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DRUGDEX DRUG EVALUATIONS
LEVODOPA/BENSERAZIDE
 CLINICAL APPLICATIONS
 COMPARATIVE EFFICACY
 E. LEVODOPA/CARBIDOPA
 1. PARKINSON'S DISEASE
 a. Levodopa/carbidopa (l/c; Sinemet(R) CR) was effective in the
treatment of 37 patients with early Parkinson's disease previously
treated with either controlled-release or standard
levodopa/benserazide (l/b; Madopar(R)). Optimal response for
controlled-release l/c was equal to the l/b controlled release dose and
12% higher than it had been with standard l/b, but the number of daily
doses of l/c was significantly lower than either l/b preparation.
Adverse effects of l/c were generally mild and transient (nausea,
vomiting, light-headedness, orthostatic hypotension, diarrhea and
confusion), and many of the end-of-dose problems (fluctuations in
disability, dyskinesias, etc) documented in long-term l/b use were
alleviated (Rinne & Rinne, 1989).
 b. In a randomized, double-blind 12-week study of 60 elderly patients
with Parkinson's disease, levodopa/benserazide (l/b) was consistently
(but not statistically) superior to levodopa/carbidopa (l/c) for
improvement in all seven symptoms measured: akinesia, rigidity,
tremor, upper extremity swing, facies, gait and speech. The average
daily dose at study end was 390 milligrams (mg) for l/b and 370 mg
for l/c. A test of daily living skills also showed marked improvement




with each regimen. Adverse effects were minimal and transient, with
nausea and hypotension being most common (Admani et al, 1985).
c. Levodopa/carbidopa (l/c) controlled-release 250 milligrams
produced significantly greater stride length (p = 0.04) than
levodopa/benserazide (l/b) in a crossover study of nine patients with
idiopathic Parkinson's disease. No difference was noted between the
drug combinations regarding foot separation. It is to be noted that all
of the subjects had been receiving the l/c preparation prior to the
study (Weller et al, 1993).
d. Significant improvement in Parkinson's disease symptoms and
functional disability was obtained for both levodopa/benserazide (l/b)
and levodopa/carbidopa (l/c) in a randomized, double-blind,
crossover trial of 49 patients. None of the patients had previously
been treated with levodopa; average doses for the 12-week week trial
ranged between 675 and 776 milligrams (mg) per day for l/b in a 4:1
ration and 844 and 940 mg/day for l/c in a 10:1 ratio. Significant
differences were not noted between drug regimens, and improvement
for each took place as early as the first week of treatment (p less than
0.001). Nausea and vomiting were more common with l/c than with l/b
(Rinne & Molsa, 1979).
e. On-off frequency, severity and duration were similar for both
levodopa/carbidopa (l/c) and levodopa/benserazide (l/b)
combinations, as was the measurement of involuntary movements in
four patients with Parkinson's disease. Onset of improvement
coincided with peak plasma DOPA levels, and, to a lesser extent, the
peak DOPA:dopamine ratio. For l/b, peak DOPA: dopamine ratio was
higher, but had a shorter half-life, which argues against a change
from l/c to l/b treatment (Lieberman et al, 1978).
f. No significant differences in treatment efficacy or tolerability were
noted between levodopa/carbidopa (l/c) mean 724 milligrams
(mg)/day in a 10:1 ratio and levodopa/benserazide (l/b) mean 756
mg/day in a 4:1 ratio for six weeks in a randomized cross-over study
of 21 patients with Parkinson's disease. Two patients discontinued the
l/b arm because of severe orofacial and limb dyskinesia. In selfassessment, nine patients preferred l/c, eight preferred l/b and two
had no preference (Greenacre et al, 1976).
 g. The frequency of gastrointestinal adverse effects and involuntary
movements of levodopa/carbidopa (l/c; Sinemet(R)) treatment were
significantly higher and more severe than seen with
levodopa/benserazide (l/b; Madopar(R)) therapy in a randomized,
triple-blind multicenter study of 92 parkinsonian patients. Patients
were treated with dosage schedules recommended by the
manufacturers. Maximum l/b dosages of 800/200 milligrams (mg) and
1500/150 mg l/c were obtained after 6 weeks and 3 weeks,
respectively. The two regimens were equally effective and had similar
onsets of action. On Sinemet(R) 83% of the patients suffered from
nausea or vomiting at least once during the study versus 57% of the
patients on Madopar(R). Abnormal involuntary movements were
observed in 35% of the patients on Madopar(R) compared to 61% on
Sinemet(R) (Pakkenberg et al, 1976).
 F. SELEGILINE
 1. PARKINSON'S DISEASE
 a. The combination of selegiline (L-deprenil), an irreversible
monoamine oxidase inhibitor, 5 to 10 milligrams (mg) daily and
levodopa/benserazide (l/b) 250 mg three times daily for six to seven
months resulted in 53% to 61% improvement compared to
prelevodopa treatment levels in 223 patients with varying degrees of
severity of Parkinson's disease. Prior treatment with l/b alone had
improved the disability between 32.8% and 38%. L-deprenil was
clinically effective within one hour of ingestion and lasted from 1 to 3
days. With the combined therapy program, adverse effects included
dyskinesias in 16 patients, psychosis (14), nausea (8) and orthostatic
hypotension (5). Of 223 patients, 14% did not respond to the
combined treatment (Birkmayer et al, 1977).
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