- July 2022: Large review of statin clinical trial data could soon end remaining uncertainty on possible statin side effects
- January 2019: Statin therapy reduces cardiovascular disease risk in older people.
- December 2018: Statin Safety and Associated Adverse Events: A Scientific Statement from the American Heart Association
- July 2018: LENS trial of fibrates in patients with diabetes and observable retinopathy commences
- April 2018: Article published in EHJ by European Atherosclerosis Society Consensus Panel: "Adverse effects of statin therapy: perception vs. the evidence – focus on glucose homeostasis, cognitive, renal and hepatic function, haemorrhagic stroke and cataract"
- October 2017: Article by Fausto Pinto (ESC President 2014-16): Cholesterol and statins: why fear the truth?
- August 2017: REVEAL trial results announced at ESC: effects of Anacetrapib in patients with atherosclerotic vascular disease
- July 2017: AMS report: how can we all best use scientific evidence?
- June 2017: CANTOS trial results: study shows ACZ885 (canakinumab) reduces cardiovascular risk in people who survived a heart attack
- March 2017: FOURIER trial results published: inhibition of PCSK9 with evolocumab on a background of statin therapy
- December 2016: LSHTM StatinWISE trial assessing muscle symptoms recruits first patients
- October 2016: ASCOT-LLA publishes adverse event analyses
- September 2016: The Lancet publishes major review about the use of statins
- July 2016: Impact of renal function on the effects of LDL-cholesterol with statin based regimens published in Lancet Diabetes Endrocrinol
- June 2016: Adverse impact on public health of misleading information about statin safety
- June 2016: Renewed call to retract BMJ articles that mislead on statin effects
- May 2016: Adverse event protocol published in AHJ
- May 2016: Tabular data (all Serious Adverse Events by MedDRA classification) now available for HPS and SEARCH trials
The Cholesterol Treatment Trialists’ (CTT) Collaboration was established in 1994, with its initial protocol being published in 1995. It was set up after it was recognized that no single lipid intervention trial would be likely to have a sufficient number of trial participants (and hence statistical power) to reliably assess mortality outcomes or look at events in particular types of patient. Its aim is to conduct periodic meta-analyses of large-scale (≥1000 participants), long-term (≥2 years scheduled treatment duration) unconfounded, randomized controlled trials of lipid intervention therapies.
The Collaboration's work to date has largely focused on statin therapy, with individual participant data on major vascular events, cancers and mortality having been collected from about 30 major statin trials (equating to approximately 175,000 trial participants). The analyses of such data have been published in a series of publications, sequentially adding to the body of evidence for the efficacy and safety of statins. These analyses have shown that:
- Reduction of LDL cholesterol using statin therapy substantially reduces the risk of major vascular events (major coronary events, strokes or the need for coronary revascularization) and vascular mortality by about one fifth for each 1 mmol/L reduction in LDL cholesterol achieved
- Further reductions in LDL cholesterol with more intensive statin therapy produce further reductions in the incidence of major vascular events
In addition, the CTT analyses have shown that statin therapy:
- Has no effect on the incidence of, or death from, any type of cancer
- Is effective in a wide range of people including those with diabetes, those at low risk of vascular disease, and in both women and men
A new programme of work is currently underway to collect and analyze individual participant data on all other types of adverse event that were recorded in large-scale statin trials, in order that comprehensive analyses of all possible effects (either adverse or beneficial) of statin therapy in these trials can be conducted. This is a substantial undertaking, and methods have been developed to convert the extensive and heterogenous data into a single analysable format through use of systems based upon commonly used standards including the Clinical Data Interchange Standards Consortium Study Data Tabulation Model (CDISC SDTM) and the Medical Dictionary for Regulatory Activities (MedDRA).
The CTT Collaboration also has plans to combine data from randomized trials of other lipid modification therapies, both for established drugs (such as fibrates) and emerging interventions (such as PCSK9 or CETP inhibitors).