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Gaceta Sanitaria

Print version ISSN 0213-9111


SICRAS MAINAR, Antoni  and  NAVARRO ARTIEDA, Ruth. Influence of substitution of brand name for generic drugs on therapeutic compliance in hypertension and dyslipidemia. Gac Sanit [online]. 2010, vol.24, n.6, pp.473-482. ISSN 0213-9111.

Objective: To determine therapeutic compliance when brand name amlodipine and simvastatin are substituted for generic drugs, and to determine patients´ and physicians´ opinions of this substitution. Patients and methods: We performed an observational study with a control group, based on a review of the medical records in six primary care centers. Participants consisted of patients >40 years old initiating treatment with a brand name drug (initial period), which was later substituted by a generic drug (final period). The study subgroups consisted of patients with hypertension (amlodipine) or dyslipidemia (simvastatin). The main measures were comorbidity, compliance, treatment length, biochemistry determinations, and patients´ and physicians´ opinions (interviews). All patients received a brand name drug for a minimum of 1 year followed by a generic drug for a minimum of 1 year (minimum continuation/patient: 24 months). Results: There were 1,252 patients (groups: 49.5% amlodipine; 50.5% simvastatin). Patients treated with amlodipine (period comparison) showed better compliance (65.8 vs. 61.3%; p=0.037) and blood pressure control (48.5 vs. 45.8%; p=0.039) with the brand name drug. The percentages with simvastatin were 62.8 vs. 58.4% (p=0.041), respectively. A total of 73.6% of the physicians interviewed prescribed generic drugs and 59.2% believed that both types of drug had the same efficacy. Most of the patients interviewed (79.8%; CI: 74.3-85.3%) accepted the substitution; 55.3% (CI: 48.5-62.1%) received the appropriate information but 61.5% were confused by the different products. Lack of compliance was reported by 18.2%. Conclusions: In patients receiving amlodipine or simvastatin, compliance decreased with time, independently of the change from a band name to a generic drug.

Keywords : Compliance; Adherence; Generic drugs; Generic substitution; Hypertension; Dyslipidemia.

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