Topical Agent for Premature Ejaculation

SOURCE: Mark KP, Kerner I. Event-level impact of Promescent on quality of sexual experience in men with subjective premature ejaculation. Int J Impot Res 2016;28:216-220.

Premature ejaculation (PE) reportedly is the most common sexual dysfunction in men, even outstripping the prevalence of erectile dysfunction. This may surprise clinicians, since patients do not present often with that complaint, nor is it routine — except when encounters specifically are focused on sexual health — for clinicians to inquire about PE.

Currently, there are no drugs specifically approved for PE; instead, clinical trials documenting the efficacy of selective serotonin reuptake inhibitors (SSRIs) and tramadol for PE have led to their off-label use as often effective treatments.

In this open-label trial in which patients (n = 91) were their own control, investigators invited study subjects who self-designated as PE and fulfilled criteria of a PE diagnostic tool to try topical Promescent (trade name) spray on their penis prior to intercourse. The active ingredient in Promescent is lidocaine.

According to the pre-set parameters of the study, Promescent was efficacious in that it essentially doubled the time to ejaculation; additionally, study subjects believed that the product was easy to use, with minimal interruption of sexual activity.

On the other hand, the latency time (time from intromission until ejaculation) was quite atypical compared to most of the PE trials in the literature. That is, in the Promescent trial, baseline ejaculatory latency time was 6.81 minutes, increasing to 11.16 minutes with treatment.

Previous trials with SSRIs enrolled PE subjects with an ejaculatory latency time of 30 seconds, which would typically increase to three to four minutes with treatment.

In any case, Promescent was effective in prolonging time to ejaculation, and was well tolerated.


Are We Using Novel Oral Anticoagulants Wisely?

SOURCE: Barra ME, Fanikos J, Connors JM, et al. Evaluation of dose-reduced direct oral anticoagulant therapy. Am J Med 2016;129:1198-1204.

There is little dispute over whether the so-called novel oral anticoagulants (NOACs), currently comprised of apixaban, dabigatran, edoxaban, and rivaroxaban, are as efficacious as warfarin, as well as simpler to use, since food interactions are minimal.

NOACs individually include labeling that calls for potential dose adjustments for chronic kidney disease, low body weight, and interacting substances (agents with p-glycoprotein and/or P450 interactions). Have clinicians performed dose-adjustments appropriately?

Barra et al retrospectively analyzed data from 224 patients who had been prescribed reduced-dose NOACs to determine if the dose reductions had been according to appropriate indications (as per labeling) as well as appropriate in amount of dose reduction.

Less than half the patients who had been prescribed reduced-dose NOACs matched labeling criteria for such dose reduction. It may have been that concern over bleeding risk prompted prescribers to choose dose reduction; however, bleeding rates even within this group of patients receiving reduced-dose NOAC actually were higher than had been seen in clinical trials of NOACs.

How dose adjustment based on clinician judgment, as opposed to specific FDA labeling, will affect long-term outcomes remains to be determined.


Lung Cancer Screening at a VA Medical Center

SOURCE: Okereke IC, Bates MF, Jankowich MD, et al. Effects of implementation of lung cancer screening at one Veterans Affairs medical center. Chest 2016;150:1023-1029.

Thanks to favorable results from a very large clinical trial of low-dose CT lung cancer screening (n > 53,000) that showed not only a reduction in lung cancer mortality but also all-cause mortality, it is incumbent on clinicians to offer screening to appropriately selected patients.

Experience at a VA medical center in Providence, RI, appears to favorably reflect some of the track record of the aforementioned National Lung Screening Trial.

When Okereke et al compared identification of lung nodules in a pre-screening period (2011-2013) to the 2013-2014 screening interval, they noted a distinct “downgrading” of lung cancer staging achieved through screening; that is, prior to screening, 37% of lung cancers were early stage (Stage I or Stage II). During the screening interval, 60% of identified lung cancers were early stage.

The prevalence of smoking usually is higher in VA medical center settings than the general public. Lung cancer screening in this population assists in identifying lung cancer at an earlier, more survivable stage.