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Oral testosterone PR release keeps readers in the dark about significant conflicts of interest

Research highlights safety and efficacy of novel treatment option for hypogonadism over 52-week period

SAN DIEGO, Calif., May 8, 2016 /PRNewswire/ — LCPN10, a novel oral testosterone undecanoate formulation has been shown to be safe and efficacious for the treatment of hypogonadal patients, according to a study being presented during the 111th Annual Scientific Meeting of the American Urological Association (AUA).

The research will be highlighted by study authors during a special press conference to be moderated by Tobias S. Köhler, MD, MPH, FACS, AUA spokesperson and associate professor of Surgery at Southern Illinois University on May 8, 2016 at 7:30 a.m. PT in the San Diego Convention Center.

Testosterone therapy is used to treat men with clinically diagnosed testosterone deficiency (serum T levels <300 ng/dL), also known as hypogonadism. It is often administered as a gel, patch, injection or implant (pellet). There is currently no oral form of testosterone therapy approved for use in the United States by the Federal Drug Agency; however researchers from Houston, TX and Torrance, CA have been evaluating the long-term safety and tolerability of LPCN 1021, a novel oral testosterone undecanoate formulation for the treatment of low testosterone.

Throughout a 52-week study period, a total of 315 hypogonadal men were randomized either to LPCN 1021 or T gel (active control). Of the 315 men, 210 were randomized to LPCN 1021 and 105 were randomized to active control. Following a 13-week efficacy phase, men continued to receive their assigned treatment for up to 52 weeks. They returned at weeks 26, 39 and 52 for safety assessments, which included an evaluation of adverse events, clinical laboratory tests and physical examinations.

Results showed:

  • LPCN 1021 was well tolerated and had a favorable safety profile in the long-term management of hypogonadal patients
  • No hepatic, cardiac or drug-related serious adverse events were reported
  • The most common drug-related adverse events for LPCN 1021 and T gel 1.62 percent were acne (2.9 percent vs. 2.9 percent, respectively), headache (0.5 percent vs. 3.8 percent, respectively), weight increase (2.4 percent vs. 0 percent, respectively), hematocrit increase (1.9 percent vs. 0 percent, respectively), liver enzyme level increase (1.4 percent vs. 0 percent, respectively), fatigue (0.5 percent vs. 1.9 percent, respectively), and hypertension (0.5 percent vs. 1.9 percent, respectively)
  • Lipid parameters (i.e., cholesterol, LDL, HDL, and TG) were comparable between treatment groups at Week 52
  • Androgenic parameters including hematocrit, hemoglobin, platelet, prothrombin, and prostate-specific antigen (PSA) showed no significant differences in change from baseline to end of study between treatments

“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,” said Dr. Köhler.  “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.”

About the American Urological Association: The 111th Annual Meeting of the American Urological Association takes place May 6 – 10 at the San Diego Convention Center in San Diego, CA.

Founded in 1902 and headquartered near Baltimore, Maryland, the American Urological Association is a leading advocate for the specialty of urology, and has more than 21,000 members throughout the world. The AUA is a premier urologic association, providing invaluable support to the urologic community as it pursues its mission of fostering the highest standards of urologic care through education, research and the formulation of health policy.

Contact:
Christine Frey, AUA
443-909-0839, cfrey@AUAnet.org

Logo – http://photos.prnewswire.com/prnh/20160210/332064LOGO

SOURCE American Urological Association

Related Links

http://www.AUAnet.org

Studies Show Oral Testosterone Safe and Efficacious in Long-term Management of Hypogonadism

Our Review Summary

testosteroneThis 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.

 

Why This Matters

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.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

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.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

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.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering here. However, the promotion of “low T” syndrome is suspect according to the FDA.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

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.

Does the news release compare the new approach with existing alternatives?

Satisfactory

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)

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

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.

Does the news release establish the true novelty of the approach?

Satisfactory

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.

Total Score: 6 of 10 Satisfactory

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