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Difficulties in addressing nonadherence may be caused by a lack of understanding of modifiable factors. Researchers from the University of East Anglia and the UK’s National Health Service Foundation Trust performed a systematic review of 57 studies involving more than 30,000 patients, mostly in the United States and Europe, to examine studies that reported these modifiable factors. The study, led by a team of pharmacists, psychiatrists, and experts in behavioral health, placed the identified factors in Theoretical Domains Framework (TDF) domains.

This study showed that major contributors to nonadherence in patients with BPD were negative emotions evoked by the idea of taking medications and intentional nonadherence. The most frequently reported TDF domain was “Environmental Context and Resources,” mentioned as factors in 63% of the studies examined. Primarily related to characteristics of the medication, this domain in patients with BPD includes side effects (sedation, weight gain, sexual dysfunction, and cognitive impairment) and the complexity of the treatment regimen. More complex regimens are typically associated with lower adherence; this is relevant in patients with BPD since lithium, the gold standard for long-term therapy in BPD, has a narrow therapeutic index and thus requires regular blood tests and dietary restrictions. A second TDF domain also mentioned in 63% of studies, “Beliefs about Consequences,” contains particularly important modifiable factors in patients with BPD. Beliefs about the necessity for pharmacologic treatment of the disorder and concerns about the medication’s effects were frequently reported causes of nonadherence. These beliefs could include any of the following:

• Medication is not needed to treat bipolar disorder.
• During periods of feeling well, without symptoms, a patient with BPD can discontinue medication.
• The patient is less productive while taking medication, reporting feeling “less like self.”

With the understanding gained from mapping of these factors (both barriers to adherence and facilitators of adherence) to TDF domains, the study can allow clinicians to expand their adherence interventions to include talking to patients concerning their feelings about being medicated for the disease and their experiences with their treatment. (University of East Anglia. (2021). Why bipolar patients don’t take their meds.

https://www.uea.ac.uk/news/-/article/why-bipolar-patients-don-t-take-their-meds; Prajapati, A. R., et al. (2021), Mapping modifiable determinants of medication adherence in bipolar disorder (BD) to the theoretical domains framework (TDF): A systematic review. Psychological Medicine, (51)7, 1082–1098. https://www.cambridge.org/core/journals/psychological-medicine/article/mapping-modifiable-determinants-of-medication-adherence-in-bipolar-disorder-bd-to-the-theoretical-domains-framework-tdf-a-systematic-review/EBFF00931816F6BF1A42C4916F034751)

Released: June 2021

© 2021 Wolters Kluwer
 

The study involved 5,217 St. Jude employees, of whom 3,052 (58.5%) received at least one dose and 2,776 (53.2%) received both doses of the Pfizer BioNTech mRNA vaccine. On follow-up, 236 of the employees included in the analysis tested positive for SARS-CoV2. Among individuals who received at least one vaccine dose, 51 tested positive during follow-up, of whom 29 were diagnosed through asymptomatic screening. Among unvaccinated individuals, 185 tested positive for the virus during follow-up, of whom 72 were diagnosed through asymptomatic screening. The study used incidence rate ratio (IRR), the ratio of confirmed COVID-19 cases per person days of follow-up in vaccinated compared with unvaccinated groups, as a measure of the association between vaccination and infection. The IRR was 0.21 for any SARS-CoV2 infection, 0.28 for positive infection results on asymptomatic screening, and 0.16 for symptomatic or known exposure cases. The IRR within the first 11 days after the first dose was 0.58 to 0.60 for all these outcomes. The IRR for positive virus results via asymptomatic screening from 12 days after the first dose until the second dose was 0.58, in the first 7 days after the second dose was 0.35, and for 7 days or longer after the second dose was 0.10.

Even one dose of the vaccine reduced the risk of asymptomatic and symptomatic SARS-CoV2 infection by 79%. Analysis of asymptomatic infections found that vaccination had reduced that risk by 72%. Protection was even greater in employees who completed two doses; by a week or more after the second dose, vaccinated employees were 96% less likely than unvaccinated peers to become infected with SARS-CoV2, with asymptomatic infections being decreased by 90%. The data from this study is particularly valuable because of the broad asymptomatic testing, which enabled researchers to identify the many hidden cases of COVID-19 in the population.

(Tang, L., et al. (2021). Asymptomatic and symptomatic SARS-CoV-2 infections after BNT162b2 vaccination in a routinely screened workforce. JAMA. https://jamanetwork.com/journals/jama/fullarticle/2779854; St Jude Children’s Research Hospital. News Releases. (2021). COVID-19 vaccine is associated with fewer asymptomatic SARS-CoV-2 infections.

https://www.stjude.org/media-resources/news-releases/2021-medicine-science-news/covid-19-vaccine-is-associated-with-fewer-asymptomatic-sars-cov-2-infections.html)

Released: June 2021

© 2021 Wolters Kluwer

The study randomly assigned 5,674 patients with CKD and type 2 diabetes to finerenone or placebo and tracked outcomes for a median of 2.6 years. Finerenone significantly lowered risk of kidney events by 18% and risk of cardiac events by 14% compared to placebo. New-onset atrial fibrillation was reported in 82 patients (3.2%) in the finerenone arm of the trial compared with 117 patients (4.5%) in those taking placebo, a significant difference (hazard ratio, 0.71). The lower incidence of new-onset atrial fibrillation with finerenone treatment was notable at month 6 and continued throughout the trial, suggesting a sustained effect.

Patients with CKD and type 2 diabetes mellitus are at increased risk of atrial fibrillation because these conditions can cause changes in the heart’s structure and electrical signaling, leading to fast and erratic heart rhythms. It’s thought that finerenone acts by blocking mineralocorticoid receptors and inhibits cardiac remodeling. Longer studies focusing specifically on new-onset atrial fibrillation are needed to confirm these findings. (Filippatos, G., et al. (2021). Finerenone reduces onset of atrial fibrillation in patients with chronic kidney disease and type 2 diabetes. J Am Coll Cardiol. Advance online publication. https://www.jacc.org/doi/pdf/10.1016/j.jacc.2021.04.079; AlphaGalileo. (2021). Finerenone may delay onset of atrial fibrillation in patients with chronic kidney disease, diabetes. American College of Cardiology 70th Annual Scientific Session. https://www.alphagalileo.org/en-gb/Item-Display/ItemId/208285?returnurl=https://www.alphagalileo.org/en-gb/Item-Display/ItemId/208285)

Released: June 2021

© 2021 Wolters Kluwer

The researchers conducted a health status analysis of EXPLORER-HCM, a Phase III double-blind randomized controlled trial that involved 251 patients with symptomatic hypertrophic obstructive cardiomyopathy and left ventricular outflow tract gradient of at least 50 mm Hg at baseline. They were randomly assigned to mavacamten or placebo for 30 weeks, followed by an 8-week washout period. Primary findings from the trial, which were reported last year at the European Society of Cardiology, demonstrated that mavacamten use resulted in an increase in peak oxygen consumption and a reduction in New York Heart Association heart failure class. These results objectively showed improvement in patients’ functioning, but researchers sought to determine effect on quality of life, a more direct measure of how patients experience symptomatic improvement.

Researchers administered the Kansas City Cardiomyopathy Questionnaire (KCCQ), a disease-specific measure of patients’ health status, at baseline, week 6, week 12, week 18, week 30, and week 38. Of 123 patients receiving mavacamten, 92 (75%) completed the questionnaire at baseline and week 30; 88 (69%) of the 128 assigned to placebo did. Changes from baseline to week 30 in KCCQ overall summary score and change in all subscales were analyzed.

At 30 weeks, the improvement in KCCQ overall summary score was greater with mavacamten than with placebo: a 14.9-point change versus a 5.4-point change, for a difference of 9.1 points. Similar benefits were seen across all subscales of the KCCQ. In addition, a significantly larger percentage of patients receiving mavacamten reported a very large improvement (at least 20 points); 36% of patients in the mavacamten arm compared with 15% of those on placebo. These quality of life gains compare favorably with most treatments for heart failure. Overall, results of EXPLORER-HCM demonstrate that mavacamten may be used as primary therapy for hypertrophic obstructive cardiomyopathy, but more study is needed to compare it to the other agents that have been used to manage the disorder (for example, beta blockers, disopyramide, verapamil) and to determine which patients do better with which drugs. (MedPage Today. (2021). Mavacamten boosts quality of life in hypertrophic cardiomyopathy. https://www.medpagetoday.com/meetingcoverage/acc/92601; Spertus, J. A., et al. (in press). Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): Health status analysis of a randomised, double-blind, placebo-controlled, phase 3 trial. The Lancet. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)00763-7/fulltext)

Released: June 2021

© 2021 Wolters Kluwer