Evaluation of the association of physical activity levels with self-perceived health, depression, and anxiety in Spanish individuals with high cholesterol levels: a retrospective cross-sectional study.

Background: Hypercholesterolemia is the most common form of dyslipidaemia in the world leading to negative health effects, both physical and mental. Physical activity (PA) can reduce total cholesterol and has positive effects on mental health. This retrospective cross-sectional study analyses the relationships between physical activity level (PAL), self-perceived health (SPH) and mental health. Methods: This study was based on data from the Spanish National Health Survey 2017 (SNHS 2017), with 3,176 Spanish adults with high cholesterol as participants. Non-parametric tests were used as the data did not follow normality. Results: Dependent relationships were found between PAL and SPH, depression and anxiety. Women had higher depression and anxiety prevalences than men, while men were more likely to report being very active, although the proportion of walkers was higher in women. The physically inactive population presented higher negative SPH, depression and anxiety proportions and psychological distress than physically active people. Conclusion: The physically inactive people had a higher risk of negative SPH, depression and anxiety. Regular PA may improve SPH and mental health in people with high cholesterol, but more studies are needed to establish causal relationships, mechanisms, and optimal doses.

Public perceptions and knowledge of cholesterol management in a multi-ethnic Asian population: A population-based survey.

INTRODUCTION: Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide. Hyperlipidemia is one of the important modifiable risk factors for CVDs. Raising public awareness of CVD risks is an important step in reducing CVD burdens. In this study, we aimed to assess public awareness and knowledge of cholesterol and its management in a multiethnic Asian population. METHODS: We recruited 1000 participants from three major ethnic groups for this nationwide population-based survey. A structured questionnaire was used to collect socio-demographics, knowledge of cholesterol and cholesterol-lowering medications. Univariate and multivariate analyses were conducted to identify factors associated with good knowledge on cholesterol and its management. RESULTS: Of the participants, 65% thought that high cholesterol produces symptoms and that lifestyle modification would be as effective as medication at lowering cholesterol. Nearly 70% believed that long term statin could lead to kidney or liver damage, and 56% thought that statin was associated with higher risk of cancer. A third saw herbal medicine or supplements as healthier and safer. About 45% believed that statin therapy should not be taken long term and that one could stop taking cholesterol medication when cholesterol is under control. Malays were more likely to have poor knowledge (adjusted OR 0.68; 95% CI 0.47-0.98; P = 0.039) compared to Chinese. Participants with intermediate education were more likely to have good knowledge of cholesterol and its management (adjusted OR 1.67; 95% CI 1.11-2.51; P = 0.013) compared to those with primary education. CONCLUSION: Public knowledge and awareness of high cholesterol and its management remains poor in Asian multi-ethnic population. Understanding gaps in public knowledge can inform the implementation of health promotion programs to effectively raise awareness of cholesterol and its management.

Development and Validation of a Questionnaire to Measure Adherence to the Mediterranean Diet in Korean Adults.

The Mediterranean diet (MD) has beneficial effects on cardiovascular diseases, cancer, and mortality. Although various attempts have been made for estimating adherence to the MD using diet quality indices, few studies involving validated questionnaires for estimating adherence have been performed in Asian populations. We aimed to develop and validate the Korean version of the Mediterranean Diet Adherence Screener (K-MEDAS) by including 211 participants that visited health check-up centers and 116 participants with overweight or hypercholesterolemia that visited obesity clinic. The participants completed both the K-MEDAS and a 106-item food frequency questionnaire (FFQ). We translated 13 questions and developed 1 question. Considering the agreement between the K-MEDAS and FFQ, nine of the 14 questions showed moderate or high kappa values (≥0.4). The total MD scores measured by the K-MEDAS and FFQ showed substantial concordance (intraclass correlation coefficient = 0.678, 95% confidence interval: 0.520, 0.785). Multiple linear regression analyses revealed significant inverse associations between MD score and the levels of serum total cholesterol, low-density lipoprotein cholesterol, and non-high-density lipoprotein cholesterol, after adjusting for confounding variables. We found that K-MEDAS is valid tool for assessing adherence to the MD in the Korean population.

Lingzhi or Reishi Medicinal Mushroom, Ganoderma lucidum (Agaricomycetes), Ameliorates Nonspatial Learning and Memory Deficits in Rats with Hypercholesterolemia and Alzheimer's Disease.

Alzheimer's disease (AD) is the leading neurodegenerative disorder affecting memory and learning of aged people. Hypercholesterolemia had been implicated as one of the stark hallmarks of AD. Recent AD control guidelines have suggested lifestyle modification to slow down the progression of AD. In this regard, medicinal mushroom Ganoderma lucidum seems apt. In the present study, hot water extract of G. lucidum (200 mg/kg body weight) was fed to the hypercholesterolemic and AD model rats for 8 weeks. Nonspatial memory and learning abilities of the model animals was assessed using novel object recognition (NOR) test, rotarod test, and locomotor/open-field test. Then, the animals were sacrificed and transmission electron micrograph (TEM) view of the hippocampal neurons was assessed. In all the nonspatial memory and learning tests, the G. lucidum HWE fed rats performed better indicating improved memory and learning abilities. TEM view showed regular arrangement of the neurons in the G. lucidum HWE fed rats compared with those of the deranged arrangement of the AD rats. G. lucidum might have aided in restoring the memory and learning abilities of the AD model animals through maintaining neuronal structure and function. Thus, G. lucidum could be suggested as a medicotherapeutic agent against AD.

Report of Health Behavior Modification Among Latinos Diagnosed With Multiple Cardiovascular Risk Factors.

INTRODUCTION: Hypertension, hypercholesterolemia, and type II diabetes are leading cardiovascular risk factors in the United States, and Latinos are disproportionately burdened by these chronic health conditions. The extent to which Latinos overall and by language spoken at home report health behavior modification following diagnosis is poorly understood. METHODS: Our inclusion criteria included participants sampled in the 2011-2016 waves of the National Health and Nutrition Examination Survey who self-identified as Latinos, were 20 years of age or above, and reported a diagnosis of hypertension, hypercholesterolemia or diabetes (N=2027). We examined associations between the language spoken at home and report of adoption of 3 recommended health behaviors in the past year: weight loss, leisure-time physical activity (LTPA) and smoking cessation. Separate log-binomial models were fit to estimate prevalence ratios (PRs) for each health behavior. RESULTS: Approximately one third (28%) of study participants had been diagnosed with diabetes and more than half reported a diagnosis of hypercholesterolemia (65%) or hypertension (60%). Most Latinos met the highest levels of smoking cessation criteria (82%), whereas less than a third met LTPA recommendations (29%) or attempted weight loss (24%) in the past year. Fully adjusted outcome specific models showed that exclusively speaking English at home was associated with a higher probability of reporting weight loss attempt and LTPA compared with Spanish only speakers, although only LTPA was statistically significant [weight loss PR: 1.23, 95% confidence interval (CI): 0.92, 1.65; LTPA PR: 1.74; 95% CI: 1.37, 2.20; smoking cessation PR: 0.93, 95% CI: 0.86, 1.01]. CONCLUSIONS: Our findings provide new evidence on patterns of behavioral modification in a population-based sample of Latinos diagnosed with chronic health conditions. Findings suggest the need to promote language and culturally relevant initiatives to increase the adoption of health-enhancing behaviors and improve chronic disease management among Spanish-speaking Latinos.

Effectiveness and easiness of adherence to behavioural guidelines for diet and lifestyle changes for cholesterol-lowering: the Increasing Adherence of Consumers to Diet & Lifestyle Changes to Lower (LDL) Cholesterol (ACT) randomised controlled trial.

BACKGROUND: The present study aimed to assess perceived effectiveness and easiness of behavioural diet and lifestyle changes related to dyslipidaemia given by physicians or dieticians as a result of diet and lifestyle modifications being difficult to maintain. METHODS: One-hundred hypercholesterolaemic individuals were enrolled in a parallel, randomised 6-week study. Fifty were advised by dietitians (dietitian group: DG) in six weekly face-to-face behavioural therapy sessions and 50 received standard advice from physicians (physician group: PG). All individuals were followed-up for another 6 weeks under real-life conditions. Questionnaires regarding perceived effectiveness, easiness of adhering, forecasted and actual adherence to specific cholesterol-lowering advice were completed. RESULTS: Scores of perceived effectiveness of advice for sufficient exercise, limiting saturated fat (SFA) intake, eating fish twice a week, consuming plenty of fresh fruit and vegetables, and limiting salt intake different scientifically (all P < 0.05) in PG and DG between study phases. Scores of the individuals' perception of effectiveness at all study phases were higher in the DG compared to PG for sufficient exercise, limiting SFA intake, eating fish twice a week, eating plenty of fruits and vegetables, and limiting salt intake, whereas scores of easiness were significant only for fish consumption (P = 0.008) and using foods with added plant sterols (all P < 0.05). DG and PG significantly differed in forecasted (week 6) versus actual adherence (week 12) to various chances, with DG reporting higher adherence. CONCLUSIONS: Lifestyle and dietary changes related to dyslipidaemia can be achieved with continuous education, monitoring and follow-ups by dieticians, as well as potentially other trained healthcare professionals.

The Effect of Symptom Clusters on Quality of Life Among Patients With Type 2 Diabetes.

PURPOSE: The purpose of this study was to examine the collective effect of a symptom cluster (depression, anxiety, fatigue, and impaired sleep quality) at baseline on the quality of life (QOL) of patients with type 2 diabetes (T2DM) over time. METHODS: This was a secondary data analysis of 302 patients with T2DM who presented with both hypertension and hyperlipidemia. All of the participants were enrolled in a randomized controlled intervention study testing strategies to improve medication adherence. The psychological symptoms and QOL were assessed at baseline, 6 months, and 12 months. Cluster analysis was used to identify subgroups of patients based on the severity of symptoms at baseline. RESULTS: Hierarchical cluster analysis identified 4 patient subgroups: all low severity, mild, moderate, and all high severity. There were significant differences in patients' QOL overall among the 4 subgroups. Compared with the all-low-severity subgroup, subgroups with higher severity of the 4 symptoms had poorer QOL across all 3 time points. QOL was most impacted by trait anxiety across the 3 time points. CONCLUSION: QOL was significantly impacted by psychological symptom clusters among patients with T2DM. Healthcare providers should not neglect psychological symptoms that patients experience. It is important to assess and manage these symptoms to improve QOL among patients with diabetes.

Patients-in-waiting or chronically healthy individuals? People with elevated cholesterol talk about risk.

Risk adopts an ambiguous position between health and illness/disease and is culturally salient in various health-related everyday practices. Previous research on risk experience has mostly focused on the illness/disease side of this risk ambiguity. Persons at risk have typically been defined as patients (of some kind) and their condition as a form of proto-illness. To allow for the cultural proliferation of health risk and to account for the health side of risk ambiguity, I chose to focus on elevated cholesterol, a condition both intensely medicalised and connected to the everyday practice of eating, among participants (n = 14) recruited from a consumer panel and approached not as patients, but as individuals concerned about their cholesterol. Utilising the biographical disruption framework developed by Bury, I show how the risk experience of my participants differed from the chronic illness experience. Instead of patients-in-waiting suffering from a proto-illness, they presented themselves as 'chronically healthy individuals' (Varul 2010), actively trying to avoid becoming patients through a responsible regimen of personal health care. The results call for a more nuanced approach to the risk experience, which accounts for both sides of the risk ambiguity.

Educational diagnosis of self-management behaviours in patients with diabetes mellitus, hypertension and hypercholesterolaemia based on the PRECEDE model: Qualitative study.

AIMS AND OBJECTIVES: To identify the key factors of adopting self-care behaviours in the treatment of diabetes mellitus II, hypertension and hypercholesterolaemia when the three conditions appear simultaneously. BACKGROUND: Diabetes, hypertension and hypercholesterolaemia are chronic health problems which often appear together. The correct monitoring of these pathologies when they concur simultaneously requires specific health management behaviours, to which a significant part of the population is unable of adhering, despite recommendations from professional healthcare workers. DESIGN: A qualitative study using focus groups techniques was carried out. The elements related to the content were drafted following the recommendations of the Consolidated Criteria for Reporting Qualitative Research (COREQ checklist). METHODS: Patients with simultaneous diabetes, hypertension and hypercholesterolaemia, as well as nursing professionals and family doctors who have treated patients at primary care centres, were the key sources of information. The methodology used to analyse the information was content analysis. RESULTS: There were factors which can positively or negatively determine the adoption of the self-management recommendations that healthcare professionals make to patients who simultaneously have diabetes, hypertension and hypercholesterolaemia. These factors were not only associated with the patient, but also with the health carers themselves and the healthcare system and policies in force. CONCLUSIONS: When health professionals provide recommendations for self-care to people diagnosed with diabetes, hypertension and hypercholesterolaemia simultaneously, they should bear in mind not only the determinants of behaviour associated with the patient, but also those that are related to the health professionals themselves and with the healthcare system. The PRECEDE model could be a good tool to identify and design health education programs. RELEVANCE TO CLINICAL PRACTICE: The knowledge of the determinants of health behaviour of patients with chronic diseases could improve adherence patients to health recommendations, avoid associated complications and increase their quality of life.

Behavioural, metabolic and neurochemical effects of environmental enrichment in high-fat cholesterol-enriched diet-fed mice.

While chronic high-fat feeding has long been associated with the rising incidence of obesity/type 2 diabetes, recent evidence has established that it is also associated with deficits in hippocampus-dependent memory. In this regard, environmental enrichment (EE) is an animal housing technique composed of increased space, physical activity, and social interactions, which in turn increases sensory, cognitive, motor, and social stimulation. EE leads to improved cerebral health as defined by increased neurogenesis, enhanced learning and memory and resistance to external cerebral insults. In the present study, the impacts of environmental enrichment (EE) on Swiss mice fed a high-fat, cholesterol-enriched diet (HFECD; 20% fat and 1.5% cholesterol) were investigated. Here, we demonstrated that EE, when initiated 4 weeks after the beginning of HFECD in mice, prevents HFECD-induced spatial memory and object recognition impairment, which were tested in T-maze and object recognition tests. Although EE did not affect HFECD-induced weight gain or hypercholesterolaemia, it improved glucose tolerance. On the other hand, EE was unable to mitigate a decrease in brain-derived neurotrophic factor (BDNF) and IL-6 hippocampal levels induced by the HFECD. Overall, while our results reinforce the positive and neuroprotective effects of EE on cognition they do not support a role for EE in preventing the neurochemical changes induced by the HFECD. Based on clinical observations that nondiabetic individuals with mild forms of impaired glucose tolerance have a higher risk of cognitive impairments, one can speculate about the connection between the effects of EE on glucose intolerance and its effects on cognition.

The effect of atorvastatin on sexual function and depressive symptoms in young women with elevated cholesterol levels - a pilot study.

INTRODUCTION: Statins were found to improve erectile function in men. No previous study has prospectively investigated sexual functioning in women receiving these agents. The aim of this study was to evaluate the impact of atorvastatin therapy on female sexual function, and depressive symptoms in young women with elevated cholesterol levels. MATERIAL AND METHODS: The study included 14 women with elevated cholesterol levels and 14 matched women with normal plasma lipids. Hypercholesterolaemic women were then treated with atorvastatin (20-40 mg daily) for 24 weeks. Apart from measuring plasma lipids, at the beginning and at the end of the study, all participants of the study completed questionnaires evaluating sexual function (Female Sexual Function Index - FSFI) and the presence and severity of depressive symptoms (Beck Depression Inventory-Second Edition - BDI-II). RESULTS: The mean total FSFI score was insignificantly lower, while the BDI-II score was higher in women with hypercholesterolaemia than in the control group. Both groups significantly differed in domain scores for arousal and orgasm. Atorvastatin decreased the domain score for desire, increased the domain score for orgasm, but did not affect the total FSFI score and the remaining domain scores. Moreover, atorvastatin tended to reduce the BDI-II score. Treatment-induced changes in desire, orgasm, and the BDI-II did not correlate with the effect of atorvastatin on plasma lipids. CONCLUSIONS: Atorvastatin treatment produces a relatively mild effect on sexual functioning and mood in women, affecting only selected elements of female sexual behaviour.

Hypercholesterolemia impairs contextual fear conditioning memory formation in female mice: evidence for cholinergic dysfunction.

The present study evaluated the effects of hypercholesterolemia in response to conditioned aversive stimuli in mice. Specifically, (a) young (3 months old) and aged (24 months old) female C57Bl/6 mice were fed daily for 4 weeks with a standard rodent diet or an enriched cholesterol diet (ECD) and then subjected to the contextual fear conditioning test. In another experimental set, 3-month-old C576Bl/6 female mice, fed daily during the 4 weeks with the standard rodent diet or ECD, were subjected to the contextual fear conditioning test and received vehicle or scopolamine (0.37 mg/kg; intraperitoneally) immediately after the training session. (b) 12-month-old C576Bl/6 and low-density lipoprotein receptor knockout mice (LDLr) female mice were subjected to the contextual fear conditioning test. In another experimental set, they were subjected to the contextual fear conditioning test and received vehicle or donepezil (3.0 mg/kg; intraperitoneally) immediately after the training session. The present results show that (a) the ECD specifically impaired retrieval of contextual fear memory in aged mice; (b) an ineffective dose of scopolamine impaired fear memory consolidation in young mice fed the ECD; (c) LDLr mice presented impaired contextual fear memory retrieval; and (d) boosting cholinergic neurotransmission with a single donepezil administration at the consolidation window led to improved fear memory consolidation in LDLr mice. These findings suggest that high levels of cholesterol induced by either an ECD or a genetic deletion of LDLr decreased freezing behavior on the contextual fear conditioning test, which seemed to involve dysfunction of the cholinergic system.

Identifying Patterns in Signs and Symptoms Preceding the Clinical Diagnosis of Alzheimer's Disease: Retrospective Medical Record Review Study and a Nested Case-control Design.

OBJECTIVE: Evidence suggests that individuals with Alzheimer's disease (AD) are often diagnosed in the later stages of their disease with a poor prognosis. This study is aimed to identify patterns in signs and symptoms preceding the clinical diagnosis of AD to suggest a predictive model for earlier diagnosis of the disease in the primary care. DESIGN: A retrospective medical record review; nested case control design. PARTICIPANTS: Participants included one hundred and nine patients from three general practice (GP) surgeries in Milton Keynes and Luton Clinical Commissioning Groups (CCG) (37 cases with AD and 72 controls without AD). MAIN OUTCOME MEASURE: A retrospective analysis using the logistic regression of the presence of signs and symptoms before the diagnosis of AD was attained. Identification of the timing and sequence of appearance of these presentations as first reported before the clinical diagnosis was measured. RESULT: Episodic memory with an odds ratio of 1.85 was the most frequent presentation, documented in 1.38% of the controls and 75.6% in cases. Auditory disturbance with an odds ratio of 3.03, which has not previously been noted except in the form of auditory hallucination, could have a diagnostic value. CONCLUSION: Auditory disturbance, which occurred mostly in the Caucasian females, could discriminate individuals with AD from those without the disease. The symptom, which presented up to 14.5 (mean time) years prior to clinical diagnosis, was identified in Caucasians and mixed race individuals only. Strengths: The study demonstrates that auditory disturbance could allow an earlier diagnosis of AD in Caucasian females. Episodic memory was confirmed as being frequently noted in AD patients prior to a clinical diagnosis as per previous publications. This study supports the development of a scoring system for the earlier diagnosis of AD. The data used was free from the confounding effects of misinformation, as this was written at the point of collection, thereby benefitting from the use of GP data that is diversified, reliable and valid. LIMITATIONS: Limited sample size that will not allow for generalization of less frequent observations due to their low prevalence in case notes. Randomisation was not achieved; however, the best available nonrandomisation which is consecutive sampling was used. Patterns identified were in LOAD, the baseline could vary with other geographical areas.

Prevalence, awareness, treatment and control of hypertension, diabetes and hypercholesterolaemia among adults in Dande municipality, Angola.

OBJECTIVES: To estimate the prevalence, awareness, treatment and control of hypertension, diabetes and hypercholesterolaemia in an Angolan population aged 15 to 64 years and to determine relationships with sociodemographic, behavioural and anthropometric characteristics. METHODS: A total of 2 354 individuals were assessed for behavioural, sociodemographic and physical characteristics in a cross-sectional, community-based survey. Post-stratification survey weights were applied to obtain prevalence levels. Adjusted odds ratios for each variable related to the conditions were calculated using logistic regression models. RESULTS: Overall, the prevalence of hypertension was 18.0%, diabetes 9.2% and hypercholesterolaemia 4.0%. Among hypertensive individuals, the awareness rate was 48.5%; 15.8% were on treatment and 9.1% had their blood pressure controlled. Only 10.8% were aware they had diabetes, 4.5% were on treatment and 2.7% were controlled. The awareness level for hypercholesterolaemia was 4.2%, with 1.4% individuals on treatment and 1.4% controlled. CONCLUSION: The prevalence levels of hypertension and diabetes, which were higher than previous findings for the region, together with the observed low rates of awareness, treatment and control of all conditions studied, constitute an additional challenge to the regional health structures, which must rapidly adapt to the epidemiological shift occurring in this population.

Provider recommendations for patient-reported muscle symptoms on statin therapy: Insights from the Understanding Statin Use in America and Gaps in Patient Education survey.

BACKGROUND: Statin-associated muscle symptoms are reported by 10% to 29% of patients in clinical practice and are a major determinant of statin nonadherence, discontinuation, and switching. Little is known about what advice patients receive from their providers when dealing with these symptoms. OBJECTIVE: The objective of the study was to assess patient's reports of provider advice when experiencing new or worsened muscle symptoms while taking a statin. METHODS: Data were analyzed from the Understanding Statin Use in America and Gaps in Education survey, a self-administered internet-based survey of 10,138 adults with a reported history of high cholesterol and statin use. RESULTS: Of the respondents, 60% of former statin users (n = 1220) reported ever experiencing new or worsened muscle pain on a statin, in contrast to 25% of current users (n = 8918; P < .001). Former statin users reported stopping more statins because of muscle symptoms (mean ± standard deviation, 2.2 ± 1.7) compared with current users (mean 1.6 ± 1.5, P < .0001). For those with muscle-related symptoms while on a statin, participants reported that providers most often suggested switching to another statin (33.8%), stopping the statin (15.9%), continuing the statin with further monitoring of muscle symptoms (12.2%), reducing the statin dose (9.8%), or getting a blood test for signs of muscle damage (9.2%). A lower percentage were advised to add either vitamin D (7.0%) or coenzyme Q10 (5.8%), or to switch to nonstatin therapy (6.1%) or red yeast rice (2.6%). CONCLUSIONS: This study highlights patient experience with statin-associated muscle symptoms and the strategies recommended by providers in managing these symptoms. More research is needed to develop patient-centric and evidence-based approaches to managing statin-associated muscle symptoms, which is especially important in light of recent data showing increased cardiovascular risk among those who discontinue statin therapy.

Cholesterol lowering by Pediococcus acidilactici LAB4 and Lactobacillus plantarum LAB12 in adult zebrafish is associated with improved memory and involves an interplay between npc1l1 and abca1.

This study assessed the cholesterol lowering effect of Pediococcus acidilactici LAB4 and Lactobacillus plantarum LAB12 using adult zebrafish. Animals were fed with a high cholesterol diet (HCD) with/without LAB for seven weeks. Serum and liver cholesterol was quantified using colorimetric and dye staining methods. Expressions of npc1l1 and abca1 in the liver and intestine and appa in the brain were quantified using RT-PCR. Serum and liver cholesterol was significantly lowered in LAB4- and LAB12-fed zebrafish (≤64% and ≤71%, respectively), with reduced liver cholesterol deposition. The cholesterol lowering effect was accompanied by down-regulation of npc1l1 in intestines (≤28.7%), up-regulation of abca1 in the liver (≥30.5%) and down-regulation of appa in the brain (≤24.5%). A moderately strong positive Pearson correlation (r = 0.617, p < 0.01) was found between appa and serum cholesterol. LAB-fed zebrafish exhibited improved spatial learning and memory. LAB4 and LAB12 can be potentially used in preventing hypercholesterolaemia and Alzheimer's diseases.

Psychometric Evaluation of a Treatment Acceptance Measure for Use in Patients Receiving Treatment via Subcutaneous Injection.

BACKGROUND: Alirocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor, significantly reduces low-density lipoprotein cholesterol, but requires subcutaneous injections rather than oral pills. To measure patients' acceptance of this treatment modality, a new patient-reported outcome, the Injection-Treatment Acceptance Questionnaire (I-TAQ), was developed. OBJECTIVES: To psychometrically evaluate the I-TAQ with patients at high risk of cardiovascular events receiving alirocumab. METHODS: The 22-item, 5-domain I-TAQ was administered cross-sectionally to 151 patients enrolled in alirocumab clinical trials. Item response distributions, factor and multitrait analyses, interitem correlations, correlations with an existing measure of acceptance (convergent validity), and comparison of known-groups were performed to assess the I-TAQ's psychometric properties. RESULTS: Completion rates were high, with no patients missing more than two items and 91.4% missing no data. All items displayed high ceiling effects (>30%) because of high treatment acceptance. Factor analysis supported the a priori hypothesized item-domain structure with good fit indices (root mean square error approximation = 0.070; comparative fit index = 0.988) and high factor loadings. All items demonstrated item convergent validity (item-scale correlation ≥0.40), except for the side effects domain, which was limited by small numbers (n = 46). Almost all items correlated most highly with the domain to which they were assigned (item discriminant validity). Internal reliability was acceptable for all domains (Cronbach α range 0.72-0.88) and convergent validity was supported by a logical pattern of correlations with the Chronic Treatment Acceptance Questionnaire. CONCLUSIONS: These findings provide initial evidence of validity and reliability for the I-TAQ in patients treated with subcutaneous alirocumab. The I-TAQ could prove to be a valuable patient-reported outcome for therapies requiring subcutaneous injection.

Influence of Baseline Psychological Health on Muscle Pain During Atorvastatin Treatment.

BACKGROUND: 3-hydroxy-3-methylglutaryl coenzyme A reductase reductase inhibitors (statins) are generally well tolerated, with statin-associated muscle symptoms (SAMS) the most common side effect (~10%) seen in statin users. However, studies and clinical observations indicate that many of the self-reported SAMS appear to be nonspecific (ie, potentially not attributable to statins). OBJECTIVE: Mental health and well-being influence self-perception of pain, so we sought to assess the effect of baseline well-being and depression on the development of muscle pain with 6 months of atorvastatin 80 mg/d (ATORVA) or placebo in healthy, statin-naive adults. METHODS: The Psychological General Well-being Index (n = 83) and Beck Depression Inventory (n = 55) questionnaires were administered at baseline in participants (aged 59.5 ± 1.2 years) from the effect of Statins on Skeletal Muscle Function and Performance (STOMP) trial (NCT00609063). Muscle pain (Short-Form McGill Pain Questionnaire [SF-MPQ]), pain that interferes with daily life (Brief Pain Inventory [BPI]), and pain severity (BPI) were then measured before, throughout, and after treatment. RESULTS: At baseline, there were no differences in well-being (Psychological General Well-being Index), depression (Beck Depression Inventory), or pain measures (SF-MPQ and BPI) (P values ≥ .05) between the placebo and ATORVA groups. Baseline well-being correlated negatively with baseline BPI pain severity (r = -0.290, P = .008). Baseline depression correlated with baseline pain (SF-MPQ; r = 0.314, P = .020). Baseline well-being and depression did not predict the change in pain severity or interference after 6 months among the total sample or between groups (P values ≥ .05). CONCLUSION: Baseline well-being and depression were not significant predictors of pain after 6 months of ATORVA (P values ≥ .05). Thus, they do not appear to increase the risk of SAMS in otherwise healthy adults.

Factors Affecting Adherence to Statins in Hypercholesterolemic Kuwaiti Patients: A Cross-Sectional Study.

OBJECTIVE: This study examined statin adherence amongst Kuwaiti hypercholesterolemic patients in order to identify factors associated with poor adherence and to determine whether or not an association exists between statin adherence and the risk profile of coronary heart disease (CHD). SUBJECTS AND METHODS: Two hundred hypercholesterolemic patients (30-69 years of age) were recruited from Kuwaiti primary healthcare clinics and interviewed about demographic characteristics, pre-existing self-reported medical conditions and prescribed medications. The Morisky Medication Adherence Scale was used to assess statin adherence (a self-reported, medication-adherence questionnaire divided into 3 levels, with a score of 8 denoting high adherence, 6 to <8 denoting medium adherence and <6 denoting low adherence). Data regarding anthropometric, psychological and serum risk factors were collected using 2 additional questionnaires, laboratory tests and bioelectrical impedance scales. Binary logistic regression was used to determine predictors of adherence and general linear modelling was used to test relationships between continuous outcomes and statin adherence. RESULTS: Of the 200 participants, 117 (58.5%) reported low adherence, 83 (41.5%) reported medium adherence and no patients (0%) scored high adherence. Younger patients (aged 30-50 years) had lower adherence than older patients (>50 years) [odds ratio (OR) 1.05; 95% confidence interval (CI) 1.01-1.09] for every extra year; p < 0.01). Those without diabetes, i.e. 113 (56.5%), were less likely to report medium adherence than those with diabetes (OR 0.42; 95% CI 0.23-0.75; p < 0.01). Low statin adherence was associated with higher levels of plasma cholesterol (p < 0.001) and low-density lipoprotein (p < 0.01). CONCLUSION: In this study, there was a high prevalence of low statin adherence, especially among younger patients with fewer concomitant diseases. The results indicated an inverse relationship between statin adherence and CHD risk profile.