Table 1.
Lineup of clinical studies evaluating effects interferon‐β (IFN‐β) in combination with statins in patients with clinically isolated syndrome (CIS) and relapsing‐remitting multiple sclerosis (RRMS)
| First author, year of publication | Study type | Patients | Allocation | Interferon‐β (IFN‐β) | Statin and dosage per day | Primary endpoint | Secondary endpoints | |
|---|---|---|---|---|---|---|---|---|
| Original articles | ||||||||
| 1 | Paul F et al. [14], 2008 | Phase II | RRMS | IFN‐β+ statin (n = 16), statin (n = 25) | IFN‐β‐1a 22 μg s.c. thrice weekly or IFN‐β‐1b s.c. every other day | Atorvastatin 80 mg | CEL at months 6–9: decrease/trend for combitherapy in number and volume of CEL | Changes in EDSS and MSFC: not stated |
| 2 | Birnbaum G et al. [10], 2008 | Safety study | RRMS | IFN‐β (n = 9), IFN‐β+ statin (n = 17) | IFN‐β‐1a 44 μg s.c. thrice weekly | Atorvastatin 40 mg (n = 7) and 80 mg (n = 10) | EDSS change, CEL or new lesion: greater clinical and MRI disease activity for patients on combitherapy | |
| 3 | Rudick RA et al. [15], 2009 | Post‐hoc analysis of other trial (SENTINEL) | RRMS | IFN‐β (n = 542), IFN‐β+ statin (n = 40) | IFN‐β‐1a 30 μg i.m. once weekly | Most frequently atorvastatin (65%) and simvastatin (32.5%) | Annualized relapse rate, disability progression, number CEL, number of new/enlarging T2‐lesions after 2 years: no differences | |
| 4 | Lanzillo R et al. [16] 2010 | Open‐label randomized study | RRMS | IFN‐β (n = 24), IFN‐β+ statin (n = 21) | IFN‐β‐1a 44 μg s.c. thrice weekly | Atorvastatin 20 mg | Number of CEL after 24 months: reduction comparable between the groups. Combitherapy; significantly reduced when compared to baseline | Relapse rate: significantly lower for combitherapy. EDSS and laboratory data: no difference |
| Communications | ||||||||
| 1 | Sörensen PS et al. [17] 2007 | Safety study, interim analysis | RRMS | Total (n = 8), IFN‐β, IFN‐β+ statin | IFN‐β‐1a 30 μg i.m. once weekly | Simvastatin 80 mg | First time to documented relapse after a mean of 6.9 months: no differences | Relapses, new/enlarging T2‐lesions: n.c. |
| 2 | Markovic‐Plese et al. [18] 2007 | Safety study | CIS | IFN‐β (n = 9), IFN‐β+ statin (n = 10) | IFN‐β‐1a 30 μg i.m. once weekly | Simvastatin 80 mg | Clinical and MRI activity: no differences | |
| 3 | Oztekin NS et al. 2009 [19] | Preliminary data at 18 months (of 24) | RRMS | IFN‐β (n = 11), IFN‐β+ statin (n = 7) | IFN‐β‐1a 44 μg s.c. thrice weekly | Atorvastatin 20 mg | MRI activity: comparable between the groups | Relapses, EDSS, safety laboratory data: n.c. |
RRMS, relapsing‐remitting MS; CEL, contrast‐(Gadolinium) enhancing lesions; EDSS, expanded disability status scale; MSFC, multiple sclerosis functional composite score; s.c., subcutaneous application; i.m., intramuscular application; n.c., not communicated.