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Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace the advice of a healthcare professional and should not be considered as a recommendation. Patients should always seek medical advice before making any decisions on their treatment. Healthcare Professionals should always refer to the specific labelling information approved for the patient's country or region. Data in this document or on the related website should not be considered as prescribing advice. The study listed may include approved and non-approved formulations or treatment regimens. Data may differ from published or presented data and are a reflection of the limited information provided here. The results from a single trial need to be considered in the context of the totality of the available clinical research results for a drug. 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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 Page 1 of 3 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% Page 2 of 3 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 Page 3 of 3