The Food and Drug Administration and the European Medicines Agency sent a warning in 2010 discouraging the concomitant use of clopidogrel with omeprazole or esomeprazole. The purpose is to know the gastroprotective approach in patients with acute coronary syndrome (ACS) and the level of follow-up of the alert. In 17 hospitals with catheterization laboratory in Spain, 1 per region, we studied 25 consecutive patients per hospital whose diagnosis of discharge since October 1, 2013, had been any type of ACS. We analyzed their baseline clinical profile, the gatroprotective agents at admission and discharge and the antiplatelet therapy at discharge. The number of patients included was 425: age 67.2 ± 12.5 years, women 29.8%, diabetes 36.5%. The patients presented unstable angina in 21.6%, non-ST-elevation myocardial infarction in 35.3% and ST-elevation myocardial infarction in 43.1%. Conservative approach was chosen in 17.9%, bare-metal stents 32.2%, ≥1 drug-eluting stent 48.5%, and surgery 1.4%. Aspirin was indicated in 1.9%, aspirin + clopidogrel 73.6%, aspirin + prasugrel 17.6%, and aspririn + ticagrelor 6.8%. Gastroprotective agents were present in 40.2% patients at admission and this percentage increased to 93.7% at discharge. Of the 313 (73.6%) on clopidogrel in 96 (30.6%) was combined with omeprazole and 3 (0.95%) with esomeprazole, whereas the most commonly used was pantoprazole with 190 patients (44.7%). In conclusion, almost the totality of the patients with an ACS receive gastroprotective agents at the moment of discharge, most of them with proton-pump inhibitors. In one every 3 cases of the patients who are on clopidogrel, the recommendation of the Food and Drug Administration and the European Medicines Agency is not followed.
In 2010, the Food and Drug Administration and the European Medicines Agency issued a warning on the concomitant administration of clopidogrel and proton-pump inhibitors (PPIs), specifically omeprazole and esomeprazole, because of a potential interaction with clopidogrel. However, there is controversy regarding the degree of interaction as, although it seems to exist on a laboratory level, the extent of its clinical relevance is questionable. The aim was to analyze the percentage of patients on gastroprotective medication at admission and discharge, the type of medication, and the extent to which the agencies’ recommendations are taken into account for an unselected cohort of patients with different manifestations of acute coronary syndrome (ACS) in various centers in Spain, one for each autonomous region.
Methods
From October 1, 2013, 25 consecutive patients with a diagnosis at admission of any form of ACS were studied in 17 Spanish hospitals, 1 from each autonomous region. Their baseline characteristics, type of treatment, antiplatelet therapy, and gastroprotective drugs administered before admission and at discharge were registered. Only patients on oral anticoagulation were excluded. A short survey to find out the reasons of the failure to follow the recommendations of the agencies was carried out.
Results
Four hundred twenty-five patients were studied. Table 1 lists the baseline characteristics, treatment strategy, antiplatelet therapy, and gastroprotective measures at admission and discharge. At admission, 173 patients (40.7%) received gastroprotective treatment, whereas almost all patients (93.6%) received it at discharge. Of the 313 patients on clopidogrel, omeprazole was prescribed in 96 patients (30.6%) and esomeprazole in 3 patients (0.95%). Among the cardiologists of the centers included in the study, 41% did not follow the recommendations of the agencies, 77.7% due to doubts about the clinical relevance of the effect, whereas in the remaining 22.2%, the reason was ignorance of those recommendations. There were only 4 of 17 centers included which had developed a specific protocol about antiplatelet therapy and gastroprotection.
| n = 425 | |
|---|---|
| Age (Years) | 67.2 ± 12.5 |
| Women | 119 (29.8%) |
| Indication | |
| Unstable angina pectoris | 92 (21.6%) |
| Non ST-elevation myocardial infarction | 150 (35.3%) |
| ST-elevation myocardial infarction | 183 (43.1%) |
| Primary angioplasty | 133 (31.3%) |
| Hypertension | 264 (62.1%) |
| Diabetes Mellitus | 155 (36.5%) |
| Hypercholesterolemia | 217 (51.1%) |
| Smoking | 213 (54.4%) |
| Past revascularization surgery | 26 (6.1%) |
| Treatment strategy | |
| No revascularization | 76 (17.9%) |
| Bare metal stent | 137 (32.2%) |
| ≥ 1 drug-eluting stent | 206 (48.5%) |
| Revascularization surgery | 6 (1.4%) |
| Antiplatelet therapy at discharge | |
| Only aspirin ∗ | 8 (1.9%) |
| Aspirin + clopidogrel | 313 (73.6%) |
| Aspirin + prasugrel | 75 (17.6%) |
| Aspirin + ticagrelor | 29 (6.8%) |
| Gastrointestinal events and anemia † | |
| Gastric or duodenal ulcer | 21 (5%) |
| Esophagitis, gastritis | 12 (2.8%) |
| Hiatus hernia, gastroesophageal reflux | 16 (3.5%) |
| Anemia | 44 (10.3%) |
| Gastroprotective treatment at admission | |
| None | 252 (59.3%) |
| Ranitidine | 14 (3.3%) |
| Omeprazole | 118 (27.8%) |
| Pantoprazole | 28 (6.6%) |
| Lansoprazole | 7 (1.6%) |
| Esomeprazole | 4 (0.9%) |
| Rabeprazole | 2 (0.5%) |
| Gastroprotective treatment at discharge | |
| None | 27 (6.4%) |
| Ranitidine | 44 (10.4%) |
| Omeprazole | 141 (33.2%) |
| Pantoprazole | 190 (44.7%) |
| Lansoprazole | 18 (4.2%) |
| Esomeprazole | 3 (0.7%) |
| Rabeprazole | 2 (0.5%) |
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