Colchicin (1) – Colxi®

• Clinical trials
  • The multicentre, double-blind, randomised controlled trial COLCOT investigated the efficacy and safety of colchicine compared with placebo in adults with a documented acute myocardial infarction (MI) that had occurred less than 30 days previously.

Adults with atherosclerotic coronary heart disease and a recent myocardial infarction (MI) who have an indication for prophylaxis of ischaemic cardiovascular events

• Hint of a minor additional benefit.
• Overall, based on the demonstrated advantage in the morbidity endpoint category in the COLCOT study, there is a hint of a minor additional benefit for colchicine in addition to optimised standard therapy compared with the appropriate comparator therapy.
• Given the uncertainties, the overall strength of the evidence is classified as ‘hint’.
• mortality
  • In the COLCOT study, no statistically significant differences in all-cause mortality were observed between the treatment arms.
  • In the COLCOT study, there was no statistically significant difference in overall mortality between the treatment groups.
• Morbidity – serious cardiovascular events
  • For the combined primary endpoint of ‘serious cardiovascular events’, a statistically significant advantage in favour of colchicine was observed.
  • For the endpoints ‘stroke (non-fatal)’ and ‘urgent hospital admission due to angina pectoris requiring coronary revascularisation’, a statistically significant advantage in favour of colchicine was observed in each case.
  • The results for the endpoints ‘cardiovascular death’, ‘resuscitated cardiac arrest’ and ‘acute myocardial infarction’ show no statistically significant differences between the treatment groups, but indicate the same direction of effect as the other individual components.
  • The advantage is considered to be minor in extent based on the absolute risk reduction.
• Morbidity – recurrent cardiovascular events
  • The dossier also contains analyses of recurrent cardiovascular events, defined as the occurrence of multiple events comprising the primary composite endpoint in a single patient.
  • As the results are therefore based on the occurrence of multiple events comprising the primary composite endpoint in a single patient, this endpoint is presented here only as supplementary information.
• Morbidity – severe heart failure events
  • Consequently, no suitable data are available on the occurrence of severe heart failure events, defined as hospitalisation due to heart failure.
• Morbidity – coronary revascularisation
  • Consequently, the endpoint ‘coronary revascularisation’ is not considered separately for the benefit assessment.
• Morbidity – deep vein thrombosis or pulmonary embolism
  • However, the pharmaceutical manufacturer has not provided any analyses relating to the individual components or to patients with a qualifying event.
• quality of life
  • The endpoint ‘health-related quality of life’ was not assessed in the COLCOT study.
• Side effects – adverse events (AEs) regardless of severity
  • In the COLCOT study, AEs, regardless of severity, were not systematically recorded.
  • Due to the lack of data collection, no figures are available for the overall rates of AEs and severe AEs.
• Side effects – serious adverse events (SAEs)
  • There was no statistically significant difference between the treatment groups in the overall rates of serious AEs.
• Side effects – discontinuation due to AEs
  • Overall, therefore, there are still no suitable data available for the endpoint of discontinuation due to AEs.
• Side effects – gastrointestinal disorders (SOC, AE)
  • No statistically significant differences were observed between the treatment groups for the SOC ‘gastrointestinal disorders’.
• Overall view
  • Overall, based on the data from the COLCOT study, there is an advantage in favour of colchicine for the primary composite endpoint ‘serious cardiovascular events’, including the individual components ‘strokes (non-fatal)’ and ‘urgent hospital admission due to angina pectoris requiring coronary revascularisation’. The advantage is assessed as minor in extent based on the absolute risk reduction.
  • Overall, the G-BA therefore concludes that there is a minor additional benefit for colchicine in addition to optimised standard therapy, compared with the appropriate comparator therapy, in adults with atherosclerotic coronary heart disease and a recent myocardial infarction (MI) with an indication for the prevention of ischaemic cardiovascular events.

Courtesy translation only, please refer to the German original.