Topical Testosterone Adherence Low Among Hypogonadal Men

Miriam E Tucker

May 11, 2017

AUSTIN, Texas — Fewer than one in five hypogonadal men are adherent to prescribed topical testosterone, new research indicates.

The findings, from a large commercial insurance database, were presented May 5 here at the American Association of Clinical Endocrinologists (AACE)  2017 Annual Scientific & Clinical Congress by Michael Grabner, PhD, of HealthCore, Wilmingon, Delaware.

Among a total of 3184 men with primary or secondary hypogonadism who had filled a prescription for topical testosterone therapy of any kind (brand-name or generic), just 17% were defined as adherent. And over 1 year, 81% of the men discontinued treatment.

These results are similar to two other studies for which data were collected in 2009, Dr Grabner told Medscape Medical News. "Adherence is still suboptimal. We're, way, way off.…It's been 7 years, and we're still pretty low."

Asked to comment, AACE president Jonathan D Leffert, MD, of North Texas Endocrine Center, Dallas, called the results "unfortunate, but not terribly surprising, from my experience." One of the problems, he noted, is that many men don't think of hypogonadism as a chronic condition.

"Hypogonadism, if it's truly diagnosed correctly, is a chronic disease just like diabetes, hypertension, or hyperlipidemia.…Some people think that 'if I just get that jump-start I'll be better, I'll feel better, and then I can just stop it and go on,' but that's not reality."

Thus, Dr Leffert advised, "When you start treating patients, you have to clearly say this is something you're going to be taking essentially for a lifetime if that's really the case."

And of course, he and Dr Grabner both pointed out, the cost of the medications may be another factor, as well as concerns about adverse effects.

Men Seen by Specialists More Likely to Adhere to Topical Testosterone

The new study data offer a few clues regarding adherence. For one, compliant men had a higher proportion of initial testosterone prescriptions from endocrinologists (38% vs 31%) and a lower share from primary-care providers (35% vs 44%).

After multivariate modeling, receiving the topical testosterone prescription from a specialist (either endocrinologist or urologist) was the only factor positively associated with adherence (P = .009).

"So having a physician specialized in this particular area who can appropriately diagnose, treat, and follow up is where adherence is the greatest," Dr Leffert commented. "I wonder if that's because treatment is given a significant import when someone goes to a specialist? Just by the mere fact of referral alone, people might think this is more important."

And, he added, "I think endocrinologists are probably familiar with issues of chronic care and making sure patients are selected well for treatment."

Adherent men also had fewer comorbidities at baseline, including coronary heart disease (9% vs 13%), depression (24% vs 29%), hypertension (40% vs 49%), insomnia (20% vs 24%), and obesity (9% vs 15%) (all P < .05).

After multivariate adjustment, factors negatively associated with adherence were the presence of depression (P = .037), hypertension (P = .002), initiation of testosterone in 2013–2014 (P = .005 compared with 2007–2009), and residing in the Midwestern United States (P = .018 vs the Northeast).

Additional post hoc analysis suggested that presence of six or more comorbidities was associated with about a 40% reduction in adherence compared with zero to  one comorbidity.

"It may be that the more comorbidities and the more medications you have, the harder it is to stay on top of all of them," Dr Grabner suggested.

Nonadherent Patients Still Seeing Some Improvement

In the study, men were classed as adherent if they had ≥80% of "days covered" — the number of days with the topical testosterone on hand divided by 365.

While the adherent men had slightly lower average total testosterone levels at baseline in the study (224 vs 248 ng/dL), their average levels were higher during follow-up, although the levels rose in the nonadherent group as well (466 vs 399 ng/mL).

At 1 year, adherent men saw a statistically significant improvement in a combination of clinical outcomes. The odds of insomnia/sleep disturbance, depression, fatigue, osteoarthritis, and erectile dysfunction combined were reduced among those complying with medication compared with those who didn't (adjusted odds ratio, 0.764; = .014).

Dr Grabner noted, "the nonadherent ones had some improvement, so maybe they got temporarily better and decided to stop, then relapsed later."

Dr Grabner said he hasn't analyzed the data by brand-name vs generic to explore the possible role of cost. But Dr Leffert pointed out that generics are "seemingly almost as difficult to get as the brand names from the prior-authorization perspective."

And, he added that some patients may be concerned about the potential for cardiovascular risk, which has yet to be well-defined.

"That has been a difficult question to define because most studies have been retrospective."

Nevertheless, Dr Leffert added, in patients with confirmed hypogonadism, "ultimately I think we need to do a better job of telling patient about the beneficial outcomes."

The study was funded by AbbVie, which contracted with Dr Grabner's employer, HealthCore, to conduct it. Dr Leffert has no relevant financial relationships.

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American Association of Clinical Endocrinologists (AACE)  2017 Annual Scientific & Clinical Congress. May 5, 2017; Austin, Texas. Abstract 925

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