Research highlights safety and efficacy of novel treatment option for hypogonadism over 52-week period
This news release from the American Urological Association reports phase 3 trial results of an oral testosterone replacement therapy for male hypogonadism, a condition in which the body doesn’t produce enough testosterone, sperm, or both. Drug developer Lipocine Inc. anticipates that its LPCN 1021 testosterone formula soon will replace topical products that now dominate the booming testosterone market. During the 52-week trial, 315 hypogonadal men were given either LPCN 1021 or a control, T gel. The news release reports that the study showed LPCN 1021 was “shown to be safe and efficacious” and quotes an association spokesman saying, “Based on the results of this study, we might be closer than ever to having an oral form of therapy to treat the millions of men with hypogonadism.” The news release fails to discuss costs, disclose conflicts of interest, or acknowledge lingering long-term safety concerns with testosterone replacement therapy. It uses the adjective “novel” to describe the oral drug — echoing company PR materials — without explaining what makes it new or unusual.
Testosterone replacement therapy has become big business as direct-to-consumer marketing peddles the notion that erectile dysfunction and other aging-related symptoms are the result of ebbing hormone levels, dubbed “low T.” Millions of men now take testosterone replacement therapy, usually in a gel or patches, without having been diagnosed with hypogonadism and despite safety and efficacy concerns. This despite the fact that the Food and Drug Administration has approved testosterone replacement therapy only for men who have demonstrated low blood levels of testosterone along with symptoms of hypogonadism, often from conditions such as pituitary or testicular problems or advanced liver disease. Last year the FDA ordered manufacturers to add heart attack and stroke risk warnings to medication labels and warned doctors against over-prescribing testosterone. An editorial in the Journal of the American Geriatrics Society called on U.S. and Canadian regulators to go a step further and ban direct-to-consumer advertising of testosterone and require clear demonstrations of pathology for testosterone prescriptions. The advent of a safe testosterone pill may benefit men who truly need hormone replacement therapy by reducing inconvenience and eliminating adverse effects associated with injections and topical applications. However, it also poses a danger of enhancing the appeal of testosterone to those who wrongly believe it is the fountain of youth.
The cost of this would-be product were not addressed even though it is under review by the FDA and potentially months away from approval.
The news release doesn’t quantify potential benefits of oral testosterone therapy. It barely mentions why it might surpass one currently available form, topical products, which carry FDA warnings related to inadvertent transfer to other people. “Making sure an oral treatment is safe and effective for men and for the children and partners at risk for inadvertent testosterone transference is the top priority, and what we’ve found so far has shown we’re on the right track,” says Tobias S. Köhler, MD, an AUA spokesperson, in the release. More light is shed on the web site of the drug manufacturer. In a company-sponsored survey of 28 leading endocrinologists and urologists reported on the manufacturer’s web site, 94% of responded that they believed an oral testosterone replacement therapy would improve patient compliance. The web site also cited problems with existing products, including skin rashes for topical products and risk of infection, scarring, injection site reactions, and lung impairment for injectables.
The news release does describe adverse effects reported in the study, including that there were no “hepatic, cardiac or drug-related serious adverse events.” It lists the percentages of patients in each of the treatment groups who had certain adverse effects, and notes that lipid levels were comparable in the two groups and androgenic measurements showed no significant differences during the study period. However, the news release fails to acknowledge long-term safety concerns, including the FDA’s call last year for manufacturers to conduct a controlled clinical trial to clarify how testosterone might affect cardiac health. The abstract presented at the medical conference (the only available information about the study) states that the total numbers of adverse events was almost the same in both groups (67% in oral group compared with 65% in the topical group) without specifying the statistical significance of that result or the types of adverse effect in these groups. The adverse events given only add up to about 10% in both groups.
The release explains that this was a randomized trial based on 315 patients It would have been stronger had it given some more details about the methodology or potential limitations of the study that might help readers evaluate the evidence. It would be helpful to know how many volunteers completed each stage of the study Also, the study found that average testosterone levels were high in the study group but doesn’t mention what the level was in the control group.
No disease mongering here. However, the promotion of “low T” syndrome is suspect according to the FDA.
The news release fails to disclose that all of the study authors have financial ties to the drug manufacturer, Lipocine Inc., as consultants, principal investigators or employees, and that one is the company’s founder.
The news release states that this oral form of testosterone was compared with T gel. It also names other delivery forms including a patch, injection or implant (pellet)
The news release states “There is currently no oral form of testosterone therapy approved for use in the United States by the Federal Drug Agency” and then talks about this new product under development. Readers can assume the product is not yet available.
The news release states this would be the first oral method of testosterone treatment, and in that regard it’s novel. However, it repeatedly calls this product a “novel” therapy, echoing a word used in Lipocine’s PR materials, without an explanation. The reader may assume that the treatment is novel because it’s taken orally, but a different delivery method does not seem to constitute a huge departure from existing therapies.
The release does not rely on sensationalist language.