This story provided solid, concise reporting on results from a recent study that indicate that patients taking Plavix and a proton pump inhibitor medication had a greater number of adverse events. It explained the nature of the study and the frequency with which the problem occurred in those who took the combination of medications as compared to those who only took Plavix. The story mentioned that the FDA had taken action by communicating to doctors about the possible increase in problems with the use of this combination. This suggests that the potential for trouble goes beyond the specific subset of patients in whom it was documented.
The story would have been strengthened by inclusion of comments from experts who might have help put these results in context. It would have valuable to include some additional background material to help readers understand why these two drugs might be so often prescribed for the same patient. While the study design was briefly described, the story should have explained the limitations on drawing conclusions from such a study.
And costs were not discussed – a significant issue in this case.
There was no discussion of cost. The cost implications are important. The results of the study question the routine use of a costly drug, and cautions that the PPI only be used in select patients and not those who are on Plavix.
It would been of interest to note that the alternative medications for the treatment of ‘heartburn and certain stomach problems’ are less costly than the PPI that appears to be problematic.
The story did not explain why it is that these two medications might be so commonly prescribed for the same patient. It should have explained that Plavix, which is strongly recommended for use by patients who have had a revascularization procedure (such as coronary bypass or stent implantation), can often result in stomach upset and bleeding. The use of a PPI was thought to confer benefit as a preventative by lessening this gastric distress side effect.
The story presented the data on the combined outcome of being re-hospitalized or dying from cardiovascular problems, indicating that this occurred in a higher percentage of patients taking the combination of a PPI and Plavix than in those taking Plavix alone. The story then went on to say that it appeared that this was due to an increase in re-hospitalization rather than cardiovascular death.
It would have been more informative to simply present the data on the individual endpoints of rehospitalization and revascularization – both of which were higher in the group taking the medication combination; but that dying of any cause did not differ among the two groups.
The story reported where and when the study had been published. It explained that it compared outcomes from two groups of patients discharged during a specific time period. That said, the story should have explained that in a retrospective cohort study (as opposed to a randomized clinical trial) investigators are not able to adjust for all factors. Nonetheless we’ll give the story the benefit of the doubt on this criterion.
Did not engage in overt disease mongering.
The story included quotes from the lead author of the study and from a drug company representative. We wish the story had included the input of a clinician not connected to the study. However, we give credit because the story noted that one of the researchers received honoraria and research support from two drug companies.
The story mentioned another class of medications, H2 inhibitors, that could be considered instead of proton pump inhibitors (PPI) for patients for whom guidelines strongly recommend the use of Plavix.
It is interesting to know that while several brand name PPI’s were mentioned in the beginning of the story, omeprazole (Prilosec) was not listed. And at the end of the story, only the brand names for H2 blockers were listed. It would have been better to list both the brand and generic names. We think that’s a better practice in health journalism.
The story makes clear that these drugs have been and continue to be readily available to patients.
Given that the data presented were generated from patients discharged between 2003 and 2006, the story made clear that these medications have been given in combination for a while.
There’s no evidence that the story relied solely or largely on a news release.