Document Detail

One year efficacy and tolerability of clonidine administered by the transdermal route in patients with mild to moderate essential hypertension--a multicentre open label study. The Antihypertensive Patch Italian Study (APIS) Investigators.
MedLine Citation:
PMID:  8193525     Owner:  NLM     Status:  MEDLINE    
The clonidine patch offers for the first time the unique possibility of a once-a-week transdermal therapy of hypertension due to direct absorption of clonidine through the skin. The present study investigates the efficacy and safety of the transdermal administration on a sample of the Italian population. 101 patients entered the study, 51 male, 50 female (mean age: 53 years, SD +/- 10; range: 30-71 years), they were given clonidine by a therapeutical transdermal system as starting dosage. If blood pressure was not adequately controlled (DBP < 90 or 10 mmHg decreased from baseline value) the dosage was increased on a 2 week basis assessment. The patients were then followed for 12 months after the start of treatment. The decrease in both systolic and diastolic blood pressure continued up to one month after start of treatment and remained constant for at least 9 months. A total of 70% of the patients were controlled by the antihypertensive treatment as monotherapy, while in 6% additional combination with a diuretic lead to blood pressure control. 5% of the patients showed no reduction in blood pressure at the end of the titration phase. 24 (23%) patients complained of skin reaction; 21 patients of these (ten male, eleven female) were withdrawn from the trial due to predefined skin reaction criteria. No serious side effects have been observed during the run of the study. No rebound phenomena occurred in the week after treatment discontinuation. It is concluded that the transdermal treatment of hypertension with a clonidine containing transdermal system is therapeutically effective and probably associated with a high acceptability and increased compliance.
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Clinical autonomic research : official journal of the Clinical Autonomic Research Society     Volume:  3     ISSN:  0959-9851     ISO Abbreviation:  Clin. Auton. Res.     Publication Date:  1993 Dec 
Date Detail:
Created Date:  1994-06-27     Completed Date:  1994-06-27     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  9106549     Medline TA:  Clin Auton Res     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  379-83     Citation Subset:  IM    
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MeSH Terms
Administration, Cutaneous
Blood Pressure
Clonidine / administration & dosage*,  adverse effects,  therapeutic use
Drug Eruptions / etiology
Heart Rate
Hypertension / drug therapy*,  physiopathology
Middle Aged
Reg. No./Substance:

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