title: Treatment of hypertension: postmarketing surveillance study results of telmisartan monotherapy, fixed dose combination of telmisartan + hydrochlorothiazide/amlodipine.
abstract: Elevated blood pressure is a staggering health problem as it is very common and it remains asymptomatic. Hypertension is most important risk factor in coronary heart disease and cerebrovascular accidents. The present study was undertaken to evaluate the efficacy and safety of telmisartan monotherapy (TELMED 20/40) and fixed dose combination of telmisartan + hydrochlorothiazide/amlodipine (TELMED-H/AM) in adult, Indian hypertensive patients. A total 350 patients were enrolled in this open, multicentric, prospective, non-comparative, phase IV, postmarketing surveillance study by 28 physicians in India. Patients were treated with telmisartan monotherapy or fixed dose combination of telmisartan + hydrochlorothiazide/amlodipine once daily for 12 weeks. Total 318 patients completed the study and 32 patients failed to follow-up and were considered as drop outs. At the end of 12 weeks therapy, 106 patients (33.33%) remained on telmisartan monotherapy while 212 patients (66.67%) received of telmisartan + hydrochlorothiazidelamlodipine. On telmisartan monotherapy a significant (p < 0.001) reduction of systolic and diastolic blood pressure was noted ie, 27.75 and 13.83 mm Hg respectively. In patients on telmisartan + hydrochlorothiazide/amlodipine reduction in systolic and diastolic blood pressure was even greater than telmisartan monotherapy ie, 38.5 and 16.06 mm Hg respectively (p < 0.001). Joint National Committee VII goal for hypertension was achieved in 82.08% patients. 'Good to excellent' efficacy and safety were reported in 97.1% patients. The present study demonstrates that telmisartan with or without combination therapy significantly reduces systolic and diastolic blood pressure and is very well tolerated and accepted by all hypertensive patients with or without diabetes, ischaemic heart diseases.
authors.affiliation: Medical Services Department, Medley Pharmaceuticals Limited, Mumbai 400093.
authors.forename: A Faruqui
authors.initials: AF
authors.lastname: Arif
authors.forename: Gopal G
authors.initials: GG
authors.lastname: Kadam
authors.forename: Chandrakant
authors.initials: C
authors.lastname: Joshi
mesh_terms: D017311:Amlodipine / Q000627:therapeutic use*; D047228:Angiotensin II Type 1 Receptor Blockers / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000627:therapeutic use*; D001565:Benzoates / Q000627:therapeutic use*; D004338:Drug Combinations; D005260:Female; D006801:Humans; D006852:Hydrochlorothiazide / Q000627:therapeutic use*; D006973:Hypertension / Q000188:drug therapy*; D007194:India; D008297:Male; D008875:Middle Aged; D000077333:Telmisartan; D016896:Treatment Outcome
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D001562:Benzimidazoles; D001565:Benzoates; D004338:Drug Combinations; C548840:telmisartan amlodipine combination; C436283:telmisartan, hydrochlorothiazide drug combination; D006852:Hydrochlorothiazide; D017311:Amlodipine; D000077333:Telmisartan