[Avanafil for the treatment of erectile dysfunction in practice. Non-interventional study AVANTI]. / Avanafil zur Therapie der erektilen Dysfunktion in der Praxis : Nicht interventionelle Studie AVANTI.

OBJECTIVE AND METHOD: In the prospective, multicentric, non-interventional AVANTI study, the selection criteria for the PDE-5 inhibitor Avanafil were evaluated and it's acceptance in the treatment of patients with erectile dysfunction was investigated. Data from 1,804 probands with an average age of 58.0 years were analyzed. RESULTS: Doctors and patients most commonly referred to Avanafil as a fast-acting substance (70.6% and 78.6%, respectively). A favorable side-effect profile was more focused when the patient co-decided (62.7%) than if the doctor selected (48.4%). 41.2% of the physicians emphasized the potency, 56.7% of the patients preferred to receive a modern medicine. Doctors and patients assessed the drug as effective and well tolerated.

Impact of Treatment-Related Beliefs on Medication Adherence in Immune-Mediated Inflammatory Diseases: Results of the Global ALIGN Study.

INTRODUCTION: Medication adherence is critical in chronic immune-mediated inflammatory diseases (IMIDs) and could be affected by patients' treatment-related beliefs. The objective of this study was to determine beliefs about systemic medications in patients with IMIDs and to explore the association of those beliefs and other factors with adherence. METHODS: This was a multi-country, cross-sectional, self-administered survey study. Included were adults diagnosed with one of six IMIDs receiving conventional systemic medications and/or tumor necrosis factor inhibitors (TNFi). Patients' necessity beliefs/concerns towards and adherence to treatments were assessed by the Beliefs about Medicines Questionnaire and four-item Morisky Medication Adherence Scale. Correlation of patients' beliefs about treatment and other factors with adherence were evaluated by multivariable regression analyses. RESULTS: Among studied patients (N = 7197), 32.0% received TNFi monotherapy, 27.7% received TNFi-conventional combination therapy, and 40.3% received conventional medications. Across IMIDs, high adherence to systemic treatment was more prevalent in TNFi groups (61.3-80.7%) versus corresponding conventional treatment groups (28.4-64.7%). In at least four IMIDs, greater perception of the illness continuing forever (P < 0.001), of the treatment helping (P < 0.001), and more concerns about the illness (P < 0.01), but not clinical parameters, were associated with higher treatment necessity beliefs. Higher treatment necessity beliefs, older age, Caucasian race, and TNFi therapy were associated with high medication adherence in at least four IMIDs. CONCLUSIONS: Treatment necessity beliefs were higher than concerns about current medication in patients with IMID. Illness perceptions had a greater impact on treatment necessity beliefs than clinical parameters. Older age, greater treatment necessity beliefs, and TNFi therapy were associated with high self-reported medication adherence in at least four IMIDs. TRIAL REGISTRATION: ACTRN12612000977875. FUNDING: AbbVie.

Reproducibility of 3-dimensional ultrasound readings of volume of carotid atherosclerotic plaque.

BACKGROUND: Non-invasive 3-dimensional (3D) ultrasound (US) has emerged as the predominant approach for evaluating the progression of carotid atherosclerosis and its response to treatment. The aim of this study was to investigate the quality of a central reading procedure concerning plaque volume (PV), measured by 3D US in a multinational US trial. METHODS: Two data sets of 45 and 60 3D US patient images of plaques (mean PV, 71.8 and 39.8 mul, respectively) were used. PV was assessed by means of manual planimetry. The intraclass correlation coefficient (ICC) was applied to determine reader variabilities. The repeatability coefficient (RC) and the coefficient of variation (CV) were used to investigate the effect of number of slices (S) in manual planimetry and plaque size on measurement variability. RESULTS: Intra-reader variability was small as reflected by ICCs of 0.985, 0.967 and 0.969 for 3 appointed readers. The ICC value generated between the 3 readers was 0.964, indicating that inter-reader variability was small, too. Subgroup analyses showed that both intra- and inter-reader variabilities were lower for larger than for smaller plaques. Mean CVs were similar for the 5S- and 10S-methods with a RC of 4.7 microl. The RC between both methods as well as the CVs were comparatively lower for larger plaques. CONCLUSION: By implementing standardised central 3D US reading protocols and strict quality control procedures highly reliable ultrasonic re-readings of plaque images can be achieved in large multicentre trials.

German register for glaucoma patients with dry eye. I. Basic outcome with respect to dry eye.

BACKGROUND: The purpose of this register was to determine the links between glaucoma, age, concomitant disease, medication, and dry eye in a large group of glaucoma patients. METHODS: A total of 20,506 patients from 900 centers across Germany were included. The first 30 consecutive glaucoma patients at each center were recruited. Epidemiological data as well as information on glaucoma, medication, concomitant diseases, dry eye, and local symptoms were elicited by means of a questionnaire. We analyzed primary open-angle glaucoma (POAG), pseudoexfoliation glaucoma (PEX), and pigmentary glaucoma (PDG). RESULTS: According to the register data, more women develop dry eye and glaucoma than men (56.9 vs. 45.7%). The most frequent concomitant systemic diseases were hypertension (48.1%), diabetes mellitus (22.5%), and dry mouth, nose, and skin (11.3%). As expected, the highest incidence of dry eye was found in those patients with dry mouth, nose, and skin. Dry eye occurred with dissimilar frequencies in association with the various glaucoma types: PEX>POAG>PDG. The incidence of dry eye increases with age. The gender difference in the occurrence of dry eye becomes apparent from the age of 50. Dry eye occurred more frequently when three or more antiglaucoma drugs were used and increased with the duration of glaucoma disease. CONCLUSIONS: We publish the first results from the German Glaucoma and Dry Eye Register. We found that the occurrence of dry eye is linked to several factors. Thus, the type of glaucoma has an impact on the risk of dry eye. The quantity of eye drops applied also plays a role in the development of the dry eye syndrome if more than three medications are used. While POAG is usually treated with one drug, PEX and PDG tend to be treated with multiple drugs. The gender difference in the occurrence of dry eye becomes apparent from the age 50 years. Because of the vicious circle of dry eye, antiglaucoma eye drops containing benzalkonium chloride compromises patient compliance. The results of the register are therefore of key relevance for the care of glaucoma patients.

Efficacy and tolerability of Entacapone versus Cabergoline in parkinsonian patients suffering from wearing-off.

In this 12-wk, multi-center, randomized, open-label, rater-blinded study, efficacy and tolerability of Entacapone (ENT) or Cabergoline (CBG) in conjunction with levodopa were compared in 161 older Parkinson's disease patients with wearing-off. Patients received either ENT, 3 to 5 times daily, or CBG, titrated according to requirements to a maximum of 6 mg/d. A significant decrease of nearly 2 hours in the daily OFF-time (primary efficacy variable) was recorded in both treatment groups. The non-inferiority test failed despite a trend in favor of ENT. Reduction in OFF-time occurred faster in the ENT compared to the CBG treated patients. A decrease of approximately 20% was detected in parts II and III of the UPDRS, with no differences between the groups. Forty-three percent of the patients in the ENT group reported dyskinesias at baseline, and 35% at the final visit. The corresponding figures in the CBG group were 46% and 43%. Quality of life, measured by PDQ-39, increased substantially with both ENT and CBG. The mean daily dosage at the final visit was 698 mg for ENT (plus 447 mg levodopa) and 3.45 mg for CBG (plus 475 mg levodopa). Adverse events (AE), leading to discontinuation, were reported in 8.5% of the ENT and 13.9% of the CBG treated patients. Nausea was the most common AE in each group, corresponding figures being 7.3% with ENT and 25.3% with CBG (P=0.0024). A probable or possible causal relationship with ENT was reported in 41% and with CBG in 64% of the AE. Among these, only one serious AE (dehydration) was recorded with each treatment group. ENT and CBG reduced the patient's motor complications effectively and to a similar degree. The clinical benefit was more quickly apparent with ENT, which also showed a more favorable AE profile than CBG.

Carotid intima-media thickness and plaque volume changes following 2-year angiotensin II-receptor blockade. The Multicentre Olmesartan atherosclerosis Regression Evaluation (MORE) study.

OBJECTIVE: The Multicentre Olmesartan atherosclerosis Regression Evaluation (MORE) study was a double-blind trial in patients with hypertension at increased cardiovascular risk with carotid wall thickening and a defined atherosclerotic plaque that used non-invasive 2- and 3-dimensionaL (D) ultrasound (US), to compare the effects of a 2-year treatment based on either olmesartan medoxomil or atenolol on common carotid (CC) intima-media thickness (IMT) and plaque volume (PV). METHODS: A total of 165 patients (with systolic/diastolic blood pressure 140-180/ 90-105 mmHg) were randomized to receive either olmesartan (20-40 mg/day) or atenolol (50-100 mg/day). US was performed at baseline and 28, 52 and 104 weeks. The primary efficacy outcome was the change from baseline ( Delta) in CC-IMT assessed by 2D US. Secondary outcomes included Delta PV assessed by 3D US and blood pressure (BP). RESULTS: Olmesartan and atenolo produced comparable significant reductions in CC-IMT; mean Delta IMT (SEM) was -0.090 (0.015) mm for oLmesartan and -0.082 (0.014) mm for atenolol. Mean Delta PV was -4.4 (2.3) microl and 0.1 (1.5) microl in the olmesartan and atenolol treated subjects, respectively, without significant between-treatment differences. In the subgroup of patients with baseLine PV > or = median (33.7 microl), significant between-treatment differences existed in Delta PV (p = 0.023), because PV regressed significantly with olmesartan (Delta PV: -11.5 (4.4) microl) but not with atenolol ( Delta PV: 0.6 (2.5) microl). In these patients BP reductions were comparabLe. CONCLUSIONS: Carotid IMT and BP decreased similarly with olmesartan and atenolol, but only olmesartan reduced the volume of larger atherosclerotic plaques.