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Release on erectile dysfunction drug mortality benefit lacks hard numbers, but otherwise performs well

Erectile dysfunction drugs are safe, possibly beneficial after heart attack

Our Review Summary

The release summarizes a Swedish study that found men who took erectile dysfunction (ED) drugs following a heart attack had a lower risk of dying or being hospitalized for heart failure than men who did not use these drugs.

The release does a good job providing information about this retrospective observational study. The study design, number of subjects and results are provided in a straightforward manner. The release also commented on the limits of observational research and didn’t make cause-and-effects claims such as that the drug “reduces risk.”

The study obtained data on ED drug from national health records data and inclusion for the study was at least a single prescription for the drugs during the study period. How even a single prescription for an ED drug can in some way alter risks is unclear. There is a suggestion that the effect may be dose related but the study itself is silent on the issue. The release did note that the ability and desire to engage in sex may be a marker of reduced risks.

 

Why This Matters

The safety of the use of drugs to treat ED in men who have suffered a myocardial infarction (heart attack) has been in question for many years. The risks of administering both a PDE-5 inhibitor such as sildenafil (Viagra) and nitroglycerin (for improving blood flow in heart disease patients) has been a concern.  An observational study that suggests that the use of the ED drugs does not add to risk is a welcomed piece of information.

The study itself did not claim that ED drugs are associated with reduced risk of subsequent heart attacks. And as noted in the release, the ability and desire to engage in sexual activity may point to enhanced longevity rather than drugs used to treat ED.

Criteria

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

Not Satisfactory

The study was observational and the number of ED drug doses men took was not reported or calculated. Since the study was conducted in Sweden, it’s possible there was no cost for individual patients but the drugs were covered by the national health system.

Since this release was issued by the American College of Cardiology to an American audience we think some comment on the cost of ED drugs or the cost of treating heart conditions would be appropriate for readers.

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

Not Satisfactory

The release notes, “Men who filled prescriptions for erectile dysfunction drugs in the years following a heart attack had a substantially lower risk of dying or being hospitalized for heart failure than men who did not use these drugs.” And it states there was a 33% reduction in death and a 40% reduction in hospitalization for heart failure among patients prescribed ED drugs. But these are relative risk numbers and we think absolute risk numbers are more useful for readers.

A quote from Dr. Andersson; “This type of erectile dysfunction treatment is beneficial in terms of prognosis, and having an active sex life seems to be a marker for a decreased risk of death” is a bit of a stretch given the study was observational and does not prove cause and effect.

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

Not Satisfactory

The study was designed to determine if there is an association between treatment for ED and death or cardiovascular outcomes after a first heart attack. Other side effects more commonly seen were not measured.

We’d still like to see at least some mention of the common harms from ED drugs in a news release distributed to a wide audience, particularly one that touts its safety and potential benefits.

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

Satisfactory

The release provides sufficient information on the study goals, design and outcomes. The readers is told the study was retrospective, and tracked more than 43,000 men for an average of 3.3 years.

The release includes several important caveats. It notes as a limitation that “researchers did not assess the effects of untreated erectile dysfunction, or conversely, the effect of having an active sex life without taking erectile dysfunction drugs.”

And it included an indirect reminder that observational studies do not prove cause and effect: “Although the results provide evidence that PDE5 inhibitors may benefit heart health, the retrospective study design makes it impossible to ascertain direct cause and effect.”  What was it about the retrospective study design that made it impossible to ascertain cause and effect? The fact that it’s observational.

It is possible that using erectile dysfunction drugs simply indicates a more active sex life, which could itself contribute to, or be a marker of, a heart-healthy lifestyle overall.

But the study did not demonstrate a reduced risk of myocardial infarction associated with ED drug use.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering. The release provides some context about the condition.

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

Not Satisfactory

The release notes the funding source: the Stockholm County Council and the Swedish Heart and Lung Foundation. The published study discloses that one of the study authors received “consultancy honoraria” from Actelion and Pfizer, two manufacturers of ED drugs. This should have been included in the release as well.

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

Not Satisfactory

The treatment of ED was not the focus of the research. Still, in a release suggesting the drug’s safety and benefits in preventing future heart disease we’d like to see some emphasis on how keeping a heart-healthy lifestyle through diet and exercise could be positive alternatives for risk reduction.

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

Satisfactory

Since the research was retrospective, it is clear that drugs used to treat ED are available and have been for some time.

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

Satisfactory

As noted in the release, the study appears to be the first to examine if there is an association between treatment for ED and death or cardiovascular outcomes after a first heart attack.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release provides the reader with a reasonable review of the research results.

Total Score: 5 of 10 Satisfactory

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