dies of another drug and may not reflect the rates observed in clinical practice.
In the controlled trial of Exforge HCT, where only the maximum dose (10/320/25 mg) was eva luated, safety data were obtained in 582 patients with hypertension. Adverse reactions have generally been mild and transient in nature and have only infrequently required discontinuation of therapy.
The overall frequency of adverse reactions was similar between men and women, younger (<65 years) and older (>65 years) patients, and black and white patients. In the active controlled clinical trial, discontinuation because of adverse events occurred in 4.0% of patients treated with Exforge HCT 10/320/25 mg compared to 2.9% of patients treated with valsartan/HCTZ 320/25 mg, 1.6% of patients treated with amlodipine/valsartan 10/320 mg, and 3.4% of patients treated with HCTZ/amlodipine 25/10 mg. The most common reasons for discontinuation of therapy with Exforge HCT were dizziness (1.0%) and hypotension (0.7%).
The most frequent adverse events that occurred in the active controlled clinical trial in at least 2% of patients treated with Exforge HCT are presented in the table below:
Preferred Term Aml/Val/HCTZ
10/320/25mg
N=582
n(%) Val/HCTZ
320/25mg
N=559
n(%) Aml/Val
10/320mg
N=566
n(%) HCTZ/Aml
25/10mg
N=561
n(%)
Dizziness 48 (8.2) 40 (7.2) 14 (2.5) 23 (4.1)
Edema 38 (6.5) 8 (1.4) 65 (11.5) 63 (11.2)
Headache 30 (5.2) 31 (5.5) 30 (5.3) 40 (7.1)
Dyspepsia 13 (2.2) 5 (0.9) 6 (1.1) 2 (0.4)
Fatigue 13 (2.2) 15 (2.7) 12 (2.1) 8 (1.4)
Muscle spasms 13 (2.2) 7 (1.3) 7 (1.2) 5 (0.9)
Back pain 12 (2.1) 13 (2.3) 5 (0.9) 12 (2.1)
Nausea 12 (2.1) 7 (1.3) 10 (1.8) 12 (2.1)
Nasopharyngitis 12 (2.1) 13 (2.3) 13 (2.3) 12 (2.1)
Orthostatic events (orthostatic hypotension and postural dizziness) were seen in 0.5% of patients. Other adverse reactions that occurred in clinical trials with Exforge HCT (>0.2%) are listed below. It cannot be determined whether these events were causally related to Exforge HCT.
Cardiac Disorders: tachycardia
Ear and Labyrinth Disorders: vertigo, tinnitus
Eye Disorders: vision blurred
Gastrointestinal Disorders: diarrhea, abdominal pain upper, vomiting, abdominal pain, toothache, dry mouth, gastritis, hemorrhoids
General Disorders and Administration Site Conditions: asthenia, non-cardiac chest pain, chills, malaise
Infections and Infestations: upper respiratory tract infection, bronchitis, influenza, pharyngitis, tooth abscess, gastroenteritis viral, respiratory tract infection, rhinitis, urinary tract infection
Injury, Poisoning and Procedural Complications: back injury, contusion, joint sprain, procedural pain
Investigations: blood uric acid increased, blood creatine phosphokinase increased, weight decreased
Metabolism and Nutrition Disorders: hypokalaemia, diabetes mellitus, hyperlipidemia, hyponatremia
Musculoskeletal and Connective Tissue Disorders: pain in extremity, arthralgia, musculoskeletal pain, muscular weakness, musculoskeletal weakness, musculoskeletal stiffness, joint swelling, neck pain, osteoarthritis, tendonitis
Nervous System Disorders: paraesthesia, somnolence, syncope, carpal tunnel syndrome, disturbance in attention, dizziness postural, dysgeusia, head discomfort, lethargy, sinus headache, tremor
Psychiatric Disorders: anxiety, depression, insomnia
Renal and Urinary Disorders |
