Skin acceptance of transcutaneous nitroglycerin patches: a prospective study of 33 patients

Vaillant, L; Biette, S.; Machet, L.; Constans, T.; C, Monpère

doi:10.1111/j.1600-0536.1990.tb04774.x

Cited by 19 publications

(11 citation statements)

References 13 publications

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“…However, a proportion of patients discontinued owing to application site problems: 27 patients left the study in year 1 and 8 patients in year 2. Similar or higher discontinuation rates of patch treatments were reported for other indications [25,26]. …”

Section: Discussionsupporting

confidence: 76%

Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch

et al. 2010

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BackgroundRotigotine is a unique dopamine agonist with activity across D1 through D5 receptors as well as select adrenergic and serotonergic sites. This study reports the 2-year follow-up safety and efficacy data of an ongoing open-label multicenter extension study (NCT00498186) of transdermal rotigotine in patients with moderate to severe restless legs syndrome (RLS).MethodsPatients received a once-daily patch application of an individually optimized dose of rotigotine between 0.5 mg/24 h to 4 mg/24 h. Safety assessments included adverse events (AEs) and efficacy was measured by the International RLS Study Group Severity Rating Scale (IRLS), RLS-6 scales and Clinical Global Impression (CGI). Quality of life (QoL) was measured by QoL-RLS.ResultsOf 310 patients who completed a 6-week placebo-controlled trial (SP709), 295 (mean age 58 ± 10 years, 66% females) were included in the open-label trial SP710. 64.7% (190/295 patients) completed the 2-year follow-up; 29 patients discontinued during the second year. Mean daily rotigotine dose after 2 years was 2.93 ± 1.14 mg/24 h with a 2.9% dose increase from year 1. Rotigotine was generally well tolerated. The rate of typical dopaminergic side effects, nausea and fatigue, was low (0.9% and 2.3%, respectively) during the second year; application site reactions were frequent but lower than in year 1 (16.4% vs. 34.5%). The IRLS total score improved from baseline of SP709 (27.8 ± 5.9) by 17.2 ± 9.2 in year 2 completers. Similar improvements were observed in RLS-6 scales, CGI scores and QoL-RLS. The responder rate in the CGI change item 2 ("much" and "very much" improved) was 95% after year 2.ConclusionsTransdermal rotigotine is an efficacious and well-tolerated long-term treatment option for patients with moderate to severe RLS with a high retention rate during 2 years of therapy.Trial registrationNCT00498186

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Section: Discussionsupporting

confidence: 76%

Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch

et al. 2010

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“…However, severity of reaction is mild to moderate and the incidence of application-site reactions is similar to, or lower than, those of other, marketed, transdermal patches. [18][19][20][21] Rotigotine is the first dopamine agonist to be successfully delivered by transdermal application that has received approval for the treatment of patients with PD. This unique method of drug delivery for PD has several advantages.…”

Section: Discussionmentioning

confidence: 99%

Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole

et al. 2007

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Rotigotine is a new, non-ergot dopamine agonist formulated in a transdermal delivery system. The present study was to investigate the efficacy and safety of the rotigotine transdermal patch in the treatment of early Parkinson's disease. Patients (n = 561) were randomized to rotigotine, ropinirole, or placebo. The titration period was up to 13 weeks, and there was a minimum dose-maintenance period of 24 weeks for ropinirole and 33 weeks for rotigotine. The primary endpoint was the proportion of patients with a minimum of 20% decrease in the combined Unified Parkinson's Disease Rating Scale Part II and Part III scores. The responder rate in the rotigotine group was significantly higher than in the placebo group (52% vs. 30%, P < 0.0001). Transdermal rotigotine at doses < or =8 mg/24 h did not show noninferiority to ropinirole at doses < or =24 mg/day. In a post-hoc subgroup analysis, rotigotine < or =8 mg/24 hours had a similar efficacy to ropinirole at doses < or =12 mg/day. The rotigotine transdermal patch was well tolerated. The most common adverse events were application-site reactions, nausea, and somnolence. Application-site reactions were predominantly mild or moderate in intensity. In conclusion, the rotigotine transdermal patch represents an effective and safe option for the treatment of patients with early Parkinson's disease.

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“…This type of reaction, which probably represents a local pharmacologic effect of nicotine on the cutaneous microvasculature, was the only identifiable cause for the skin problems in 2 of our subjects. Contact sensitization to a component of the TIS or the active ingredient is a common problem and has been reported of all drugs available in such a delivery system (1,2,8). This is the most important adverse skin reaction, because it may prevent further use of the TIS involved.…”

Section: Discussionmentioning

confidence: 99%

Adverse skin reactions to nicotine in a transdermal therapeutic system

Bircher

Howald

Rufli³

1991

Contact Dermatitis

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Nicotine in a transdermal therapeutic system (TTS) has been introduced recently to help people to stop smoking. 14 volunteers (10 male, 4 female) with a history of former adverse skin reactions to this device were investigated. Skin tests for contact urticaria and patch tests for contact allergy were done with the individual components of the TTS. Contact sensitization to nicotine was identified in 5 and to the TTS itself in 1 individual. Irritant reactions due to occlusion were present in 9 subjects. The optimal test agent and concentration for elucidating the adverse skin reaction was an aqueous solution of 10% nicotine base. Atopy, as diagnosed by history and skin prick tests to common inhalant allergens, and contact sensitization to standard patch test allergens, were each identified in 6 subjects. Nicotine should be added to the expanding list of transdermally delivered drugs which may elicit contact dermatitis.

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Skin acceptance of transcutaneous nitroglycerin patches: a prospective study of 33 patients

Cited by 19 publications

References 13 publications

Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch

Treatment of moderate to severe restless legs syndrome: 2-year safety and efficacy of rotigotine transdermal patch

Rotigotine transdermal patch in early Parkinson's disease: A randomized, double‐blind, controlled study versus placebo and ropinirole

Adverse skin reactions to nicotine in a transdermal therapeutic system

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