Characteristics and outcomes in patients with a prior myocardial infarction treated with extended dual antiplatelet therapy with ticagrelor 60 mg: findings from ALETHEIA, a multi-country observational study.

BACKGROUND: Guidelines recommend extended dual antiplatelet therapy, including ticagrelor 60 mg twice daily, in high-risk post-myocardial infarction (MI) patients who have tolerated 12 months and are not at high bleeding risk. The real-world utilization and bleeding and ischaemic outcomes associated with long-term ticagrelor 60 mg in routine clinical practice have not been well described. METHODS: Register and claims data from the USA (Optum Clinformatics, IBM MarketScan, and Medicare) and Europe (Sweden, Italy, UK, and Germany) were extracted. Patients initiating ticagrelor 60 mg ≥12 months after MI, meeting eligibility criteria for the PEGASUS-TIMI (Prevention of Cardiovascular Events in Patients with Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin - Thrombolysis in Myocardial Infarction 45) 54 trial, were included. The cumulative incidence of the composite of MI, stroke, or all-cause mortality and that of bleeding requiring hospitalization were calculated. Meta-analyses were performed to combine estimates from each source. RESULTS: A total of 7035 patients treated with ticagrelor 60 mg met eligibility criteria. Median age was 67 years and 29% were females; 12% had a history of multiple MIs. The majority (95%) had been treated with ticagrelor 90 mg prior to initiating ticagrelor 60 mg. At 12 months from initiation of ticagrelor 60 mg, the cumulative incidence [95% confidence interval (CI)] of MI, stroke, or mortality was 3.33% (2.73-4.04) and was approximately three-fold the risk of bleeding (0.96%; 0.69-1.33). CONCLUSIONS: This study provides insights into the use of ticagrelor 60 mg in patients with prior MI in clinical practice. Observed event rates for ischaemic events and bleeding generally align with those in the pivotal trials, support the established safety profile of ticagrelor, and highlight the significant residual ischaemic risk in this population.Clinical Trials.gov Registration NCT04568083.

Pharmacoepidemiology at Nordic School of Public Health NHV: Examples from 1999 to 2014.

BACKGROUND: Pharmacoepidemiology is a branch of public health and had a place at the Nordic School of Public Health. Courses, Master's theses and Doctorates of Public Health (DrPH) in Pharmacoepidemiology were a relatively minor, but still important part of the school's activities. METHODS: This paper gives a short background, followed by some snapshots of the activities at NHV, and then some illustrative case-studies. These case-studies list their own responsible co-authors and have separate reference lists. RESULTS: In the Nordic context, NHV was a unique provider of training and research in pharmacoepidemiology, with single courses to complete DrPH training, as well as implementation of externally-funded research projects. CONCLUSIONS: With the closure of NHV at the end of 2014, it is unclear if such a comprehensive approach towards pharmacoepidemiology will be found elsewhere in the Nordic countries.

Influence of refill adherence method when comparing level of adherence for different dosing regimens.

PURPOSE: To examine the impact of two methods when estimating refill adherence in patients using bisphosphonates with different dosing regimens. METHODS: In the Swedish Prescribed Drug Register, 18,203 new users of bisphosphonates aged 18-85 years were identified between 1 July 2006 and 30 June 2007 and followed for a maximum of 2 years. The patients were categorised based on dosing regimen: one tablet daily, one tablet weekly, switching between these regimens, and other regimens. Refill adherence was estimated with Continuous measure of Medication Acquisition (CMA, adherent if CMA ≥ 80 %) and the maximum gap method (adherent if gaps <45 days). Differences in adherence between patients in the groups were assessed with logistic regression models controlling for confounding factors. RESULTS: The proportion of patients classified as adherent was higher using CMA compared with patients classified as adherent using the maximum gap method. Patients on one tablet weekly had significantly lower adherence compared with patients on one tablet daily in the main analyses of both methods (the maximum gap method: 73 % vs. 80 %; adjusted OR=0.71; 95 % CI 0.57-0.89 and CMA: 84 % vs. 88 %, adjusted OR=0.75; 95 % CI 0.57-0.99). Patients using the other two dosing regimens had significantly lower adherence compared with patients on one tablet daily using both methods. CONCLUSION: Choice of method has an impact on the estimates of refill adherence to bisphosphonates. Patients on one tablet weekly dosing had lower adherence compared with patients on one tablet daily dosing using both methods.

Aspirin in cardiology--benefits and risks.

AIMS: To review the current knowledge of the benefits and risks of long-term aspirin therapy for the prevention of cardiovascular disease. METHODS: Relevant articles published in English between 1996 and 2006 were obtained from the Current Contents Science Edition, EMBASE and MEDLINE databases. RESULTS: Secondary aspirin prophylaxis is effective in reducing the risk of ischaemic events in patients with cardiovascular disease. However, its utility in reducing primary ischaemic events is more controversial; it appears to reduce the incidence of ischaemic stroke, but increase the incidence of haemorrhagic stroke. Aspirin therapy can also lead to an increased risk of gastrointestinal ulcers, upper gastrointestinal bleeding and other haemorrhagic complications. Lower doses of aspirin are associated with a reduced risk of gastrointestinal side effects and are equally effective in reducing cardiovascular risk. Co-therapy with non-steroidal anti-inflammatory drugs, clopidogrel or warfarin increases the risk of gastrointestinal side effects, while co-therapy with proton pump inhibitors reduces it. CONCLUSIONS: Both the benefits and risks need to be considered carefully when prescribing aspirin, particularly in primary prevention. Patients should be prescribed lower doses rather than higher doses of aspirin in line with prescribing guidelines. Co-prescription of a proton pump inhibitors may be necessary in patients at high risk for upper gastrointestinal complications.