Usability of the Novel Liraglutide 3.0 mg Pen Injector Among Overweight or Obese Adult Patients With or Without Prior Injection Experience

Background:

Obesity is associated with multiple comorbidities and increased mortality, making it an important target for treatment. However, achieving and maintaining weight loss by diet and physical activity remains challenging, and may often require pharmacotherapy. Liraglutide 3.0 mg has recently been approved for weight management in the United States, Canada, and EU. The current analysis used a summative usability test to assess safety and effectiveness, ease of use, and training requirements for the novel liraglutide 3.0 mg pen injector.

Methods:

Of the 234 participants, half received instructions for use and video-based training and/or opportunity to handle the device. All participants (excluding pharmacists) performed 6 tasks followed by post- task interviews on task difficulty, device ease of use, and any use errors, close calls, and operational difficulties. Tasks included differentiation of correct box and pen injector, medication clarity assessment, normal, dose reversal, and end-of-content injection. Number/type of use errors, close calls, and operational difficulties were evaluated.

Results:

All assessed participants interpreted the instructions for use correctly. No potentially serious use errors, and low numbers of nonserious errors, were reported. Overall, participants committed 105 use errors related to handling, with no potential for harm. A total of 25 close calls and 44 operational difficulties were reported without any pattern indicative of a design flaw. Marked differences in the incidence of events were observed for trained versus untrained participants regardless of prior injection experience. Participants rated ease of use as 6.4/7.

Conclusions:

The liraglutide 3.0 mg pen injector is safe and easy to use for liraglutide administration. New device features allow for safe use after brief training.     

治疗射血分数降低的心力衰竭的药物研究进展

心血管疾病是导致死亡的主要原因,并在世界范围内增加卫生保健的费用支出。心力衰竭可简单地描述为心脏无法满足机体的需求,它是很多其他心血管疾病的终点。过去的30年间我们见证了为改善心衰患者存活率及生活质量所做出的巨大努力,其中多数尝试是成功的。考虑到大多数成功的案例都是针对左心室射血分数降低的心力衰竭(reduced left ventricular ejection fraction,HFr EF)患者,本文将针对HFr EF的药物治疗研究进展进行综述,重点介绍临床应用中的新型药物和正处于临床试验中的新型药物。     

Pharmacotherapeutic strategies for treating hypertension in patients with obesity

Introduction: Hypertension and obesity are important health challenges that independently increase cardiovascular morbidity and mortality. There is a lack of randomized controlled trials to clearly inform on preferred drug choices to be adopted in clinical practice for the treatment of obesity-related hypertension (OHT). Adequate differentiation of drug classes for preferential use in obesity or the metabolic syndrome aimed at avoiding adverse effects on body weight and the metabolic profile is neglected in this population, at least in part due to the lack of specific pharmacologic recommendations in hypertension guidelines.

Areas covered: The authors summarize and suggest pharmacotherapeutic strategies based on pathophysiologic rationale to achieve blood pressure (BP) control and avoid adverse metabolic consequences in OHT.

Expert opinion: Combinations of various pharmacologic antihypertensive approaches are required in the management of OHT. It is recommended that targeting sympathetic overactivity with a centrally acting sympatholytic agent such as moxonidine should be considered as a preferred second line treatment choice in combination with renin angiotensin system (RAS) blockade, the current first line choice. Though not all obese subjects have sympathetic overdrive, this approach is likely to provide effective control of blood pressure and improve the metabolic profile of patients with OHT along with positive implications for cardiovascular risk reduction.     

Pharmacotherapy and nutritional supplements for seasonal affective disorders: a systematic review

Introduction: A seasonal affective disorder (SAD) is a subtype of unipolar and bipolar major depressive disorders. It is characterized by its annual recurrence of depressive episodes at a particular season, mostly seen in winter and is responsible for 10–20% of the prevalence of major depressive disorders. Some pathophysiological hypotheses, such as the phase delay and the monoamine depletion hypotheses, have been postulated but the exact cause has not been fully unraveled yet. Studies on treatment for SAD in the last decade are lacking. To tackle this chronic disease, attention needs to be drawn to the gaps in this research field.

Areas covered: In this systematic review, the authors give a broad overview of the pharmacological therapy available for SAD. Also, nutritional substances fitting well with the postulated hypotheses are reviewed for the treatment and prevention of SAD. There is a specific focus on the quality of the currently performed studies.

Expert opinion: Light therapy and fluoxetine are the only proven and effective acute treatment options for SAD, while bupropion is the only registered drug for prevention of SAD. This area of research is in dire need of valid large-scale and sufficiently reproducible randomized control trials.     

Are there advances in pharmacotherapy for panic disorder? A systematic review of the past five years

Introduction: Several effective medications are available for treating panic disorder (PD). However, outcomes are unsatisfactory in a number of patients, suggesting the usefulness of expanding the array of antipanic drugs and improving the quality of response to current recommended treatments.

Areas covered: The authors have performed an updated systematic review of pharmacological studies (phase III onwards) to examine whether advances have been made in the last five years. Only four studies were included. D-cycloserine no longer seemed promising as a cognitive-behavioral therapy (CBT) enhancer. Some preliminary findings concerning the optimization of recommended medications deserved consideration, including: the possibility that SSRIs are more effective than CBT alone in treating panic attacks, combined therapy is preferable when agoraphobia is present, and clonazepam is more potent than paroxetine in decreasing panic relapse.

Expert opinion: Given the lack of novel treatments, expanding a personalized approach to the existing medications seems to be the most feasible strategy to improve pharmacotherapy outcomes regarding PD. Recent technological progress, including wearable devices collecting real-time data, ‘big data’ platforms, and application of machine learning techniques might help make outcome prediction more reliable. Further research on previously promising novel treatments is also recommended.     

Vascular complications in steroid treated patients undergoing transfemoral aortic valve implantation

• Steroids if taken chronically or periprocedurally contribute to delayed wound healing and decreased vascular patency
• Access site complications after diagnostic interventional procedures carry significant morbidity, increased cost, and prolonged hospital stay
• TAVI offers high risk surgical candidates with severe aortic stenosis a significant survival advantage

     

The relevance of heart failure severity for treatment with evidence-based pharmacotherapy in general practice

AIMS: Internationally, research indicates that pharmacotherapy for chronic heart failure (CHF) is sub-optimal. Traditionally, assessment of drug use in heart failure has focused on the use of individual agents irrespective of CHF severity. This study investigates drug use for CHF patients in general practice with respect to the available evidence, incorporating both disease severity and the use of combination drug regimes. METHODS AND RESULTS: A cross-sectional survey of 769 Dutch CHF patients was performed as part of IMPROVEMENT of HF study. For each New York Heart Association severity classification the minimum treatment appropriate for the heart failure severity according to the scientific evidence available at the time of the study (1999) was defined. The proportion of patients treated with each drug increased with increasing severity, with the exception of the beta-blockers. Patients with less severe heart failure were approximately four to eight times more likely to receive evidence-based treatment than those with more severe heart failure. DISCUSSION: To assess pharmacological treatment of heart failure, in relation to the available evidence, it is important to take severity into account. While the number of drugs prescribed increased with increasing severity, the use of evidence-based regimes was lower in patients with more severe heart failure.     

REVIEW OF NUTRITIONAL SUPPLEMENTS FOR THE TREATMENT OF BIPOLAR DEPRESSION

Many patients view psychotropics with skepticism and fear and view nutritional supplements as more consistent with their values and beliefs. The purpose of this review was to critically evaluate the evidence base for nutritional supplements in the treatment of bipolar depression (BD). A literature search for all randomized, controlled clinical trials using nutritional supplements in the treatment of BD was conducted via PubMed and Ovid MEDLINE computerized database. The studies were organized into essential nutrients/minerals, nonessential nutrients, and combinations of nutritional products. Among essential nutrients/minerals, omega‐3‐fatty acids (O3FAs) have the strongest evidence of efficacy for bipolar depression, although some studies failed to find positive effects from O3FAs. Weak evidence supports efficacy of vitamin C whereas no data support the usefulness of folic acid and choline. Among nonessential nutrients, cytidine is the least supported treatment. Studies of N‐acetylcysteine have not resolved its efficacy in treating acute depressive episodes relative to placebo. However, one study demonstrates its potential to improve depressive symptoms over time and the other, though nonsignificant, suggests it has a prophylactic effect. Studies of inositol have been mostly negative, except for 1 study. Those that were negative were underpowered but demonstrated numerically positive effects for inositol. There is no evidence that citicholine is efficacious for uncomplicated BD depression, though it may have value for comorbid substance abuse among BD patients. Finally, combination O3FA‐cytidine lacks evidence of efficacy. The findings of this review do not support the routine use of nutritional supplements in the treatment or prophylaxis of BD depression. Studies with more rigorous designs are required before definitive conclusions can be made. Despite the inadequacy of the existing data, clinicians should remain open to the value of nutritional supplements: after all, lithium is a mineral too.