The role of collaborative, multistakeholder partnerships in reshaping the health management of patients with noncommunicable diseases during and after the COVID-19 pandemic.

BACKGROUND: Policies to combat the COVID-19 pandemic have disrupted the screening, diagnosis, treatment, and monitoring of noncommunicable (NCD) patients while affecting NCD prevention and risk factor control. AIMS: To discuss how the first wave of the COVID-19 pandemic affected the health management of NCD patients, identify which aspects should be carried forward into future NCD management, and propose collaborative efforts among public-private institutions to effectively shape NCD care models. METHODS: The NCD Partnership, a collaboration between Upjohn and the European Innovation Partnership on Active and Healthy Ageing, held a virtual Advisory Board in July 2020 with multiple stakeholders; healthcare professionals (HCPs), policymakers, researchers, patient and informal carer advocacy groups, patient empowerment organizations, and industry experts. RESULTS: The Advisory Board identified barriers to NCD care during the COVID-19 pandemic in four areas: lack of NCD management guidelines; disruption to integrated care and shift from hospital-based NCD care to more community and primary level care; infodemics and a lack of reliable health information for patients and HCPs on how to manage NCDs; lack of availability, training, standardization, and regulation of digital health tools. CONCLUSIONS: Multistakeholder partnerships can promote swift changes to NCD prevention and patient care. Intra- and inter-communication between all stakeholders should be facilitated involving all players in the development of clinical guidelines and digital health tools, health and social care restructuring, and patient support in the short-, medium- and long-term future. A comprehensive response to NCDs should be delivered to improve patient outcomes by providing strategic, scientific, and economic support.

The potential long-term impact of the COVID-19 outbreak on patients with non-communicable diseases in Europe: consequences for healthy ageing.

The early stages of the COVID-19 pandemic have focused on containing SARS-CoV-2 infection and identifying treatment strategies. While controlling this communicable disease is of utmost importance, the long-term effect on individuals with non-communicable diseases (NCD) is significant. Although certain NCDs appear to increase the severity of COVID-19 and mortality risk, SARS-CoV-2 infection in survivors with NCDs may also affect the progression of their pre-existing clinical conditions. Infection containment measures will have substantial short- and long-term consequences; social distancing and quarantine restrictions will reduce physical activity and increase other unhealthy lifestyles, thus increasing NCD risk factors and worsening clinical symptoms. Vitamin D levels might decrease and there might be a rise in mental health disorders. Many countries have made changes to routine management of NCD patients, e.g., cancelling non-urgent outpatient visits, which will have important implications for NCD management, diagnosis of new-onset NCDs, medication adherence, and NCD progression. We may have opportunities to learn from this unprecedented crisis on how to leverage healthcare technologies and improve procedures to optimize healthcare service provision. This article discusses how the COVID-19 outbreak and related infection control measures could hit the most frail individuals, worsening the condition of NCD patients, while further jeopardizing the sustainability of the healthcare systems. We suggest ways to define an integrated strategy that could involve both public institutional entities and the private sector to safeguard frail individuals and mitigate the impact of the outbreak.

Real-world Evidence for Adherence and Persistence with Atorvastatin Therapy.

Atorvastatin, which has been approved by regulatory agencies for primary- and secondary-prevention patients with dyslipidemia, has historically been the most commonly prescribed statin and is now widely available in generic formulations. Despite widespread statin usage, many patients fail to attain recommended (LDL-C) targets. While several factors impact the successful treatment of dyslipidemia, suboptimal patient adherence is a major limiting factor to medication effectiveness. In this narrative review we sought to investigate patient adherence and persistence with atorvastatin in a real-world setting and to identify barriers to LDL-C goal attainment and therapy outcomes beyond the realm of clinical trials. Moreover, in light of growing generic usage, we carried out targeted literature searches to investigate the impact of generic atorvastatin availability on patient adherence/persistence, and on lipid and efficacy outcomes, compared with branded formulations. Unsurprisingly, real-world data suggest that patient adherence/persistence to atorvastatin is suboptimal, but few studies have attempted to address factors impacting adherence. Data from studies comparing adherence/persistence in patients prescribed branded or generic atorvastatin are limited and show no clear evidence that initiation of a specific preparation of atorvastatin impacts adherence/persistence. Furthermore, results from studies comparing adherence/persistence of patients who switched from the branded to the generic drug are conflicting, although they do suggest that switching may negatively impact adherence over the long term. Additional real-world studies are clearly required to understand potential differences in adherence and persistence between patients initiating treatment with branded versus generic atorvastatin and, moreover, the factors that influence adherence. Targeted education initiatives and additional research are needed to understand and improve patient adherence in a real-world setting.

Impact of single-pill combination therapy on adherence, blood pressure control, and clinical outcomes: a rapid evidence assessment of recent literature.

OBJECTIVE: The 2018 European Society of Cardiology/European Society of Hypertension Guidelines for the management of arterial hypertension raised the need for evidence to support the use of single-pill combination (SPC) therapy in preference to free-dosed therapy for hypertension. This systematic rapid evidence assessment sought to determine if initiating SPC therapy improves adherence, blood pressure (BP) control and/or cardiovascular outcomes vs. initiation of free-dose combination therapy. METHODS: Rapid evidence assessment conducted in MEDLINE, EMBASE, and Cochrane Library (1 January 2013-11 January 2019) to identify studies investigating SPC therapy for adults with hypertension. Information on adherence/persistence, BP lowering/goal attainment, and cardiovascular outcomes/events were extracted via two-phase screening process. Studies not focusing on adherence, persistence, or compliance with SPC therapy were excluded. Methodological quality was assessed using appropriate scales. RESULTS: Of 863 citations, 752 failed to meet inclusion or were duplicates. Twenty-nine studies remained following full-text screening. Just four studies (14%) were randomized controlled studies; 25 (86%) were observational. A range of SPC therapies were studied, with calcium channel blocker/angiotensin receptor blocker combinations most common (11/29 studies). Adherence and persistence were generally higher with SPC vs. free-dose combination therapy; 15 studies (54%) directly compared adherence and four (14%) compared persistence. Patients achieving BP targets ranged from 25 to 89%. Despite all studies investigating patients with hypertension only 16 (55%) reported change in BP. Few studies reported on cardiovascular outcomes. Methodological reporting was often suboptimal. CONCLUSION: Adherence and/or persistence were generally higher in patients taking antihypertensives as SPC vs. free-dose combination; however, methodological reporting was suboptimal to facilitate comparison. Specifically designed, well reported studies are required to determine if the increased adherence/persistence seen in patients on SPC regimen leads to improved BP control and/or cardiovascular outcomes.

Cost-effectiveness of eplerenone in NYHA class II chronic heart failure patients with reduced LVEF: an analysis for Greece.

OBJECTIVES: The aim of the study was to evaluate the cost-effectiveness (CE) of treatment with eplerenone versus standard care in adult patients with New York Heart Association class II chronic heart failure and reduced left ventricular ejection fraction from the perspective of the Greek national health care payer. METHODS: A discrete-event model simulating the clinical course and respective outcomes of eplerenone as an add-on to standard therapy versus standard therapy alone based on the pivotal Eplerenone in Mild Patients Hospitalization and SurvIval Study in Heart Failure (EMPHASIS-HF) trial was locally adapted for the Greek setting. Data on medications followed the resource use from eplerenone in mild patients hospitalization and survival study in heart failure and were estimated on a lifetime basis (or until discontinuation). Cost calculations were based on year 2014, event costs (cardiovascular hospitalizations, adverse events, and devices) were sourced from published diagnosis-related groups. A 3% discount rate was applied. In order to test the robustness of the model projections, a range of deterministic and probabilistic sensitivity analyses were carried out. RESULTS: Over a patient's lifetime, the addition of eplerenone to standard care compared to standard care alone led to an incremental gain of 1.33 quality-adjusted life-years (QALYs) (6.53 vs 5.20 QALYs, respectively) as well as an increase in the cost of treatment by €2,160; these outcomes produced an incremental CE ratio of €1,624/QALY for the Greek setting. On the basis of probabilistic sensitivity analysis, there was a 100% likelihood of eplerenone being cost-effective versus standard care at a threshold of €3,500/QALY. CONCLUSION: This analysis indicates that eplerenone may be a cost-effective option versus standard care accompanied by additional clinical benefits and an added incremental cost at an acceptable, if not low, CE ratio. The results are consistent with the previously published studies on the CE of eplerenone as an add-on therapy to standard care, such as those regarding the health care settings of Spain, the UK, and Australia.

Cost-effectiveness of varenicline versus bupropion, nicotine-replacement therapy, and unaided cessation in Greece.

BACKGROUND: Varenicline was designed to relieve symptoms of nicotine withdrawal, including cigarette craving, and to block the reinforcing effects of continued nicotine use. The cost-effectiveness of varenicline in some countries has not been studied. OBJECTIVE: The aim of this study was to compare the cost-effectiveness of varenicline to that of bupropion, nicotine-replacement therapy (NRT), and unaided cessation in the Greek health care setting. The analysis takes into account a societal security (third-party payer) perspective. METHODS: To perform the analyses of the benefits of smoking cessation in terms of smoking-related morbidity, mortality, and associated medical costs, a Markov model was used that simulated the progress of a hypothetical cohort of current smokers making a single attempt to quit smoking at the beginning of the timeframe of the analysis. The robustness of the results was assessed using a series of 1-way sensitivity analyses. RESULTS: Varenicline was associated with the potential prevention of 14.1, 14.2, and 35.1 additional cases of the 4 smoking-related diseases incorporated into the model, per 1000 smokers willing to quit, versus bupropion, NRT, and unaided cessation, respectively. Potentially avoided smoking-related deaths with varenicline were estimated at 3.24, 3.26, and 7.5 per 1000 quitters versus the 3 comparators. Varenicline led to a potential gain of 33.78, 33.91, and 83.97 QALYs per 1000 persons willing to make a quit attempt versus the 3 comparators. Varenicline was associated with cost-savings against both active comparators for the lifetime horizon. Overall, the cost per additional quitter with varenicline, considering only the costs of the smoking-cessation strategy, was €2659 (€1015) for a lifetime horizon compared with bupropion (NRT); however, when all direct costs were incorporated into the analysis, varenicline was cost-saving. CONCLUSION: The findings from the present study suggest that, compared with the widely used treatment options bupropion and NRT, as well as unaided cessation, varenicline may enhance smoking-cessation treatment outcomes while substantially reducing the overall costs of smoking to the health care system.

Varenicline as a smoking cessation aid in a Greek population: a subanalysis of an observational study.

BACKGROUND: Greece has the highest proportion of smokers in the European Union with 42% of Greeks admitting that they smoke, based on a 2009 survey. This post-hoc analysis of a prospective, observational study evaluated the effectiveness and safety profile of the smoking cessation aid varenicline, as well as potential predictors of quit success in a Greek population. METHODS: Participants were prescribed varenicline according to the recommendations of the European Summary of Product Characteristics (1 mg twice daily). The 7-day point prevalence of abstinence at Week 12 was determined based on verbal reporting using a nicotine use inventory. Abstinence was confirmed by carbon monoxide measurements of exhaled air at the last visit of the study. The safety profile of varenicline was also assessed. RESULTS: At baseline, the Greek subsample (n = 196) had a mean age of 42.6 years, with 54.6% of them being men. Participants had a smoking history of 23.5 years and a Fagerström Test for Nicotine Dependence total score of 6.6. After 12 weeks of varenicline therapy, 70.4% (95% CI, 64.0-76.7) of all participants had quit smoking. This increased to 86.2% among participants who had taken the study medication for 80% of the planned number of treatment days. Age was a significant predictor of quit success. The most frequently observed treatment-emergent adverse event was nausea, occurring in 13.3% of participants. CONCLUSIONS: In this 'real-world' observational study, 70.4% of Greek smokers successfully quit smoking after 12 weeks of varenicline therapy, providing support that varenicline is an effective smoking cessation medication. Further studies with longer follow-up are warranted. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00669240.