PMID- 18705533
OWN - NLM
STAT- MEDLINE
DCOM- 20080916
LR  - 20191111
IS  - 0803-8023 (Print)
IS  - 0803-8023 (Linking)
VI  - 1
DP  - 2008 Jun
TI  - The safety profile of telmisartan as monotherapy or combined with 
      hydrochlorothiazide: a retrospective analysis of 50 studies.
PG  - 32-40
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.
FAU - Schumacher, Helmut
AU  - Schumacher H
AD  - Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany. 
      SCHUMACH@ing.boehringer-ingelheim.com
FAU - Mancia, Giuseppe
AU  - Mancia G
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - Sweden
TA  - Blood Press Suppl
JT  - Blood pressure. Supplement
JID - 9300787
RN  - 0 (Angiotensin II Type 1 Receptor Blockers)
RN  - 0 (Benzimidazoles)
RN  - 0 (Benzoates)
RN  - 0 (Drug Combinations)
RN  - 0 (telmisartan, hydrochlorothiazide drug combination)
RN  - 0J48LPH2TH (Hydrochlorothiazide)
RN  - U5SYW473RQ (Telmisartan)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Angiotensin II Type 1 Receptor Blockers/*therapeutic use
MH  - Benzimidazoles/adverse effects/*therapeutic use
MH  - Benzoates/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Humans
MH  - Hydrochlorothiazide/adverse effects/*therapeutic use
MH  - Hypertension/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Retrospective Studies
MH  - Telmisartan
EDAT- 2008/08/19 09:00
MHDA- 2008/09/17 09:00
CRDT- 2008/08/19 09:00
PHST- 2008/08/19 09:00 [pubmed]
PHST- 2008/09/17 09:00 [medline]
PHST- 2008/08/19 09:00 [entrez]
AID - 10.1080/08038020802144383 [doi]
PST - ppublish
SO  - Blood Press Suppl. 2008 Jun;1:32-40. doi: 10.1080/08038020802144383.