Sildenafil strip on par with tablet form for ED

Sildenafil orally disintegrating strips (ODS) are just as effective and safe as the conventional tablet formulation for the treatment of erectile dysfunction (ED), a Thai study suggests.

“[ODS] are a novel orodispersible drug delivery system that can dissolve rapidly and disperse its payload when placed in the mouth without the need for water … Compared to tablets, [ODS] provide a more convenient delivery method with a reduced risk of choking and a potentially accelerated onset,” said the researchers.

“[In our study,] both sildenafil formulations resulted in significantly improved erectile function after treatment,” they continued.

With sildenafil ODS, there were significant increases in IIEF-5* score (14.47), both at 4 and 8 weeks (17.38 and 18.03, respectively). EHS** also increased from 2.63 to 3.07 and 3.05 at the respective 4- and 8-week timepoints. Sildenafil tablets also generated similar improvements in IIEF-5 score (from 14.67 to 17.46 [4 weeks] and 18.05 [8 weeks]) and EHS (from 2.59 to 3.00 and 3.13, respectively; p<0.001 for all). [Sex Med 2021;9:100453]

Comparisons between the ODS and tablet formulations yielded no significant differences (mean IIEF-5 scores, 17.69 vs 17.75; p=0.89 and mean EHS, 3.06 vs 3.07; p=0.95), suggesting the comparable efficacy between the two formulations.

From a clinical perspective, the scores shifted from the mild-to-moderate ED scale range pretreatment to the mild range post-treatment, the researchers noted. “[Men] with moderate ED are unable to have successful sexual intercourse because of insufficient penile erection, whereas those with mild ED are able to have successful sexual activity despite a possible decrease in penile erection. Both formulations significantly improved penile erection to the point where achieving successful sexual activity was likely.”

Flushing was more common with tablet vs ODS (9 percent vs 4 percent; p=0.04). Should this become intolerable for tablet users, the ODS formulation may be a viable alternative, noted the researchers. The rates of the most common adverse events were similar between the tablet and ODS arms (12 percent for both [headaches] and 12 percent vs 10 percent [nasal congestion]).

One better than the other in some aspects?

There were no significant differences between ODS and tablet in terms of onset (47.11 vs 54.21 minutes; p=0.58) and duration of action times (85.86 vs 90.84 minutes; p=0.74). “[However, the] slight differences may still have clinical ramifications,” the researchers pointed out. “An onset of action time that was 7 minutes faster [and a duration of action time that was 5 minutes longer] than the conventional response time may be considered clinically significant by some ED patients.”

The tablet had a little edge over ODS in terms of preference, with 53 percent of participants rooting for the former over the latter owing to convenience.

An alternative for a more spontaneous response

A total of 120 men with ED (mean age 64.48 years) were allocated equally into two arms. They initially received sildenafil ODS*** (50 mg) or tablet*** (100 mg) for 8 weeks. A 4-week wash-out period ensued thereafter, followed by a cross over into the alternate formulation for another 8 weeks.

“[Despite the lack of blinding and a placebo arm,] the study design afforded each patient the opportunity to use both treatment formulations, thereby informing their preference for one or the other,” said the researchers.

“[Taken together,] the present data indicate that both [sildenafil] formulations had comparable efficacy and safety profiles,” they said. While the tablet formulation continues its reign in the market, ODS offer an alternative for ED treatment when a more natural or spontaneous response is desired, consequently improving the health and quality of life of both patients and their partners.