The safety profile of telmisartan as monotherapy or combined with hydrochlorothiazide: A retrospective analysis of 50 studies

Helmut Schumacher, Giuseppe Mancia

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

Background. To compare the tolerability and safety of telmisartan ± hydrochlorothiazide (HCTZ). Methods. This retrospective analysis was performed on all hypertensive patients that were enrolled in telmisartan studies. A total of 30 double-blind (n = 8023) and 20 open-label (n = 8393) studies were available at the time of this analysis, and were included. Treatments investigated were placebo, telmisartan 10-160 mg, or telmisartan 10-160 mg plus HCTZ 6.25-25 mg. The incidence and causality of all adverse events (AEs) and laboratory abnormalities occurring during treatment were recorded. Results. The incidences of all-cause AEs in the double-blind studies were: 2.73 per patient-year (PY) (36.1%; placebo); 2.03/PY (37.4%; telmisartan monotherapy) and 2.09/PY (44.8%; telmisartan plus HCTZ). The respective numbers in the open-label studies were: 0.65/PY (49.6%; telmisartan monotherapy) and 0.70/PY (40.3%; telmisartan plus HCTZ). The most frequent suspected adverse reactions were dizziness and headache, which were comparable across groups and studies. The overall incidence of drug-related laboratory abnormalities was low in all treatment groups. Treatment-related hyperuricaemia and hypokalaemia occurred in less than 0.1% of patients, respectively, treated with telmisartan plus HCTZ. Incidences of discontinuation due to an AE were 4.6%, 4.5% and 4.7%, respectively, for the placebo, telmisartan and telmisartan plus HCTZ treatment groups. Conclusion. The consolidated data show that telmisartan ± HCTZ are well tolerated in patients of all ages and have placebo-like tolerabilities.

Original languageEnglish
Pages (from-to)32-40
Number of pages9
JournalBlood Pressure
Volume17
Issue numberSUPPL. 1
DOIs
Publication statusPublished - Jun 2008

Fingerprint

Hydrochlorothiazide
Safety
Placebos
Incidence
Therapeutics
Hypokalemia
telmisartan
Dizziness
Double-Blind Method
Causality
Headache
hydrochlorothiazide drug combination telmisartan

Keywords

  • Angiotensin II receptor blockers
  • Hydrochlorothiazide
  • Safety
  • Telmisartan
  • Thiazide diuretic
  • Tolerability

ASJC Scopus subject areas

  • Internal Medicine
  • Cardiology and Cardiovascular Medicine

Cite this

The safety profile of telmisartan as monotherapy or combined with hydrochlorothiazide : A retrospective analysis of 50 studies. / Schumacher, Helmut; Mancia, Giuseppe.

In: Blood Pressure, Vol. 17, No. SUPPL. 1, 06.2008, p. 32-40.

Research output: Contribution to journalArticle

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abstract = "Background. To compare the tolerability and safety of telmisartan ± hydrochlorothiazide (HCTZ). Methods. This retrospective analysis was performed on all hypertensive patients that were enrolled in telmisartan studies. A total of 30 double-blind (n = 8023) and 20 open-label (n = 8393) studies were available at the time of this analysis, and were included. Treatments investigated were placebo, telmisartan 10-160 mg, or telmisartan 10-160 mg plus HCTZ 6.25-25 mg. The incidence and causality of all adverse events (AEs) and laboratory abnormalities occurring during treatment were recorded. Results. The incidences of all-cause AEs in the double-blind studies were: 2.73 per patient-year (PY) (36.1{\%}; placebo); 2.03/PY (37.4{\%}; telmisartan monotherapy) and 2.09/PY (44.8{\%}; telmisartan plus HCTZ). The respective numbers in the open-label studies were: 0.65/PY (49.6{\%}; telmisartan monotherapy) and 0.70/PY (40.3{\%}; telmisartan plus HCTZ). The most frequent suspected adverse reactions were dizziness and headache, which were comparable across groups and studies. The overall incidence of drug-related laboratory abnormalities was low in all treatment groups. Treatment-related hyperuricaemia and hypokalaemia occurred in less than 0.1{\%} of patients, respectively, treated with telmisartan plus HCTZ. Incidences of discontinuation due to an AE were 4.6{\%}, 4.5{\%} and 4.7{\%}, respectively, for the placebo, telmisartan and telmisartan plus HCTZ treatment groups. Conclusion. The consolidated data show that telmisartan ± HCTZ are well tolerated in patients of all ages and have placebo-like tolerabilities.",
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AU - Mancia, Giuseppe

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N2 - Background. To compare the tolerability and safety of telmisartan ± hydrochlorothiazide (HCTZ). Methods. This retrospective analysis was performed on all hypertensive patients that were enrolled in telmisartan studies. A total of 30 double-blind (n = 8023) and 20 open-label (n = 8393) studies were available at the time of this analysis, and were included. Treatments investigated were placebo, telmisartan 10-160 mg, or telmisartan 10-160 mg plus HCTZ 6.25-25 mg. The incidence and causality of all adverse events (AEs) and laboratory abnormalities occurring during treatment were recorded. Results. The incidences of all-cause AEs in the double-blind studies were: 2.73 per patient-year (PY) (36.1%; placebo); 2.03/PY (37.4%; telmisartan monotherapy) and 2.09/PY (44.8%; telmisartan plus HCTZ). The respective numbers in the open-label studies were: 0.65/PY (49.6%; telmisartan monotherapy) and 0.70/PY (40.3%; telmisartan plus HCTZ). The most frequent suspected adverse reactions were dizziness and headache, which were comparable across groups and studies. The overall incidence of drug-related laboratory abnormalities was low in all treatment groups. Treatment-related hyperuricaemia and hypokalaemia occurred in less than 0.1% of patients, respectively, treated with telmisartan plus HCTZ. Incidences of discontinuation due to an AE were 4.6%, 4.5% and 4.7%, respectively, for the placebo, telmisartan and telmisartan plus HCTZ treatment groups. Conclusion. The consolidated data show that telmisartan ± HCTZ are well tolerated in patients of all ages and have placebo-like tolerabilities.

AB - Background. To compare the tolerability and safety of telmisartan ± hydrochlorothiazide (HCTZ). Methods. This retrospective analysis was performed on all hypertensive patients that were enrolled in telmisartan studies. A total of 30 double-blind (n = 8023) and 20 open-label (n = 8393) studies were available at the time of this analysis, and were included. Treatments investigated were placebo, telmisartan 10-160 mg, or telmisartan 10-160 mg plus HCTZ 6.25-25 mg. The incidence and causality of all adverse events (AEs) and laboratory abnormalities occurring during treatment were recorded. Results. The incidences of all-cause AEs in the double-blind studies were: 2.73 per patient-year (PY) (36.1%; placebo); 2.03/PY (37.4%; telmisartan monotherapy) and 2.09/PY (44.8%; telmisartan plus HCTZ). The respective numbers in the open-label studies were: 0.65/PY (49.6%; telmisartan monotherapy) and 0.70/PY (40.3%; telmisartan plus HCTZ). The most frequent suspected adverse reactions were dizziness and headache, which were comparable across groups and studies. The overall incidence of drug-related laboratory abnormalities was low in all treatment groups. Treatment-related hyperuricaemia and hypokalaemia occurred in less than 0.1% of patients, respectively, treated with telmisartan plus HCTZ. Incidences of discontinuation due to an AE were 4.6%, 4.5% and 4.7%, respectively, for the placebo, telmisartan and telmisartan plus HCTZ treatment groups. Conclusion. The consolidated data show that telmisartan ± HCTZ are well tolerated in patients of all ages and have placebo-like tolerabilities.

KW - Angiotensin II receptor blockers

KW - Hydrochlorothiazide

KW - Safety

KW - Telmisartan

KW - Thiazide diuretic

KW - Tolerability

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