Boston Collaborative Drug Surveillance Program

Combined oral contraceptives (COCs) are contraindicated in migraine with aura due to stroke risk, and some hormone therapy for menopause guidelines recommend caution in this population. However, this guidance is informed by sparse or older evidence reflective of higher doses than typically prescribed today. This study aimed to describe modern-day utilization of COCs and hormone therapy among female individuals with migraine with aura from 2000 to 2024. Using United Kingdom medical record data, this study evaluated the use of COCs and progestogen-only pills (POPs) among reproductive-age individuals and hormone therapy among post-reproductive age individuals, before and after migraine with aura diagnosis. Post-diagnosis medication utilization was described relative to baseline characteristics and pre-diagnosis use of each medication, overall and longitudinally. Among 142 867 individuals of reproductive age, 84 374 (59%) used oral contraceptives on or after migraine with aura diagnosis, predominantly POPs (n = 75 823, 53% of those with any oral contraceptive) over COCs (n = 21 968, 15%). Most oral contraceptive users in the year pre-diagnosis used COCs (n = 36 909/56760, 66%). Among 46 913 individuals of post-reproductive age, 20 990 (45%) had a prescription for hormone therapy after migraine with aura diagnosis, with transdermal formulations used increasingly over calendar time. Utilization of COCs declined but did not fully cease after migraine with aura diagnosis. Post-diagnosis utilization of hormone therapy for menopause was common. Given this utilization among individuals with migraine with aura, high-quality evidence quantifying the risk of stroke associated with modern-day use of these medications in this population is needed to inform patient and provider decision making.

PurposeTo assess the risk of acute infections in patients with first ever diagnosed depression compared to patients with no diagnosed depression in a primary-care database.MethodsWe conducted a cohort study using the UK CPRD GOLD database (2000–2019). We identified patients aged 18 years or older with a recorded Read code for depression (cohort entry date) and compared them to patients with no Read codes for depression using risk set sampling. Comparison groups were frequency-matched on age and sex, and comparison patients were required to have ≥ 1 general practitioner (GP) contact within 14 days before cohort entry. The primary outcome was a composite of outpatient diagnosed acute infections, including respiratory, gastrointestinal, urogenital infections and septicemia) within the two-years after cohort entry. We applied propensity score fine stratification and estimated incidence rates and IR ratios (IRR) using negative binomial regression.ResultsIn a weighted population of 285,922 patients with diagnosed depression and 285,921 comparison patients, the IR of acute infections was 97.3/1000 person-years (py) in patients with and 83.7/1000 py in patients with no diagnosed depression. The weighted IRR of acute infection was 1.18 (95% CI 1.16–1.20) comparing those with and with no diagnosed depression. Excluding patients with baseline comorbidities yielded an IRR even closer to the null: 1.07 (95% CI, 1.04–1.09).ConclusionsOur results suggest that patients with diagnosed depression are not at a meaningfully increased risk of acute infections compared to patients with no diagnosed depression. Slightly increased overall relative risks of infections can be explained by residual differences in health care utilization and by the severity of comorbidities.

Abstract Background:Previous studies suggested an elevated risk of venous thromboembolism (VTE) among patients with type 2 diabetes mellitus (T2DM), with a possible sex difference. The impact of glycemic control on the risk of VTE is unclear. Our objective was to analyze the association between glycemic control and the risk of unprovoked (idiopathic) VTE in men and women with T2DM.Methods:We conducted a nested case-control analysis (1:4 matching) within a cohort of patients with incident T2DM between 1995–2019 using data from the CPRD GOLD. We excluded patients with known risk factors for VTE prior to onset of DM. Cases were T2DM patients with an unprovoked treated VTE. The exposure of interest was glycemic control measured as HbA1c levels. We conducted conditional logistic regression analyses adjusted for several confounders.Results:We identified 3’896 VTE cases and 15’584 controls (56% females). We found no association between the HbA1c level and the risk of VTE in our main analysis. However, when the most recent HbA1c value was within 90 days before the index date, women with HbA1c levels > 7.0% had an 18–35% increased relative risk of VTE when compared to women with HbA1c > 6.5-7.0%.Conclusions:Our study raises the possibility that female T2DM patients with HbA1c levels > 7% may have a slightly higher risk for unprovoked VTE compared to women with HbA1c level > 6.5-7.0%. This increase may not be causal and may reflect differences in life style or other characteristics. We observed no effect of glycemic control on the risk of VTE in men.

PurposePsoriasis and psoriatic arthritis (PsA) are associated with an increased infection risk. In this cohort study of patients with treated psoriasis or PsA, we used MarketScan (2014–2018) to estimate rates of herpes zoster, hepatitis C (HepC) and tuberculosis (TB) with apremilast compared to other systemic treatments.Materials and MethodsPatients were exposed from first apremilast [APR], DMARD, TNF-inhibitor [TNF], IL-inhibitor [IL], or corticosteroids [CS] prescription after March 21, 2014. Study exposures were APR, DMARDs only, TNF-only, IL-only, CS-only, DMARDs+CS, TNF+DMARDs and/or CS, IL+DMARDs and/or CS. Cases had treated herpes zoster, HepC, or TB event. We calculated incidence rates (IRs) [95% confidence intervals] per 1000 patient-years.ResultsThe study population included 131,604 patients. For herpes zoster (N=2271), IRs were highest for users of DMARDs+CS (12.5 [9.8–15.7]), CS-only (12.5 [10.4–14.1]), and TNF+DMARDs and/or CS (11.9 [10.6–13.4]), compared with DMARDs only (9.9 [8.7–11.2]). IRs were lowest for users of IL-only (6.7 [5.8–7.8]) and APR (7.0 [5.8–8.4]). IRs of HepC (N=150) and TB (N=81) were low and between-treatment differences were not significant.ConclusionRates of herpes zoster varied by treatment: highest among those who received polytherapy, lowest in users of apremilast only. IRs for HepC and TB were low for all exposures.

Describe comorbidities among multiple sclerosis (MS) patients.

Using the UK Clinical Practice Research Datalink, we examined the incidence of glucocorticoid (GC)-related serious adverse events (SAEs) in rheumatoid arthritis (RA) and non-RA patients and quantified the risk of SAEs in patients with RA. We matched incident patients with RA to an age- and sex-matched, non-RA comparison group of equal size. In a cohort analysis, we estimated incidence rates (IRs) and IR ratios (IRRs) for GC-related AEs (i.e., diabetes mellitus [DM], osteoporosis, fractures, glaucoma, hypertension, gastrointestinal [GI] perforation or bleeding, thrombotic stroke or myocardial infarction [MI], or death), stratified by GC use. We conducted a series of nested case-control analyses among patients with RA, evaluating the effects of increasing cumulative and average daily GC dose. Cases of each outcome were matched to controls for age, sex, and general practice. We calculated adjusted odds ratios (ORs) with 95% confidence intervals (95% CIs) for each outcome. Patients with RA had a higher incidence for all investigated SAEs except glaucoma, compared to non-RA patients. IRRs were greater in those patients prescribed a GC than in those without. In patients with RA, GCs were associated with an elevated risk of DM (adjusted OR 1.33 [95% CI 1.14-1.56]), osteoporosis (adjusted OR 1.41 [95% CI 1.25-1.59]), thrombotic stroke or MI (adjusted OR 1.28 [95% CI 1.07-1.52]), serious infection (adjusted OR 1.28 [95% CI 1.11-1.48]), and death (adjusted OR 1.33 [95% CI 1.19-1.48]). There was a trend of increasing risk with increasing cumulative and average daily GC dose for all outcomes other than glaucoma, hypertension, and GI perforations or bleeding (P < 0.05). Patients with RA had an increased incidence of GC-related AEs. Increasing cumulative and average daily GC doses were found to be associated with an increasing risk of developing an AE.

To investigate the association between statin therapy initiation and incident hand osteoarthritis (OA). We performed a propensity score-matched cohort study using data from the UK-based Clinical Practice Research Datalink. Statin initiators had ≥1 statin prescription between 1996 and 2015 and were matched 1:1 on their propensity score to noninitiators within 10 sequential 2-year cohort entry blocks. After a 180-day run-in period, patients were followed in an as-treated approach until a recorded diagnosis of hand OA or until censoring (change in exposure status, development of an exclusion criterion, or maximum follow-up of 5.5years). We applied Cox proportional hazard regression to calculate hazard ratios (HRs) with 95% confidence intervals (95% CIs) overall and in subgroups of sex, age, statin dose, statin agent, preexisting dyslipidemia, and treatment duration. To compare results, we ran all analyses with negative and positive control outcomes and assessed generalized OA as a secondary outcome. We further performed the overall analysis with an active comparator (topical glaucoma therapy initiators). Among 233,608 statin initiators and the same number of noninitiators, we observed an overall HR for hand OA of 0.98 (95% CI 0.88-1.09). The observed null result remained unchanged in all subgroups. Results were highly similar for generalized OA and negative control outcomes. In addition, the active comparator analysis showed a null result with an HR for hand OA of 0.85 (95% CI 0.56-1.29). Previously known associations with positive control outcomes were observed. There was no association between statin initiation and incident hand OA in this study.