{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,21]],"date-time":"2026-08-21T12:57:25Z","timestamp":1787317045002,"version":"build-2736575974"},"reference-count":14,"publisher":"BMJ","issue":"6","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2012,10,29]]},"published-print":{"date-parts":[[2012]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Sinemet, a combination drug containing carbidopa and levodopa is considered the gold standard therapy for the treatment of Parkinson's disease (PD). When approved by the Food and Drug Administration (FDA) in 1988, a maximum daily dosage limit of 800\u2005mg (eight tablets) of the 25\/100 carbidopa\/levodopa formulation was introduced. Overall, the FDA approval was a historic success; however, the pill limit has been hardcoded into many online medical record systems. This study investigates the 800\u2005mg threshold by using a prospectively collected database of patient information.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A retrospective cohort study: (Part I) cross-sectional, (Part II) longitudinal.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting and participants<\/jats:title>\n                    <jats:p>PD patients at a Movement Disorders Center in a large academic, tertiary medical setting.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Outcome measures<\/jats:title>\n                    <jats:p>An analysis was performed using carbidopa\/levodopa at dosages below and above the 800\u2005mg threshold. A secondary analysis was then performed using two consecutive clinic visits to determine the effects of crossing the 800\u2005mg threshold. Comparisons were made on standardised scales.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>There was no significant difference in motor, mood and quality-of-life scores in patients consuming below and above the 800\u2005mg carbidopa\/levodopa threshold, though a mild worsening in dyskinesia duration was noted without worsening in dyskinesia pain and disability. In PD patients who crossed the 800\u2005mg threshold between two consecutive clinic visits, a significant improvement in depressive symptoms and quality-of-life measures was demonstrated, and in these patients there was no worsening of motor fluctuations or dyskinesia.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The data suggest that PD patients have the potential for enhanced clinical benefits when eclipsing the 800\u2005mg carbidopa\/levodopa threshold. Many patients will likely need to eclipse the 800\u2005mg threshold and pharmacies and insurance companies should be aware of the requirements that may extend beyond approval limits.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2012-001971","type":"journal-article","created":{"date-parts":[[2012,12,11]],"date-time":"2012-12-11T20:19:54Z","timestamp":1355257194000},"page":"e001971","source":"Crossref","is-referenced-by-count":9,"title":["Carbidopa\/levodopa dose elevation and safety concerns in Parkinson's patients: a cross-sectional and cohort design"],"prefix":"10.1136","volume":"2","author":[{"given":"David W","family":"Brodell","sequence":"first","affiliation":[{"name":"Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole T","family":"Stanford","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles E","family":"Jacobson","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Schmidt","sequence":"additional","affiliation":[{"name":"National Parkinson Foundation, Miami, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael S","family":"Okun","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Florida Center for Movement Disorders and Neurorestoration, Gainesville, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2012,12,11]]},"reference":[{"key":"2025121221465013000_2.6.e001971.1","first-page":"106","article-title":"Clinical inquiry. Which drugs work best for early Parkinson's disease?","volume":"61","author":"Jain","year":"2012","journal-title":"J Fam Pract"},{"key":"2025121221465013000_2.6.e001971.2","first-page":"11","article-title":"Practice parameter: initiation of treatment for Parkinson's disease: an evidence-based review: report of the Quality Standards Subcommittee of the American Academy of Neurology","volume":"58","author":"Miyasaki","year":"2002","journal-title":"J Neurol"},{"key":"2025121221465013000_2.6.e001971.3","unstructured":"Merck & Co., Inc. United States. Food and Drug Administration. Sinemet 1988."},{"key":"2025121221465013000_2.6.e001971.4","doi-asserted-by":"crossref","first-page":"524","DOI":"10.1111\/j.1445-5994.2006.01123.x","article-title":"Reasons for admission to hospital for Parkinson's disease","volume":"36","author":"Temlett","year":"2006","journal-title":"J Intern Med"},{"key":"2025121221465013000_2.6.e001971.5","doi-asserted-by":"publisher","DOI":"10.1001\/archneur.56.5.529"},{"key":"2025121221465013000_2.6.e001971.6","doi-asserted-by":"publisher","DOI":"10.1002\/mds.870060205"},{"key":"2025121221465013000_2.6.e001971.7","doi-asserted-by":"crossref","first-page":"260","DOI":"10.1111\/j.1468-1331.2009.02866.x","article-title":"Large differences in levodopa dose requirement in Parkinson's disease: men use higher doses than women","volume":"17","author":"Nyholm","year":"2010","journal-title":"Eur J Neurol"},{"key":"2025121221465013000_2.6.e001971.8","doi-asserted-by":"publisher","DOI":"10.1093\/brain\/awf080"},{"key":"2025121221465013000_2.6.e001971.9","doi-asserted-by":"crossref","first-page":"455","DOI":"10.1001\/jama.287.4.455","article-title":"Excessive daytime sleepiness and sudden-onset sleep in Parkinson disease: a survey by the Canadian Movement Disorders Group","volume":"287","author":"Hobson","year":"2002","journal-title":"JAMA"},{"key":"2025121221465013000_2.6.e001971.10","doi-asserted-by":"publisher","DOI":"10.2147\/CIA.S6456"},{"key":"2025121221465013000_2.6.e001971.11","doi-asserted-by":"crossref","first-page":"205","DOI":"10.1097\/WNF.0b013e3182613dea","article-title":"Intrajejunal levodopa versus conventional therapy in Parkinson disease: motor and nonmotor effects","volume":"35","author":"Reddy","year":"2012","journal-title":"Clin Neuropharmacol"},{"key":"2025121221465013000_2.6.e001971.12","doi-asserted-by":"publisher","DOI":"10.1136\/jnnp.69.6.820"},{"key":"2025121221465013000_2.6.e001971.13","doi-asserted-by":"publisher","DOI":"10.1007\/s00702-012-0796-9"},{"key":"2025121221465013000_2.6.e001971.14","doi-asserted-by":"crossref","first-page":"380","DOI":"10.1111\/j.1755-5949.2011.00253.x","article-title":"Patient diaries as a clinical endpoint in Parkinson's disease clinical trials","volume":"18","author":"Papapetropoulos","year":"2012","journal-title":"CNS Neurosci Ther"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2012-001971","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,13]],"date-time":"2025-12-13T05:46:57Z","timestamp":1765604817000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2012-001971"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012]]},"references-count":14,"journal-issue":{"issue":"6","published-online":{"date-parts":[[2012,12,11]]},"published-print":{"date-parts":[[2012]]}},"alternative-id":["10.1136\/bmjopen-2012-001971"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2012-001971","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012]]}}}