Current guidelines and recommendations issued by regulatory agencies [11–16] for patients with GI and CV risk factors require NSAIDs and have introduced an unavoidable complexity in the clinical decision-making process. A recent report has shown that 86% of OA patients seen by rheumatologists are at increased GI risk and that almost half of them are at high CV risk . The current study, carried out at primary care and orthopedist sites, reached a similar conclusion.
Whether recommendations issued are being followed or implemented in clinical practice is generally unknown. This study has shown that in over half of the OA population examined, the prescription of NSAIDs did not follow current guidelines or recommendations. The most critical areas where the recommendations were not being followed or were over-looked, were in patients with both high GI and CV history and in those with a high GI risk alone. In the first group, over 74% of cases received prescriptions of either non-selective NSAIDs or COX-2-selective NSAIDs. In the second group, 49% received non-selective NSAIDs and a PPI instead of no NSAID therapy or a COX-2-selective NSAID and a PPI. Naproxen was seldom prescribed overall or for those with CV risk, despite being pointed out as the safest NSAID for those with CV events . However, other recommendations seem to be well adopted and followed in clinical practice. For example, our study showed high rates of PPI co-prescription with nsNSAIDs to patients with increased GI risk. These rates increased in parallel with higher levels of GI risk. Similar trends, although with lower rates of prescription, were observed with COX-2-selective NSAIDs alone. However, half of patients with low GI risk and no CV history were still treated with nsNSAIDs plus a PPI or a COX-2-selective NSAID, which are not recommended by current guidelines.
Overall, the data suggest that although some of the recommendations are being followed, others are not; especially those concerning the assessment of CV risk, which seems far from being implemented in routine clinical practice. These data contrast with some other reports at the specialist level (for example, rheumatologists), who seem to comply better with existing guidelines [17, 22].
Increased blood pressure is another frequent side effect of NSAID therapy. Patients with hypertension should be monitored when receiving NSAIDs and these drugs should be avoided when patients suffer from uncontrolled hypertension. As shown in this study, over half of the OA study population received antihypertensive therapy and one-fourth had uncontrolled hypertension. An overwhelming majority of these patients with uncontrolled hypertension were receiving NSAIDs, including etoricoxib . This suggests another area for improvement in clinical practice.
This study had both strengths and limitations. The strengths include: the cross-sectional approach for the collection of data in a single day for all patients; and the size of the study carried out at the primary and orthopedist care sites where OA patients are more commonly treated and prescribed therapy. Other strengths were the wide geographical distribution within the country and the fact that the data agreed with recent reports. This supports the value of the study . Another important aspect of the study is that it highlights the existing problem in patients that require NSAID treatment. It reveals the necessity of guideline implementation strategies to improve clinical practice. Limitations include the fact that we had to rely on data reported by the investigators, based on recorded charts, although the consistency of the data across investigators and the multiple sites of the study reduced the impact of this limitation. Also, data on uncontrolled hypertension were based on blood pressure readings obtained during the clinical visit and confirmed with values previously recorded in patient charts when available, which may have overestimated the incidence of hypertension. However, the CV risk probably was underestimated, because it was based on the history of CV events; whereas had CV scores been available, the percentage of patients at high CV risk might have been higher . However, we did not use those scores in order to simplify the study due to the size of the surveyed population. Finally, one may question whether the data obtained in patients from one country may apply to other countries. Whereas this may be true, it is possible that the validity of the conclusions may apply especially to other European countries due to similarities among health systems and the similar strategies and guidelines issued by different European scientific societies under the same regulatory body (the EMA). However, the high rates of PPI prescription found in Spain may be different from those observed in other European countries , which may even increase the gap of appropriate prescriptions for these patients.