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Telmisartan in combination with hydrochlorothiazide 12.5 mg for the management of patients with hypertension.
Curr Med Res Opin. 2014 Sep; 30(9):1715-24.CM

Abstract

OBJECTIVE

To compare the efficacy and safety of telmisartan 40 mg (T40) or 80 mg (T80) plus hydrochlorothiazide 12.5 mg (H12.5) single-pill combinations (SPCs) with telmisartan monotherapies, in a pooled analysis of patients with mild to moderate hypertension.

METHODS

Six phase 3, double-blind studies of 8 weeks' duration that assessed the T/H12.5 SPC and T40 or T80 monotherapy, were included in the analysis. Data was pooled separately for the two T40 non-responder studies (T40 NR group, two T80 non-responder studies (T80 NR group), and the two factorial design dose-response studies (FD-DR group).

RESULTS

After 8 weeks' treatment, the adjusted mean reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP), and the SBP, DBP, and blood pressure (BP) goal rates were significantly higher with the T40/H12.5 SPC than T40 in the T40 NR group and with the T80/H12.5 SPC than T80 in the T80 NR group. In the FD-DR group, the adjusted mean reduction in SBP and DBP, and DBP goal rates were significantly higher for T40/H12.5 versus T40. The percentage of patients with an adverse event was numerically higher with T40/H12.5 versus T40 in the T40 NR group, and was similar in telmisartan monotherapies and the T/H12.5 SPCs in the T80 NR group and FD-DR group. A limitation of this study is the retrospective and pooled nature of the analysis. Also, >75% of patients were <65 years of age, which limits the applicability of the results to older patients.

CONCLUSIONS

In patients with mild to moderate hypertension, 8 weeks' treatment with the T/H12.5 SPC is significantly more efficacious than telmisartan monotherapies. The safety and tolerability of the T/H12.5 SPC are comparable to that of telmisartan monotherapy and consistent with that reported in previous studies.

Authors+Show Affiliations

Rødovre Centrum 294 , Rødovre , Denmark.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24834808

Citation

Neldam, Steen, et al. "Telmisartan in Combination With Hydrochlorothiazide 12.5 Mg for the Management of Patients With Hypertension." Current Medical Research and Opinion, vol. 30, no. 9, 2014, pp. 1715-24.
Neldam S, Schumacher H, Kjeldsen SE, et al. Telmisartan in combination with hydrochlorothiazide 12.5 mg for the management of patients with hypertension. Curr Med Res Opin. 2014;30(9):1715-24.
Neldam, S., Schumacher, H., Kjeldsen, S. E., & Neutel, J. M. (2014). Telmisartan in combination with hydrochlorothiazide 12.5 mg for the management of patients with hypertension. Current Medical Research and Opinion, 30(9), 1715-24. https://doi.org/10.1185/03007995.2014.924912
Neldam S, et al. Telmisartan in Combination With Hydrochlorothiazide 12.5 Mg for the Management of Patients With Hypertension. Curr Med Res Opin. 2014;30(9):1715-24. PubMed PMID: 24834808.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Telmisartan in combination with hydrochlorothiazide 12.5 mg for the management of patients with hypertension. AU - Neldam,Steen, AU - Schumacher,Helmut, AU - Kjeldsen,Sverre E, AU - Neutel,Joel M, Y1 - 2014/06/13/ PY - 2014/5/20/entrez PY - 2014/5/20/pubmed PY - 2015/5/30/medline KW - Essential hypertension KW - Hydrochlorothiazide KW - Renin KW - Single-pill combination KW - Telmisartan KW - angiotensin system inhibitor SP - 1715 EP - 24 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 30 IS - 9 N2 - OBJECTIVE: To compare the efficacy and safety of telmisartan 40 mg (T40) or 80 mg (T80) plus hydrochlorothiazide 12.5 mg (H12.5) single-pill combinations (SPCs) with telmisartan monotherapies, in a pooled analysis of patients with mild to moderate hypertension. METHODS: Six phase 3, double-blind studies of 8 weeks' duration that assessed the T/H12.5 SPC and T40 or T80 monotherapy, were included in the analysis. Data was pooled separately for the two T40 non-responder studies (T40 NR group, two T80 non-responder studies (T80 NR group), and the two factorial design dose-response studies (FD-DR group). RESULTS: After 8 weeks' treatment, the adjusted mean reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP), and the SBP, DBP, and blood pressure (BP) goal rates were significantly higher with the T40/H12.5 SPC than T40 in the T40 NR group and with the T80/H12.5 SPC than T80 in the T80 NR group. In the FD-DR group, the adjusted mean reduction in SBP and DBP, and DBP goal rates were significantly higher for T40/H12.5 versus T40. The percentage of patients with an adverse event was numerically higher with T40/H12.5 versus T40 in the T40 NR group, and was similar in telmisartan monotherapies and the T/H12.5 SPCs in the T80 NR group and FD-DR group. A limitation of this study is the retrospective and pooled nature of the analysis. Also, >75% of patients were <65 years of age, which limits the applicability of the results to older patients. CONCLUSIONS: In patients with mild to moderate hypertension, 8 weeks' treatment with the T/H12.5 SPC is significantly more efficacious than telmisartan monotherapies. The safety and tolerability of the T/H12.5 SPC are comparable to that of telmisartan monotherapy and consistent with that reported in previous studies. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/24834808/Telmisartan_in_combination_with_hydrochlorothiazide_12_5_mg_for_the_management_of_patients_with_hypertension_ L2 - https://www.tandfonline.com/doi/full/10.1185/03007995.2014.924912 DB - PRIME DP - Unbound Medicine ER -