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Efficacy, Tolerability and Influence on "Quality of Life" of Nifedipine GITS versus Amlodipine in Elderly Patients with Mild-moderate Hypertension
Open accessAbstract
OBJECTIVE: The main purpose of this study was to compare efficacy, tolerability and influence on quality of life (QOL) of nifedipine gastrointestinal therapeutic system (NI) 30-60 mg once a day vs amlodipine (AM) 5-10 mg once a day in elderly patients with mild-moderate hypertension. DESIGN: This was a randomized, double-blind, parallel-group, multicenter study. After a 2-week single-blind placebo run-in, patients were randomized to either NI 30 mg or AM 5 mg. Responders continued on the same dosage for 16 additional weeks, while non-responders were titrated to 60 mg NI or 10 mg AM. METHODS: Blood pressure was measured by mercury sphygmomanometer and efficacy equivalence of NI and AM tested by covariance analysis. Diastolic blood pressure (DBP) was the primary efficacy parameter, its baseline value being taken as covariate while centers effect and treatment interaction were included as fixed effects in the analysis model. The secondary efficacy variables systolic blood pressure (SBP) and scores for QOL were analyzed according to the same model. RESULTS: At the end of the study, overall mean DBPs, calculated as least-square means (LSMEANS), in the "by protocol" population were 87.5 mmHg for NI and 86.7 for AM (difference 0.8 mmHg with 90% CI -1.2 to 2.8 mmHg). In the "by intention to treat" (ITT) population LSMEANS were 87.6 mmHg for NI and 86.4 mmHg for AM (difference 1.2 mmHg with 90% CI -0.6 to 3.1 mmHg). SBP LSMEANS in the "by protocol" population were 147.7 mmHg for NI and 147.3 mmHg for AM (difference 0.3 mmHg, with 90% CI -3.7 to 4.3); corresponding values in the "by ITT" population were 148.0 mmHg for NI and 147.2 for AM (difference 0.8 mmHg, with 90% CI -2.8 to 4.6). Mean values for QOL parameters were not significantly different. A total of 173 episodes of adverse events were documented in 54 patients (26 NI and 28 AM), dropouts were 15 (20% of group) on NI and 21 (28%) on AM. CONCLUSIONS: NI 30-60 mg was shown to be as efficacious and safe as AM 5-10 mg in elderly patients with mild-moderate hypertension. QOL improved compared to baseline with no significant difference between the two drugs, thus confirming a positive class effect for calcium antagonists.
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References 40 · Cited by 10
Metadata
- Authors
- Pessina, A. C., Boari, L., De Dominicis, E., Giusti, C., Marchesi, M., Marelli, G., Mattarei, M., Mos, L., Novo, S., Pirrelli, A., Santini, M., Santonastaso, M., Semeraro, S., Uslenghi, E., & Ochan Kilama, M.
- Affiliations
- University of Padua (IT)
- Istituti Ospitalieri di Cremona (IT)
- Ospedale di Bolzano (IT)
- Ospedale Civile di Voghera (IT)
- University of Palermo (IT)
- University of Bari Aldo Moro (IT)
- Ospedale San Filippo Neri (IT)
- IRCCS Azienda Ospedliero-Universitaria di Bologna Policlinico di Sant'Orsola (IT)
- Azienda Sanitaria Ospedaliera S.Croce e Carle Cuneo (IT)
- Venue
- Blood Pressure
- Publisher
- Informa UK Limited
- Published
- 2001-01
- Volume
- 10
- Issue
- 3
- Pages
- 176-183
- ISSN
- 0803-7051 (ISSN-L)
- 1651-1999
- OpenAlex
- W2098693685
- Cited by
- 10
- References
- 40
- FWCI
- 1.40
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Blood Pressure (publishedVersion)
- PubMed (publishedVersion)
- Padua Research Archive (University of Padova) (submittedVersion)
- Topics
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Blood Pressure and Hypertension Studies
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Heart rate and cardiovascular health
- Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Cardiovascular Health and Disease Prevention
- Keywords
- nifedipine, amlodipine, calcium channel blockers, hypertension, elderly patients, once-daily dosing, gastrointestinal therapeutic system, blood pressure control, quality of life, tolerability, diastolic blood pressure, systolic blood pressure, antihypertensive efficacy, dose titration, adverse events, drug discontinuation, patient satisfaction
- MeSH terms
- Aged, Aged, 80 and over, Blood Pressure, Calcium Channel Blockers, Double-Blind Method, Humans, Hypertension, Middle Aged, Nifedipine, Quality of Life, Therapeutic Equivalency, Amlodipine
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