bleeding, anemia, or stroke were excluded. Separate examination of a sample of records validated the data.FindingsOf 6467 eligible patients, 256 (4%) were hospitalized or referred to the ED due to fall, syncope, or dizziness during a mean observation period of 20.1 months. After multivariate regression analysis, statistically independent risk factors were found to be age (hazard ratio [HR] = 1.04, P < 0.0001) and benzodiazepine use (HR = 1.33, P = 0.03). No statistically significant difference was found among the different DOAC types regarding the primary outcome (apixaban and rivaroxaban HR = 0.97, P = 0.85; dabigatran and rivaroxaban HR = 1.2, P = 0.386).ImplicationsThe study results failed to confirm the claimed association between the use of a DOAC and syncopal symptoms unrelated to bleeding, anemia, or stroke in this relatively large Israeli patient population. Age and benzodiazepine treatment were significant independent risk factors of these events.     

A Review of New Findings in Adult T-cell Leukemia–Lymphoma: A Focus on Current and Emerging Treatment Strategies

Adult T-cell leukemia–lymphoma (ATL), a rare and aggressive T-cell malignancy caused by human T-cell lymphotropic virus type 1 (HTLV-1), is associated with a poor prognosis. Evidence-based standard treatment options are lacking and outcomes are generally unsatisfactory, particularly for patients with relapsed or refractory disease. Continued research is contributing to changing treatment landscape as a number of existing and investigational agents are evaluated. We describe the epidemiology of HTLV-1 and ATL, discuss the biology behind the disease, review current treatment practices and guidelines, and provide an overview of emerging therapies in ATL, with a focus on those for relapsed or refractory disease.     

Safety of donating multiple products in a single apheresis collection: Are we expecting too much?

Modern blood separators rapidly process many liters of donor blood and efficiently collect vast quantities of blood components from donors, who may be stimulated with potent recombinant hematopoietic growth factors or cytokines. Accordingly, the potential risks of modern multiple product/unit apheresis donations and recombinant growth factors is analyzed in this report. As is true for all medical procedures, risks are associated with apheresis donations. Risks of a "standard" apheresis donation, in which one unit of PLTs or plasma is collected, are comparable to the risks of whole blood donation. Risks of multiple unit apheresis donations, in which either vast quantities of a single blood component or multiple units of various components are collected, are incompletely understood, particularly, when donors are stimulated with recombinant hematopoietic growth factors to increase component yields. To minimize donor risks and to increase knowledge of multiple component apheresis donations, both short-term problems (e.g., donor reactions accompanying apheresis procedures and pre- vs. post-procedure changes in results of donor laboratory studies) and long-term problems (e.g., medical diagnoses/problems and abnormalities of donor blood counts and laboratory test results) should be monitored, ideally, by a repeat donor registry. When recombinant hematopoietic growth factors are prescribed, donors should give informed consent, and blood center professionals must be aware of 1) the effects of these drugs given at pharmacologic, rather than physiologic, doses; 2) the differences between the molecular structure of recombinant vs. natural/endogenous growth factors; 3) the fact that recombinant growth factors have both narrow/focused and broad biological activities; and 4) the probability that results of studies in sick/immunosuppressed patients may not be applicable to healthy/immunocompetent donors.     

Valence and Arousal Value of Visual Stimuli and Their Role in the Mitigation of Chronic Pain: What Is the Power of Pictures?

The present study investigated the pain-reducing effects of various pictures in a sample of 88 patients receiving inpatient treatment for chronic pain. We investigated whether the pain-attenuating effects of the pictures were mediated by picture valence, arousal, or change in subjective social support. The study was carried out over 4 consecutive days. Patients were presented with photographs of loved ones, strangers, landscapes, or optical illusions via digital albums and were asked to rate their pain intensity and their sensory and affective experience of pain immediately before and after viewing the pictures. They also evaluated the valence of the pictures and the extent to which they were arousing. Before and after participation in the study, patients provided information on their subjective social support. The valence attributed to the pictures varied; photographs of loved ones elicited the greatest pleasure. Pictures of varying emotional content and arousal value all reduced affective and sensory perceptions of pain. Viewing photographs of loved ones reduced pain intensity more than viewing other picture types. The association between picture type and decrease in pain intensity was mediated by picture valence. These findings suggest an easy to implement supplementary intervention that could be used in multidisciplinary pain treatment.