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High-alert therapy area: Cardiovascular outcome trials generate highly complex data sets that are repeatedly misrepresented in promotional materials. CVOT endpoint confusion, renal benefit claim expansion, class effect statements without product-level data, and prescribing beyond the licensed indication are the top triggers for PMCPA proceedings.
Conflating heart failure hospitalisation reduction with major adverse cardiovascular event prevention, or vice versa, is one of the most common PMCPA triggers in cardiovascular. SGLT-2 inhibitor materials are particularly exposed.
Attributing outcomes demonstrated for one SGLT-2 inhibitor or PCSK9 inhibitor to the entire class — without product-specific trial data — has resulted in multiple upheld PMCPA complaints against cardiovascular brands.
Promoting SGLT-2 inhibitors for heart failure in patients without diabetes before the indication was extended, or implying broader use than licensed, is a well-documented risk in cardiovascular promotion.
Statements about renoprotective effects of SGLT-2 inhibitors require careful attention to which indication the supporting data relates to, whether the claim is within the licensed indication, and how it is contextualised.
For anticoagulants such as rivaroxaban and apixaban, conflating atrial fibrillation stroke prevention data with venous thromboembolism data — or vice versa — is a recurring source of promotional complaints.
Comparative efficacy or tolerability claims between statins, or between statins and PCSK9 inhibitors, require head-to-head data or very careful qualification to avoid claims of superiority without substantiation.
Built specifically for pharma teams working in cardiovascular — not generic compliance content repurposed for your therapy area.
The pack includes expert walkthroughs of all relevant PMCPA adjudications in the cardiovascular space. Here are three landmark cases.
The pack includes all relevant cardiovascular PMCPA cases with video walkthroughs, expert commentary and quiz questions.
MSLs and medical advisors presenting CVOT data, renal outcome data and discussing SGLT-2 inhibitor use across cardiology, nephrology and primary care
Sales representatives and brand managers responsible for cardiovascular promotional materials, CVOT data visualisations and HCP communications
HEOR and market access teams making NHS, NICE and formulary claims for cardiovascular products — particularly around HF, CKD and MACE outcome data
Regulatory affairs and compliance officers reviewing cardiovascular promotional materials, CVOT endpoint language and indication boundary statements
Speak to us about the Cardiovascular Compliance Pack. Tell us your team size and therapy area focus and we'll put together the right package.
Need more therapy areas? See all 12 therapy area packs →
GLP-1 agonists, SGLT-2 inhibitors, insulins. Cardiorenal benefit claims and weight loss promotion risk.
All 2,000+ PMCPA cases. Video. Podcast. Quiz. 5 points per case. The only case library of its kind in the UK.
12 therapy area packs covering Respiratory, Oncology, Cardiovascular, CNS, Diabetes, Immunology, Infectious Diseases, Dermatology, Musculoskeletal, Ophthalmology and more.
One real case. One key lesson. Every week — free.