Clinical Briefs
By Louis Kuritzky, MD, Clinical Assistant Professor, University of Florida, Gainesville. Dr. Kuritzky is an advisor for Endo, Kowa, Pricara, and Takeda.
Adverse Effects on Semen from SSRI Treatment of Premature Ejaculation
Source: Koyuncu H, et al. Int J Impot Res 2011;23:257-261.
Several treatments have been shown to be highly effective in management of premature ejaculation (pEJ), including behavioral therapy, systemic modulation of serotonin, and topical agents. The most popular current treatment is sustained use of selective serotonin reuptake inhibitors (SSRIs), which typically increase intravaginal latency (the time from intromission to ejaculation) from pretreatment times of < 1 minute to over 5 minutes. There has been little study of the impact of SSRI treatment on parameters such as semen, perhaps because most of the pEJ trials have been short-term. Studies in which SSRIs are added to semen preparations in vitro have shown adverse changes in sperm motility and viability, prompting consideration of potential adverse effects from systemically administered SSRIs.
Escitalopram is an SSRI sometimes used to treat pEJ. To elucidate the effects of escitalopram on semen, subjects with lifelong pEJ (n = 25) and normal baseline semen analysis were enrolled. Additionally, at baseline all subjects had normal scrotal ultrasound, CBC, glucose, hormone levels, lipid levels, and genito-rectal examinations.
At 1 month, no alterations in semen were detected. However, at 3 months there were multiple statistically significant changes: sperm count decreased (68 million/mL to 26 million/mL), number of motile spermatozoa decreased by more than 50%, and the number of morphologically normal sperm decreased by over 50%. In the absence of a control group, these findings cannot be considered definitive. Additionally, it is possible that sperm function might return to pretreatment levels upon drug discontinuation. However, the prominent effects on semen within a short interval merit our awareness.
Establishing the CV Safety Profile of ADHD Meds in Children and Young Adults
Source: Cooper WO, et al. N Engl J Med 2011;365:1896-1904.
Case reports of adverse cardiovascular (CV) events in children and young adults taking attention deficit-hyperactivity disorder (ADHD) medications have included myocardial infarction (MI), stroke, and sudden death. These individual cases, however, neither prove causation nor provide insight into event frequency, since the denominator is unknown. Because of the seriousness of these events, a clearer understanding of their epidemiology is important.
Cooper et al performed a retrospective cohort study based on data from four large health plans, which included data from more than 1 million persons 2-24 years of age. Among this population, there were data on 373,667 person-years of ADHD drug treatment in these children and young adults.
In this entire population, there were 81 serious CV events (rate = 3.1/100,000 person-years). However, persons currently using ADHD drugs did not demonstrate an increased risk for CV events compared to non-users; in fact, the hazard ratio (HR) demonstrated a trend (not statistically significant) toward fewer serious CV events in persons taking ADHD medications (HR = 0.75). Whether CV events were looked at in composite (MI + stroke + sudden death) or individually, the same generally favorable trend was seen (HR = 0.70, P = NS). Similarly, former users of ADHD medications were at no greater risk for CV events than never-users. This study was not funded by industry, but by the federal agencies AHRQ and FDA.
If You're Already on a Statin, Does Adding Niacin Help?
Source: AIM-HIGH Investigators. N Engl J Med 2011;365:2255-2267.
Results from intervention trials with statins for secondary prevention of cardiovascular (CV) events are consistently impressive. Nonetheless, significant residual risk remains; that is, even though statin treatment reduces risk of events by as much as 20-30% over 5 years, persons with existing CV disease are still at substantially greater risk of having another CV event than age-matched controls without CV disease. Observational studies suggest that increasing high-density lipoprotein (HDL) might provide an even greater incremental CV risk reduction than LDL modulation, although evidence from interventional trials is conflicting.
The AIM-HIGH trial enrolled patients with existing CV disease (n = 3414) who were already receiving simvastatin (plus ezetimibe if LDL goals were not attained with simvastatin alone). Study subjects were randomized to extended-release niacin or placebo.
Although intended to conclude after 4.6 years, the study was stopped early (at 3 years) subsequent to the recommendation by the data and safety monitoring board that the trial be discontinued due to both a lack of positive efficacy as well as an unanticipated elevation of ischemic stroke in niacin recipients. Adding niacin to statins in persons with stable atherosclerotic vascular disease does not reduce CV events.
Several treatments have been shown to be highly effective in management of premature ejaculation (pEJ), including behavioral therapy, systemic modulation of serotonin, and topical agents.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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