Risk of adverse effects with fluticasone propionate as compared to other intranasal steroids

Risk of Adverse Effects with Fluticasone Propionate as Compared
to Other Intranasal Steroids
Stephen P Motsko, PharmD, PhD1, Marlo A Corrao, MPH2, Ruby M Vendiola1, Kourtney J Davis, PhD2, Earl L Goehring1, Judith K Jones, MD, PhD1
1The Degge Group, Ltd., Arlington, VA, and 2Worldwide Epidemiology, GlaxoSmithKline, Research Triangle Park, NC, United States
Table 1. Number of Events and Event Rates of FP and Other INS users
FP Cohort (n= 52,870)
INS Cohort (n=73,743)
Despite lower systemic bioavailability of intranasal corticosteroids (INS) # of Events
# of Events
10,000 PY
10,000 PY
compared to oral or inhaled corticosteroids, it is possible that rare adverse effects (AEs) may still result from the use of INS. The risk of AEs may differ due to product specific pharmacokinetic properties. OBJECTIVE
The purpose of this retrospective cohort study in a large US population database was to determine the rates of steroid-related adverse effects (AEs) of interest among patients using fluticasone propionate (FP) nasal spray, compared to patients using other INS (including: beclomethasone dipropionate, budesonide, flunisolide, mometasone furoate, and triamcinolone acetonide).
We used a population-based, retrospective cohort study design. The study period used was January 1, 1995 through September 30, 2002.
Exposure episodes were created within each patient’s claims history, a break of Figure 1. Adjusted Rate Ratios, by Event (FP vs. Other INS)
> 60 days constituting a separate episode. Only one randomly selected episode was chosen per patient.
Poisson regression modeling was used to estimate rate ratios (RR) and corresponding 95% confidence intervals (CI) for thirteen separate effects, while the addition of covariates controlled for potential confounders (e.g., age, Stratified analyses were also performed to investigate modifying factors. Study outcomes included: adrenal insufficiency, cataracts, fractures, glaucoma, hypercorticism, nasal septum perforation, osteoporosis, sinusitis and five The study identified 52,870 FP users and 73,743 patients using other INS.
The mean age of the FP cohort was 43 (SD ± 20) years of age and the mean age of the INS cohort was 45 (SD ± 21) years of age. Females comprised 59% 97% of FP and INS patients were categorized as intermittent users (receiving 1-3 consecutive prescriptions); with 84% – 86% of patients receiving one prescription and 9% - 10% receiving two prescriptions.
In adjusted models, rates for seven outcomes were not statistically different between the two cohorts (see Table 1 & Figure 1):
Adrenal Insufficiency (RR, 1.57; 95% CI, 0.74 – 3.35); Fracture (RR, 1.10; 95% CI, 0.88 – 1.38); Glaucoma (RR, 0.97; 95% CI, 0.83 – 1.15); Osteoporosis (RR, 1.08; 95% CI, 0.77 – 1.52); Cellulitis (RR, 0.84; 95% CI, 0.56 – 1.27); Encephalitis (RR, 2.19; 95% CI, 0.52 – 9.26); Meningitis (RR, 0.63; 95% CI, 0.27 – 1.45).
Five outcomes were statistically associated with an FP dispensing as compared with other INS use: CONCLUSIONS
Nasal septum perforation (RR, 1.10; 95% CI, 1.00 - 1.22); There were no differences of clinical significance in rates of AEs between patients receiving FP and other INS. Hypercorticism and empyema were Sinusitis (RR, 1.10; 95% CI, 1.07 - 1.14); associated with use of inhaled and/or oral steroids in this analysis.
Hypercorticism (RR, 2.59; 95% CI, 1.21 - 5.59); LIMITATIONS
Empyema (RR, 2.20; 95% CI, 1.27 - 3.83). Most patients were intermittent INS users; thus, results may not be generalizable to the 3% of the study population who had continuous exposure FP users had a lower rate of cataracts than patients taking other INS to intranasal steroids. Other limitations inherent to most observational studies were also present (e.g., ICD-9-CM code validity, unmeasured confounders, Cataracts (RR, 0.80; 95% CI, 0.71 - 0.89). Acknowledgement
When patients taking concomitant oral or inhaled steroids were excluded from the analyses, rates of hypercorticism and empyema were no longer statistically Funding for this project was provided by GlaxoSmithKline.
For Further Information
Hypercorticism (RR, 2.12; 95% CI, 0.75 - 5.97); Please contact Stephen Motsko at smotsko@deggegroup.com. A link to the Empyema (RR, 1.60; 95% CI, 0.87 – 2.94).
electronic version of this poster is available at www.deggegroup.com.
22nd International Conference on Pharmacoepidemiology & Therapeutic Risk Management. Lisbon, Portugal. Abstract #429

Source: http://www.deggegroup.com/2006-ISPE%20-%20Fluticasone%20AEs.pdf

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CURRICULUM VITAE James E. Patrick, Ph.D. Patrick’s Pharmaceutical Consulting, LLC Date Established: 22 Nov 2004 Consultant, Drug Disposition: • Drug Disposition Program Design, Management • Study Placement, GLP/Scientific Monitoring • Report Preparation, Regulatory Document Preparation (Pharmacokinetics Written and Areas of Drug Disposition Expertise: • Drug Dispo

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