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Hile persistence represents the long-term continuation of treatment. For each study

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Hile persistence represents the long-term continuation of treatment. For each study subject, treatment compliance was estimated by calculating the ratio of effective treatment duration over expected treatment duration. Effective treatment duration was estimated by the quantity of medication received and the corresponding number of days of treatment. Treatment compliance was estimated over a oneyear period. Patients were considered compliant if their compliance ratio was equal to or greater than 80 . In a complementary analysis, patients were considered compliant if their compliance ratio was equal to or greater than 50 . Treatment persistence was estimated over a 3-, 6-, PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/14136816 and 12-month period. Patients were considered persistent for as long as the treatment (spironolactone, ACE inhibitors, ARBs, or b-blockers) had not definitively ceased. Treatment cessation was determined when the patients had not received treatment for at least six months. Differences in incidence of adverse events in spironolactone users and non users were tested for significance using Pearson’s chi square test. This statistical test was also performed to compare treatment compliance and persistence with spironolactone and standard therapy (ACE inhibitors, ARBs, b-blockers).Lachaine et al. BMC Clinical Pharmacology 2011, 11:4 http://www.biomedcentral.com/1472-6904/11/Page 3 ofResults During the period from January 1, 2000 to September 30, 2008, a total of 238,721 patients had received at least one diagnosis of HF. In accordance with the RAMQ’s restrictions on the number PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/7667330 of subjects available for analysis by external parties, data were obtained on a random sample of 82,018 of these patients. Of this sample, 15.1 (n = 12,344) used spironolactone. There was a higher proportion of men among spironolactone users, as opposed to the overall HF group, where the proportion of women was higher. In addition, comorbidity level, estimated by the modified Von Korff score, was higher for patients using spironolactone. A large proportion of spironolactone users received concomitant treatment with ACE inhibitors and b-blockers, and to a lesser extent with ARBs (Table 1). Incidence of hyperkalemia, breast complications in men, and more specifically gynecomastia, was significantly higher in spironolactone users than in non-users (Table 2). Over a one-year period, treatment compliance was significantly lower with spironolactone compared to ACE inhibitors, b-blockers, and ARBs, according to both 80Table 1 Patient characteristicsCHF n = 82 018 Age group <20 20-39 40-59 60-79 80+ Average age (SD) Gender – male – Female Average Von Korff score (SD) Selected drug use – ACE – ARB – b-blocker Concomitant use with – ACE – ARB – b-blocker 6,702 (54.3 ) 2,654 (21.5 ) 7,217 (58.5 ) 49,140 (59.9 ) 23,326 (28.4 ) 48,772 (59.5 ) 9,493 (76.9 ) 4,455 (36.1 ) 39,132 (47.7 ) 42,886 (52.3 ) 7.6 (3.4) 6,368 (51.6 ) 5,976 (48.4 ) 8.8 (2.9) 518 (0.6 ) 1,366 (1.7 ) 6,114 (7.5 ) 31,499 (38.4 ) 42,521 (51.8 ) 77.2 (14.1) 11 (0.1 ) 62 (0.5 ) 716 LS-102 (5.8 ) 5,093 (41.3 ) 6,462 (52.3 ) 78.5 (11.4) CHF using spironolactone n = 12,Table 2 Incidence of adverse eventsSpironolactone users Hyperkalemia Breast complications in men Breast hypertrophy in men (gynecomastia)* p < 0.001 (Pearson's chi square test).Spironolactone non-users 955/69,674 (1.4 )* 380/32,764 (1.2 )* 233/32,764 (0.7 )*408/12,344 (3.3 ) 158/6,368 (2.5 ) 117/6,368 (1.8 )and 50 thresholds (Table 3). Moreover, persistence to treatment after 3-, 6-, and 12-mo.

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