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Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication.
Expert Opin Pharmacother. 2009 Feb; 10(3):345-52.EO

Abstract

OBJECTIVE

To assess the safety and efficacy of long-term treatment with telmisartan 80 mg/hydrochlorothiazide 25 mg (T80/H25) fixed-dose combination (FDC) in patients who completed a previous double-blind study, in which T80/H25 provided more blood pressure (BP) reduction and produced a BP response in more patients than did T80/H12.5 FDC.

METHODS

Patients received open-label T80/H25 for 24 weeks; further antihypertensive medication was permitted. Seated trough BP was measured at weeks 0, 4, 12 and 24.

RESULTS

Primary end point (seated trough diastolic BP (DBP) control (< 90 mmHg)) was achieved in 71.4% of patients versus 52.4% at baseline (n = 639). The improvement was apparent at week 4 and sustained thereafter. In patients who received more antihypertensive medication (111/639 (17.4%)), DBP control increased from 24.8% at baseline to 58.6% at week 24. Seated trough systolic BP (SBP)/DBP were reduced from 141.0/89.0 mmHg at baseline by 4.6/3.6 mmHg by week 24. SBP response (< 140 or > or = 20 mmHg reduction from start of previous trial) and DBP response (< 90 or > or = 10 mmHg reduction from start of previous trial) increased at week 24 versus baseline from 51.8 to 69.3% and from 55.8 to 74.3%, respectively. At week 24, 110 (17.4%) patients achieved normal SBP/DBP (< 130/< 85 mmHg) and a further 24 (3.8%) patients achieved optimal SBP/DBP (< 120/< 80 mmHg). T80/H25 FDC was well tolerated; drug-related adverse events occurred in 29 (4.5%) patients.

CONCLUSION

T80/H25 provides sustained and well-tolerated additive BP control, given alone or as part of a multi-antihypertensive therapy.

Authors+Show Affiliations

Rødovre Centrum 238, DK-2610 Rødovre, Denmark. neldam@dadlnet.dkNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

19191674

Citation

Neldam, Steen, and Colin Edwards. "Long-term, Open-label Evaluation of the Safety and Efficacy of Telmisartan 80 Mg/hydrochlorothiazide 25 Mg Fixed-dose Combination Alone or With Other Antihypertensive Medication." Expert Opinion On Pharmacotherapy, vol. 10, no. 3, 2009, pp. 345-52.
Neldam S, Edwards C. Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication. Expert Opin Pharmacother. 2009;10(3):345-52.
Neldam, S., & Edwards, C. (2009). Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication. Expert Opinion On Pharmacotherapy, 10(3), 345-52. https://doi.org/10.1517/14656560802707937
Neldam S, Edwards C. Long-term, Open-label Evaluation of the Safety and Efficacy of Telmisartan 80 Mg/hydrochlorothiazide 25 Mg Fixed-dose Combination Alone or With Other Antihypertensive Medication. Expert Opin Pharmacother. 2009;10(3):345-52. PubMed PMID: 19191674.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term, open-label evaluation of the safety and efficacy of telmisartan 80 mg/hydrochlorothiazide 25 mg fixed-dose combination alone or with other antihypertensive medication. AU - Neldam,Steen, AU - Edwards,Colin, PY - 2009/2/5/entrez PY - 2009/2/5/pubmed PY - 2009/5/21/medline SP - 345 EP - 52 JF - Expert opinion on pharmacotherapy JO - Expert Opin Pharmacother VL - 10 IS - 3 N2 - OBJECTIVE: To assess the safety and efficacy of long-term treatment with telmisartan 80 mg/hydrochlorothiazide 25 mg (T80/H25) fixed-dose combination (FDC) in patients who completed a previous double-blind study, in which T80/H25 provided more blood pressure (BP) reduction and produced a BP response in more patients than did T80/H12.5 FDC. METHODS: Patients received open-label T80/H25 for 24 weeks; further antihypertensive medication was permitted. Seated trough BP was measured at weeks 0, 4, 12 and 24. RESULTS: Primary end point (seated trough diastolic BP (DBP) control (< 90 mmHg)) was achieved in 71.4% of patients versus 52.4% at baseline (n = 639). The improvement was apparent at week 4 and sustained thereafter. In patients who received more antihypertensive medication (111/639 (17.4%)), DBP control increased from 24.8% at baseline to 58.6% at week 24. Seated trough systolic BP (SBP)/DBP were reduced from 141.0/89.0 mmHg at baseline by 4.6/3.6 mmHg by week 24. SBP response (< 140 or > or = 20 mmHg reduction from start of previous trial) and DBP response (< 90 or > or = 10 mmHg reduction from start of previous trial) increased at week 24 versus baseline from 51.8 to 69.3% and from 55.8 to 74.3%, respectively. At week 24, 110 (17.4%) patients achieved normal SBP/DBP (< 130/< 85 mmHg) and a further 24 (3.8%) patients achieved optimal SBP/DBP (< 120/< 80 mmHg). T80/H25 FDC was well tolerated; drug-related adverse events occurred in 29 (4.5%) patients. CONCLUSION: T80/H25 provides sustained and well-tolerated additive BP control, given alone or as part of a multi-antihypertensive therapy. SN - 1744-7666 UR - https://www.unboundmedicine.com/medline/citation/19191674/Long_term_open_label_evaluation_of_the_safety_and_efficacy_of_telmisartan_80_mg/hydrochlorothiazide_25_mg_fixed_dose_combination_alone_or_with_other_antihypertensive_medication_ L2 - https://www.tandfonline.com/doi/full/10.1517/14656560802707937 DB - PRIME DP - Unbound Medicine ER -