PMID- 24562476 OWN - NLM STAT- MEDLINE DCOM- 20141201 LR - 20151119 IS - 1753-9455 (Electronic) IS - 1753-9447 (Linking) VI - 8 IP - 2 DP - 2014 Apr TI - Real-life effectiveness, safety, and tolerability of amlodipine/valsartan or amlodipine/valsartan/hydrochlorothiazide single-pill combination in patients with hypertension from Pakistan. PG - 45-55 LID - 10.1177/1753944714525496 [doi] AB - OBJECTIVE: EXCITE (clinical EXperienCe of amlodIpine and valsarTan in hypErtension) evaluated the real-life effectiveness, safety, and tolerability of single-pill combinations (SPCs) of amlodipine/valsartan (Aml/Val) and amlodipine/valsartan/hydrochlorothiazide (Aml/Val/HCTZ) in patients with hypertension from 13 countries in the Middle East and Asia. Here, we present data from Pakistan. METHODS: This was a 26-week observational, multicenter, prospective, open-label study. At week 26, change from baseline in mean sitting systolic (msSBP) and diastolic blood pressure (msDBP) and the proportion of patients achieving BP goal (SBP/DBP <140/90 mmHg; <130/80 mmHg in patients with diabetes) and response rates (SBP <140 mmHg [130 mmHg for patients with diabetes] or reduction of >/=20 mmHg; DBP <90 mmHg [80 mmHg for patients with diabetes] or reduction of >/=10 mmHg), were evaluated. Incidence of adverse events (AEs) and serious AEs (SAEs) was recorded as safety variables. Subjective assessment of effectiveness, compliance and tolerability was done by the physician. RESULTS: A total of 500 patients with hypertension (mean age of 48 years) were prescribed Aml/Val (n = 471, 94%) or Aml/Val/HCTZ (n = 29, 6%); 439 (87.8%) patients completed the study. At week 26, the mean BP decreased from 153.4/91.1 mmHg at baseline to 128.9/78.4 mmHg in the Aml/Val cohort (-24.5/-12.7 mmHg; p < 0.0001) and from 171.6/99.3 mmHg at baseline to 127.7/77.4 mmHg (-43.9/-21.9 mmHg; p < 0.0001) in the Aml/Val/HCTZ cohort. BP goals were achieved by 57% and 55.2% of patients in the Aml/Val and Aml/Val/HCTZ cohorts, respectively. A total of 40 (8%) patients reported at least one AE during the study period. Most common AEs included nausea (1.6%), headache (1.2%), vomiting (1.2%), and edema (1.2%). Most patients in Aml/Val cohort and all patients in Aml/Val/HCTZ cohort rated the effectiveness, compliance and tolerability as 'good' or 'very good'. CONCLUSIONS: Aml/Val with or without HCTZ in a SPC was effective and well-tolerated for BP reduction in this cohort of patients with hypertension from Pakistan. FAU - Khan, Waheed AU - Khan W AD - Adil Hospital Lahore, Lahore, Pakistan. FAU - Moin, Nasir AU - Moin N FAU - Iktidar, Somia AU - Iktidar S FAU - Sakrani, Javed AU - Sakrani J FAU - Abid, Rizwan AU - Abid R FAU - Afzal, Javed AU - Afzal J FAU - Maheshwary, Neeta AU - Maheshwary N FAU - Kumar, Kishore AU - Kumar K FAU - Siddiqi, Ahson AU - Siddiqi A FAU - Qadir, Murad AU - Qadir M LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study PT - Research Support, Non-U.S. Gov't DEP - 20140220 PL - England TA - Ther Adv Cardiovasc Dis JT - Therapeutic advances in cardiovascular disease JID - 101316343 RN - 0 (Amlodipine, Valsartan Drug Combination) RN - 0 (Antihypertensive Agents) RN - 0 (Drug Combinations) RN - 0 (Tetrazoles) RN - 0J48LPH2TH (Hydrochlorothiazide) RN - 1J444QC288 (Amlodipine) SB - IM MH - Adult MH - Aged MH - Amlodipine/adverse effects/*therapeutic use MH - Amlodipine, Valsartan Drug Combination MH - Antihypertensive Agents/adverse effects/*therapeutic use MH - Blood Pressure/drug effects MH - Drug Combinations MH - Female MH - Humans MH - Hydrochlorothiazide/*administration & dosage/adverse effects MH - Hypertension/*drug therapy/physiopathology MH - Male MH - Middle Aged MH - Prospective Studies MH - Tetrazoles/adverse effects/*therapeutic use OTO - NOTNLM OT - amlodipine OT - angiotensin receptor blocker OT - calcium channel blocker OT - diastolic blood pressure OT - hydrochlorothiazide OT - hypertension OT - systolic blood pressure OT - valsartan EDAT- 2014/02/25 06:00 MHDA- 2014/12/15 06:00 CRDT- 2014/02/25 06:00 PHST- 2014/02/25 06:00 [entrez] PHST- 2014/02/25 06:00 [pubmed] PHST- 2014/12/15 06:00 [medline] AID - 1753944714525496 [pii] AID - 10.1177/1753944714525496 [doi] PST - ppublish SO - Ther Adv Cardiovasc Dis. 2014 Apr;8(2):45-55. doi: 10.1177/1753944714525496. Epub 2014 Feb 20.