Gout drug non-cloth is not safe for cardiovascular health? The Lancet has published large-scale cross-border trials

On November 9th, local time, the results of FAST, a large-scale multinational trial of long-term cardiovascular safety of non-cloth and allopurinol in gout patients, were published in The Lancet, providing important and reassuring evidence of this concern over the years.
results showed that non-cloths were not inferior to allopurinol in major cardiovascular outcomes, and that long-term medication was not associated with an increased risk of death or serious adverse events.
screenshot source: Lancet's eight-year-old new study, based on the European Medicines Agency's (EMA) recommendations for non-bust safety reassessing, was led by academics at the University of Dundee in the UK and carried out in several European countries.
this is a forward-looking, randomized, open-label double-blind trial that included 6,128 patients aged ≥60 who had been treated with allopurol and had at least one additional cardiovascular risk factor between 2011 and 2018.
85.3 per cent of these patients were men and 33.4 per cent had previous cardiovascular disease, with a median time of six years for patients who had previously taken allosterol.
during the trial period, the researchers adjusted the patient's dose of allopurinol, resulting in a serum uric acid concentration of <0.357 mmol/L (6 mg/dL), followed by a 1:1 random group acceptance of allopurinol (3065) For example, the optimal dose, mostly at 100 mg - 300 mg) or non-clothta (3063 cases, starting at 80 mg/day, 2.5% of patients due to uric acid compliance needs to increase to 120 mg/day).
as of the end of the study (31 December 2019), the medium follow-up time was 1324 days.
6.2% and 5.5% of patients in the non-cloth and other allopurinol groups did not follow up successfully.
At the main endpoint of the study, the number of hospitalizations, non-fatal strokes or cardiovascular deaths due to non-fatal heart attack or acute coronary artery syndrome in both groups was 172 (1.72 events/per 10 0 person-year) and 241 cases (2.05 events/per 100 person-year), the risk of the above cardiovascular events in the non-bust group was 15% lower, compared to the non-poor effectiveness of allopurinol.
the main endpoint event rates of the study of the non-clothing group and the sterol group (photo source: Resources1) were compared separately, and the non-clothing group also showed non-poor effectiveness.
was also found to increase the risk of adverse cardiovascular events in the subgroup of patients who previously suffered from heart attack, stroke, or acute coronary artery syndrome.
222 cases (7.2%) and 263 (8.6%) deaths were reported in the non-substasy and allopurinol groups, respectively.
combined with a number of data, the researchers point to the important point - no signs of increased death were observed in the FAST study.
Among other safety manifestations, at least one serious adverse event occurred in the non-substasta group and 1812 cases (59.4%) of patients who took at least one dose of the study drug and were included in the safety analysis.
, the incidence of endocrine abnormalities was higher in the non-subsacreatic group and the incidence of tumors (including good malignancy, cysts and psychics) was lower.
The severe adverse events in
24 patients were considered to be related to treatment, including 23 incidents in 19 patients (0.6%) in the non-substasty group and 5 events in 5 patients (0.2%) in the beanol group, with the main difference between the two treatment groups being gastrointestinal diseases.
In uric acid level control, the uric acid concentration decreased significantly and varied significantly from year to year in patients in the non-busta group, with 1017 cases (17.95 seizures per 100 patients-years) and 1044 patients (19.85 seizures per 100 patients-years) having at least one gout attack.
based on new data, how do you view non-bust security? In fact, this isn't the first major post-market study to test the cardiovascular safety of non-busts.
A large-scale trial, CARES, previously conducted at the request of the FDA, found that the risk of adverse cardiovascular events after treatment with non-bustamol was no higher in patients with gout combined with major cardiovascular diseases, but there was a slight increase in the risk of death and cardiovascular death.
the two trials are similar in size, how do you see the results that differ slightly? In a commentary published in the Lancet at the same time, Dr Thomas Bardin, of the rheumatology department at the University of Paris, noted that the non-bust dose used in the FAST study was higher than the CARES trial, but had not shown an increased risk of cardiovascular events.
consistent conclusion of the two trials on this point is the most important consideration.
screenshot source: Lancet and the secondary endpoint, the increased risk of cardiovascular death and all-cause death observed in the CARES study was not observed in the FAST study.
, considering that 45 percent of patients in the CARES study lost late in the study, it was not actually a good way to assess the risk of death over a longer period of time, but the follow-up quality of the FAST study was very good.
On the other hand, the CARES study included patients with more severe gout, higher uric acid burden also has an important impact on cardiovascular risk, and all patients have a history of cardiovascular disease, and the overall health of patients in the FAST study may not be sufficient to observe the risk of non-busses in people with pre-existing serious cardiovascular problems.
, both studies were conducted primarily in white male patients, and the results were not fully extended to other populations.
also noted that neither trial included a placebo group and therefore could not assess the potential cardiovascular benefits of reducing uric acid.
But overall, Dr. Thomas Bardin commented that the results of the study supported non-clothing and his cardiovascular tolerance, and agreed with the authors' team's recommendation that "the regulatory recommendations to avoid the use of non-cloths in patients with cardiovascular disease should be reconsidered and revised."
Among Asians, there is not enough evidence to increase the risk of sudden cardiac death in non-buscea, according to a 2018 study published in NEJM, and a Chinese expert group has now recommended non-cloth as a first-line uric acid-lowering drug for gout patients.
References to the World, Isla S Mackenzie, et al., (2020). Long-term cardiovascular safety of febuxostat compared with allopurinol in patients with gout (FAST): a multicentre, prospective, randomised, open-label, non-inferiority trial. The Lancet, DOI: [2] Thomas Bardin, et al., (2020). FAST: new look at the febuxostat safety profile. The Lancet, DOI: Guidelines for the Diagnosis and Treatment of High Uric acidEmia and Glyph in China (2019)