A randomized, multicenter, controlled trial using intravenous pulses of methylprednisolone in the initial treatment of simple forms of giant cell arteritis: a one year followup study of 164 patients.
OBJECTIVE
(1) To evaluate the corticosteroid sparing effect of an initial intravenous (i.v.) pulse of methylprednisolone (MP) in the treatment of simple forms of giant cell arteritis (GCA). (2) To analyze corticosteroid response, steroid related side effects, and GCA complications.


METHODS
Patients received a 240 mg i.v. pulse of MP followed by 0.7 mg/kg/day oral prednisone (Group 1) or 0.7 mg/kg/day prednisone without an i.v. pulse (Group 2, controls), or a 240 mg i.v. pulse of MP followed by 0.5 mg/kg/day prednisone (Group 3). Corticosteroid dosage was reduced after normalization of 2 biological inflammatory variables to obtain half-dosage after 4 weeks in Groups 1 and 2 and 20 mg/day after 2 weeks in Group 3. Tapering was systematically attempted from the 6th month of treatment.


RESULTS
One hundred sixty-four patients were included in the trial (1992-96). Cumulative doses of corticosteroids after one year were identical for all groups (p = 0.39). No significant differences were observed in the time required for normalization of C-reactive protein, corticosteroid resistance (13.5%), and corticosteroid related side effects (39% of patients; p = 0.37). Corticosteroid resistant patients received larger doses and showed a high risk of GCA related complications (p = 0.02).


CONCLUSIONS
MP pulses have no significant longterm, corticosteroid sparing effects in the treatment of simple forms of GCA and should be limited to complicated forms. Moreover, corticosteroid resistance is a real risk factor for GCA complications.
Chevalet
P
P
Department of Internal Medicine, University Hospital, Nantes, France.
Barrier
J H
JH
Pottier
P
P
Magadur-Joly
G
G
Pottier
M A
MA
Hamidou
M
M
Planchon
B
B
El Kouri
D
D
Connan
L
L
Dupond
J L
JL
De Wazieres
B
B
Dien
G
G
Duhamel
E
E
Grosbois
B
B
Jego
P
P
Le Strat
A
A
Capdeville
J
J
Letellier
P
P
Agron
L
L
D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects; D000368:Aged; D000369:Aged, 80 and over; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004351:Drug Resistance; D005260:Female; D005500:Follow-Up Studies; D013700:Giant Cell Arteritis / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008775:Methylprednisolone / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D020551:Pulse Therapy, Drug; D013375:Substance Withdrawal Syndrome / Q000276:immunology; D019966:Substance-Related Disorders; D016896:Treatment Outcome
D000276:Adjuvants, Immunologic; D000893:Anti-Inflammatory Agents; D008775:Methylprednisolone