3 results on '"Stepien, Sandrine"'
Search Results
2. Effect of Oral Methylprednisolone on Decline in Kidney Function or Kidney Failure in Patients With IgA Nephropathy
- Author
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Lv, Jicheng, Wong, Muh Geot, Hladunewich, Michelle A., Jha, Vivekanand, Hooi, Lai Seong, Monaghan, Helen, Zhao, Minghui, Barbour, Sean, Jardine, Meg J., Reich, Heather N., Cattran, Daniel, Glassock, Richard, Levin, Adeera, Wheeler, David C., Woodward, Mark, Billot, Laurent, Stepien, Sandrine, Rogers, Kris, Chan, Tak Mao, Liu, Zhi-Hong, Johnson, David W., Cass, Alan, Feehally, John, Floege, Jürgen, Remuzzi, Giuseppe, Wu, Yangfeng, Agarwal, Rajiv, Zhang, Hong, and Perkovic, Vlado
- Subjects
Proteinuria ,Administration, Oral ,Humans ,Glomerulonephritis, IGA ,General Medicine ,Glucocorticoids ,Original Investigation - Abstract
IMPORTANCE: The effect of glucocorticoids on major kidney outcomes and adverse events in IgA nephropathy has been uncertain. OBJECTIVE: To evaluate the efficacy and adverse effects of methylprednisolone in patients with IgA nephropathy at high risk of kidney function decline. DESIGN, SETTING, AND PARTICIPANTS: An international, multicenter, double-blind, randomized clinical trial that enrolled 503 participants with IgA nephropathy, proteinuria greater than or equal to 1 g per day, and estimated glomerular filtration rate (eGFR) of 20 to 120 mL/min/1.73 m(2) after at least 3 months of optimized background care from 67 centers in Australia, Canada, China, India, and Malaysia between May 2012 and November 2019, with follow-up until June 2021. INTERVENTIONS: Participants were randomized in a 1:1 ratio to receive oral methylprednisolone (initially 0.6-0.8 mg/kg/d, maximum 48 mg/d, weaning by 8 mg/d/mo; n = 136) or placebo (n = 126). After 262 participants were randomized, an excess of serious infections was identified, leading to dose reduction (0.4 mg/kg/d, maximum 32 mg/d, weaning by 4 mg/d/mo) and addition of antibiotic prophylaxis for pneumocystis pneumonia for subsequent participants (121 in the oral methylprednisolone group and 120 in the placebo group). MAIN OUTCOMES AND MEASURES: The primary end point was a composite of 40% decline in eGFR, kidney failure (dialysis, transplant), or death due to kidney disease. There were 11 secondary outcomes, including kidney failure. RESULTS: Among 503 randomized patients (mean age, 38 years; 198 [39%] women; mean eGFR, 61.5 mL/min/1.73 m(2); mean proteinuria, 2.46 g/d), 493 (98%) completed the trial. Over a mean of 4.2 years of follow-up, the primary outcome occurred in 74 participants (28.8%) in the methylprednisolone group compared with 106 (43.1%) in the placebo group (hazard ratio [HR], 0.53 [95% CI, 0.39-0.72]; P
- Published
- 2022
3. Fixed-combination, low-dose, triple-pill antihypertensive medication versus usual care in patients with mild-to-moderate hypertension in Sri Lanka: a within-trial and modelled economic evaluation of the TRIUMPH trial
- Author
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Anthony Rodgers, Nitish Naik, Sandrine Stepien, Gotabhaya Ranasinghe, Senaka Rajapakse, Thomas Lung, Stephen Jan, Rama K Guggilla, Dorairaj Prabhakaran, Pallab K. Maulik, Vanessa Selak, Ruth Webster, Arjuna P. De Silva, Simon Thom, Tracey Lea-Laba, H Asita de Silva, Abdul Salam, Anushka Patel, Lung, Thomas, Jan, Stephen, de Silva, H Asita, Guggilla, Rama, Maulik, Pallab K, Naik, Nitish, Patel, Anushka, de Silva, Arjuna P, Rajapakse, Senaka, Ranasinghe, Gotabhaya, Prabhakaran, Dorairaj, Rodgers, Anthony, Salam, Abdul, Selak, Vanessa, Stepien, Sandrine, Thom, Simon, Webster, Ruth, Lea-Laba, Tracey, and TRIUMPH Study Group
- Subjects
triple pill ,medicine.medical_specialty ,Cost-Benefit Analysis ,low-income and middle-income countries ,030231 tropical medicine ,MEDLINE ,elevated blood pressure ,03 medical and health sciences ,0302 clinical medicine ,Humans ,Medicine ,030212 general & internal medicine ,Amlodipine ,Antihypertensive Agents ,health care economics and organizations ,Sri Lanka ,Cost–benefit analysis ,business.industry ,lcsh:Public aspects of medicine ,Australia ,lcsh:RA1-1270 ,General Medicine ,3. Good health ,Blood pressure ,Pill ,Hypertension ,Economic evaluation ,Emergency medicine ,Chlorthalidone ,Telmisartan ,business ,medicine.drug - Abstract
© 2019 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background: Elevated blood pressure incurs a major health and economic burden, particularly in low-income and middle-income countries. The Triple Pill versus Usual Care Management for Patients with Mild-to-Moderate Hypertension (TRIUMPH) trial showed a greater reduction in blood pressure in patients using fixed-combination, low-dose, triple-pill antihypertensive therapy (consisting of amlodipine, telmisartan, and chlorthalidone) than in those receiving usual care in Sri Lanka. We aimed to assess the cost-effectiveness of the triple-pill strategy. Methods: We did a within-trial (6-month) and modelled (10-year) economic evaluation of the TRIUMPH trial, using the health system perspective. Health-care costs, reported in 2017 US dollars, were determined from trial records and published literature. A discrete-time simulation model was developed, extrapolating trial findings of reduced systolic blood pressure to 10-year health-care costs, cardiovascular disease events, and mortality. The primary outcomes were the proportion of people reaching blood pressure targets (at 6 months from baseline) and disability-adjusted life-years (DALYs) averted (at 10 years from baseline). Incremental cost-effectiveness ratios were calculated to estimate the cost per additional participant achieving target blood pressure at 6 months and cost per DALY averted over 10 years. Findings: The triple-pill strategy, compared with usual care, cost an additional US$9·63 (95% CI 5·29 to 13·97) per person in the within-trial analysis and $347·75 (285·55 to 412·54) per person in the modelled analysis. Incremental cost-effectiveness ratios were estimated at $7·93 (95% CI 6·59 to 11·84) per participant reaching blood pressure targets at 6 months and $2842·79 (−28·67 to 5714·24) per DALY averted over a 10-year period. Interpretation: Compared with usual care, the triple-pill strategy is cost-effective for patients with mild-to-moderate hypertension. Scaled up investment in the triple pill for hypertension management in Sri Lanka should be supported to address the high population burden of cardiovascular disease. Funding: Australian National Health and Medical Research Council.
- Published
- 2019
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