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Clinical Study Synopsis
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Clinical Trial Results Synopsis
Study Design Description
Study Sponsor:
Bayer Healthcare AG
Study Number:
14881
Study Phase:
Official Study Title:
Therapeutic Area:
NCT01211171
IV (Observational)
Cough among hypertensive patients treated with telmisartan who had
to stop previous angiotensin convertase inhibitor treatment due to
cough (COUGH NIS)
CV Risk Management
Test Product
Name of
Test Product:
Name of
Active Ingredient:
Dose and
Mode of Administration:
Pritor/Pritor Plus
telmisartan or telmisartan/hydrochlorothiazide
40 mg, 80 mg; 40 mg/12,5 mg, 80 mg/12,5 mg once daily p.o.
Reference Therapy/Placebo
Reference Therapy:
none
Dose and
Mode of Administration:
none
Duration of Treatment:
Studied period:
Study Center(s):
Methodology:
4 months
Date of first subjects’ first visit:
10.05.2009
Date of last subjects’ last visit:
18.12.2009
200 medical centers in Poland
Non interventional, observational, open, uncontrolled prospective
study
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Indication/
Main Inclusion Criteria:
Primary hypertension in adults. All patients at the age over 18 years
with untreated or pretreated hypertension who had to stop
angiotensin convertase inhibitor treatment due to cough
Study Objectives:
Overall:
Evaluation of the efficacy, safety and tolerance of telmisartan (Pritor)
in hypertensive patients who do not tolerate angiotensin convertase
inhibitor treatment due to cough.
Primary:
The main aim of the study was to evaluate how the change from
angiotensin convertase inhibitor to telmisartan influences the
character and frequency of treatment related cough.
Secondary:
The additional aim of the study was to evaluate the tolerance and
safety of telmisartan (Pritor/Pritor Plus) in hypertensive patients who
had to stop treatment with angiotensin convertase inhibitor due to
cough.
Evaluation Criteria:
Efficacy (Primary):
Cough frequency among telmisartan treated patients, who had to stop
their previous ACE-I treatment due to cough.
Efficacy (Secondary):
General tolerability and safety of telmisartan treatment among
patients, who had to stop their previous ACE-I treatment due to
cough.
Safety:
General tolerability of study drug with special emphasis put on the
change in the frequency of dry cough in study population, resulting
from the switch from angiotensin convertase inhibitor to telmisartan.
Any untoward medical occurrence in a patient during the treatment
period. Adverse reactions had to be documented and assessed in
Adverse Event Report included into study documents, regardless of
whether a relation with the investigated drug can be established ot not
Statistical Methods:
Efficacy (Primary:
A biometric evaluation - primarily descriptive or explanatory was
carried out according to a statistical analysis at the end of the study
and summarized in a final report.
Number of Subjects:
2498
Study Results
Results Summary — Subject Disposition and Baseline
Non-interventional, prospective study without control group, involving 2498 hypertensive
patients who had to stop angiotensin convertase inhibitor treatment due to cough (60,1%
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women, age 58 +/- 11 years, baseline blood pressure 152/92 mm Hg) was conducted
between May and December 2009.
Results Summary — Efficacy
At initial visit majority of patients (75%) had insufficiently controlled hypertension (SBP/DBP
>140/90 mm Hg). At initial visit mean blood pressure values were 152 /92 mm Hg). At the
control follow-up visit, after about 4 months of treatment with telmisartan (Pritor/Pritor Plus),
those values were decreased to 133/81 mm Hg and this change was statistically significant
(p<0,001). At the control follow-up visit blood pressure was normalized in 80,3 % of
patients.
At the control follow-up visit, physicians assessed the overall efficacy as “good” or “very
good” in 76,8% of the pts. In 1,24 % and 0,72 % of the patients, efficacy was assessed by
the physicians as sufficient or insufficient, respectively.
Results Summary — Safety
During the treatment with telmisartan (Pritor/Pritor Plus), positive changes in cough
character and frequency were observed. Substitution of previous ACE-I treatment with
telmisartan resulted in marked reduction of the frequency of cough resulting from ACE-I use.
Mean cough frequency at the initial and the second follow-up visits were 74,2% and 2,92 %,
respectively (p<0,001). The efficacy of telmisartan (Pritor/Pritor Plus) in cough elimination
was slightly but significantly diminished in patients with asthma, bronchitis and with gastric
reflux. Smoking (neither present or in history) did not influenced the effect of study drug on
cough rates.
Treatment with telmisartan was very well tolerated. In total only 17 adverse events were
reported of which 7 was considered ADRs. The physicians' overall tolerability rating was “very
good” or “good” in 76,8 % of patients at control follow-up visit. The physicians rated
tolerability as “sufficient” in 0,48 % and as “insufficient” in 0,04 % of pts. The most common
adverse effects were cough and hypotension. One study drug related serius adverse event
(SAE) was reported (Pritor: asthenia plus visual disturbances) and it resulted in temporary
discontinuation and then starting of the study drug.
Conclusion(s)
Treatment with telmisartan or telmisartan/HCTZ is safe and results in a marked reduction of
cough caused by previous angiotensin convertase inhibitor therapy. Telmisartan effectively
reduces blood pressure and restores blood pressure control in a majority of patients with mild
and moderate hypertension. Treatment with telmisartan (Pritor/Pritor Plus) was safe and well
tolerated.
Publication(s):
Date Created or
Date Last Updated:
none
22.06.2011
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