To use best practices in pharmacoepidemiology to assess the association between new use of brain-penetrant calcium channel blockers (BP-CCBs) compared with use of non-brain-penetrant CCBs (NP-CCBs) and the incidence of neuropsychiatric outcomes.

Retrospective comparative cohort study.

Secondary data from nine claims and electronic health record databases from across the globe were used.

First use of a CCB was the index date. There were 1.2 million BP-CCB patients and 9.3 million NP-CCB patients identified across all databases, with 881 758 matched in each group.

Patients were categorised as either initiating BP-CCBs or NP-CCBs. On-treatment and intention-to-treat analyses were conducted. Large-scale propensity models were used to match cohorts and control for observed confounding. Cox models were used to analyse the time to incident neuropsychiatric disorders. Negative control outcomes were used to calibrate estimates, CIs and p values to account for residual confounding. Diagnostics were used to assess the validity of the analysis.

The time to first diagnosis of schizophrenia, schizoaffective disorder, major depressive disorder (MDD) and bipolar disorder was assessed independently. HRs compared the BP-CCB group to the NP-CCB group.

For the outcome of incident MDD in the intention-to-treat design, the meta-analytic HR (95% CI) was 1.02 (0.97, 1.08). Meta-analytic HRs for bipolar disorder (1.04 (0.96, 1.13)), schizophrenia (1.05 (0.94, 1.18)) and schizoaffective disorder (1.04 (0.87, 1.23)) showed similar null effects. The on-treatment analysis was largely consistent: MDD (1.01 (0.96, 1.06)), bipolar (1.05 (0.86, 1.27)), schizophrenia (1.09 (0.87, 1.38)) and schizoaffective (1.00 (0.71, 1.40)).

There was no evidence of an association with any of the neuropsychiatric conditions of interest between use of BP-CCB and NP-CCB. This does not rule out the potential beneficial effect of CCB formulations and doses targeted specifically for the brain rather than the cardiovascular system.

Lateral hip pain due to hip abductor tendon pathology (ie, gluteal tendinopathy or tendon rupture) is a relatively new diagnosis. This patient group has previously been described as a clinical dilemma due to the often-short-lived effects of treatment. In the process of identifying the underlying pathology, however, more targeted treatment strategies have been explored. Recent research recommends exercise as a first-line treatment for this patient group along with patient education. However, patients seen in a hospital setting (secondary healthcare) often present recalcitrant lateral hip pain, tendon ruptures and multiple comorbidities. Whether patient education and exercise therapy are beneficial for patients in secondary healthcare has only been sparsely investigated. Therefore, this study aims to investigate changes in lateral hip pain following a 3 month physiotherapist-led patient education and exercise intervention in patients with MRI-proven hip abductor tendon pathology seen in a hospital setting.

In this prospective cohort trial, 60 patients, presenting lateral hip pain and MRI-verified hip abductor tendon pathology at the orthopaedic outpatient clinic at Horsens Regional Hospital, Denmark, a public teaching hospital, are included. Hip abductor tendon pathology will be diagnosed by clinical tests and MRI. The intervention consists of seven physiotherapist-led patient education and exercise sessions at the hospital during 3 months. The instructions will guide the patients in their daily home-based exercise sessions.

The primary outcome is change in lateral hip pain measured by the ‘pain’ subscale from the patient-reported outcome measure: the revised Copenhagen Hip And Groin Outcome Score (HAGOS). Secondary outcomes are changes in the remaining subscales of the revised HAGOS, Oxford Hip Score, Victorian Institute of Sports Assessment-Gluteal Questionnaire, European Questionnaire-Five Dimensions Five-Level, lateral hip pain (numeric rating scale score, 0–10), hip muscle strength and the 30 s chair stand test. Also, patient-reported Global Rating of Change in hip condition, as well as adherence and harms, will be reported.

This trial has been accepted by the Central Denmark Regions Ethics Committee (1-10-72-136-22). The study is registered at the Central Denmark Region List of Research Projects (Journal No 1-16-02-180-24) and clinicaltrials.gov (NCT06418217).

All results from this study, regardless of the direction, will be published in a peer-reviewed journal and presented at national and international congresses.

NCT06418217.