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Epanova® for Lowering Very High Triglycerides II (EVOLVE II)
Phase 3 trial testing Epanova in Hypertriglyceridemia in 379 participants. Completed in 23 December 2014.
| Lead sponsor | AstraZeneca |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 379 |
| Start date | 16 December 2013 |
| Primary completion | 23 December 2014 |
| Estimated completion | 23 December 2014 |
| Sites | 40 locations across Denmark, Netherlands, Russia, Hungary, Canada, United States, Czechia |
AstraZeneca — full company profile →
Adults 18 to 130, any sex, with Hypertriglyceridemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
This primary endpoint was tested in parallel together with the first of the secondary endpoints, each at 0.025 Type I error rate.
| Group | Value | 95% CI |
|---|---|---|
| Epanova | -28.1 | -42.1 – -5.5 |
| Olive Oil | -10.2 | -36.4 – 23.0 |
This first secondary endpoint in subjects with at least 1 qualifying triglyceride \>885 mg/dL was tested in parallel together with the primary endpoint, each at 0.025 Type I error rate.
| Group | Value | 95% CI |
|---|---|---|
| Epanova | -37.5 | -46.1 – -18.1 |
| Olive Oil | -9.3 | -36.3 – 27 |
This secondary endpoint, together with the 3rd. and 4th secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.
| Group | Value | 95% CI |
|---|---|---|
| Epanova | -8.8 | -15.7 – -1.4 |
| Olive Oil | 0.4 | -13.5 – 14.2 |
This secondary endpoint, together with the 2nd. and 4th. secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.
| Group | Value | 95% CI |
|---|---|---|
| Epanova | 3.4 | -5.1 – 12.5 |
| Olive Oil | 3.1 | -6.3 – 10.9 |
This secondary endpoint in subjects with Biochemically Defined Fredrickson Type V (Triglyceride/Very-Low-Density Lipoprotein Cholesterol ≥6), together with the 2nd. and 3rd.secondary ones, was treated as the core secondary, and the p value from the hypothesis test on its treatment comparison was adjusted by using Hommel's procedure.
| Group | Value | 95% CI |
|---|---|---|
| Epanova | -24.7 | -43.3 – -2.8 |
| Olive Oil | -12.4 | -38.8 – 14.2 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Epanova | Olive Oil |
|---|---|---|---|
| Rectal haemorrhage | Gastrointestinal disorders | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — |
| Clavicle fracture | Injury, poisoning and procedural complications | — | — |
| Reaction | System | Epanova | Olive Oil |
|---|---|---|---|
| All | Gastrointestinal disorders | — | — |
| ALL | Infections and infestations | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| ALL | Nervous system disorders | — | — |
| ALL | Metabolism and nutrition disorders | — | — |
| ALL | Musculoskeletal and connective tissue disorders | — | — |
| ALL | Investigations | — | — |
| Eructation | Gastrointestinal disorders | — | — |
| Nasopharyngitis | Infections and infestations | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| ALL | Vascular disorders | — | — |
| Hypertension | Vascular disorders | — | — |
| ALL | Respiratory, thoracic and mediastinal disorders | — | — |
| ALL | General disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Blood creatine phosphokinase increased | Investigations | — | — |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | — | — |
| ALL | Ear and labyrinth disorders | — | — |
| ALL | Injury, poisoning and procedural complications | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Flatulence | Gastrointestinal disorders | — | — |
| Food poisoning | Gastrointestinal disorders | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — |
| Toothache | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — |
| Rectal haemorrhage | Gastrointestinal disorders | — | — |
| Bronchitis | Infections and infestations | — | — |
| Erysipelas | Infections and infestations | — | — |
| Gastroenteritis viral | Infections and infestations | — | — |
| Influenza | Infections and infestations | — | — |
| Respiratory tract infection viral | Infections and infestations | — | — |
Most-reported serious reactions: Rectal haemorrhage, Pancreatitis, Clavicle fracture.
Data from ClinicalTrials.gov NCT02009865 adverse events section.
This is a double-blind, randomized, olive oil-controlled study to investigate the efficacy and safety of Epanova as an adjunct therapy to diet for reduction of TG levels in subjects with severe hypertriglyceridemia. The study consists of an approximately 8-week screening period that includes a diet and lifestyle stabilization and washout period and a 12-week treatment period.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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