Hostname: page-component-78c5997874-4rdpn Total loading time: 0 Render date: 2024-11-10T08:02:38.347Z Has data issue: false hasContentIssue false

Long-Term Evaluation of Sinemet® CR in Parkinsonian Patients with Motor Fluctuations

Published online by Cambridge University Press:  18 September 2015

J. Thomas Hutton*
Affiliation:
Parkinson's Disease Research Center, St. Mary of the Plains Hospital, Lubbock, Texas
Jerry L. Morris
Affiliation:
Parkinson's Disease Research Center, St. Mary of the Plains Hospital, Lubbock, Texas
*
Parkinson's Disease Research Center, St. Mary of the Plains Hospital, 4012 - 22nd PL Suite 2, Lubbock, Texas, U.S.A. 79410
Rights & Permissions [Opens in a new window]

Abstract:

Core share and HTML view are not available for this content. However, as you have access to this content, a full PDF is available via the ‘Save PDF’ action button.

The safety and efficacy of Sinemet® CR, a controlled-release formulation of carbidopa/levodopa, were investigated in a three year, open-label trial involving 18 parkinsonian patients with fluctuating motor response. The average daily levodopa dosing frequency did not change significantly during long-term treatment. Efficacy measures generally revealed a gradual progression of parkinsonian disability. Patient diaries of motor fluctuations revealed relative stability of time “on” but with a tendency toward increased time “on with dyskinesias” over the 36 month followup period. There were no adverse laboratory results deemed to be related to Sinemet® CR and no unexpected side effects were observed.

Type
Articles
Copyright
Copyright © Canadian Neurological Sciences Federation 1991

References

REFERENCES

1.Fahn, S.On-off” phenomenon with levodopa therapy in parkinsonism. Neurology 1974; 24: 431441.CrossRefGoogle ScholarPubMed
2.Sweet, RD, McDowell, FH. Plasma dopa concentrations and the “on-off” effect after chronic treatment of Parkinson’s disease. Neurology 1974; 24: 953956.CrossRefGoogle ScholarPubMed
3.Shoulson, I, Glaubiger, GA, Chase, TN. On-off response: Clinical and biochemical correlations during oral and intravenous levodopa administration in parkinsonian patients. Neurology 1975; 25: 11441148.CrossRefGoogle ScholarPubMed
4.Quinn, N, Marsden, CD, Parkes, JD. Complicated response fluctuations in Parkinson’s disease: Response to intravenous infusion of levodopa. Lancet 1982; 2: 412415.CrossRefGoogle ScholarPubMed
5.Hardie, RJ, Lees, AJ, Stern, GM. On-off fluctuations in Parkinson’s disease: A clinical and neuropharmacological study. Brain 1984; 107: 487506.CrossRefGoogle ScholarPubMed
6.Quinn, N, Parkes, JD, Marsden, CD. Control of on/off phenomenon by continuous intravenous infusion of levodopa. Neurology 1984; 34: 11311136.CrossRefGoogle Scholar
7.Kurlan, R, Nutt, JG, Woodward, WR, et al. Duodenal and gastric delivery of levodopa in parkinsonism. Ann Neurol 1988; 23: 589595.CrossRefGoogle ScholarPubMed
8.Sage, JI, Trooskin, S, Sonsalla, PK, et al. Long-term duodenal infusion of levodopa for motor fluctuations in parkinsonism. Ann Neurol 1988; 24: 8789.CrossRefGoogle ScholarPubMed
9.Sage, JI, Trooskin, S, Sonsalla, PK, et al. Experience with continuous enteral levodopa infusions in the treatment of 9 patients with advanced Parkinson’s disease. Neurology 1989; 539 (suppl 2): 6063.Google Scholar
10.Fabbrini, G, Juncos, J, Mouradian, MM, et al. Levodopa pharmacokinetic mechanisms and motor fluctuations in Parkinson–s disease. Ann Neurol 1987; 21: 370376.CrossRefGoogle ScholarPubMed
11.Hutton, JT, Dippel, RL, Bianchine, JR, et al. Controlled-release carbidopa/levodopa in the treatment of parkinsonism. Clin Neuropharmacol 1984; 7: 135139.CrossRefGoogle ScholarPubMed
12.Nutt, JG, Woodward, WR, Carter, JH. Clinical and biochemical studies with controlled-release levodopa/carbidopa. Neurology 1986; 36: 12061211.CrossRefGoogle ScholarPubMed
13.Cederbaum, JM, Breck, L, Kutt, H, et al. Controlled-release levodopa/carbidopa. 1. Sinemet CR-3 treatment of response fluctuations in Parkinson–s disease. Neurology 1987; 37: 233241.CrossRefGoogle Scholar
14.Hutton, JT, Albrecht, JW, Román, GC, et al. Prolonged serum levodopa levels with controlled-release carbidopa-levodopa in the treatment of Parkinson’s disease. Arch Neurol 1988; 45: 5557.CrossRefGoogle ScholarPubMed
15.Yeh, KC, August, TF, Bush, DF, et al. Pharmacokinetics and bioavailability of Sinemet CR: A summary of human studies. Neurology 1989; 39 (suppl 2): 2538.Google ScholarPubMed
16.Cederbaum, JM, Breck, L, Kutt, H, et al. Controlled-release levodopa/carbidopa. II. SINEMET CR 4 treatment of response fluctuations in Parkinson’s disease. Neurology 1987; 37: 16071612.CrossRefGoogle Scholar
17.Goetz, CG, Tanner, CM, Klawans, HL, et al. Parkinson’s disease and motor fluctuations: Long-acting carbidopa/levodopa (CRSINEMET). Neurology 1987; 37: 875878.CrossRefGoogle Scholar
18.Goetz, CG, Tanner, CM, Carroll, S, et al. Controlled-release carbidopa/levodopa: Long-term open label and short-term doubleblind data. Neurology 1987; 37 (suppl 1): 270.Google Scholar
19.Ahlskog, JE, Muenter, MD, McManis, PG, et al. Controlled-release Sinemet (CR-4): A double-blind crossover study in patients with fluctuating Parkinson–s disease. Mao Clin Proc 1988; 63: 876886.CrossRefGoogle ScholarPubMed
20.Hutton, JT, Morris, JL, Román, GC, et al. Treatment of chronic Parkinson’s disease with controlled-release carbidopa/levodopa. Arch Neurol 1988; 45: 861864.CrossRefGoogle ScholarPubMed
21.Sage, JI, Mark, MH. Comparison of controlled-release Sinemet (CR4) and standard Sinemet (25mg/100mg) in advanced Parkinson’s disease: A double-blind, crossover study. Clin Neuropharmacol 1988; 11: 174179.CrossRefGoogle Scholar
22.Cederbaum, JM, Hoey, M, McDowell, FH. A double-blind crossover comparison of Sinemet CR4 and standard Sinemet 25/100 in patients with Parkinson’s disease and fluctuating motor performance. J Neurol Neurosurg Psychiatry 1989; 52: 207212.CrossRefGoogle Scholar
23.Hutton, JT, Morris, JL, Bush, DF, et al. Multicenter controlled study of Sinemet CR vs Sinemet (25/100) in advanced Parkinson’s disease. Neurology 1989; 39 (suppl 2): 67–72.Google ScholarPubMed
24.Aarli, JA, Gilhus, NE. Sinemet, CR in the treatment of patients with Parkinson’s disease already on long-term treatment with levodopa. Neurology 1989; 39 (suppl 2): 8285.Google ScholarPubMed
25.Bush, DF, Liss, CL, Morton, A, et al. An open multicenter long-term treatment evaluation of Sinemet CR. Neurology 1989; 39 (suppl 2): 101104.Google ScholarPubMed
26.Rondot, P, Ziegler, M, Aymard, N, et al. Effect of controlled-release carbidopa/levodopa on motor performance in advanced Parkinson’s disease. Neurology 1989; 39 (suppl 2): 7477.Google ScholarPubMed
27.Goetz, CG, Tanner, CM, Gilley, DW, et al. Development and progression of motor fluctuations and side effects in Parkinson's disease: Comparison of Sinemet CR versus carbidopa/levodopa. Neurology 1989; 39 (suppl 2): 6366.Google ScholarPubMed
28.Rodnitzky, RL, Dickins, QS, Dobson, J. Long-term clinical efficacy of Sinemet CR in patients with Parkinson’s disease. Neurology 1989; 39(suppl 2): 9295.Google ScholarPubMed
29.Fahn, S. Fluctuation of disability inParkinson’s disease: Pathophysiology. In: Marsden, CD, Fahn, S, eds. Movement Disorders. London: Butterworths, 1982: 119126.Google Scholar
30.Roller, WC, Hubble, JP. Levodopa therapy in Parkinson's disease. Neurology 1990; 40 (suppl 3): 4047.Google Scholar
31.Obeso, JA, Grandas, F, Vaamonde, J, et al. Motor complications associated with chronic levodopa therapy in Parkinson’s disease. Neurology 1989; 39 (suppl 2): 1119.Google ScholarPubMed
32.Chase, TN, Baronti, F, Fabbrini, G, et al. Rationale for continuous dopaminometic therapy of Parkinson's disease. Neurology 1989; 39 (suppl 2): 710.Google ScholarPubMed