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This study evaluated the efficacy and safety of pramipexole in treating restless legs syndrome (RLS) by analyzing data from a 6-week randomized, double-blind clinical trial of 345 patients. The results showed that patients receiving pramipexole had significantly greater reductions in RLS severity scores compared to the placebo group based on the International RLS Rating Scale. Pramipexole was also generally well-tolerated with few adverse effects reported. However, the study was limited by potential biases from patient self-reporting on assessment scales and a lack of data on RLS interacting with other conditions.
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- 1. Efficacy of Pramipexole in Restless Legs Syndrome Critical review of a Six-Week, Multicenter, Randomized, Double Blind Study Effect-RLS Study By: Prathu Raj Singh Kushwah
- 2. Background • Restless legs Syndrome (RLS) is characterized by an urge to move limbs and is usually associated with unpleasant sensations such as parethesias. • Occurrence at rest typically in evening and nights. • Prevalance 2.5% to 10% in General Population • Dopaminergic Pathways • Pramipexole, a nonergoline doapmine agonist is a successful drug at doses of 0.375 to 1.5 mg/day
- 3. Authorship • This was a multicenter study under Dr Wolfgang H. Oretel, Department of Neurology, Philipps-University Marburg, Germany • Article Was published in Movement Disorder Society, Vol 22. Bo. 2, 2007 and is governed by their copyrights. • Trip Database
- 4. Aim To show the efficacy and safety of pramipexole in the treatment of RLS Sample Population Male and Female Patients, 18 to 80 years of Age from European centers. All Patients had an baseline International RLS rating Scale (IRLS) of 15.
- 5. Experiments • In 2004, a total of 345 patients were randomly (1:2) assigned to receive either palcebo (n=115) or parmipexole (n=230). • However, 7 people dropped out because of low IRLS score (final Placebo, 114 and Pramipexole, 224) • α = 0.05 and β = 0.20
- 6. Assessment Methods International RLS Study group rating scale (IRLS): – 10-Item rating, patient self rating instrument – Assesses severity of RLS in 5 degrees from 0 (“None”) to 4 (“Very Severe”) – Maximum Total Score = 40 Clinical Global Impressions Scale (CGI): – For proportion of patients with “Much Improved” and “Very much Improved” assessments – Patients marked their satisfaction on a 10 cm line from 0 (“Very Bad”) to 100 (“Fully Satisfied”)
- 7. Results • Results confirmed their claim that pramipexole was effective in RLS treatment and there was significant decrease in baseline IRLS scores for treatment group Placebo Pramipexole RLS Severity Mean (+/- Adjusted mean Mean (SD) Adjusted mean P- Value SD) at change from at baseline change from baseline baseline (+/- SE) baseline (+/- SE) While going 52.6 (30.9) -13.8(2.7) 56.8 (29.7) -30.6(1.9) <0.0001 to Sleep In the 60.7 (28.8) -12.4(2.7) 57.2(29.7) -32.3(2.0) <0.0001 course of the night In the 32.5 (26.9) -1.5(2.1) 32.1(26.8) -12.1(1.5) <0.0001 course of day
- 8. SWAT Analysis • The study was effective in studying effects of Pramipexole on RLS patients. • It included a large pool of different patients and individualized assesment method for different pools. • However, the comparison of these scales is dependent on self examination so there might be individual biases and sensitivity issues. • People have excluded patients with other disabilities, so there is no data for RLS interaction with other dopaminergic diseases such as Parkinson’s and Multiple Sclerosis.
- 9. Thank You! Prathu Raj Singh Kushwah