Treatment Satisfaction of Men and Partners Following Switch from On‐Demand Phosphodiesterase Type 5 Inhibitor Therapy to Tadalafil 5 mg Once Daily

IntroductionTreatment satisfaction of men receiving phosphodiesterase 5 inhibitors (PDE5) for erectile dysfunction (ED) and their partners is essential to successful long‐term therapy.AimThis study aims to assess treatment satisfaction, in men with a partial response to on‐demand (PRN) PDE5 and their female partners, following tadalafil 5 mg once daily or placebo.MethodsThe study was randomized, double‐blind, parallel, and placebo‐controlled in men primarily with mild to moderate ED. Treatment satisfaction was assessed following a 4‐week maximum dose PRN lead‐in, 4‐week nondrug washout, and treatment through 12 weeks. Men were ≥18 years old with ED for ≥3 months and International Index of Erectile Function Erectile Function score of ≥17 and <26 at screening and <26 following PRN lead‐in.Main Outcome MeasuresTreatment satisfaction was assessed using the Treatment Satisfaction Scale (TSS) for patients and partners. TSS domain scores range from 0 to 100, with higher values indicating greater satisfaction. Statistical comparisons were made using analysis of covariance.ResultsTreatment satisfaction was significantly greater with tadalafil once daily vs. placebo across all TSS domains for both patients and their partners (all P < 0.001). For patients, mean scores for the TSS domains Confidence to Complete Sexual Activity and Satisfaction with Orgasm ranged from 53.7 to 57.8 after the PRN lead‐in and 26.7 to 31.9 following the nondrug washout. Following randomized treatment, scores for tadalafil and placebo were 55.4 and 32.6, respectively, for Confidence to Complete Sexual Activity and 57.5 and 37.9, respectively, for Satisfaction with Orgasm. Results were comparable for other TSS domains and between men and their partners.ConclusionsTreatment satisfaction was comparable for tadalafil 5 mg once daily and PRN PDE5 for both patients and female partners, suggesting that tadalafil once daily is a viable therapy option for men with ED who had a partial response to PRN PDE5 therapy. Burns PR, Rosen RC, Dunn M, Baygani SK, and Perelman MA. Treatment satisfaction of men and partners following switch from on‐demand phosphodiesterase type 5 inhibitor therapy to tadalafil 5 mg once daily. J Sex Med 2015;12:720–727.     

Clinical efficacy and adverse effects of weekly single dose leflunomide in refractory rheumatoid arthritis

AimTo study the clinical efficacy and adverse events of weekly single dose of leflunomide in patients with refractory rheumatoid arthritis in comparison with conventional daily regimen.MethodsPatients with refractory rheumatoid arthritis were taken up for the study; 91 patients were enlisted of whom 3 became non-compliant and were excluded. A concurrent parallel study was designed with the patients divided into two groups and efficacy and adverse events recorded at third and sixth months.ResultsA total of 88 patients were included in the study and were divided into two groups. At the end of 6 months, in the daily group 37 (82.2%) out of 45 patients had disease activity score (DAS) less than 3.2 indicating a low disease activity and 8 patients (17.8%) had moderate disease activity. None had high disease activity. In the weekly group, 36 (83.7%) out of 43 patients had low disease activity and 7 (16.3%) had moderate disease. None had high disease activity. Four (8.9%) patients developed adverse reactions in the daily group. One patient (2.2%) had alopecia and the other (2.2%) had diarrhoea and were withdrawn from the study. Two (4.4%) patients had elevated liver enzymes and the drug was stopped at 6 months. None in the weekly group reported any adverse events.ConclusionsWeekly regimen was found to be better in terms of compliance and had a lower adverse effect profile. The result was statistically significant. Clinical efficacy of weekly therapy was found to be similar to that of conventional therapy in terms of DAS.     

Multivariate modelling of responses to conditional items: New possibilities for latent class analysis

Questionnaire data may contain missing values because certain questions do not apply to all respondents. For instance, questions addressing particular attributes of a symptom, such as frequency, triggers or seasonality, are only applicable to those who have experienced the symptom, while for those who have not, responses to these items will be missing. This missing information does not fall into the category ‘missing by design’, rather the features of interest do not exist and cannot be measured regardless of survey design. Analysis of responses to such conditional items is therefore typically restricted to the subpopulation in which they apply. This article is concerned with joint multivariate modelling of responses to both unconditional and conditional items without restricting the analysis to this subpopulation. Such an approach is of interest when the distributions of both types of responses are thought to be determined by common parameters affecting the whole population. By integrating the conditional item structure into the model, inference can be based both on unconditional data from the entire population and on conditional data from subjects for whom they exist. This approach opens new possibilities for multivariate analysis of such data. We apply this approach to latent class modelling and provide an example using data on respiratory symptoms (wheeze and cough) in children. Conditional data structures such as that considered here are common in medical research settings and, although our focus is on latent class models, the approach can be applied to other multivariate models. Copyright © 2009 John Wiley & Sons, Ltd.