Pravastatin Sodium (Page 2 of 6)

5.4 Increases in HbA1c and Fasting Serum Glucose Levels

Increases in HbA1c and fasting serum glucose levels have been reported with statins, including pravastatin sodium. Optimize lifestyle measures, including regular exercise, maintaining a healthy body weight, and making healthy food choices.

6 ADVERSE REACTIONS

The following important adverse reactions are described below and elsewhere in the labeling:

Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.1)]
Immune-Mediated Necrotizing Myopathy [see Warnings and Precautions (5.2)]
Hepatic Dysfunction [see Warnings and Precautions (5.3)]
Increases in HbA1c and Fasting Serum Glucose Levels [see Warnings and Precautions (5.4)]

6.1 Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In pravastatin sodium placebo-controlled clinical trials, 1313 patients (age range 20 to 76 years, 32% women, 93.5% White, 5% Black, 0.9% Hispanic, 0.4% Asian, 0.2% Other) with a median treatment duration of 14 weeks, 3.3% of patients on pravastatin sodium and 1.2% patients on placebo discontinued due to adverse reactions (regardless of causality). The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: hepatic transaminase elevations, nausea, anxiety/depression, and dizziness.

Adverse reactions (regardless of causality) reported in ≥2% of pravastatin sodium-treated patients in placebo-controlled trials of up to 8 months duration are identified in Table 1:

Table 1: Adverse Reactions in ≥2% of Patients Treated with Pravastatin (Any Dose) and at an Incidence Greater Than Placebo in Short-Term Placebo-Controlled Trials

% Placebo

N=411

% Any Dose

N=902

Nausea/Vomiting

7.1

7.4

Diarrhea

5.6

6.7

Headache

4.6

6.3

Upper Respiratory Infection

5.8

5.9

Angina Pectoris

3.4

4.5

Rash

1.4

4.5

CPK Increased

3.6

4.1

Dizziness

3.4

3.5

ALT Increased

1.2

2.9

Chest Pain

1.9

2.7

Cough

1.7

2.5

Myalgia

1.2

2.3

Influenza

0.7

2

g-GT Increased

1.2

2

Adverse Reactions (regardless of causality)

The safety and tolerability of pravastatin sodium at a dose of 80 mg in 2 controlled trials with a mean exposure of 8.6 months was similar to that of pravastatin sodium at lower doses except that 4 out of 464 patients taking 80 mg of pravastatin had a single elevation of CK >10 times ULN compared to 0 out of 115 patients taking 40 mg of pravastatin.

In pravastatin sodium placebo-controlled clinical trials, 21,483 patients (age range 24 to 75 years, 10.3% women, 52.3% White, 0.8% Black, 0.5% Hispanic, 0.1% Asian, 0.1% Other, 46.1% not recorded) had a median treatment duration of 261 weeks.

Adverse reactions (regardless of causality) were pooled from 7 double-blind, placebo-controlled trials (West of Scotland Coronary Prevention Study [WOS]; Cholesterol and Recurrent Events study [CARE]; Long-term Intervention with Pravastatin in Ischemic Disease study [LIPID]; Pravastatin Limitation of Atherosclerosis in the Coronary Arteries study [PLAC I]; Pravastatin, Lipids and Atherosclerosis in the Carotids study [PLAC II]; Regression Growth Evaluation Statin Study [REGRESS]; and Kuopio Atherosclerosis Prevention Study [KAPS]) involving a total of 10,764 patients treated with pravastatin sodium 40 mg and 10,719 patients treated with placebo. Patients were exposed to pravastatin sodium for a mean of 4 to 5.1 years in WOS, CARE, and LIPID and 1.9 to 2.9 years in PLAC I, PLAC II, KAPS, and REGRESS. Adverse reactions (regardless of causality) occurring in ≥5% of patients treated with pravastatin sodium in these studies are identified in Table 2.

Table 2: Adverse Reactions in ≥5% of Patients Treated with Pravastatin 40 mg and at an Incidence Greater than Placebo in Long-Term Placebo-Controlled Trials

Placebo

(N=10,719)

% of patients

Pravastatin sodium

(N=10,764)

% of patients

Musculoskeletal Pain

24.4

24.9

Upper Respiratory Tract Infection

20.2

21.2

Musculoskeletal Traumatism

9.6

10.2

Chest Pain

9.8

10

Influenza

9

9.2

Fatigue

7.8

8.4

Cough

7.4

8.2

Dizziness

6.6

7.3

Rash (including dermatitis)

7.1

7.2

Sinus Abnormality

6.7

7

Muscle Cramp

4.6

5.1

Adverse Reactions (regardless of causality)

No new adverse reactions were identified in a study of pediatric patients with HeFH.

Laboratory Abnormalities

Increases in ALT, AST values and CK have been observed.

Transient, asymptomatic eosinophilia has been reported. Eosinophil counts usually returned to normal despite continued therapy. Anemia, thrombocytopenia, and leukopenia have been reported with statins.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.