A patient follow-up survey programme for alosetron: assessing compliance to and effectiveness of the risk management programme.
BACKGROUND
In November 2002, alosetron HCl (Lotronex, GlaxoSmithKline Research Triangle Park, NC, USA) was re-introduced to the US marketplace for women with severe diarrhoea-predominant irritable bowel syndrome. In support of the re-introduction, a risk management programme was implemented, which included a patient follow-up study in which all users of alosetron could participate.


OBJECTIVE
We report on the methods used and the effectiveness of key elements of the risk management programme.


METHODS
Patients voluntarily enroled in the study and completed questionnaires at baseline, after 5 and 10 weeks, and quarterly thereafter. Questions focussed on patient eligibility, knowledge of risks and benefits, and adherence to the recommended programme elements for education, prescribing and dispensing.


RESULTS
Between December 2002 and 2004, 4,803 patients enrolled in the study, and <3% were lost to follow-up. The average follow-up time was approximately 6 months, and the response rate for each assessment was >95%. A total of 90% of patients at baseline met the full clinical criteria recommended for the treatment. Patient adherence to the risk management programme was >87%.


CONCLUSIONS
Using the Lotronex risk management programme, patients met clinical criteria, were knowledgeable about treatment risks and benefits, and were adherent to the process elements of the programme. These patients seemed to engage in active dialogue with their physicians about symptoms and use of alosetron.
Miller
D
D
RTI Health Solutions, USA. dpmiller@rti.org
Bennett
L
L
Hollis
K
K
Tennis
P
P
Cook
S
S
Andrews
E
E
D000293:Adolescent; D000328:Adult; D000368:Aged; D002243:Carbolines / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy* / Q000523:psychology*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000523:psychology*; D010353:Patient Education as Topic / Q000379:methods; D012308:Risk Management / Q000379:methods*; D012720:Severity of Illness Index
D002243:Carbolines; D005765:Gastrointestinal Agents; C090840:alosetron