Therapie最新文献

Retinal vein occlusions and central retinal artery occlusions have been reported with coronavirus disease 2019 (COVID-19) vaccines. We aim to provide a descriptive analysis of cases reported in France until mid-2023, and recorded in the French pharmacovigilance database. An independent ophthalmologist reviewed all cases. We analyzed 290 cases (228 retinal vein occlusions, 58 central retinal artery occlusions, and four combinations). Retinal vein occlusions occurred with mRNA vaccines (68.0%) and adenovirus-vectored vaccines (32%), with an 11-day median onset delay. Almost half of the patients had retinal vein occlusion risk factors, mainly hypertension, and five had a positive rechallenge. Considering the lower adenovirus-vectored vaccines exposure in France, their proportion of retinal vein occlusions appears high. Among the 58 central retinal artery occlusion cases, most occurred with mRNA vaccines in patients with retinal artery occlusion risk factors (mainly hypertension), with a 17-day median onset delay. In conclusion, there was a temporal association in almost half of cases, but few cases with positive rechallenge, and many cases were confounded by risk factors (e.g., cardiovascular disorders, diabetes), which are also COVID-19 risk factors. Therefore, the risk of retinal vascular occlusion does not challenge the benefit-risk ratio of the vaccination, especially for mRNA vaccines.

Pharmacy decision support systems (PDSS) help clinical pharmacists to prevent and detect adverse drug events. The coding of hospital stays by the department of medical information (DMI) requires expertise, as it determines hospital revenues and the epidemiological data transmitted via the French national hospital database. The aim was to study the interest and feasibility of using a PDSS, in collaboration with the DMI, to help with the coding of hospital stays. Over 5 months, three rules were implemented in the PDSS to detect gout, Parkinson's disease and oro-pharyngeal candidiasis. The PDSS alerts were analyzed by a pharmacy resident and then forwarded to the DMI, who analyzed the stays to see whether or not the coding for the disease corresponding to the alert was present. The absence of coding was evaluated and tracked, along with the resulting change in severity and valuation. Three hundred and ninety-nine alerts from the PDSS were analyzed and sent to the DMI, representing 211 stays and 309 uniform hospital standardized discharge abstract (UHSDA) in the fields of medicine, surgery and obstetrics. Two hundred and eight (67.3%) UHSDA did not have the coding corresponding to the alert. For the majority of these UHSDAs, apart from diagnostic precision, there was no impact on the valuation of stays. For 4 UHSDAs, the addition of the diagnosis code led to an increase in the value of the stay and the severity of the homogeneous patient groups. The total revaluation corresponding to this modification was €5416. The use of PDSS has helped in the precision of diagnosis coding and the valuation of stays. This result must be weighed against the time invested in analyzing alerts and associated coding. An improvement in disease detection and data processing is needed to be feasible in practice, given the more than 227,600 RSS performed per year at our facility.

Real-life data on the impact of sacubitril-valsartan and sodium-glucose cotransporter type 2 (SGLT-2) inhibitors on heart failure (HF) in France is lacking. Using French health insurance databases, we examined the ten-year evolution in HF medication use, focusing on SGLT-2 inhibitors and sacubitril/valsartan, and incidence of HF hospitalizations during the same period. We conducted a repeated cross-sectional study using medical-administrative data from French health insurance databases between 2014 and 2023. These included "OpenMedic" for outpatient medication reimbursements and "ScanSanté" for annual hospitalization data. Medications were classified using ATC codes, and hospitalizations were identified using ICD-10 codes. Statistical analyses encompassed annual rates of users and boxes dispensed for HF medications, along with HF, ischemic heart disease and ischemic stroke hospitalization rates. Prevalence of SGLT-2 inhibitors and sacubitril-valsartan use was also studied regionally, with direct standardization by age and sex, with the French population as the standard population. Between 2014 and 2023, HF drug use increased significantly, with beta-blockers and ACE inhibitors/ARBs leading in prevalence of use. ARNi and SGLT-2 inhibitors, introduced later, showed remarkable rises: +506% and +3766% in users since their market introduction, respectively. Meanwhile, HF hospitalizations slightly increased by +3.6% between 2016 and 2019, followed by a notable decline of -12.5% during 2019-2023, coinciding with the introduction of SGLT-2 inhibitors. In contrast, hospitalizations for ischemic heart disease rose by 11.6% over the period 2016-2019 and by +5.2% over the period 2019-2023, and hospitalizations for ischemic stroke rose by 8.2% over the period 2016-2019 and declined by -0.6% over the period 2019-2023. We observed regional disparities in SGLT-2 inhibitors use, with prevalence ranging from 0.9% in Bretagne to 1.5% in Hauts-de-France. The data suggests a temporal correlation between the increase in SGLT-2 inhibitors use and the decline in HF hospitalizations since 2019. More studies are needed to measure real life effectiveness of SGLT-2 inhibitors in heart failure.

Purpose: Based on potential adverse health effects including genotoxicity concerns, the European Union banned titanium dioxide (TiO₂) as a food additive in 2022, but food-grade TiO₂ can still be used in pharmaceutical products.

Methods: This study described the presence of TiO₂ in drugs available on the French market and estimated the population exposure to TiO₂ through drug consumption. We used annual drug claim data aggregated at the national level together with data on the TiO₂ content of pharmaceutical products available on the French market in 2001-2020.

Results: Of the 17 171 pharmaceutical specialties identified on the French market between 2001 and 2020, 38% contained TiO₂. That figure reached 95% for capsules, 92% for film-coated tablets, 74% for coated tablets and 66% for soft capsules. Only 1% of non-oral specialties contained TiO₂. The median TiO₂ amount in one common dispensing unit was 1.5mg for oral specialties containing TiO₂. We estimated that the mean exposure to TiO₂ per inhabitant through the consumption of reimbursed drugs between 2012 and 2020 was 1.71mg per day, with women (1.81mg/d) slightly more exposed than men (1.54mg/d) and people older than 59 years (4.00mg/d) much more exposed than younger people (1.24 and 0.21mg/d for 20-59 and<20 years old individuals, respectively).

Conclusion: This study highlights a widespread presence of TiO₂ in drugs on the French market. The health impact of exposure to TiO₂ through drug consumption should be evaluated in future epidemiological studies.