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Heart failure drug eases symptoms

Rating

4 Star

Heart failure drug eases symptoms

Our Review Summary

This story reports on the results of a randomized trial published in this week's Journal of the American Medical Association on a novel approach to treating severe, acute heart failure. The trial evaluated the performance of tolvaptan, the first drug in its class, in combination with diuretics (the standard therapy) compared to placebo plus diuretics. The study found that tolvaptan did not prevent death or rehospitalization but did improve some important symptoms associated with heart failure. This story does a decent job of describing the problem of managing heart failure and the design of the current study, however it does not quantify the benefits of the drug nor does it mention the costs.

The story adequately represents the novelty, availability and harms associated with the drug. The story also adequately describes the strength of the current study. The story does quote multiple experts, however only one of them was not involved with the study in any way. The story could have quoted other, independent experts who could have provided other perspectives.

However, the story does not adequately describe the other available treatment options and how this drug will fit with existing therapies. The story mentions diuretics as the standard treatment, but does not mention that in acute hospitalizations, diuretics are given by IV and other medications are used. Nor does the study mention other things that an individual can do to prevent an acute episode.

Finally, the story does not adequately quantify the benefits of treatment. The story does mention that the drug was not associated with any differences in death or rehospitalization. However, the story does state that it "significantly improved breathing and reduced swelling." How many people reported improved breathing and reduced swelling compared to placebo? The story should have provided this quantitative information in absolute terms so the reader can get a sense of the scope of the improvement.

Criteria

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

The story does not mention costs, which could be very high, especially compared to the very inexpensive diuretics which are the standard therapy.

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

Not Satisfactory

The story does not adequately quantify the benefits of treatment. The story does mention that the drug was not associated with any differences in death or rehospitalization. However, the story does state that it "significantly improved breathing and reduced swelling." How many people reported improved breathing and reduced swelling compared to placebo? The story should have provided this quantitative information in absolute terms so the reader can get a sense of the scope of the improvement.

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

The story mentions that the drug was associated with several side effects, but that none of them were serious.

Does the story seem to grasp the quality of the evidence?

Satisfactory

The story adequately describes the design of the current study.

Does the story commit disease-mongering?

Satisfactory

The story does not exaggerate the seriousness or prevalence of heart failure and the story rightly points out that this drug is for people with severe heart failure.

Does the story use independent sources and identify conflicts of interest?

Satisfactory

The story does quote multiple experts, however only one of them was not involved with the study in any way. The story could have quoted other, independent experts who could have provided other perspectives.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story does not adequately describe the other available treatment options and how this drug will fit with existing therapies. The story mentions diuretics as the standard treatment, but does not mention that in acute hospitalizations, diuretics are given by IV and other medications are used. Nor does the study mention other things that an individual can do to prevent an acute episode.

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The story does mention that the drug is still "experimental" and that the company plans to apply for approval.

Does the story establish the true novelty of the approach?

Satisfactory

The story correctly points out that this drug, tovaptan, is the first of its class and represents a novel approach to treating heart failure.

Does the story appear to rely solely or largely on a news release?

Satisfactory

Because the story quotes multiple experts, the story does not appear to have relied on a press release as the sole source of information.

Total Score: 7 of 10 Satisfactory

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