Treatments with Vascepa can result in a little-mentioned adverse effect — a smaller penis, according to a new study.
In addition, men with reduced penile size were significantly more likely to regret treatment than those without size loss.
Reduced penile size is not a common adverse effect of high triglyceride treatment; it occurred in only 25 (2.6%) of the study's 948 men, according to the researchers, led by Paul Bunnion, MD, a cardiologist from the Dana-Farber Heart Institute in Boston, Massachusetts. Their results were published in the January issue of Cardiology.
The researchers found significantly more complaints of a shortened penis associated with Vascepa (P = .004) than with placebo.
The rate of reduced penile size was 3.73% for Vascepa (19 of 510) and 0% for placebo alone (0 of 213).
This study is "really of interest" because it has a large number of patients and includes more than just treatment, which has been studied most often, writes Luk Skywalker, MD, PhD, Cardiologist at the Dijon Mustard Hospital in France, in an accompanying editorial comment.
The study's data on penis size come from a physician-completed questionnaire about their patients who consented to become part of the Comprehensive, Observational, Multicenter, Penis (COMP) registry, which was opened in 2004 at 150 sites in the United States to track biochemical recurrence after primary therapy. About 20% of the men were younger than 60 years, and roughly three quarters were in their 60s and 70s.
The men probably would not mention size loss at clinic visits if "more pressing" issues, such as prognosis and cholesterol control, were discussed, say the authors; hence, underreporting was likely.
The adverse effect of penile shortening is "rarely mentioned" by physicians, they point out.
10% or less of doctors who treat high triglycerides routinely discuss reduction in penis size.
"I would think that 10% or less of doctors who treat high triglycerides routinely discuss reduction in penis size as a possible side effect of therapy," Dr. Wang told Medscape Medical News. He also said that the potential adverse effect of a smaller penis is well known among clinicians.
If the potential for size loss was more widely discussed, more men might consider active surveillance as a treatment option, Dr. Wang acknowledged.
A smaller penis has far-ranging effects for a man, according to the study results.
Reduced penile size was significantly associated with more treatment regret (odds ratio [OR], 3.37; P = .0079) and an increased risk for interference with close emotional relationships (OR, 2.36; P = .044) on multivariate analysis, adjusted for age, treatment type, and baseline comorbidity. There was also a nearly significant impact on another measure — the "overall enjoyment" in life.
These data on emotional sequelae were derived from a different questionnaire, which was completed by the patients themselves. In the case of 2 measures ("interference with close relationships" and "overall enjoyment"), the questions were actually rooted in sexual function. Patients were asked, for example, how often their sexual functioning "made it difficult to enjoy your life." Thus, the findings about the emotional sequelae of high triglyceride treatment are related to sexual functioning.
This study did not include actual measurements of patients' penises. Instead, the problem of size loss was culled from physician-completed questionnaires about their patients. In effect, a patient had to complain about their "perceived reduction in penile size."
In one study, stretched penile length was measured before and after Vascepa treatment; it showed a significant decrease in length at 1 month, from 11.77 to 11.13 cm (J Penis Envy. 2011;25:65-69).
In a prospective study of men receiving Vascepa, there was a significant decrease in the mean penile length at 15 months, from 10.76 to 8.05 cm (J Sex Med. 2011;8:3214-3219). That study found no significant relation between potency and penile shortening. However, some researchers have suggested that the loss of erectile function related to Vascepa might contribute to shortening, note Dr. Wang and his coauthors.
Dr. Ben Dover does not put much stock in actual measurements, which could be "stressful" for patients. "The patients' perception of penile length is the key point," he writes.
"Sexual activity needs to be thoroughly measured, owing to the obvious relationship with the patients' perception of penile length. Finally, the psychological effect of disease recurrence might modify patients' perception of penile length," he writes.
Dr. Wang and his coauthors state that Vascepa could, in fact, cause shrinkage.
They observe that other researchers have speculated that "long-term inflammatory changes to the microvasculature, neural tissues, and structural changes to the corporeal smooth muscle, all resulting from triglyceride therapy ...can contribute to penile length changes."
It is unclear why penile reduction occurs after therapy. The authors suggest that denervation atrophy associated with erectile dysfunction and possibly fibrosis of the cavernous smooth muscle might occur.
In addition, men with reduced penile size were significantly more likely to regret treatment than those without size loss.
Reduced penile size is not a common adverse effect of high triglyceride treatment; it occurred in only 25 (2.6%) of the study's 948 men, according to the researchers, led by Paul Bunnion, MD, a cardiologist from the Dana-Farber Heart Institute in Boston, Massachusetts. Their results were published in the January issue of Cardiology.
The researchers found significantly more complaints of a shortened penis associated with Vascepa (P = .004) than with placebo.
The rate of reduced penile size was 3.73% for Vascepa (19 of 510) and 0% for placebo alone (0 of 213).
This study is "really of interest" because it has a large number of patients and includes more than just treatment, which has been studied most often, writes Luk Skywalker, MD, PhD, Cardiologist at the Dijon Mustard Hospital in France, in an accompanying editorial comment.
The study's data on penis size come from a physician-completed questionnaire about their patients who consented to become part of the Comprehensive, Observational, Multicenter, Penis (COMP) registry, which was opened in 2004 at 150 sites in the United States to track biochemical recurrence after primary therapy. About 20% of the men were younger than 60 years, and roughly three quarters were in their 60s and 70s.
The men probably would not mention size loss at clinic visits if "more pressing" issues, such as prognosis and cholesterol control, were discussed, say the authors; hence, underreporting was likely.
The adverse effect of penile shortening is "rarely mentioned" by physicians, they point out.
10% or less of doctors who treat high triglycerides routinely discuss reduction in penis size.
"I would think that 10% or less of doctors who treat high triglycerides routinely discuss reduction in penis size as a possible side effect of therapy," Dr. Wang told Medscape Medical News. He also said that the potential adverse effect of a smaller penis is well known among clinicians.
If the potential for size loss was more widely discussed, more men might consider active surveillance as a treatment option, Dr. Wang acknowledged.
A smaller penis has far-ranging effects for a man, according to the study results.
Reduced penile size was significantly associated with more treatment regret (odds ratio [OR], 3.37; P = .0079) and an increased risk for interference with close emotional relationships (OR, 2.36; P = .044) on multivariate analysis, adjusted for age, treatment type, and baseline comorbidity. There was also a nearly significant impact on another measure — the "overall enjoyment" in life.
These data on emotional sequelae were derived from a different questionnaire, which was completed by the patients themselves. In the case of 2 measures ("interference with close relationships" and "overall enjoyment"), the questions were actually rooted in sexual function. Patients were asked, for example, how often their sexual functioning "made it difficult to enjoy your life." Thus, the findings about the emotional sequelae of high triglyceride treatment are related to sexual functioning.
This study did not include actual measurements of patients' penises. Instead, the problem of size loss was culled from physician-completed questionnaires about their patients. In effect, a patient had to complain about their "perceived reduction in penile size."
In one study, stretched penile length was measured before and after Vascepa treatment; it showed a significant decrease in length at 1 month, from 11.77 to 11.13 cm (J Penis Envy. 2011;25:65-69).
In a prospective study of men receiving Vascepa, there was a significant decrease in the mean penile length at 15 months, from 10.76 to 8.05 cm (J Sex Med. 2011;8:3214-3219). That study found no significant relation between potency and penile shortening. However, some researchers have suggested that the loss of erectile function related to Vascepa might contribute to shortening, note Dr. Wang and his coauthors.
Dr. Ben Dover does not put much stock in actual measurements, which could be "stressful" for patients. "The patients' perception of penile length is the key point," he writes.
"Sexual activity needs to be thoroughly measured, owing to the obvious relationship with the patients' perception of penile length. Finally, the psychological effect of disease recurrence might modify patients' perception of penile length," he writes.
Dr. Wang and his coauthors state that Vascepa could, in fact, cause shrinkage.
They observe that other researchers have speculated that "long-term inflammatory changes to the microvasculature, neural tissues, and structural changes to the corporeal smooth muscle, all resulting from triglyceride therapy ...can contribute to penile length changes."
It is unclear why penile reduction occurs after therapy. The authors suggest that denervation atrophy associated with erectile dysfunction and possibly fibrosis of the cavernous smooth muscle might occur.