Clinical Briefs By Louis Kuritzky
By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is an advisor for Endo, Kowa, Pricara, and Takeda.
Once-daily Tadalafil for ED: Efficacy and Safety
By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville
Source: Seftel AD, et al. Int J Impot Res 2013;25:91-98.
The utilization of pde5 inhibition (PDE5-i) for restoration of sexual function in men suffering erectile dysfunction (ED) is well established, beginning with the introduction of sildenafil (Viagra) in 1998. In the earliest years of PDE5-i treatment, regimens were typically targeted to PRN use. Almost a decade later, consideration of lower-dose, daily use of tadalafil became popular.
In this retrospective analysis, Seftel et al report on the safety and efficacy of once-daily tadalafil (TAD-QD) in doses ranging from 2.5-10.0 mg/day. The rationale for their study was to specifically define whether age impacts the efficacy of TAD-QD, since older men (age > 50 years, by their definition) might be more refractory to PDE5-i than younger men (age < 50 years). Additionally, they wished to examine the tolerability profile of TAD-QD in men with mild-moderate ED, who comprise the largest segment of men taking PDE5-i. The dataset used in this analysis included 522 men, predominantly Caucasian (> 75%), most of whom had long-standing ED and about half of whom had comorbidities of hypertension and/or diabetes.
TAD-QD more than doubled the rates of successful intercourse (from 33.4% pretreatment to 76.8% on treatment), with no discernible difference in younger men vs older men. TAD-QD was also well tolerated, with the most common adverse events headache, dyspepsia, and myalgias consistent with what has been seen in prior literature.
The authors conclude that TAD-QD provides substantial improvements in ED, independent of age, in men with mild-moderate ED, and is well tolerated.
Psychological Disorders: How to Give Patients What They Want and What They Need
Source: McHugh RK, et al. J Clin Psych 2013;74:595-602.
Commonplace psychiatric disorders such as anxiety, depression, posttraumatic stress disorder, and obsessive compulsive disorder respond to pharmacotherapy, psychotherapy, and their combination. The National Comorbidity Survey Replication data have indicated that persons with psychiatric disorders often do not use mental health services because of perceived barriers to access (e.g., cost, logistics). Identification of patient preferences for treatment is of value not only for patient satisfaction, but also because clinical outcomes are better among patients who receive their treatment of choice. Additionally, patients who are concordant with the therapeutic choice have been reported to be more adherent with therapy.
Data from 34 clinical trials (total patient n = 90,071) were assessed by meta-analysis. Overall, patients expressed a preference for psychological treatment over pharmacotherapy by 3:1. This preference was consistent irrespective of the underlying psychiatric disorder studied, including depression, anxiety, and hypochondriasis. The availability of additional alternatives (e.g., combination treatment, watchful waiting, no treatment) did not affect the balance of patient preferences.
At the current time, treatment of patients with mild-moderate psychiatric disorders with pharmacotherapy vs psychotherapy is at equipoise. Hence, identification of patient preference in situations where outcomes are similar between choices is a sensible direction to take. This large literature base suggests that as many as 75% of patients with commonplace psychiatric issues prefer psychological treatment to pharmacotherapy. Although pharmacotherapy is often a more expedient path for primary care clinicians, the importance of addressing patient preference is well highlighted by this study.
Reducing Stroke Risk After TIA or Minor Ischemic Stroke
Source: Wang Y, et al. N Engl J Med 2013;369:11-19.
The very large clopidogrel for high Atherothrombotic Risk and Ischemic Stabilization, Management, and Avoidance (CHARISMA) clinical trial concluded that dual antiplatelet therapy in stable ambulatory vasculopathic patients who are distant at least 1 year post-MI, post-stroke from their vascular event does not meaningfully reduce risk over monotherapy, and is associated with increased risk of bleeding. As convincing as this dataset is, it only addresses populations who are distant from their vascular event, rather than subjects who are in the higher risk period immediately following an acute event.
The Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events (CHANCE) trial enrolled within 24 hours of onset Chinese subjects (n = 5170) who had sustained a minor ischemic stroke or transient ischemic attack (TIA). Subjects were randomized to treatment (double-blind) with low-dose aspirin (75 mg/d-300 mg/d) plus clopidogrel (300 mg on day 1, then 75 mg/d [CLO + ASA]) or low-dose aspirin plus placebo (ASA). The primary outcome was incidence of stroke (ischemic or hemorrhagic) over 90 days of follow-up.
CLO + ASA was associated with a 32% reduction in risk for stroke compared to aspirin alone. Risk for central nervous system hemorrhage was no different in the CLO + ASA group than ASA alone. In the immediate post-TIA/minor stroke period (up to 90 days), dual antiplatelet treatment meaningfully reduced risk without increasing bleeding.
