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Intensive Urate Lowering Therapy of Febuxostat Compared to Allopurinol on Cardiovascular Risk in Patients With Gout
Phase 4 trial testing Febuxostat 80/120mg/day in Gout in 196 participants. Completed in 10 May 2017.
| Lead sponsor | Menarini International Operations Luxembourg SA |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 196 |
| Start date | 17 August 2015 |
| Primary completion | 10 May 2017 |
| Estimated completion | 10 May 2017 |
| Sites | 26 locations across Italy, Netherlands, Serbia, Germany, Poland, Romania |
Menarini International Operations Luxembourg SA — full company profile →
18 and older, any sex, with Gout. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Comparison of the effects of Febuxostat and Allopurinol on Pulse Wave Velocity (PWV) after 36 weeks of treatment.
| Group | Value | 95% CI |
|---|---|---|
| Febuxostat 80/120 mg/Day | 9.0 | ± 2.04 |
| Allopurinol 100 up to 600 mg/Day | 9.05 | ± 1.99 |
Time frame: From signing of informed consent at visit -1 (from 7 to 30 days before treatment phase in case of retesting) to follow-up period of 2 weeks after the administration of the last treatment dose. Treatment duration was of 36 weeks.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Febuxostat 80/120 mg/Day | Allopurinol 100 up to 600 … |
|---|---|---|---|
| aortic aneurysm | Vascular disorders | — | — |
| Adhesiolysis | Surgical and medical procedures | — | — |
| Appendicectomy | Surgical and medical procedures | — | — |
| Colectomy | Surgical and medical procedures | — | — |
| Coronary artery bypass | Surgical and medical procedures | — | — |
| Gastric bypass | Surgical and medical procedures | — | — |
| Large intestine operation | Surgical and medical procedures | — | — |
| Intraocular lens implant | Surgical and medical procedures | — | — |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Hypersensitivity | Immune system disorders | — | — |
| Post Procedural complication | Injury, poisoning and procedural complications | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — |
| Blood triglycerides increased | Investigations | — | — |
| Angina pectoris | Cardiac disorders | — | — |
| Atrial flutter | Cardiac disorders | — | — |
| Pericarditis | Cardiac disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Ischemic cardiomyopathy | Cardiac disorders | — | — |
| Myocardial Ischemia | Cardiac disorders | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | Respiratory, thoracic and mediastinal disorders | — | — |
| Cataract | Eye disorders | — | — |
| Large intestinal obstruction | Gastrointestinal disorders | — | — |
| Peritoneal adhesions | Gastrointestinal disorders | — | — |
| Renal impairment | Renal and urinary disorders | — | — |
| Reaction | System | Febuxostat 80/120 mg/Day | Allopurinol 100 up to 600 … |
|---|---|---|---|
| gout | Metabolism and nutrition disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| Blood glucose increased | Investigations | — | — |
| Hepatic enzyme increased | Investigations | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| edema peripheral | General disorders | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — |
| Blood triglycerides increased | Investigations | — | — |
| Gamma-glutamyltransferase increased | Investigations | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Blood lactate dehydrogenase increased | Investigations | — | — |
| Blood pressure increased | Investigations | — | — |
| Blood thyroid stimulating hormone increased | Investigations | — | — |
| Heamoglobin decreased | Investigations | — | — |
| Laboratory test abnormal | Investigations | — | — |
| Blood insulin decreased | Investigations | — | — |
| Type V hyperlipidaemia | Congenital, familial and genetic disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Paraesthesia | Nervous system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Spinal pain | Musculoskeletal and connective tissue disorders | — | — |
| Arteriosclerosis | Vascular disorders | — | — |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Blood uric acid increased | Investigations | — | — |
| C-reactive protein increased | Investigations | — | — |
| eosinophil count decreased | Investigations | — | — |
| Blood pressure abnormal | Investigations | — | — |
| Blood Thyroid stimulating hormone decreased | Investigations | — | — |
| International normalised ratio increased | Investigations | — | — |
| Prothrombin time shortened | Investigations | — | — |
Most-reported serious reactions: aortic aneurysm, Adhesiolysis, Appendicectomy, Colectomy, Coronary artery bypass, Gastric bypass, Large intestine operation, Intraocular lens implant.
Data from ClinicalTrials.gov NCT02500641 adverse events section.
There is a mounting and clear association between hyperuricaemia, gout and the presence of traditional cardiovascular (CV) risk factors and CV event-equivalent conditions such as chronic kidney disease, metabolic syndrome, and diabetes. Gout is associated with increased risk of CV events such as myocardial infarction and CV death. Furthermore hyperuricaemia is clearly associated with an increased arterial stiffness, a marker of pre-clinical atherosclerosis. Carotid-femoral pulse wave velocity (PWV) is the "gold standard" measurement of arterial stiffness and it is considered, in this trial, as a valid surrogate endpoint with clearly established relevance to predict cardiovascular disease (CVD) clinical outcome In this randomised trial conducted on adult subjects with a history of gout, we use surrogate endpoints to investigate the efficacy of febuxostat compared with allopurinol to predict (CVD) clinical outcome. Eligible subjects were randomised in a 1:1 ratio to the following treatment groups: * Test product: febuxostat 80 mg or 120 mg once daily (120 mg daily, if serum urate was \>6 mg/dL after 2 weeks of treatment at 80 mg daily). * Active comparator: allopurinol 100 mg once daily (up to a maximum dose of 600 mg daily escalated in 100 mg increments every 2 weeks, if serum urate acid (sUA) was \>6 mg/dL after 2 weeks of treatment at the previous dose). The study duration was 39 weeks, which included the: * Run-in/screening period: 1 week (extendable up to a maximum of 30 days according to variability of sUA levels); * Treatment period: 36 weeks; * Safety follow-up period: 2 weeks.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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