Pravastatin Brand Name– Pravachol
What is Pravastatin
Pravastatin is an oral antilipemic agent which inhibits HMG-CoA reductase and is indicated for the treatment of primary hypercholesterolemia.
In contrast to lovastatin and simvastatin, pravastatin is relatively hydrophilic and does not require hydrolysis for activation.
Several studies have documented the benefit of pravastatin for the treatment of hypercholesterolemia and for primary and secondary prevention of cardiac events.
The West of Scotland Coronary Prevention Study (WOSCOPS) study documented the benefit of pravastatin for primary prevention of myocardial infarction in men with hypercholesterolemia.
In 2007, additional data were published regarding the long-term safety and efficacy of pravastatin in patients enrolled in the WOSCOPS trial.
After completion of the trial, patients were followed for an additional 10 years and evaluated for various outcomes including all deaths, hospitalizations, coronary events and strokes, and cancers and deaths from cancer.
Treatment with pravastatin for 5 years was associated with a significant reduction in coronary events for a subsequent 10 years in men with hypercholesterolemia who did not have a history of myocardial infarction.
The CARE trial demonstrated that pravastatin therapy resulted in a decreased incidence of secondary cardiac events in patients following myocardial infarction.
The LIPID study (1997) was terminated early due to the documented benefit of pravastatin for secondary prevention in patients who had a prior myocardial infarction or were hospitalized for unstable angina.
In 2002, the PROSPER trial demonstrated that it reduced risk of cardiovascular events in high-risk elderly patients without adverse effects on cognitive function relative to placebo.
In the ALLHAT-LLT trial, 40 mg/day did not reduce either all-cause mortality or CHD significantly when compared with usual care in older participants with well-controlled hypertension and moderately elevated LDL cholesterol.
The lack of efficacy in the non-blinded ALLHAT-LLT trial may be due to a smaller differential in LDL cholesterol (16.7%) between pravastatin and usual care compared with prior placebo-controlled trials.
However, a large retrospective study demonstrated that continuation of statin therapy provides an ongoing reduction in all-cause mortality in patients with and without known coronary heart disease (CHD), with the greatest risk reduction among patients with a baseline LDL-C >= 190 mg/dl and patients initiated on higher efficacy statins (i.e., simvastatin, pravastatin, or lovastatin 80 mg/day; atorvastatin >= 20 mg/day; rosuvastatin >= 10 mg/day).
Among patients with a proportion of days covered (PDC) of >= 90%, determined by the number of statin prescriptions dispensed during the time between the first statin prescription and the end of follow up, there was a 45% and 51% lower mortality risk in the primary (patients without known CHD) and secondary (patients with known CHD) prevention groups, respectively, compared to patients with a PDC<= 10%.
The mean length of follow up was 4 and 5 years in the primary and secondary prevention groups, respectively, with a maximum length of follow up of 9.5 years.
In October 1991, the FDA approved pravastatin at 10, 20, or 40 mg once daily (mean LDL reductions of 22—34%).
It received additional approval in July 1996 for primary prevention in patients with hypercholesterolemia who are at risk for myocardial infarction, and was subsequently approved for the secondary prevention of cardiovascular events based on findings of the CARE trial.
A higher maximum dosage (80 mg once daily, mean 37% LDL reduction) was approved in December 2001; the recommended starting dose was also increased to 40 mg/day based on results from cumulative clinical outcomes trials which utilized this dosage.
Another pravastatin product, Pravigard™ PAC, was approved in June 2003; this co-package contains separate aspirin and pravastatin tablets in various dosage strengths (see the Aspirin, ASA; Pravastatin monograph).
Bristol-Myers Squibb submitted an application to the FDA for OTC status for pravastatin in January 2005.
Indications
- atherosclerosis
- cerebral vasospasm prophylaxis
- hypercholesterolemia
- hyperlipoproteinemia
- hypertriglyceridemia
- myocardial infarction prophylaxis
- reduction of cardiovascular mortality
- stroke prophylaxis
For the treatment of hypercholesterolemia, including hyperlipidemia, hyperlipoproteinemia, or hypertriglyceridemia, as an adjunct to dietary control
to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglyceride concentrations, and to increase HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson types IIa or type IIb); or to treat Fredrickson Type IV (hypertriglyceridemia, increased VLDL) or Fredrickson Type III (primary dysbetalipoproteinemia) hyperlipoproteinemias
Side Effects
- abdominal pain
- alopecia
- amnesia
- anaphylactoid reactions
- anemia
- angina
- angioedema
- anorexia
- anxiety
- arthralgia
- blurred vision
- cataracts
- chest pain (unspecified)
- chills
- cholestasis
- cirrhosis
- Co-Enzyme Q-10 deficiency
- confusion
- constipation
- cough
- depression
- diabetes mellitus
- diarrhea
- diplopia
- dizziness
- drowsiness
- dysgeusia
- dyspepsia
- dyspnea
- dysuria
- edema
- elevated hepatic enzymes
- eosinophilia
- erythema multiforme
- fatigue
- fever
- flatulence
- flushing
- gynecomastia
- headache
- hemolytic anemia
- hepatic failure
- hepatic necrosis
- hepatitis
- hepatoma
- hyperglycemia
- immune-mediated necrotizing myopathy
- increased urinary frequency
- infection
- influenza
- insomnia
- interstitial lung disease
- jaundice
- leukopenia
- libido decrease
- libido increase
- lupus-like symptoms
- malaise
- memory impairment
- muscle cramps
- musculoskeletal pain
- myalgia
- myasthenia
- myoglobinuria
- myopathy
- nausea
- nightmares
- nocturia
- pancreatitis
- paresthesias
- peripheral neuropathy
- photosensitivity
- pruritus
- purpura
- pyrosis (heartburn)
- rash
- renal failure (unspecified)
- renal tubular obstruction
- rhabdomyolysis
- rhinitis
- Stevens-Johnson syndrome
- thrombocytopenia
- toxic epidermal necrolysis
- tremor
- urticaria
- vasculitis
- vertigo
- vomiting
- weakness
- xerosis
Monitoring Parameters
- creatine phosphokinase (CPK)
- LFTs
- serum cholesterol profile
Contraindications
- alcoholism
- breast-feeding
- children
- contraception requirements
- diabetes mellitus
- electrolyte imbalance
- endocrine disease
- females
- geriatric
- hepatic disease
- hepatic encephalopathy
- hepatitis
- hypotension
- hypothyroidism
- infants
- infection
- jaundice
- myopathy
- organ transplant
- pregnancy
- renal disease
- renal failure
- renal impairment
- reproductive risk
- rhabdomyolysis
- seizure disorder
- surgery
- trauma
Pravastatin is contraindicated in any patient with pravastatin hypersensitivity or hypersensitive to any component of the medication.
Interactions
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Atazanavir
- Atazanavir; Cobicistat
- Azithromycin
- Bempedoic Acid
- Bempedoic Acid; Ezetimibe
- Boceprevir
- Bortezomib
- Cholestyramine
- Cimetidine
- Clarithromycin
- Clofarabine
- Cobicistat
- Colchicine
- Colchicine; Probenecid
- Colestipol
- Cyclosporine
- Daclatasvir
- Daptomycin
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Elexacaftor; tezacaftor; ivacaftor
- Eltrombopag
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Erythromycin
- Erythromycin; Sulfisoxazole
- Etravirine
- Everolimus
- Fenofibrate
- Fenofibric Acid
- Fibric acid derivatives
- Fostemsavir
- Gemfibrozil
- Glecaprevir; Pibrentasvir
- Idelalisib
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Lanthanum Carbonate
- Leflunomide
- Letermovir
- Lovastatin; Niacin
- Niacin, Niacinamide
- Niacin; Simvastatin
- Nitisinone
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole; Amoxicillin; Rifabutin
- Orlistat
- Raltegravir
- Red Yeast Rice
- Rifabutin
- Rifampin
- Rifapentine
- Simeprevir
- Sirolimus
- Sofosbuvir; Velpatasvir; Voxilaprevir
- Tacrolimus
- Telbivudine
- Telithromycin
- Teriflunomide
- Tolvaptan
- Warfarin
