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CADUET (AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM) TABLETS: ADVERSE REACTIONS / SIDE EFFECTS

Caduet

Caduet (Amlodipine Besylate, Atorvastatin Calcium) has been evaluated for safety in 1092 patients in double-blind placebo controlled studies treated for co-morbid hypertension and dyslipidemia. In general, treatment with Caduet was well tolerated. For the most part, adverse experiences have been mild or moderate in severity. In clinical trials with this drug, no adverse experiences peculiar to this combination have been observed. Adverse experiences are similar in terms of nature, severity, and frequency to those reported previously with amlodipine and atorvastatin.

The following information is based on the clinical experience with amlodipine and atorvastatin.

Amlodipine

Amlodipine has been evaluated for safety in more than 11,000 patients in U.S. and foreign clinical trials. In general, treatment with amlodipine was well tolerated at doses up to 10 mg daily. Most adverse reactions reported during therapy with amlodipine were of mild or moderate severity. In controlled clinical trials directly comparing amlodipine (N=1730) in doses up to 10 mg to placebo (N=1250), discontinuation of amlodipine due to adverse reactions was required in only about 1.5% of patients and was not significantly different from placebo (about 1%). The most common side effects are headache and edema. The incidence (%) of side effects which occurred in a dose related manner are as follows: edema, dizziness, flushing, palpitations.

Other adverse experiences which were not clearly dose related but which were reported with an incidence greater than 1.0% in placebo-controlled clinical trials include the following:

Placebo-Controlled Studies

Adverse events: headache, fatigue, nausea, abdominal pain, somnolence

For several adverse experiences that appear to be drug and dose related, there was a greater incidence in women than men associated with amlodipine treatment: edema, flushing, palpitations, somnolence

The following events occurred in < 1% but > 0.1% of patients treated with amlodipine in controlled clinical trials or under conditions of open trials or marketing experience where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:

Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), chest pain, bradycardia, hypotension, syncope, peripheral ischemia, tachycardia, postural hypotension, postural dizziness, vasculitis.

Central and Peripheral Nervous System: neuropathy peripheral, hypoesthesia, paresthesia, vertigo, tremor.

Gastrointestinal: constipation, anorexia, dyspepsia, dysphagia, flatulence, diarrhea, pancreatitis, gingival hyperplasia, vomiting.

General: asthenia, back pain, allergic reaction, hot flushes, pain, malaise, rigors, weight decrease, weight gain.

Musculoskeletal System: arthrosis, arthralgia, muscle cramps, myalgia.

Psychiatric: insomnia, sexual dysfunction (male and female), nervousness, abnormal dreams, depression, anxiety, depersonalization.

Respiratory System: dyspnea, epistaxis.

Skin and Appendages: erythema multiforme, angioedema, pruritus, rash, rash erythematous, rash maculopapular.

Special Senses: conjunctivitis, abnormal vision, diplopia, eye pain, tinnitus.

Urinary System: micturition disorder, micturition frequency, nocturia.

Autonomic Nervous System: sweating increased, dry mouth.

Metabolic and Nutritional: thirst, hyperglycemia.

Hemopoietic: purpura, leukopenia, thrombocytopenia.

The following events occurred in < 0.1% of patients treated with amlodipine in controlled clinical trials or under conditions of open trials or marketing experience: pulse irregularity, cardiac failure, extrasystoles, skin discoloration, skin dryness, urticaria, alopecia, muscle weakness, dermatitis, twitching, hypertonia, ataxia, migraine, cold and clammy skin, agitation, apathy, amnesia, increased appetite, gastritis, loose stools, rhinitis, coughing, dysuria, parosmia, polyuria, taste perversion, abnormal visual accommodation, xerophthalmia.

Other reactions occurred sporadically and cannot be distinguished from medications or concurrent disease states such as myocardial infarction and angina.

Amlodipine therapy has not been associated with clinically significant changes in routine laboratory tests. No clinically relevant changes were noted in serum potassium, serum glucose, total triglycerides, total cholesterol, HDL cholesterol, uric acid, blood urea nitrogen, or creatinine.

In the CAMELOT and PREVENT studies the adverse event profile was similar to that reported previously (see above), with the most common adverse event being peripheral edema.

The following postmarketing event has been reported infrequently with amlodipine treatment where a causal relationship is uncertain: gynecomastia. In postmarketing experience, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis) in some cases severe enough to require hospitalization have been reported in association with use of amlodipine.

Amlodipine has been used safely in patients with chronic obstructive pulmonary disease, well-compensated congestive heart failure, peripheral vascular disease, diabetes mellitus, and abnormal lipid profiles.

Atorvastatin

The following serious adverse reactions of Caduet are discussed in greater detail in other sections of the label: rhabdomyolysis, myopathy, liver enzyme abnormalities.

Clinical Adverse Experiences

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the Lipitor placebo-controlled clinical trial database of 16,066 patients (8755 Lipitor vs. 7311 placebo; age range 10.93 years, 39% women, 91% Caucasians, 3% Blacks, 2% Asians, 4% other) with a median treatment duration of 53 weeks, 9.7% of patients on Lipitor and 9.5% of the patients on placebo discontinued due to adverse reactions regardless of causality. The five most common adverse reactions in patients treated with Lipitor that led to treatment discontinuation and occurred at a rate greater than placebo were: myalgia (0.7%), diarrhea (0.5%), nausea (0.4%), alanine aminotransferase increase (0.4%), and hepatic enzyme increase (0.4%).

The most commonly reported adverse reactions (incidence >= 2% and greater than placebo) regardless of causality, in patients treated with Lipitor in placebo controlled trials (n=8755) were: nasopharyngitis (8.3%), arthralgia (6.9%), diarrhea (6.8%), pain in extremity (6.0%), and urinary tract infection (5.7%).

Clinical adverse reactions occurring in > 2% in patents treated with any dose of Lipitor: nasopharyngitis, arthralgia, diarrhea, pain in extremity, urinary tract infection, dyspepsia, nausea, musculoskeletal pain, muscle spasms, myalgia, insomnia, pharyngolarynge al pain.

Other adverse reactions of Caduet reported in placebo-controlled studies include:

Body as a whole: pyrexia, malaise.

Digestive system: eructation, abdominal discomfort, flatulence, cholestasis, hepatitis.

Musculoskeletal system: muscle fatigue, musculoskeletal pain, neck pain, joint swelling.

Metabolic and nutritional system: liver function test abnormal, transaminases increase, blood alkaline phosphatase increase, hyperglycemia, creatine phosphokinase increase.

Nervous system: nightmare.

Respiratory system: epistaxis

Skin and appendages: urticaria

Special senses: tinnitus, vision blurred.

Urogenital system: white blood cells urine positive.

Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT)

In ASCOT involving 10,305 participants (age range 40.80 years, 19% women; 94.6% Caucasians, 2.6% Africans, 1.5% South Asians, 1.3% mixed/other) treated with atorvastatin 10 mg daily (n=5,168) or placebo (n=5,137), the safety and tolerability profile of the group treated with atorvastatin was comparable to that of the group treated with placebo during a median of 3.3 years of follow-up.

Collaborative Atorvastatin Diabetes Study (CARDS)

In CARDS involving 2838 subjects (age range 39.77 years, 32% women; 94.3% Caucasians, 2.4% South Asians, 2.3% Afro-Caribbean, 1.0% other)with type 2 diabetes treated with Lipitor 10 mg daily (n=1428) or placebo (n=1410), there was no difference in the overall frequency of adverse reactions or serious adverse reactions between the treatment groups during a median follow-up of 3.9 years. No cases of rhabdomyolysis were reported.

Treating to New Targets Study (TNT)

In TNT involving 10,001 subjects (age range 29.78 years, 19% women; 94.1% Caucasians, 2.9% Blacks, 1.0% Asians, 2.0% other) with clinically evident CHD treated with Lipitor 10 mg daily (n=5006) or Lipitor 80 mg daily (n=4995), there were more serious adverse reactions and discontinuations due to adverse reactions in the high-dose atorvastatin group (92, 1.8%; 497, 9.9%, respectively) as compared to the low-dose group (69, 1.4%; 404, 8.1%, respectively) during a median follow-up of 4.9 years. Persistent transaminase elevations ( >= 3 x ULN twice within 4-10 days) occurred in 62 (1.3%) individuals with atorvastatin 80 mg and in nine (0.2%) individuals with atorvastatin 10 mg. Elevations of CK ( >= 10 x ULN) were low overall, but were higher in the high-dose atorvastatin treatment group (13, 0.3%) compared to the low-dose atorvastatin group (6, 0.1%).

Incremental Decrease in Endpoints Through Aggressive Lipid Lowering Study (IDEAL)

In IDEAL involving 8,888 subjects (age range 26-80 years, 19% women; 99.3% Caucasians, 0.4% Asians, 0.3% Blacks, 0.04% other) treated with Lipitor 80 mg/day (n=4439) or simvastatin 20-40 mg daily (n=4449), there was no difference in the overall frequency of adverse reactions or serious adverse reactions between the treatment groups during a median follow-up of 4.8 years.

Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL)

In SPARCL involving 4731 subjects (age range 21.92 years, 40% women; 93.3% Caucasians, 3.0% Blacks, 0.6% Asians, 3.1% other) without clinically evident CHD but with a stroke or transient ischemic attack (TIA) within the previous 6 months treated with Lipitor 80 mg (n=2365) or placebo (n=2366) for a median follow-up of 4.9 years, there was a higher incidence of persistent hepatic transaminase elevations ( >= 3 x ULN twice within 4.10 days) in the atorvastatin group (0.9%) compared to placebo (0.1%). Elevations of CK ( > 10 x ULN) were rare, but were higher in the atorvastatin group (0.1%) compared to placebo (0.0%). Diabetes was reported as an adverse reaction in 144 subjects (6.1%) in the atorvastatin group and 89 subjects (3.8%) in the placebo group.

In a post-hoc analysis, Lipitor 80 mg reduced the incidence of ischemic stroke (218/2365, 9.2% vs. 274/2366, 11.6%) and increased the incidence of hemorrhagic stroke (55/2365, 2.3% vs. 33/2366, 1.4%) compared to placebo. The incidence of fatal hemorrhagic stroke was similar between groups (17 Lipitor vs. 18 placebo). The incidence of non-fatal hemorrhagic strokes was significantly greater in the atorvastatin group (38 non-fatal hemorrhagic strokes) as compared to the placebo group (16 non-fatal hemorrhagic strokes). Subjects who entered the study with a hemorrhagic stroke appeared to be at increased risk for hemorrhagic stroke [7 (16%) Lipitor vs. 2 (4%) placebo].

There were no significant differences between the treatment groups for all-cause mortality: 216 (9.1%) in the Lipitor 80 mg/day group vs. 211 (8.9%) in the placebo group. The proportions of subjects who experienced cardiovascular death were numerically smaller in the Lipitor 80 mg group (3.3%) than in the placebo group (4.1%). The proportions of subjects who experienced non-cardiovascular death were numerically larger in the Lipitor 80 mg group (5.0%) than in the placebo group (4.0%).

Postintroduction Reports with Atorvastatin

The following adverse reactions have been identified during postapproval use of the atorvastatin component of Caduet. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reactions associated with atorvastatin therapy reported since market introduction, that are not listed above, regardless of causality assessment, include the following: anaphylaxis, angioneurotic edema, bullous rashes (including Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis), rhabdomyolysis, tendon rupture, fatigue, hepatic failure, memory impairment, dizziness, depression, peripheral neuropathy.

Pediatric Patients (ages 10-17 years)

In a 26-week controlled study of Caduet in boys and postmenarchal girls (n=140, 31% female; 92% Caucasians, 1.6% Blacks, 1.6% Asians, 4.8% other), the safety and tolerability profile of atorvastatin 10 to 20 mg daily was generally similar to that of placebo.



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