atients with unmanageable levels of cholesterol in the UK have been given a new treatment option with the launch of Merck Sharp & Dohme’s dyslipidaemia treatment Tredaptive.
Tredaptive (nicotinic acid/laropiprant) is designed to help patients who are unable to hit target levels of choelsterol, and, specifically, has been cleared to treat combined mixed dyslipidaemia or primary hypercholesterolaemia in combination with a statin or as a single agent when statins are inappropriate or not tolerated.
Statins have undoubtedly markedly improved lipid management since their introduction, providing a relative cut in the risk of heart disease of about 30%, but, as MSD points out, many patients are not able to reach their cholesterol targets with statins alone and there is still “a significant CVD residual risk in some patients”, highlighting the need for new, effective therapies.
While the lipid-modifying properties of nicotinic acid have been known for more than 50 years its use to date has been marred by its facial flushing side-effect. To address this, Tredaptive has combined the power of nicotinic acid with an anti-flushing agent called laropirant, which has significantly lowered the incidence of this side-effect and thereby should improve patient compliance and treatment outcomes, and potentially give it a competitive edge over Abbot’s nicotinic acid-based rival Niaspan (niacin).
Clinical studies with Tredaptive have clearly demonstrated its ability to improve lipid levels, with results from an efficacy study showing that treatment with the drug, with or without a statin, not only reduced low-density lipoprotein cholesterol levels by 18%, but also cut triglycerides by 26% and raised high-density lipoprotein levels by 20% (placebo adjusted) over a 24 week period.
"With the NICE Lipid Guidelines setting more stringent goals for secondary prevention patients, a statin may not be sufficient for some patients,” commented Dr George Kassianos, GP in Bracknell and Fellow of the European Society of Cardiology, and he added: “In order to help manage a patient's overall cardiovascular risk, combination therapy to address not just LDL-C but also HDL-C and triglycerides, is increasingly being recognised as a valuable approach”.